For application training only V2.

Standard Operation Procedure

&
Precautions

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Contents
1. Prepare for Power On ·····································································································4
1.1 Preparation List ···················································································································4
1.2 Attention & cautions ···········································································································4
2. Power On ·······················································································································5
2.1 Main procedure ···················································································································5
2.2 Startup of the BS-120/200 software ····················································································5
2.2.1 Lamp background measurement ·············································································5
2.2.2 Cuvettes replacement ······························································································6
2.2.3 Washing solution check ····························································································7
2.3 Attention & Cautions ···········································································································7
3. Prepare for analysis ········································································································8
3.1 Reagent ·······························································································································8
3.1.1 Reagent parameter configuration ············································································8
3.1.1.1 Database import (for Mindray reagent) ························································8
3.1.1.2 Manually type-in (for mindray reagents) ······················································9
3.1.1.3 Manually type-in (for other reagent brand) ················································10
3.1.2 Reagent storage(Mindray only) ··············································································10
3.1.3 Reagent positioning································································································13
3.1.4 Attention & precautions ·························································································14
3.2 Calibrator···························································································································15
3.2.1 Calibrator brief introduction ··················································································15
3.2.2 Calibrator storage condition ···················································································16
3.2.3 Calibrator material preparation ·············································································17
3.2.4 Calibrator parameter setup ····················································································18
3.2.4.1 Positioning and assay value input ·······························································18
3.2.4.2 Calibration rule setup ··················································································20
3.3 Control·······························································································································20
3.3.1 Control brief introduction & storage ······································································20
3.3.2 Control material preparation ·················································································22
3.3.3 Control parameter setup ························································································22
3.3.3.1 Positioning and assay value input ·······························································22
3.3.3.2 QC rules setup ·····························································································23
3.3.3.3 Westgard rule introduction,, ········································································23
3.4 Samples ·····························································································································25
3.4.1 Sample types ··········································································································25
3.4.2 Sample preparation ································································································26
3.4.3 Sample storage conditions ·····················································································26
4. Perform Routine Analysis ······························································································26
4.1 Calibration ·························································································································26
4.1.1 Purpose of Calibration ····························································································26
4.1.2 Calibration frequency requirement ········································································27
4.1.3 Calibration request ·································································································27
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4.1.4 Calibration results ··································································································28
4.2 QC program ·······················································································································30
4.2.1 Purposes of QC program ························································································30
4.2.2 QC request··············································································································30
4.2.3 QC results ···············································································································31
4.3 ISE module (Optional) ·······································································································32
4.3.1 ISE introduction ······································································································32
4.3.2 ISE reagent··············································································································33
4.3.3 ISE calibration ·········································································································34
4.3.4 ISE QC program ······································································································35
4.3.5 ISE Maintenance schedule and reagent consumption ···········································37
5. Analyze daily patient samples ·······················································································38
5.1 Normal routine sample request ························································································38
5.2 Emergency samples ···········································································································38
5.3 Sample request in batch ····································································································39
5.4 Other functions ·················································································································40
5.4.1 Sample dilution ······································································································40
5.4.1.1 Why sample dilution ···················································································40
5.4.1.2 Sample dilution on BS series ·······································································41
6. Shut down the machine ································································································42
6.1 Exit the operation software·······························································································42
6.2 Switch off the machine······································································································42
7. Easy maintenance ·········································································································44

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1. Prepare for Power On

1.1 Preparation List

1 Power supply and power cord of the analyzer, computer and printer

2 Connections between the analyzer and computer, as well as computer and printer

3 Enough paper in printer

4 Deionized water tank (full) and the connection with the analyzer (sensor and tube)

5 Waste tank (empty) and the connection with the analyzer (sensor and tube)

6 Syringe is installed properly

7 Probe is installed properly

8 Mixing bar is installed properly

9 CD80 solution for probe washing in position 35/39 of reagent disk

10 Distilled water in position 36/40 of reagent disk

11 Urine diluent (38) and Cleaning solution for ISE(37) in reagent disk (if ISE installed)

1.2 Attention & cautions

 The washing solution on reagent position 39 is 10% CD80 solution. If necessary the
concentration of CD-80 solution can be elevated to increase the washing efficiency. However,
the original concentrated CD80 liquid is not recommended for the direct usage due to the
self-crystallization under low temperature.
 The DI water quality is very important. The water filter in the DI water tank should be
regularly checked before switching on the power, and replacement is required if the filter
turns to dark color. The normal replacement frequency is about 4-6 months; the DI water
supplier should be changed if the filter is replaced less than 3 months.
 The ISE module is optional with the main chemistry analyzer. The area might be empty if no
ISE module mentioned on your purchase order. Since the installation of ISE module is strictly
prohibited out of Mindray factory, please make sure to double check with customers
whether the ISE module is required within few years.

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2. Power On

2.1 Main procedure

1 Place the Main Power to the ON position

2 Place the Power to the ON position

3 Turn on the monitor of the computer

4 Turn on the computer

5 Turn on the printer

6 Starting the Operating Software, Logon in(Default username: Admin; password: Admin)

2.2 Startup of the BS-120/200 software

Since BS-120 and BS-200 require the disposable cuvettes, there are some more steps before
entering into the main display.

2.2.1 Lamp background measurement

Fig 2.2.1-1
Open the reaction disk window and unload the cuvette on position 1, then close the window and
click ‘OK’ to process the measurement.
N.B. there are two circus holder points on the cuvettes segments, please makes sure this holder
points fix with the reaction disk position tightly. The cuvette segments might fall off the reaction
disk under the high speed rotation if this step is not completed properly.
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Fig 2.2.1-2 connection point on cuvette segment

2.2.2 Cuvettes replacement

Fig 2.2.2-1
(1) Open the reaction disk window and load a clean cuvette segment, then close the window
(2) Click ‘OK’ to ensure the background measurement
(3) If the background checking is passed, the current status will be changed into ‘unused’
(4) Repeat step 1 and 2 until there are enough clean and unused cuvettes for the tests
(5) Click ‘Next’ to leave this page.

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2.2.3 Washing solution check

Fig 2.2.3-1
Please make sure again the washing solution is placed on reagent position 39 (For BS-120, the
detergent position is 35)
Routine wash means the washing process only require the DI water to wash the probe.
Enhanced wash means the washing process consume some CD80 detergent to extra wash probe.

2.3 Attention & Cautions

 There are two switches on the machine, the back one is the main power and the one the
right/left hand side of machine is to control the analysis part except refrigerator. The main
switch is turned on all the time and the analyzing switch can be turned off when the daily
works are finished every day.
 The disposable cuvettes on BS-120 and BS-200 are different. There are 5 cuvettes on each
BS-120 segment and 10 cuvettes on each BS-200 segment. Those cuvettes are not allowed to
reuse. Even though the background checking is passed, some unexpected and transparent
contaminators remain on the walls.

Fig 2.3-1 BS-200(top) and BS-120(bottom) cuvette segment

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3. Prepare for analysis

Before any test, the reagents, calibrator, control material and samples should be prepared
carefully to ensure the accurate results.

3.1 Reagent

3.1.1 Reagent parameter configuration

Test parameters should be input before entering any reagent information. There are two
pathways to enter the parameter application data:

3.1.1.1 Database import (for Mindray reagent)

(1) When you contact Mindray application specialist, you will receive the database files called
‘DB200.mdb’. The database name is exactly the same for all three modules but they cannot
be swapped. Please make sure you receive the correct file.
(2) Exit the operation software
(3) Copy the database file and paste it into the ‘Database’ folder under the software installation
folders. You need to replace the previous file with the given one. (Please make sure that the
previous database backup has been done properly since the new database will erase the
history documents and the customer might lose all the patient results if no backup.)

Fig 3.1.1.1-1

(4) Restart the software and log in properly

(5) Go to ‘Parameters’ page, and all the parameters setup details are shown in list.

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Fig 3.1.1.1-2

3.1.1.2 Manually type-in (for mindray reagents)

(1) Please contact mindray application specialist and ask for a latest copy of application
parameter sheet.

Fig 3.1.1.2-1
(2) Go to ‘ParametersTestParameters’ page
(3) Click ‘Add’ to create a new parameter account.
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(4) Fill in the parameter information by using the sheets
(5) Click ‘OK’ to save any changes

3.1.1.3 Manually type-in (for other reagent brand)

If the customers use other brand reagent, please contact your regional application specialist to
check about the details. With your query, please enclose the following information:
(1) The reagent insert with the experimental procedures.
(2) The insert paper should include wavelength, reagent principle, reagent/sample volume,
manual operation procedure, incubation/reaction time and etc.
The application specialist will send you the instruction or final setup data if the reagent is valid on
our machine. However Mindray cannot guarantee the accuracy or traceability of final results if
using other brand reagents.

Fig 3.1.1.3-1

3.1.2 Reagent storage(Mindray only)

 The reagents are valid up to the expiration date on the label when stored unopened at
correct temperature and protected from light. The detailed shelf life for all mindray reagent
are shown on next few pages(Table 3.1.2-2/3/4). All the reagent should be stored at 2-8
degrees except bilirubin DSA reagents which require the room temperature conditions due
to the self sedimentation under low temperature.
 Once opened, the reagents are stable for centain days when refrigerated on analyzer or
refrigerator and the reagents are strictly prohibited to freeze under any circumstances. The
detailed onboard stability dates are also shown in next few pages(Table 3.1.2-1). Please
make sure the reagent should keep fresh all the time to ensure the accuracy of the final
results.
 The contamination of reagents must be avoided. The contaminating source might be from
the air, condensation water, human saliva, carryover of other reagent, abnormal samples,
machine spare parts and etc. Please make sure the reagent disk cover should be closed all
the time.

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 Some parameters require the instant working solutions which has lower stability, please
make sure the working solution should be strictly stored in the refrigenator all the time.
 On the low throughput machine, some new parameter is not valided. Please contact your
mindray regional application specialist for the details.

Table 3.1.2-1 Onboard stability list

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Table 3.1.2-2 the following parameters with the theoretical shelf life: 18 months

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Table 3.1.2-3 The following parameters with the theoretical shelf life: 15 months

Table 3.1.2-4 The following parameters with the theoretical shelf life: 12 months

3.1.3 Reagent positioning

(1) The reagent could randomly insert into the reagent holder, there are three different
configured reagent package for BS series analyzer, and on BS-120/200/200E, the reagent
package is in green colour.

Fig 3.1.3-1

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(2) The standard configuration for BS-120/200/200E series reagent bottles are totally 40ml and
20ml for R1 and R2 respectively. And R1 and R2 are sharing with the same reagent disk and
probe. The dead volume for R1 and R2 bottles are 2.5ml and 1.5ml respectively.
(3) Please make sure the refrigenator of analyzer is swtiched on and the temperature inside is
dropped down. The reagent disk cover should be closed all the time to avoid any
condensation water production.
(4) After insert the reagent into the reagent disk, please note down the position number.
(5) Go to software page ‘ReagentReagent setup’, and enter into the reagent position and
expiration date information properly. The orange background means the logically incorrect
input of reagent information.
For the double reagent parameter, you need to fill in both R1 and R2 information correctly to
carry on the following tests.

Fig 3.1.3-2

3.1.4 Attention & precautions

 During the transportation, the reagent will be placed in a sealed and heat isulated box with
some ice bag inside. Those ice bags will perform a cool environment between 2-8 degrees
for about 3 days. However it takes about a week for the whole boxes reach to the room
temperature. Please make sure you finish the custom clearance documentary works as soon
as possible.
 When you open the boxes, please pay more attention on the reagent status. Please
immediately contact the express company if any of those situations happened:

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 The ice bags are thoroughly thawed and the inside temperature is almost room
temperture or above.
 Lots of condensation water is remaining on the bottom of the box.
 Any leakage of reagent or ice bags materials.
 Any irritating smells
 Any abnormal or foreign objects in the box

3.2 Calibrator

3.2.1 Calibrator brief introduction

 Mindray calibrator includes two group materials, the multi parameter calibrators and
individual single parameter calibrators.
 Multi parameter calibrator includes multi sera calibrator, specific protein calibrator and lipids
calibrator, which could support more than one parameter. The single parameter calibrators
are usually unique for a certain parameter and also can be sold individually or included in
the total reagent package.

Fig 3.2.1-1 Mindray calibrators

 Most of the calibrator materials are based on human serum or mammal serum, except
HbA1c calibrator which is from human whole blood.
 Each lot number of material should enclose with the target value sheet or print directly on
the bottles. If the value information is missing from the package, please contact mindray
regional application specialist with the lot numbers.

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Table3.2.1-1 Mindray Calibrator list

No. Product Name Part No. Package Size Included Paramters

ALB, ALP, ALT, AMY, AST, DB-DSA, DB-

105-001144-00 10×3 mL
VOX, TB-DSA, TB-VOX, Ca, TC, CK,
1 Multi Sera Calibrator Crea-Jaff, Crea-S, GLU-HK, GLU-O,
GGT, HBDH, LDH-L, Mg, P, TP, TG,
105-001127-00 20×3 mL
Urea, UA, CHE, LIP

2 Specific Proteins Calibrator 105-001129-00 5×1 mL C3, C4, CRP, IgA, IgG, IgM

3 Lipids Calibrator 105-001128-00 5×1 mL APOA1, APOB, HDL-C, LDL-C

4 Prealbumin Calibrator 105-001130-00 3×1 mL PA

5 Lipoprotein(a) Calibrator 105-001131-00 3×1 mL Lp(a)

6 CK-MB Calibrator 105-001132-00 3×1 mL CK-MB

7 HbA1c Calibrator 105-003680-00 2×1mL HbA1c

8 RF Calibrator 105-003683-00 5×0.5mL RF

9 ASO Calibrator 105-003682-00 1×0.5mL ASO

10 HS-CRP Calibrator 105-003685-00 5×0.5mL HS-CRP

11 HCY Calibrator 105-003681-00 1×1mL HCY

12 FER calibrator 105-002311-00 1×4 levels×2 mL FER

13 ACE calibrator 105-002313-00 1×1 level×1 mL ACE

14 MALB calibrator 105-002315-00 1×5 levels×1 mL MALB

15 TRF calibrator 105-002317-00 1×5 levels×1 mL TRF

16 β-HB calibrator 105-002319-00 1×1 level×1 mL β-HB

17 ADA Calibrator 105-003687-00 1×1mL ADA

18 5'-NT Calibrator 105-003688-00 1×1mL 5'-NT

19 CysC Calibrator 105-003684-00 6×1 mL CysC

20 β2-MG Calibrator 105-003686-00 1×1mL β2-MG

N.B. Please make sure the correct calibrator materials are purchased after you order reagents.

3.2.2 Calibrator storage condition

This information is clearly shown on the calibrator insert paper, please make sure you have
already read and fully understand all the storage and stability content before use any materials.

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Fig 3.2.2-1 Multi sera calibrator storage conditions

3.2.3 Calibrator material preparation

In this section, multi sera calibrator is taken as an example.

(1) Take the calibrator bottle out of the refrigerator and allow reaching room temperature.
Please make sure the bottle is already close to the room temperature before uncapping,
otherwise the lyophilized material might absorb the waters from air or the condensation
water on the wall so that to affect the final concentration accuracy.
(2) Tab the vertically positioned bottle gently and ensure that the lyophilized material is at the
bottom of the bottle.
Please make sure the powders are located on the bottom of the bottle as much as possible,
this could largely avoid the loss of powder when open the cap.
(3) Remove the screw cap and rubber stopper carefully, avoiding any loss of powder.
On the rubber stopper, there are usually sticking certain amount of powder which is very
easy to lose with the air flows. Please make sure to save all the material as much as you can.

Fig 3.2.3-1
(4) Reconstitute by adding 3.0 mL deionized water to the side of the bottle slowly.
The pipette or burette is strongly recommended to measure and transfer the deionized
water. And please try not to use measuring cylinder, syringe, or other rough scaled
measuring equipment since the inaccurate measurement would cause the incorrect
concentration of calibrator.

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Fig 3.2.3-2
Secondly the quality of water is also very important. Please make sure the fresh deionized
water is required for the calibrator preparation process each time.
(5) Carefully replace the rubber stopper and mix contents by inverting several times and
swirling gently to ensure all the components of powder are dissolved.
Please mix the content really carefully and avoid forming the foams and bubbles as possible.
After mixing process, the calibrator solution should be kept still for at least 15 mins at room
temperature.
(6) Divide the calibrator solution into small portions to micro tubes as shown below. The dead
volume of this micro tube is about 200ul, so we recommend that 500ul calibrator material in
each vials.
The vials should be stored in the freezer at -20 degrees all the time. Once the material is
taken out of the freezer and thawed to room temperature, the calibrator should not be
re-frozen.

Fig 3.2.3-3

3.2.4 Calibrator parameter setup

3.2.4.1 Positioning and assay value input

(1) Go to ‘CalibrationCalibrator’ page and click ‘Add’ to create a new calibrator account.
(2) Type in the calibrator name, exp. date, position and lot number

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(3) Take the assay value insert paper out of calibrator package and read the target value for each
parameter.

Fig 3.2.4.1-1

(4) Click ‘ok’ to save the information.

(5) Usually DI water is also a good calibrator material with 0 concentration value for all
parameters. Please make sure the fresh DI water is required for the calibration.

Fig 3.2.4.1-2

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3.2.4.2 Calibration rule setup

(1) Go to ‘ParametersTestCalibration’ page, and select one test item.

(2) Select the rule for test item.
Normally there are linear and non-linear calibration rules. For the linear calibration rule,
two-point linear is strongly recommended by using mindray calibrator and DI water. For
non-linear calibration, according to the property of different reagent, the calibrator dilution
process is also required. Please contact your regional application specialist for the
instruction details of calibrator dilution setup.
(3) Setup the replicates number for calibration
Calibration is a very sensitive and important step for clinical chemistry. In order to receive
the most reasonable results, mindray suggest that you should repeat the calibration process
at least three times so that the final average value will be used for the calculation.
(4) Select the calibrators required for the calibration
(5) Click ‘OK’ to confirm.

3.3 Control

3.3.1 Control brief introduction & storage

 Mindray controls also include two group materials, the multi parameter controls and
individual single parameter controls. And each control includes two levels, the normal level
and pathological level.
 Please check the table 3.3.1-1 very carefully and make sure you purchased the correct
control material for your test items.

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 The storage conditions of control are also closed to calibrator and please read the insert
paper carefully before any actions.

Fig 3.3.1-1

Table 3.3.1-1 Mindray controls list

No. Product Name Part No. Package Size Included Paramters

1 0 5 -0 0 1 1 4 5 -0 0 1 0 ×5 mL A L B, A L P , A L T , A M Y , A ST , D B- D SA , D B- V O X, T B- D SA , T B-
V O X, C a, T C , C K, C rea- Jaff, C rea- S, G L U - H K, G L U - O , G G T ,
1 M ulti C ontrol Sera N
H BD H , I gA , I gG , I gM , L D H - L , M g, P , T P , T G , U rea, U A , Fe, C H E ,
1 0 5 -0 0 1 1 3 3 -0 0 2 0 ×5 mL L I P , N a +, K +, C l -

1 0 5 -0 0 1 1 4 6 -0 0 1 0 ×5 mL A L B, A L P , A L T , A M Y , A ST , D B- D SA , D B- V O X, T B- D SA , T B-
V O X, C a, T C , C K, C rea- Jaff, C rea- S, G L U - H K, G L U - O , G G T ,
2 M ulti C ontrol Sera P
H BD H , I gA , I gG , I gM , L D H - L , M g, P , T P , T G , U rea, U A , Fe, C H E ,
1 0 5 -0 0 1 1 3 4 -0 0 2 0 ×5 mL L I P , N a +, K +, C l -

1 0 5 -0 0 1 1 3 8 -0 0 5 ×1 mL
Spec ific P roteins
3
C ontrol N
1 0 5 -0 0 1 1 4 7 -0 0 1 0 ×1 mL
C 3 , C 4 , C RP , I gA , I gG , I gM , T P , A L B
1 0 5 -0 0 1 1 3 9 -0 0 5 ×1 mL
Spec ific P roteins
4
C ontrol P
1 0 5 -0 0 1 1 4 8 -0 0 1 0 ×1 mL

P realbumin C ontrol
5 1 0 5 -0 0 1 1 3 7 -0 0 (N )3 ×1 mL +(P )3 ×1 mL PA
N &P

6 L ipids C ontrol N 1 0 5 -0 0 1 1 3 5 -0 0 6 ×3 mL A P O A 1 , A P O B, T C , T G , H D L - C , L D L - C

7 L ipids C ontrol P 1 0 5 -0 0 1 1 3 6 -0 0 6 ×3 mL A P O A 1 , A P O B, T C , T G

L ipoprotein(a) C ontrol
8 1 0 5 -0 0 1 1 4 3 -0 0 (N )2 ×1 mL +(P )2 ×1 mL L p(a)
N &P

H D L &L D L C holes terol

9 1 0 5 -0 0 1 1 4 0 -0 0 4 ×3 mL HDLC , LDLC
C ontrol P

10 C K- M B C ontrol N 1 0 5 -0 0 1 1 4 1 -0 0 4 ×3 mL
C K- M B
11 C K- M B C ontrol P 1 0 5 -0 0 1 1 4 2 -0 0 4 ×3 mL

12 H bA 1 c C ontrol P 1 0 5 -0 0 2 1 3 8 -0 0 4 ×1 mL
H bA 1 c
13 H bA 1 c C ontrol N 1 0 5 -0 0 2 1 4 0 -0 0 4 ×1 mL

14 Rhematois m C ontrol N 1 0 5 -0 0 2 1 3 6 -0 0 4 ×3 mL
H S- C RP , A SO , RF
15 Rhematois m C ontrol P 1 0 5 -0 0 2 1 3 7 -0 0 4 ×3 mL

16 H C Y C ontrol N 1 0 5 -0 0 2 1 4 1 -0 0 3 ×1 mL
HC Y
17 H C Y C ontrol P 1 0 5 -0 0 2 1 3 9 -0 0 3 ×1 mL

18 C O 2 C ontrol N 1 0 5 -0 0 2 1 4 2 -0 0 3 ×5 mL CO2

19 FU N C ontrol P 1 0 5 -0 0 2 1 4 3 -0 0 3 ×1 mL FU N

20 D - D imer c ontrol 1 0 5 -0 0 2 3 0 1 -0 0 1 ×2 levels ×0 .5 mL D-DI M E R

21 M ultimmun c ontrol 1 0 5 -0 0 2 3 0 3 -0 0 1 ×2 levels ×3 mL M Y O , FE R, I gE

22 RBP c ontrol 1 0 5 -0 0 2 3 0 5 -0 0 1 ×1 level×1 mL RBP

23 U I BC c ontrol 1 0 5 -0 0 2 3 0 7 -0 0 1 ×1 level×5 mL U I BC

24 G 6 P D c ontrol 1 0 5 -0 0 2 3 0 8 -0 0 1 ×2 levels ×1 mL G6P D

25 A C E c ontrol 1 0 5 -0 0 2 3 1 4 -0 0 1 ×2 levels ×1 mL ACE

26 M A L B c ontrol 1 0 5 -0 0 2 3 1 6 -0 0 1 ×1 level×1 mL M A LB 21 / 47
International
27 IVD application1 0team
T RF c ontrol 5 -0 0 2 3 1 8 -0 0 1 ×2 levels ×1 mL T RF

28 β- H B c ontrol 1 0 5 -0 0 2 3 2 0 -0 0 1 ×2 levels ×5 mL β- H B

1 0 5 -0 0 3 6 9 7 -0 0 1 ×1 mL
29 A D A C ontrol L A DA
1 0 5 -0 0 3 6 9 8 -0 0 3 ×1 mL

1 0 5 -0 0 3 6 9 3 -0 0 1 ×1 mL
 15 Rhematois m C ontrol P 1 0 5 -0 0 2 1 3 7 -0 0 4 ×3 mL

16 H C Y C ontrol N 1 0 5 -0 0 2 1 4 1 -0 0 3 ×1 mL
HC Y
17 H C Y C ontrol P 1 0 5 -0 0 2 1 3 9 -0 0 3 ×1 mL

18 C O 2 C ontrol N 1 0 5 -0 0 2 1 4 2 -0 0 3 ×5 mL CO2

19 FU N C ontrol P 1 0 5 -0 0 2 1 4 3 -0 0 3 ×1 mL FU N

For2 0application training only

D - D imer c ontrol 1 0 5 -0 0 2 3 0 1 -0 0 1 ×2 levels ×0 .5V2.0
mL D-DI M E R

21 M ultimmun c ontrol 1 0 5 -0 0 2 3 0 3 -0 0 1 ×2 levels ×3 mL M Y O , FE R, I gE

22 RBP c ontrol 1 0 5 -0 0 2 3 0 5 -0 0 1 ×1 level×1 mL RBP

23 U I BC c ontrol 1 0 5 -0 0 2 3 0 7 -0 0 1 ×1 level×5 mL U I BC

24 G 6 P D c ontrol 1 0 5 -0 0 2 3 0 8 -0 0 1 ×2 levels ×1 mL G6P D

25 A C E c ontrol 1 0 5 -0 0 2 3 1 4 -0 0 1 ×2 levels ×1 mL ACE

26 M A L B c ontrol 1 0 5 -0 0 2 3 1 6 -0 0 1 ×1 level×1 mL M A LB

27 T RF c ontrol 1 0 5 -0 0 2 3 1 8 -0 0 1 ×2 levels ×1 mL T RF

28 β- H B c ontrol 1 0 5 -0 0 2 3 2 0 -0 0 1 ×2 levels ×5 mL β- H B

1 0 5 -0 0 3 6 9 7 -0 0 1 ×1 mL
29 A D A C ontrol L A DA
1 0 5 -0 0 3 6 9 8 -0 0 3 ×1 mL

1 0 5 -0 0 3 6 9 3 -0 0 1 ×1 mL
30 5 '- N T C ontrol L 5 '- N T
1 0 5 -0 0 3 6 9 4 -0 0 3 ×1 mL

1 0 5 -0 0 3 6 8 9 -0 0 1 ×1 mL , 1 ×1 mL
31 C ys C C ontrol L &H C ys C
1 0 5 -0 0 3 6 9 0 -0 0 3 ×1 mL , 3 ×1 mL

1 0 5 -0 0 3 6 9 1 -0 0 1 ×1 mL
32 β2 - M G C ontrol L β2 - M G
1 0 5 -0 0 3 6 9 2 -0 0 3 ×1 mL

1 0 5 -0 0 3 6 9 7 -0 0 1 ×1 mL , 1 ×1 mL
33 A FU C ontrol L &H A FU
1 0 5 -0 0 3 6 9 8 -0 0 3 ×1 mL , 3 ×1 mL

1 0 5 -0 0 3 6 9 5 -0 0 1 ×5 mL
34 T BA C ontrol L T BA
1 0 5 -0 0 3 6 9 6 -0 0 3 ×5 mL

3.3.2 Control material preparation

Please kindly follow the instruction on section 3.2.3 calibrator material preparation.
N.B. Please read the instruction paper carefully and dissolve the material with the correct
amount of ID water.

3.3.3 Control parameter setup

3.3.3.1 Positioning and assay value input

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Go to ‘QCControl’ page:
(1) Click ‘Add’ to create a new control account.
(2) Edit the control name, lot numbers, position and expired date.
(3) Select the test items you required in your lab.
(4) Fill in the target and SD value by reading from the assay value insert paper of control
material. (Please refer to section 3.3.2 calibrator parameter setup.)
(5) Click ‘OK’ to confirm all your setup.

3.3.3.2 QC rules setup

Go to ‘ParametersTestQC’ page:
(1) Select the parameter item that requires the QC test.
(2) Select the Westgard rule. (Refer to Section 3.3.3.3 Westgard rule introduction)
(3) Choose the control materials needed for the QC program for this test.
(4) Click ‘OK’ to confirm your settings.

3.3.3.3 Westgard rule introduction1,2,3

 13s refers to a control rule that is commonly used with a Levey-Jennings chart when the
control limits are set as the mean plus 3s and the mean minus 3s. A run is rejected when a
single control measurement exceeds the mean plus 3s or the mean minus 3s control limit.

1 Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem 1981;27:493-501.
2 Westgard JO, Klee GG. Quality Management. Chapter 17 in Textbook of Clinical Chemistry, 2nd edition. Burtis C, ed., WB Saunders Company, Philadelphia, 1994,
pp.548-592.
3 www.westgard.com

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 12srefers to the control rule that is commonly used with a Levey-Jennings chart when the
control limits are set as the mean plus/minus 2s. In the original Westgard multi rules QC
procedure, this rule is used as a warning rule to trigger careful inspection of the control data
by the following rejection rules.

 22s - Reject when 2 consecutive control measurements exceed the same mean plus 2s or

the same mean minus 2s control limit.

 R4s - reject when 1 control measurement in a group exceeds the mean plus 2s and another
exceeds the mean minus 2s.

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 41s - Reject when 4 consecutive control measurements exceed the same mean plus 1s or
the same mean minus 1s control limit.

 10x - reject when 10 consecutive control measurements fall on one side of the mean.

3.4 Samples

3.4.1 Sample types

 Normal sample type: Serum, plasma (EDTA), plasma (heparin), urine.

 Abnormal sample type (might bring the interferences): whole blood, hemolysis, lipemia,
Icterus sample.
 N.B. Please carefully check the reagent insert paper for each individual test item and strictly
follow the instruction to collect the samples in the correct vacuum tubes.

Fig 3.4.1-1 ALT sample type requirement

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3.4.2 Sample preparation

(1) The serum sample should be centrifuged at 2500-3000rpm for 5 mins until all the serum is
separated from red cells. If the centrifugal machine cannot reach this speech, please extend
the working time.
(2) The plasma sample should be centrifuged at 3000 rpm for 10 mins until all the plasma is
separated from red cells. If the centrifugal machine cannot reach this speech, please extend
the working time. Then use a tip to pick up the visible fibro protein material present in
plasma.
(3) During the transportation, the violent vibration of samples is strictly prohibited because it
would cause the hemolysis problem and largely affect the final results.

3.4.3 Sample storage conditions

 The sample should be centrifuged within 30 mins after blood draw and remove any visible
impurities or fibrins in plasma.
 If the tests are carried out within 8 hours, the sample could be stored at room temperature.
 If the tests are running after 8 hours to 48 hours, the serum/plasma should be placed in
refrigerator at 2-8 degrees.
 If the specimens are not completed within 48 hours, the serum/plasma should be frozen at
-15 to -20 degrees. Frozen samples could be thawed only once( analytes degeneration may
occur in samples that are repeated frozen and thawed)
 The sample should be stored in the dark and dry place all the time.

4. Perform Routine Analysis

4.1 Calibration

4.1.1 Purpose of Calibration

The instrument measures the light intensity through photoelectric conversion, linear
amplification and AD conversion. And according to different reaction method, the response will
be calculated from absorbance readings.
However our end users expect the concentration as the final results that printed on the report
and send to patients, response means nothing in the clinical record.
In this case, calibration is introduced to plot relationship curves between response and
concentration. After calibration, once instrument reads certain absorbance, the machine will
automatically calculate and translate into the concentration as the common results on the report.
Calibration curves include linear and non-linear types. It is strong recommended to use two-point
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linear method to plot a straight linear line for the relationship. Please do not use one-point linear
method otherwise mentioned specially.

4.1.2 Calibration frequency requirement

(1) First installation

(2) Long term vacancy of the machine
(3) Replacement of the main spare parts of machine
(4) Reagent manufacturer or lot number or test parameter setup has been changed
(5) QC program is out of control.

4.1.3 Calibration request

Fig 4.1.2-1
Go to ‘Calibration Calibration Request’ page
(1) Select the items for calibration.
N.B. if the item is in gray background and unselected, it means that during the setup process,
there are some invalid errors occurred. Please put the mouse on that item and a simple hint
will display to provide the direct solution for errors. However only one hint displayed on the
screen even though there are more than one error.

Fig 4.1.2-2
(2) Select the request type.

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 Calibration: the instrument will straightly run the calibration tests by using calibrators
selected.
 Reagent blank: the instrument will only use DI water (position 40 on BS-200/200E and
position 36 on BS-120) as sample to run the tests and record the blanks.
 Calibration + reagent blank: the instrument will run both processes together.
(3) Make sure the calibrator material and DI water are placed properly in the correct position,
and click ‘ok’ to confirm. Words ‘Requested tests exist’ will display on the top of screen if
successfully request.

Fig 4.1.2-3
(4) If you want to cancel any requested calibration test, select the item again and when the item
background turns back to white, click ‘ok’ to confirm the change.

4.1.4 Calibration results

Fig 4.1.4-1 Calibration results

Go to ‘Calibration  Results’ to check all the calibration information.
 Current: All the latest or default calibration results are displayed on this page.
 History: This page displays individual parameter calibration summaries and the default
calibration results also could be setup on this window.

Fig 4.1.4-2 ALT calibration history

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N.B. If the regional application specialist requires your calibration information, please feedback
the following message to them:
(1) Reproducibility of the responses results
The purpose of this step is to ensure the correct results of all the repeated absorbance
reading for the same material. (The replicate of calibration process is recommended as 3)

Fig 4.1.4-3 Calibration Data

(2) Reaction Curves
The purpose of this step is to check the reaction status at each section.

Fig 4.1.4-4 Normal Reaction Curve

Fig 4.1.4-5 Abnormal reaction curve

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4.2 QC program

4.2.1 Purposes of QC program

“Quality Control” is a measure of precision or how well the measurement system reproduces the
same result over time and under varying operating conditions. The purpose of QC is to detect,
reduce and correct deficiencies in Lab’s internal analytical process.
QC program is strongly recommended as daily routine analysis procedure, because it could
monitor the basic status of the whole system and track the tiny performance changes of reagents,
or spare parts of machine.
Both normal and pathological controls should be worked out before running the samples.

4.2.2 QC request

Fig 4.2.2-1
Since the QC program is the daily routine works, a shortcut is created on the left column.
(1) Select the test items for QC program.
N.B. if the item is in gray background and unselected, it means that during the setup process,
there are some invalid errors occurred. Please put the mouse on that item and a simple hint
will display to provide the direct solution for errors. However only one hint displayed on the
screen even though there are more than one errors.

Fig 4.2.2-2

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(2) Input the tests replicate number.
(3) Make sure the control materials are placed in the correct position in the sample disk and click
‘OK’ to confirm the request.
(4) Click ‘Start’ to run the QC program.

4.2.3 QC results

QC results are displayed in the following

 Real-time
On this page, the online QC results could be monitored on an L-J chart for the individual
parameter. The history results will not be displayed on this page.
 Daily QC
On a selected date, all the QC results for a single parameter can be displayed in table or L-J
graph forms.

Fig 4.2.3-1 Daily QC review

 Day to Day QC
Within a selected duration, the QC results for a single parameter can be displayed in table or
L-J graph forms. Only the average value will be shown on graph for each day no matter how
many replicates of the QC program have been done on the same day.
 QC summary
Within a selected duration, all QC results with the same control material can be displayed in
tables. The machine is able to provide the comments on the results if they are out of control.

Fig 4.2.3-2 Comments on QC results

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4.3 ISE module (Optional)

4.3.1 ISE introduction

An Ion Selective Electrode (ISE) measures the individual potential voltage for a specific ion against
the constant potential voltage from a stable reference electrode. The potential difference
between two electrodes depends on the activity of the specific ion in sample.
The BS-120/200/200E ISE module is from Medica (USA) and the overview appearance of the
measuring channel is shown below:

Fig 4.3.1-1 Medica ISE measuring channel

So far, Mindray can only offer with three ion tests: sodium, potassium and chloride, and lithium is
not available currently.
The ISE module should be installed in the mindray manufactured center, any person or company
is not allowed to install the ISE module privately. So when you write down your purchase order,
you need to double confirm that whether the chemistry analyzer is occupied with ISE module.

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In order to activate the ISE module on the software, operator should log in the software with
engineers password and follow the process as shown below:

Fig 4.3.1-2 ‘Maintenance’  ‘Alignment’  ‘Optional’  ‘ISE Module’

4.3.2 ISE reagent

(1) Reagent package

(2) Urine Diluent 125 ml

(3) Cleaning Solution kit

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(4) Tri Level Quality Control Kit

Please read all the reagent insert carefully for the further details.

4.3.3 ISE calibration

The calibration of ISE module is two-point linear method by using reagent A and B respectively.
After the reagents, electrodes and spare parts are well fixed on the machine, operator can carry
out the calibration process as below:
Link: ‘Maintenance’  ‘ISE’  ‘Daily Maint’  ‘Calibration’

Fig 4.3.3-1 ISE calibration request

And the calibration results are listed on the following page:

Link: ‘Calibration’  ‘ISE’  ‘Refresh’

Fig 4.3.3-2 ISE calibration results

The calibration is passed if the slope is within certain range, the range of all three different
electrodes are shown below:

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Table 4.3.3-1 ISE slope range
Electrode Na+ K+ Cl-

Slope (mV/decade) 52-64 52-64 40-55

Please kindly contact the local engineers if the calibration process is always failed.
Cautions: link: ‘Setup’  ‘System’  ‘ISE’

Fig 4.3.3-3 ISE auto-calibration setup

(1) When the electrodes and reagent package have been installed in the ISE module, DO NOT
TURN OFF THE MAIN POWER IN ANY CASE.
(2) The pump calibration should be performed every day, please select ‘Calibrate Pumps When
Started Up’ option.
(3) Two-point calibration should be done every 8 hours when switch on. Please fill in the
interval numbers for the auto-calibration and the recommended number is 8.
(4) If the user is running more than 50 samples each day, both cleaning and two-point linear
calibration should be performed after every 50 sample. Please select ‘Wash After 50 sample
runs’ options for the auto cleaning process.

4.3.4 ISE QC program

(1) Please refer to ‘chapter 3.3.3.1 Control parameter setup’ to enter the assay value and range
from the control insert paper.

Fig 4.3.4-1 Tri level control insert paper

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Fig 4.3.4-2 ISE control setup

(2) Please refer to ‘Chapter 3.3.3.2 QC rules setup’ to determine the QC rules

Fig 4.3.4-3 ISE QC rules setup

(3) Please refer to ‘Chapter 4.2.2 QC request’ to apply the ISE QC tests.

Please contact the local agent or mindray application specialist for any further information.

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4.3.5 ISE Maintenance schedule and reagent consumption

Table 4.3.5-1 ISE maintenance schedule and reagent consumption

The ISE module need to be maintained strictly as shown above.

Cleaning Caution:
 ONLY use Medica Cleaning Solution to run ISE cleaning about every 50 ISE samples. Do not
use any other solution, such as DI water, CD80 solution and etc.
 Cleaning Cycle need to be run at the end of the day to give the electrodes extra time to
stabilize.
 After adding the cleaning diluent into the cleanser powder, mix well before use. Store them
at 2~8℃ when not in use and discard after 4 weeks.
 Right after cleaning, MUST run calibration first before any other actions.
Standby Caution:
 The ISE module goes into standby mode after 30 minutes since the latest ISE test. During
standby mode, Cal A and Cal B are purged into the ISE module every 30 mins to activate the
electrodes. So DO NOT TURN OFF THE MAIN POWER when ISE components are installed.

Spare parts replacement schedule

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5. Analyze daily patient samples

5.1 Normal routine sample request

Fig 5.1-1 single sample request page

(1) Enter the sample number and position number, the patient name and barcode number are
optional to input.
(2) Select the test items for the single sample.
(3) Click ‘Start’ to run the tests.
Please make sure the correct sample is placed in the position as entered.

5.2 Emergency samples

The process is very similar to 5.1 normal sample request part, but the STAT option must be
selected. The software will give those emergency samples the highest priority in all experiments.

Fig 5.2-1 STAT option

If the STAT samples are required during the tests, please follow the steps below to insert
emergency samples.
Step 1: When the instrument is in the experiment process, click ‘probe stop’ button on the left

column to pause. (this button can only be selectable during the experiment)
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Step 2: Read the information on the pumped window carefully and click ‘OK’ to continue.

Fig 5.2-2 Probe stop confirming window

Step 3: Wait until the pumped window below disappeared.

Fig 5.2-3 pausing window

Step 4: When the instrument is ready, quickly request the STAT tests and insert the sample tube
in the correct position. Please make sure the whole process is as quick as possible. Too long
pausing duration might cause some problem on the current running tests.
Step 5: click ‘Resume’ button to return to running status and confirm to continue the experiment.

Fig 5.2-4 Resume window

5.3 Sample request in batch

Fig 5.3-1 request in batch

The process is similar to the single request, and the operator should only request the multiple
samples in this method under the conditions below:
(a) All the samples are placed continuously in the sample disk without any interruption in the

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middle. For example, in the picture above, there are 6 samples with the initial position 5 and
finished at position 11. The samples should be placed in the correct order from 6 to 11.
(b) All the samples should share the same test panel. And there test items should be exactly the
same.
(c) The patient information cannot be input directly but should be edited individually after
request.

5.4 Other functions

5.4.1 Sample dilution

5.4.1.1 Why sample dilution

Question: Why do we need to perform the sample dilution function?

To answer this question, firstly the operator should understand what the meaning of reagent
linearity range is.
In the photometric analysis, the reagent is capable to lead a certain accurate and stable results
range within which the final tests results should be strictly proportional to the substrate
concentration.

For example, Mindray ALT reagent insert paper clearly declare that the linearity range of this
reagent is 4-1000 U/L, which means when the real substrate concentration is within 4-1000 U/L,
mindray can offer the end user a guaranteed and accurate results.
However, if the sample substrate is exceeded this declared range, the results are not making any
sense and cannot be printed in the final patient reports.

Fig 5.4.1.1-1 ALT linearity range statement

The most common method to avoid the linearity problem for those high concentration samples is
to dilute with certain ratio and finally multiply back with the ratio number in the final results.

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5.4.1.2 Sample dilution on BS series

Fig 5.4.1.2-1 Sample dilution setup

There are three options on the drop-down list:
(1) None: the sample will not be diluted before analyzed
(2) Auto: the analyzer automatically mixes specified amount of deionized water and sample in
an extra clean cuvette and aspirates the diluted sample for the further reaction.
(3) Manual: the operator should dilute the sample outside of machine manually and then
placed the diluted sample into the sample disk for the further reaction. The software will
calculated automatically to show the original sample results.
And there are two numbers:
(1) Number 30: this blank refers the amount of the original undiluted sample. The input range
for this number is 3 ~ 45
(2) Number 10: this blank refers the ratio at which the sample will be diluted.
Caution:
The original sample is aspirated by sample probe and the amount should be within the measuring
range. The diluent is aspirated by reagent probe (which is same as sample probe but different
dispensing range) and also need to be within the measuring range. Please kindly check the
following table:
Table 5.4.1.2-1 Sample and reagent measuring range
Original sample
/uL Diluent amount Mixture amount
amount
BS-120 3 ~ 45 180 ~ 450 180 ~ 500
BS-200 3 ~ 45 180 ~ 450 180 ~ 500
BS-200E 2 ~ 45 150 ~ 350 150 ~ 500
For more information, please carefully read the operation manual or contact Mindray application
specialist for the further details.

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6. Shut down the machine

6.1 Exit the operation software

When the daily operation and tests are all finished, please follow the steps below to switch off
the instrument. (If there is any unfinished test, the request will be invalided after exit software)

(1) Click ‘Exit’ button on the left column.

(2) Make sure the detergent is placed on the proper position on the reagent disk.

Fig 6.1-1
(3) Replace the used cuvettes with the clean one. This step is optional. Please click ‘OK’ to
replace the cuvettes or click ‘Next’ to skip this step and exit software directly.

Fig 6.1-2

6.2 Switch off the machine

Please kindly turn off the switch on the left or right hand side of machine and turn the main
power on to keep the refrigerator working all the time. If the electricity supplement cannot be
guaranteed in the continuous and stable manner, please make sure the reagents are placed in the
commercial refrigerator in advance.
Please make sure the front cover on the top should be always closed to avoid any dust or other
contaminators.
Please avoid any contact with the reaction liquid when change the cuvettes or empty the waste
tank, and those liquid might contain the harmful virus or bacteria inside and should be labelled as
biohazard material if necessary.
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Please immediately rinse the contacted skin if get any spillage of liquids from cuvettes or waste
tank, and then go to doctors’ for the further treatment if necessary.

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7. Easy maintenance

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For the further information, please kindly contact the service engineers team.
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