130219018M

MAGLUMI 2019-nCoV IgM/IgG

Cat. # 130219018M

For U.S.A. only, Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical
laboratory; and use is restricted to by or on the order of a physician.

For in vitro diagnostic use

For Emergency Use Authorization Only
For Prescription Use only

INTENDED USE
The MAGLUMI 2019-nCoV IgM/IgG is an in vitro chemiluminescence immunoassay intended for the qualitative detection and differentiation of
immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum and serum in separating gel tubes (SST) using
the MAGLUMI 2000 series fully-automated chemiluminescence immunoassay analyzer. The MAGLUMI 2019-nCoV IgM/IgG is intended for use
as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown
for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The MAGLUMI 2019-nCoV
IgM/IgG should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity testing.

Results are for the detection and differentiation of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in
blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals
may have detectable virus present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

The sensitivity of the MAGLUMI 2019-nCoV IgM/IgG early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection.
If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False positive results for the MAGLUMI 2019-nCoV IgM/IgG may occur due to cross-reactivity from pre-existing antibodies or other possible
causes.

The MAGLUMI 2019-nCoV IgM/IgG is only for use under the Food and Drug Administration’s Emergency Use Authorization.

SUMMARY AND EXPLANATION OF THE TEST

The novel coronavirus (2019-nCoV) causes an epidemic of acute respiratory syndrome in humans1 and belongs to the genus Betacoronavirus.
The virus has an envelope; viral particles are round or oval, often polymorphic, and the diameter is 60 - 140nm. Its genetic characteristics are
significantly different from SARS-CoV and MERS-CoV. Current research shows that it has more than 85% homology with bat SARS-like
coronavirus (bat-SL-CoVZC45) 2.

2019-nCoV is mainly transmitted through respiratory droplets and can also be transmitted through direct contact. The symptoms of infection seen
so far are mainly patients with pneumonia infected by the novel coronavirus2.

Research has shown that IgM and IgG antiviral antibodies can be detected in serum samples from a patient3. After human infection with 2019-
nCoV, its antigen stimulates the immune system to produce an immune response, and corresponding antibodies appear in the blood after several
days.

The kit should not be used to diagnose or exclude acute SARS-CoV-2 infection or to inform infection status. The test is used as an aid to identify
patients with antibodies to SARS-CoV-2 indicating recent or past infection.

The World Health Organization announced the interim name of the novel coronavirus as 2019-nCoV on January 7, 2020: The International
Committee on Taxonomy of Viruses (ICTV) announced Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) as the official name of
the virus on February 11, 2020. On the same day, the Director General of the World Health Organization (WHO) Tedros Adhanom Ghebreyesus
announced that the name for the disease associated with infected with SARS-CoV-2 would be officially named "COVID-19," short for coronavirus
disease 2019.

PRINCIPLE OF THE TEST

The MAGLUMI 2019-nCoV IgM/IgG is a capture chemiluminescence immunoassay for IgM and an indirect chemiluminescence immunoassay
for IgG. There are two cassettes that are run separately one for the detection of IgG antibodies to SARS-CoV-2 and another for the detection of
IgM antibodies to SARS-CoV-2 from barcoded patient samples. After both cassettes have been run individually, one report with results for both
IgM and IgG detection is generated by the system.
MAGLUMI 2019-nCoV IgM/IgG – Cassette for IgM Detection

The sample (serum in standard sampling tubes or tubes containing separating gel (SST)), buffer, and magnetic microbeads coated with anti-
human IgM monoclonal antibody are mixed thoroughly and incubated, forming immune-complexes. After precipitation in a magnetic field, the
supernatant is decanted, and a wash cycle is performed. Then, the 2019-nCoV recombinant antigen, expressing the full-length spike and
nucleocapsid proteins, labeled with ABEI is added and incubated to form complexes. After precipitation in a magnetic field, the supernatant is
decanted and another wash cycle is performed. Subsequently, the Starter Buffer is added to initiate a chemiluminescent reaction. The light signal
is measured by a photomultiplier as relative light units (RLUs), which is proportional to the concentration of IgM present in the sample. The test is
performed with the MAGLUMI 2000 series fully automated chemiluminescence immunoassay analyzer.

MAGLUMI 2019-nCoV IgM/IgG – Cassette for IgG Detection

The sample (serum in standard sampling tubes or tubes containing separating gel (SST)), buffer and magnetic microbeads coated with 2019-
nCoV recombinant antigen, expressing the full-length spike and nucleocapsid proteins, are mixed thoroughly and incubated, forming immune-
complexes. After precipitation in a magnetic field, the supernatant is decanted, and a wash cycle is performed. Then, the anti-human IgG antibody
labeled with ABEI is added and incubated to form complexes. After precipitation in a magnetic field, the supernatant is decanted and another wash
cycle is performed. Subsequently, the Starter Buffer is added to initiate a chemiluminescent reaction. The light signal is measured by a
photomultiplier as relative light units (RLUs), which is proportional to the concentration of IgG presented in the sample. The test is performed with
the MAGLUMI 2000 series fully automated chemiluminescence immunoassay analyzer.

KIT COMPONENTS – One kit contains two cassettes, one for SARS-CoV-2 IgG detection and another for SARS-CoV-2 IgM detection. The
components for IgG and IgM detection with the MAGLUMI 2019-nCoV IgM/IgG are provided below and can be ordered under Catalog # 130219018M.

Cassette Components Contents 100 tests

Magnetic Magnetic microbeads coated with 2019-nCoV recombinant antigen,

2.5 mL
Microbeads PBS buffer and BSA, NaN3 (<0.1%)

Calibrator Low 2019-nCoV IgG, PBS buffer and BSA, NaN3 (<0.1%) 1.0 mL

Calibrator High 2019-nCoV IgG, PBS buffer and BSA, NaN3 (<0.1%) 1.0 mL

For SARS Buffer NaCl and BSA, NaN3 (<0.1%). 23.5 mL

CoV-2 IgG
antibodies Anti-human IgG antibody labeled with ABEI, Tris-HCl buffer, Mouse IgG,
ABEI Label 23.5 mL
Goat IgG, and BSA, NaN3 (<0.1%)

Diluent PBS buffer and BSA, NaN3 (<0.1%) 23.5 mL

Negative Control PBS buffer, containing BSA, NaN3 (<0.1%) 1.0 mL

Positive Control 2019-nCoV IgG, PBS buffer, containing BSA and NaN3 (<0.1%). 1.0 mL

Magnetic Magnetic microbeads coated with anti-human IgM monoclonal

2.5 mL
Microbeads antibody, PBS buffer and BSA, NaN3 (<0.1%).

Calibrator Low 2019-nCoV IgM, PBS buffer and BSA, NaN3 (<0.1%). 1.0 mL

Calibrator High 2019-nCoV IgM, PBS buffer, and BSA, NaN3 (<0.1%). 1.0 mL

PBS buffer, Goat anti-Human IgG, Goat anti-Human IgA Mouse IgG,
Buffer 23.5 mL
Goat IgG and BSA, NaN3 (<0.1%).

For SARS- 2019-nCoV recombinant antigen labeled with ABEI, Tris-HCl buffer,
CoV-2 IgM ABEI Label 23.5 mL
Mouse IgG, Goat IgG, and BSA, NaN3 (<0.1%).
antibodies
PBS buffer, Goat anti-Human IgG, Goat anti-Human IgA Mouse IgG,
Diluent 23.5 mL
Goat IgG and BSA, NaN3 (<0.1%).

Negative Control PBS buffer, containing BSA, NaN3 (<0.1%). 1.0 mL

Positive Control 2019-nCoV IgM, PBS buffer, containing BSA and NaN3 (<0.1%). 1.0 mL

All reagents are provided ready-to-use.

Components Required but Not Included in the MAGLUMI 2019-nCoV IgM/IgG Test Kit :

Component Catalog number Contents Quantity/Volume

Reaction Module 630003 polypropylene 64/box

 Starter Buffer 130299004M Catalyst in 1.5% NaOH, 0.18% H2O2 230 mL×1

Wash Concentrate 130299005M Tris-HCl buffer solution 714 mL×1

Light Check 130299006M ABEI (N-(4-Aminobutyl)-N-ethylisoluminol ), BSA 2mL×5

Instrument

MAGLUMI 2000 series fully-automated chemiluminescence immunoassay analyzer

Please order all above from Shenzhen New Industries Biomedical Engineering Co., Ltd. (SNIBE) or our authorized representative.

CALIBRATION
Traceability: This method has been standardized against the SNIBE internal reference substance.

Testing of assay specific calibrators allows the RLU values to adjust the assigned master curve. Results are determined automatically by the system via
a calibration curve, which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent Radio Frequency
Identification (RFID) CHIP.

Recalibration is recommended if any of the following conditions occurs:

 After each exchange of lots (Reagent or Starter Buffer).

 Every week and/or each time a new reagent kit is used.

 After instrument service is required.

 If controls lie outside the expected range.

QUALITY CONTROL
Follow government regulations or accreditation requirements for quality control frequency.

Quality controls (positive and negative controls) are only applicable with MAGLUMI system.

For details about entering quality control values, refer to the operating instructions of MAGLUMII 2000 series fully-auto chemiluminescence
immunoassay analyzer.

To monitor system performance, quality control materials (positive and negative) are required. Treat all quality control with the same level of care as
patient samples. A satisfactory level of performance is achieved when analyte values obtained are within the acceptable pre-established ranges. If
the quality control results fall outside the pre-established ranges of less than 0.7 AU/mL for negative controls and 2.8-5.2 AU/mL for positive controls,
measurement of the quality control should be repeated. If the quality control results still falls outside the pre-established range, do not report results
and take the following actions:

 Verify that the quality control materials (positive and negative) are not expired.

 Verify that the analyzer required maintenance was performed.

 Verify that the assay was performed according to the instruction for use.

 Rerun the assay with new quality control samples (positive and negative).

 If necessary, contact your local technical support provider or distributor for assistance.

SPECIMEN COLLECTION AND PREPARATION- WARNINGS AND PRECAUTIONS

 Serum in standard sampling tubes or tubes containing separating gel is the recommended sample matrix. The sample volume required for a single
determination is 10 µL.

 Samples may be infectious so heat inactivated of the samples at 56°C for 30 minutes should be performed before testing, or according to the
requirements of state and local governments2.

 Ensure that complete clot formation in specimens has taken place prior to centrifugation. Some specimens, especially those from patients receiving
anticoagulant or thrombolytic therapy, may exhibit increased clotting time.

 If the specimen is centrifuged before complete clotting, the presence of fibrin may cause erroneous results. Samples must be free of fibrin and
other particulate substances.

 Grossly hemolyzed specimens or specimens containing particulate matter or exhibiting obvious microbial contamination should not be used. All
specimens should be inspected for bubbles and bubbles removed before analysis for optimal results.

 All samples (patient specimens and controls) should be tested within 3 hours of placing them on board the MAGLUMI System. Refer to the SNIBE
service for more detailed discussion of onboard sample storage constraints. (website : https://www.snibe.com/zh_en/en_index.aspx)
 Specimens removed from the separator gel, cells, or clot may be stored for 3 days at 2-8°C. If longer storage is required, the specimens should
be kept at -20°C or colder4.

 Avoid more than three freeze and thaw cycles. Frozen specimens must be mixed thoroughly after thawing by low speed vortex or by gently
inverting.

 For optimal results, specimens should be free of fibrin, red blood cells, or other particulate matter. Such specimens may give inconsistent results
and must be transferred to a centrifuge tube and centrifuged at ≥ 10,000RCF (Relative Centrifugal Force) for 10 minutes. Transfer clarified
specimens to a sample cup or secondary tube for testing. For centrifuged specimens with a lipid layer, transfer only the clarified specimen and not
the lipemic material.

 Before shipping specimens, it is recommended that specimens be removed from the separator, red blood cells, or clot. When shipped, specimens
should be packaged and labeled in compliance with applicable state, federal and international regulations covering the transport of clinical
specimens and infectious substances. Specimens should be shipped frozen.

WARNING AND PRECAUTIONS FOR USERS

 For In Vitro Diagnostic Use.

 For Emergency Use Authorization Only

 For Prescription Use only

• This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under
CLIA and meet requirements to perform moderate or high complexity tests.
• This test has been authorized only for the presence of IgG or IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens.
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in
vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner.
 Follow the package insert carefully. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package
insert.

Safety Precautions

 CAUTION: This product requires the handling of human specimens. It is recommended that all human sourced materials be considered potentially
infectious and handled in accordance with the 29 CFR 1910.1030 Occupational exposure to bloodborne pathogens. Biosafety Level 2 or other
appropriate biosafety practices should be used for materials that contain or are suspected of containing infectious agents.

 All samples, biological reagents, and materials used in the assay should be considered potentially able to transmit infectious agents. They should
therefore be disposed of in accordance with the practices of your institution. Discard all materials in a safe and acceptable manner and in
compliance with prevailing regulatory requirements.

 This product contains Sodium azide. Dispose of contents and container must be in accordance with all local, regional and national regulations.

 Refer to safety data sheets, which are available on request.

Handling Precautions

 Do not use reagent kits beyond the expiration date.

 Do not interchange reagent components from different reagents or lots.

 Prior to loading the Reagent Kit on the system for the first time, the Reagent Kit requires mixing to re-suspend magnetic microbeads that have
settled during shipment. For magnetic microbeads mixing instructions, refer to the Preparation of the Reagent section of this package insert.

 To avoid contamination, wear clean gloves when operating with a reagent kit and sample.

 Over time, residual liquids may dry on the septum surface. These are typically dried salts which have no effect on assay efficacy.

 To avoid evaporation of the liquid in the opened reagent kits in a refrigerator, it is recommended that the opened reagent kits be sealed with
reagent seals contained within the packaging. The reagent seals are "single use," and if more seals are needed, please contact Shenzhen New
Industries Biomedical Engineering Co., Ltd. (SNIBE) or our authorized representative. .For detailed discussion of handling precautions during
system operation, refer to the SNIBE service information (website : https://www.snibe.com/zh_en/en_index.aspx)

STORAGE AND STABILITY

 Store at 2-8°C. Do not freeze.

 Keep upright for storage to facilitate later proper resuspension of magnetic microbeads.

 Keep away from sunlight.

Stability of the reagent

unopened at 2-8°C until the stated expiration date

opened at 2-8°C 6 weeks

onboard 4 weeks

 To ensure the best kit performance, it is recommended to place opened kits in the refrigerator after the end of the intraday test work.
TEST PROCEDURE
Preparation of the Reagent

 Take the reagent kit out of the box and inspect the sealing film and other parts of the reagent kit to see if there is any leakage. In case of leakage,
please contact your local distributor immediately. Then, tear off the kit sealing film carefully.

 Open the reagent area door; hold the reagent handle to get the RFID label close to the RFID reader (for about 2 seconds); the buzzer will beep;
one beep sound indicates successful sensing.

 Keeping the reagent straight insert to the bottom along the blank reagent track.

 Observe whether the reagent information is displayed successfully in the software interface, otherwise repeat the above steps.

 Resuspension of the magnetic microbeads takes place automatically when the kit is loaded successfully, ensuring the magnetic microbeads are
totally resuspended and homogenous prior to use.

Assay Calibration

 Click <Calibration> or <Batch Calibration> button to execute the calibration operation; for specific information on ordering calibrations, refer to
the Calibration Section of the Operating Instructions.

 Execute recalibration according to the calibration interval required in this package insert.

Quality Control

 In order to avoid manually error in entry of QC information, the provided barcode labels of quality control (positive and negative)) in the kit should
be attached to the test tubes.

 If users do not use the provided barcode labels for positive and negative controls contained within the packaging, then quality controls (positive
and negative) should be ordered manually.

 For specific information on ordering quality controls (positive and negative), refer to the Quality Control Section of the Operating Instructions.

Sample Testing

 Carefully transfer serum samples with each minimum volume of 160µL into sample tubes.

 Load sample tubes to sample racks and start testing.

 Order the samples in the Sample Area of the software and click the <Start> button to execute testing. For specific information on ordering patient
specimens, refer to the Sample Ordering Section of the Operating Instructions.

 Samples from the same patient must be loaded in separate cassettes due to the design of the cleared instrument, MAGLUMIITM series fully-
automated chemiluminescence immunoassay analyzer and a single report results for both IgM and IgG SARS-CoV-2 antibodies will be generated
per patient.

To ensure proper test performance, strictly adhere to the operating instructions of MAGLUMIITM series fully-auto chemiluminescence immunoassay
analyzer.

LIMITATIONS
 This test is suitable only for investigating single samples, not for pooled samples.

 The product can only be used with MAGLUMIITM series fully-auto chemiluminescence immunoassay analyzer.

 The MAGLUMI 2019-nCoV IgM/IgG has not been evaluated for specimens other than human serum.

 Bacterial contamination or repeated freeze-thaw cycles may affect the test results.

 Assay results should be utilized in conjunction with other clinical and laboratory methods to assist the clinician in making individual patient decisions.

 Assay results should not be used to diagnose or exclude acute COVID-19. Direct viral nucleic acid detection or antigen detection methods should
be performed if acute infection is suspected.

• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
• A negative or non-reactive result can occur if the quantity of antibodies for the SARS-CoV-2 virus present in the specimen is below the
detection limit of the assay, or the virus has undergone minor amino acid mutation(s) in the epitope recognized by the antibody detected by
the test.

• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43,
or 229E.
• SARS-CoV-2 IgM and IgG antibodies may be below detectable levels in patients who have been exhibiting symptoms for less than 8 days.
 If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.

 HAMA antibodies in test samples may cause interference in immunoassays at concentrations greater than 30ng/mL.

 It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to re-infection.

 A positive result may not indicate previous SARS-CoV-2 infection. Consider other information including clinical history and local disease prevalence,
in assessing the need for a second but different serology test to confirm an immune response.
 Not for the screening of donated blood.

Conditions of Authorization for the Laboratory

The MAGLUMI 2019-nCoV IgM/IgG Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact
Sheet for Patients, and authorized labeling are available on the FDA website:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

Authorized laboratories using the MAGLUMI 2019-nCoV IgM/IgG must adhere to the Conditions of Authorization indicated in the Letter of
Authorization as listed below:

• Authorized laboratoriesa using the MAGLUMI 2019-nCoV IgM/IgG will include with test result reports, all authorized Fact Sheets. Under
exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.

• Authorized laboratories will use the MAGLUMI 2019-nCoV IgM/IgG as outlined in the authorized labeling. Deviations from the authorized
procedures, including the authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized
materials required to use the product are not permitted.

• Authorized laboratories that receive the MAGLUMI 2019-nCoV IgM/IgG will notify the relevant public health authorities of their intent to run
the assay prior to initiating testing.

• Authorized laboratories using the MAGLUMI 2019-nCoV IgM/IgG will have a process in place for reporting test results to healthcare providers
and relevant public health authorities, as appropriate.

• Authorized laboratories will collect information on the performance of the MAGLUMI 2019-nCoV IgM/IgG and report to DMD/OHT7-
OIR/OPEQ/CDRH (via email: CDRH EUA Reporting@fda.hhs.gov) and to Snibe Co. Ltd (pgshugart@carolinachemistries.com and
MAGLUMI Technical Support (http://www.snibe.com/zh_en/en_services.aspx?id=66)) any suspected occurrence of false reactive or false
non-reactive results and significant deviations from the established performance characteristics of the assay of which they become aware.

• All laboratory personnel using the MAGLUMI 2019-nCoV IgM/IgG must be appropriately trained in immunoassay techniques and use
appropriate laboratory and personal protective equipment when handling this kit, and use the MAGLUMI 2019-nCoV IgM/IgG Combo Test
Kit in accordance with the authorized labeling. All laboratory personnel using the assay must also be trained in and be familiar with the
interpretation of results of the the MAGLUMI 2019-nCoV IgM/IgG.

• Snibe Co. Ltd., authorized distributors, and authorized laboratories using the MAGLUMI 2019-nCoV IgM/IgG will ensure that any records
associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon
request.

a
The letter of authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42
U.S.C. §263a, that meet requirements to perform moderate and high complexity tests” as “authorized laboratories".

RESULTS
Calculation of Results

The analyzer automatically calculates the numerical output in each sample by means of a calibration curve which is generated by a two-point
calibration master curve procedure. The results are expressed in absorbance unit AU/mL. The results are reported to the end user as “Reactive” and
“Non-Reactive”. No AU/mL numerical values are reported to the end user. For further information please refer to the operating instructions of
MAGLUMI series fully-automated chemiluminescence immunoassay analyzer.

Interpretation of Results

 Non-reactive: A result less than 1.00 AU/mL (<1.00 AU/mL) is considered to be non-reactive.

 Reactive: A result greater than or equal to 1.00 AU/mL (≥1.00 AU/mL) is considered to be reactive.

Analyte Results Interpretation Description*

 SARS-CoV-2 IgG IgG antibodies against SARS-CoV-2
<1.00 AU/mL
Non-Reactive are not detected
SARS-CoV-2 IgG
SARS-CoV-2 IgG IgG antibodies against SARS-CoV-2
≥1.00 AU/mL
Reactive are detected

SARS-CoV-2 IgM IgM antibodies against SARS-CoV-2

<1.00 AU/mL
Non-Reactive are not detected
SARS-CoV-2 IgM
SARS-CoV-2 IgM IgM antibodies against SARS-CoV-2
≥1.00 AU/mL
Reactive are detected

*If external controls are outside the pre-established ranges do not report results and test the sample again.

PERFORMANCE CHARACTERISTICS

Precision

Precision of the MAGLUMI 2019-nCoV IgM/IgG assay was determined as described in the CLSI EP5-A3.2. Controls and three human serum pools
containing different levels of analyte were assayed in duplicate at three sites over 5 days, with three runs per day, and one lot of reagent for each
run. The results are summarized in the following table:

Mean Repeatability Between-Lot Between-Day Between-Site Reproducibility

Analyte Sample Value N
SD (AU/mL) %CV SD (AU/mL) %CV SD (AU/mL) %CV SD (AU/mL) %CV SD (AU/mL) %CV
(AU/mL)
NQC 0.293 90 0.024 NA 0.005 NA 0.008 NA 0.023 NA 0.035 NA
PQC 3.915 90 0.199 5.08 0.069 1.76 0.032 0.82 0.265 6.77 0.340 8.68
IgG S1 0.491 90 0.043 NA 0.015 NA 0.004 NA 0.013 NA 0.047 NA
S2 3.486 90 0.212 6.08 0.060 1.72 0.050 1.43 0.071 2.04 0.237 6.80
S3 9.807 90 0.159 1.62 0.122 1.24 0.082 0.84 0.639 6.52 0.675 6.88
NQC 0.293 90 0.020 NA 0.006 NA 0.007 NA 0.007 NA 0.023 NA
PQC 3.920 90 0.167 4.26 0.046 1.17 0.062 1.58 0.284 7.24 0.339 8.65
IgM S1 0.492 90 0.033 NA 0.016 NA 0.009 NA 0.012 NA 0.040 NA
S2 1.797 90 0.037 2.06 0.018 1.00 0.053 2.95 0.088 4.90 0.111 6.18
S3 3.411 90 0.076 2.23 0.000 0.00 0.049 1.44 0.226 6.63 0.244 7.15

Potentially Interfering Substances The effect of potential interference substances of the performance of the MAGLUMI 2019-nCoV IgM/IgG assay
was evaluated using one negative serum sample and one positive serum sample spiked with whether SARS-CoV-2 IgG or SARS-CoV-2 IgM
antibodies. Both cassettes (for IgM and IgG) were tested separately according to the instructions for use. No interference was observed up to the
concentrations included in the table below:

Potential Interferent Highest Concentration of Potential Interferent tested with no Interferent Effect

Bilirubin 40 mg/dL
Triglycerides 1000 mg/dL
Endogenous Hemoglobin 2000 mg/dL
Rheumatoid Factor 1500 IU/mL
Anti-Mitochondrial 1:64(titer)
HAMA 30 ng/mL
Total IgG 1600 mg/dL
Total IgM 280 mg/dL
Interferon α 1500 U/mL
Ribavirin 90 mg/dL
Oseltamivir 1.0 mg/dL
Levofloxacin 1.776 mg/dL
Azithromycin 1.201 mg/dL
Exogenous
Ceftriaxone sodium 81.03 mg/dL
Meropenem 80.15 mg/dL
Tobramycin 2.4 mg/dL
Diphenhydramine 4.5 mg/dL
Oxymetazoline 2.5 mg/dL
Sodium chloride 45 mg/dL
Beclomethasone 2.5 mg/dL
Dexamethasone 18 mg/dL
Triamcinolone acetonide 5.5 mg/dL
Budesonide 3.2 mg/dL
Mometasone 2.5 mg/dL
Fluticasone propionate 2.5 mg/dL

Cross-Reactivity
The cross-reactivity of the MAGLUMI 2019-nCoV IgM/IgG was evaluated by testing SARS-CoV-2 seronegative serum samples from patients with
antibodies to various viruses and other possible cross- reactants. The cassette used for IgM detection was tested with the potential cross-reactants
separately from the cassette for IgG detection following the instructions for use. No false positive results were observed. The results of the potential
interference study are listed in the following table:

Number of
Number of Samples Containing False Positive Results
Condition
Potential Cross-Reactants
SARS- SARS-
CoV-2 IgM CoV-2 IgG

Influenza A virus
17 0 0
antibodies

Influenza B virus
19 0 0
antibodies

Parainfluenza virus
23 0 0
antibodies

Respiratory syncytial
7 0 0
virus antibodies

Adenovirus antibodies 9 0 0

EBV NA IgG 10 0 0

EBV VCA IgG 4 0 0

EBV VCA IgM 6 0 0

Measles virus 2 0 0

CMV IgG 6 0 0

CMV IgM 2 0 0

Varicella zoster virus

2 0 0
antibodies

M. pneumonia IgG 3 0 0

M. pneumonia IgM 4 0 0

Chlamydia
3 0 0
pneumoniae IgG

Chlamydia
3 0 0
pneumoniae IgM

Monilia albicans 1 0 0

Antinuclear Antibodies
6 0 0
(ANA)

anti-HCV (IgG and

5 0 0
IgM)

anti-HBV (IgG and

5 0 0
IgM)

anti-HIV (IgG and IgM) 16 0 0

Total 159 0 0

CLINCAL PERFORMANCE
A total of 490 subjects were enrolled to evaluate the MAGLUMI 2019-nCoV IgM/IgG test clinical performance. Among the 490
serum samples collected, 264 were from SARS-CoV-2 PCR-confirmed positive subjects while 226 were from SARS-CoV-2 PCR-
confirmed negative subjects. All samples collected were tested using the MAGLUMI 2019-nCoV IgM/IgG test. The negative
percent agreement (NPA) and the positive percent agreement (PPA) were calculated. Out of the 226 PCR negative subjects 3
tested positive with the MAGLUMI 2019-nCoV IgM/IgG (2 false positive for IgG and 1 for IgM), so the NPA is 98.67% (95% CI:
96.17% - 99.55%

The following tables describe the PPA calculations, by time of sampling days post symptom onset, for IgG and IgM separately
as well as combined.

MAGLUMI 2019-nCoV IgM/IgG – SARS-CoV-2 IgG PPA (Stratified by Days Post-Symptom Onset)

PCR Comparator
 Days Post PCR Total
IgG PPA 95% Confidence Interval (CI)
IgG Positive Results
Symptom Positive

≤7 16 5 31.25% 14.16% - 55.60%

8-14 106 96 90.57% 83.50% - 94.80%

≥15 142 142 100.00% 97.37% - 100.00%

Total 264 243 92.05% 88.15% - 94.74%

MAGLUMI 2019-nCoV IgM/IgG - SARS-CoV-2 IgM PPA (Stratified by Days Post-Symptom Onset)

Days Post PCR Total PCR Comparator

Symptom Positive
IgM Positive Results IgM PPA 95% CI
Onset

≤7 16 7 43.75% 23.10% - 66.82%

8-14 106 83 78.30% 69.54% - 85.08%

≥15 142 110 77.46% 69.92% - 83.56%

Total 264 200 75.76% 70.24% - 80.53%

MAGLUMI 2019-nCoV IgM/IgG – SARS-CoV-2 IgM and IgG Combined PPA (Stratified by Days Post-Symptom Onset)

PCR Comparator
Days Post
PCR Total IgG/IgM
Symptom IgG/IgM combined
Positive Combined 95% CI
Onset Positive Results
PPA

≤7 16 7 43.75% 23.10% - 66.82%

8-14 106 99 93.40% 86.99% - 96.76%

≥15 142 142 100% 97.37% - 100.00%

Total 264 248 93.94% 90.38% - 96.24%

SYMBOLS EXPLANATIONS

Consult instructions for use Manufacturer

Temperature limit
Use-by date
(Store at 2-8°C)

Contains sufficient for <n> tests Keep away from sunlight

This way up Kit components

In vitro diagnostic medical device Batch code

Catalogue number
Shenzhen New Industries Biomedical Engineering Co., Ltd.

No.16, Jinhui Road, Pingshan New District, Shenzhen, 518122, China

www.snibe.com

sales@snibe.com

Tel: 0086-755-21536601

Fax:0086-755-28292740
Maglumi 2000 Immunoassay Analyzer

Operating Instructions
Dear users! Thank you for using our MAGLUMI® 2000 Immunoassay
Analyzer!

To make sure you using the analyzer safely and skillfully, and improve your
working efficiency, please read the instructions carefully before operating
the analyzer.

Please properly keep the instructions after reading, and placed it in a readily
accessible place in order to obtain easily at any time.
Intellectual Property Statement

Shenzhen New Industries Biomedical Engineering Co., Ltd owns the intellectual
properties to this product and copyright of this instruction.

Any part of this operating instructions may not be reproduced, stored, retrieved, or
transmitted in any form or by any means without permission.

, , , and are the registered trademarks

or trademarks owned by Snibe in China and other countries.

Information about the Product

Device Name: Maglumi 2000 Immunoassay Analyzer

Intended Use: The Maglumi 2000 Immunoassay system is an automated,

immunoassay analyzer designed to perform in vitro diagnostic tests on clinical
specimens. The Maglumi 2000 Immunoassay system’s assay application utilizes
chemiluminescents technology for clinical use.
The Maglumi 2000 Immunoassay system is intended for prescription use.

Device Name Catalogue Number

Maglumi 2000 Immunoassay Analyzer 23020006

Information of operating instructions

Issued Date: 2020-07

Version: 1.4
Applicable Scope of Software: above2.14.8.8

Company Contact

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.

Address: No. 23, Jinxiu East Road, Pingshan District, 518122 Shenzhen, P.R.China
Tel: + 86 755 21536601
Fax:+ 86 755 28292740
 TABLE OF CONTENTS
INTELLECTUAL PROPERTY STATEMENT ......................................................................................................................... 5
INFORMATION ABOUT THE PRODUCT ........................................................................................................................... 5
INFORMATION OF OPERATING INSTRUCTIONS ................................................................................................................ 5
COMPANY CONTACT ................................................................................................................................................ 5
NOTES ........................................................................................................................................................... 1
PURPOSE ............................................................................................................................................................... 2
SAFETY NOTE ......................................................................................................................................................... 2
OPERATION NOTES .................................................................................................................................................. 6
OTHER NOTES ........................................................................................................................................................ 9
WARNING SYMBOLS............................................................................................................................................... 10
OTHER SYMBOLS ................................................................................................................................................... 12
1 ABOUT THIS INSTRUCTIONS ........................................................................................................................ 1
1.1 TEXT CONVENTIONS ........................................................................................................................................... 1
1.2 BUTTON .......................................................................................................................................................... 1
1.3 WORD............................................................................................................................................................. 2
1.4 GLOSSARY ........................................................................................................................................................ 2
2 MEASURING PRINCIPLE............................................................................................................................... 1
2.1 ASSAY PROCEDURE ............................................................................................................................................ 1
2.2 MEASURING PRINCIPLE ....................................................................................................................................... 2
2.3 CALIBRATION .................................................................................................................................................... 3
3 SYSTEM DESCRIPTION ................................................................................................................................. 1
3.1 SYSTEM STRUCTURE ........................................................................................................................................... 1
3.2 ANALYZER ........................................................................................................................................................ 2
3.2.1 Sample Area.......................................................................................................................................... 3
3.2.2 Reagent Area ........................................................................................................................................ 4
3.2.3 Barcode Reader and RFID Reader......................................................................................................... 5
3.2.3.1 Barcode Reader .............................................................................................................................................. 5
3.2.3.2 RFID Reader .................................................................................................................................................... 7
3.2.4 Pipettor ................................................................................................................................................. 7
3.2.5 Stacker .................................................................................................................................................. 8
3.2.6 Incubator .............................................................................................................................................. 9
3.2.7 Incubator Loader and Washer Loader ................................................................................................ 10
3.2.8 Washer ............................................................................................................................................... 10
3.2.9 Pusher ................................................................................................................................................. 11
3.2.10 Back Transport .................................................................................................................................. 11
3.2.11 Chamber ........................................................................................................................................... 12
3.2.12 Pump System .................................................................................................................................... 12
3.2.13 Starter ............................................................................................................................................... 13
3.2.14 System Liquid.................................................................................................................................... 13
3.2.15 Cuvette Waste Bag Bin and Waste Liquid ........................................................................................ 13
3.3 COMPUTER SYSTEM ......................................................................................................................................... 15
3.3.1 Computer System Components.......................................................................................................... 15
3.3.2 Basic Operations in Software Interface .............................................................................................. 15
3.3.2.1 Using the Touch monitor Mouse and Keyboard ........................................................................................... 15
3.3.2.2 Software Components .................................................................................................................................. 16
3.4 TESTING PERFORMANCE ................................................................................................................................... 19
3.4.1 Batch Assay Repeatability................................................................................................................... 19
3.4.2 Linear Correlation ............................................................................................................................... 19
3.4.3 Carryover Rate .................................................................................................................................... 19
3.4.4Stability ................................................................................................................................................ 19
4 INSTALLATION AND STARTUP ..................................................................................................................... 1
 4.1 ANALYZER TRANSPORTATION AND STORAGE REQUIREMENTS ..................................................................................... 1
4.1.1 Transportation Requirements .............................................................................................................. 1
4.1.2 Storage Requirements .......................................................................................................................... 1
4.2 INSTALLATION REQUIREMENTS ............................................................................................................................. 1
4.2.1 Installation Environment Requirements............................................................................................... 1
4.2.2 Power Requirements ............................................................................................................................ 1
4.2.3 Space Requirements ............................................................................................................................. 2
4.2.4 Temperature and Humidity Requirements........................................................................................... 2
4.3 UNPACKING INSPECTION ..................................................................................................................................... 2
4.3.1 Unpacking Procedure ........................................................................................................................... 2
4.3.2 Analyzer Transportation and Fastening ................................................................................................ 2
4.4 ANALYZER INSTALLATION .................................................................................................................................... 3
4.4.1 System Circuit Connection.................................................................................................................... 3
4.4.2 System Liquid Tank and Waste Liquid Tank Connection ...................................................................... 3
4.4.3 Starter Connection ............................................................................................................................... 4
4.4.4 Waster Bag Placement ......................................................................................................................... 4
4.4.5 Cuvettes Loading .................................................................................................................................. 5
4.5 POWER-ON AND SYSTEM STARTUP ....................................................................................................................... 5
4.5.1 Starting the Analyzer ............................................................................................................................ 5
4.5.2 Starting the PC System and Operating Software .................................................................................. 5
4.5.3 Performing System Test........................................................................................................................ 6
5 DAILY OPERATING PROCESS ........................................................................................................................ 1
5.1 DAILY OPERATING PROCESS ................................................................................................................................. 1
5.2 TEST PREPARATION ............................................................................................................................................ 2
5.2.1 Check before Starting ........................................................................................................................... 2
5.2.2 Power-on and Login the Software ........................................................................................................ 2
5.2.3 Check Consumables .............................................................................................................................. 3
5.2.4 Confirm Device Status .......................................................................................................................... 3
5.2.5 Confirm Test Condition ......................................................................................................................... 5
5.2.6 Prepare Reagent ................................................................................................................................... 5
5.3 TEST ANALYSIS .................................................................................................................................................. 6
5.3.1 Assay Calibration .................................................................................................................................. 6
5.3.2 Control Registration ........................................................................................................................ 8
5.3.3 Sample Registration ............................................................................................................................ 10
5.3.4 Start Test ............................................................................................................................................ 11
5.3.5 Additional Samples and Assays .......................................................................................................... 11
5.4 TEST RESULTS ................................................................................................................................................. 11
5.5 END OF ANALYSIS ............................................................................................................................................ 12
5.5.1 Shutdown ........................................................................................................................................... 12
5.5.2 Operation after Shutdown.................................................................................................................. 12
6 [SYSTEM] MENU ......................................................................................................................................... 1
6.1 [SYSTEM] MENU INTRODUCTION .......................................................................................................................... 1
6.2 <INFO> ........................................................................................................................................................... 1
6.3 <MODE> ......................................................................................................................................................... 2
6.4 <ONLINE>........................................................................................................................................................ 4
6.5 <USER>........................................................................................................................................................... 5
6.6 <LANGUAGE> ................................................................................................................................................... 6
6.7 <MAINTENANCE>.............................................................................................................................................. 7
6.8 <WASH PIPE> ................................................................................................................................................... 9
7 [DEFINITION] MENU ................................................................................................................................... 1
7.1 [DEFINITION] MENU INTRODUCTION ..................................................................................................................... 1
7.2 <TEST> ........................................................................................................................................................... 1
7.2.1 <Auto Dil.> ............................................................................................................................................ 4
7.2.2 <Format> .............................................................................................................................................. 5
 7.2.3 <Qualit. Lbl>.......................................................................................................................................... 5
7.2.4 <Reflex> ................................................................................................................................................ 6
7.2.5 <Master Curve> .................................................................................................................................... 7
7.3 <CONTROL> ..................................................................................................................................................... 8
7.4 <GROUP> ...................................................................................................................................................... 11
7.5 <PROFILE> ..................................................................................................................................................... 12
7.6 <DILUTER> .................................................................................................................................................... 13
7.7 <SENDER> ..................................................................................................................................................... 15
7.8 <RESULT DEFINE> ........................................................................................................................................... 16
8 [PROCESS] MENU........................................................................................................................................ 1
8.1 [PROCESS] MENU INTRODUCTION ........................................................................................................................ 1
8.2 <INITIALIZE> ..................................................................................................................................................... 2
8.3 <INIT W. CLEAR> .............................................................................................................................................. 2
8.4 <RESTART> ...................................................................................................................................................... 3
8.5 <RETURN ASY> ................................................................................................................................................. 3
8.6 <LOW LEVEL> ................................................................................................................................................... 4
8.7 <PROTOCOL> ................................................................................................................................................... 4
8.8 <WARNING OPT.> ............................................................................................................................................ 5
9 [SYSTEM TEST] MENU ................................................................................................................................. 1
9.1 [SYSTEM TEST] MENU ........................................................................................................................................ 1
9.2 LOAD LIGHT CHECK ............................................................................................................................................ 2
9.3 ADD LIGHT CHECK ............................................................................................................................................. 3
10 [REAGENTS] MENU ................................................................................................................................... 1
10.1 [REAGENT] INTERFACE ...................................................................................................................................... 1
10.2 REAGENT AREA ............................................................................................................................................... 2
10.3 REAGENT DATA ............................................................................................................................................... 4
10.3.1 Calibrators .......................................................................................................................................... 5
10.3.2 Tolerances .......................................................................................................................................... 5
10.3.3 Remaining Tests.................................................................................................................................. 6
10.4 CALIBRATION .................................................................................................................................................. 6
10.4.1 <Calibrate> ......................................................................................................................................... 7
10.4.2 <View> ................................................................................................................................................ 7
10.4.2.1 <Calculate Curve> ......................................................................................................................................... 9
10.4.2.2 <Print> .......................................................................................................................................................... 9
10.4.2.3<Calibrate History> ........................................................................................................................................ 9
10.4.2.4 <Change Calibrator> ................................................................................................................................... 10
10.5 REAGENT CALIBRATION AND VALIDATION ........................................................................................................... 10
10.6 <BATCH CALIBRATION> .................................................................................................................................. 11
10.7 <REAGENT INVENTORY> ................................................................................................................................. 11
10.8 <OK> ......................................................................................................................................................... 12
11 [PATIENTS] MENU..................................................................................................................................... 1
11.1 [PATIENTS] MENU INTRODUCTION...................................................................................................................... 1
11.2 [PATIENTS] MENU ........................................................................................................................................... 2
11.2.1 Rack Station ........................................................................................................................................ 2
11.2.2 Sample Info ......................................................................................................................................... 3
11.2.3 Assay Selection ................................................................................................................................... 5
11.2.4 Profile Selection .................................................................................................................................. 6
11.2.5 Loading ............................................................................................................................................... 6
11.2.5.1 <Work List> and <Edit> ................................................................................................................................. 7
11.2.5.2 <STAT> .......................................................................................................................................................... 7
11.2.5.3 <Control> ...................................................................................................................................................... 8
11.2.5.4 <Std/LC> ....................................................................................................................................................... 8
11.2.5.5 <Dilute> ........................................................................................................................................................ 9
11.6 <Save> ................................................................................................................................................... 9
12 [REPORT] MENU ....................................................................................................................................... 1
12.1 [REPORT] MENU INTRODUCTION ........................................................................................................................ 1
12.2 <JOURNAL>.................................................................................................................................................... 2
12.2.1<Sort> .................................................................................................................................................. 2
12.2.2 <Today Rpt.> ....................................................................................................................................... 3
12.2.3 <Recalculate> ..................................................................................................................................... 4
12.2.4 <Online> ............................................................................................................................................. 4
12.2.5 <Edit> .................................................................................................................................................. 5
12.2.6 <Delete> ............................................................................................................................................. 7
12.2.7 <Valid> ................................................................................................................................................ 7
12.2.8 <Print> ................................................................................................................................................ 8
12.2.9 <Remeasure> ...................................................................................................................................... 9
12.3 <VALID> ........................................................................................................................................................ 9
12.4 <CALIBRATOR> ............................................................................................................................................. 11
12.5 <CONTROL> ................................................................................................................................................. 12
12.6 <SYSTEM TEST> ............................................................................................................................................ 12
12.7 <REPORT> ................................................................................................................................................... 14
12.7.1 <Import> ........................................................................................................................................... 14
12.7.2 <Search> ........................................................................................................................................... 16
12.7.3 <QC> ................................................................................................................................................. 17
12.7.4 <Dictionary> ..................................................................................................................................... 18
12.7.5 <Setting>........................................................................................................................................... 19
12.7.6 <Return> ........................................................................................................................................... 21
13 STATUS DISPLAY AND HANDLING .............................................................................................................. 1
13.1 STATUS DISPLAY .............................................................................................................................................. 1
13.1.1 Consumables ...................................................................................................................................... 1
13.1.1.1 Cuvettes ........................................................................................................................................................ 2
13.1.1.2 System Liquid................................................................................................................................................ 2
13.1.1.3 Starter Reagents ........................................................................................................................................... 3
13.1.2 Temperature and Voltage................................................................................................................... 3
13.1.3 WASTE ....................................................................................................................................................... 4
13.1.3.1 Waste Liquid ................................................................................................................................................. 4
13.1.3.2 Waste Cuvettes............................................................................................................................................. 4
13.2 HANDLING CONSUMABLES ................................................................................................................................ 5
13.2.1 Placing Cuvette ................................................................................................................................... 5
13.2.2 Adding System Liquid ......................................................................................................................... 5
13.2.3 Change Starter Reagents .................................................................................................................... 6
13.2.4 Waste Cuvettes................................................................................................................................... 7
13.2.5 Waste Liquid ....................................................................................................................................... 7
14 REAGENT LOADING ................................................................................................................................... 1
14.1 REAGENT STRUCTURE ....................................................................................................................................... 1
14.2 REAGENT LOADING .......................................................................................................................................... 1
14.2.1 Prepare the Reagent ........................................................................................................................... 1
14.2.2 Loading the Reagent ........................................................................................................................... 2
14.2.3 Remove the reagent ........................................................................................................................... 3
14.3 PROPERLY STORE THE REAGENT.......................................................................................................................... 3
15 SAMPLE LOADING ..................................................................................................................................... 1
15.1 SAMPLE RACK ................................................................................................................................................. 1
15.1.1 Structure of Sample Rack ................................................................................................................... 1
15.1.2 Type of Sample Rack ........................................................................................................................... 2
15.2 SAMPLE LOADING ............................................................................................................................................ 3
15.2.1 Prepare the Sample ............................................................................................................................ 3
15.2.2 Sample Rack Loading .......................................................................................................................... 4
15.2.3 Remove the Sample Rack ................................................................................................................... 5
 15.3 Maintenance of Sample Rack ................................................................................................................ 5
16 LIS INTERFACE ........................................................................................................................................... 1
16.1 DESCRIPTION OF ONLINE MODE ......................................................................................................................... 1
16.1.1 Enable Online Mode ........................................................................................................................... 1
16.1.2 Setting Parameters of Online Mode ................................................................................................... 1
16.1.3 Methods of Sending Results ............................................................................................................... 3
16.2 INSTRUCTION ON CONTROL CODES ..................................................................................................................... 4
16.3 INSTRUCTION ON BASIC COMMUNICATION FORMAT............................................................................................... 4
16.4 INSTRUCTION ON DELIMITERS ............................................................................................................................ 4
16.5 INSTRUCTION ON TYPE OF MESSAGE ................................................................................................................... 4
16.5.1 Message head record (H) ................................................................................................................... 5
16.5.2 Patient Info Record (P) ....................................................................................................................... 5
16.5.3 Assays Record (O) ............................................................................................................................... 6
16.5.4 Result Record (R) ................................................................................................................................ 7
16.5.5 Info Required Record (Q) .................................................................................................................... 7
16.5.6 Message End Record (L) ..................................................................................................................... 8
16.6 EXAMPLE ....................................................................................................................................................... 8
16.6.1 Enquiring Assay................................................................................................................................... 8
16.6.2 Returning Assays ................................................................................................................................ 9
16.6.3 Sending Assay Results....................................................................................................................... 10
17 SYSTEM MAINTENANCE ............................................................................................................................ 1
17.1 DAILY MAINTENANCE ....................................................................................................................................... 1
17.2 WEEKLY MAINTENANCE.................................................................................................................................... 1
17.3 MONTHLY MAINTENANCE ................................................................................................................................. 1
17.4 ETENDED SHUNTDOWN-SYSTEM IDLE 5 DAYS OR MORE ......................................................................................... 2
18 TROUBLESHOOTING AND DIAGNOSTICS .................................................................................................... 1
18.1 MANAGE OF SYSTEM INFO AND ERROR MESSAGES ................................................................................................ 1
18.2 EMERGENCY STOP ........................................................................................................................................... 3
18.3 COMMON PROBLEMS ....................................................................................................................................... 5
18.4 ERROR MESSAGE AND SOLUTION...................................................................................................................... 10
APPENDIX A ADJUST NEEDLES ....................................................................................................................... 1
A.1 PREPARATION BEFORE ADJUSTING ........................................................................................................................ 1
A.2 NEEDLES ADJUST PROGRAM ................................................................................................................................ 4
A.3 REFERENTIAL POSITION ADJUST ........................................................................................................................... 5
A.3.1 Left Referential Position Adjust............................................................................................................ 5
A.3.2 Right Referential Position Adjust ......................................................................................................... 6
A.4 LEFT PIPETTING POSITION ADJUST ........................................................................................................................ 7
A.4.1 Left Needle Adjust on Left Pipetting Position ...................................................................................... 7
A.4.2 Right Needle Adjust on Left Pipetting Position .................................................................................. 10
A.5 INCUBATOR PIPETTING POSITION ADJUST............................................................................................................. 12
A.5.1 Left Incubator Pipetting Position Adjust ............................................................................................ 13
A.5.2 Right Incubator Pipetting Position Adjust .......................................................................................... 15
A.6 RIGHT PIPETTING POSITION ADJUST .................................................................................................................... 17
A.6.1 Left Needle Adjust on Right Pipetting Position .................................................................................. 18
A.6.2 Right Needle Adjust on Right Pipetting Position ................................................................................ 21
A.7 WASHING POSITION ADJUST ............................................................................................................................. 24
A.7.1 Left Washing Position Adjust ............................................................................................................. 24
A.7.2 Right Washing Position Adjust ........................................................................................................... 25
A.8 ADJUST OF NEEDLE POSITION IN SAMPLE AREA ..................................................................................................... 26
A.8.1 Adjust of Left Position in Sample Area ............................................................................................... 27
A.8.2 Adjust of Right Position in Sample Area ............................................................................................. 30
A.9 ADJUST OF NEEDLE POSITION IN REAGENT AREA ................................................................................................... 33
A.9.1 Adjust of Left Needle in Reagent Area ............................................................................................... 34
 A.9.2 Adjust of Right Needle in Reagent Area ............................................................................................. 39
A.10 CUVETTE HIGH-LEVEL ADJUST .......................................................................................................................... 44
A.10.1 Left Cuvette High-level Adjust .......................................................................................................... 45
A.10.2 Right Cuvette High-level Adjust........................................................................................................ 46
A.11 ADJUST OF START POSITION OF REAGENTS ......................................................................................................... 47
A.11.1 Adjust of Left Start Position of Reagents ......................................................................................... 47
A.11.2 Adjust of Right Start Position of Reagents ....................................................................................... 50
APPENDIX B SOFTWARE UPGRADE ................................................................................................................ 1
B.1 SOFTWARE UPGRADE ......................................................................................................................................... 1
B.1.1 Installing the Software Installer of New Version .................................................................................. 1
B.1.2 Installing the Service Pack .................................................................................................................... 6
B.2 PROGRAM UPGRADE OF MAIN CONTROL CIRCUIT BOARDS ....................................................................................... 6
B.2.1 Upgrade the Program of 08-E00-COP Circuit Board ............................................................................. 6
B.2.2 Upgrade and Burning of the Programs of No. 01~07 Circuit Boards .................................................... 7
 Notes

Notes

This chapter covers all important

information and regulations about safety
and operation.

Read the operating instructions before you

start using the analyzer.

Maglumi 2000 Operating Instructions Page 1

Notes

Purpose

Maglumi 2000 Immunoassay Analyzer and reagents are strictly restricted to

professional in vitro diagnosis (IVD) use.

The operating instructions are intended for the Maglumi 2000 Immunoassay Analyzer.
This instruction mainly helps users to understand the principle structure, operation,
maintenance and troubleshooting of the Maglumi 2000 Immunoassay Analyzer. Follow
the instructions in this manual when operating the analyzer.

Safety Note

To ensure safe use of this system, read these instructions carefully before operating
the analyzer. Any operation in violation of safety precautions may cause personnel
injury or damage to the analyzer.

Production of the system complies with safety requirements for electronic analyzer and
medical analyzer. There are related legal requirements for installation and operation of
the system, and installation personnel and operators are obliged to comply with these
legal provisions.

WARNING
1) If a user fails to perform analyzer maintenance required by the
instructions, analyzer faults may occur and endanger personnel
health.
2) To ensure analyzer safety and reliability, installation and
maintenance of the analyzer can only be carried out by our
authorized service engineers and personnel or upon their
approval , and all analyzer parts must be checked and provided by
our company or our authorized distributors.

1. Prevention of Injury Caused by Moving Parts

Observe the following precautions to prevent injury caused by moving parts when the
analyzer is running.

WARNING
1) When the analyzer is running, do not touch its moving parts or the
movement path. These moving parts include the pipetting needle,
incubator, washer, washer loader, Incubator loader, back transport,
and pusher.
2) When the analyzer is running, do not place any obstacle in the path
of moving parts. Otherwise, it may cause injury or damage to the
analyzer.
3) Caps on sample tubes will collide with the pipetting needle.
Therefore, remove caps from all sample test tubes.
4) The analyzer has a cover with a lock. Close and lock the cover
when the analyzer is running. If you need to open the cover, cut off
the main power to avoid injury or damage to the analyzer.

Page 2 Maglumi 2000 Operating Instructions

 Notes

Figure 1 Do Not Actuate During Operation

2. Electrical Hazard Prevention

Observe the following precautions to prevent electric shock.

WARNING
1) When the analyzer is powered on, non-authorized service
personnel cannot open the analyzer rear cover and side cover.
2) If any liquid, such as the reagent and sample, flows into the
analyzer, it may cause analyzer failure and electric shock. In this
case, cut off the power immediately and contact our technical
service department.
3) Cut off the power supply before opening the rear cover and side
cover to replace parts.
4) Incorrect grounding may cause electric shock and damage to the
analyzer.
5) Ensure that the input voltage meets the requirements of the
analyzer.
6) Do not touch or conduct electrostatic discharge on components
with static protection warning labels.

3. Fire Hazard Prevention

Observe the following precautions to prevent fire hazards when using organic solutions.

WARNING
1) Do not use organic solutions in the test.
2) The analyzer is not in explosion-proof design. Use any organic
solution with caution to prevent fire or explosion.

Maglumi 2000 Operating Instructions Page 3

Notes

4. Laser Hazard Prevention

Observe the following precautions to prevent laser burns caused by the barcode reader.

WARNING
Direct exposure of human retinas to lasers from the barcode reader will
cause eye injury. Do not look directly to laser beams from the barcode
reader.

Figure 2 Warning Symbol in the Sample Area

5. Waste Liquid Disposal

Observe the following precautions to prevent environmental pollution and injury when
disposing of waste liquid.

WARNING
1) Certain substances in waste liquid are subject to pollution control
regulations and emission standards. All departments shall comply
with local emission standards and consult the manufacturer or
distributor.
2) Discharge waste liquid of infectious patient samples to the
infectious disease disposal device.

6. Chemical Hazard Prevention

Observe the following precautions to prevent chemical hazards caused by reagents
and consumables.

WARNING
1) Read the reagent and consumable SDS carefully to understand
safety instructions and preventive measures.
2) Prevent hands and clothes from direct contact with reagents and
consumables. In case of accidental contact, wash hands or clothes
with soap and water immediately. If any reagent or consumable
contacts your eyes by accident, rinse your eyes with plenty of water
immediately and consult an ophthalmologist.

Page 4 Maglumi 2000 Operating Instructions

 Notes

7. Biochemistry Hazard Prevention

Observe the following precautions to effectively prevent biochemistry hazards.

WARNING
1) Incorrect use of samples may lead to infection. Do not touch
samples, mixtures or waste liquid with hands or other body parts.
During operation, always wear gloves and work clothes to prevent
infection, and wear protective glasses when necessary.
2) Cuvettes will contact potentially infectious patient samples, and
therefore used cuvettes must be disposed in waste bags to isolate
the potential infection source.
3) Use reagents with caution to prevent direct contact with hands and
clothes. In case of accidental contact, wash hands or clothes with
soap and water immediately. If contacts your eyes by accident,
rinse your eyes with plenty of water immediately and consult an
ophthalmologist.
4) If a small amount of sample or reagent spills on the analyzer, use
soft cloth and alcohol to clean it. If a large amount of sample or
reagent spills on the analyzer, immediately stop using it and timely
contact an authorized engineer for handling.
5) Before transporting the analyzer in a long distance, thoroughly
disinfect the analyzer to prevent spread of a potential infection
source.

Figure 3 Warning Symbol on the Waste Bag Bin

8. Waste analyzer Disposal

Adhere to the following requirements when disposing waste analyzer.

WARNING
Certain substances in waste analyzer are subject to pollution control
regulations. Comply with local regulations in disposal.

Maglumi 2000 Operating Instructions Page 5

Notes

9. Computer Virus Prevention

Observe the following precautions to prevent computer viruses.

WARNING
1) Use data movement and other data communication functions only
in the permitted range to prevent computer viruses or software
system damage caused by misoperation. Computer viruses can
spread via floppy disks, USB disks, network and other channels.
2) Do not install any unspecified software or hardware that may affect
normal operation of computer software systems. During system
operation, do not run other software.

Operation Notes

Carefully read the following operation precautions for proper and effective use of this
analyzer.
1. General Precautions
Before using this analyzer, understand application and general precautions of this
analyzer. If you do not follow the methods specified in the instructions, protection
provided by the analyzer may be undermined.

NOTE
1) This product is an in vitro diagnostic medical device used for
quantitative assay of metabolites in various endocrine hormones,
tumor markers, virus antibodies in human blood and urine. The
analysis results should be used with clinical symptoms or other
experimental results for clinical judgment.
2) Operating instructions are subject to change without prior notice.
Users can consult customer representatives according to the actual
situation.
3) This analyzer should only be used by medical laboratory
professionals or trained doctors, nurses, and laboratory
technicians.
4) Do not touch the computer monitor, mouse or keyboard using
hands with chemicals.
5) Do not fold or squash the drainage pipe. Otherwise, waste liquid
will overflow from other parts due to poor drainage. In severe
cases, it will cause damage to the analyzer.
6) The analyzer will generate heat during operation and the heat is
discharged through the rear of the analyzer. Therefore, the working
environment should be well ventilated to ensure cooling, and
ventilation analyzer can be used if necessary. Avoid direct airflow
blowing to the analyzer because it may affect reliability of results.
7) Before first use, adjust all parts of the analyzer to ensure the
accurate parts parameters.
8) The starter and system liquid must be free of bubbles. Otherwise,
reliability of test results cannot be ensured.
9) Ensure correct connection of starter bottles, and do not use the
mixed starters. Otherwise, reliability of test results cannot be
ensured.
10) Use new or pollution-free cuvettes to ensure analyzer operation
safety and test result accuracy.
11) To ensure analyzer operation safety and test result consistency, do

Page 6 Maglumi 2000 Operating Instructions

 Notes

not use expired system liquid.

12) Start the analyzer at least 30 minutes before use so that the
measurement system is stable. The temperature accuracy of the
incubator should be within ±0.5°C of the set value, with a deviation
no more than 1.0°C.
13) Before the test, check whether consumables (system liquid,
starters, cuvettes, control solution, etc.) are adequate.
14) Before the test, conduct at least one BGW and ensure the BGW
results are within the normal range. Otherwise, reliability of test
results cannot be ensured.
15) During pippeting, there should be no bubbles on the sample
surface to avoid pippeting error. Please do not remove the reagent
before the analyzer finish pippeting procedure.
16) When using this analyzer for sample analysis, quality control
procedures must be carried out. Otherwise, reliability of test results
cannot be ensured.
17) An alarm indicator is installed at the top of the analyzer. If any fault
occurs in the analyzer, the alarm indicator flashes and the buzzer
sounds. In this case, rectify the fault to ensure analyzer normal
operation and accurate test results. For detailed troubleshooting
methods, see Chapter 18.
18) Use our designated system tubing cleaning solution to clean and
maintain pipes.

2. Operation Environment

NOTE
Correctly install this analyzer in the installation environment required by
this manual. If the installation environment does not meet the
requirements, test results may be inaccurate and the analyzer may be
damaged.

3. Electromagnetic Compatibility

NOTE
1) Maglumi 2000 Immunoassay Analyzer complies with emission and
immunity requirements in IEC 61326-2-6-2012.
2) Users are responsible for ensuring the electromagnetic compatibility
environment that allows the analyzer to work properly.
3) You are advised to assess the electromagnetic environment before
using the analyzer.

WARNING
1) Maglumi 2000 Immunoassay Analyzer is designed and tested
according to requirements for Class A analyzer in IEC/CISPR
11:2010 . This analyzer may cause radio interference in the home
environment, and therefore protective measures should be taken.

2) It is prohibited to use the analyzer next to a strong radiation source

(for example, non-shielded RF source) because it may interfere
with normal operation of the analyzer.

Maglumi 2000 Operating Instructions Page 7

Notes

4. System Maintenance

CAUTION
1) Follow instructions in this manual to perform regular analyzer
maintenance. Incorrect maintenance measures may affect
accuracy and precision of test results, and may even lead to
analyzer failure or injury.
2) Before maintenance and repair, cut off all power supplies to the
system and disconnect the power plug. Otherwise, it may result in
analyzer failure or injury.
3) The analyzer may be stained with potentially infected patient
samples. During maintenance and repair, always wear gloves and
work clothes to prevent infection.
4) The analyzer surface may be covered by dust after long-term
placement. Use soft wet cloth to gently clean it. Take proper
measures to prevent water drops from getting into the analyzer.
5) The analyzer does not contain user-serviceable parts. Do not
attempt to remove the analyzer enclosure or dismantle parts. When
you need assistance, call the company's authorized personnel.

5. Sample, Reagent and Control Solution

WARNING
1) Drugs, anticoagulants and preservatives in samples may affect
certain test results.
2) Take correct sample storage measures. Incorrect sample storage
measures may change sample composition and lead to incorrect
test results.
3) To prevent sample volatilization, do not expose samples in the air
for a long time. Volatilized samples may lead to incorrect test
results.
4) Incorrect storage of reagents and control solutions may result in
inaccurate test results and poor system performance, even when
they are still within the validity period. Follow manufacturer
instructions for using reagents and control solutions.
5) Carry out calibration analysis after replacing reagents. Without the
calibration analysis, you may fail to get correct test results.

6. Data Backup

WARNING
This system allows automatic data storage on the computer's hard disk.
However, data cannot be restored if the data is deleted from the hard
disk or the hard disk is damaged due to certain reasons. Regularly back
up test results and analyzer parameters to other media, such as CD-
ROM.

Page 8 Maglumi 2000 Operating Instructions

 Notes

Other Notes

Observe the following precautions to ensure transportation safety and correct operation
of the analyzer.

1. Transportation Safety Information

The person in charge of transportation should transport goods according to the
information provided on the packing. Correctly pack the analyzer as the company's
requirements before transportation.
Wood packing dimensions:

Maglumi 2000
Length: 150 cm
Width: 94 cm
Height: 110.2 cm

2. Rated Input Information

 Input voltage: a.c.100 V-240 V
 Frequency: 50 Hz/60 Hz
 Input power: 500 VA, well grounded (neutral to ground: < 2 V)

3. Input and Output Connection Terminals

RS232 port: used for

communication and
control between the
analyzer and computer

4. Switches

Main Switch

Subman Switch

5. Requirements for Storage and Operation Environments

 Storage conditions: temperature: -20°C~55°C; relative humidity: ≤ 93%;

 Operation conditions: temperature: 10°C~30°C; relative humidity: ≤ 70%, air-
conditioner recommended; atmospheric pressure: 85 kPa~106 kPa.

Maglumi 2000 Operating Instructions Page 9

Notes

6. Analyzer Dimensions and Weight

Maglumi 2000
Front length: 135 cm
Width: 64 cm
Height: 87 cm
Working height: 130 cm
Weight: 158 kg

Warning symbols

Warning infection
This sign is located in all area of the machine involving risk of biological infection to
remind the people around. It is on
The frontage of the waste container
The frontage of the waste tank
The right side of the sample area
The up side of the reagent area

No Mixing
This sign is located in the area where the solution is placed to remind not mixing up the
solution together. It is on
The tray of the starter

Warning danger
This sign is located in the area where it is easy to get hurt to remind the safty.It is on
Below the hinge in the middle of the main support
Interior of the reagent area
Interior of the sample area

Page 10 Maglumi 2000 Operating Instructions

 Notes

Watch out for the laser

This sign is located in the area with laser beam to the danger of the laser beam. It is on
The shell of the machine

Laser window
This sign is located at the laser beam exit window. It is in
The right side of the interior of the sample area

Watch out for the movement of moving component

This sign is located in the moving part of the machine to remind not touching the
moving component during operation. It is in
The frontage of the pipetting arm

Watch out for your safety when opening the cover

This sign is to remind not opening the cover when the machine is working. It is on
The positive side of the handle on the cover

Maglumi 2000 Operating Instructions Page 11

Notes

Warning hands pinching

This sign is located in the component with squeezing moving part to remind the danger
of clamping hand. It is on
the plate covering the pipetting area
incubator stacker

Warning for electric shock

Pay attention the words on the sign. It is on
The top right side of the shell on the back side of the machine

Other symbols

Symbols Description

Manufactured

Catalogue Number

In Vitro diagnostic medical device

Serial Number

Page 12 Maglumi 2000 Operating Instructions

 Notes

This way up
This sign is to remind the direction of the package should be upright during transport. It
is on
The frontage of the package
The frontage of the wooden box

Keep away from rain

This sign is to remind keeping the package from rain during transport. It is on
The frontage of the package
The frontage of the wooden box

Fragile
This sign is to remind fragile subject inside, moving carefully. It is on
The frontage of the package
The frontage of the wooden box

Rolling is forbided
This sign is to remind not rolling the package during transport. It is on
The frontage of the package
The frontage of the wooden box

Maglumi 2000 Operating Instructions Page 13

Notes

Page 14 Maglumi 2000 Operating Instructions

 1 About This Instructions

1 About This Instructions

1.1 Text conventions

To facilitate quick understanding and use of this manual, text styles occur in this
document are defined as follows:
 Menu, interface and dialog names are boldfaced and put in the symbol []. For
example, [Definition] menu, [Sender] interface and [Sender Input] dialog.
 Button names are boldfaced and put in <>. For example, <OK> and <Add> button.
 User input is boldfaced and appears in "". For example, [Sample Pipetting
Volume] "2" [μl].

1.2 Button

Common buttons explain:

Button Description
Red means the assay is not selected.

Green means the assay is selected.

Page front

Page back

Turn to the first page

Page up

Move to previous line

Move to next line

Page down

Turn to the last page

Maglumi 2000 Operating Instructions Page 1-1

1 About This Instructions

1.3 Word

Symbols Words Description

Read the statement following the symbol. The
WARNING statement is alerting you to an operating hazard
that can cause personal injury.
Read the statement following the symbol. The
CAUTION statement is alerting you to a possibility of
system damage or unreliable results.
Read the statement following the symbol. The
NOTE statement is alerting you to information that
requires your attention.

1.4 Glossary

Glossary Description
Analyzer The instrument, but not PC, printer and connection cables
Back Transport In second pipetting step, transfers cuvettes to proper positions in
the incubator
Barcode Reader Assembly to read the sample barcode
BGW Backgroud Wash, test to check quality of analyzer washing
Chamber Assembly for measurement
Cuvette Every cuvette has six cavities plastic module, in which
immunometrical reaction can take place
CV% Coefficient of variation, shows dispersion rate of measurements
Incubator Assembly in which cuvettes are incubated and pipetted
LC-le Light check of left pipettor is used to test accuracy of pump
volume and stability of the analyzer.
LC-ri Light check of right pipettor is used to test accuracy of pump
volume and stability of the analyzer.
Light Check Consumable provided as lyophilized material.
Loader Including incubator loader and washer loader.
Pipettor Left and right pipetting needles are used for pipetting samples
and reagents
Pump system For high-precision pipetting, washing and starter injection
Pusher Exchanges cuvettes between washer and chamber.
Reader Including Barcode reader and RFID reader
Reagent Area Loading area for reagent
RFID Radio Frequency Identification Devices, micro-chip present on
reagent to allow recognition and data storage
RLU Relative Light Unit (signal measurement unit)
Samples Anything that can be introduced by operator into sample area
racks, including patient samples, controls and external calibrators
Samples Area Loading area for samples
Samples Rack 12 positions module to host sample tubes
Stacker Assembly to store cuvettes
Starter Reagents Reagents dispensed during the reading to generate
chemiluminescent signal
System Liquid Solution (to be diluted 1:13 in purified water) to wash pipetting
needles and magnetic microbeads after reaction.
Washer For washing unreacted material in cuvettes.
Waste Bag Container for used cuvettes.

Page 1-2 Maglumi 2000 Operating Instructions

 2 Measuring Principle

2 Measuring Principle

2.1 Assay Procedure

Figure 2.1-1 Assay Procedure

Maglumi 2000 Operating Instructions Page 2-1

2 Measuring Principle

2.2 Measuring Principle

The analyzer's photomultiplier is used to detect light produced in chemiluminescence

reaction, within the wavelengths range between 300nm to 650nm. The light peak of the
chemiluminescence is emitted at a wavelength of 420nm The light produced in
chemiluminescence reaction is emitted to the photomultiplier and reaches the
photocathode plane through the incidence window, triggering photons on the
photocathode plane emitting photoelectrons into a vacuum. Photoelectrons accumulate
at the first dynode through the focusing electrode, pass subsequent dynodes for
secondary electron multiplication, and then secondary electrons emitted from the last
dynode are output through the anode. The photomultiplier anode collects secondary
electrons after multiplication by dynodes and outputs current signals through an
external circuit.

To eliminate differences between photomultipliers and ensure test result consistency

between different analyzer, relative light unit (RLU) is used as the unit of measurement
for original data.

After being pipetted to the cuvette, samples and reagents are blended, washed and
separated before the cuvette is sent to the chamber. Starter 1 is injected into the first
hole in the cuvette bar, and then Starter 2 is injected into the same hole after 2.5
seconds, triggering chemiluminescence reaction. Detection of optical signals starts 0.1
second after the chemiluminescence reaction and obtains optical signals of 3.0
seconds. Repeat this step to detect the other five holes in the cuvette bar.

Figure 2.2-1 Kinetics Curve

Page 2-2 Maglumi 2000 Operating Instructions

 2 Measuring Principle

2.3 Calibration

Because there are differences between the actual working environment and laboratory
environment, the master curve should be adjusted to generate the working curve that
meets the actual work environment.

Brief description:
 The master curve is determined by 10 standard calibrators.
 Compare two calibration RLUs obtained by calibrators with RLUs of related
concentration on the master curve.
 Calculate the difference between two calibration RLUs obtained by calibrators and
RLUs of related concentration on the master curve, and carry out linear inference
using the recalculated RLU (Y-axis) and concentration (X-axis).
 Calculate RLU differences of other calibrators on the master curve with the
correction carve and recalculate the RLU and concentration.
 The recalculated curve is a valid working curve.

Figure 2.3-1 Calibration Principle

Maglumi 2000 Operating Instructions Page 2-3

2 Measuring Principle

Page 2-4 Maglumi 2000 Operating Instructions

 3 System Description

3 System Description

Maglumi 2000 Immunoassay Analyzer and a series of supporting diagnostic reagents

constitute a precise trace assay system, which features direct chemiluminescence
immunoassay based on magnetic separation of ABEI markers. It is used to
quantitatively or qualitatively analyze analytes in common clinical samples, including
serum, plasma, urine, whole blood. The analyzer automatically completes sample and
reagent pipetting, incubation, washing, measurement and result calculation, reducing
errors in test results and improving accuracy and precision of test results.

3.1 System Structure

The analyzer is composed of material supply module, tubing system module,

temperature control module, mechanical transmission module, optical path detection
module and circuit control module.
 The material supply module includes stacker, sample area module, reagent area
module, system liquid module, waste liquid module, starter module and cuvette
Waste Bag Bin module.
 The tubing system module comprises a pipetting tubing system, system liquid
tubing system, optical path detection tubing system and condensate water tubing
system.
 The temperature control module consists of an incubator heating module,
incubator loader heating module, back transport pipetting area heating module,
reagent cooling module and photomultiplier cooling module.
 The mechanical transmission module comprises cuvette loader, stacker, reagent
shaker, incubator, incubator loader, washer loader, washer transport, washer lift,
back transport, pusher, chamber transport, chamber lift and pipettor.
 The optical path detection module is composed of a chamber module,
photomultiplier module and main control circuit.
 The circuit control module consists of a power module, main control board, wire
harness and a variety of sensors and motors. The computer is an optional
accessory.

Maglumi 2000 Operating Instructions Page 3-1

3 System Description

3.2 Analyzer

Figure 3.2-1 Maglumi 2000 System Components

(1) Stacker (2) Loader (3) Left pipettor (4) Incubator

(5) Washer (6) Right pipettor (7) Pusher (8) Chamber
(9) Pump unit (10) Reagent area (11) Barcode reader (12) RFID reader
(13) Sample area

Figure 3.2-2 Schematic Diagram of the Components (view from above without cover and pipetting
units).

Page 3-2 Maglumi 2000 Operating Instructions

 3 System Description

Pipetting area:
a) First step pipetting
b) Second step pipetting
c) Third step pipetting

Hose connection:
a) System liquid (pipetting system)
b) System liquid (washer)
c) Waste liquid 1
d) Waste liquid 2

Power connector/data cable connector:

a) Serial port
b) Power connector
c) Main power switch
d) Subman power switch

3.2.1 Sample Area

Open the sample area door and run the operating software to automatically log in to
the [Patients] interface.

There are 12 rack tracks in the sample area, and each rack rear panel corresponds to
an LED.

 Green LED on: There is no rack or rack use is complete.

 Orange LED on: The rack is in use.

CAUTION
When the orange LED is on, do not remove the rack.

1. Loading samples
Ensure that sample tubes are placed upright in the rack.

NOTE
When labels with barcodes are used on sample tubes, ensure that
barcodes face the right to the opening of the rack.

Figure 3.2-3 12 Sample Slots in the Rack

2. Loading sample rack

The rack has a handle on the user side and a bolt for mechanical locking on the
analyzer side. Hold the rack handle and slide the rack into the track till the stopper
position, accompanied by a "click". When the rack is correctly inserted, the software
automatically detects and displays it on the display.

Maglumi 2000 Operating Instructions Page 3-3

3 System Description

When the rack is correctly inserted, the operating software automatically detects and
displays it on the display. If barcodes are used, ID information of samples is
automatically displayed in the editable input box in Sample Info of [Patients] interface.
Other sample information can be called through a remote computer or manually input.
If there is no barcode, you can enter sample information manually in the input box.

NOTE
Use only the rack provided by our company. Using other racks may
cause damage to the analyzer.

Figure 3.2-4 12 Sample Tracks in the Sample Area

3.2.2 Reagent Area

The reagent area is accessible from the front cover. Open the reagent area door or run
the operating software to automatically call the [Reagents] interface. Because the
reagent needs to be kept at a low temperature, only open the reagent door temporarily
for loading reagents.

The reagent area has 15 reagent tracks. The reagent is covered by a piece of holed
(reserved for pipetting) organic glass.

ID label
Magnetic microbeads
mixing gear
RFID label

Figure 3.2-5.Reagent Structure

Page 3-4 Maglumi 2000 Operating Instructions

 3 System Description

Each reagent provides space a maximum of 7 positions. The first position of each kit is
for magnetic microbeads. After the analyzer starts, it keeps the magnetic microbeads in
the evenly mixing state through the action of a shaker spline.

An RFID tag is attached to one side of the reagent and the RFID data can be read by
the RFID reader. The reagent has a handle at the end and a clip in the front for
fastening the reagent.

Figure 3.2-6 15 Reagent Tracks in the Reagent Area

Loading reagent
Remove the seal on the reagent. Hold the reagent handle and put the RFID tag near to
the RFID reader. If reading is correct, the buzzer beeps. Insert the reagent to the
selected track till the stopper position. When the reagent integral is correctly inserted,
the software automatically detects and displays it on the display. Before the test, keep
the reagent in the track for at least 30 minutes so that the magnetic microbeads are
mixed evenly and get suspended.

NOTE
Read related information provided by the manufacturer before using
reagents.

3.2.3 Barcode Reader and RFID Reader

3.2.3.1 Barcode Reader

WARNING
A barcode reader emits laser beams that are harmful to eyes.
Therefore, do not look into the barcode reader.

The barcode reader is located between the sample area and reagent area. When you
open the sample area door, the barcode reader starts up automatically.

After a sample rack is inserted, barcode labels of the rack and sample tubes are
automatically read. The inserted rack is displayed in [Patients] interface, and sample
information is displayed in Sample Info.

Maglumi 2000 Operating Instructions Page 3-5

3 System Description

Table 3.2-7 Printing Requirements for Sample Tube Barcodes

Data
Barcode Barcod
Supported Length Recommended Recommended
Parity Width e
Coding type Range Width (mm) Height (mm)
(mm) Height
(characters)
Code128
1-25 Mandatory 0.3 -0.8 N/A 0.33 10
/EAN128
Code39 1-25 Optional 0.3 -0.8 N/A 0.33 10
Codabar 1-2 Optional 0.3 -0.8 N/A 0.33 10
Code
8 Mandatory 0.3 -0.8 N/A 0.33 10
UPCA/UPCE
Code EAN
8 or 13 Mandatory 0.3 -0.8 N/A 0.33 10
8/13
Code93 1-25 Mandatory 0.3 -0.8 N/A 0.33 10
Code2/5
2-24 Optional 0.3 -0.8 N/A 0.33 10
Interleaved

Blank area at both sides shall be at least 7 times the width of the barcode

When the coding type is Code39, Codabar or Code2/5 Interleaved, the barcode reader
does not check parity during data reading and processes parity as common bits, which
may cause inconsistency between read information and encoded information. If you
print a barcode with parity for the above three coding types, the following system
settings can be used to avoid information misreading.

1. Click Maglumi Service icon on the desktop to open [Maglumi 2000 Service]
software.

Figure 3.2-8 [Maglumi Service] software

2. Click <Globals> button to open the [Globals] dialog.

Page 3-6 Maglumi 2000 Operating Instructions

 3 System Description

Figure 3.2-9 [Globals] dialog.

3. Click <Barcode> button to open the [Barcode] dialog box.

Figure 3.2-10 [Barcode] dialog

4. Change the CheckSum of the related coding type to 1.

3.2.3.2 RFID Reader

The RFID reader uses wireless technology to read RFID data from the kit. Its operating
band is 13.553~13.567 MHz, within the fundamental frequency of ISM analyzer.

Place the RFID side of the reagent within 30 mm of the reader. If the buzzer beeps
once, means that the data is successfully read. Then, insert the reagent into a reagent
track. The [Reagents] interface displays information about this reagent.

NOTE
When multiple reagents need to be loaded, repeat the above operating
procedure for loading one by one.

3.2.4 Pipettor

Left and right pipetting needles are used for pipetting samples and reagents,
respectively.

Maglumi 2000 Operating Instructions Page 3-7

3 System Description

Left pipettor is used for pipetting samples, control and calibrators. This pipetting needle
is washed in washing hole 1 (See Figure 3.2-2).
Right pipettor is used for pipetting reagents. This pipetting needle is washed in washing
hole 2 (See Figure 3.2-2).

The pipetting unit is automatically positioned in the pipetting area by the software.

Figure 3.2-11 Pipetting Needle

NOTE
To ensure correct pipetting operation, liquid surface in sample tubes
must be free of bubbles.

Clot detection function

The pipetting needle can detect clots in samples. When a clot is detected or pipetted,
the left pipetting unit immediately moves to the left washing hole and washes the
pipetting needle. The second pipetting unit completes the pipetting procedure
independently. The software notifies the user of clots detected and adds a mark (D) to
this sample in [Test Result].

3.2.5 Stacker

A stacker has 7 layers and each layer can store 14 cuvette bars, providing a maximum
processing capacity of 120 cuvettes.

Loading cuvettes

The cuvette loading area is located on the left of the analyzer.

Place 8 cuvette bars each time. After the photoelectric sensor detects the cuvettes,
horizontal conveyor automatically transfers the cuvettes to the stacker. When the
number of cuvette bars on a layer of the stacker reaches 14, the stacker automatically
lifts a layer and continues to load cuvettes till the seventh layer.

NOTE
The stacker should be emptied once a month to ensure its cleanliness!

Page 3-8 Maglumi 2000 Operating Instructions

 3 System Description

Figure 3.2-12 Cuvette Loading Area

3.2.6 Incubator

Figure 3.2-13 Incubator

According to test requirements, cuvettes loaded with samples and reagents are
incubated at 36.8°C ± 0.5°C in the incubator. The incubator can incubate 16 cuvettes
each time, and the incubation time is controlled by software.

If the temperature is abnormal, the icon automatically appears on the display.

(See Chapter 13)

Maglumi 2000 Operating Instructions Page 3-9

3 System Description

3.2.7 Incubator Loader and Washer Loader

Washer loader
Incubator loader

Figure 3.2-14 Incubator Loader and Washer Loader

Incubator loader
The incubator loader transfers cuvettes in the stacker to the left pipetting area and
pushes them to blank positions in the incubator after pipetting.

Washer loader
The washer loader transfers cuvettes from the incubator to the washer. after cuvette
incubation completes.

3.2.8 Washer

Figure 3.2-15 Washer

Magnetic microbeads are washed in the washer with waste liquid pumped away. Three
independently controlled washing pumps connected three injecting needles pump
system liquid.

Page 3-10 Maglumi 2000 Operating Instructions

 3 System Description

Fastened to the washer lift, 3 aspirating needles are connected to a wash soak
(peristaltic pump) for draining waste liquid from cuvettes.

The washer lift has the 4 positions:

 Initial position: At this position, waste liquid needles are fully elevated to a position
where cuvettes can move freely.
 Injection position: At this position, the center of wash needle outlet and the top
edge of cuvette should at the same height.
 Pipetting position: At this position, waste liquid needles touch the bottom of
cuvettes.
 Washing position: At this position, the washer lift is slightly above transport track.

3.2.9 Pusher

Figure 3.2-16 Pusher

After being washed by the washer, cuvettes are transferred to the pusher.

 Scenario 1: cuvettes are transferred to the right pipetting area for second-step
pipetting, incubation, washing and measurement.
 Scenario 2: cuvettes are transferred to the chamber for measurement

3.2.10 Back Transport

Figure 3.2-17 Back Transport

The back transport is used for second pipetting of cuvettes.

 Step 1: cuvettes are transferred from the pusher to the right pipetting area.
 Step 2: After cuvettes are pipetted in the right pipetting area, the back transport
transfers cuvettes to proper positions in the incubator.

Maglumi 2000 Operating Instructions Page 3-11

3 System Description

3.2.11 Chamber

Figure 3.2-18 Chamber

After going through the washer, samples are sent to the sealed dark chamber for
measurement. Starter 1 and Starter 2 are injected successively at certain angles into
cuvettes to through two independently controlled starter pumps ensure that the
magnetic microbeadss are resuspended. The geneated optical signals are accurately
measured through the photomultiplier.
After each measurement, the waste liquid is drained. After being measured, the cuvette
is transferred to the waste bag.

3.2.12 Pump System

Maglumi 2000 Immunoassay Analyzer offers a range of independently operating pump

systems for high-precision pipetting, washing and starter injection, including:
 Two plunger pumps for pipetting units.
 Waste liquid pump for two washing holes of the pipetting unit.
 Vacuum pump for washing pipetting needles.
 Pump for the washer.
 Starter pump for the chamber.
 Wash soak for draining waste liquid from the washer.
 Waste liquid pump for the chamber.

NOTE
Pump maintenance must be carried out by professionals or according
to the instructions.

Page 3-12 Maglumi 2000 Operating Instructions

 3 System Description

3.2.13 Starter

Starter reagents containers are located on the right of the analyzer. S1 and S2 are
marked to indicate Starter 1 and Starter 2, respectively. Starter status is detected by a
liquid level detector in the starter container. After starter supplement or replacement,
you need to click <SystemTest> in the menu bar to prime the tubing system to ensure
that the tubing system is filled with starter.
Starter tubing system pressure: -0.5~0.1 bar

Figure 3.2-19 Starter Reagents Container

CAUTION
Do not spill starter in this area!

3.2.14 System Liquid

System liquid is used to wash pipetting needles and magnetic microbeads after
reaction.
The system liquid container has a liquid level detector for detecting remaining liquid
amount. After supplement or replacement of system liquid, you need to click
<SystemTest> in the menu bar to fill up the tubing system.
System liquid inlet pressure:-0.5~0.5 bar
The ports are connected to the analyzer using a coupling head. Press the metal clip to
release and remove the pipe.

3.2.15 Cuvette Waste Bag Bin and Waste Liquid

1.Cuvette Waste Bag Bin

Located on the right of the analyzer, the cuvette waste bag bin is next to the chamber.
Put a waste bag in the waste bag bin to collect waste cuvettes.

CAUTION
It is essential to correctly place a waste bag under the cuvette outlet.
Otherwise, the waste bag edge will block cuvettes and cause
interruption of operation.

Maglumi 2000 Operating Instructions Page 3-13

3 System Description

When the waste bag is full, users must take it out of the waste container and seal it with
a cover.

NOTE
During assays, cuvettes may come into contact with potentially
infectious materials. Therefore, it is necessary to properly dispose of
waste bags.

Figure 3.2-20 Cuvette Waste Bag Bin

2. Waste Liquid
Two waste liquid pipes are connected to Waste liquid 1 and 2 outlets on the right of the
analyzer.
 Waste liquid 1 comes from washer and liquid in cuvettes, containing magnetic
microbeads, starter, patient samples and laboratory reagents.
 Waste liquid 2 comes from the pipetting needles washing, mainly composed of
system liquid.
Waste liquid outlet pressure: -0.5~0.1 bar.

WARNING
Biological waste must be disposed of in accordance with related
laboratory regulations.
Do wear protective gloves!
Waste bag and waste bin status is displayed by <Waste Status> icon.(See Chapter 13)

Page 3-14 Maglumi 2000 Operating Instructions

 3 System Description

3.3 Computer System

3.3.1 Computer System Components

A computer system is installed with operating software to control system operation and
data processing. It is composed of a computer, 19-inch LCD minitor, keyboard, mouse
and printer.
 Computer: installed with Windows operating system, specific application software
and database.
 Minimum configuration: CPU frequency ≥ 2.0 GHz, hard disk ≥ 320 GB, memory ≥
1 GB, three RS-232 serial ports, USB port.
 Touch monitor: windows, curves and test data of Maglumi 2000 Immunoassay
Analyzer operating software are displayed on the monitor.
 Keyboard: for operation control and data input of Maglumi 2000 Immunoassay
Analyzer.
 Mouse: for software operation.
 Printer: for printing test data and charts.

3.3.2 Basic Operations in Software Interface

3.3.2.1 Using the Touch monitor Mouse and Keyboard

The software is easy to use with a touch screen, mouse and keyboard.

Touch monitor operation

Touch the monitor with a finger or a touch pen to realize the same functions of the
mouse.
 Touch a button to activate the related function.
 Touch an option or control zone to activate the corresponding function.
 Touch an input box and use the keyboard to input content at the cursor.

Mouse operation
Commonly used mouse functions can be executed.
 Click to select a function or option.
 Double-click to open the selected file.
 Drag the mouse to select an area or range

Keyboard operation
Enter letters, words and numbers using the keyboard.
In the dialog box, repeatedly press <Tab> key till the desired option is selected and
press the <Enter> key to confirm. Press <Del> key to delete the selected document.

Maglumi 2000 Operating Instructions Page 3-15

3 System Description

3.3.2.2 Software Components

Figure 3.3-1 Software Interface

The software has 5 different levels of windows:

1. Menu Bar: displays different menu. It has 9 menu buttons.

Figure 3.3-2 Menu bar

Button Description

<Start> It is for starting measuring samples or controls.

It is for entering system test functions e.g. flush tube system
<System Test>
and carry out internal test measurements.
<Patients> It shows the information of samples.

<Reagents> It shows the information of reagents.

It is for entering process functions e.g. automatic clearance of
<Process>
the cuvettes.
It is for users to set assays, controls, dilutions, assay groups
<Definitions>
and assay profiles, sample senders.
It displays system parameters as well as selection of
<System>
operating modes.
<Report> It is for managing results.

<Home> Return to the home.

2. Interface: displays function interface in different menu, including [Home] interface,

[Patients] interface, [Reagents] interface and submenu interface.

Page 3-16 Maglumi 2000 Operating Instructions

 3 System Description

Figure 3.3-3 [Home] Interface

3. Status Bar: display analyzer status and relogin or exit the software.

Figure 3.3-4 Status Bar

Icon Button Description

< Message Box> It is used for showing the actual system
and error messages.
<Pause Measure>
It is for emergency stop of the analyzer.

<Reservoir Status> It indicates the status of the system

liquid, starter reagents and cuvettes.
<System Parameter> It indicates the supply voltage and
temperature.
<Waste Status> It indicates the status of waste liquid and
waste cuvette.
<Relogin>
It is used for relogin the software.

<Close Software>
It is used for exiting the software.

4. Submenu: click the <Process>, <Definitions>, <System> or <Report> button on

the menu bar, on the left display its submenu buttons.

Maglumi 2000 Operating Instructions Page 3-17

3 System Description

Figure 3.3-5 [System] Submenu

5. Dialog
A dialog box can open one or more sub-dialog boxes.
There are two different types of dialog boxes.
a) Clicking submenu button triggers a dialog. For example, click <Initialize> button in
[Process] menu to open message confirmation dialog.

Figure 3.3-6 Message Dialog

b) Clicking a button in submenu interface triggers a dialog. For example, click <Edit>
button in [Test] interface to open [User Specific Assay Data] dialog.

Page 3-18 Maglumi 2000 Operating Instructions

 3 System Description

Figure 3.3-6 [User Specific Assay Data] Dialog

3.4 Testing Performance

3.4.1 Batch Assay Repeatability

Assay repeatability in a batch (CV%) ≤ 8%.

3.4.2 Linear Correlation

In the concentration range of two or more orders of magnitude, the linear correlation
coefficient should be equal or more than 0.99.

3.4.3 Carryover Rate

The Carryover rate should be equal to or less than10-5.

3.4.4Stability

Differences between the test results in the 4th and 8th hours after the analyzer runs
stably and those in the initial stable running status are within ±10%.

Maglumi 2000 Operating Instructions Page 3-19

3 System Description

3.5 Accessories Required But Not Provided

Catalogue Number Name

630003 Reaction Modules

21060625 Waste Bag

130299005M Wash Concentrate

System Tubing Cleaning
130299007M
Solution
130299004M Starter 1+2

130299006M Light Check

Page 3-20 Maglumi 2000 Operating Instructions

 4 Installation and Startup

4 Installation and Startup

This chapter describes how to install and start Maglumi 2000 Immunoassay Analyzer.
Basic analyzer installation is implemented by engineers trained and authorized by
Snibe.
Users can install and use the system according to the installation procedure.

NOTE
1) To ensure user safety, installation and commissioning of analyzer
can only be implemented by professionals trained and authorized
by Snibe.
2) Analyzer must run under the operating conditions specified in the
instructions.

4.1 Analyzer Transportation and Storage Requirements

4.1.1 Transportation Requirements

 The analyzer must be transported in the upright direction and cannot be tilted.
 Analyzer must be free of moisture, water, violent vibration and extrusion during
transportation, and handled gently during loading and unloading.

4.1.2 Storage Requirements

 The analyzer should be stored in a well-ventilated indoor environment without

chemicals, corrosive gases or strong sunlight.
 The temperature should be -20°C~55°C and relative humidity ≤ 93%.

4.2 Installation Requirements

4.2.1 Installation Environment Requirements

 For indoor installation and use only. The installation environment should be well-
ventilated and free of dust, mechanical vibration, loud noise and power
interference.
 The table should be flat and able to withstand a minimum weight of 158 kg.
 When the analyzer is working properly, the highest volume at 1 m distance is 40
db.
 Atmospheric pressure: 85 kPa~106 kPa.
 No corrosive or flammable gases.

4.2.2 Power Requirements

 Voltage: a.c.100 V-240 V, frequency: 50 Hz/60 Hz.

 Rated power: 500 VA
 Circuit breaker specifications: F6AL250V (power filter), F3AL250V, F5AL250V,
F10AL250V, F15AL250V (control circuit board)

Maglumi 2000 Operating Instructions Page 4-1

4 Installation and Startup

 The analyzer requires a well grounded electrical outlet to provide desired power.

4.2.3 Space Requirements

To ensure space required for repair and maintenance, analyzer installation must meet
the following requirements:
 Analyzer dimensions: length x width x height: 135 cm x 64 cm x 87 cm
 Analyzer weight: 158 kg
 The distance between the analyzer rear and the wall cannot be less than 50 cm.
 The distance between left and right sides of the analyzer and the wall cannot be
less than 50 cm.
 The distance between the analyzer front and other analyzer cannot be less than
100 cm
 The power outlet should be located in a place with enough space to facilitate
connecting and disconnecting the power cable. Do not place the analyzer in a
place where it is difficult to operate the disconnecting device.

4.2.4 Temperature and Humidity Requirements

 Ambient temperature: 10°C~30°C, air-conditioner recommended;

 Relative humidity: ≤ 70%

4.3 Unpacking Inspection

4.3.1 Unpacking Procedure

After arrival of the analyzer, carefully check analyzer packing. If there is damage,
contact with Snibe or your local dealer. If there is no external damage, unpack the
analyzer under the following procedure:
1) The packing case must be placed upright to the arrow direction.
2) Open the accessory box and main box, and check inside items according to the
packing list. If there is any item missing, contact with Snibe or your local dealer.
3) Carefully check the appearance of the analyzer. If it is damaged, immediately
contact with Snibe or your local dealer.

4.3.2 Analyzer Transportation and Fastening

 The analyzer can be directly moved in a short distance and stable manner. Two
installation holes can be installed with metal handles on the two sides of the
analyzer. When it is necessary to move the analyzer, install the handles;
 The analyzer should be kept in an upright position all the time during
transportation.
 Minimize vibration during transportation. After transportation, check and
commission the analyzer before use.
 Adjust foot height to ensure analyzer levelness when fastening the analyzer.

Page 4-2 Maglumi 2000 Operating Instructions

 4 Installation and Startup

Metal handle

Figure 4.3-1 Metal Handle

4.4 Analyzer Installation

4.4.1 System Circuit Connection

Computer connection:
1) Connect the monitor, keyboard and mouse to the related ports on the rear of the
computer case.
2) Connect the connection cable of the monitor touch screen to the USB port on the
rear of the computer case.
3) Connect power cables of the computer case and monitor to the related ports.
4) Connect an RS232 cable to the COM1 serial port on the rear of the computer
case.

Analyzer connection:
1) Connect the other end of the RS232 cable to the RS232 port next to the power
supply port on the left side of analyzer.
2) Connect the analyzer's power cable to the power supply port on the left side of
analyzer.
3) Connect all power cable to electrical outlet.

4.4.2 System Liquid Tank and Waste Liquid Tank Connection

Connection ports for the system liquid tank and waste liquid tank are on the right of the
analyzer. System liquid preparation should follow the corresponding instructions for
use.

Maglumi 2000 Operating Instructions Page 4-3

4 Installation and Startup

Figure 4.4-1 System Liquid and Waste Liquid connection ports

Use a coupling head to connect conduits to the analyzer, and press the metal clip to
remove the conduits.
1) Install the cover with a system liquid level detector to the tank marked "System
liquid".
2) Install the cover with a waste liquid level detector to the tank marked "Waste
liquid".
3) Connect two hoses from the system liquid tank to ports "System liquid 1" and
"System liquid 2" on the right of the analyzer.
4) Connect two hoses from the waste liquid tank to ports "Waste liquid 1" and "Waste
liquid 2" on the right of the analyzer.
5) Connect the level sensor cable from the system liquid tank to the port "System
Liquid Sensor" on the right of the analyzer.
6) Connect the level sensor cable from the waste liquid tank to the port "Waste
Liquid Sensor" on the right of the analyzer.

4.4.3 Starter Connection

The starters reagent storage box housing is located on the right of the analyzer.
Open the protective cover of the starter storage box.
1) Connect the white conduit marked "S1" to the bottle marked starter 1.
2) Connect the white conduit marked "S2" to the bottle marked starter 2.
3) Connect the level sensor cable to the reagent bottle marked starter 1 and "S1"
port on the right of the analyzer.
4) Connect the level sensor cable to the reagent bottle marked starter 2 and "S2"
port on the right of the analyzer.
5) Close the protective cover of the reagent storage box.

4.4.4 Waster Bag Placement

The waste bag bin is located on the right of the analyzer chamber.
1) Open the protective cover of the waste bag bin.
2) Place a waste bag.
3) Close the protective cover of the waste bag bin.

CAUTION
Waste bag must be properly installed to ensure that the waste bag is
under the chamber outlet. Otherwise, the waste bag may block cuvettes

Page 4-4 Maglumi 2000 Operating Instructions

 4 Installation and Startup

from the chamber, causing analyzer error reporting and operation

interruption.

4.4.5 Cuvettes Loading

Each cuvettes has six reaction holes used as sample reaction and result assay
reactors.
Cuvettes loading procedure:
1) Open a bag of cuvettes and take out a set (4 to 8) of cuvettes.
2) Place the cuvettes on the conveyor of the cuvette loader.
3) The conveyor automatically moves and transfers the cuvettes to the stacker.
4) When the conveyor stops, place the next set of cuvettes.
5) Repeat the above steps until the stacker is full (maximum capacity: 120 cuvettes).

4.5 Power-on and System Startup

Before starting the system, ensure that the procedure in section 4.4.1 "System Circuit
Connection" has been completed.
Start the system as follows:
1) Start the analyzer.
2) Start the PC system and operating software.
3) Perform system testing.

4.5.1 Starting the Analyzer

Power on the analyzer and turn on the main switch and submain switch on the left of
the analyzer.

4.5.2 Starting the PC System and Operating Software

Power on the host and monitor, and wait for the system to start (when the system
desktop appears, the system startup is complete).
The Maglumi 2000 user software button is generally located on the Windows system
desktop.
1) Double-click the User.exe on the desktop using a mouse or a touch screen.
2) Enter a correct user name and password to access the Maglumi software system.
The default user name and password are snibe.

Figure 4.5-1 [Login] Dialog

3) After you enter a correct user name and password, the Maglumi software system

Maglumi 2000 Operating Instructions Page 4-5

4 Installation and Startup

automatically starts.
4) After the system is connected to the analyzer, the system automatically runs the
initialization command to initialize analyzer components.
5) After initialization is complete, the analyzer is ready to work if there are no error
messages or pop-up windows.

4.5.3 Performing System Test

When analyzer initialization is complete and there are no error messages or pop-up
windows, perform system testing as follows:
1) Perform the component prime test according to the requirements in Table 4.5-2.
Table 4.5-2 System test (round 1)
Number of Times
Priming Pipettor 3

Washer 6
Chamber 3
Cuvettes BGW 0

LC-le 0

LC-ri 0

2) After the prime test is complete, perform the background test and left and right
pipetting needle checks according to the requirements in Table 4.5-3.

Table 4.5-3 System test (round 2)

Number of
Times
Priming Pipettor 0

Washer 0
Chamber 0
Cuvettes BGW 1

LC-le 1

LC-ri 1

The requirement of system test results : details see 9.1.

Page 4-6 Maglumi 2000 Operating Instructions

 5 Daily Operating Process

5 Daily Operating Process

This chapter mainly introduces the basic operating process of this system. After
learning the content of this chapter, users are able to use this system to complete basic
daily operation.

5.1 Daily Operating Process

Table 5.1-1 Operating process for daily testing

Operating steps Operation

1. Check before starting
Confirm the power supply is normal;
(1) Check the power supply
Make necessary check for the appearance and status
(2) Check the analyzer
of the analyzer.
2. Power-on
Connect the power supply , and turn on the main
switch and submain switch of the analyzer .
3. Log in the user software
Input the user name and password in [Login] dialog .
4. Check consumables Confirm the system liquid, starter 1, starter 2 and
cuvettes are enough to complete the test.
System liquid must be prepared and standing 6 hours
prior to use.
5. Confirm device status
(1) Confirm incubator Confirm whether incubator temperature is stable. The
temperature range of incubator temperature shall be (36.8±0.5)℃
(2) Confirm system test after it gets stable, with a fluctuation range within ±
1℃.
Perform system test operation and confirm the tubing
is full of system liquid and starter. Confirm whether
the measured values of LC test and BGW test are
within the allowable range.

6. Confirm test condition

(1) Confirm assay Confirm assay parameters.
Set profile/group according to actual situation.
(2) Profile/group setting

7. Prepare reagent
Confirm the remaining reagent tests of each assay is
(1) Confirm the remaining
enough to complete the test.
tests of reagent
Confirm the mixing time of the magnetic microbeads
(2) Mixing time of magnetic
is at least 30 minutes.
microbeads

Maglumi 2000 Operating Instructions Page 5-1

5 Daily Operating Process

Confirm whether the reagent has been calibrated,

8. Assay calibration
and perform calibration for the reagent without valid
calibration.
QC assay registration
Perform QC operation for the reagent.
Perform conventional sample registration;
9. Sample registration Perform STAT sample registration;
Perform dilution sample registration.
10. Test start Click <Start> button to perform test.
Users can register additional samples during the test.
(If the additional samples are STAT samples, STAT
11. Test of additional sample registration should be performed; if the
samples additional samples are dilution samples, dilution
sample registration should be performed);
Click <Start> button to perform test.

12. Confirm test results Search, recalculate, delete and print test results.
13. Operation at end of the
test
Quit operating software Quit the software.
Turn off the main switch and submain switch and
14. Shutdown disconnect the power supply of the device and the
computer.
Take away the reagent from reagent area;
15. Operation after the test
Empty the waste tank;
is finished
Remove the discarded cuvettes.

5.2 Test preparation

Complete the preparation work of conventional sample test via the following steps.

5.2.1 Check before Starting

Before starting, the following checks should be made to ensure the system works
properly after starting.

NOTE
Make sure to wear gloves and work clothes to prevent infection. If
necessary, wear protective glasses.

1) Check the power supply to confirm it supplies power normally. Check the
communication cables and power cables of the analyzer, the computer and the
printer to confirm they are connected properly.
2) Check whether the pipetting needle is at the correct position, whether the needle
tip has water drop, pollution or bending.

5.2.2 Power-on and Login the Software

1) Connect the power supply , and turn on the main switch and submain switch of
the analyzer.
2) Connect the power supplies of computer and printer.
3) After logging in Windows operating system, double click the shortcut icon of the
user software on the desktop. After starting, [login] dialog will appear on the
screen. Enter the user name and password, and click <OK> button to enter the
user software interface.

Page 5-2 Maglumi 2000 Operating Instructions

 5 Daily Operating Process

4) After the analyzer and all components complete initialization, wait until the
incubator temperature gets stable. Then the test can be started.

NOTE
The user name of system administrator is “snibe”. Its initial password is
“snibe”.

Figure 5.2-1 [Login] Dialog

5.2.3 Check Consumables

1) Check whether tubes for system liquid, starter 1 and starter 2 are connected
properly and the liquid volume is enough; System liquid must be prepared and
standing 6 hours prior to use;
2) Check whether there are enough cuvettes to complete the test;
3) Check whether the waste liquid is drained;
4) Check whether the discarded cuvettes are removed.

5.2.4 Confirm Device Status

Confirm whether the device is normal via the following steps:

1. Confirm incubator temperature

Observe the color of button in the status bar. Test can only be started when the color
is stable green. If incubator temperature exceeds (36.8±0.5)℃ in the test process, the
button turns red, but the analyzer will continue testing.

NOTE
After the analyzer is started, it will take about 30 minutes for the
temperature in the incubator to be stable at (36.8±0.5)℃. Therefore,
wait for 30 minutes after startup of analyzer to perform sample test.

2. Confirm system test

Put the light check liquid on the rack with its tag facing the code reader, and load it to
Channel 11 or 12 of the sample area. The light check liquid is automatically identified
and displayed in yellow color in the Sample Info of the software, i.e. $lc$, as shown
below.
Light Check inspection should be made once every week, or after any analyzer
component is replaced.

Maglumi 2000 Operating Instructions Page 5-3

5 Daily Operating Process

Figure 5.2-2 [Patients] interface

Click <System Test> button in the menu bar to enter [System Test] dialog. Here you
can perform parameter setting for system test.

Figure 5.2-3 [System Test] Dialog

Input the priming times of the pipettor, the washer and the chamber. Input test times of
BGW, LC-le and LC-ri.

Click <OK> button, [Message] dialog appears to confirm parameter setting, click
<OK> button again.

Click <Cancel> button to cancel system test and exit [System Test] dialog.

Page 5-4 Maglumi 2000 Operating Instructions

 5 Daily Operating Process

Figure 5.2-4 Confirmation Dialog

 Priming: Ensure the tubing of pipetting needle, washer and chamber is full of liquid.
See Chapter 9 for details.
 BGW: The reference range of BGW results is 200-1200. See Chapter 9 for details.
 LC: The reference range of LC results is 400000-650000. , CV ≤ 3%. difference
between LC(ri) and LC(le) ≤ 5%. See Chapter 9 for details.
Please refer to the specific expectations LC reagent instructions.

Test can be conducted only when BGW results and LC results meet the requirements.
In case of measurement abnormity, the test results might be not reliable.

5.2.5 Confirm Test Condition

Before performing tests, confirm that the reagent parameters and settings of this assay
are correct. Perform the settings of group/profile.

1. Confirm assay parameters

Before using a new reagent, please read the instruction for use of the reagent carefully,
and set up or confirm its parameters item by item according to actual requirements.

The set-up steps are as follows:

 Click <Definition> button in the menu bar, then click <Test> button.
 Select the assay to be edited, click <Edit> button to enter [User Specific Assay
Data] dialog for test setting.
 Finally, click <Save> button to complete test setting.

2. Profile/group setting
In order to facilitate sample registration, the assays can be set with profile/group:

The set-up steps are as follows:
 Click <Definition> button in the menu bar, then click <Profile> button to enter
[Profile Definition] dialog, where you can set the profile according to specific
needs.
 Click <Definition> button in the menu bar, then click <Group> button to enter
[Assay Group Definition] dialog, where you can set the group according to
specific needs.

5.2.6 Prepare Reagent

Scan reagent in the reagent area.Reagent calibration, QC test and sample test can be
started when

Maglumi 2000 Operating Instructions Page 5-5

5 Daily Operating Process

 the reagent in the expiry date,

 the remaining test of the reagent is enough to complete the test,
 the shaking time of the magnetic microbeads of the reagent reaches 30 minutes.

1. Notes on use of reagent

CAUTION
Please remove the seals on the reagent kit before using a new reagent,

The preparation, use and storage of the reagent must be in strict accordance with its
user manual. Prevent bubbles from forming in the reagent; or else the pipetting
accuracy will be affected, hence affecting the test results.
The reagents of different kits cannot be mixed, or else the reliability of the test results
might be affected.

2. Confirm remaining tests of reagent

After scanning RFID tag of the reagent in the reagent area and inserting the kit, make
sure the remaining number of tests is enough to complete the number of tests needed.
If it is not enough to complete the testing, please insert another reagent in the reagent
area.

3. Shaking time of magnetic microbeads

When inserting the kit, the assay name, the remaining tests, the calibration information
and the shaking time of magnetic microbeads are displayed in the window
corresponding to associated buttons.

NOTE
The shaking time of the magnetic microbeads must be 30 minutes; or
else the reliability of the test results cannot be ensured!

5.3 Test Analysis

After completing the preparation, the sample test can be performed.

5.3.1 Assay Calibration

Click <Reagents> button in the menu bar or in the [Home] interface, or open the
reagent area door to enter [Reagents] interface.

Page 5-6 Maglumi 2000 Operating Instructions

 5 Daily Operating Process

Figure 5.3-1 [Reagents] Interface

Confirm whether the reagent used in the test is calibrated and valid. If the reagent is
without valid calibration, click <Calibration> or <Batch Calibration> button to execute
calibration operation.

Valid calibration is required for the assay to calculate sample concentration.

After calibration, click <View> button to open [Calibration Dialog] dialog, where you
can view working curve information and accept/reject new working curve.

Figure 5.3-2 [Calibration Dialog]

Select Validate and click <OK> button to accept the new calibration data.
Select Reject and click <OK> button to give up the new calibration data. Click
<Calibration> or <Batch Calibration> button in [Reagents] interface to re-execute
calibration operation.

Maglumi 2000 Operating Instructions Page 5-7

5 Daily Operating Process

5.3.2Control Registration

1. Click <Definition> button in the menu bar, then click <Control> button in
[Definition] menu to set up controls .

Figure 5.3-3 [Control] interface

2. Click <Add> button to open [Control Data Input] dialog.

Figure 5.3-4 [Control Data Input] Dialog

3. Input the name and lot No. of the Control product, select the assay in need of
control test, and click <Add> button to open [Control Detail Description] dialog.

Page 5-8 Maglumi 2000 Operating Instructions

 5 Daily Operating Process

Figure 5.3-5 [Control Detail Description] Dialog

4. Input the expected concentration range, target value, target SD and replication
times of this assay.
5. Click <Save> button, [Message] dialog appears to confirm parameter setting, click
<OK> button to complete the control parameter setting.
6. Enter [Sample] interface. Properly load the rack with the control product, select the
position of the control, and click <Control> button in the loading information area to
open [Controls Selection] dialog, select the control information which has been
set up, click <OK> button, and select “Start in Next Run“ and click <Save> button
to complete QC assay registration.

Figure 5.3-6 [Patients] Interface

NOTE
Sample test can be conducted only when the control test results of the
reagent meet the requirements; or else the reliability of the sample test
results cannot be ensured!

Maglumi 2000 Operating Instructions Page 5-9

5 Daily Operating Process

5.3.3 Sample Registration

NOTE
1) The samples with hemolysis, lipemia and icterus will affect the test
results;
2) Ensure the sample is exclusive of clot; or else the pipetting needle
will be blocked, which seriously affects the test results;
3) Some substances in the sample, such as drug, anticoagulant and
preservative, will interfere with the test results;
4) Do not leave the sample open for a long time; or else the sample
will volatilize, which affects the test results;
5) Improper parameter setting will affect the test results;
6) Snibe recommends that the test results shall not be modified in
any manner, and shall not be liable for any consequences arising
there from.

Click <Patients> button in the menu bar or in the [Home] interface, or open the
sample area door to enter [Sample] interface. Users can perform sample registration
and view rack status.

Put the sample on the rack with its barcode facing the code reader, and load it to the
samples area. The sample is automatically identified in the [Sample] interface.

Figure 5.3-7 [Patient] Interface

Select the needed assay in the Assay Selection (green represents selected), or select
the assay in the Profile Selection.

For STAT sample registration, select <STAT> button. The currently-registered STAT
samples will be prioritized.
For dilute samples, select <Dilute> button, and select dilution ratio for the assay need
to be diluted.

If the samples of the same rack are given the same assay, the whole rack can be
selected so that the assay information can be added at one time for faster sample
editing.

Page 5-10 Maglumi 2000 Operating Instructions

 5 Daily Operating Process

LIS application function can be used to obtain the assay info of the sample from the
LIS server.
Click <Save> button to complete sample registration.

5.3.4 Start Test

After completing sample registration, click <Start> button in the menu bar to send the
test command, and the analyzer will start test.

5.3.5 Additional Samples and Assays

1. Additional assay for registered samples

If additional assays are required for registered samples in the test process, assay
registration should be first performed. In the Rack Station of the [Sample] interface,
select the samples that need additional assay, select the assay in the Assay Selection
area, and click <Save> button to complete registration.
After the additional assay is registered, if there is no reagent for this assay in the
reagent area, the reagent should be loaded; if there is reagent in the reagent area,
click <Start> button in the menu bar to complete the continuous loading for the
additional assay.

2. Test of additional samples

If additional samples need to be added in the test process, sample registration should
be firstly performed (refer to 5.3.3 Sample registration). Use a blank rack for the new
samples. Load the samples properly, select the needed assay in the Assay Selection
area, and click <Save> button to complete sample registration.
For STAT sample registration, select <STAT> button. The currently-registered STAT
samples will be prioritized.
To dilute samples, select <Dilute>button, and select dilution ratio for the assay need to
be diluted.
If there is no reagent for this assay in the reagent compartment, the reagent should be
loaded in the reagent compartment; if there is reagent in the reagent compartment,
click <Start> button in the menu bar to complete continuous loading.

5.4 Test Results

After the test, the test results can be searched in [Report] function. Processing of test
results includes confirmation, printing, etc.
Click <Report> in the menu bar, then click <Journal> button on the left. Users can
view, delete and modify the test results and print the journal.

Figure 5.4-1 [Journal] Interface

Maglumi 2000 Operating Instructions Page 5-11

5 Daily Operating Process

Click <Sort> button and input corresponding date to search for historical journal
information. You can also enquire journal information of certain ID, and choose to
display test results according to the selected sorting criterion.
Click <Valid> button to confirm the selected test results according to the selected
conditions. The confirmed journal is displayed in [Valid] interface.

5.5 End of Analysis

When all the tests have been completed, quit the operating software and Windows
operating system. Turn off the power supply of all parts.

5.5.1 Shutdown

When all the tests have been completed, quit the user software and Windows
operating system. Turn off the power of all parts in the following order:
1) Turn off the power of the printer;
2) Turn off the power of the computer;
3) Turn off the power of the submain switch of the device.

NOTE
After the submain switch of the device is turned off, the reagent
refrigerating system still works. Shutdown reagent refrigerating system
should turn off the main power switch.

5.5.2 Operation after Shutdown

To make preparation for the next test, inspect the following items:
1) Remove the samples in the sample area;
2) Remove the reagents in the reagent area;
3) Empty the waste tank;
4) Empty the discarded cuvettes in the waste bag;
5) Inspect whether the analyzer surface has stains. If so, wipe off the stains with a
clean and soft cloth.

Page 5-12 Maglumi 2000 Operating Instructions

 6 [System] Menu

6 [System] Menu

6.1 [System] Menu Introduction

Click <System> button in the menu bar to enter [System] menu, where you can set up
a series of functions, as described below:

Figure 6.1-1 [System] Menu

Button Functions
<Info> Display PC software, PLC software version info and analyzer
serial number.
<Mode> Select running mode and edit sample mode.
<Online> Used for setting software parameters for connecting to hospital
Lis server.
<User> Set or modify username, login password and user rights.
<Language> Switch the interface languages of PC software.
<Maintenance> Set up maintenance reminder, pipe washing, display maintenance
procedure and calculate reagent consumption.
<Wash Pipe> Using system tubing cleaning solution for performing tubing
cleaning operation.

6.2 <Info>

Click <Info> button in [System] menu to open [Info] interface.

Maglumi 2000 Operating Instructions Page 6-1

6 [System] Menu

Figure 6.2-1 [Info] Interface

[Info] interface contains the following information:

1. Software Info
Software Version: Version information of software.

2. PLC Info

COP Version: Version information of COP.

Stacker Version: Version information of stacker.
Incubator & Pusher Version: Version information of incubator and pusher.
Washer Version: Version information of washer.
Chamber Version: Version information of chamber.
Sample Version: Version information of sample area.
Reagent Version: Version information of reagent area.
Left Pipe Version: Version information of left pipetting neddle.
Right Pipe Version: Version information of right pipetting neddle.

3. Device Name
Serial Number: Serial number of device.

6.3 <Mode>

This software provides multiple sample editing modes and running modes. Users can
set according to the actual situation.
Click <Mode> button in [System] menu to open [Mode] interface.

Page 6-2 Maglumi 2000 Operating Instructions

 6 [System] Menu

Figure 6.3-1 [Mode] Interface

[Mode] interface contains the following information:

1. Running Mode
 Random Access Mode——processing one rack after another, prioritized as
follows:
A.STAT assay;
B.Assays with automatic reference and automatic dilution;
C.From left to right racks;
D.According to incubation time, from the longest to the shortest;
E.According to assay name abbreviations, from A to Z;
F.According to positions of sample tubes on racks;
Advantage: this mode allows removal of a rack after the whole rack is process and
re-adding of new samples.
Disadvantage: processing time is not optimal.

 Batch mode——Processing all samples with optimal time, prioritized as follows:

A.STAT assay;
B.Assays with automatic reference and automatic dilution;
C.According to incubation time, from the longest to the shortest;
D.According to assay name abbreviations, from A to Z
E.From left to right racks, from back tubes to front tubes within a rack.
Advantage: This mode makes full use of cuvettes with the highest efficiency.
Disadvantage: Unable to process a whole rack so as to add new samples.

2. Edit Sample Mode:

 Normal Mode:
Barcode reader directly reads the barcode from sample tubes to generate sample
ID.
 Quick Mode:
Software directly generates sample ID without reading barcode from sample tubes.
 Online Mode:
Software reads assay information from Lis server via sample ID, and sends test
results to hospital Lis server.
 Emergency Mode:
When there is an error with the sample area door sensor or barcode reader (after
the rack is loaded, the corresponding position of “rack station” in [Patients]
interface displays “ERROR”) and thus “sample info” cannot be edited in the
sample loading interface, emergency mode can be enabled. In this mode, users
can still edit sample info.

Maglumi 2000 Operating Instructions Page 6-3

6 [System] Menu

Select required running mode and sample editing mode, click <Save> to confirm mode
selection.

6.4 <Online>

This software provides two-way communication with LIS server in the hospital. It is able
to acquire assay information from hospital LIS server via sample ID and send test
results to the LIS server.
Click <Online> button in [System] menu to open [Online] interface.

Figure 6.4-1 [Online] Interface

[Online] interface contains the following information:

1. Protocol
 None: Not connect to hospital LIS server.
 ASTM: Use ASTM protocol to communicate with hospital LIS server.

2. Host Configuration
 Analyzer ID: Input name of the analyzer that communicates with hospital LIS
server.
 Host ID: Input the name of hospital LIS server.

3. Automatic Operation
 Enable Automatic Downloading: Enable the analyzer to automatically acquire the
assay info of samples from hospital LIS server.
 Enable Automatic Uploading: Enable the analyzer to automatically upload the test
results of samples to hospital LIS server.
 Enable QC Data Uploading: Enable the analyzer to automatically upload the test
results of QC to hospital LIS server.

4. Automatic Upload Result Type

 All Results: Enable the analyzer to send all test results to hospital LIS server.
 Results without Pipettor Error: Enable the analyzer to send all the test results
without pipettor error to hospital LIS server.
 Results without Error: Enable the analyzer to send all the test results without
instrument error to hospital LIS server.

5. Communications

Page 6-4 Maglumi 2000 Operating Instructions

 6 [System] Menu

 COM Port: Select the serial number of the COM Port that communicates with
hospital’s LIS.
 Baud Rate: Select the Baud rate for communicating with hospital’s LIS.
 Data Bits: Select the data bits for communicating with the hospital’s LIS.
 Stop Bits: Select the stop bits for communicating with the hospital’s LIS.
 Parity: Select the parity bits for communicating with the hospital’s LIS.

6. ASTM Delimiters
 Field Delimiter: Display the field delimiter for communicates with hospital’s LIS.
 Repeat Delimiter: Display the repeat delimiter for communicating with hospital’s
LIS.
 Comp. Delimiter: Display the component delimiter for communicating with the
hospital’s LIS.
 Escape Delimiter: Display the escape delimiter stop bits for communicating with
the hospital’s LIS

7. Current Status
 COM Port Status: Display the status of the currently-used COM port.
Click <Save> button to complete the parameter setting for two-way communication
between the software and hospital LIS server.

6.5 <User>

This software provides a user managemnt system. An authorized system administrator

can assign different user rights to different users, as well as add, edit username,
password and user rights.

Click <User> button in [System] menu to open [User] interface.

Figure 6.5-1 [User] Interface

[User] interface contains the following information:

1.Users: A list displays existing users.
2.Selected User Properties: Display info of the selected user in users list.
3.<Add>: Add new users.
Click <Add> to open [User Properties] dialog, in which you can input user info.

Maglumi 2000 Operating Instructions Page 6-5

6 [System] Menu

Figure 6.5-2 [User Properties] Dialog

 User: Input alphanumeric characters.

 Password: Input password for the user.
 Access: User properties.
Normal User: can use specified functions;
Super User: can use all functions of the software.

Click <OK> button to complete adding a new user.

Click <Cancel> button to cancel adding new user and quit [User Properties] dialog.

4.<Edit>: Edit the selected user data (modify username, password and user rights).
Select a user in users list, then click <Edit> button to open [User Properties] dialog,
where you can modify the selected user data.

Click <OK> button to complete modifying the selected user data.

Click <Cancel> button to cancel modifying the selected user data and quit [User
Properties] dialog.

5.<Delete >: Delete existing users.

Select a user in [Users] list, click <Delete> button, and then click [OK] button to
confirm deletion of this user.

6.6 <Language>

This software supports 9 interface languages, including Simplified Chinese, English,

French, German, Italian, Portuguese, Russian, Spanish and Turkish.

Click <Language> button in [System] menu to open [Language] interface. Click

correspondig language button to change to that language.

Page 6-6 Maglumi 2000 Operating Instructions

 6 [System] Menu

Figure 6.6-1 [Language] Interface

6.7 <Maintenance>

Click <Maintenance > button in [System] menu to open [Maintenance] interface.

Figure 6.7-1 [Maintenance] Interface

[Maintenance] interface contains the following information:

1. Maintenance Reminder
 Autoreminders: Daily Maintenance
When starting the software for the first time every day, you will be reminded of
daily maintenance.
 Autoreminders: Weekly Maintenance
When starting the software for the first time every Monday, you will be reminded of
weekly maintenance.
 Autoreminders: Monthly Maintenance
When starting the software for the first time on the 1st day of each month, you will
be reminded of monthly maintenance.
Check the desired maintenance item, and click <Save> button to complete
maintenance reminder setting.

2. Maintenance
 <Priming for All >: Execute priming and cleaning actions.

Maglumi 2000 Operating Instructions Page 6-7

6 [System] Menu

 <Daily Maintenance>: Display daily maintenance procedure.

 <Monthly Maintenance>: Display monthly maintenance procedure.
 <Weekly Maintenance>: Display weekly maintenance procedure.

Click < Priming for All> to complete automatic priming and cleaning.
Click <Daily Maintenance>, <Weekly Maintenance> or <Monthly Maintenance> to
open [Maintain Info Dialog], where maintenance procedures can be viewed.

Figure 6.7-2 [Maintain Info Dialog]

3. Statistics
Click <Reagent Consumption> button to open [Assay Dosage Dialog].

Figure 6.7-3 [Assay Dosage Dialog]

In Search Settings, input start time and end time, and then click <Search> to display
the reagent consumption within the specified time period. Check an assay and click
<Print> to print consumption info, and click Select/Cancel to check or cancel all assays.

Page 6-8 Maglumi 2000 Operating Instructions

 6 [System] Menu

6.8 <Wash pipe>

This system can wash system tubing to reduce blockage caused by residues in tubing
sytem, which can affect the reliability of the test results. Meanwhile, it enhances the
maintenance performance of analyzer. The cleaning process contains cleaning of
pipetting needle, washer waste liquid tube and chamber waste liquid tube.

Click <Wash Pipe> button in [System] menu to open [Wash Pipe] interface.

Figure 6.8-1 [Wash Pipe] Interface

According to the instruction of System Tubing Cleaning Solution, load System Tubing
Cleaning Solution (insert the kit filled with System Tubing Cleaning Solution into the
Track 1 of the reagent area) and click <Start Wash> button to start tubing washing.
The whole cleaning process takes about 40 minutes.
Please refer to the instruction for use of System Tubing Cleaning Solution for relevant
details.

NOTE
Do not abort wash during the cleaning process.

Maglumi 2000 Operating Instructions Page 6-9

6 [System] Menu

Page 6-10 Maglumi 2000 Operating Instructions

 7 [Definition] Menu

7 [Definition] Menu

7.1 [Definition] Menu Introduction

Basic tests have been set up for this system in the factory. The basic tests can also be
modified and redefined by click the function buttons of [Definition] menu. Normally,
parameters can be used by all assays after input once.
Click <Definition> button in the main bar to enter [Definition] menu. The function
buttons described as follow:

Figure 7.1-1 [Definition] Menu

Button Functions
<Test> Set detailed parameters of the assay;
<Control> Define control
<Group> Define check group
<Profile> Define several assays as a profile. When many samples are
given the same assays, you can edit profile for collective
processing
<Diluter> Define the assay to be diluted and the dilution ratio
<Sender> Define the sender
<Result Definition> Define settings to display, edit and print results.

7.2 <Test>

Click <Test> in [Definition] menu to enter [Test] interface.

Maglumi 2000 Operating Instructions Page 7-1

7 [Definition] Menu

Figure 7.2-1 [Test] Interface

1. Assay: contains all the assays provided by Snibe.

2. Selected: displays the name of selected assay.

3. <Export>: Export the data file of a selected assay to specified path.

When software must be reinstalled, assay data files can be exported to store the
previous data of the selected assay, such as calibration data

4. <Import>: Import assay files from a hard disk or CD-ROM to system database.
Snibe provides the required assay data files. Click <Import> button to open [ASY-File
Selection] dialog. Open the directory of assay files and select the required assay from
Assay List.

Figure 7.2-2 [ASY-File Selection] Dialog

Click <OK> button to complete importing parameter file of the selected assay.
Click <Cancel> button to cancel importing parameter file of the selected assay.

If this assay already exists, [Message] dialog appear to prompt asking if you want to
rewrite. Click <OK> button to confirm rewriting data of this assay.
After importing an assay file, users must redefine the following options of this assay:
 Control definition;
 Dilution definition;
 Group definition;
 Profile definition.

5. <Delete>: Delete the parameter file of the selected assay.

Select an assay in Assay area of [Test] interface, click <Delete> button to delete the
parameters of this assay.

6. <Edit>: Set parameters for the selected assay.

Page 7-2 Maglumi 2000 Operating Instructions

 7 [Definition] Menu

Select an assay in Assay area of [Test] interface, click <Edit> button to open [User
Specific Assay Data] dialog.

Figure 7.2-3 [User Specific Assay Data] dialog

Field Description
Name Assay name, article-No.;
Abbreviation Abbreviation of the assay’s English name and company’s
English name;
Lis ID Signal channel used to communicate with LIS system
Unit Measurement unit. When different measurement units are
required, adjacent fields can be input with conversion factors
and results;
Sample replication Definition of sample retest times (range 1-3)
Calibration Definition of calibration retest times (range 1-3);
replication
Calibrate Definition of valid days of calibration;
Normal range Different countries and labs can set their own normal
reference range. In [Journal], there is “<” or “>” flag when
the range is exceeded;
Assay range The reagent manufacturer determines its assay range, but it
can be modified downward by users. In [Journal], there is
“<<” or “>>” flag when the range is exceeded;
Reflex range Can be modified by users; when the test results of this assay
are within the reflex range, reflex shall be made again;
Calculation factor Calculate the results according to the calculation factors “a”
(Y=ax+b) and “b”, which are input by users.
Extended Calculate the results exceeding the linear range; the upper
calculation bound of extended calculation can be set.

Maglumi 2000 Operating Instructions Page 7-3

7 [Definition] Menu

NOTE
Only when there is no reagent of the assay in reagent area, the
definitions in this dialog can be modified. Otherwise, <Save> cannot be
clicked, thus the modified parameters of the assay cannot be saved.

7.2.1 <Auto Dil.>

Click <Auto Dil.> button in [User Specific Assay Data] dialog to open [Auto Dilution
Settings] dialog.

Figure 7.2-4 [Auto Dilution Settings] dialog

1. Concentration:
 Threshold: Used to set the initial value for the auto dilution;

2. 1st Dilution Step:

 Sample volume: Used to set the sample volume pipetted for 1st auto dilution step;
 Buffer volume: Used to set the buffer volume pipetted for 1st auto dilution step;

3. 2nd Dilution Step (Optional):

 Vol. from 1st: Used to set the diluted sample volume pipetted for 2nd auto dilution
step;
 Buffer volume: Used to set the buffer volume pipetted for 2nd auto dilution step.

4. Dilution: Display the dilution rate of auto dilution

5. Click the start to generate schedule

 Select: If the concentration of test results exceeds auto dilution
concentration,registration of diluted sample will be automatically completed, but
<Start> button should be manually clicked to complete auto dilution test.

 Not select: If the concentration of test results exceeds auto dilution concentration,
registration of diluted sample in the Patients area will be automatically completed
and schedule command will be sentautomatically to complete auto dilution test.

Click <OK> button to complete auto dilution parameter setting.

Click <Cancel> button to cancel auto dilution parameter setting.

Page 7-4 Maglumi 2000 Operating Instructions

 7 [Definition] Menu

7.2.2 <Format>

Click <Format> button in [User Specific Assay Data] dialog to open [Result Format]
dialog, where you can define number of decimal digits corresponding to measurement
ranges.

Figure 7.2-5 [Result Format] Dialog

1. Unit: Concentration unit

2. Measurement Ranges: Measurement ranges of concentration results;

3. Formats [X.XXX]: Number of decimal digits corresponding to concentration ranges.

 If you input the upper bound of a measurement range, the lower bound of the next
higher measurement range will be automatically changed. Result formats can be
defined. For example, “x.xx” means one integer and two decimals of the
measurements in [Journal].

Click <OK> button to complete format setting.

Click <Cancel> button to cancel format setting.

7.2.3 <Qualit. Lbl>

Tags can be defined for measured result to indicate it is within a specific range, and
the tags are displayed in [Journal] interface for the convenience of result analysis.
Click <Qualit. Lbl> button in [User Specific Assay Data] dialog to open [Qualitative
Settings] dialog.

Maglumi 2000 Operating Instructions Page 7-5

7 [Definition] Menu

Figure 7.2-6 [Qualitative Settings] Dialog

1. Number of thresholds: define the number of threshold concentrations;

2. Thresholds: threshold concentrations;

3. Labels: use alphanumeric, characters or words as labels, such as negative, positive;

Click <OK> button to complete qualitative label setting.

Click <Cancel> button to cancel qualitative label setting.

7.2.4 <Reflex>

Reflex is to start an associated assay when the test results of the current assay are within
the reflex range.
Click <Reflex 1> in [User Specific Assay Data] dialog to enter [Assay Selection] dialog.

Figure 7.2-7 [Assay Selection] Dialog

In Assays field, select an assay to be reflexed, click <OK> button to save assay
information and return to [User Specific Assay Data] dialog. <Reflex 1> button will
change to the name of reflex assay. If you click the reflex assay in [Assay Selection]
dialog again, it will changes to <Reflex 1> and click <Save> button to save operation.

<Reflex 2> button has the same function and operation to <Reflex 1> button.

Page 7-6 Maglumi 2000 Operating Instructions

 7 [Definition] Menu

7.2.5 <Master Curve>

Master curve is the basis of calibration. The data is determined by Snibe. The master
curve of each assay is marked with ID-No. and lot-No..
Click <Master Curve> button in [User Specific Assay Data] dialog to open [Master
Curve Selection] dialog, where users can modify master curve data.

Figure 7.2-8 [Master Curve Selection] Dialog

1. Master Curve ID: display the ID-No. of master curve.

2. <Add>: Add new master curve.

 Click <Add> button to open [Loading of Master Curve] dialog.

3. <Edit>: Edit existing master curve.

 Select one master curve and click <Edit> button to open [Loading of Master
Curve] dialog.

4. <Delete>: Delete master curve.

 Select one master curve, click <Delete> button, and click <OK> button to delete
this master curve.

Figure 7.2-9 [Loading of Master Curve] Dialog

1. Data of Master Curve: display the data of master curve, with 10 thresholds at most;
 Identifier: display the ID-No. of master curve;

Maglumi 2000 Operating Instructions Page 7-7

7 [Definition] Menu

 Lot-No.: display the Lot-No. of master curve;

 Number of Points: number of thresholds of master curve;
 RLU: display RLU value;
 Conc.: display corresponding concentration;

2. <Recalc.>: After inputting data, click <Recalc.> button to refit and display master
curve;

3. <Print>: Print master curve and data.

Click <OK> button, [message] dialog appear to prompt whether you want to save the
modified master curve.
Click <OK> button to confirm master curve setting.
Click <Cancel> button to cancel master curve setting.

7.3 <Control>

In order to monitor the reliability of system and reagent, control must be performed.
Click <Control> button in [Definition] menu to open [Control] interface.

Figure 7.3-1 [Control] Interface

1. <Add>: Add new control.

 Click <Add> button to open [Control Data Input] dialog.

2. <Edit>: Edit existing control.

 Select the control to be edited and click <Edit> button to open [Control Data
Input] dialog, in which the corresponding control data is displayed.

3. <Delete>: Delete existing control.

 Select the control to be deleted and click <Delete> button.

4. <QC Inventory >: Conduct overall browse for all controls.

 Click <QC Inventory> to open [QC Information Summary] dialog, in which all
defined control data are displayed.

Page 7-8 Maglumi 2000 Operating Instructions

 7 [Definition] Menu

Figure7.3-2 [Control Data Input] dialog

1. Control Specification:
 Name: Control name
 Lot-No.: Lot number
 Expiry Date: Date of expiration

2. Assay Selection:
 This area displays all assays. Each control at least corresponds to an assay.
Select an assay in Assay Selection, then the assay name will display in the Refers to
Assay.

3. Control Detail Description:

 Refers to Assay: display the selected assay which associated with this QC
product;
 <Add>: Used to input detailed QC data. Click <Add> button to open [Control
Detail Description] dialog.
 <View>: Used to browse existing QC data, which cannot be modified. Select a
defined assay in [Assay Selection] areaand click <View> button to open
[Control Detail Description] dialog, in which the corresponding control data are
displayed.
 <Edit>: Used to edit or browse existing QC data. Select a defined assay in Assay
Selection area, and then click <Edit> button to open [Control Detail Description]
dialog, where you can edit corresponding control data. After edit and save the QC
detail infomation in [Control Detail Description] dialog, the small window of the
assay in Assay Selection will turn to green.
 <Delete>: Used to delete assays associated with the QC products. After selecting
a defined assay, click <Delete> button, and then click <OK> button to confirm
deletion. The selected assay is no longer associated with this QC product.

Click <Save> button to complete the input of control data and quit [Control Data Input]
dialog. The new control is added to the control list in [Control] interface.
Click <Cancel> button to cancel the input of control data and quit [Control Data Input]
dialog.

Maglumi 2000 Operating Instructions Page 7-9

7 [Definition] Menu

Figure 7.3-3 [Control Detail Description] Dialog

Refers to Assay：display the selected assay which associated with this QC product;

Control Data
 Control Name: quality control name;
 Replication: times of replication,upper limit 99.;
 Range: upper bound and lower bound of the expected concentration of quality
control for specified assays;
 Ref. range: quality control reference range defined by user;
 Target value: mid-value of the range;
 Target SD: uncertainty of target value, reflecting the accuracy of measurement;
 Target CV [%]: coefficient of variation of target value.

Click <Save> button to complete the input of control details and quit [Control Detail
Description] dialog.
Click <Cancel> button to cancel the input of control details and [Control Detail
Description] dialog.
.

Page 7-10 Maglumi 2000 Operating Instructions

 7 [Definition] Menu

Figure 7.3-4 [QC Information Summary] dialog

Select the control to be printed and click <Print> button to print control information list.
Click <OK> button and quit [QC Information Summary] dialog.

7.4 <Group>

Users can define groups and these groups are displayed page by page in [Patients]
interface (one group contains 15 assays at most) for faster sample registration.
Click <Group> button in [Definitions] menu to open [Group] interface.

Figure 7.4-1 [Group] interface

1. <Add>: add a new group;
 Click <Add> button to open [Assay Group Definition] dialog.

2. <Insert>: insert a new group;

 Select a group and click <Insert> to open [Assay Group Definition] where you
can add the assay you need and input group name to save as. The new group will
insert before the selected group automatically.

3. <Edit>: edit an existing group;

 Select a group to be edited and click <Edit> button to open [Assay Group
Definition] dialog.

Maglumi 2000 Operating Instructions Page 7-11

7 [Definition] Menu

4. <Copy>: copy an existing group;

 Select a group and click <Copy> to open [Assay Group Definition] where the
assay information of this group is copied. You can edit the group and input group
name to save as a new group.

5. <Delete>: delete an existing group;

 Select a group to be deleted and click <Delete> button to delete this group.

Figure 7.4-2 [Assay Group Definition] dialog

Selected assay: displays the name of the selected assay;

Assay selection: displays the assay list provided by Snibe;
Assay Group: displays 15 positions in consecutive numbers, each of which
represents an optional assay;
 Name: group name, where you can input alphanumeric characters;
 Page: serial No. of continuous pages, automatically allocated to groups.
Click <Save> button to complete the assay group edit option.
Click <Cancel> button to cancel the assay group edit option.

7.5 <Profile>

Users can use several assays to create a profile, which is displayed in the Profile
Selection area of [Patients] interface. You can use one button to allocate several
assays to one sample for faster sample registration.
Click <Profile> button in [Definition] menu to open [Profile] interface.

Figure 7.5-1 [Profile] Interface

Page 7-12 Maglumi 2000 Operating Instructions

 7 [Definition] Menu

1. <Add>: add a new profile;

 Click <Add> button to open [Profile Definition] dialog;

2. <Edit>: edit an existing profile;

 Select a profile in [Profile] interface and click <Edit> button to open [Profile
Definition] dialog.

3. <Copy>: copy an existing profile;

 Select a profile in [Profile] interface and click <Copy> button to open [Profile
Definition] dialog, where the assay information of this profile is copied. You can
edit the profile and input profile name to save as a new profile.

4. <Delete>: delete an existing group;

 Select a profile in [Profile] interface and click <Delete> button to delete this group.

Figure 7.5-2 [Profile Definition] dialog

Assays: The assays are provided by Snibe. When selected, the small window of the
assay will turn from red to green;
Profile Name: Input alphanumeric characters as profile name;
Profile Assay: List the assays contained in this profile.

Click <OK> button to save the profile setting.

Click <Cancel> button to cancel the profile setting.

7.6 <Diluter>

Dilution can be defined for a reagent that comtains buffer. The system supports up to 9
dilution ratios, which can be customized by users.
Click <Diluter> button in [Definitions] menu to open [Diluter] interface.

Maglumi 2000 Operating Instructions Page 7-13

7 [Definition] Menu

Figure 7.6-1 [Diluter] interface

1. Assay：The selected assay.

2.Assay Selection: the assays defined by Snibe. When you select an assay in Assay
Selection field, all buttons of [Selected Dilutions] area are activated.

3. Dilution Selection: the dilutions defined by Snibe;

4. Selected Dilutions: dilutions selected by users(maximum is 9).

5. <Edit>: edit dilution parameters.

 Select a dilution and click <Edit> button to open [Dilution Specification] dialog.

6. <Delete>: delete dilution parameters

 Select a dilution and click <Delete> button to delete this dilution setting.

Select a assay in Assay Selection field, the acquiescent dilutions defined by Snibe
displays in the Dilution Selection field. Select a dilution ratio in Dilution Selection
field, then click any button in Selected Dilutions field, the dilution ratio added to the
selected assay. If user need more dilution ratio, follow the steps:
1. Select a assay in Assay Selection field;
2. Click any button in Selected Dilutions field;
3. Click <Edit> button to open [Dilution Specification] dialog

Figure 7.6-2 [Dilution Specification] Dialog

Page 7-14 Maglumi 2000 Operating Instructions

 7 [Definition] Menu

Dilution can be performed for the same sample in two steps. Dilution ratio for each
step is 50 times at the most (maximum dilution: 1:2500).
Name: the dilution name to be edited;
1st Dilution Step:
 Sample Volume: volume of the sample;
 Buffer Volume: volume of the buffer.
2nd Dilution Step (Optional):
 Vol. from 1st: Volume of the sample pipetted after 1st dilution step;
 Buffer Volume: Volume of the buffer;
Dilutions: Total dilution factors obtained from automatic computation.

NOTE
Pay attention to the pipetted sample volume (total pipetting volume).
The maximum volume of pipetting needle is 380 µL. The maximum
volume of cuvette is 600µL.

Click <OK> button to save the dilution setting.

Click <Cancel> button to cancel the dilution setting.

7.7 <Sender>

Users can create a sender list to differentiate the sources of patient samples. Samples
can be assigned to a sender in the <Patient> button on [Patients] interface and the
sender info is included in the journal.
Click <Sender> button in [Definition] menu to open [Sender] interface.

Figure 7.7-1 [Sender] Interface

1. <Add>: add a new sender;

 Click <Add> button to open [Sender Input] dialog to define a new sender.

2. <Edit>: edit an existing sender;

 Select a sender in [Sender] interface, and click <Edit> button to open [Sender
Input] dialog.

3. <Copy>: copy an existing sender;

 Select a sender in [Sender] interface, and click <Copy> button to open [Sender
Input] dialog, where the sender information is copied. You can also modify the
sender’s info and save as a new sender.

4. <Delete>: delete an existing sender;

 Select a sender in [Sender] interface, click <Delete> and <OK> button to delete
the sender from the sender list.

Maglumi 2000 Operating Instructions Page 7-15

7 [Definition] Menu

Figure 7.7-2 [Sender Input] Dialog

Code: Code of the sender;

Name: Name of the sender;
Section: Section of the sender;
Comment: You can add brief comments;
Street: Street of the sender;
Postcode, City: Postcode and city of the sender;
Phone: Phone number of the sender.

Click <Save> button to save the sender info setting.

Click <Cancel> button to cancel the sender info setting.

7.8 <Result Define>

Users can define screening conditions for test results to output valid results in order to
improve test efficiency. Check the required option, and click <Save> button to
complete result definition setting.
Click <Result Define> button in [Definition] menu to open [Result define] interface.

Figure 7.8-1 [Result Define] Interface

1. Definition:
 Results not shown while pipetting needle error occurred:
If you check this option, the results with pipetting error flag are displayed as Error;
 Results not transmitted to LIS system while pipetting needle error occurred:
If you check this option, the results with pipetting error flag are not transmitted to
LIS system;
 Automatically valid all results:

Page 7-16 Maglumi 2000 Operating Instructions

 7 [Definition] Menu

If you check this option, the test results are automatically validated;
 Automatically print all results:
If you check this option, a report for all assays of the sample is automatically
generated and printed after all the assay results are obtained.

2. <Save>：Save the seletion

Check the required option and then click <Save> to complete setting.

Maglumi 2000 Operating Instructions Page 7-17

7 [Definition] Menu

Page 7-18 Maglumi 2000 Operating Instructions

 8 [Process] Menu

8 [Process] Menu

8.1 [Process] Menu Introduction

Click <Process> button in the menu bar to enter [Process] menu, where you can set up
a series of functions, as described below:

Figure 8.1-1 [Process] Menu

Button Function
< Initialize> Initialize the analyzer
<Init W. Clear> Initialization with Cuvette(s) Clear
< Restart> Restart uncompleted assays
<Return Asy> Return uncompleted test time.
<Low Level> Send command to control specific components of PLC
<Protocol> Record the intraday communication between PC and PLC
<Warning Opt.> Set up the warning message in emergency circumstances.

Maglumi 2000 Operating Instructions Page 8-1

8 [Process] Menu

8.2 <Initialize>

Click <Initialize> button in [Process] menu to open [Message] dialog to confirm the
operation.

Figure 8.2-1 [Message] Dialog for Initialization

Click <OK> button to confirm the operation. The analyzer will be initialized. Initialization
contains the test of various functions of the analyzer and the reset of its components.
After <Initialize>, the analyzer is in standby state.
After powering-off or quit the operating software, initialization is required when you
power on the analyzer or login the operating software again. If there are severe
problems in analyzer hardware or if the analyzer fails to connect with the operating
software, the analyzer needs to be initialized as well.

8.3 <Init W. Clear>

If there has(have) cuvette(s) in the transmission channel when the analyzer is powered
off, initialization with cuvette(s) clear is required. The following conditions are required
treatment:
 If you have exit out the software, open the software, input the user name and
password and select Initialization with Cuvette(s) Clear in [Login] dialog. The
analyzer will remove residual cuvette(s) after initialization operation.

Figure 8.3-1 [Login] Dialog

Page 8-2 Maglumi 2000 Operating Instructions

 8 [Process] Menu

 If you are still running the software, click <Init W. Clear> in [Process] menu to
open [Message] dialog to confirm the operation. The analyzer will remove
residual cuvette(s) after initialization operation.

8.4 <Restart>

In the assay process, if the analyzer crashes due to some irresistible reason but PC
software is not closed. To avoid users reediting tests, the uncompleted assays can be
restarted after clicking <Restart> in [Process] menu. It is convenient for operation.

Click <Restart> in [Process] menu to open [Message] dialog to confirm the operation.

Figure 8.4-1 [Message] Dialog for Restart

Click <OK> button to confirm the operation. PC regenerates schedule for the
unfinished assays edited before the analyzer is turned off and send it to PLC to
continue the assay.
Click <Cancel> button to cancel the operation.

NOTE
If the analyzer stop by some irresistible reason, only when the software
didn’t close, the <Restart> function can be used. If software shut down
before the restart, this function is invalid.

8.5 <Return Asy>

After editing samples and assays, click <Start>. The software calculates available test
times of reagents by deducting the number of edited tests. In the assay process, if the
analyzer crashes due to some irresistible reason with pipetting for some reagents not
completed, after the analyzer is turned on again, click <Return Asy> to recalculate the
available test times of the reagents by returning the assays for which reagent pipetting
is not completed.
Click <Return Asy> in [Process] menu to open [Message] dialog to confirm the
operation.

Maglumi 2000 Operating Instructions Page 8-3

8 [Process] Menu

Figure 8.5-1 [Message] dialog for Return Assay

Click <OK> button to confirm the operation. The software will recalculate the available
test times of the reagents by returning the assays for which reagent pipetting is not
completed.
Click <Cancel> button to cancel the operation.

8.6 <Low Level>

<Low Level> function is used to control specific components of PLC. Input PC and
PLC communication protocol codes in Command bar, click <Send> button to make
the corresponding components of the analyzer complete corresponding actions.

Click <Low Level> in [Process] menu to open [Low Level] interface.

Figure 8.6-1 [Low Level] Interface

For example, input 02 01 51 04 04 in Command bar and click <Send>, the 4th
incubator of the analyzer will be aligned to the incubator loader. This button is intended
for service engineers.

8.7 <Protocol>

<Protocol> function is used to record the intraday communication between PC and

PLC.
Click <Protocol> in [Process] menu to open [Protocol] interface.

Page 8-4 Maglumi 2000 Operating Instructions

 8 [Process] Menu

Figure 8.7-1 [Protocol] Interface

Input file name and extension “.txt”, “.xls” or “.doc” in New Protocol File bar and click
<Save>, the intraday communication between PC and PLC will be recorded in the
installation directory: Maglumi 2000\protocol.

8.8 <Warning Opt.>

<Warning Opt.> function is used to ignore the warning message in emergency

circumstances. After masking the warning message will not prompt and beep.
Click <Warning Opt.> in [Process] menu to open [Warning Opt.] interface.

Figure 8.8-1 [Warning Opt.] Iinterface

1. Stacker Status
 Stop Using Stacker

2. Disable the warning message

 Running out of cuvettes soon;
 Washer peristaltic pump soak abnormally;
 No cuvette in chamber;
 Chamber waster pump soak abnormally;
 Starter 1 is almost empty. Please replace;
 Starter 2 is almost empty. Please replace;
 Shaker is out of normal range;
 Waste bag is full. Please empty the waste bag;
 System liquid is almost empty. Please replace;
 Waste liquid is almost full. Please replace;

Maglumi 2000 Operating Instructions Page 8-5

8 [Process] Menu

 The cover of analyzer is open, please pay attention to safety;

 Software cannot connect to LIS.

Click the <Save> button to complete the operation, while the status bar
<Message Box> button will display the operating information.

Page 8-6 Maglumi 2000 Operating Instructions

 9 [System Test] Menu

9 [System Test] Menu

9.1 [System Test] Menu

[System Test] menu is used to wash pipe system of the analyzer. BGW and LC are
used to detect pipetting system, washer, chamber and starter. All system test must be
performed before the analyzer starts an assay. Click [System Test] button in the menu
bar to enter [System test] dialog.

Figure 9.1-1 [System Test] Dialog

[System Test] dialog contains:

 Pipettor: Set up wash cycles for the pipe, hose and pipetting needle of the
pipetting system.
 Washer: Set up wash cycles for the wash pump, hose and wash needle of the
washer. Users must perform wash before the analyzer runs.
 Chamber: Set up wash cycles for the pipe system of the chamber.
 BGW: Input cuvette BGW cycles (default: 1).
 LC-le/ri: Input LC cycles. Use left pipetting needle to pipette light check liquid
(default: 1).
BGW and LC must be performed after any starter is replaced.

The requirement of of system test results is:

1) BGW: RLU is 200-1200, CV ≤ 10%;
2) LC: RLU is 400000-650000, CV ≤ 3%;
3) For two-needles modes: mean difference between LC(ri) and LC(le) ≤ 5%.
Please refer to the LC Reagent Manual of the specific expected value.

To perform BGW and LC, the default cycle (1) can be changed according to needs.
Meanwhile, the cuvettes of corresponding number should be put in. If BGW or LC is
not necessary, the default cycle (1) can be changed to (0).

Click <OK> button, [Message] dialog appears to confirm parameter setting, click
<OK> button again.

Maglumi 2000 Operating Instruction Page 9-1

9 [System Test] Menu

Click <Cancel> button to cancel system test and exit [System Test] dialog.

Figure 9.1-2 [Message] Dialog for System Test

NOTE
When selecting LC-le / LC-ri, the rack carrying the LC liquid must be
placed on Track 11 or 12 on the right in the sample area!

When the analyzer is running an assay, if you want to enter <System Test> from the
menu bar, a message confirmation dialog appears to prompt that system test can only
be performed after end of the assay.

Figure 9.1-3 [Message] Dialog for Operations Canceled

9.2 Load Light Check

MAGLUMI Light Check producted by Snibe is used for testing the pipetting needle
performance of analyzer. When performing Light Check, put prepared Light Check
liquid on the rack with its tag surface facing the code reader and load it to channel 11
or 12 in the sample area. The liquid will be automatically identified and displayed in
Sample Info of the software in yellow, i.e. $lc$.

Manually run LC sample

If the code reader fails or the tag of Light Check liquid is damaged, manual editing can
be made in the software. Put LC liquid on the tube rack and load it to channel 11 or 12
in the sample area. Use the mouse or touch the screen to select the position of Light

Page 9-2 Maglumi 2000 Operating Instruction

 9 [System Test] Menu

Check liquid in the sample area; Light Check must be defined by pressing <Std/LC>,
with this position displayed in yellow, i.e. $LC$. Click <Save> to return to the [Home]
interface, and click <Start> to perform LC.

The requirement of of system test results is:

1) LC: RLU is 400000-650000, CV ≤ 3%;
2) For two-needles modes: mean difference between LC(ri) and LC(le) ≤ 5%.
Please refer to the LC Reagent Manual of the specific expected value.

9.3 Add Light Check

Light Check is obtained by re-dissolution of lyophilized product in certain purified water.

It can be used for LC in system test.
LC should be performed under the following three circumstances:
1) Before the instrument starts the first round of test every day;
2) After change the Lot-No. of starter reagents;
3) After maintenance of the instrument.
Opened LC fluid should be stored at 2-8°C till the shelflife specified in the Instruction
for use.

Prepare Light Check solution:

1. Take a bottle of Light Check out of the packaging box.
2. Carefully unplug the bottle.
3. Use a pipettor to inject 2ml of purified water into the Light Check bottle for re-
dissolution.
4. Shake carefully (avoid foam generation) to ensure that lyophilized product
adherent to the bottle cap is also completely dissolved.
5. Prior to use, the Light Check solution must be placed still for at least 5min. Light
Check test should be performed at room temperature.
6. Insert the Light Check bottle (with rubber plug removed) to the sample rack;
ensure that the barcode on the bottle directly faces the opening position of the
sample rack. Then insert the sample rack into channel 11 or 12 in the sample area
of the analyzer.

Figure 9.3-1 Insert the Light Check Bottle to the Sample Rack

WARNING
Prevent air bubbles from forming, which may affect the Light Check
result in system test, and further affecting the reliability of test result
obtained by the instrument.

Maglumi 2000 Operating Instruction Page 9-3

9 [System Test] Menu

Page 9-4 Maglumi 2000 Operating Instruction

 10 [Reagents] Menu

10 [Reagents] Menu

10.1 [Reagent] interface

Users can open the [Reagents] menu in the following 3 ways:

 Click <Reagents> on the menu bar;
 Open the reagent area door;
 Click the Reagents icon on the [Home] interface.

After entering the interface, users can:

1. Load or unload reagents;
2. View/ accept/reject/validate calibrator results and start calibrate.

Figure 10.1-1 [Home] Interface

On the [Home] interface, Reagents icon is mainly shown in five colors:

 Red: Not recognized by the system;
 Yellow: Recognized by the system, without valid calibration data;
 Green: Recognized by the system, with valid calibration data;
 Purple:Recognized by the system, with expired calibration data;
 Black: Recognized by the system, but with expired reagents.

Maglumi 2000 Operating Instructions Page 10-1

10 [Reagents] Menu

Click <Reagent> button in the menu bar to enter [Reagents] interface.

Figure 10.2-2 [Reagents] Interface

Reagent Area Shows the status and name of the reagent.

Reagent Data Shows the relevant data of the reagent kit.
Calibration View the calculate curve of the reagent. Start calibrate.
Reagent Operations Exit [Reagents] interface. Perform batch calibration.

10.2 Reagent Area

Reagent Area shows the status and name of the reagent in the reagent area, the
magnetic microbeads mixing time, etc.
The digits below the assay name indicate the number of tests that can be performed
with the reagent. The countdown timer indicates the magnetic microbeads mixing time.

1. Definitions of numbers and colors

Red and green are used to show the state of reagents and give prompts as to when
the reagent can be taken out of the reagent area.
Table 10.2-1 States of reagent

Number 1 means the reagent is located in No. 1 track of reagent area.

Green means the reagent is not used and can be taken out of the
reagent area.
Red means the reagent is being used and cannot be taken out of the
reagent area.

Number 1 means the reagent is located in No. 1 track of reagent area.

Red means the reagent is being used and cannot be taken out of the
reagent area.

NOTE
Users must pay attention to the usage state of each reagent!

Page 10-2 Maglumi 2000 Operating Instructions

 10 [Reagents] Menu

2. Reagent loading conditions

There are four types of reagent loading conditions.
Table 10.2-2 Reagent loading Conditions

No reagent inserted into this channel.

The reagent has been recognized by the system; the reagent is located
in No. 2 track of reagent area; the background color is light gray,
indicating the reagent is not selected.

The reagent has been recognized by the system; the reagent is located
in No. 2 track of reagent area; tthe background color is dark gray,
indicating the reagent is selected.

Reagent is available in the channel, but has not been recognized by

the system. The reagent needs to be reloaded.

3. Status of calibration
Two small squares with different color display the status of calibration, as shown in
Table 10.2 -3.

Maglumi 2000 Operating Instructions Page 10-3

10 [Reagents] Menu

Table 10.2-4Status of Calibration

Symbol Definition

(Red) (Gray) Without valid calibration.

(Red) (Red) Without valid calibration, calibration in progress.

(Red) (Green) Without valid calibration, new calibration has been

executed but has not been validated.

(Green) (Gray) With valid calibration (calibration has taken effect).

(Green) (Red) With valid calibration, the second calibration is in

progress.

(Green) (Green) With valid calibration, and the second calibration

has been executed but has not taken effect.

(Purple) (Gray) The calibration has expired.

(Purple) (Red) The calibration has expired; the second calibration

is in progress.

(Purple) (Green) The calibration has expired; the second calibration

has been executed but has not been validated.

(Black) (Black) The reagent has expired.

4. Status of time
The countdown timer indicates the magnetic microbeads mixing time, which is 30min
by default; when users click <Start> before the countdown timer reaches 00:00, the
analyzer will give a prompt message indicating that magnetic microbeads are not
homogeneously mixed. In such case, users need to click the <OK> button to start test.

The magnetic microbeads mixing time will be reset to 30:00 in the following two ways:
1) The magnetic microbeads mixing time will be reset after the analyzer is restarted.
2) The reagent is reloaded after it has been taken out for more than 2min.

5. Order of using reagents

When there are more than one reagent of the same type loaded in the reagent area,
such reagents should be used in the following sequence:
1) Priority is given to reagents allowing fewer remaining tests.
2) Use reagents from left to right.

10.3 Reagent Data

Get the electronic tag on the reagent close to the sensing area; the buzzer beep once
indicating successful reading of the electronic tag, beep twice indicating reading failed.
Insert the reagent into the reagent area; all experimental data will be automatically read
by the PC software and displayed in the Reagent Data area. If the data are not
correctly recognized during reading, the data must be manually input into the editable
region according to the tag on the reagent.

Page 10-4 Maglumi 2000 Operating Instructions

 10 [Reagents] Menu

Figure 10.3-1 Reagent Data

Field Description
Article-No. Used for assay search in the system.
Kit-No. The reagent number, used for the system to detect whether
the reagent has been placed in and the consumption of the
reagent. The amount is calculated and displayed
accordingly.
Layout The number of reagent bottles contained in the reagent.
Master Curve ID The identification number of the master curve that the
reagent uses.
Lot-No. The lot number of the reagent.
Expiry Dte The data of expiration (Year; Month; Day).
Determinations The total number of tests with the reagent.

Remaining Tests The remaining number of tests with the reagent.

10.3.1 Calibrators

The unit and concentration of Calibrator 1 and Calibrator 2 are shown in this zone.

Figure 10.3-2 Reagent Calibrators

10.3.2 Tolerances

The upper and lower deviation limits of RLU value and concentration of calibrator 1 and
calibrator 2.

Figure 10.3-3 Reagent Tolerances

Maglumi 2000 Operating Instructions Page 10-5

10 [Reagents] Menu

10.3.3 Remaining Tests

The Remaining Tests displays the remaining number of tests with the reagent. If the
number does not match the actual remaining test, users can be appropriate to modify
the remaining number according to the actual situation.
After clicking the Remaining Tests zone, the input space will double in size
automatically, allowing users to input relevant info twice.

Figure 10.3-4 Remaining Tests with the Reagent

When entering Remaining Tests, the keyboard will automatically lock to the first row;
after inputting the number, press <Enter> or <Tab> to switch to the second row. Input
the same number again, the number input in the first row will automatically change to
"***".

Figure 10.3-5 Double input

If the same number is input twice, the following will be shown in the field:

Figure 10.3-6 Input correctly

If different numbers are input, the following will be shown in the field:

Figure 10.3-7 Input error

10.4 Calibration

Calibration is required before use of each reagent. Calibration verifies the compatibility
between the reagent and the analyzer and provides more accurate working curves.

Figure 10.4-1 Calibration

Page 10-6 Maglumi 2000 Operating Instructions

 10 [Reagents] Menu

10.4.1 <Calibrate>

Click <Calibrate> to start calibration of the selected reagent (dark gray background). If
the system cannot recognize the reagent, this button will be locked by the system.

10.4.2 <View>

Click <View> to open [Calibration Dialog], users can:

1) View working curve and calibration result;
2) Modify the calibration result;
3) Print calibration info;
4) View the history calibration;

Figure 10.4-2 [Calibration Dialog]

Lot-No. Shows the lot number of the reagent selected.

Kit-No. Shows the reagent number of the reagent selected.
Master Curve ID Show the master curve id of the reagent selected.
Expires Shows the expiry time of the working curve.
Last Run Shows the time of the last calibration.
1. Geometric Curve Check
Click <Calculate Curve> to obtain relevant geometric curve. It can serve as a non-
standard additional reference curve to help determine whether the calibration results
reliable or not. "Ratio" is obtained by B/A.

2. Info of working curve

Maglumi 2000 Operating Instructions Page 10-7

10 [Reagents] Menu

Figure 10.4-3 Info of Working Curve

Calibrator 1 Show the test results of two calibrations.

Calibrator 2
RLU Shows the measured RLU value of calibration; at most three times
Mean The mean of RLU values.
CV The variation coefficient of measured values.
Dev[%] The deviation between mean and factory value.
Concentration Shows the measured value of calibration concentration.
Expect Sets the calibration concentration.
Calcul. The concentration value of the last calibration curve or new
calibration curve calculated by click <Calculate Curve> button.
Dev[%] The percentage of deviation between expected value and actual
calibration value.
Tolerances The allowable variation range of measured calibration concentration
and RLU value set by the analyzer.
3. Status Info

Figure 10.4-4 Status Info

Status: Shows the assessment of calibration result, including:

 No description: no calibration result.
 Not Validated: calibration result has not been validate.
 Validated: calibration result has been validate.
 Calculated: calibration result has been operated <Calculate Curve> or <Change
Calibrator>.
Activity: Shows situation of calibration, including:
 No description: calibration operation has not been done.
 Finished: calibration operation has been done.

Page 10-8 Maglumi 2000 Operating Instructions

 10 [Reagents] Menu

10.4.2.1 <Calculate Curve>

If the tolerances are within the acceptable range, click <Calculate Curve> to calculate
the valid working curve, as shown in Fig. 10.2-11 (tolerances are shown in green).

Figure 10.4-5 Calculate Curve

 If the result is acceptable, select Validate; the calibrator result will be accepted by
the system.
 If the result is not acceptable, select Reject; the calibrator result will be rejected
by the system.
 If Recalc Associated Samples is selected, all sample results of this assay will be
recalculated with a new calibration curve (limited to the sample results and quality
control results on the current day).
10.4.2.2 <Print>

Users can click <Print> to print all information related to the reagent and the calibration
working curve.
10.4.2.3<Calibrate History>

Click <Calibrate History> to open the [Calibration History Data] dialog, where users
can view the calibration history of the reagent selected.

Figure 10.4-6 [Calibration History Data] Dialog

Select a record of calibration history; click <Details Info> to open the [Calibration
History Detail] dialog, where users can view details info of this calibration.

Maglumi 2000 Operating Instructions Page 10-9

10 [Reagents] Menu

Figure 10.4-7 [Calibration History Detail] Dialog

Click <Print> in [Calibration History Detail] dialog to print all information related to
the reagent and the calibration working curve.

In the [Calibration History Data] dialog, select a record of calibration history, and click
<Calibration Recover>. The current reagent calibration record will be overwritten by
the selected history record. Click <OK> to exit the dialog box.

10.4.2.4 <Change Calibrator>

After manually changing the calibration info, click <Change Calibrator> to complete
manual change of the calibration data.

WARNING
Snibe does not recommend users to change calibrator results, and will
assume no liability for any consequences arising there from.

Press <OK> to exit [Calibration Dialog]. The data and assessment results saved at
the same time.
Press <Cancel> to exit [Calibration Dialog] without saving data. <Change
Calibrator> only can be performed after confirm calibration.

10.5 Reagent Calibration and Validation

Follow the following steps after the reagent is correctly inserted into the reagent
channel for at least 30min:
1) Enter the [Reagents] interface;
2) Select the reagent for calibration; click <Calibrate> to start calibration;
3) When calibration is finished, select <View> to confirm the calibrator result;
4) Now users have two options:
a.Accept the working curve, or
b.Reject the working curve.

Users may decide whether or not to accept the calibrator result on their own, or make a
judgment according to the following:
 The Ratio of Geometric curve check
 RLU Dev(%)
 Concentration Dev(%)

For example:

Page 10-10 Maglumi 2000 Operating Instructions

 10 [Reagents] Menu

 The Ratio or Dev(%) shown in greenThe measured value is within the allowable
range; the measured result is valid.
 The Ratio or Dev(%) shown in redThe measured value is beyond the allowable
range; the measured result is invalid.

If any of the above results is marked in red, the calibrator result should be deemed
invalid. Select Reject and click <OK> to reject it, and then perform recalibration.
Select Validate to accept the calibrator result and validate the working curve.
Select Recalc Associated Samples to recalculate all results of associated samples
completed on the current working day.
Click <OK> button to activate the new working curve. Click <Print> to print the
calibrator result.

10.6 <Batch Calibration>

Click <Batch Calibration> to open [Batch Calibration] dialog. Select the reagent for
calibration, click <OK> to start calibration; click <Cancel> to exit the [Batch
Calibration] dialog box.

Figure 10.6-1 [Batch Calibration] Dialog

NOTE
A reagent not validated is shown in gray; recalibration can be
performed only after validation.

10.7 <Reagent Inventory>

Click <Reagent Inventory> to open [Reagent Inventory] dialog. Users can view all
reagent inventories having been loaded to this analyzer.

Maglumi 2000 Operating Instructions Page 10-11

10 [Reagents] Menu

Figure 10.7-1 [Reagent Inventory] Dialog

Check an assay name, and click <Delete> to delete the reagent info selected.
Check an assay name, and click <Print> to print the reagent info selected.
Select any reagent, and click <Calibrate History> to open [Calibration History Data]
dialog. (See 10.4.2.3)
Click <OK> to exit the [Reagent Inventory] dialog.

10.8 <OK>

Click <OK> button, software will exit [Reagents] interface and go back to [Home]
interface.

Page 10-12 Maglumi 2000 Operating Instructions

 11 [Patients] Menu

11 [Patients] Menu

11.1 [Patients] Menu Introduction

The [Patients] menu can be opened in the following 3 ways:

 Open the door of the sample area.
 Click the Patients icon the [Home] interface.
 Click <Patients> button in menu bar.

After entering the Patients interface, users can:

1) Load the type of test sample, including: Sample, Control, and LC;
2) Select assays for the sample;
3) Define STAT test or Dilution test;
4) Edit sample Information.

Figure 11.1-1 [Home] Interface

The Patients bar graph is shown in two colors:

 Red: Indicates the rack at this position is not recognized by the system.
 Green: Indicates the rack at this position is recognized by the system.

Maglumi 2000 Operating Instructions Page 11-1

11 [Patients] Menu

11.2 [Patients] Menu

[Patients] interface is divided into the following areas:

Figure 11.2-1 [Patients] Interface

Rack Station Shows the rack loading condition.

Loading Definition of test type, such as STAT, Control,
Dilution Selection or LC.
Sample Info Shows the sample number.
Assay Selection Allows users to select assays for different samples.
Profile Selection Allows users to quickly select a required profile.
<Save> Exit [Patients] interface

In the Assay Selection area, the BGW, LC-le and LC-ri are for system test, please see
Chapter 9 System Test.

11.2.1 Rack Station

This area contains 12 sample channels. After a rack is added, relevant sample data will
be read by the barcode reader. Each button represents a sample channel. Select a
rack number, and press the button; the sample ID will be shown in the Sample Info
area, and the sample channel is shown in blue.

Figure 11.2-2 Rack Station

Page 11-2 Maglumi 2000 Operating Instructions

 11 [Patients] Menu

This area contains 12 sample channels. The meanings of different colors are listed
below:

This icon indicates the sample channel is empty.

This icon indicates the channel has valid samples and

has been selected.

This icon indicates the channel has valid samples but

has not been selected.

This icon indicates the rack inserted in the channel is

not recognized and must be reinserted.

11.2.2 Sample Info

Figure 11.2-3 Sample Info

The sample ID is shown in the corresponding position; a selected sample will be

marked with a red arrow. Users can select an assay or profile in the Assay Selection

Maglumi 2000 Operating Instructions Page 11-3

11 [Patients] Menu

and Profile Selection areas, respectively; the assay or profile selected is shown in
green window.
Different colors of sample frame and arrow represent different sample types.

Blue: Patient sample

Red: STAT sample

Green: Control (#)

Yellow: LC fluid ($) or externally calibrated

sample

Input Sample ID

NOTE
If barcode label is not used, the Patient ID should be manually input
into the corresponding position. ID shall be input twice: input the ID,
then press, <Enter> or <TAB>to enter the second line, and input the ID
again. If the two results are identical to each other, the arrow color will
change to green; otherwise to red, in which case, re-input is required.

Use the mouse or touch screen to lock the cursor to the corresponding sample ID input
field; input the sample ID, for example, to No. 9 position in the figure below:

Figure 11.2-4 First input

After first input, use the <ENTER> or <TAB> key on the keyboard to confirm the input
info; the info in the sample edit field will change to "*******".

Figure 11.2-5 Finish first input

Then input the same sample ID again; if the input info is identical to that input at the
first time, the background of the edit field turns green.

Figure 11.2-6 Second input

Use the <ENTER> or <TAB> key on the keyboard to confirm the re-input, and move
the cursor to the next sample ID input field.

Page 11-4 Maglumi 2000 Operating Instructions

 11 [Patients] Menu

Figure 11.2-7 Input successfully

If the input in the second line is not identical to that in the first line, the background of
the edit field turns red, with <ERROR> displayed, In such case, input the sample ID
again.

Figure 11.2-8 Input failed

11.2.3 Assay Selection

This area is for assay selection. First select a sample, then select the required assay.
If the reagents for the selected assay are not available in the reagent area, the text on

this option is in black ( ); if the reagents are available in the reagent area, the

text is shown in blue ( ).

Figure 11.2-9 Assay Selection

How to quickly allocate assays for all samples on the same rack
1. Click a gray area on the rack info bar, as shown in the figure below; after
successful selection, the entire rack info bar changes to gray (non-editable state)

Maglumi 2000 Operating Instructions Page 11-5

11 [Patients] Menu

Click a gray
area on the
rack info bar

Figure 11.2-10 Sample rack information

2. Select assays in the Assay Selection on the right side. (Users can select one or
several assays)
3. After completion, click the gray area on the rack info bar so that the rack will return
to the editable state.

11.2.4 Profile Selection

Profile Selection allows users to select a series of assays of the same type. This
function can help users to avoid repeated operations during assay selection. For profile
settings, please see Section 7.4.
First select a sample, then select a required profile. After a profile is selected, all
assays included in this profile will be allocated to the sample.

Figure11.2-11 [Profile] Selection

11.2.5 Loading

The buttons in Loading is used to subdivide the running status of the sample in
[Sample Info].

Page 11-6 Maglumi 2000 Operating Instructions

 11 [Patients] Menu

Figure 11.2-12 Loading information

11.2.5.1 <Work List> and <Edit>

Select a rack, then click <Work List> to view the assay list of all samples on this rack.
<Work List> button changes to <Edit> button, as shown in the figure below:

Figure11.2-13 [Patient] Interface with Assay List

Users can click <Edit> to return to the previous assay edit mode.

Figure11.2-14 [Patient] Interface with Assay Selection

11.2.5.2 <STAT>

The STAT function is used to obtain the assay result for an emergency sample. The
emergency sample has the highest priority.

Maglumi 2000 Operating Instructions Page 11-7

11 [Patients] Menu

First select a sample, then click <STAT> to define the sample as a STAT sample. Then
select assays in the Assay Selection on the right side.

11.2.5.3 <Control>

Click <Control> to open [Control Selection] dialog.

Figure11.2-15 [Control Selection] Dialog

After selecting a control material, you can press <OK> to exit and return to [Patient]
interface; if there is no preset control, press <Add> to add a new control (see Chapter
7).

In Sample Info, # is marked before the selected control name, and this column is
marked in green.
Control selected are listed in Refers to Assays
Control Cycles is preset by the operator (see Chapter 7).
Press [Start in Next Run] (marked with ) to activate the Assay button under Refers
to Assays a selected assay is shown in green window. Press the Assay button again
to cancel the selection, and the window color will change to red. Then press <Start> in
the menu bar to begin the control test.

Figure 11.2-16 Select Start in Next Run

11.2.5.4 <Std/LC>

Click <Std/LC> button to perform LC test. $ is marked before the sample name; and
this column is shown in yellow. For details on system tests, see Chapter 9.

Page 11-8 Maglumi 2000 Operating Instructions

 11 [Patients] Menu

Figure 11.2-17 Manual editing LC number

11.2.5.5 <Dilute>

This function allows users to define the dilution ratio for sample assay.
Click <Dilute> button. Press the corresponding button to select an assay to display the
Dilution Ratio List (see Chapter 7).

Press the corresponding Dilution Ratio to set a sample and assay dilution ratio. A
selected dilution ratio button is shown in green. Press this button again to cancel the
selection, and the window color will change to red. If <Undiluted> is pressed, users
can register an undiluted sample test in registering diluted tests. Press <OK> to save
settings and return to [Patients] interface.

11.6 <Save>

Click <Save> to save the registered sample info and exit [Patient] interface to [Home]
interface.

Maglumi 2000 Operating Instructions Page 11-9

11 [Patients] Menu

Page 11-10 Maglumi 2000 Operating Instructions

 12 [Report] Menu

12 [Report] Menu

12.1 [Report] Menu Introduction

Click <Report> on the menu bar to open [Report] menu. The buttons on the left:

Figure 12.1-1 [Report] Menu

Button Function
<Journal> display the journals on the then-current day, and search and
display historical journals
<Valid> display the validated journals on the then-current day, and
search and display historical valid results
<Calibrator> display the validated calibrator results on the then-current day,
and search and display historical calibrator results
<Control> display the validated control test results on the then-current
day
<System Test> display all system test results
<QC> display content related to quality control chart
<Report> display the assay report and relevant settings

Maglumi 2000 Operating Instructions Page 12-1

12 [Report] Menu

12.2 <Journal>

Click <Journal> button on [Report] menu to enter [Journal] interface.

Figure 12.2-1 [Journal] Interface

All journals satisfying the current search criteria will be shown on [Journal] interface
which also supports searching historical journals; the journal on the then-current day is
displayed by default.
Journal list includes the information below:
Sample ID ($) is marked before and after Calibration or System Test; (#)
is marked before and after QC Name.
Assay English abbreviation of an assay
Dil. Dilution ratio for diluting the sample
RLU and CV (%) Shows the experimental status of the sample and the RLU
value and CV (%).
Concentration Test result expressed in concentration unit.
Flag Warning sign of the test result; different symbols can be used
depending on circumstances.

12.2.1<Sort>

Click <Sort> button to open [Sort Criterion] dialog, where users can set the search
criteria and search journals satisfying the search criteria.

Page 12-2 Maglumi 2000 Operating Instructions

 12 [Report] Menu

Figure 12.2-2 [Sort Criterion] Dialog

Chronological Shows journals satisfying the search criteria according to the
time of journals.
Sample ID + Assay First shows the journals according to the first sort criterion:
Sample ID; then sorts the journals by assay name (in
alphabetical order).
Assay + Sample ID First shows the journals by assay name (in alphabetical order)
according to the first sort criterion; then sorts the journals by
Sample ID.
Sender Sorts the journals by sample sender.
Patient Name Sorts the journals satisfying the search criteria by patient name
of sample.
Status Sorts the journals satisfying the search criteria by experimental
status, such as Placed, To Do, Active, Done, and Failed.
Position Sorts the journals satisfying the search criteria by the position
of sample in the sample area (from left to right, from 1 to 12).
Filter Set the filter criteria, including Sample ID, Patient Name, Assay
and Status. Enter the expected keyword to show the journals
satisfying the filter criteria.
Order Function selection, showing the journals satisfying the search
criteria by Ascending or Descending.
Date Select the expected range of search date.
Status of Result Select the expected Status of Result, such as All Results,
Results without Error Flag, and Results with Error Flag.

12.2.2 <Today Rpt.>

Click <Today Rpt.> in [Journal] interface, then shows all journals on the then-current
day. It facilitates users' search of all journals on the then-current day.

Maglumi 2000 Operating Instructions Page 12-3

12 [Report] Menu

12.2.3 <Recalculate>

For journals satisfying the selection criteria, the concentration value of the sample will
be recalculated according to the working curve confirmed most recently. Click
<Recalculate> to open [Recalculation Selection Dialog]. The Segment zone is for
specifying journals to be recalculated.

Figure 12.2-3 [Recalculation Selection Dialog]

Tagged The tagged journals on [Journal] interface will be recalculated
All All journals on [Journal] interface will be recalculated.
All Samples The sample journals on [Journal] interface will be recalculated.
Allows range selection, where users can enter the start and
From…To the end of a range. Journals within this range will be
recalculated.

Click <OK> to recalculate journals satisfying the selection criteria.

Click <Cancel> to cancelrecalculation.

12.2.4 <Online>

Click <Online> in [Journal] interface to open [Online Selection Dialog]. The

Segment field is for specifying journals to be sent to the LIS.

Page 12-4 Maglumi 2000 Operating Instructions

 12 [Report] Menu

Figure 12.2-4 [Online Selection Dialog]

Tagged The tagged journals on [Journal] interface will be sent to the LIS
All All journals on [Journal] interface will be sent to the LIS.
All Samples The sample journals on [Journal] interface will be sent to the LIS.
Allows range selection, where users can enter the start and the
From…To
end of a range. Journals within this range will be sent to the LIS.

Click <OK> to send journals satisfying the criteria.

Click <Cancel> to cancel sending journals.

12.2.5 <Edit>

After selecting a journal on [Journal] interface, click <Edit> to open [Detailed Sample
Result] dialog, where details of the tagged journals will be displayed.

Figure 12.2-5 [Detailed Sample Result] Dialog

Maglumi 2000 Operating Instructions Page 12-5

12 [Report] Menu

Patient: Shows patient info associated with the journal

Name Name of the patient
Date of Birth Birthday of the patient.
Sex Sex of the patient.
Sender Name of the organization or individual sending the sample.
Sample: Records relevant info of the journal on the analyzer
ID Identification number of the sample.
Position Position of the rack where the sample is positioned and Position of
the sample on the rack.
Status Assay status of the sample
Registration Date Time when the sample is registered.
Result: Shows details of results
RLU RLU value of the journal
Mean RLU Mean RLU value of several tubes.
CV% Variation coefficient of RLU of several tubes.
Conc. Concentration value of the journal.
Mean Conc. Mean concentration value of several tubes.
CV% Variation coefficient of concentration value of several tubes.
Dilution Dilution ratio for diluting the sample.
Ranges: Shows and judges the Assay Range and the Normal Range of the journal
Assay Range Shows the assay range of the journal, and judges whether the
journal is within the Assay Range.
Normal Range Shows the normal range of the journal, and judges whether the
journal is within the Normal Range.
Reagent Data Shows the reagent data of the assay, including Kit-No., Lot-No.
and Master Curve ID.
Flags Shows the flag info associated with the journal, including Analyzer
Failure, Reagent Expired, Calibration Expired, Above Normal
Range, Below Normal Range, Recalculate, Above Assay Range,
Below Assay Range, Blood Clot, Pipette Error, Pipette Suction,
Above Control Range, and Below Control Range.
List of Warning Symbols：
* Analyzer failure;
The reagent using which the result is obtained has been
E
expired;
The working curve using which the result is calculated has been
C
expired;
>/< The sample journal is beyond the Normal Range;
R The journal has been recalculated;

>Q and <Q The quality control result is beyond the set Control Range;

Page 12-6 Maglumi 2000 Operating Instructions

 12 [Report] Menu

S The sample or a component of the reagent is not sufficient;

D The pipette detects blood clots;

N The pipette impacts against the cuvette, sample rack, bottom of

test tube, etc., which causes pipette error;
>>/<< The journal is above or below the Assay Range

Click <Save> to save the modified info.

Click <OK> to cancel the modified info.

WARNING
Snibe does not recommend users to change results, and will assume
no liability for any consequences arising there from.

12.2.6 <Delete>

Click <Delete> in [Journal] interface to open [Delete Selection Dialog]. Select the
journal to be deleted in the Segment field.

Figure 12.2-6 [Delete Selection Dialog]

Tagged The tagged journals on [Journal] interface will be deleted.
All All journals on [Journal] interface will be deleted.
All Samples The sample journals on [Journal] interface will be deleted.
Allows range selection, where users can enter the start and the
From…To
end of a range. Journals within this range will be deleted.
Click <OK> to delete the selected journals.
Click <Cancel> to cancel deleting the selected journals.

12.2.7 <Valid>

Click <Valid> in [Journal] interface to open [Validation Selection Dialog]. Select the
journal to be validated in the Segment field.

Maglumi 2000 Operating Instructions Page 12-7

12 [Report] Menu

Figure 12.2-7 [Validation Selection Dialog]

Tagged The tagged journals on [Journal] interface will be valided
All without Flag All journals without flag will be valided.
All Samples without The sample journals without flag will be valided.
Flag
From…To Allows range selection, where users can enter the start and the
end of a range. Journals within this range will be valided.

Click <OK> to validate the selected journals.

Click <Cancel> to cancel validating the selected journals.

12.2.8 <Print>

Click <Print> in [Journal] interface to open [Printout Selection Dialog]. Select the
journal to be printed in the Segment field.

Figure 12.2-8 [Printout Selection Dialog]

Tagged The tagged journals on [Journal] interface will be printed
All All journals on [Journal] interface will be printed.
All Samples The sample journals on [Journal] interface will be printed.

Page 12-8 Maglumi 2000 Operating Instructions

 12 [Report] Menu

Allows range selection, where users can enter the start and the
From…To
end of a range. Journals within this range will be printed.
Select Redirect to File to save a file in Text or Excel format.
Format Format in which a file is saved, supporting Text and Excel.
File name Specifies the name of a file.

Click <OK> to print the selected journals.

Click <Cancel> to abort printing the selected journals.

12.2.9 <Remeasure>

Click <Remeasure> in [Journal] interface to open [Review Selection Dialog]. Select

the journal to be remeasured in the Segment area.

Figure 12.2-9 [Remeasure Selection Dialog]

Tagged The tagged journals on [Journal] interface will be remeasured.
All All journals on [Journal] interface will be remeasured.
All Samples The sample journals on [Journal] interface will be remeasured.
Allows range selection, where users can enter the start and the
From…To
end of a range. Journals within this range will be remeasured.
Click <OK> to remeasure the selected journals.
Click <Cancel> to cancel remeasuring the selected journals.

12.3 <Valid>

Click <Valid> on [Report] menu to open [Valid] interface, where validated sample
journals satisfying the criteria will be displayed.

Maglumi 2000 Operating Instructions Page 12-9

12 [Report] Menu

Figure 12.3-1 [Valid] Interface

[Valid] interface is similar to [Journal] interface, there has <Sort>, <Today Rpt.>,
<Online>,<View>, <Delete> and <Print> button.
The functions of <Sort>, <Today Rpt.>, <Online>, <Delete> and <Print> button are
identical to those of [Journal] interface. The functions of <View> button is to view the
detail of the valid result.

Click <View> to open [Detailed Sample Result - Validated] dialog

Figure 12.3-2 [Detailed Sample Result - Validated] Dialog

Patient: Shows patient info associated with the valid result.
Last Name Last name of the patient
First Name First name of the patient
Date of Birth Birthday of the patient.
Sex Sex of the patient.
Patient ID Identification number of the patient sample.

Page 12-10 Maglumi 2000 Operating Instructions

 12 [Report] Menu

Sender: Shows details of the sending organization.

Name Name of the sending organization.
Code Identification number of the sending organization.
Section Section of the sending organization.
City City where the sending organization is located.
Street Street where the sending organization is located.
Phone No. Phone number of the sending organization.
Sample: Shows the sample info.
ID Identification number of the sample.
Method Assay that the sample undergoes.
Dilution Dilution ratio for diluting the sample.
Result: Shows relevant data of the result
Conc. Concentration value of the sample result.
Qualit. Lbl Qualitative label of the assay, which can be defined in [Reagent
Definition].
RLU RLU value of the sample result.
Date/Time Time of sample test.
Reagent Shows the reagent data of the assay, including Kit-No., Lot-No.
and Master Curve ID.
Flags： Shows the identifier of result status.（See section 12.1.5）
Assay Range： Shows the assay range of the journal, and judges whether the
journal is within the Assay Range.
Normal Range: Shows the normal range of the journal, and judges whether the
journal is within the Normal Range.

12.4 <Calibrator>

Click <Calibrator> button in [Report] menu to open [Calibrator] interface, where

validated calibrator results satisfying the criteria will be displayed.

Figure 12.4-1 [Calibrator] Interface

Maglumi 2000 Operating Instructions Page 12-11

12 [Report] Menu

[Calibrator] interface is similar to [Journal] interface, there has <Sort>, <Today

Rpt.>, <Online>,<View>, <Delete> and <Print> button.
The functions of <Sort>, <Today Rpt.>, <Online>, <Delete> and <Print> button are
identical to those of [Journal] interface. The function of <View> button is identical to
this of [Valid] interface.

12.5 <Control>

Click <Control> button in [Report] menu to open [Control] interface, where validated
control results satisfying the criteria will be displayed.

Figure 12.5-1 [Control] Interface

[Control] interface is similar to [Journal] interface, there has <Sort>, <Today Rpt.>,
<Online>,<View>, <Delete> and <Print> button.
The functions of <Sort>, <Today Rpt.>, <Online>, <Delete> and <Print> button are
identical to those of [Journal] interface. The function of <View> button is identical to
this of [Valid] interface.

12.6 <System Test>

Click <System Test> button in [Report] menu to open [System Test] interface, where
all system test results will be shown.

Figure12.6-1 [System Test] Interface

Page 12-12 Maglumi 2000 Operating Instructions

 12 [Report] Menu

<Sort> Click <Sort> button to open [Search System Test Result Dialog] to
select and view the types of system test results shown.

Figure 12.6-2 [Search System Test Result Dialog]

<View> Click <Sort> button to open [Detailed System Test Result] dialog to
view details of system test results. If the value exceeds the set value,
the numerical value of this result will be shown in red. Set the range of
set value in Maglumi 2000 Service software.

Figure 12.6-3 [Detailed System Test Result] Dialog

Info: Details of system test.

ID Name of system test, before and after which ($) is marked.
Status Processing status of system test.
Performed Editing time of system test.
Method: Name of system test
Results: Details of system test result
RLU Shows the RLU value of each assay in system test.
Mean Mean value in system test.
CV% Variation coefficient of six RLU values.

Maglumi 2000 Operating Instructions Page 12-13

12 [Report] Menu

12.7 <Report>

Click <Report> button on [Report] menu to open [Report] interface, where the test
report satisfying the criteria will be displayed and users can set the print info and
quality control chart for the test report.

Figure 12.7-1 [Report] Interface

12.7.1 <Import>

Figure 12.7-2 [Import] Dialog

Display Type: Select the type of test report to be displayed, including: Recorded, But
not Value; Recorded, And with Value; All Record.
Recorded, But Test report with patient data imported, but journal not received.
not Value
Recorded, And Test report with patient data imported and journal received.
with Value
All Record Test report of both the above states.

Sample ID Number of test report, and also the Sample ID in the journal;

Page 12-14 Maglumi 2000 Operating Instructions

 12 [Report] Menu

Patient No. Patient number registered in the hospital;

Priority Options include: Normal, Prioritized, Urgent, and Immediate;
Patient Name Name of the patient;
Sex Sex and age of the patient;
Dept. No. Department where the patient sees a doctor;
Bed No. Bed number of the patient during hospitalization;
Doctor Doctor of the patient;
Sample Type Type of the sample tested;
Sample Status Status of the sample tested;
Sender Current user logging into Maglumi software;
Verifier Doctor verifying the patient journal;
Diagnosis Diagnosis content of patient test report;
Entry Date Time when the test report is entered;
Report Entry: Enter the patient sample ID; Pat.-ID, Name and Bed No. in text box,
and select the Priority, Sex, Dept. No., Doctor, Sample Type, Sample Status, and
Verifier; click <Save> to finish info entry for the test report.

The Sample ID in the test report is associated with the Sample ID in the journal. After
journal validation in [Journal] dialog, result info will be added to the test report with
patient info entered; if no test report is available, a test report will be created.

Figure12.7-3 Manually Add Result

Manually Add Result: Click the test report to which the result will be added; click
<Modify>; select the assay to be added in the "Manual Assay" drop-down menu;
enter the concentration value for the corresponding assay into the Result text box; click
<Save> to finish adding the journal.
Modify Result: Select the test report of which the result is to be modified; click
<Modify>; select the assay to be modified; modify the result value; click <Save> to
finish modifying the result value.

Maglumi 2000 Operating Instructions Page 12-15

12 [Report] Menu

Modify Patient Data: Select the test report of which the patient data is to be modified;
click <Modify>; then modify the data item by item according to the actual situation;
click <Save> to finish modifying the test report data.

Delete Test Report: Select the test report to be deleted; click <Delete> to finish
deleting the test report.

Print Test Report: Select the test report to be printed; click <Print>; select the criteria
for printing the test report in [Report Print Dialog].

Figure 12.7-4 [Report Print Dialog]

Add Diagnosis: To add diagnosis info to the test report, click <Modify>, and add
relevant diagnosis info under "Diagnosis"; click <Save> to finish adding diagnosis info
to the test report.

12.7.2 <Search>

Search historical test reports according to the set search condition. Click <Result
Search> to show test reports satisfying the current search criteria. Input the
corresponding search condition (Patient No., Dept. No., Doctor, Date Range for
Search, Name, Sample ID); click <Search> to show test reports satisfying the
condition. Click <Preview>; the test report selected will be shown in the form of test
report sheet. Click <Print> to print the test report selected.

Figure 12.7-5 [Search] Dialog

Page 12-16 Maglumi 2000 Operating Instructions

 12 [Report] Menu

Search Condition: Input the condition for searching historical test reports
Patient No. Search a specific patient number;
Dept. No. Search test reports of a department;
Doctor Search test reports issued by a doctor;
From Starting date for search;
To Ending date for search;
Name Search the test report of a specific patient;
Sample ID Search the test report of a specific sample ID;

12.7.3 <QC>

Quality control is to ensure the reliability of each sample test result. The reliability of
test results, including the meaning of two aspects, one is the precision and the
repeatability of test results, the laboratory test results every day change is very small,
mainly to eliminate or reduce the effects of random error; On the other hand is high
accuracy, and the test result is correct, close to the true value, mainly to eliminate or
reduce the influence of system error.
Click <QC> to show [QC] dialog box; select the Year of QC, Month of QC, QC Assay
and QC Materials; the trend of control result change will be shown in the form of curve
in the middle of the dialog box. The QC test time and the corresponding test result will
be shown at the lower left corner; the assessment result will be shown at the lower
right corner.
Data about control result come from validated control result in [Journal] dialog box.
Info about QC materials is defined in [QC Definition] dialog box under the
[Definitions] menu.
<Save> Save input data.
<Add> Add a control result for the QC material selected;
<Delete> Select a control result to be deleted; click <Delete> to finish
deleting the control result.
<Print> Print the control result and curve.

Figure 1 2.7-6 [QC] Dialog

Maglumi 2000 Operating Instructions Page 12-17

12 [Report] Menu

12.7.4 <Dictionary>

Click <Dictionary> to show the [Dictionary] dialog.

Figure 12.7-7 [Dictionary] Dialog

Select an option to be edited from the Select Category drop-down box; users can edit
the Department Name, Doctor Name, Sample Type, Sample Status, Reference Range,
and Assay Definition.

Figure12.6-8 [Select Category] Drop-down Menu

<Save> Save the newly entered info;
<Add> Add a new info record;
<Delete> Delete an info record;
Department Select Department Name from the "Select Category" drop-down
Name box; click <Add> to show a blank sheet below; input the
department name in the corresponding blank space below "Dept.
Name"; to add "Enter Code", enter the corresponding content
below; after entry, click <Save> to finish entering the department
name.
The method for editing Doctor Name, Sample Type and Sample Status is the same
as that for editing Department Name.
Reference Click Reference Range"in the Select Category drop-down box, to
Range edit the normal reference range for the assay. Select the assay for
which the reference range is to be edited from "Assay" at the
upper right corner of the dialog box; then click <Add>; click "Age
Range" to show the Age Category Range menu; select the desired
age range, such as "Male Adult" and "Female Adult"; enter digits
under [Lower Bound] and [UpperBound], respectively; click
<Save> to finish setting the reference range for the designated age

Page 12-18 Maglumi 2000 Operating Instructions

 12 [Report] Menu

category in the selected assay. To continue adding, please repeat

the above operations. To input multiple lines of reference values,
please input "Special Immune Male " or "Special Immune
Female" under [Age Range]; input "－1" under [Lower Bound]
and [Upper Bound]; then input multi-line reference under
[Remark]; use ";" in English input mode to separate reference
values.

Fi
gure 12.7-9 [Reference Range] Drop-down Menu

Assay Define Select Assay Define from the "Select Category" drop-down box;
click <Add> to show a blank sheet below; input the "Assay Abbr"
in the corresponding blank space below " Assay Abbr ","Printer
Order"and"Assay Method", after entry, click <Save> to finish
entering the department name.

12.7.5 <Setting>

Click <Setting> buttonto open [Setting] dialog, where users can set report sheet and
format of report sheet and carry out print setting. Click <Save> to save the newly
entered info;

Maglumi 2000 Operating Instructions Page 12-19

12 [Report] Menu

Figure 12.7-10 [Setting] Dialog

Paper Size Set the size of paper used in the printer; options include A4 Paper,
B5 Paper, and User-defined Paper.
Paper Width, The attributes of Paper Width and Paper High are valid only for
Paper High user-defined paper. Paper Width and Paper High define the size of
the paper used in the printer (unit: mm).
Upper, The attributes of Upper, Bottom, Left and Right Margins
Bottom, Left respectively define the blank region at the upper, bottom, left and
and Right right edges of the printer paper selected, i.e., define the non-
Margins printing region (unit: mm).
Print Mode Two print mode options are available: Fixed Mode and Compact
Mode. In Fixed Mode, the endnotes of a report are printed above
the bottom margin of the paper, regardless of the number of result
details. In Compact Mode, the endnotes of a report are printed
immediately following the last assay.
Change Pages Options for changing pages include: Continuous, and Auto
Change. Continuous is selected when there is a large number of
assays and it is impossible to print all on one page of the defined
size, which ignores the size (height) of paper to continuously print
all assays. This option usually applies to perforated paper and
stylus printers. Auto Change is selected when it is impossible to
print all assays on one page, which divides the report into two or
more pages for printing. When the assays contain multiple
references (i.e., multiple reference ranges, multi-line output
required during printing), Auto Change will be ignored
automatically.
Tester If Print is selected, the tester name will be printed on the report. If
Not Print is selected, the tester name will not appear on the report
printed or previewed; in such case, the report to be sent can be
confirmed by manual signature.
Verifier If Print is selected, the verifier name will be printed on the report. If
Not Print is selected, the verifier name will not appear on the report
printed or previewed; in such case, the report to be sent can be
verified by manual signature.
Re-print Tag For a report not entered on the then-current day, the [Re-print] tag
will be printed at the upper left corner of the report. If Not Print is
selected, this tag will not appear on the report printed or previewed.
Diagnosis If Print is selected, diagnosis will appear at the header of the report
printed or previewed; otherwise it will not appear on the report.
Histogram For a test report containing any histogram, users can select to

Page 12-20 Maglumi 2000 Operating Instructions

 12 [Report] Menu

Location output the histogram on the right side (longitudinal) or bottom side
(transverse) of the report; the corresponding options are Right
Longitudinal and Bottom Transverse, respectively.
Report Title Words describing the report content, such as "Biochemical Test
Report" and "Immunoquantitation Report"; the title is shown after
the Name of Hospital.
Remark Detailed content after [Remark] in the report; for example, "This
report is responsible only for this sample"
Remark Font Font and font size of the remark printed; press the arrow key in the
and Font Size Font input box or double click to get the list of fonts currently
available in the system; the font size should not be expressed in
decimals.
Name of Name of the user organization, for example, "XX People's
Hospital Hospital", which will be displayed at the title of report.
Row Space of Row space of assay details in the report (unit: mm).
Details
Details Font Font and font size of assay details to be printed.
and Font Size
Title Font and Font and font size of the title of report to be printed.
Font Size
Header Font Header of report refers to the area above assay details in the
and Font Size report. Font and font size of the header of report to be printed.
Content Font Font and font size of assay details of the header content of report
and Font Size to be printed.

After changing the options under Setting, click <Save> to save the changed content of
Setting. After saving, the system will update the settings immediately; it is unnecessary
to restart the system program.

12.7.6 <Return>

Click <Return> to go back to the [Journal] interface.

Maglumi 2000 Operating Instructions Page 12-21

12 [Report] Menu

Page 12-22 Maglumi 2000 Operating Instructions

 13 Status Display and Handling

13 Status Display and Handling

13.1 Status Display

Figure 13.1-1 Status Bar

Software interface at the bottom of the status bar has three buttons to display the status

information of the analyzer.They are <Reservoir> button（ ）, <Temp/Volt>

button（ ）, <Waste> button（ ）.

13.1.1 Consumables

<Reservior> button is used to show whether there are sufficient cuvettes, system
liquid and starter 1+2.
The status of <Reservior> button means:

All consumables are sufficient.

Green

One or more consumables are not sufficient.

Yellow

One or more consumables are almost used up.

Red

WARNING
In case of an alarm, please check which consumable has run out and
replenish it.

Click <Reservior> button to open [Reservoir Status] dialog, where shows the status
of cuvettes , starter reagents and system liquid.

Maglumi 20000 Operating Instructions Page 13-1

13 Status Display and Handling

Figure 13.1-2 [Reservoir Status] Dialog

13.1.1.1 Cuvettes

Layer graph is used to represent the number of cuvettes in the stacker.

WARNING
Please confirm that there are sufficient cuvettes in the stacker before
running the analyzer! When there are less than 4 cuvettes bars in the
stacker, the analyzer will report an error and shut down.

Green Number of cuvettes bars > 17.

4 ≤ Number of cuvettes bars ≤ 17. At this moment, a warning
Yellow prompt "Running out of cuvettes soon!" will appear, and an
alarm sound will be given.
Number of cuvettes bars < 4. At this moment, a warning prompt
Red "Run out of cuvettes!" will appear, and an alarm sound will be
given. The analyzer will report an error and shut down.
13.1.1.2 System Liquid

Different volume of system liquid show by following icon

OK Volume of system liquid ≥ 20%.

WARING Volume of system liquid < 20%.

EMPTY System liquid has run out; the analyzer reports an error and
shuts down.

WARNING
1) Change the system liquid only when the analyzer has shut down.
But users can connect the system liquid tank to another one with
the "Continuous Loading Pipe",so that add system liquid during the
analyzer working
2) System liquid must be prepared and standing 6 hours prior to use.
Please store and use the system liquid according to the Instruction
Manual provided in its package.

Page 13-2 Maglumi 20000 Operating Instructions

 13 Status Display and Handling

13.1.1.3 Starter Reagents

Different volume of starter reagents show by following icon

OK Volume of starter 1+2 ≥ 20%.

WARING Volume of starter 1+2 < 20%.

FULL Starter 1+2 has run out; the analyzer reports an error and
shuts down.

WARNING
The starter 1+2 can not be exchanged when the analyzer is testing.

13.1.2 Temperature and Voltage

The status of <Temp/Volt> button means:

All temperatures and voltages in the analyzer are normal.

One or several temperatures or voltages in the analyzer are

beyond the normal

Click <Temp/Volt> button to open [System Parameter] dialog, which shows the
temperature and voltage parameters of the analyzer.

Figure 13.1-3 [System Parameter] Dialog

Maglumi 20000 Operating Instructions Page 13-3

13 Status Display and Handling

13.1.3 Waste

The status of <Waste> button :

The status of all kinds of waste are normal.

One or more kinds of waste is nearly full.

One or more kinds of waste have been full.

Click <Waste> button to open [Waste Status] dialog, where shows the volume of
liquid in the waste liquid tank and the number of waste cuvettes in the waste bag.

Figure 13.1-4 [Waste Status] Dialog

13.1.3.1 Waste Liquid

Different volume of waste liquid show by following icon

OK Volume of liquid in the waste liquid tank≤ 80%.

WARING Volume of liquid in the waste liquid tank reaches 80-90%.

FULL Volume of liquid in the waste liquid tank reaches 90-100%.

WARNING
When yellow or red appears, the system will display a warning
message; in such case, please empty the waste liquid tank.

13.1.3.2 Waste Cuvettes

Green Number of waste cuvettes bars < 60.

Yellow 60 ≤Number of waste cuvettes bars < 80.

Red Number of waste cuvettes bars ≥80.

Page 13-4 Maglumi 20000 Operating Instructions

 13 Status Display and Handling

WARNING
When yellow or red appears, the system will display a warning
message; in such case, please empty the waste bag.

13.2 Handling Consumables

When consumables are running out or waste is fulling up, the analyzer will report an
error and shut down, the software interface will open [Machine is halted] dialog at the
same time. After replenishing the consumables and clearing away waste, click
<Continue> button to continue the assay (The stacker component need initialize).

13.2.1 Placing Cuvette

Figure 13.2-1 Placing Cuvette

Operation Steps:
1. Unpack the cuvettes as instructed, and take out a layer of (8) cuvettes bars.
2. Place the cuvettes on the conveyor belt along the proper direction.
3. The conveyor belt will automatically transfer the cuvettes into the stacker.
4. When the conveyor belt stops, users can continue adding cuvettes.
5. Repeat the above steps until the stacker becomes full; the stacker can hold 110
cuvettes bars at most.
Cuvettes can be added at any time when the analyzer is running.

NOTE
1) Pay attention to the remaining number of cuvettes during assay!
2) The stacker should be emptied once a week to ensure cleanness of
cuvettes.

13.2.2 Adding System Liquid

System liquid is connected at the right side of the analyzer. "System liquid" is used
for cleaning pipette, system pipe and magnetic microbeads. The volume of system

Maglumi 20000 Operating Instructions Page 13-5

13 Status Display and Handling

liquid is detected by the level detector, and shown with the "Warning Light" of
<Consumables> icon on the main menu. Click <Consumables> button to open
[Reservoir Status] window. The displayed information includes the stock of cuvettes
in the stacker, starters and system liquid.

WARNING
Make sure there is sufficient system liquid before and during operation
of the analyzer!

The way of add System Liquid in standby:

1. Take the sealing cover with level detector and hose out of the corresponding
bottle.
2. Add system liquid, and close the sealing cover.
3. Fill the hoses: Select <System Test> on the menu bar, and select pipettor and
washer in the [System Test] dialog. Enter (3) and (2) in corresponding cycles, and
click <OK> to start priming.

The way of add System Liquid in testing:

Use the "Continuous Loading Pipe" and another "System Tank" which equips with
System Liquid to add system liquid during the test.

13.2.3 Change Starter Reagents

The container of starter is on the right side of the analyzer. S1 and S2 are marked on
the container. The digit "S1" and "S2" represent starter 1 and starter 2, respectively.
The reagent bottle is sealed with an openable screw cap. The level of starter can be
detected with the level detector fixed to the cap.

WARNING
1) Make sure there is sufficient starter before operation of the
analyzer!
2) The starters can not be changed when the analyzer is testing.
3) Please make sure hoses for starters 1 and 2 are connected
correctly.

WARNING
1) Never pour out starters, liquid splash is not allowed in this area!
2) Never mix starter 1 and starter 2 manually.
3) Chemical burn risk! Please read the reagent instructions in the
package of starter.

Operation steps:
Change starters of the same lot number：
1. Open the starter 1 and take out the connecting hose.
2. Place a new bottle of starter 1 at the corresponding position.
3. Close the screw cap.
4. Replace starter 2 according to the above steps.
5. Fill the hoses: Select <System Test> on the menu bar, and select chamber in the
[System Test] dialog. Enter (3in corresponding cycles, and click <OK> to start
priming.

Page 13-6 Maglumi 20000 Operating Instructions

 13 Status Display and Handling

Change starters of different lot number, please do the following additional

operations:
6. Background test: Select <System Test> on the menu bar. Change (1) preset in
the BGW, Lc-le and Lc-ri area to (0), and press <OK> to start the BGW test.

13.2.4 Waste Cuvettes

The waste bag holder for placing waste cuvettes is positioned on the right side of the
analyzer, close to the chamber. The software will automatically count the number of
waste cuvettes and prompt users.
When the waste bag is full, users can take it out of the holder and seal it with a cover.
Replace with a new waste bag and correctly fit in the holder. Click <Waste> button in
status bar to open [Waste Status] dialog, click <Reset> button to reset the number of
waste cuvettes.

WARNING
1) After replace the waste bag, please reset the number of waste
cuvettes. Or the warning message will always remain.
2) Make sure the waste bag is placed properly; otherwise the analyzer
may be disrupted as the cuvettes are stuck at the edge of the waste
bag when they are pushed out of the chamber.
3) The used cuvettes must be placed in the waste bag since residual
substances in the cuvettes may cause contamination. Please
dispose of waste cuvettes in accordance with local laws and
regulations.

13.2.5 Waste Liquid

The two waste liquid ports used for waste liquid are positioned on the right side of the
analyzer, which are marked "Waste Liquid ① and
②".
Waste liquid comes from cuvettes, pipetting system and washer during assay,
including magnetic microbeads, starters, samples, reagents, and system liquids.

WARNING
1) Please wear gloves for operation!
2) Please dispose of waste liquid in accordance with local laws and
regulations.
3) Please clean the waste liquid tank on a regular basis according to
the Maintenance Manual.

Maglumi 20000 Operating Instructions Page 13-7

13 Status Display and Handling

Page 13-8 Maglumi 20000 Operating Instructions

 14 Reagent Loading

14 Reagent Loading

14.1 Reagent Structure

All reagent basically have the following structure:

RFID label

ID label
Magnetic microbeads
mixing gear

Figure 14.1-1 Reagent Structure

1. Seal is for sealing reagent. The pipetting needle enters the kit from here to absorb
reagent;
2. Handle is convenient for users to hold the kit by hand;
3. The RFID label which behind the ID label records the reagent data;
4. The ID label indicates the reagent components, name, expiry date and other info
of the kit;
5. The magnetic microbeads mixing gear is used in conjunction with the rocker in the
reagent area to mix magnetic microbeads homogeneously;
6. ID Tab is used to block optocoupler when the reagent is inserted to the reagent
area so that it can be identified;
7. Clamp is used to fix the reagent inserted to the reagent area.

14.2 Reagent Loading

14.2.1 Prepare the Reagent

Please ensure that the up and down orientations of the reagents are correct when
storing; upside-down status is not allowed. Besides, please do not shake the reagent.

1. Take the reagent out of the refrigerator;

2. Take the reagent kit out of the packaging box;
3. Observe the sealing film and other parts of the reagent kit to see if there is any
leakage. In case of leakage, please contact your local agent immediately;
4. Observe each component liquid of the reagent kit to see if air bubbles exist. If yes,
please use a pipettor to remove the air bubbles; the reagent integral can be used
after confirming that all air bubbles are eliminated;
5. Gently turn the magnetic microbeads mixing gear to make sure it can rotate freely;

Maglumi 2000 Operating Instructions Page 14-1

14 Reagent Loading

6. Carefully tear off the kit sealing film;

7. Clean up liquid on the reagent kit surface to avoid cross infection.

14.2.2 Loading the Reagent

Before inserting the reagent to the reagent area, please make sure the software and
the lower computer are working normally.
1. Open the reagent area door; the software will automatically display the [Reagents]
interface;
2. Hold the reagent handle to get the RFID label close to the sensing area (for about
2s); the buzzer will beep; one beep sound indicates successful sensing;
3. Keeping the reagent straight insert to the bottom along the blank reagent track;
4. Relevant reagent data will be read out via computer software; the [Reagents]
interface will show the reagent name, and the corresponding reagent position
button will change to dark gray;
5. In case of failure to read data, please repeat the above operations;
6. After finishing reading reagent data, please close the reagent area door and exit
the [Reagents] interface.

Figure 14.2-1 Scanning Reagent

Figure 14.2-2 Inserting Reagent

Page 14-2 Maglumi 2000 Operating Instructions

 14 Reagent Loading

14.2.3 Remove the reagent

When taking the kit out of the analyzer, users should make sure both the software and
the analyzer are running normally, so as to ensure the reagent is removed in normal
condition. The reagent should not be removed if there are still some assays in
progress or pending for results on the analyzer. Otherwise the result will be an error,
and may cause damage to the analyzer.
1. Open the reagent area door;
2. Hold the reagent handle to take the kit out of the reagent area;
3. Please ensure that the up and down orientations of the reagent are correct.

If the reagent is empty

4. Please properly dispose of the reagent;
If the reagent is not empty
5. Put the kit and store it in a refrigerator,ensure that the up and down orientations of
the reagent are correct.

14.3 Properly Store the Reagent

1. Keep the reagent at 2-8°C with correct up and down orientations ensured;
2. If the reagent is opened, please use additional sealing film to cover each hole of
the reagent in order to avoid liquid evaporation.

Maglumi 2000 Operating Instructions Page 14-3

14 Reagent Loading

Page 14-4 Maglumi 2000 Operating Instructions

 15 Sample Loading

15 Sample Loading

15.1 Sample Rack

The sample rack specified for the analyzer has 12 sample positions, where sample
tubes with or without barcode can be inserted; barcodes of sample tubes can be
automatically scanned into the analyzer.

15.1.1 Structure of Sample Rack

1. Operating 2. Sample 3. Sample tube 4. Rack fixing clamp

handle position barcode position
Figure 15.1-1 Sample Rack
The structure of sample rack:
1. Operating handle: is used for loading and unloading the sample rack;
2. Sample position barcode: can be used to determine the position of a sample tube;
3. Sample tube position: has a retaining clip inside to fix a sample tube ;
4. Rack fixing clamp: can be used to fix the sample rack and detect the status of
sample tube..

The barcodes on the sample rack are used to determine the specific positions of
sample tubes. When sample rack is inserted, the barode detector will scan barcode
info on the rack one by one; the position of each sample and other info contained in the
barcode will all be displayed on the Sample Info of [Patients] interface.

Maglumi 2000 Operating Instructions Page 15-1

15 Sample Loading

Figure 15.1-2 Sample Tube Barcodes on the Sample Rack

After the sample rack is correctly inserted to the sample reservoir, the sample info will
be read.

Figure 15.1-3 Sample Position Info

No. 3 & 4 sample tubes have no barcode, therefore cannot be automatically identified.
If a sample is not automatically identified, users can manually edit the sample info.

15.1.2 Type of Sample Rack

The analyzer only uses one type of sample rack. Sample tubes with the inner diameter
of φ8 mm~φ12 mm and the height of 60 mm~100mm can be used.

Page 15-2 Maglumi 2000 Operating Instructions

 15 Sample Loading

15.2 Sample Loading

WARNING
1) Please make sure the sample tube has been uncapped before
pipetting; otherwise the sampling needle will get damaged.
2) In order to avoid infection, please wear gloves before operating
each sample.

15.2.1 Prepare the Sample

NOTE
In case of lack or absence of sample solution, the analyzer will still
show the result; therefore, when the analyzer shows a warning
message such as " Left/Right Needle can not detect Liquid!, retest
should be performed.

The following conditions must be satisfied before measuring sample:

1. Samples include: serum, plasma, urine, cerebrospinal fluid, etc.;
2. Prepare anticoagulants such as EDTA and heparin;
3. The blood drawing process should be standardized; serum should be separated
from blood clots;
4. If the sample contains suspended solids or is turbid, or has blood lipids or RBC
fragments, filtering or centrifugation must be performed prior to test;
5. Samples with hemolysis or lipemia, or infected by microorganism, should not be
used for test;
6. Please ensure the sample contains no air bubbles prior to measure.

NOTE
To ensure safety, the sample must satisfy relevant requirements and
operation conditions to avoid air bubbles and blood clots!

The sample satisfying all conditions can be put in a sample tube to be inserted to the
sample rack. The operation steps are described as follows:
1. Test tubes must conform to specification requirements;
2. Carefully insert each sample tube to the sample rack;
3. If barcode scanning will be performed for the sample rack, each barcode should
face rightward so that it can be read by the barcode reader.

Figure 15.2-1 Sample Tubes with Barcode

Maglumi 2000 Operating Instructions Page 15-3

15 Sample Loading

NOTE
1) Do not revolve a sample tube with barcode in the sample rack to
avoid damaging the barcode.
2) After a sample tube is read by the barcode successfully or has been
edited manually, it cannot be pulled out and inserted to other slot.

Like samples, each barcode of Light Check fluid provided by Snibe should face the
barcode reader so that it can be read. If a sample tube is not properly inserted to the
sample rack, please pull it out and reinsert it.

15.2.2 Sample Rack Loading

Please load the sample rack according to the steps below:

1. Open the door of sample area;
2. Select an empty slot to push in the sample rack;
3. Slowly insert the sample rack so that each barcode can be read effectively;
4. Make sure the sample rack is kept vertical when it is pushed in; push in the
rack smoothly until the edge of sample rack is in close contact with the edge
of sample area;
5. In case of barcode scanning failure, please reload the sample rack and scan
the barcode.

NOTE
1) Before pushing the sample rack into the sample compartment,
please make sure both the machine and the software have entered
the working status. Otherwise, the sample cannot be read and
subsequent operation will be invalid.
2) The barcode reader has laser radiation hazard. Please avoid
looking directly at the laser beam!

the laser beam

Figure 15.2-2 Barcode Scanning

Page 15-4 Maglumi 2000 Operating Instructions

 15 Sample Loading

Figure 15.2-3 Fixing Sample Rack

15.2.3 Remove the Sample Rack

Before removing the sample rack, please make sure both the analyzer and the
software are running normally. The sample rack to be removed should not be in active
status (orange light is on); otherwise, a result error will occur and the analyzer may get
damaged.
1. Open the door of sample area;
2. Grasp the rack handle with your thumb and index finger to smoothly pull the
sample rack out of the sample area until the sample rack completely leaves the
sample area;

If the sample tube is empty

3. Dispose of the sample tube according to relevant regulations;

If the sample tube is not empty and may be used in the future
4. Seal and store the sample properly according to relevant laboratory regulations;

15.3 Maintenance of Sample Rack

The maintenance of sample rack is necessary under the following special

circumstances.
1. The rack is in direct contact with any biochemical substance.
2. A sample tube cannot be inserted to the sample rack stably.

In the first case:

1. Transfer all samples on the contaminated sample rack to another clean rack;
2. Soak the contaminated sample rack in 0.1% sodium chloride solution for
15~30min. In order to avoid corrosion of the sample rack, the duration should not
exceed 30min;
3. Take out the sample rack; use a clean, dry towel to wipe it dry.

In the second case:

1. Take a ball-point pen; insert its tip below the retainer of metal plate inside the
sample rack slot, as shown in Fig. 15.3-1; then, apply gentle force to make the
retainer upwarp;
2. Insert a sample tube conforming to specification requirement and check if the
problem is fixed;
3. If the sample tube is still loose, please repeat Step 1 and 2 until the tube can be
inserted firmly.

Maglumi 2000 Operating Instructions Page 15-5

15 Sample Loading

Figure 15.3-1 Adjust the Metal Dome Inside the Slot

Page 15-6 Maglumi 2000 Operating Instructions

 16 LIS Interface

16 LIS Interface

16.1 Description of Online Mode

This chapter describes settings of laboratory information system (LIS). Only

information related to users is provided. Special settings about LIS connection and
details of configuration are not covered in this manual.
LIS is now widely used for management of chemical or microbiological assays in
clinical laboratories. As an external software, it forms a part of the central information
processing system in clinical institutes.

16.1.1 Enable Online Mode

Maglumi 2000 Immunoassay Analyzeroperates under different modes. In order to

activate the online mode, the user must set up the operating mode first.

Click <Mode> button in [System] menu to open [Mode] interface.

Figure 16.1-1 [Mode] Interface

The software cannot connect to LIS until the Online Mode is selected. After selecting
the Online Mode, click the <Save> button to confirm.

16.1.2 Setting Parameters of Online Mode

Click <Online> button in [System] menu to open [Online] interface to set the
parameters related to LIS.

Maglumi 2000 Operating Instructions Page 16-1

16 LIS Interface

Figure 16.1-2 [Online] Interface

The following options are provided in the [Online] interface:

Protocol
None Do not connect to hospital’s LIS.
ASTM Communicate with the hospital’s LIS server with ASTM
protocol.
Host Configuration
Analyzer ID Enter the name of the analyzer that communicates with
the hospital’s LIS.
Host ID Enter the name of the hospital’s LIS.
Automatic Operation
Enable Automatic Enable the analyzer to automatically download the test
Downloading information of the sample from hospital’s LIS.
Enable Automatic Uploading Enable the analyzer to automatically upload the results
of the sample to hospital’s LIS server.
Enable Upload QC Data Enable the analyzer to automatically upload the results
of QC to hospital’s LIS server.
Automatic Upload Result
Type
All Results Enable the analyzer to upload all test results to
hospital’s LIS.
Results without Pipettor Enable the analyzer to upload all results without
Error pipettor error to hospital’s LIS.
Results without Error Enable the analyzer to upload all results without any
analyzer error to hospital’s LIS server.
Communications
COM Port Select the serial number of the COM Port that
communicates with hospital’s LIS.
Baud Rate Select the Baud rate for communicating with hospital’s
LIS.
Data Bits Display the data bits for communicating with the
hospital’s LIS.
Stop Bits Display the stop bits for communicating with the
hospital’s LIS.
Parity Display the parity bits for communicating with the
hospital’s LIS
ASTM Delimiters
Field Delimiter Display the field delimiter for communicates with
hospital’s LIS.
Repeat Delimiter Display the repeat delimiter for communicating with

Page 16-2 Maglumi 2000 Operating Instructions

 16 LIS Interface

hospital’s LIS.
Comp. Delimiter Display the component delimiter for communicating
with the hospital’s LIS.
Escape Delimiter Display the escape delimiter stop bits for
communicating with the hospital’s LIS

Current Status
COM Port Status Display the status of the COM Port currently used.

Click <Save> button to save parameters. The software is ready for communicating with
LIS.

16.1.3 Methods of Sending Results

After sample is tested, the user can send the results to remote host through the
following methods:

1. Manually send validated results

After the results are validated on analyzer, they can be manually sent to the host in
[Valid]. Click the <Valid> button in [Report] menu to enter [Valid] interface. Click the
<Online> button in the [Valid] interface to send the validated results to LIS.

Figure 16.1-3 [Valid] Interface

2. Manually send results before validation

The results are manually sent to and validated on the remote host, instead of
validated on the analyzer. Click the <Journal> button in [Report] menu to enter
[Journal] interface. Click the <Online> button to send the results to LIS before
validation.

3. Automatically send results before validation

The results are automatically sent to and validated on the remote host, instead of
validated on the analyzer. When Enable automatic uploading is selected, each result
obtained in the process of test will be sent to LIS.

If the software fails to send all results to LIS, the user can manually send the results
again to LIS.

Maglumi 2000 Operating Instructions Page 16-3

16 LIS Interface

16.2 Instruction on Control Codes

The software employs ASTM E1394 protocol for communication. All communication
information between the software and LIS is stored in the directory \online\log.
Table 16.2-1 Instruction on Control Codes
Character Meaning Corresponding ASCII
<ENQ> Request 0x05
<ACK> Confirm Response 0x06
<STX> Start 0x02
<ETX> End 0x03
<CR> Home key 0x0D
<EOT> End Transmission 0x04

16.3 Instruction on Basic Communication Format

Example:
<ENQ><STX>TEXT< ETX ><EOT>

Table 16.3-1 Instruction on Basic Communication Format

Character Meaning Corresponding ASCII
<ENQ> Request 0x05
<STX> Start 0x02
T Letter T 0x54
E Letter E 0x45
X Letter X 0x58
T Letter T 0x54
<ETX> End 0x03
<EOT> End Transmission 0x04

16.4 Instruction on Delimiters

There are 4 delimiters defined in ASTM E1394, which are used for separating contents
of communication. See section 6.4 of E1394 for details. Meaning of each delimiter is
shown in the following table:

Table 16.4-1 Instruction on Delimiter

Delimiter Meaning Corresponding ASCII
<CR> Home key 0x0D
| Field Delimiter 0x7C
\ Repeat Delimiter 0x5C
^ Comp. Delimiter 0x5E
& Special Delimiter 0x26

16.5 Instruction on Type of Message

Table 16.5-1 Instruction on Type of Message

Message Identifier Meaning
H Message head record

Page 16-4 Maglumi 2000 Operating Instructions

 16 LIS Interface

P Patient info record

O Assay item record
R Result record
Q Info required record
L Message end record

16.5.1 Message head record (H)

Instruction:
Contents in this section are corresponding to section 7 of ASTM E1394.
Message head record is placed in the front of all transmitted records. It is used to
describe basic information of some protocols and transmission.

Examples：
H|\^&||PSWD|Maglumi|||||Lis||P|E1394-97|20100323<CR>
Table 16.5-2 Message Head Record
Name of ASTM Maximum Required or
Field E1394 Content
Field Length Not
1 7.1.1 Type of message H 1 Yes
2 7.1.2 Delimiter definition |\^& 4 Yes
4 7.1.4 Password PSWD 20 No
5 7.1.5 Name of transmitter Maglumi 20 Yes
10 7.1.10 Name of receiver Lis 20 Yes
12 7.1.14 Mode of processing P 1 Yes
Protocol Version
13 7.1.13 E1394-97 10 Yes
No.
14 7.1.14 Date YYYYMMDD 14 Yes

NOTE
1) There are 14 fields in the protocol, but only the fields required by
this software are listed here. Other fields can be added in actual
communication process and automatically recognized by the
software. If there is blank field, use the delimiter “|” to separate
fields as shown in the example.
2) “<CR>” at the end of a message record is required, and this
delimiter shall be added to the end of each message record for
indicating the end of the record.

16.5.2 Patient Info Record (P)

Instruction:
Contents in this section are corresponding to section 8 of ASTM E1394.
Information of each patient shall be described by this record.

Examples:
P|1||||ABC|||F <CR>

Maglumi 2000 Operating Instructions Page 16-5

16 LIS Interface

Table 16.5-3 Patient Info Record

Name of ASTM Maximum Required or
Field E1394 Content
Field Length Not
1 8.1.1 Type of message P 1 Yes
2 8.1.2 Serial No. 1 6 Yes
6 8.1.6 Name of Patient ABC 30 No
9 8.1.9 Sex M,F,U 1 No

NOTE
1) Only the first and second fields are required. In the software, this
record is normally in following format: P|1 <CR>.
2) There are 35 fields in the protocol, but only the fields required by
this software are listed here. Other fields can be added in actual
communication process and automatically recognized by the
software.
3) “<CR>” at the end of a message record is required, and this
delimiter shall be added to the end of each message record for
indicating the end of the record.

16.5.3 Assays Record (O)

Instruction:
Contents in this section are corresponding to section 9 of ASTM E1394.
Assays of each test shall be described by this record.

Examples:
O|1|1234567||^^^TSH|R<CR>
Table 16.5-4 Assays Record
Name of ASTM Maximum Required or
Field E1394 Content
Field Length Not
1 9.1.1 Type of message O 1 Yes
2 9.1.2 Serial No. 1 6 Yes
3 9.1.3 Sample No. 1234567 22 Yes
5 9.1.5 Assays ^^^TSH 30 Yes
6 9.1.6 Priority S,R 1 Yes

NOTE
1) “^^^” in the front of the fifth field “Assays” are required, and the
following TSH is the project name.
2) In the sixth field “Priority”, S means emergency, R means regular. R
is used by default.
3) There are 31 fields in the protocol, but only the fields required by
this software are listed here. Other fields can be added in actual
communication process and automatically recognized by the
software.
4) <CR> at the end of a message record is required, and this delimiter
shall be added to the end of each message record for indicating the
end of the record.

Page 16-6 Maglumi 2000 Operating Instructions

 16 LIS Interface

16.5.4 Result Record (R)

Instruction:
Contents in this section are corresponding to section 10 of ASTM E1394.
Each result shall be described by this record.
Examples:
R|1|^^^TSH|4.3|μIU/mL |0.658 to 4.864|N||||||20160326172956<CR>

Table 16.5-5 Result Record

Name of ASTM Maximum Required or
Field E1394 Content
Field Length Not
1 10.1.1 Type of message R 1 Yes
2 10.1.2 Serial No. 1 5 Yes
3 10.1.3 Assay record ^^^TSH 10 Yes
4 10.1.4 Result 4.3 12 No
5 10.1.5 Unit μIU/mL 10 No
6 10.1.6 Reference range 0.658 to 4.864 30 No
7 10.1.7 Result flag L,H,N 1 No
YYYYMMDDH
13 10.1.13 Test finish time 14 No
HMMSS

NOTE
1) “^^^” in the front of the third field “Assays” are required, and the
following TSH is the project name.
2) In the seventh field “Result flag”, L means lower than normal, H
means higher than normal, and N is normal.
3) There are 14 fields in the protocol, but only the fields required by
this software are listed here. Other fields can be added in actual
communication process and automatically recognized by the
software.
4) <CR> at the end of a message record is required, and this delimiter
shall be added to the end of each message record for indicating the
end of the record.

16.5.5 Info Required Record (Q)

Instruction:
Contents in this section are corresponding to section 12 of ASTM E1394.
It is used to request information on assays corresponding to the sample.

Examples:
Q|1|^1234567||ALL||||||||O<CR>
Table 16.5-6 ENQ Info Record
Name of ASTM Maximum Required or
Field E1394 Content
Field Length Not
1 12.1.1 Type of message Q 1 Yes
2 12.1.2 Serial No. 1 6 Yes
3 12.1.3 Sample No. ^1234567 22 Yes
5 12.1.5 Assay record ALL 10 Yes
13 10.1.13 Required info status O 1 Yes

Maglumi 2000 Operating Instructions Page 16-7

16 LIS Interface

NOTE
1) “^” in the front of the third field “Sample No.” is required, and the
following 1234567 is the sample number.
2) There are 13 fields in the protocol, but only the fields required by
this software are listed here. Other fields can be added in actual
communication process and automatically recognized by the
software.
3) <CR> at the end of a message record is required, and this delimiter
shall be added to the end of each message record for indicating the
end of the record.

16.5.6 Message End Record (L)

Instruction:
Contents in this section are corresponding to section 13 of ASTM E1394.
It is used as the last piece of all transmitted records, indicating completion of
transmission.

Examples:
L|1|N<CR>
Table 16.5-7 Message end record
Name of ASTM Maximum Required or
Field E1394 Content
Field Length Not
1 13.1.1 Type of message L 1 Yes
2 13.1.2 Serial No. 1 6 Yes
3 13.1.3 Termination code N 1 Yes

NOTE
<CR> at the end of a message record is required, and this delimiter
shall be added to the end of each message record for indicating the end
of the record.

16.6 Example

16.6.1 Enquiring Assay

User inserts a sample rack into the sample area, after the sample barcode is scanned
by the analyzer, the software requests for assay info from LIS with the following
message.
Message Content:
--><ENQ>
<--<ACK>
--><STX>
<--<ACK>
-->H|\^&||PSWD|Maglumi 2000|||||Lis||P|E1394-97|20100323<CR>
Q|1|^1234567||ALL||||||||O<CR>
L|1|N<CR>
<--<ACK>
--><ETX>
<--<ACK>
--><EOT>
<--<ACK>
Table 16.6-1 The Meaning of Characters

Page 16-8 Maglumi 2000 Operating Instructions

 16 LIS Interface

Corresponding
Character Meaning
ASCII
--> Software sending
<-- Software receiving
<ENQ> Request 0x05
<ACK> Confirm Response 0x06
<STX> Start 0x02
<ETX> End 0x03
<CR> Home key 0x0D
<EOT> End Transmission 0x04

Therein:
H|\^&||PSWD|Maglumi 2000|||||Lis||P|E1394-97|20100323<CR>
Q|1|^1234567||ALL||||||||O<CR>
L|1|N<CR>

In ASTM E1394 protocol, this message is used to request reagent information

corresponding to the sample. In the previous example, the reagent corresponding to
the sample 1234567 is requested.

NOTE
1) <ACK> in above example is returned by LIS, and corresponding
<ACK> command must be sent in specified position; otherwise this
software deems that LIS is disconnected.
2) Upon receiving this content, LIS must return assay info.

16.6.2 Returning Assays

After LIS receives assay request from the software, it must return information on
assays.
Message Content:
<--<ENQ>
--><ACK>
<--<STX>
--><ACK>
<--H|\^&||PSWD|Maglumi 2000|||||Lis||P|E1394-97|20100319<CR>
P|1<CR>
O|1|1234567||^^^TSH|R<CR>
L|1|N<CR>
--><ACK>
<--<ETX>
--><ACK>
<--<EOT>
--><ACK>
The meaning of characters is the same to Table 16.6-1.

Therein:
H|\^&||PSWD|Maglumi 2000|||||Lis||P|E1394-97|20100319<CR>
P|1<CR>
O|1|1234567||^^^TSH|R<CR>
L|1|N<CR>

In ASTM E1394 protocol, this message is used by LIS to return information on assays
corresponding to the sample.

Maglumi 2000 Operating Instructions Page 16-9

16 LIS Interface

In the previous example, the LIS returns assays, i.e. reagent TSH for the sample
1234567.

NOTE
<ACK> in above example is returned by LIS, and corresponding <ACK>
command must be sent in the position specified; otherwise this software
deems that LIS is disconnected.

16.6.3 Sending Assay Results

--><ENQ>
<--<ACK>
--><STX>
<--<ACK>
-->H|\^&||PSWD|Maglumi 2000|||||Lis||P|E1394-97|20100326<CR>
P|1<CR>
O|1|1234567||^^^TSH<CR>
R|1|^^^TSH|4.3|μIU/mL|0.658 to 4.864|N||||||20100326172956<CR>
L|1|N<CR>
<--<ACK>
--><ETX>
<--<ACK>
--><EOT>
<--<ACK>

The meaning of characters is the same to Table 16.6-1.

Therein:
H|\^&||PSWD|Maglumi 2000|||||Lis||P|E1394-97|20100326<CR>
P|1<CR>
O|1|1234567||^^^TSH<CR>
R|1|^^^TSH|4.3|μIU/mL |0.658 to 4.864|N||||||20100326172956<CR>
L|1|N<CR>
In ASTM E1394 protocol, this message is used to send assay results to LIS. In the
previous example, the software transmits results of the reagent TSH corresponding to
the sample 1234567 to LIS.

NOTE
<ACK> in above example is returned by LIS, and corresponding <ACK>
command must be sent in the position specified; otherwise this software
deems that LIS is disconnected.

Page 16-10 Maglumi 2000 Operating Instructions

 17 System Maintenance

17 System Maintenance

17.1 Daily Maintenance

Materials needed:
Clean waste bag, clean cotton cloth.

Maintenance Process:
1. Use the clean cotton cloth to clean the analyzer surface;
2. Empty the waste bag to remove cuvettes and replace a clean waste bag;; empty
the waste liquid container;
3. Check the volume of starters; if not enough for use of the next day, please
replenish or change it;
4. Check the volume of system liquid; if not enough for use of the next day, prepare
a new system liquid to have ready. System liquid must be prepared 6 hours prior
to use;
5. Perform the "Priming for All" function once.

17.2 Weekly Maintenance

Materials needed:
Cotton swabs, alcohol

Maintenance Process:
Use cotton swabs dipped in alcohol to clean the outer walls of pipette needle, washer's
injecting needle and aspirating needle; then perform the "Priming for All" function
twice.

17.3 Monthly Maintenance

Materials needed:
160 ml 84 disinfectant, purified water, System Tubing Cleaning Solution, Light Check
Liquid

Maintenance Process:
1. Use 40 ℃ purified water to replace starters, and perfuse the chamber 30 times;
then replace the water with starters, and perfuse the chamber 10 times;
2. Use System Tubing Cleaning Solution to perform the "Wash Pipe" function once;
3. Empty the System Liquid Tank and the waste liquid Tank; clean them with 80mL
84 disinfectant + 2L purified water respectively, and empty the tanks; then use
purified water (2L each time) to clean the System LIquid Tank five times; last
replace the water with System Liquid to perfuse the pipettor and the washer 30
times each;
4. Place the Light Check Liquid at the upper right corner of the sample compartment;
perform BGW and LC once; view the results and make records thereof;
5. Requirements on system test results:
1) BGW: RLU is 200-1200, CV ≤ 10%;
2) LC: RLU is 400000-650000, CV ≤ 3%;
3) For two-needles modes: mean difference between LC(ri) and LC(le) ≤ 5%.
Please refer to the LC Reagent Manual of the specific expected value.

Maglumi 2000 Operating Instructions Page 17-1

17 System Maintenance

17.4 Etended Shuntdown-System Idle 5 Days or More

If users don’t use the analyzer for 5 or more day, the following steps should be
completed:
1. Replace the Starter 1+2 bottles with the two bottles of purified water.
2. Replace the system liquid tank with a tank of purified water.
3. Click <System Test> button in menu bar, select Pipettor, Washer and Chamber,
the cycles is 30, 20 and 10 respectively.

When using the analyzer again, the following steps should be completed:
1. Remove the purified water bottles and the purified water tank. Click <System Test>
button in menu bar, select Pipettor, Washer and Chamber, the cycles is 30, 20
and 10 respectively.
2. Place two bottles of Starter 1+2.
3. Place a tank of system liquid.
4. Click <System Test> button in menu bar, select Pipettor, Washer and Chamber,
the cycles is 30, 20 and 10 respectively. And system test results must meet the
requirements.

Page 17-2 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

18 Troubleshooting and Diagnostics

18.1 Manage of System Info and Error Messages

All system info and error messages are stored in a list of system database. Technical
service staff and users are able to obtain summary of all system info from there. This is
helpful for understanding the causes and solution of errors.
The current system info and error messages are displayed on the lower left corner of
the main menu. By clicking this dialog box, you can obtain the following [Message
Box].

Figure 18.1-1 [Message Box] Dialog for Error Message

1. Each message includes the following information(from left to right):

 Date/Time: The date and time when the error appears;
 Description: The description of system info and error message.

2. Sort Criterion: Display the current sorting order, include date/time, error code.

3. <Sort>
Click the <Sort> button to open [Sort Criterion] dialog, and select error ordering
principle.

Figure 18.1-2 [Sort Criterion] Dialog

Sort criterion of error:

Maglumi 2000 Operating Instructions Page 18-1

18 Troubleshooting and Diagnostics

 Date/Time: Sort by the date and time when the error appears;
 Error Code: Sort by the number of error code;
 Ascending: Sort by ascending;
 Descending: Sort by descending.
The selected assay is represented by symbol . Click the <OK> button to return
to the [Message Box], and error will be displayed in the selected order.

4. No. : The number of error messages,

5. <View>
Select an error and message and click the <View> button to enter [Detailed log
View] dialog which contains additional information.

Figure 18.1-3 [Detailed log View] Dialog

Click the <OK> button to return to the [Message Box] dialog.

6. <Print>
Click the <Print> button to enter [Printout Selection Dialog]; select the errors to
be printed in segment area.

Figure 18.1-4 [Printout Selection Dialog]

Segment::
 Tagged: The selected errors will be printed;
 All: All errors will be printed;
 From.. To: Range selection, enter start and end ranges of selected
condition. Errors within this range will be printed.

Click the <OK> button to return to [Message Box] dialog; the errors meeting the
selected conditions will be printed.

7. <Delete>

Page 18-2 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

Click the <Delete> button to enter [Delete Selection Dialog]; select the errors to
be deleted in segment area.

Figure 18.1-5 [Delete Selection Dialog]

Segment::
 Tagged: The selected errors will be printed;
 All: All errors will be printed;
 From.. To: Range selection, enter start and end ranges of selected
condition. Errors within this range will be printed.

Click the <OK> button to return to [Message Box] dialog; the errors meeting the
selected conditions will be deleted.

18.2 Emergency Stop

1. Automatic halt
When any mechanical failure occurs, the analyzer automatically halts and pops up
[Machine is Halted] debugging dialog box. If there is no operation in the software within
10 seconds, the failed component is initialized automatically and the [Machine is
Halted] dialog box is closed. If the initialization succeeds, the analyzer will continue to
work; if the initialization fails, the analyzer halts again with the [Machine is Halted]
dialog opened, and automatic initialization will not be carried out again.

2.Manual halt

When the button in the menu bar is clicked, the analyzer will suspend work and
open the [Machine is Halted] dialog.

Maglumi 2000 Operating Instructions Page 18-3

18 Troubleshooting and Diagnostics

Figure 18.2-1 [Machine is Halted] Dialog

Cuvette Loader The conveyor that transports the cuvette to the stacker.
Stacker The stacker holding cuvettes.
Incubator Loader The loader that transports the cuvette from the stacker to left
pipetting position and the incubator.
Incubator Incubator.
Washer Loader The loader that transports the cuvette from the incubator to
the washer.
Washer Transport The rack that moves the cuvette in the washer.
Washer Lift The washing component with injecting needle and aspirating
needle for washing the cuvette.
Pusher The mechanism for transporting the cuvette to the back
transport or the chamber.
Back Transport The mechanism for transporting the cuvette to the right
pipetting area.

Chamber Transport The component that moves the cuvette in the chamber.
Chamber Lift The mechanism with sprayer and probe in the chamber for
injecting starter reagents.
Pipettor The mechanism for finishing sample and reagent pipetting.
Wash Soak The peristaltic pump that is connected to washer aspirating
needle for extracting liquid in cuvette.
Low-Level The command for controlling motion of singular component.
Command
<Send> Used for sending Low-Level commands.
<Continue> Used for sending error recovery command to make the
analyzer continue to work after any error occurs.

When a mechanical failure occurs, the analyzer also triggers audio alarm in addition to
displaying error message. You can check the option “off the Beeper“ to block audio
alarm triggered by a certain error.

Page 18-4 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

18.3 Common Problems

Problems Possible Reasons Self-Check Solution

Clean the wash tank

Check system liquid is too following monthly
Expired system liquid, thick, check filth inside the maintence, apply
poor water quality or wash tank or check the distilled water with
improper preparation distilled water conductivity <2μs/cm;
of system liquid conductivity >2μs/cm or Make system liquid
not following the
instruction of insert.
Check the injection
volume of 3 pairs of
injection needles, see if
Abnormal injection of Contact technical
there is any tubing tangle,
washer needle support
air leakage or whether
fixing screws of magnetic
valve are loose
Abnormal soaking
Check whether the flow
Abnormal System Washer peristaltic Contact technical
speed of the waste tubes
Test Results: pump or blocking in support
is too low or not
CV and/or RLU out washer needles
of range Contamination inside
Check if there are liquid or Contact technical
Chamber or dection
crystal inside chamber support
window blurred
Check the remaining
starters, if there is any
The abnormal
strange noise whlie the Contact technical
injection of Starter
starter pumps are working, support
pump
whether the starter tubes
are bent or retracted
Contact technical
PMT failure Check BGW result
support
Use Tube cleaning
long time using Check tubing system, if
solution to clean
without maintence there are dirty or aging
tubing system
Check starter expire date,
Expired starters make sure the storing is Change new starters
under desired condition

Maglumi 2000 Operating Instructions Page 18-5

18 Troubleshooting and Diagnostics

Problems Possible Reasons Self-Check Solution

Check the distilled water

Apply distilled water
Water quality conductivity >2μs/cm or
conductivity <2μs/cm
not
Abnormal cordination Contact technical
Check Cordination
of pipett needle support
Check any leakages
at juction；
Check if there is drop or Check remaining
bubble at the tip of need system liquid；
air leakage within after washing；bubbles Check wash position
pipetting system within pipetting system； of washing；
leakage or crystal at Re-priming after
junction above checkings,
Contact technical
support if still leakage
Check warming
Sample pump， massage：
Contact technical
Washer pump or Initial failed or any liquid support
High CV of light related valve failure leakage or ejection within
check tubing system
Liquid level detection The rusults are nearly Contact technical
error or suction failure zero support
Check if there are crystals Wipe pipett needle if
Dirty or damaged on the surface or needle dirty, Contact
pipetting needle or the Teflon layer technical support to
damaged replace if damaged
Contamination inside
Check if there are liquid or Contact technical
Chamber or dection
crystal inside chamber support
window blurred
Check the remaining
starters, if any strange
Abnormal injection of Contact technical
noise whlie working, any
Starter pump support
bent or retracted
happened
Contact technical
PMT failure Check BGW result
support
Use Tube cleaning
Long time using Check tubing system, if
solution to clean
without maintence there are dirty or aging
tubing system

Page 18-6 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

Problems Possible Reasons Self-Check Solution

Clean the wash tank

Check system liquid is too following monthly
Expired system liquid, thick, check filth inside the maintence, apply
poor water quality or wash tank or check the distilled water with
improper preparation distilled water with conductivity <2μs/cm;
of system liquid conductivity >2μs/cm or Make system liquid
not following the
instruction of insert.
Check any leakages
at juction；
Check if there is drop or Check remaining
bubble at the tip of need system liquid；
Air leakage within after washing；bubbles Check wash position
pipetting system within pipetting system； of washing；
leakage or crystal at Re-priming after
junction above checkings,
Contact technical
support if still leakage
Check warming
Sample pump， massage：
Contact technical
Washer pump or Initial failed or any liquid support
related valve failure leakage or ejection within
tubing system
Liquid level detection Check recent results, if
Contact technical
error, suction failure there are RLU extremly
support
Test results with on sample or reagent high or low
high CV Check if there are crystals Wipe pipett needle if
Dirty or damaged on the surface or needle dirty, Contact
pipetting needle or the Teflon layer technical support to
damaged replace if damaged
Check the injection
volume of 3 pairs of
injection needles, see if
Abnormal injection of Contact technical
there is any tubing tangle,
washer needle support
air leakage or whether
fixing screws of magnetic
valve are loose
Abnormal soaking
Check whether the flow
Washer peristaltic Contact technical
speed of the waste tubes
pump or blocking in support
is too low or not
washer needles
Check the surface of
needles: if there are
crystals or the Teflon layer
Dirty or damaged
damaged Wipe pipett needle if
washer needle or
Check if the washer lift dirty, Contact
incorrect washer
injection position too low technical support
position not
or suction position too
high

The Chamber or
Check if have any crystal Contact technical
glass window
or liquid in chamber support
contaminated

Maglumi 2000 Operating Instructions Page 18-7

18 Troubleshooting and Diagnostics

Check the Starter injection

Starter injection Contact technical
volume, Starter pump,
volume inaccuracy support
and the Starter tube
Contact technical
PMT failure Check the BGW result
support
Use Tube cleaning
Long time using Check tubing system, if
solution to clean
without maintence there are dirty or aging
tubing system
Bubble or others in
Visual inspection Remove bubble
serum or reagent
Sample centrifuge Centrifuge in a proper
Visual inspection
insufficient condition
Make the tube touch
Sample tube loaded
Visual inspection the bottom of the
in rack improper
sample rack

Problems Possible Reasons Self-Check Solution

Adjust the sample

Check the sample needle
Probe not clean needle position
position and the
enough correctly and clean
contamination outside
the probe
Check the historical alarm
information about the
Diluter pump, washer
peristaltic pump Contact technical
pump or valve
initialization, check the support
abnormal
pump damaged or
leakage or not
Check any crystal or Clean the probe or
Probe contaminated
Teflon breakage outside of ask after-sales to
or damaged
probe replace it
Check the Wash
Wash Concentration Concentration and tank Clean the System
expired; storage, the contaminated or not. Liquid Tank, dilute
dilute ratio or water Check the specific system liquid by pure
Cross-
improper conductance of pure water water(<2μs/cm)
Contamination
less than 2μs/cm or not.
Check all the Washer
The volume of the
injection volume, injection Contact technical
Washer injection
tubes and the tighten of support
abnormal
valves
Peristaltic pump
abnormal or waste Check the flow speed of Contact technical
needle of Washer liquid in waste tube support
stuck
Check whether the
Needles of Washer
needles in Washer Clean the needles in
contaminated,
contaminated or Washer or contact
damaged or in
damaged; check the after-sales
incorrectly position
position of washer lift
Chamber or the glass Check if have any crystal
Contact technical
window of chamber or liquid in chamber and
support
lift contaminated chamber lift

Page 18-8 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

Sample contaminated Split sample to test or

during the transport None prior at Maglumi
or other analyzer system

Problems Possible Reasons Self-Check Solution

LLD function
Check the recent results,
abnormal; didn’t add Contact technical
especially too high or too
any sample or support
low RLU sample
reagent
Sample insufficient Visual inspection Add sample
Check the Starter injection
Low RLU on sample
Starter pump injection volume, Starter pump Contact technical
（even 0） abnormally and Starter tubes support
abnormal or not
Check the Background in
PMT abnormal Contact after-sales
Service
Calibration improper,
Check the Calibration Recalibrate or confirm
or not validate the
result abnormal or not it
calibration curve
Sample concentration
None Dilute
exceed linear range
Check the Wash
Wash Concentration Concentration and tank Clean the System
expired; storage, the contaminated or not. Liquid Tank, dilute
dilute ratio or water Check the specific system liquid by pure
improper conductance of pure water water(<2μs/cm)
less than 2μs/cm or not.
Check all the Washer
Washer injection injection volume, injection Contact technical
abnormal tubes and the tighten of support
valves
Peristaltic pump
abnormal or waste Check the flow speed of Contact technical
High RLU on sample
needle of Washer liquid in waste tube support
stuck
Needles of Washer Check the needles in
contaminated, Washer contaminated or Clean the needles or
damaged or in damaged, and the position contact after-sales
incorrectly position of washer lift
Check the RLU of other Contact technical
Light leakage of
samples in same batch support
chamber
abnormal or not
Check the Background in Contact technical
PMT abnormal
Service support
Serum treatment Centrifuge the sample
Visual inspection
incorrectly in proper condition

Maglumi 2000 Operating Instructions Page 18-9

18 Troubleshooting and Diagnostics

18.4 Error Message and Solution

Cuvette Loader
Message Message
Alarm Method Cause Recovery Method
code implication
1. Visually inspect
the beeper whether the belt is broken
beeps ,the dialog or dropped.
box [Error The analyzer should be 2. When it returns to
Cuvette loader
01010001 Message] is initialized before use, normal, select “Cuvette
not initialized!
displayed, but t the or a belt is broken. Loader” in the dialog box
machine is not [Machine is Halted], and
halted. then click <Send> and
<Continue>.
The beeper beeps,
the dialog box [Error
The stacker is empty or
Running out of Message] is Please place the cuvette
01020004 the layer sensor
cuvettes soon! displayed, but the again.
detects no signal.
machine is not
halted.
1. Confirm whether the
stacker is empty, if so,
place cuvettes, otherwise
The beeper beeps, check whether the layer
the dialog box The stacker is empty or sensor is effective.
Run out of
01020005 [Machine is Halted] the layer sensor 2. When it returns to
cuvettes!
is displayed and the detects no signal. normal, select “Cuvette
machine is halted. Loader” in the dialog box
[Machine is Halted], and
then click <Send> and
<Continue>.

Page 18-10 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

Incubator Loader
Message Message
Alarm Method Cause Recovery Method
code Implication
1. Select “Incubator Loader”
The incubator loader
or Incubator in [Machine is
cannot move as a
The beeper beeps, Halted] dialog box, and then
result of mechanical
Incubator the dialog box click <Send> and
failure, the incubator
01030001 loader can not [Machine is Halted] <Continue>.
position is not
move forward! is displayed and the 2. If the problem continues,
aligned or the sensor
machine is halted ask technical staff to inspect
of the incubator
mechanical parts and the
loader fails
sensor.
1. Select “Incubator Loader"
The incubator loader in [Machine is Halted] dialog
The beeper beeps,
cannot move as a box, and then click <Send>
Incubator the dialog box
result of mechanical and <Continue>.
01030002 loader can not [Machine is Halted]
failure, or the sensor 2. If the problem continues,
move back! is displayed and the
of the incubator ask technical staff to inspect
machine is halted
loader fails. mechanical parts and the
sensor.
1. Select “Incubator Loader"
The incubator loader
or in [Machine is Halted]
The beeper beeps, cannot move as a
dialog box, and then click
Incubator the dialog box result of mechanical
<Send> and <Continue>.
01030003 loader not [Machine is Halted] failure or the
2. If the problem continues,
initialized! is displayed and the machine isn’t
ask technical staff to inspect
machine is halted initialized before
mechanical parts and the
operating
sensor.
The beeper beeps, Check whether there is
Before the incubator
the dialog box cuvette in front of the loader
No cuvette loader loads, it
01030004 [Machine is Halted] and whether the cuvette
available! detects there is no
is displayed and the detection sensor is correctly
cuvette at the outlet.
machine is halted. positioned.
This error will occur
The beeper beeps， in case loading is
the dialog box carried out before the
No cuvette
01030005 [Machine is Halted] error “there is no Input cuvette.
transported!！
is displayed and the cuvette on the
machine is halted incubator loader rail”
is solved.

Maglumi 2000 Operating Instructions Page 18-11

18 Troubleshooting and Diagnostics

Washer Loader
Message Message
Alarm Method Cause Recovery Method
Code Implication
1. Select “Washer Loader” in
[Machine is Halted] dialog
box, and then click <Send>
The washer loader
and <Continue>.
cannot move as a
The beeper beeps, 2. If the problem continues,
result of mechanical
Washer loader the dialog box technical staff shall remove
failure, the incubator
01040001 can not move [Machine is Halted] the main cover of the
position is not
forward! is displayed and the machine and check whether
aligned or the sensor
machine is halted there is barrier, e.g. The
of the incubator
incubator is not alligned and
loader fails.
is at a wrong position. Check
whether the sensor is
effective.
1. Select “Washer Loader” in
[Machine is Halted] dialog
box, and then click <Send>
The beeper beeps, The washer loader and <Continue>.
Washer loader the dialog box cannot move or the 2. If the problem continues,
01040002 can not move [Machine is Halted] washer loader sensor technical staff shall remove
back! is displayed and the fails as a result of the main cover of the
machine is halted mechanical failure. machine and check whether
there is barrier, e.g. Check
whether the sensor is
effective.
1. Select “Washer Loader” in
[Machine is Halted] dialog
box, and then click <Send>
The beeper beeps, The machine must and <Continue>.
the dialog box be initialized before 2. If the problem continues,
Washer loader
01040003 [Machine is Halted] operating or the technical staff shall remove
not initialized!
is displayed and the washer loader sensor the main cover of the
machine is halted fails. machine and check whether
there is barrier, e.g. Check
whether the sensor is
effective.

Page 18-12 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

Incubator Loader
Message Message Alarm
Cause Recovery Method
Code Implication Method
1. Select ”Incubator” or simultaneously
select Incubator Loader or Washer
The beeper
A kind of barrier Loader in [Machine is Halted] dialog
beeps, the
(such as box, and then click <Send> and
dialog box
incubator loader) <Continue>.
Incubator not [Machine is
02010001 prevents it for 2. If the problem continues, technical
initialized! Halted] is
moving or the staff shall inspect the friction of the
displayed and
intial position incubator guide rail, inspect whether
the machine is
sensor fails.. each position of the incubator is
halted
aligned, and inspect the initial position
sensor, etc.
1. Select ”Incubator” or simultaneously
The beeper select Incubator Loader or Washer
beeps, the Loader in [Machine is Halted] dialog
A kind of barrier
dialog box box, and then click <Send> and
(such as
Incubator [Machine is <Continue>.
02010002 incubator loader)
regulation front! Halted] is 2. If the problem continues, technical
prevents it for
displayed and staff shall inspect the friction of the
moving.
the machine is incubator guide rail, inspect whether
halted each position of the incubator is
aligned, etc.
1. Select ”Incubator” or simultaneously
The beeper select Incubator Loader or Washer
beeps, the Loader in [Machine is Halted] dialog
A kind of barrier
dialog box box, and then click <Send> and
(such as
Incubator [Machine is <Continue>.
02010003 incubator loader)
regulation back! Halted] is 2. If the problem continues, technical
prevents it for
displayed and staff shall inspect the friction of the
moving.
the machine is incubator guide rail, inspect whether
halted each position of the incubator is
aligned, etc.
1. Select ”Incubator” or simultaneously
select Incubator Loader or Washer
The beeper
Loader in [Machine is Halted] dialog
beeps, the A kind of barrier
box, and then click <Send> and
dialog box (such as
<Continue>.
Incubator can [Machine is incubator loader)
02010004 2. If the problem continues, technical
not move front! Halted]x is prevents it for
staff shall inspect the friction of the
displayed and moving or the
incubator guide rail, inspect whether
the machine is encoder fails.
each position of the incubator is
halted
aligned, and inspect whether the
encoder is effective.
1. Select ”Incubator” or simultaneously
select Incubator Loader or Washer
The beeper
Loader in [Machine is Halted] dialog
beeps, the A kind of barrier
box, and then click <Send> and
dialog box (such as
<Continue>.
Incubator can [Machine is incubator loader)
02010005 2. If the problem continues, technical
not move back! Halted] is prevents it for
staff shall inspect the friction of the
displayed and moving or the
incubator guide rail, inspect whether
the machine is encoder fails.
each position of the incubator is
halted
aligned, and inspect whether the
encoder is effective.

Maglumi 2000 Operating Instructions Page 18-13

18 Troubleshooting and Diagnostics

Washer Transport
Message Message
Alarm Method Cause Recovery Method
Code Implication
The beeper beeps,
Contact technical service
the dialog box Initial position (sensor)
Wash transport staff to inspect
03010001 [Machine is Halted may be incorrectly
not initialized! mechanical parts and
is displayed and the adjusted.
circuits.
machine is halted
This error may be 1. Select “Washer
caused by failure of Transport” in [Machine
washer transport sensor. is Halted] dialog box,
The beeper beeps, It may be also due to and then click <Send>
the dialog box another kind of washing and <Continue>.
Wash transport
03010002 [Machine is Halted path obstruction such as 2. If the problem
can not move!
is displayed and the the width of washing continues, please
machine is halted path is incorrectly contact technical service
adjusted or adjusting staff to inspect
parameters of washer mechanical parts and
transport are incorrect. circuits.

Page 18-14 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

Washer Lift
Message Message
Alarm Method Cause Recovery Method
Code Implication
The beeper beeps, Select “Washer Lift” in
the dialog box Initial position sensor [Machine is Halted]
Wash lift not
03020001 [Machine is Halted] fails or the friction is dialog box, and then click
initialized!
is displayed and the large. <Send> and <Continue>.
machine is halted
1. Select “Washer Lift” in
[Machine is Halted]
The beeper beeps, dialog box, and then click
the dialog box The friction is large or <Send> and <Continue>.
Wash lift
03020002 [Machine is Halted] there is a kind of 2. If the problem
regulation up!
is displayed and the obstruction. continues, please contact
machine is halted。 technical service staff to
inspect mechanical parts
and circuits.
1. Select “Washer Lift” in
[Machine is Halted]
The beeper beeps, dialog box, and then click
the dialog box The friction is large or <Send> and <Continue>.
Wash lift
03020003 [Machine is Halted] there is a kind of 2. If the problem
regulation down!
is displayed and the obstruction. continues, please contact
machine is halted technical service staff to
inspect mechanical parts
and circuits.
1. Select “Washer Lift” in
[Machine is Halted]
The beeper beeps, dialog box, and then click
the dialog box The friction is large, or <Send> and <Continue>.
Wash lift can
03020004 [Machine is Halted] it may be caused by 2. If the problem
not move up!
is displayed and the encoder failure. continues, please contact
machine is halted technical service staff to
inspect mechanical parts
or encoder.
1. Select “Washer Lift” in
The friction is large or
[Machine is Halted]
there is obstruction by
The beeper beeps, dialog box, and then click
a kind of barrier (such
the dialog box <Send> and <Continue>.
Wash lift can as cuvette position in
03020005 [Machine is Halted] 2. If the problem
not move down! washer transport is
is displayed and the continues, please contact
incorrect), or it may be
machine is halted technical service staff to
caused by encoder
inspect mechanical parts
failure.
or encoder.

Maglumi 2000 Operating Instructions Page 18-15

18 Troubleshooting and Diagnostics

Pusher
Message Message Alarm
Cause Recovery Method
Code Implication Method
1. Select “Pusher” in [Machine is
The beeper Due to a kind of
Halted] dialog box, and then click
beeps, the dialog obstruction such as
<Send> and <Continue>.
box [Machine is the chamber
Pusher not 2. If the problem continues, check
02020001 Halted] is transport is not
initialized! whether the cuvette is stuck between
displayed and initialized or the
the washer transport and pusher; if
the machine is initial position
not, please contact technical service
halted sensor fails.
staff to inspect mechanical parts.
1. Select “Pusher” in [Machine is
The beeper
Halted] dialog box, and then click
beeps, the dialog
Pusher block <Send> and <Continue>.
Pusher box [Machine is
moves slowly. It 2. If the problem continues, check
02020002 regulation Halted] is
may be obstructed whether the cuvette is stuck between
front! displayed and
when it moves. thewasher transport and pusher; if
the machine is
not, please contact technical service
halted
staff to inspect mechanical parts.
1. Select “Pusher” in [Machine is
The beeper
Halted] dialog box, and then click
beeps, the dialog
Pusher moves <Send> and <Continue>.
Pusher box [Machine is
slowly. It may be 2. If the problem continues, check
02020003 regulation Halted] is
obstructed when it whether the cuvette is stuck between
back! displayed and
moves. the washer transport and pusher; if
the machine is
not, please contact technical service
halted
staff to inspect mechanical parts.
Due to a kind of 1. Select “Pusher” in [Machine is
obstruction such as Halted] dialog box, and then click
The beeper chamber transport <Send> and <Continue>.
beeps, the dialog unit is not initialized 2. If the problem continues, check
box [Machine is or position of slider whether the cuvette is stuck between
Pusher can not
02020004 Halted] is belt tension clamp the washer transport and pusher; if
move front!
displayed and (under the not, please contact technical service
the machine is baseboard) is staff to inspect mechanical parts.
halted incorrect.Or it may
be caused by
failure of encoder.
Due to a kind of 1. Select “Pusher” in [Machine is
obstruction such as Halted] dialog box, and then click
The beeper chamber transport <Send> and <Continue>.
beeps, the dialog unit is not initialized 2. If the problem continues, check
box [Machine is or position of slider whether the cuvette is stuck between
Pusher can not
02020005 Halted] is belt tension clamp the washer transport and pusher; if
move back!
displayed and (under the not, please contact technical service
the machine is baseboard) is staff to inspect mechanical parts.
halted incorrect.Or it may
be caused by
failure of encoder.

Page 18-16 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

Back Transport
Message Message
Alarm Method Cause Recovery Method
Code Implication
1. Check whether there is
obstruction, if not, select
The beeper beeps, “ Back transpor” in [Machine
Some barriers make
the dialog box is Halted], and click <Send>
Backtransport the back transport
03030001 [Machine is Halted] and <Continue>.
not initialized! cannot move or
is displayed and the 2. If the problem continues,
sensor fail
machine is halted ask technical staff to inspect
mechanical parts and the
sensor.
1. Check whether the
incubator is aligned, and
whether there is an extra
cuvette in the tank; if not,
The beeper beeps,
Some barriers make select “ Back transpor” in
Backtransport the dialog box
the back transport [Machine is Halted], and
03030002 can not move [Machine is Halted]
cannot move or click <Send> and
left!！ is displayed and the
sensor fail <Continue>.
machine is halted
2. If the problem continues,
ask technical staff to inspect
mechanical parts and the
sensor.
1. Check whether the
incubator is aligned, and
whether there is an extra
cuvette in the tank; if not,
The beeper beeps,
Some barriers make select “ Back transpor” in
Backtransport the dialog box
the back transport [Machine is Halted], and
03030003 can not move [Machine is Halted]
cannot move or click <Send> and
right! is displayed and the
sensor fail <Continue>.
machine is halted
2. If the problem continues,
ask technical staff to inspect
mechanical parts and the
sensor.

Maglumi 2000 Operating Instructions Page 18-17

18 Troubleshooting and Diagnostics

Chamber Transport Component

Message Message
Alarm Method Cause Recovery Method
Code Implication
1. Select “Chamber
Transport” in [Machine is
This is due to Halted] dialog box, and then
The beeper beeps,
mechanical click <Send> and <Continue>.
Chamber the dialog box
obstruction (such as 2. If the problem continues,
04010001 transport not [Machine is Halted]
there is a cuvette in please check whether the
initialized! is displayed and the
chamber) or sensor chamber lift height is correct or
machine is halted
failure. contact technical staff to
inspect mechanical parts and
circuits.
1. Select “Chamber
Transport” in [Machine is
This is due to Halted] dialog box, and then
The beeper beeps,
mechanical click <Send> and <Continue>.
Chamber the dialog box
obstruction (such as 2. If the problem continues,
04010002 transport can not [Machine is Halted]
chamber lift height please check whether the
move! is displayed and the
is incorrect) or chamber lift height is correct or
machine is halted
sensor failure. contact technical staff to
inspect mechanical parts and
circuits.

Page 18-18 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

Chamber Lift
Message Message Alarm
Cause Recovery Method
Code Implication Method
The beeper 1. Select “Chamber Lift” in [Machine
beeps, the is Halted] dialog box, and then click
dialog box Chamber lift is <Send> and <Continue>.
Chamber lift [Machine is obstructed or 2. If the problem continues, please
04020001
not initialized! Halted] is initial position contact technical service staff to
displayed and sensor fails. inspect mechanical parts and circuits.
the machine is
halted
Upward moving 1. Select “Chamber Lift” in [Machine
The beeper
speed of chamber is Halted] dialog box, and then click
beeps, the
lift is too slow. It <Send> and <Continue>.
dialog box
may be due to 2. If the problem continues, ask
Chamber lift [Machine is
04020002 overflow of liquid technical staff to remove the chamber
regulation up! Halted] is
in chamber or cover and inspect if the lift rack is
displayed and
incorrect obstructed, e.g. Obstructed cuvette,
the machine is
adjustment of the apparent crystallization (white powder).
halted
lift rack .
Downward 1. Select “Chamber Lift” in [Machine
The beeper
moving speed of is Halted] dialog box, and then click
beeps, the
chamber lift is too <Send> and <Continue>.
dialog box
Chamber lift slow. It may be 2. If the problem continues, ask
[Machine is
04020003 regulation due to overflow of technical staff to remove the chamber
Halted] is
down! liquid in chamber cover and inspect if the lift rack is
displayed and
or incorrect obstructed, e.g. Obstructed cuvette,
the machine is
adjustment of the apparent crystallization (white powder).
halted
lift rack.
1. Select “Chamber Lift” in [Machine
The chamber lift
is Halted] dialog box, and then click
is blocked when it
<Send> and <Continue>
The beeper moves upwards.
2. If the problem continues, ask
beeps, the It may be
technical staff to remove the chamber
dialog box because liquid in
Chamber lift cover and inspect if the chamber inlet
[Machine is the chamber once
04020004 can not move rail or lift rack is obstructed, e.g.
Halted] is overflowed on
up! Obstructed cuvette, apparent
displayed and test inlet door or
crystallization (white powder). It may
the machine is rack caused
also because that the balls of lifter
halted adhesion. Or it
dropped out from rail or the reflection
may be due to
sensor (under the test module) is
failure of encoder.
damaged.
The chamber lift 1. Select “Chamber Lift” in [Machine
is blocked when it is Halted] dialog box, and then click
moves <Send> and <Continue>
The beeper downwards. It 2. If the problem continues, ask
beeps, the may be because technical staff to remove the chamber
dialog box liquid in the cover and check whether there is
Chamber lift
[Machine is chamber once obstruction on test module lift rail or
04020005 can not move
Halted] is overflowed on test module lift transfer rod, e.g.
down!
displayed and test inlet door or Obstructed cuvette, apparent
the machine is rack caused crystallization (white powder). It may
halted adhesion, or the also because that the balls of lifter
cuvette is stucked dropped out from rail or the reflection
in chamber sensor is damaged.
transport. Or it

Maglumi 2000 Operating Instructions Page 18-19

18 Troubleshooting and Diagnostics

may be due to
failure of encoder.

The problem is
The beeper
caused by
beeps, the
incorrect setting Contact technical staff to inspect
dialog box [Error
No cuvette in of minimum light photomultiplier or blue light; if there is
04020006 Message] is
chamber! intensity on global no problem, adjust the minimum value
displayed, but
parameter cuvette.
the machine is
interface of the
not halted.
service software
The beeper
It may be
beeps, the
because liquid
dialog box
Cuvette not overflow in the
[Machine is
04020007 moved out chamber resulted Contact technical service staff.
Halted] is
from chamber! in deviation of
displayed and
chamber
the machine is
transport.
halted

Page 18-20 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

All kinds of Pump

Message Message Alarm
Cause Recovery Method
Code Implication Method
The beeper
beeps, the
Washer
dialog box [Error It may be because Manually twist the knurled nut that
peristaltic
03070001 Message] is the clamp is too presses the spring; if it still doesn’t
pump soak
displayed, but loose or too tight. work, please contact technical staff.
abnormally!
the machine is
not halted.
The beeper
beeps, the
Chamber The waste liquid
dialog box [Error
waste Pump pipe is blocked or
04050001 Message] is Contact technical service staff.
can not the waste liquid
displayed, but
aspirate! pump is broken.
the machine is
not halted.
Washer
The beeper
Injector_1
beeps, the
inject The system liquid
dialog box
abnormally. pipe is stuck by Check whether the system liquid pipe
[Machine is
03040001 Please shut any other is stuck; if not, please contact
Halted] is
down the component or the technical staff.
displayed and
analyzer and pump is broken.
the machine is
check
halted
carefully!
Washer
The beeper
Injector_2
beeps, the
inject The system liquid
dialog box
abnormally. pipe is stuck by Check whether the system liquid pipe
[Machine is
03050001 Please shut any other is stuck; if not, please contact
Halted] is
down the component or the technical staff.
displayed and
analyzer and pump is broken.
the machine is
check
halted
carefully!
Washer
The beeper
Injector_3
beeps, the
inject The system liquid
dialog box
abnormally. pipe is stuck by Check whether the system liquid pipe
[Machine is
03060001 Please shut any other is stuck; if not, please contact
Halted] is
down the component or the technical staff.
displayed and
analyzer and pump is broken.
the machine is
check
halted
carefully!
The beeper
Starter 1 inject
beeps, the
abnormally.
dialog box
Please shut
[Machine is
04030001 down the
Halted] is
analyzer and
displayed and
check
the machine is
carefully!
halted

Maglumi 2000 Operating Instructions Page 18-21

18 Troubleshooting and Diagnostics

The beeper
Starter 2 inject
beeps, the
abnormally.
dialog box
Please shut
[Machine is
04040001 down the
Halted] is
analyzer and
displayed and
check
the machine is
carefully!
halted

Pipetting Needle System

Message Message
Alarm Method Cause Recovery Method
Code Implication
The beeper beeps, the dialog
Left Needle X Resistance on
box [Machine is Halted] is Contact technical service
09010001 direction not X direction is
displayed and the machine is staff.
initialized! too large.
halted

The beeper beeps, the dialog

Left Needle Resistance on
box [Machine is Halted] is Contact technical service
09010002 can not move X direction is
displayed and the machine is staff.
left! too large.
halted
The beeper beeps, the dialog
Left Needle Resistance on
box [Machine is Halted] is Contact technical service
09010003 move can not X direction is
displayed and the machine is staff.
move right! too large.
halted

The beeper beeps, the dialog

Left Needle Y Resistance on
box [Error Message] is Contact technical service
09010011 direction not Y direction is
displayed, but the machine is not staff.
initialized! too large.
halted.

The beeper beeps, the dialog

Left Needle Resistance on
box [Machine is Halted] is Contact technical service
09010012 can not move Y direction is
displayed and the machine is staff.
forward! too large.
halted
The beeper beeps, the dialog
Left Needle Resistance on
box [Machine is Halted] is Contact technical service
09010013 can not move Y direction is
displayed and the machine is staff.
back! too large.
halted
Operating Shut down the analyzer,
The beeper beeps, the dialog
Left Needle Z resistance is and manually lift Z-axis to
box [Machine is Halted] is
09010021 direction not too large or it check if it can be lifted. If
displayed and the machine is
initialized! is stuck by it still doesn’t work,
halted
debris. contact technical staff.
Operating Shut down the analyzer,
The beeper beeps, the dialog
Left Needle resistance is and manually lift Z-axis to
box [Machine is Halted] is
09010022 can not move too large or it check if it can be lifted. If
displayed and the machine is
up! is stuck by it still doesn’t work,
halted
debris. contact technical staff.
Operating Shut down the analyzer,
The beeper beeps, the dialog
Left Needle resistance is and manually lift Z-axis to
box [Machine is Halted] is
09010023 can not move too large or it check if it can be lifted. If
displayed and the machine is
down! is stuck by it still doesn’t work,
halted
debris. contact technical staff.

Page 18-22 Maglumi 2000 Operating Instructions

 18 Troubleshooting and Diagnostics

1. Re-initialize the left

The beeper beeps, the dialog pipettor;
Left Needle
box [Machine is Halted] is 2. If it cannot be restored
09010031 Inject Pump
displayed and the machine is or any other fault occurs,
not initialized!
halted please contact technical
staff.
The beeper beeps, the dialog If it cannot be restored or
Left Needle
box [Error Message] is any other fault occurs,
09010041 can not detect
displayed, but the machine is not please contact technical
Liquid!
halted. staff.

The beeper beeps, the dialog If it cannot be restored or

Left Needle
box [Error Message] is any other fault occurs,
09010051 detect blood
displayed, but the machine is not please contact technical
clot.
halted. staff.

The beeper beeps, the dialog

Right Needle X Resistance on
box [Machine is Halted] is Contact technical service
0A010001 direction not X direction is
displayed and the machine is staff.
initialized! too large.
halted

The beeper beeps, the dialog

Right Needle Resistance on
box [Machine is Halted] is Contact technical service
0A010002 can not move X direction is
displayed and the machine is staff.
left! too large.
halted
The beeper beeps, the dialog
Right Needle Resistance on
box [Machine is Halted] is Contact technical service
0A010003 move can not X direction is
displayed and the machine is staff.
move right! too large.
halted

The beeper beeps, the dialog

Right Needle Y Resistance on
box [Error Message] is Contact technical service
0A010011 direction not Y direction is
displayed, but the machine is not staff.
initialized! too large.
halted.

The beeper beeps, the dialog

Right Needle Resistance on
box [Machine is Halted] is Contact technical service
0A010012 can not move Y direction is
displayed and the machine is staff.
forward! too large.
halted

The beeper beeps, the dialog

Right Needle Resistance on
box [Machine is Halted] is Contact technical service
0A010013 can not move Y direction is
displayed and the machine is staff.
back! too large.
halted
Operating Shut down the analyzer,
The beeper beeps, the dialog
Right Needle Z resistance is and manually lift Z-axis to
box [Machine is Halted] is
0A010021 direction not too large or it check if it can be lifted. If
displayed and the machine is
initialized! is stuck by it still doesn’t work,
halted
debris. contact technical staff.
Operating Shut down the analyzer,
The beeper beeps, the dialog
Right Needle resistance is and manually lift Z-axis to
box [Machine is Halted] is
0A010022 can not move too large or it check if it can be lifted. If
displayed and the machine is
up! is stuck by it still doesn’t work,
halted
debris. contact technical staff.
Operating Shut down the analyzer,
The beeper beeps, the dialog
Right Needle resistance is and manually lift Z-axis to
box [Machine is Halted] is
0A010023 can not move too large or it check if it can be lifted. If
displayed and the machine is
down!！ is stuck by it still doesn’t work,
halted
debris. contact technical staff.

Maglumi 2000 Operating Instructions Page 18-23

18 Troubleshooting and Diagnostics

1. Re-initialize the left

The beeper beeps, the dialog pipettor;
Right Needle
box [Machine is Halted] is 2. If it cannot be restored
0A010031 Inject Pump
displayed and the machine is or any other fault occurs,
not initialized!
halted please contact technical
staff.
The beeper beeps, the dialog If it cannot be restored or
Right Needle
box [Error Message] is any other fault occurs,
0A010041 can not detect
displayed, but the machine is not please contact technical
Liquid!
halted. staff.

Page 18-24 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

Appendix A Adjust Needles

After the analyzer and the software are installed, the plane position and maximum limit
of the left and right pipetting needles shall be calibrated at first.

A.1 Preparation before Adjusting

Take 2 cuvette bars and fill 100μL water into the positions 1 and 6 of each bar. Place
the two cuvette bars onto the first front cuvette position of the left pipetting area and
the right pipetting area respectively.

Figure A.1-1 2 cuvette bars place position

Five tubes filled with 100μL of water should be respectively placed at the position 1
and 10 of track1, position 1 and 10 of track11, position 10 of track12.

Take an empty, clean and dry reagent integral and fill 300μL water into its first hole (for
magnetic microbeads), fill 300μL water into the second hole (for low calibrator), fill
300μL water into the fourth hole (for displacing reagent), fill 1300μL water into the
seventh hole (for buffer), and insert the reagent integral into the first reagent position of
the reagent area.
Turn on the main switch and the submain switch of the analyzer, and start the
computer.

Click Maglumi Service icon on desktop and enter password to open [Maglumi 2000
Service] software.

Maglumi 2000 Operating Instructions Page A-1

Appendix A Needles Adjust

Figure A.1-1 [Maglumi 2000 Service] Interface

1. Click <Initialize> button to initialize the components on the working plane.

2. Click <Incubator> button to display the [Incubator] dialog. Select Incload and
click <Return> to return to the [Maglumi 2000 Service] interface.

Figure A.1-2 [Incubator] Dialog

3. Click <Inc. Loader> button to display the [Incubator Loader] dialog.

Page A-2 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

Figure A.1-3 [Incubator Loader] Dialog

4. Click <Move> button to convey a cuvette bar to the left pipetting position and
convey another cuvette bar to the pipetting position of the incubator.

5. Click <Return> to return to the [Maglumi 2000 Service] interface.

6. Click <Back Trans> button to open the [Back Transport] dialog.

Figure A.1-4 [Back Transport] Dialog

7. Click <Move> button to convey a cuvette bar to the right pipetting position. Click
<Return> to return to the [Maglumi 2000 Service] interface.

Maglumi 2000 Operating Instructions Page A-3

Appendix A Needles Adjust

A.2 Needles Adjust Program

Click <Coordinates> button on the upper left corner of the [Maglumi 2000 Service]
interface to open [Needles Adjust] dialog.

Figure A.2-1 [Needles Adjust] Dialog

Table A.2-2 Shortcut keys for Needles Adjust

Keyboard
Name Icon
shortcut keys
Moves leftwards on X-axis X-axis fine tuning ←

Moves rightwards on X-axis X-axis fine tuning →

Moves forwards on Y-axis Y-axis fine tuning ↑

Moves backwards on Y-axis Y-axis fine tuning ↓

Moves upwards on Z-axis Z-axis fine tuning Page Up

Moves downwards on Z-axis Z-axis fine tuning Page Down

Moves to the middle between

Shift on Keyboard
the current position and the
+ button <Z-Max>
maximum limit on Z-axis
Remark: the directions in the table are based on facing to the analyzer

Page A-4 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.3 Referential Position Adjust

Figure A.3-1 Referential position adjust tool

A.3.1 Left Referential Position Adjust

Click <Ref. Left> button in [Needles Adjust] interface to display [Ref. Left Adjust]
dialog.

Figure A.3-2 [Ref.Left Adjust] dialog

In Adjust Ref. Left area, set the Stepsize by changing the number of selected bars.
First use a large stepsize to move the pipetting needle to nearby the top of referential
position adjust tool, and then use a small stepsize to fine-tune the horizontal position
and vertical height until the needle position meets requirements described below. Upon
completion, click <Writeparam> to save the adjusted position parameters, and click
<Return> to exit this interface.

Requirements:
1) In the top view, the needle point is at the central white point of the referential

Maglumi 2000 Operating Instructions Page A-5

Appendix A Needles Adjust

position adjust tool;

Adjust tool

Top view
2) In the side view, the needle point is 0.5mm above the central white point of the
referential position adjust tool;

Side view

A.3.2 Right Referential Position Adjust

Click <Ref. Right> button in [Needles Adjust] interface to display [Ref. Right Adjust]
dialog.

Figure A.3-3 [Ref.Right Adjust] Dialog

In Adjust Right Ref. area, set the step size by changing the number of selected bars.
First use a large step size to move the pipetting needle to nearby the top of
referential position adjust tool, and then use a small step size to fine-tune the
horizontal position and vertical height until the needle position meets requirements
described below. Upon completion, click <Writeparam> to save the adjusted position
parameters, and click <Return> to exit this interface.

Page A-6 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

Requirements:
1) In the top view, the needle point is at the central white point of the referential
position adjust tool;
Adjust tool

Top view
2) In the side view, the needle point is 0.5mm above the central white point of the
referential position adjust tool;

Side view

A.4 Left Pipetting Position Adjust

Click icon on the left of [Needles Adjust] interface to display [Left

Pipetting Position Adjust] dialog.

Figure A.4-1 [Left Pipetting Position Adjust] Dialog

A.4.1 Left Needle Adjust on Left Pipetting Position

Select Left Needle in Select Position area.

1. Select Position of 1 in Select Area:

Maglumi 2000 Operating Instructions Page A-7

Appendix A Needles Adjust

Figure A.4-2 [Left Pipetting Position Adjust] Dialog (Left Needle, Position of 1)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the first cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.
Requirements:
1) On the top view, the edge of the pipetting needle must be on a straight line
with the lower left corner of the cuvette hole.
Top View
The edge of the pipetting needle
must be on a straight line with the
lower left corner of the cuvette hole.

2) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-8 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

2. Select Position of 6 in Select Area:

Figure A.4-3 [Left Pipetting Position Adjust] Dialog (Left Needle, Position of 6)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the sixth cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.

Requirements:
1) On the top view, the edge of the pipetting needle must be on a straight line
with the lower left corner of the cuvette hole.
The edge of the pipetting needle Top View
must be on a straight line with the
lower left corner of the cuvette hole.

2) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-9

Appendix A Needles Adjust

A.4.2 Right Needle Adjust on Left Pipetting Position

Select right needle in Select Position area.

1. Select Position of 1 in Select Area:

Figure A.4-4 [Left Pipetting Position Adjust] Dialog (Right Needle, Position of 1)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the first cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.

Requirements:
1) On the top view, the edge of the pipetting needle must be on a straight line
with the lower left corner of the cuvette hole.
Top View
The edge of the pipetting needle
must be on a straight line with the
lower left corner of the cuvette hole.

2) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until the
needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-10 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

2. Select Position of 6 in Select Area:

Figure A.4-5 [Left Pipetting Position Adjust] Dialog (Right Needle, Position of 6)

Move the pipetting needle to nearby the sixth cuvette, and then use a small step
size to fine-tune the horizontal position and vertical height until the needle position
meets requirements described below.

Requirements:
1) On the top view, the edge of the pipetting needle must be on a straight line
with the lower left corner of the cuvette hole.
The edge of the pipetting needle
Top View
must be on a straight line with the
lower left corner of the cuvette hole.

2) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until the
needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

When right needle adjustment is finished, click <Return> button to return to the
[Needles Adjust] dialog.

Maglumi 2000 Operating Instructions Page A-11

Appendix A Needles Adjust

A.5 Incubator Pipetting Position Adjust

Click icon in the middle of the [Needles Adjust] dialog to enter [Incubator
Position Adjust] dialog .

Figure A.5-1 [Incubator Position Adjust] Dialog

Page A-12 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.5.1 Left Incubator Pipetting Position Adjust

Select left needle in Select Position area.

1. Select Position of 1 in Select Area:

Figure A.5-2 [Incubator Position Adjust] Dialog (Left Needle, Position of 1)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the first cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.

Requirements:
1) On the top view, the edge of the pipetting needle must be on a straight line
with the lower left corner of the cuvette hole.
The edge of the pipetting needle Top View
must be on a straight line with the
lower left corner of the cuvette hole.

2) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until the
needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-13

Appendix A Needles Adjust

2. Select Position of 6 in Select Area:

Figure A.5-3 [Incubator Position Adjust] Dialog (Left Needle, Position of 6)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the sixth cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.

Requirements:
1) On the top view, the edge of the pipetting needle must be on a straight line
with the lower left corner of the cuvette hole.
The edge of the pipetting needle Top View
must be on a straight line with the
lower left corner of the cuvette hole.

2) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until the
needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-14 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.5.2 Right Incubator Pipetting Position Adjust

Select right needle in Select Position area.

1. Select Position of 1 in Select Area:

Figure A.5-4 [Incubator Position Adjust] Dialog (Right Needle, Position of 1)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the first cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.

Requirements:
1) On the top view, the edge of the pipetting needle must be on a straight line
with the lower left corner of the cuvette hole.
Top View
The edge of the pipetting needle
must be on a straight line with the
lower left corner of the cuvette hole.

2) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until the
needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-15

Appendix A Needles Adjust

2. Select Position of 6 in Select Area:

Figure A.5-5 [Incubator Position Adjust] Dialog (Right Needle, Position of 6)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the sixth cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.

Requirements:
1) On the top view, the edge of the pipetting needle must be on a straight line
with the lower left corner of the cuvette hole.
Top View
The edge of the pipetting needle
must be on a straight line with the
lower left corner of the cuvette hole.

2) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until the
needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-16 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.6 Right Pipetting Position Adjust

Click icon on the right of the [Needles Adjust] dialog to enter [Right
Pipetting Position Adjust] dialog.

Figure A.6-1 [Right Pipetting Position Adjust] Dialog

Maglumi 2000 Operating Instructions Page A-17

Appendix A Needles Adjust

A.6.1 Left Needle Adjust on Right Pipetting Position

Select left needle in Select Position area.

1. Select Position of 1 in Select Area:

Figure A.6-2 [left Pipetting Position Adjust] Dialog (Left Needle, Position of 1)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the first cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.

Requirements:
1) On the top view:
The pipetting needle is in the center of the front left corner, about 1-2mm
away from the front wall of the cuvette;
The pipetting needle is in the center of the
front left corner, about 1-2mm away from
the front wall of the cuvette

2) Maximum Limit:
Click UP/DOWN arrows to adjust the pipetting needle until the needle tip
touch the liquid surface. Click <Writeparam> when the level detection
indicator light is on.

Page A-18 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

2. Select Position of 6 in Select Area:

Figure A.6-3 [Left Pipetting Position Adjust] Dialog (Left Needle, Position of 6)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the sixth cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.

Requirements:
1) On the top view:
The pipetting needle is in the center of the front left corner, about 1-2mm
away from the front wall of the cuvette;

The pipetting needle is in the center of the

front left corner, about 1-2mm away from
the front wall of the cuvette

2) Maximum Limit:
Click UP/DOWN arrows to adjust the pipetting needle until the needle tip
touch the liquid surface. Click <Writeparam> when the level detection
indicator light is on.

Maglumi 2000 Operating Instructions Page A-19

Appendix A Needles Adjust

3. Select Position of Mix in Select Area:

Figure A.6-4 [Left Pipetting Position Adjust] Dialog (Left Needle, Position of Mix)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the first cuvette on the X-axis, and
then use a small step size to fine-tune the needle position on the X-axis until it
meets requirements described below.

Requirements:
The pipetting needle is in
the center of the front right
corner of the cuvette.

Page A-20 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.6.2 Right Needle Adjust on Right Pipetting Position

Select right needle in Select Position area.

1. Select Position of 1 in Select Area:

Figure A.6-5 [Right Pipetting Position Adjust] Dialog (Right Needle, Position of 1)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the first cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.

Requirements:
1) On the top view:
The pipetting needle is in the center of the front left corner, about 1-2mm
away from the front wall of the cuvette;
The pipetting needle is in the center of the
front left corner, about 1-2mm away from
the front wall of the cuvette

2) Maximum Limit:
Click UP/DOWN arrows to adjust the pipetting needle until the needle tip
touch the liquid surface. Click <Writeparam> when the level detection
indicator light is on.

Maglumi 2000 Operating Instructions Page A-21

Appendix A Needles Adjust

2. Select Position of 6 in Select Area:

Figure A.6-6 [Right Pipetting Position Adjust] Dialog (Right Needle, Position of 6)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the sixth cuvette, and then use a small
step size to fine-tune the horizontal position and vertical height until the needle
position meets requirements described below.

Requirements:
1) On the top view:
The pipetting needle is in the center of the front left corner, about 1-2mm
away from the front wall of the cuvette;
The pipetting needle is in the center of the
front left corner, about 1-2mm away from
the front wall of the cuvette

2) Maximum Limit:
Click UP/DOWN arrows to adjust the pipetting needle until the needle tip
touch the liquid surface. Click <Writeparam> when the level detection
indicator light is on.

Page A-22 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

3. Select Position of Mix in Select Area:

Figure A.6-4 [Right Pipetting Position Adjust] Dialog (Right Needle, Position of Mix)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the first cuvette on the X-axis, and
then use a small step size to fine-tune the needle position on the X-axis until it
meets requirements described below.
Requirements:
The pipetting needle is in the center of the front right corner of the cuvette.

The pipetting needle is in

the center of the front right
corner of the cuvette.

Maglumi 2000 Operating Instructions Page A-23

Appendix A Needles Adjust

A.7 Washing Position Adjust

A.7.1 Left Washing Position Adjust

Click icon on the left of [Needles Adjust] dialog to display [Left Washing
Position Adjust] dialog .

Figure A.7-1 [Left Washing Position Adjust] Dialog

Select Waste Position or Prime Position in Select Area. Set the step size by changing
the number of selected bars. First use a large step size to move the pipetting needle to
nearby left washing hole, and then use a small step size to fine-tune the horizontal
position and vertical height until the needle position meets requirements described
below. Upon completion, click <Writeparam> to save the adjusted position parameters,
and click <Return> to exit this dialog.

Requirements:
1) At Waste Position, the pipetting needle shall be adjusted to the center of the oval
washing hole, and the needle must be higher than the hole wall of the Prime
Position; otherwise the pipetting needle will crash into the wall when it moves from
the Waste Position to the Prime Position;
2) At Prime Position, the pipetting needle shall be adjusted to the center of the round
washing hole. The whole needle tip shall drop below the slope at the top of the
washing hole.
Waste Position The pipetting needle
shall be higher than the
hole wall of the Prime
Position; otherwise it will
Waste Position Prime Position crash into the wall.

The whole needle tip shall

drop below the slope at the
top of the washing hole.

Prime Position
Top view
Side view

When adjustment is finished, click <Return> to exit this dialog.

Page A-24 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.7.2 Right Washing Position Adjust

Click icon on the right of [Needles Adjust] dialog to display [Right Washing
Position Adjust] dialog .

Figure A.7-2 [Right Washing Position Adjust] Dialog

Select Waste Position or Prime Position in Select Area. Set the step size by changing
the number of selected bars. First use a large step size to move the pipetting needle
downwards to nearby the right washing hole, and then use a small step size to fine-
tune the horizontal position and vertical height until the needle position meets
requirements described below. Upon completion, click <Writeparam> to save the
adjusted position parameters, and click <Return> to exit this dialog .

Requirements:
1) At Waste Position, the pipetting needle shall be adjusted to the center of the oval
washing hole, and the needle must be higher than the hole wall of the Prime
Position; otherwise the pipetting needle will crash into the wall when it moves from
the Waste Position to the Prime Position;
2) At Prime Position, the pipetting needle shall be adjusted to the center of the round
washing hole. The whole needle tip shall drop below the slope at the top of the
washing hole.

The pipetting needle shall be

Waste Position
higher than the hole wall of
the Prime Position; otherwise
Prime Position
it will crash into the wall.
Waste Position

The whole needle tip shall

drop below the slope at the
top of the washing hole.

Prime Position
Top view
Side view

When adjustment is finished, click <Return> to exit this dialog.

Maglumi 2000 Operating Instructions Page A-25

Appendix A Needles Adjust

A.8 Adjust of Needle Position in Sample Area

Click icon in [Needles Adjust] dialog to enter [Sample Area Adjust] dialog.

Figure A.8-1 [Sample Area Adjust] Dialog

Page A-26 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.8.1 Adjust of Left Position in Sample Area

Select the left needle in Select Position.

1. Select Position of Track 1 and Tube 1 in Select Area:

Figure A.8-2 [Sample Area Adjust] Dialog (Left Needle, Position of Track 1 and Tube1)

Set the stepsize by changing the number of selected bars. First use a large
stepsize to move the pipetting needle to nearby the position of Track 1 and Tube1,
and then use a small stepsize to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 100μL water into the tube in advance;
2) Position on the top view: Move the needle to the center of the tube located in
the position of Track 1 and Tube1;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-27

Appendix A Needles Adjust

2. Select Position of Track 1 and Tube 10 in Select Area:

Figure A.8-3 [Sample Area Adjust] Dialog (Left Needle, Position of Track 1 and Tube 10)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 1 and Tube 10,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 100μL water into the tube in advance;
2) Position on the top view: Move the needle to the center of the tube located
in the position of Track 1 and Tube 10;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-28 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

3. Select Position of Track 12 and Tube 10 in Select Area:

Figure A.8-4 [Sample Area Adjust] Dialog (Left Needle, Position of Track 12 and Tube10)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 12 and Tube 10,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 100μL water into the tube in advance;
2) Position on the top view: Move the needle to the center of tube located in
the position of Track 12 and Tube 10;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-29

Appendix A Needles Adjust

A.8.2 Adjust of Right Position in Sample Area

Select the right needle in Select Position.

1. Select Position of Track 11 and Tube 1 in Select Area:

Figure A.8-5 [Sample Area Adjust] Dialog (Right Needle, Position of Track 11 and Tube 1)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 11 and Tube 1,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 100μL water into the tube in advance;
2) Position on the top view: Move the needle to the center of the tube located
in the position of Track 11 and Tube 1;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-30 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

2. Select Position of Track 11 and Tube 10 Select Area:

Figure A.8-6 [Sample Area Adjust] Dialog (Right Needle, Position of Track 11 and Tube10)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 11 and Tube 10,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 100μL water into the tube in advance;
2) Position on the top view: Move the needle to the center of the tube located in
the position of Track 11 and Tube 10;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-31

Appendix A Needles Adjust

3. Select Position of Track 12 and Tube 10 in Select Area:

Figure A.8-7 [Sample Area Adjust] Dialog (Right Needle, Position of Track 12 and Tube10)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 12 and Tube 10,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 100μL water into the tube in advance;
2) Position on the top view: Move the needle to the center of the tube located in
the position of Track 12 and Tube 10;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-32 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.9 Adjust of Needle Position in Reagent Area

Click icon to enter [Reagent Area Adjust] dialog .

Figure A.9-1 [Reagent Area Adjust] Dialog

Maglumi 2000 Operating Instructions Page A-33

Appendix A Needles Adjust

A.9.1 Adjust of Left Needle in Reagent Area

Select the left needle in Select Position

1. Select Position of Track 1 and Tube 1 in Select Area:

Figure A.9-2 [Reagent Area Adjust] Dialog (Left Needle, Position of Track 1 and Tube 1)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 1 and Tube 1,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 300μL water into the first tube of the integral in advance;
2) Position on the top view: Move the needle to the center of the silicone sealing
film of the first tube in the first tube located in the position of Track 1 and Tube
1;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-34 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

2. Select Position of Track 1 and Tube 2 in Select Area:

Figure A.9-3 [Reagent Area Adjust] Dialog (Left Needle, Position of Track 1 and Tube 2)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 1 and Tube 2,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 300μL water into the second tube of the reagent in advance;
2) Position on the top view: Move the needle to the center of the silicone sealing
film of the second tube in the first tube;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-35

Appendix A Needles Adjust

3. Select Position of Track 1 and Tube 4 in Select Area:

Figure A.9-4 [Reagent Area Adjust] Dialog (Left Needle, Position of Track 1 and Tube 4)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 1 and Tube 4,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 300μL water into the fourth tube of the reagent in advance;
2) Position on the top view: Move the needle to the center of the seal located in
the position of Track 1 and Tube 4;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-36 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

4. Select Position of Track 1 and Tube 7 in Select Area:

Figure A.9-5 [Reagent Area Adjust] Dialog (Left Needle, Position of Track 1 and Tube 7)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 1 and Tube 7,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 1300μL water into the seventh tube of the reagent in advance;
2) Position on the top view: Move the needle to the center of the seal located in
the position of Track 1 and Tube 7;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-37

Appendix A Needles Adjust

5. Insert the reagent into the Track 15 of reagent area. Select Position of Track 15
and Tube 7 in Select Area:

Figure A.9-6 [Reagent Area Adjust] Dialog (Left Needle, Position of Track 15 and Tube7)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 15 and Tube 7,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 1300μL water into the seventh tube of the reagent in advance;
2) Position on the top view: Move the needle to the center of the seal located in
the position of Track 15 and Tube 7;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

After needle adjustment is finished, insert the reagent into Track 1 of reagent area.

Page A-38 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.9.2 Adjust of Right Needle in Reagent Area

Select the right needle in Select Position.

1. Select Position of Track 1 and Tube 1 in Select Area:

Figure A.9-7 [Reagent Area Adjust] Dialog (Right Needle, Position of Track 1 and Tube 1)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 1 and Tube 1,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 300μL water into the first tube of the reagent in advance;
2) Position on the top view: Move the needle to the seal located in the position
of Track 1 and Tube 1;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-39

Appendix A Needles Adjust

2. Select t Position of Track 1 and Tube 2 in Select Area:

Figure A.9-8 [Reagent Area Adjust] Dialog (Right Needle, Position of Track 1 and Tube 2)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 1 and Tube 2,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 300μL water into the second tube of the reagent in advance;
2) Position on the top view: Move the needle to the center of the seal located in
the position of Track 1 and Tube 2;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-40 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

3. Select Position of Track 1 and Tube 4 in Select Area:

Figure A.9-9 [Reagent Area Adjust] Dialog (Right Needle, Position of Track 1 and Tube 4)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 1 and Tube 4,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 300μL water into the fourth tube of the reagent in advance;
2) Position on the top view: Move the needle to the center of the seal located in
the position of Track 1 and Tube 4;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-41

Appendix A Needles Adjust

4. Select Position of Track 1 and Tube 7 in Select Area:

Figure A.9-10 [Reagent Area Adjust] Dialog (Right Needle, Position of Track 1 and Tube 7)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 1 and Tube 7,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 1300μL water into the seventh tube of the reagent in advance;
2) Position on the top view: Move the needle to the center of the seal located in
the position of Track 1 and Tube 7;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Page A-42 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

5. Insert the reagent into Track 15 of reagent area. Select Position of Track 15 and
Tube 7 in Select Area:

Figure A.9-11 [Reagent Area Adjust] Dialog (Right Needle, Position of Track 15 and Tube7)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 15 and Tube 7
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
1) Fill 1300μL water into the seventh tube of the reagent in advance;
2) Position on the top view: Move the needle to the center of the seal located in
position of Track 15 and Tube 7;
3) Maximum Limit: Click UP/DOWN arrows to adjust the pipetting needle until
the needle tip touch the liquid surface. Click <Writeparam> when the level
detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-43

Appendix A Needles Adjust

A.10 Cuvette High-level Adjust

Take a cuvette bar, fill 600μL water into the first cuvette, and place it into the left
pipetting position.

600μl volume

Click <Z-Dispense> button to display [Z-Dispense Adjust] dialog.

Figure A.10-1 [Z-Dispense Adjust] Dialog

Page A-44 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.10.1 Left Cuvette High-level Adjust

Select left needle in Select Needle area:

FigureA.10-2 [Z-Dispense Adjust] Dialog (Left Needle)

Set the step size by changing the number of selected bars. First use a large step size
to move the pipetting needle to nearby the first cuvette on the left pipetting position,
and then use a small step size to fine-tune the vertical height until the needle position
meets requirements described below.

Requirements:
Click UP/DOWN arrows to adjust the pipetting needle until the needle tip touch the
liquid surface. Click <Writeparam> when the level detection indicator light is on.

Maglumi 2000 Operating Instructions Page A-45

Appendix A Needles Adjust

A.10.2 Right Cuvette High-level Adjust

Select right needle in Select Needle area:

Figure A.10-3 [Z-Dispense Adjust] Dialog (Right Needle)

Set the step size by changing the number of selected bars. First use a large step size
to move the pipetting needle to nearby the first cuvette on the right pipetting position,
and then use a small step size to fine-tune the vertical height until the needle position
meets requirements described below.

Requirements:
Click UP/DOWN arrows to adjust the pipetting needle until the needle tip touch the
liquid surface. Click <Writeparam> when the level detection indicator light is on.

Page A-46 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

A.11 Adjust of Start Position of Reagents

Click <Z-Start> button to display [Z-Start Adjust] dialog.

Figure A.11-1 [Z-Start Adjust] Dialog

A.11.1 Adjust of Left Start Position of Reagents

Insert the reagent into the first reagent position.

Select left needle in needle selection area.
1. Select Position of Track 1 and Tube 1 in Select Area:

Figure A.11-2 [Z-Start Adjust] Dialog (Left Needle, Position of Track 1 and Tube1)

Maglumi 2000 Operating Instructions Page A-47

Appendix A Needles Adjust

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the seal located in the Position of
Track 1 and Tube 1, and then use a small step size to fine-tune the horizontal
position and vertical height until the needle position meets requirements described
below.

Requirements:
2/3 of Teflon-coated part of the pipetting needle tip is exactly below the seal
located in the Position of Track 1 and Tube 1 of the reagent. Click <Writeparam>
after adjusting is finished.

2. Select Position of Track 1 and Tube 7 in Select Area:

Figure A.11-3 [Z-Start Adjust] Dialog (Left Needle, Position of Track 1 and Tube 7)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 1 and Tube 7,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
2/3 of Teflon-coated part of the pipetting needle tip is exactly below the seal
located in the position of Track 1 and Tube 7 of the reagent. Click <Writeparam>
after adjusting is finished.

Page A-48 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

3. Insert the reagent into Track 15 of reagent area. Select Position of Track 15 and
Tube 7 in Select Area:

Figure A.11-4 [Z-Start Adjust] Dialog (Left Needle, Position of Track 15 and Tube 7)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the position of Track 15 and Tube 7,
and then use a small step size to fine-tune the horizontal position and vertical
height until the needle position meets requirements described below.

Requirements:
2/3 of Teflon-coated part of the pipetting needle tip is exactly below the seal
located in the position of Track 15 and Tube 7 of the reagent. Click <Writeparam>
after adjusting is finished.

Maglumi 2000 Operating Instructions Page A-49

Appendix A Needles Adjust

A.11.2 Adjust of Right Start Position of Reagents

Insert the reagent into the first reagent position.

Select right needle in Select Needle area.
1. Select Position of Track 1 and Tube 1 in Select Area:

Figure A.11-5 [Z-Start Adjust] Dialog (Right Needle, Position of Track 1 and Tube1)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby seal located in the position of Track 1
and Tube 1, and then use a small step size to fine-tune the horizontal position and
vertical height until the needle position meets requirements described below.

Requirements:
2/3 of Teflon-coated part of the pipetting needle tip is exactly below the seal
located in the position of Track 1 and Tube 1 of the reagent. Click <Writeparam>
after adjusting is finished.

Page A-50 Maglumi 2000 Operating Instructions

 Appendix A Needles Adjust

2. Select Position of Track 1 and Tube 7 in Select Area:

Figure A.11-6 [Z-Start Adjust] Dialog (Right Needle, Position of Track 1 and Tube 7)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the seal located in the position of
Track 1 and Tube 7, and then use a small step size to fine-tune the horizontal
position and vertical height until the needle position meets requirements described
below.

Requirements:
2/3 of Teflon-coated part of the pipetting needle tip is exactly below the seal
located in the position of Track 1 and Tube 7 of the reagent. Click <Writeparam>
after adjusting is finished.

Maglumi 2000 Operating Instructions Page A-51

Appendix A Needles Adjust

3. Insert the reagent into Track 15 of reagent area. Select Position of Track 15 and
Tube 7 in Select Area:

Figure A.11-7 [Z-Start Adjust] Dialog (Right Needle, Position of Track 15 and Tube 7)

Set the step size by changing the number of selected bars. First use a large step
size to move the pipetting needle to nearby the seal located in the position of
Track 15 and Tube 7, and then use a small step size to fine-tune the horizontal
position and vertical height until the needle position meets requirements described
below.

Requirements:
2/3 of Teflon-coated part of the pipetting needle tip is exactly below the seal
located in the position of Track 15 and Tube 7 of the reagent. Click <Writeparam>
after adjusting is finished.

Page A-52 Maglumi 2000 Operating Instructions

 Appendix B Software Upgrade

Appendix B Software Upgrade

B.1 Software Upgrade

In order to continuously improve the operating software for Maglumi 2000, upgrade is
necessary.
Upgrade can be realized by:
1) Installing the software installer of new version;
2) Installing the service pack.

This section will introduce the general operation process required for upgrade. There
will be a special guide for each specific upgrade task.

WARNING
To ensure safety and reliability of the analyzer, software upgrade of the
analyzer can be performed only by persons having been trained by our
Company or after approval by engineers in our Company.

B.1.1 Installing the Software Installer of New Version

In case of any change of the operating software, the new version of operating software
for Maglumi 2000 analyzer should be reinstalled.
The new version of operating software will be stored in the upgrade disc. It is
suggested to back up the original operating software prior to upgrade.

Upgrade Steps:
1. Back up the original operating software;
2. Uninstall the original operating software;
3. Insert the disc into the computer optical drive; open the disc folder; find the
installation file "Maglumi.exe" and run it;
4. Copy the "component" folder in the original operating software having been
backed up to the root directory of the new software; otherwise it will be necessary
to readjust the analyzer parameters;
5. Restart the computer;
6. Start the analyzer; run Service.exe; check and confirm the position of pipette and
cuvette transfer module; exit the software after completion;
7. Run User.exe to finish software upgrade.

Maglumi 2000 Operating Instructions Page B-1

Appendix B Software Upgrade

Please see the figures below for the detailed installation steps:

Figure B.1-1 Step 1

Figure B.1-2 Step 2

Page B-2 Maglumi 2000 Operating Instructions

 Appendix B Software Upgrade

Figure B.1-3 Step 3

Figure B.1-4 Step 4

Maglumi 2000 Operating Instructions Page B-3

Appendix B Software Upgrade

Figure B.1-5 Step 5

Figure B.1-6 Step 6

Page B-4 Maglumi 2000 Operating Instructions

 Appendix B Software Upgrade

Figure B.1-7 Step 7

Figure B.1-8 Step 8

Maglumi 2000 Operating Instructions Page B-5

Appendix B Software Upgrade

B.1.2 Installing the Service Pack

For information safety or software compatibility reason, the upgrade patch of operating
software for Maglumi 2000 may be sent. Upgrade of the operating software can be
realized by running the upgrade patch found in the upgrade disc or downloaded online.
Refer to the instructions provided in the service pack for details of upgrade method.

B.2 Program Upgrade of Main Control Circuit Boards

Each component of the analyzer has a corresponding control circuit board. A data port
for upgrade is available on each control circuit board.
The analyzer has 8 main control circuit boards that can be upgraded, which control the
corresponding components. Their codes and names are listed below:
 01-E00-Stacker
 02-E00-Incubator Pusher
 03-E00-Washer
 04-E00-Chamber
 05-E00-Sample Area
 06-E00-Reagent Area
 07-E01-Pipettor
 08-E00-COP
Program upgrade of 8 main control circuit boards is carried out by two case below:
1) Upgrade the program of 08-E00-COP circuit board;
2) Upgrade the programs of No. 01~07 circuit boards.

B.2.1 Upgrade the Program of 08-E00-COP Circuit Board

Upgrade Steps:
1. Power off the analyzer prior to upgrade.. Use the RS232 data cable supplied by
our Company to connect the COM port on the computer with the RS232 port on
the analyzer;
2. Remove the 08-E00-COP circuit board from the analyzer, and put the two Jumper
Caps at correct position, as shown below which in Red box. Otherwise the
program burning cannot be carried out.

Figure B.2-1 Put the two Jumper Caps at correct position

3. Put the 08-E00-COP back into the analyzer. Start the computer and the analyzer.
Run FlashDownload.exe on the computer; then select options as follows:

Page B-6 Maglumi 2000 Operating Instructions

 Appendix B Software Upgrade

Table B.2-1 Parameter Settings of FlashDownload

Step Option Content Meaning
1 Device LPC2214 Burning chip
2 COM Port COM1 Communication port
3 Baud Rate 115200 Burning speed
4 Oscillator(KHz) 14318.18 Frequency (fixed)
Select the burning file (COP.hex),
5 Hex File hex file
which is provided by Snibe

Figure B.2-2 Program Upgrade Process for 08-E00-COP Main Control Circuit Board

4. After selecting the above options, click the <Start> button; after successful
burning, "Finished" will be displayed at the "Status" position;
5. When the writing process is finished, power off the analyzer and get the 08-E00-
COP circuit board out of the analyzer again, and put the two Jumper Caps at the
position which shown below in Red box. Otherwise the analyzer will not work
properly.

Figure B.2-3 Restore the two Jumper Caps

B.2.2 Upgrade and Burning of the Programs of No. 01~07 Circuit Boards

Upgrade Steps:
1. Power off the analyzer prior to upgrade. Use the RS232 data cable and program
download cable supplied by our Company to connect the COM port on the
computer with the program download port on No. 01~07 circuit boards in the

Maglumi 2000 Operating Instructions Page B-7

Appendix B Software Upgrade

analyzer. The program download cable and the connection method are shown in
the figures below;

Figure B.2-4 Program Download Cable for No. 01~07 Main Control Circuit Boards

Figure B.2-5 Program Download Connection Ports of Main Control Circuit Boards

Figure B.2-6 Program Download Connection Method for Main Control Circuit Boards

Page B-8 Maglumi 2000 Operating Instructions

 Appendix B Software Upgrade

Main control circuit

PC serial port Program download board
cable

RS232 connecting
cable

Figure B.2-7 Diagram of Connection Method

2. After cable connection, start the computer and the analyzer. Run
FlashDownload.exe on the computer; then select options as follows:
Table B.2-8 Parameter Settings of FlashDownload
Step Option Content Meaning
LPC2132 (01-06)
1 Device Burning chip
LPC2368 (07)
2 COM Port COM1 Communication port
3 Baud Rate 115200 Burning speed
Oscillator
4 14318.18 Frequency (fixed)
(KHz)
Select the burning file; the above 7
main control circuit boards have 8
different files; each file name
5 Hex File hex file corresponds to a circuit board
name, where 07-E01-Pipettor
corresponds to two files, which are
provided by Snibe.

Figure B.2-9 Program Upgrade Process for No. 01-07 Main Control Circuit Boards

3. After selecting the above options, click the <Start> button; after successful
burning, Status will display finished;
4. When the writing process is finished, exit the FlashDownload.exe program.
5. Power off the analyzer; remove the program download cable; reconnect the
RS232 data cable with the RS232 port on the analyzer; restart the analyzer.

WARNING
1) During program upgrade, users must follow the principle that hot

Maglumi 2000 Operating Instructions Page B-9

Appendix B Software Upgrade

plugging of the connecting cable is not allowed; the analyzer must

be powered off before the connecting cable is plugged, otherwise
the main control circuit board will be burnt.
2) The 07-E01-Pipettor circuit board corresponds to 2 program files,
one file for the left pipettor and the corresponding program
download connector, and the other file for the right pipettor and the
corresponding program download connector.
Left pipettor program Right pipettor program
download左加样臂程
connector 右加样臂程
download connector
序下载接口 序下载接口

Figure B.2-10 Download Connector of 07-E01-Pipettor Circuit Board

WARNING
1)For the 05-E00-Sample Area main control circuit board, during
upgrading program, it is needed to pull off the two Jumper Caps on
the board; otherwise, program burning cannot be carried out or the
circuit board may get damaged.
2)After program upgraded, you should push the two Jumper Caps back
to the circuit board, Otherwise the barcode data reading function will
not work properly.

Figure B.2-11 Jumper of 05-E00-Sample Area Main Control Circuit Board

Page B-10 Maglumi 2000 Operating Instructions