MICROPOINT qLabs ElectroMeter Q-3 Pro User manual

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

i
Revision History
Version Revision Date Changes
A1 2020-04 New Release

ii
1 Introduction.....................................................................1
1.1 Before You Start.............................................................1
1.2 Intended Use .................................................................1
1.3 Test Principle..................................................................1
1.4 Packaging......................................................................1
2 Product Overview...........................................................2
3 Operation Summary .......................................................4
4 Before Testing.................................................................4
5 Precautions, Limitations and Warnings .......................5
5.1 Care of Your qLabs®ElectroMeter..................................5
5.2 Patient Health Status .....................................................5
5.3 Performing a Test ...........................................................6
5.4 Collecting a Fingerstick Blood Sample ...........................6
5.5 Collect fresh venous whole blood samples.....................7
5.6 Electromagnetic Compatibility ........................................7
5.7 Warning Information on Built-in Lithium Battery ............8
6 Power On/Off ..................................................................9
6.1 Battery and Charging ...................................................9
6.2 Power On ......................................................................9
6.3 Sleep mode .................................................................10
6.4 Power Off.....................................................................11
7 Settings .........................................................................12
7.1 Enter Settings Screen ..................................................12
7.2 Language.....................................................................12
7.3 WIFI .............................................................................12
7.4 Bluetooth .....................................................................14
Table of Contents

iii
7.5 Test Parameter.............................................................16
7.5.1 Sample No. ........................................................16
7.5.2 Codechip............................................................16
7.5.3 Reference Range................................................ 18
7.5.4 INR Precision......................................................19
7.5.5 PT Units ............................................................. 19
7.5.6 APTT Units .........................................................20
7.6 System Parameter .......................................................20
7.6.1 Date/Time .......................................................... 21
7.6.2 Beeper ............................................................... 21
7.6.3 Screen Rotation ................................................. 22
7.6.4 Brightness Adjustment .......................................22
7.6.5 Sleep Setting......................................................22
7.6.6 Print and Upload ................................................23
7.6.7 Transport Mode .................................................. 23
7.7 About the Device .........................................................24
7.8 Operator ID..................................................................24
8 Sample Test...................................................................27
8.1 Input Sample No..........................................................27
8.2 Insert a Test Strip .........................................................27
8.3 Input Test Strip Information ..........................................28
8.4 Install Codechip ...........................................................28
8.5 Heating ........................................................................29
8.6 Add Sample.................................................................30
8.7 Perform a Test..............................................................32
8.8 Test Results .................................................................33
9 Quality Control..............................................................34
9.1 Insert a Test Strip .........................................................34

iv
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
14 Operating Condition and Product Specications ...51
14.1 Operating Condition...................................................51
14.2 Product Specications ..............................................51
15 Special storage conditions and methods ................52
16 Warranty ......................................................................52

1
1 Introduction
1.1 Before You Start
Before using qLabs®ElectroMeter, read the User’s Manual as well as the
package inserts for all relevant consumables carefully.
1.2 Intended Use
The qLabs®monitoring system, which consists of qLabs®ElectroMeter
and qLabs®Test Strips family, intended for use by healthcare professionals
to perform coagulation tests in a Point of Care environment. The qLabs®
monitoring system uses fresh capillary whole blood or fresh venous whole
blood.
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. After a
drop of blood is applied to the strip, the sample channel automatically
carries the blood sample into the reaction zone through capillary action,
where the blood mixes with pre-printed reagent and starts coagulation
process. As the blood coagulates, conductivity across the test strip
changes. The system measures this electrical change and calculates the
development of a clot. The values are then displayed.
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
2 Product Overview
Front View
1.Test Strip Guide
2.Touch Screen
3
4
5
Back View
3.Footpad
4.Battery Cover with Label
5.Magnetic Charging Port

3
Left View
6.Power Button
Right View
7. Codechip Slot
Top View
8.Data Port
9.Power Supply Jack
6
7
89

4
3 Operation Summary
4 Before Testing
Materials provided
• qLabs®ElectroMeter
• Power supply
• USB disk (Electronic manual, Training video, Data Management
Software)
Materials required (but not provided)
• qLabs®Test Strips
• Puncture-resistant container for medical sharps
Testing ngerstick blood samples
• Alcohol Pads and Gauze
• 23-gauge or larger Lancet Device
Testing fresh venous whole blood samples
• 21-gauge needle or larger with 1.0 mL syringe
• Sterile alcohol
• Disposable glove
• Sterile band aid
Operation
Preparation
Meter Setup
Performing a
Test
Results
Query
Sample
Test
Insert
Test
Strip
Insert
Codechip of
Test Strip
Heating
Add
Sample
Test
Language
Setting
Bluetooth
Switch
Setting
Screen
Rotation
Reference
Range
Setting
Date/Time
Setting
Beeper
Setting
Backlight
Setting
Sleep
Setting
Sample No.
Switch
Setting
Upload/Print
Setting
Codechip
Input Test
Strip
Information
QC Test
Input QC
Liquid
Information
Insert
Codechip of
QC Liquid
Heating
Add
Sample
Insert
Test
Strip
Test
Input Test
Strip
Information
Insert
Codechip of
Test Strip
Review Sample
Test Result
Delete
Result
Upload
Result
Query
Result
Review QC Test
Result
Transport
Mode Operator ID
Print Result
Test
Type
INR
Precision
Setting
PT Units
Setting
APTT Units
Setting
WIFI

5
5 Precautions, Limitations and Warnings
The qLabs®monitoring system is intended for in vitro
diagnostics use only. Before using this system, 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 first 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.
If any serious incident related to the instrument has occurred, please
report it to us and the competent authority of the Member State in which
you are established.

6
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 specified 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 fingerstick with alcohol wipe before testing.
• Use a fresh capillary fingerstick blood sample for testing.
• Squeezing the fingerstick site excessively (milking) may release in-
terstitial fluid into the blood sample, which may lead to inaccurate
results.
• The site of the fingerstick must be completely dry. If any alcohol
remains on the finger, it may cause hemolysis, which may lead to
inaccurate results.

7
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,
fluoride, oxalate, or heparin) to collect the blood sample.
• Discard the first 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 specified 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.

8
5.7 Warning Information on Built-in Lithium Battery
• qLabs meter has a built-in lithium battery, which cannot be
removed by any user.
• The user must use the matching 5V special charger provided by
Micropoint to charge.
• Do not bring the meter close to a high-temperature heat source.
• Do not allow the meter to be hit or exert heavy pressure on the
meter.
• If it is found that there is leakage from the battery cover on the
back of the meter, direct skin contact should be avoided as much
as possible. In case of accidental contact with skin due to battery
leakage, please rinse with water. If your eyes come into contact
with battery liquid, you should also seek medical care.
• The battery should be disposed with the meter in accordance with
local regulations.

9
6 Power On/Off
6.1 Battery and Charging
When turning on the meter for the rst time after unpacking, please
connect the adapter for power supply and turn off the transportation
mode. You do not need to repeat this operation for subsequent reboot.
Ensure the meter is fully charged before using for the rst time.
Approximately 3.5 hours to fully charge.
When the screen displays E001, the adapter should be connected
immediately for charging. If the battery charge display shows only one bar,
it is recommended that the user connect the power adapter to charge as
soon as possible.
When the meter automatically shuts down due to insufcient power, the
user should charge the meter within 7 days. Otherwise the time and date
will require a reset.
The test results and all settings of the meter will be permanently stored in
the memory except the time and date.
6.2 Power On
When the instrument is turned on for the rst time, the battery must be
fully charged. If the battery is low, do not 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 power
off mode, short press the Power button and wait 2 seconds to power on.
If the instrument is in sleep mode, short press the Power button or insert a
test strip and wait 2 seconds 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 Operator
ID and Password (The default
Operator ID is "admin" and all
must be lower case. The default
password is "123456".) and touch
“ ” to enter Main menu.
Please set Operator ID function
according to Section 7.8 of this
manual.
(2-1)

10
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.
If 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.
6.3 Sleep mode
After a short press and release of the Power button, the screen will be
off and enter sleep mode. The sleep mode is a low power mode to save
battery power. Short press the Power button or insert a test strip and wait
2 seconds for device start-up.
If auto sleep function is enabled, the meter will automatically shut down
after the idle time reaches the sleep waiting time.taken to get the meter
fully charged from zero)
(2-2)
(2-3)

11
6.4 Power Off
After a press of the Power button
for 3 seconds, the system will
deliver a message to select. Press
" " to power off the instrument, or
press " " to cancel the operation
(see gure 2-4).
When the battery power of
the meter is exhausted, it will
automatically shut down.
(2-4)

12
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.
7.3 WIFI
WIFI connectivity allows the meter to connect with Data Management
System (DMS) or other software system without connecting to eStation II.
This function can be used for data transmission.
(3-1)
(3-2)

13
Click “WIFI” from Settings menu (see
Figure 3-1) to enter the WIFI menu
(see Figure 3-3). When the WIF
button is displayed in blue, it means
WIFI is turned on; when the WIFI
button is grayed out, it means WIFI
is turned off. Once WIFI is turned
on and connected successfully, the
WIFI icon on the upper right corner
of the menu is highlighted.
However, if WIFI is turned on but
fails to connect, the WIFI icon is
grayed out. Click “ ” to return to
the previous screen and click “ ”
to return to the main menu.
The system will search nearby
hotspot list automatically. Click the
hotspot name to enter the pass-
word to connect successfully. The
system will remember the password
and connect to the last connected
hotspot automatically.
The server is used for wireless data
transmission with the specic Data
Management System. Click “Server”
to enter the server IP address and
port number, and click “ ” to
save. Please set the instrument’s
IP address and port number to be
consistent with DMS.
(3-3)
(3-4)
(3-5)

14
The loss of signal or access to bandwidth of one particular client may vary
depending on one or more of the following situations: the type and num-
ber of other clients, the performance of the Access Point, the presence of
electromagnetic disturbances, and other potential interfering factors, e.g.,
concrete walls.
7.4 Bluetooth
Click “Bluetooth” from Settings
menu (see Figure 3-1) to enter
the Bluetooth menu (see gure
3-6). 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.
"Discoverable" option pops up
automatically when Bluetooth is
set to On. When "Discoverable"
option is displayed in blue, it means
Discoverable 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 "Discoverable" option is
grayed out, it means Discoverable
Mode is closed.
(3-6)
(3-7)

15
When Bluetooth is set to On and
Discoverable 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.
(3-8)
(3-9)