MICROPOINT qLabs ElectroMeter User manual

A
qLabs®ElectroMeter
User’s Manual
For Health Care Professional Use Only
REF Q-3 Plus

1
Table of Contents
1 Introduction..................................................................................................... 4
1.1 Before You Start ...................................................................................... 4
1.2 Intended Use............................................................................................ 4
1.3 Test Principle ........................................................................................... 4
1.4 Packaging ................................................................................................ 4
2 Product Overview ........................................................................................... 5
3 Operation Summary........................................................................................ 7
4 Before Testing ................................................................................................. 7
5 Precautions, Limitations and Warnings........................................................... 8
5.1 Care of Your qLabs®ElectroMeter.......................................................... 8
5.2 Patient Health Status ............................................................................... 8
5.3 Performing a Test..................................................................................... 9
5.4 Collecting a Fingerstick Blood Sample................................................... 9
5.5 Collect fresh venous whole blood samples ........................................... 10
5.6 Electromagnetic Compatibility.............................................................. 10
6 Power On/Off.................................................................................................11
6.1 Power On............................................................................................... 11
6.2 Power Off .............................................................................................. 12
7 Settings.......................................................................................................... 13
7.1 Enter Settings Screen............................................................................. 13
7.2 Language ............................................................................................... 13
7.3 Bluetooth ............................................................................................... 14
7.4 Test Parameter ....................................................................................... 16
7.4.2 Codechip......................................................................... 16
7.4.3 Reference Range............................................................. 18
7.4.4 INR Precision.................................................................. 19
7.5 System Parameter .................................................................................. 20
7.5.2 Beeper............................................................................. 21
7.5.3 Screen Rotation .............................................................. 22
7.5.5 Sleep Setting ................................................................... 22
7.5.6 Print and Upload............................................................. 23

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7.5.7 Transport Mode............................................................... 23
7.6 About the Device................................................................................... 24
7.7 Operator ID............................................................................................ 24
8 Sample Test ................................................................................................... 26
8.1 Input Sample No.................................................................................... 26
8.2 Insert a Test Strip................................................................................... 26
8.3 Input Test Strip Information .................................................................. 27
8.4 Install Codechip..................................................................................... 28
8.5 Heating .................................................................................................. 29
8.6 Add Sample ........................................................................................... 29
8.6.2 Collect fresh venous whole blood samples ........................................ 31
8.7 Perform a Test........................................................................................ 31
8.8 Test Results............................................................................................ 32
9 Quality Control ............................................................................................. 34
9.1 Insert a Test Strip................................................................................... 34
9.2 Input Test Strip Information .................................................................. 35
9.3 Install Test Strip Codechip .................................................................... 35
9.4 Input QC Information............................................................................ 36
9.5 Install QC Liquid Codechip .................................................................. 36
9.6 Heating .................................................................................................. 37
9.7 Add Sample ........................................................................................... 38
9.8 QC Test.................................................................................................. 38
9.9 QC Test Results ..................................................................................... 39
10 Results......................................................................................................... 41
10.1 Result Channel .................................................................................... 41
10.2 Test Result ........................................................................................... 42
10.3 QC Results........................................................................................... 43
11 Maintenance ................................................................................................ 44
11.1 Care and Cleaning of Your qLabs® ElectroMeter.............................. 44
11.2 Precautions for Lithium-ion Battery................................................... 46
11.3 Servicing.............................................................................................. 46
12 Troubleshooting .......................................................................................... 47
13 Symbols....................................................................................................... 50

3
14 Operating Condition and Product Specifications........................................ 51
14.1 Operating Condition ............................................................................ 51
14.2 Product Specifications ........................................................................ 51
15 Special storage conditions and methods ..................................................... 52
16 Warranty...................................................................................................... 52

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1 Introduction
1.1 Before You Start
Before using the qLabs®ElectroMeter to test Prothrombin Time (PT) ,
International Normalized Ratio (INR) and Activated Partial Thromboplastin
Time (APTT), read the entire User’s Manual carefully.
1.2 Intended Use
The qLabs®monitoring system is used for quantitative measurement of
Prothrombin Time in fresh, fresh capillary whole blood or fresh venous
whole blood samples. The qLabs®monitoring system is intended for in
vitro diagnostics and is not intended to be used for screening purposes.
1.3 Test Principle
The qLabs®ElectroMeter automatically detects the insertion of a qLabs®
test strip and heats the strip to a preset operating temperature. When a
drop of blood is added to the sample well of the strip, the blood ows
through the test channels to two reaction zones: a Test Zone and a
Control Zone. In these zones the blood reacts with pre-printed reagents
and begins to coagulate. Each reaction zone contains a pair of electrodes
to which a constant voltage is applied by the qLabs®ElectroMeter. As the
coagulation of the blood proceeds, the current monitored across the two
electrodes changes. The qLabs®ElectroMeter detects the change of the
current in the test zone and determines the PT and/or APTT results. The
qLabs®ElectroMeter and test strips provide APTT, PT and INR results.
1.4 Packaging
The qLabs®ElectroMeter is packed individually.
Upon receiving the package, please open and remove the packaging
materials. Place the qLabs®ElectroMeter on a at surface and connect
the power adapter.
Do not keep the qLabs®ElectroMeter in direct sunlight, near a high heat
source, or near an area with a strong magnetic eld.
2 Product Overview

5
Front View
1.Test Strip Guide
2.Touch Screen
Back View
3.Footpad
4.Battery Cover
5.Magnetic Charging Port

6
Left View
6.Power Button
Right View
7. Codechip Slot
Top View
8.Data Port
9.Power Supply Jack

7
3 Operation Summary
4 Before Testing
Before using the qLabs®monitoring system to do a test, you will need:
• qLabs®Test Strips
• Power supply
• Puncture proof container
Testing ngerstick blood sample:
• Alcohol Pads and Gauze
• Lancet Device
Testing Fresh venous whole blood sample:
21-gauge needle or larger with 1.0 mL syringe
• Sterile alcohol
• Disposable glove
• Sterile adhesive bandage

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5 Precautions, Limitations and Warnings
The qLabs®monitoring system is intended for in vitro
diagnostics use only. Before using this system to
test, take special note of CAUTIONS throughout this
User’s Manual.
5.1 Care of Your qLabs®ElectroMeter
• The qLabs®ElectroMeter is a delicate instrument and should be
handled with care. Dropping or other mishandling may cause
malfunction of the qLabs®ElectroMeter.
• The qLabs®ElectroMeter should be transported in a carrying case
or a secure container.
• DO NOT spill any liquid on the qLabs®ElectroMeter. If this should
occur, immediately contact your local distributor from Micropoint
Biotechnologies Co., Ltd.
• DO NOT store the qLabs®ElectroMeter below -10 ºC or above
40 ºC.
• DO NOT use the qLabs®ElectroMeter for any other types of test
strips not provided by Micropoint Biotechnologies Co., Ltd.
• This instrument should be used in an environment free from high-
frequency vibrations.
• When connecting the power supply of the instrument or any other
external power, care should be taken to avoid electric shock.
• When the instrument is turned on for the rst time, the battery must
be fully charged.
• Make sure the instrument is fully charged before testing, or the
system will indicate that the battery is running low.
Do not perform other operation during the test.
• Do not disassemble the instrument.
5.2 Patient Health Status
Current patient health status may cause inaccurate or unexpected test
results. It is important to take certain health factors into consideration
when interpreting the test results and deciding on a course of action for
your patients. Failure to do so may lead to an incorrect interpretation of
the test result.

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5.3 Performing a Test
• The qLabs®ElectroMeter should be operated on a level surface that
is free of vibration. Testing on an uneven or unstable surface may
cause inaccurate results. DO NOT hold the qLabs®ElectroMeter in
your hands during the testing.
• Strictly follow the test procedure specied in the manual to perform
the test.
• DO NOT move or touch the qLabs®ElectroMeter during testing.
• Do not use expired or damaged test strips.
• The blood sample must be applied to the test strip immediately
after collection. Otherwise, the blood sample may begin clotting,
causing inaccurate results.
• Plasma samples or whole blood samples with anticoagulation
reagents are not suitable for the qLabs®test.
• Do not add the sample until the system prompts you to start
adding sample.
• The sample should be added in one continuous operation, do not
reapply additional sample.
• Do not use the instrument for unintended purposes, which may
cause unexpected test results.
• Use the correct sample to perform the test, failure to do so may
cause inaccurate result.
• This instrument should be operated by professional medical
personnel.
• Do not use the test results to diagnose unintended conditions.
• Do not use the test results for unstated clinical purposes.
5.4 Collecting a Fingerstick Blood Sample
• Sanitize the site of the ngerstick with alcohol wipe before testing.
• Use a fresh capillary ngerstick blood sample for testing.
• Squeezing the ngerstick site excessively (milking) may release
interstitial uid into the blood sample, which may lead to inaccurate
results.
• The site of the ngerstick must be completely dry. If any alcohol
remains on the nger, it may cause hemolysis, which may lead to
inaccurate results.

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5.5 Collect fresh venous whole blood samples
• Use a syringe at least 1 ml to puncture a vein to collect fresh
venous whole blood.
• Avoid repeated use of the same syringe for puncture acquisition.
• Do not use syringe with anti-coagulants (e.g., EDTA, citrate,
uoride, oxalate, or heparin) to collect the blood sample.
• Discard the rst four drops of blood collected. Then immediately
apply one drop of blood (at least 10 μL) directly onto the strip for
testing.
• Begin collecting fresh venous whole blood by syringe to start
testing within 30 seconds.
• When collecting samples always observe the general precautions
and guidelines relating to blood sampling.
• Dispose of all test strips used for patient testing in accordance with
the disposal policy of your laboratory or practice.
5.6 Electromagnetic Compatibility
• This equipment has been tested and found to comply with
applicable EMC emission requirements as specied in EN 61326-1:
2013 and EN 61326-2-6: 2013, immunity to electrostatic discharge
as specied in IEC 61000-4-2, and immunity to radio-frequency
interference at the frequency range and test levels specied in IEC
61000-4-3. The emissions of the energy used are low and not likely
to cause interference in nearby electronic equipment.
• Do not use this instrument in a dry environment, especially if
synthetic materials are present. Synthetic clothes, carpets, etc.,
may cause damaging static discharges in a dry environment.
This may cause incorrect operation or damage to the device. The
recommended humidity operating range for qLabs®ElectroMeter is
10% to 90%.
• Do not use this instrument near cellular or cordless telephones,
walkie talkies, garage door openers, radio transmitters, or other
electronic equipment that are sources of electromagnetic radiation,
as these may interfere with the proper operation of the instrument.

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6 Power On/Off
6.1 Power On
When the instrument is turned on for the first time, the battery must
be fully charged. If the battery is running low, please don’t turn on the
instrument until the power adapter provided with the instrument is inserted
into the power jack and connected to the external power supply. If the
instrument is in sleep mode, just press and hold the Power button for 1
second or insert a test strip to wake it up.
If Operator ID is set to On, the
meter automatically enters Operator
ID menu (see gure 2-1) after it
is turned on. Manually input any
character (or obtain Operator ID by
scanning) and touch “ ” to enter
Main menu.
Once Operator ID is On, the Log
out icon in Main screen will be
enabled and displayed in brown
(see gure 2-2). To switch between
the operators, please return to the
screen for inputting the operator ID
by pressing the Log out icon, and
then re-enter the operator ID.
（2-2）
（2-1）

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IIf Operator ID is Off, the Log out
icon in Main screen will be disabled
and grayed out (see gure 2-3), and
the meter then directly enters the
Main screen after it is turned on.
6.2 Power O
Press and hold the Power button for 1 second to turn it off.
If auto sleep function is enabled, the meter will automatically shut down
after the idle time reaches the sleep waiting time.
When the battery power of the meter is exhausted, it will automatically
shut down.
（2-3）

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7 Settings
7.1 Enter Settings Screen
Click the "Settings" icon from the
main menu screen (Figure 2-2) to
enter the Settings screen (Figure
3-1).
7.2 Language
Click "Language" from the Settings
screen (Figure 3-1) to enter the
screen that prompts the user to
select a language (Figure 3-2). The
user can select different language
by touching the desired one. Click
"" to return to the previous
screen and click " " to return to
the main menu.
（3-1）
（3-2）

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7.3 Bluetooth
Click “Bluetooth” from Settings
menu (see gure3-1) to enter
the Bluetooth menu (see gure
3-3). When the Bluetooth button
is displayed in blue, it means
Bluetooth is turned on; when
the Bluetooth button is grayed
out, it means Bluetooth is turned
off. Once Bluetooth is turned on
and connected successfully, the
Bluetooth icon on the upper right
corner of the menu is highlighted.
However, if Bluetooth is turned on
but fails to connect, the Bluetooth
icon is grayed out. Click " " to
return to the previous screen and
click " " to return to the main
menu.
"Detectable" option pops up
automatically when Bluetooth is
set to On. When "Detectable"
option is displayed in blue, it means
Detectable Mode is opened, and
the meter can be searched by
other Bluetooth devices. However,
the meter cannot search other
Bluetooth devices actively in the
mode. If "Detectable" option is
grayed out, it means Detectable
Mode is closed.
（3-3）
（3-4）

15
When Bluetooth is set to On and
Detectable Mode is closed, the
meter automatically searches for the
connectable base. Touch one of the
bases in the search result list after
completing the search, the screen
then displays “connecting...”, and
the meter displays "connected"
after the connection is completed.
Touch " " to manually search for
the connectable Bluetooth devices.
Touch the connected Bluetooth
device, and the system prompts
whether to disconnect, then touch
OK to disconnect the current
connection.
Bluetooth can be used to connect the meter to eStation II and a
speci c mobile APP. Once connected to eStation II, the test results can
be transferred to eStation II for printing. The test results can also be
transferred to DMS, LIS or HIS system via eStation II. After connecting
with a specic mobile APP, Micropoint cloud can be accessed to upgrade
and maintain the meter’s software when necessary.
When Bluetooth is disconnected or
failed to connect during operation,
the system pops up a box and
prompts the user to reconnect. In
such case, please turn on Bluetooth
again and then reconnect.
（3-6）
（3-5）

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7.4 Test Parameter
Click "Test Parameter" from the
Setting screen (Figure 3-1) to enter
the screen (Figure 3-7) that prompts
the user to set the parameters.
7.4.1 Sample No.
Click "Sample No." from the Test
Parameter screen (Figure 3-7) to
enter the screen (Figure 3-8) that
prompts the user to set the sample
No. If the sample No. button is
grayed out, then the sample does
not need to be numbered. If the
sample No. button is blue, the
sample can be numbered manually
or automatically. Click " " to
return to the previous screen and
click " " to return to the main
menu.
7.4.2 Codechip
Click “Codechip” from Test
Parameter menu (see gure 3-7) to
enter Codechip menu (see gure
3-9). Touch “ ” to search and
view the corresponding Codechip
information displayed based on the
search criteria.Click " " to return
to the previous screen and click
" " to return to the main menu.
（3-9）
（3-7）
（3-8）

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Click “Test Strip” from Codechip
menu (see gure 3-9) to enter
Test Strip menu (see gure 3-10).
The Codechip information of the
installed strip then displayed in this
menu. A new strip Codechip can
also be installed by inserting the
strip Codechip into the Codechip
slot (see the right gure on P6).
Please make sure the side with the
arrow is facing up and the Codechip
is inserted into the end. If the
Codechip has not been installed, the
Codechip is automatically installed
into the meter and displayed in the
list. Click " " to return to the
previous screen and click " " to
return to the main menu.
Click “Control” from Codechip
menu (see gure 3-9) to enter
Control menu (see gure 3-11).
The Codechip information of the
installed control then displayed in
this menu. A new control Codechip
can also be installed by inserting the
control Codechip into the Codechip
slot (see the right gure on P6).
Please make sure the side with the
arrow is facing up and the Codechip
is inserted into the end. If the
Codechip has not been installed, the
Codechip is automatically installed
into the meter and displayed in the
list. Click " " to return to the
previous screen and click " " to
return to the main menu.
In addition to being installed from Codechip menu, a Codechip can also
be installed during the test. When testing with a test strip or control with a
Codechip installed, the installation operation is no longer required during
（3-11）
（3-10）

18
the test; otherwise, the system enter the prompt menu which enables the
user to install the desired Codechip accordingly.
The Codechip provides the meter with important information that it needs
to perform the coagulation test. The chip contains information about the
test strip code, the lot number, and the expiration date. The Codechip is
required, whenever a new test strip lot is used, so that the meter can read
and store the lot information about that particular lot of test strips.
• Do not forget to use the test strip Codechip that is supplied with
each pack of test strips before you perform the rst test with these
strips. We recommend that you leave the Codechip in the meter to
protect the electrical contacts in the meter from becoming dirty.
• Each Codechip belongs to a particular lot of test strips. Only
remove the Codechip when you are testing with test strips taken from
a new pack.
• Protect the Codechip from moisture and equipment that produces
magnetic elds.
7.4.3 Reference Range
Click "Reference Range" from
Test Parameter screen (Figure
3-7) to enter the screen (Figure
3-12) that prompts the user to set
the reference range switch. Grey
button indicates the reference range
function is disabled and blue button
indicates the reference range is
enabled.
（3-12）

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Click any value in the Reference
Range table to automatically enter
the menu which allow the user to
modify the value, and the user can
re-modify the upper and lower limits
(see gure 3-13) within the given
setting range. After the value range
is modied, if the test result is below
the lower limit, " " then displays
in the result menu; if the test result
is above the upper limit, " " then
displays. Touch “ ” to return to
the previous menu.
7.4.4 INR Precision
Click “INR Precision” from Test
Parameter menu (see gure 3-7)
to enter the INR Precision menu
(see gure 3-14). The INR accuracy
displayed can be set as needed.
When 0.1 is selected, the INR value
is displayed as one decimal place.
When 0.01 is selected, the INR
value is displayed as two decimal
places. Click " " to return to the
previous screen and click " " to
return to the main menu.
7.4.5 PT Units
Click “PT Units” from Test
Parameter menu (see gure 3-7) to
enter the PT Units menu (see gure
3-15). The display format of the PT
test result can be set as required.
The available display formats are:
PT/INR/QC, PT/INR, INR, INR/%Q.
After selecting a format, PT test
result is displayed accordingly. Click
"" to return to the previous
screen and click " " to return to
the main menu.
（3-14）
（3-15）
（3-13）