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.