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MulticareIN Users Manual ENG

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USER’S MANUAL

MULTIPARAMETER DIAGNOSTIC
DEVICE
INDEX

4 Introduction
4 The MULTICAREIN system
5 Informations about MULTICAREIN system line
6 The device
7 The display
8 The measurement
8 Insertion of the data-chip
10 How to obtain a drop of blood
11 Application of the blood
11 Procedure to test glucose
12 Procedure to test cholesterol
13 Procedure to test triglycerides
14 Warnings
15 The strips
16 Control solutions
17 Memory functions
18 General settings
18 Changing the settings
20 Setting the acoustic signal
20 Setting the alarms
21 Enabling data transfer to a computer
22 Maintenance and storage conditions
22 Care and maintenance
23 Storage and measuring conditions
24 Error messages
27 Replacing the batteries
28 Warranty
30 Technical features
31 Symbols
INTR ODUCTION

THE MULTICAREIN SYSTEM


Thank you for choosing MULTICAREIN system. MULTICAREIN is a new system, suitable for the
monitoring of glucose, cholesterol and triglycerides in the blood*.

MULTICAREIN
• Amperometric, with MULTICAREIN glucose strips.
• Reflectometric, with MULTICAREIN cholesterol and triglycerides strips.

Self-testing of glucose, cholesterol and triglycerides could be helpful, but any treatment has to be
anyway agreed with the physician.

The system is calibrated for the use of capillary blood; for the use of
*CAUTION venous blood (only possible with cholesterol and triglycerides strips)
contact the Customer Service for the correct calibration.

4
INFORMATIONS ABOUT MULTICAREIN SYSTEM LINE
The MULTICAREIN system line includes:

• MULTICAREIN device
• MULTICAREIN strips
• Autolancet
• MULTICAREIN control solutions
• MULTICAREIN data manager software
• MULTICAREIN mobile app. and cloud (only for bluetooth MULTICAREIN**)

Read carefully the instructions for use of the MULTICAREIN strips that you are using and read the
instructions for use of the autolancet device contained in the MULTICAREIN meter box.
**Bluetooth represents an optional

GLUCOSE TRIGLYCERIDES CHOLESTEROL


STRIP STRIP STRIP

5
THE DEVICE

1. Display: shows test results, error messages and results stored in memory.
FRONT 2. Power button, press this button to:

b. enter the SETTINGS (SET) when the device is on;


c. confirm the SETTINGS.
6
1 3. “+” button, press this button to:
a. enter the MEMORY of the device;
b. recall results stored in the MEMORY of the device;
c. change parameters and values while setting.
4. “-” button, press this button to:
a. enter the MEMORY of the device;
b. recall results stored in the MEMORY of the device;
c. change parameters and values while setting;
d. delete the test results.
4 2 3
5. Test strip slot: insert the test strip here. When the test strip is inserted, the
device will turn on automatically.
6. PC connector:
a. Connector to transfer data from the device to a computer.
7 b. Connection with Biosys device.
5 7. Cover: open this part for cleaning the optical window.

6
8. Battery housing: sliding cover for batteries replacement.
BACK 9. Data-chip slot: insert the data-chip here.
10. Strip ejector: slide it to dispose of the used strip.

8 1 Data-chip symbol.
THE DISPLAY 2 Average results symbol
3 Memory mode symbol
2 3 4
4 Settings mode symbol

1 5 5 Low battery warning

9 6 Result or error messages

6 7 Unit of measurement
8 Test analytes
7
10 9 Temperature symbol
8 9
10 Time
11 Acoustic alarm
10 11 12 12 Date (month, day and year)

7
THE MEASUREMENT

When you switch on the device check always that the date (month, day and year) and time are correctly
set to obtain accurate results (see page 18).

INSERTION OF THE DATA-CHIP

The MULTICAREIN device uses a data-chip which is contained


in the strips box.
It is necessary to change the data-chip in the following situations:
a. When you want to change analyte.
b. Before using a new strips box.
How to insert the data-chip
1. Remove the data-chip from the strips box.
2. Insert the data-chip in the slot placed on the lateral side of the device.
3. Gently press the data-chip up to the complete insertion.

8
4. Press the power button and check if the code
shown on the display matches the one printed on
the label vial of the strips.
5. If the data-chip is not inserted, it is not possible to
perform the measurement.

6. Analytes:

GLC EL CH TGL
= = =
GLUCOSE CHOLESTEROL TRIGLYCERIDES

9
HOW TO OBTAIN A DROP OF BLOOD

To perform a measurement with MULTICAREIN system, it is necessary


to collect a drop of capillary blood according to the following procedure:
1. Wash the hands with soap and hot water to increase the blood flow at
the fingertips to ease the blood collection. Dry well the hands and
check that the finger to be pricked is completely dried. Do not apply
disinfectant or beauty cream before the finger pricking.
2. Prepare the autolancet that is contained inside the MULTICAREIN box meter.
Instruction for USE:

1. Twist and pull off the protective cap.


Discard the protective cap into the waste container.

2. Press the lancet against the sampling site.

3. Dispose of the used lancet into the waste container.

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APPLICATION OF THE BLOOD

Read carefully the instructions for use of the strips that you want to use to perform the measurement.

1. Press the power button after inserting the data-chip. The code of the data-chip
that appears on the display has to match the one printed on the strips vial. If it
doesn’t match please contact the Customer Service.
2. Wash your hands and dry them thoroughly.
3. Take out a strip from the vial and insert it in the device, with the printed or
coloured part facing up. You will hear a click and the device will emit an
acoustic signal (“beep”).

PROCEDURE TO TEST GLUCOSE

3a. Perform the finger pricking with the autolancet.


Apply a drop of blood on the side of the strip that comes out
of the device. Let the strip aspirate the blood until to see the moving
segments on the display and you will hear an acoustic signal (“beep”).
If the blood volume is not enough the measurement does not start.

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PROCEDURE TO TEST CHOLESTEROL

3.b.1. Sit down for one minute with the arm along the body. Massage the finger to
be pricked to increase the blood flow. After inserting the strip, for cholesterol
test, “F” (female) on the left and “M” (male) on the right will appear on the
display. Press the corresponding button “-” or “+” to select the gender. After
about two seconds, “A” (before meal) on the left and “P” (after meal) on the right
will appear on the display. Press the corresponding button “-” or “+” to select
the nutritional state. The selected letter will be shown for two seconds on the
display. After that, the blinking drop will appear on the display, indicating that
the meter is ready to receive the blood. Execute the puncture of the finger by
the autolancet. Remove the first drop with a sterile gauze and gently press the
finger to obtain the second drop. Apply the blood on the white circular area of
the strip coming out from the meter. Wait until moving segments will appear
on the display and until to hear an acoustic signal (“beep”).

12
PROCEDURE TO TEST TRIGLYCERIDES

3.b.2. Sit down for one minute with the arm along the body. Massage the finger to
be pricked to increase the blood flow. After inserting the strip, the code of the
data-chip and the blinking drop will appear on the display, indicating that the
meter is ready to receive the blood. Perform the finger pricking by using the
autolancet. Remove the first drop with a sterile gauze and gently press the
finger to obtain the second drop. Apply the blood on the white circular area
of the strip coming out from the meter. Wait until moving segments will appear
on the display and until to hear an acoustic signal (“beep”).

4. Wait for the result, which will be displayed and stored in the memory of the device
automatically (refer to the instructions for use of the strips that you are using to
know the reading time).
5. Use the ejector on the back side of the device to remove the used strip, pointing
the device down.

13
WARNINGS

If you get results which do not correspond to your feelings, run a check of the MULTICAREIN device and
contact your physician. If you get extreme results, too high (Hi) or too low (Lo), contact your physician
immediately.
IN device. The device will

The last measured value, along with date and time, will be saved in position 1 in the memory of the
device. The values previously measured will be saved in position 2, 3 etc. starting from the most recent.
How to recall from the memory a measured value and how to erase memorized values is described on
page 17.
The used strips and materials have to be properly disposed, avoiding contamination. The device has to be
disposed following the electric and electronic waste law.

In laboratories and hospitals, the procedures of biological safety must be


followed when handling potentially infected material, in particular when

To avoid infections, clean the device regularly and dispose of the used
strips in a way that there is no risk of infections for other people.

14
THE STRIPS

MULTICAREIN STRIPS
The correct use of MULTICAREIN strips is very important to obtain accurate results.
Therefore it is important to keep in mind the following points:
• The strips are sensitive to light and humidity, store them only in their original vial.
• Keep the vial away from direct sunlight. Store it at temperatures between 5-30°C (41-86°F).
• Use the strip immediately after removing from the vial and close the vial immediately with its cap.
• The strips must not be used after the expiry date.
• Write down the date of the first opening on the vial: the strips must be used within 90 days after
the vial has been opened.
• Do not use damaged strips.
• Read carefully the instructions for use contained in the strips box.
• Perform measurements only with original MULTICAREIN strips.
• For using venous blood with cholesterol and triglycerides strips,
please contact the Customer Service.

15
CONTROL SOLUTIONS

MULTICAREIN CONTROL SOLUTIONS

Read carefully the instructions for use of the control solutions that you are using.

It is possible to check the proper working of MULTICAREIN device by using the MULTICAREIN control
solutions. The control solutions can be purchased as a separate accessory through specialized retailers.
The control solution is applied on the strips just like blood. When the test is performed with the control
solutions, the result must fall within the range printed on the strips vial label that you are using. Write
down the date of the first opening on the vial of the control solution. The control solutions must be used
within 90 days from the first opening. Do not use control solutions after the expiration date.
You should perform a control solutions test when:
• Suspecting a possible defect of the MULTICAREIN device.
• Suspecting the possibility of a malfunction or wrong measurement.
The result obtained with the control solutions must be deleted by the memory of the device in order to
not interfere with the average calculation of the results, in particular with the average of the glycemia.

16
MEMORY FUNCTIONS

The MULTICAREIN device stores up to 500 test results for all analytes, letting you review them from the
most recent 1 to the oldest 500.

To recall memory data it is necessary to


insert the data-chip of the analyte you want
to recall the memories.

1. After turning on the device press and release the button “-” or “+”, the device will enter the MEMORY and
the average of the results (AVG) will be displayed.
2. Hold on the button “+” the number 1 will be displayed which refers to the most recent result. When you
release the button, the stored result will be displayed.
3. Pressing again the button “+”, the number 2 will be displayed.
4. Press the button “-” together with the power button for half second to delete a single stored result; after
deleting a single result “deL” will be displayed.
5. Press the button “-” together with the power button for 5 seconds to delete all results stored in
memory; After deleting all results “Clr” will be displayed.

17
GENERAL SET TINGS

CHANGING THE SETTINGS

1. With the device on, press the power button for 3 seconds to enter
the setting (SET).
2. Press and release the “-” or “+” button until reaching the correct
month. Confirm the setting by pressing and releasing the power
button.
3. Press and release the “-” or “+” button until reaching the correct day.
Confirm the setting by pressing and releasing the power button.
4. Press and release the “-” or “+” button to modify the date format
(mm-dd) or (dd-mm). Confirm the wanted format by pressing and
releasing the power button.
5. Press and release the “-” or “+” button to modify the year, until
reaching the correct year. Confirm the setting by pressing and
releasing the power button.
6. Press and release the “-” or “+” button until reaching the correct
hour. Confirm the setting by pressing and releasing the power
button.

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7. Press and release the “-” or “+” button until reaching correct
minutes. Confirm the setting by pressing and releasing the power
button.
8. Press and release the “-” or “+” button to modify the time format
12h or 24h. Confirm the wanted format pressing and releasing the
power button.
9. Press and release the “-” or “+” button to modify the unit of
measurement, mg/dL or mmol/L. Confirm the wanted unit of
measurement by pressing and releasing the power button.
10. Press and release the “-” or “+” button to modify the number
of days you want the average of results (0,7,14,21,28 days - “0”
means that the device will not show any average when recalling
the memories. Confirm the setting by pressing and releasing the
power button.

IMPORTANT
When replacing the batteries, the setting of the device will end with
step 10 described above. Otherwise the setting of the device will
continue with the following steps.
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SETTING THE ACOUSTIC SIGNAL

11. Press and release the “-” or “+” button to enable or disable the
acoustic signal. Confirm the setting by pressing and releasing
the power button.

SETTING THE ALARMS

12. Press and release the “-” or “+” button to select


first the hour and then the minutes of the first
alarm. It is possible to set 4 alarms. The alarms
are not activated if they are all set on12.00am
or 0.00.

20
ENABLING DATA TRANSFER TO A COMPUTER

All test results stored in MULTICAREIN device can be downloaded


to a computer.
1. Install the software according to the manufacturer’s
instructions.
2. Connect the device to a computer by means of the cable.
3. Press and release the power button. The message “PC” will
appear on the display.
4. Set up your computer software to receive information from
the meter. After the data has been transferred, it is possible to
switch OFF the device by pressing the power button and remove
the cable.

If you have a bluetooth MULTICAREIN , you can use a dedicated


application to share and manage the data.

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MAINTENANCE AND STORAGE CONDITIONS

CARE AND MAINTENANCE

For glucose measurement it is not necessary a


particular cleaning procedure, only if blood or other
material (debris, dust, etc..) come into direct contact
with the plastic support of the device. If so, wipe the
device surface with a soft cloth dampened with 70%
alcohol solution.

22
For cholesterol and triglycerides measurement the device uses an optical measuring method, thereby its
components must be kept clean. To clean the optical components, lift the frontal cover and wipe the glass
surface of the optic window with a soft cloth dampened with water. After cleaning, dry the optic of the
device, avoiding scratching.

measurement with a 70% alcohol solution before proceeding with the next measurement.

STORAGE AND MEASURING CONDITIONS


In order to get accurate results the measurement with MULTICAREIN strips has to be performed between
10-40°C (50-104°F). The MULTICAREIN kit (device and strips) must be stored at temperatures between
5°C (41°F) and 30°C (86°F).

WARNINGS
If the device is too cold or too hot for example after being stored in a car at very low or high
temperatures, let it to cool down or to heat up slowly at room temperature for about 20
minutes.
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ERROR MESSAGES

DISPLAY PROBLEMS SOLUTIONS


Place the device in an area with temperature
The measurement was carried out
between 10°-40°C (50°-104°F) and wait until
at a temperature out of the correct
the device reaches the room temperature before
range.
performing the measurement.

The strip is used or the reactive area


Use a new strip to perform the measurement.
is colored.

Insert again the strip; please make sure that the strip
The strip is not inserted correctly.
does not remain lifted up with respect to its support.

The blood was applied on the strip


Take a new strip, insert it in the device, and apply
before waiting for the drop blinking
the blood only after the blinking drop is displayed.
on the display.
Open the plastic cover and clean the optical window
The optical window is dirty.
without using soap or solvents.

The strip has been removed from the


device without applying the drop of Insert again the strip and apply the blood without
blood. removing the strip from the device.

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DISPLAY PROBLEMS SOLUTIONS
Remove the data-chip and use the one
The strip that you are using does
corresponding to the strips that you are using and
not correspond to the analyte of the
check whether the parameter symbol is the right
data-chip.
one.
Remove the wrong data-chip and insert the correct
Wrong data-chip. one making sure that it corresponds to the test that
you are performing.

Remove and insert again the data-chip. If the


Wrong reading of the data-chip or
problem persists contact the MULTICAREIN
data-chip error.
Customer Service.

Repeat the test with a new strip and apply a higher


The blood volume is not enough.
volume of blood.

Insert the data-chip corresponding to the strips that


The data-chip is not inserted.
you want to use.

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DISPLAY PROBLEMS SOLUTIONS
If the result does not correspond to the personal
The result is lower than the lower
sensations repeat the test. If “Lo” symbol appears
limit of reading of that parameter (see
again, contact your physician for additional
also instructions for use of the strips).
informations.

The result is higher than the upper


Contact immediately your physician and repeat the
limit of reading of that parameter (see
test in the hospital.
also instructions for use of the strips).

Result with battery symbol. Batteries are draining; please get new batteries.

Replace the batteries to perform the test


Blinking battery symbol.
(see page 27).

Check the expiry date of the strips and repeat the


Blinking result. test with new strips. The blinking result will not be
stored in the memory.

26
REPLACING THE BAT TERIES

MULTICAREIN device needs two 3V lithium batteries (type CR2032). If the battery icon is blinking, the charge is low
and the batteries must be replaced before taking measurement.

Check whether the new batteries are the right ones.


How to replace batteries:
1. Let the battery housing slide out by pressing on the arrow
printed on the battery compartment.
2. Remove the batteries from the plastic holder.
3. Place the new batteries with the negative side facing up.
Insert the cover of battery compartment and close it.
Dispose of used batteries according to local regulations.

WARNINGS 1 2 3

If batteries are replaced or simply removed for more than 60 seconds, it is necessary to set
time and date again.
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WARRANTY

INFORMATIONS OF WARRANTY CONDITIONS

Biochemical Systems International S.p.A. grants to the customer that the device MULTICAREIN will be
free of material defects and manufacturer handling for 3 years starting from the purchasing date.
During such period Biochemical Systems International S.p.A. should replace the defected device with an
equivalent version or the same model after verifying the defect.
Such warranty is subject to exceptions and limitations as described below. The warranty is limited to the
replacement due to defects in some parts handling. Devices that present defects due to damages caused
from improper use, alteration, negligence, technical assistance performed by not authorized personnel,
IN will not be replaced.

Biochemical Systems International S.p.A. reserves the right to apply technical modifications to the
device MULTICAREIN without the obligation to insert such specifications to those products already
introduced in the market.
Any other warranty will be guaranteed for this product unless the replacement option described above.
Every responsibility for special, indirect or consequential damages is excluded.

In order to provide you with future information and optimal service, please send us the registration
card situated on the next page, duly completed at Biochemical Systems International.
It is possible to register your device on the web: www.biosys.it, or throughs e-mail: info@biosys.it

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WARRANTY CARD

Name: .................................................................... Surname: ..............................................................................


Address: ...................................................................................................................................................................
City: .................................................................. Zip code: ....................................................................................
Telephone: .......................................................... E-mail: .....................................................................................
Serial No. (Meter back): .......................................................................................................................................
Date of purchase: ..................................................................................................................................................
In accordance with D.L.gs.196 / 2003 on the protection of personal data, Biochemical Systems
International S.p.A. would like to inform you that all the information you want to provide us will be treated
in order to send you the requested material and processed electronically with the adoption of appropriate
measures to guarantee safety.
AGREE NOT AGREE

Date .................................................................... Signature .................................................................................

Ship to: BIOCHEMICAL SYSTEMS INTERNATIONAL S.p.A.


Loc. Palazzo del Pero, 23 - 52100 Arezzo (AR) - ITALY
29
TECHNICAL FEATURES

10-600 mg/dL (0.6-33.3 mmol/L) glucose.


Range of measurement 130-400 mg/dL (3.3-10.2 mmol/L) cholesterol.
50-500 mg/dL (0.56-5.6 mmol/L) triglycerides.
2x3V lithium batteries, type CR2032. The batteries can be used for approx.
Batteries
1 year with 3 measurements per day (approx. 1000 measurements).
Dimensions/Weight 97 mm length; 49 mm width; 20,5 mm height/65gr (including batteries).

Display LCD display.

Temperature limits From 10°C to 40°C (from 50°F to 104°F).

Humidity limits From 0% to 90% relative humidity (non condensing).

Memory capacity 500 measurements with date and time.

Interface for data processing Connecting cable.


CE mark on the device indicates that it complies with the requirements of
Special requirements for electromagnetic
the CE directives 89/336/EEC relating to electromagnetic compatibility and
radiation
73/23/EEC.
Hints for Healthcare Professionals The accuracy of the device should be checked after 3 years.
Waste management disposal when the
Please refer to local updated regulations.
device is unusable

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SYMBOLS

Number of pieces Do not reuse Recyclable Direct current Manufacturer CE mark

Expiry date Date of Lot In-Vitro Serial Catalogue


Read instruction
manufacture for use number Diagnosticum number number

Keep away Store at Caution!


from temperatures Follow
sunlight between ... instructions

Do not dispose the device in the urban waste. Perform a separated collecting specific for electric
and electronic waste. Please refer to local updated regulation.

31
MCIN.MAN.ENG.ED2021JUN

BIOCHEMICAL SYSTEMS INTERNATIONAL S.p.A.

Loc. Palazzo del Pero, 23 - 52100 Arezzo (AR) - Italy


Tel. +39 0575 984164 - Fax +39 0575 984238

www.biosys.it - info@biosys.it

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