MICROPOINT QLABS VET User Manual

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REF QV-1

Vet

Table of Contents

1. Introduction....................................................................................3

1.1 Before You Start

1.2 Intended Use

1.3 Test Principle

1.4 Packaging

2. Accessory List...............................................................................5

3. Product Overview..........................................................................5

4. Operation Summary......................................................................7

5. Before Testing................................................................................7

6. Precautions, Limitations and Warnings.......................................8

6.1 Care of Your qLabs® Vet

6.2 Patient Health Status

6.3 Performing a Test

6.4 Collecting Blood Sample

6.5 Electromagnetic Compatibility

7. Powering the qLabs® Vet ON and OFF........................................9

7.1 Power Connection

7.2 Powering the qLabs® Vet On

7.3 Powering the qLabs® Vet Off

8. qLabs® Vet Settings.....................................................................11

8.1 Enter Setup Mode

8.2 Setting the Date

8.3 Setting the Time

8.4 Setting the Normal Range

8.5 Patient ID Setup

8.6 Lot Number Setup

8.7 Selecting Language

9. Perform a Test.............................................................................14

9.1 Entering Test mode

9.2 Insert a Test Strip

9.3 Entering the Patient ID

9.4 Conrming the Patient ID

9.5 Selecting the Species

9.6 Entering the Strip Code and Lot Number (if enabled)

9.7 After Conrming the Code

9.8 Heating Up

9.9 Getting a Finger stick Sample

9.10 Performing the Test

9.11 Results and Explanation

9.12 Finishing the Test

10. Reviewing Previous Results.......................................................21

10.1 Displaying QC Test Results

10.2 Displaying Patient Test Results

11. Quality Control..............................................................................25

11.1 Onboard QC Tes

11.2 Liquid QC Test

12. Maintenance.................................................................................25

12.1 Care and Cleaning of Your Screen

12.2 Installing/Replacing Batteries

12.3 Maintenance

13. Troubleshooting...........................................................................27

14. Symbols........................................................................................29

15. Performance Characteristics & Product Specications.........30

15.1 Operation Condition

15.2 Product Specications

16. Warranty........................................................................................31

17. Contact Address and Phone Number........................................33

1. Introduction

1.1 Before You Start

Before using qLabs® Vet, read the User’s Manual carefully.

1.2 Intended Use

The qLabs® Vet is intended for use with qLabs® Vet test strips for in vitro quantication measurement of a patient’s PT and APTT.

The qLabs® Vet is for veterinary use only. The qLabs® Vet is validated for use with canine and feline samples only.

1.3 Test Principle

qLabs® Vet 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 capillary channels carry the blood to the reaction zones, where the blood mixes with pre-printed reagents and starts to coagulate. Each strip contains two reaction zones. Each reaction zone contains a pair of metallic electrodes, to which a constant voltage is applied by the qLabs® Vet. As the coagulation of the blood proceeds, the current monitored across the two electrodes changes. The qLabs® Vet detects the change of the current in the test zone and determines the PT and/or APTT results. The qLabs® Vet and test strips provide APTT, PT results.

1.4 Packaging

The qLabs® Vet was packed individually.

Upon receipt of package, please open and remove the packaging materials. Place the qLabs® Vet on a at surface and connect the power adapter.

Do not keep the qLabs® Vet in direct sunlight, near a high heat source, or near an area with a strong magnetic eld.

2. Accessory List

qLabs® Vet includes the following accessories:

• Power Adapter

• User’s Manual

• Quick Start Guide

• Data Manager Installation DVD

• Data Manager Operation Guide

• eCable

NOTES:

• To avoid the possibility of damage, use only the power adapter

supplied with the qLabs

• Standard AA batteries can also be used for qLabs

• The qLabs

eStation can be purchased separately from Micropoint Biotechnologies, Inc. Please contact your local distributor for ordering information.

Vet.

3. Product Overview

Identication of Components

Front View

1) LCD Screen

2) Returning/Power Button

3) Right Button

4) Left Button

5) OK Button

6) Test Strip Guide

Back View

1) Battery Cover

2) Battery Cover Screw

3) Battery Cover Release

Top View

1) Power Supply Jack

2) Data Port

Bottom View

1) Barcode Scanner (Laser)

qLabs® Vet Test Strip

1) Electrode Leads

2) Test Zone

3) Sample Well

4) Test Name

4. Operation Summary

Operation

Preparation

Date Setting

Meter Setup

Power ON Time Setting

Performing a Test

Enter Patient ID and or Strip Lot Number

Reviewing Previous

Results

Review QC Data Review Patient Data

Normal Range

Setting

Select Species

Patient ID

Collect Sample

Lot Number

Language

Test Sample

Upload Data Print DataDelete Data

5. Before Testing

Before using qLabs® Vet to do a test, you will need:

• qLabs

• Power supply or batteries

If you are testing fresh venous blood samples, you will also need:

• 21-gauge needle or larger with 1.0 mL syringe

• Sterile alcohol

• Disposable glove

• Puncture-resistant container for medical sharps

• Sterile band aid

• Bio-hazardous container

Or if you are testing citrated whole blood samples, you will also need:

• Eppendorf tube rack

Vet test strip

• 200 uL pipette and pipette tips

• Disposable glove

• Sterile alcohol

• Disposable venous blood lanet

• 1.8 or 2.7 mL 3.2% (w/v) sodium citrate venous collection tube

• Bio-hazardous container

6. Precautions, Limitations and Warnings

qLabs® Vet is used only for animals in vitro diagnostics. Before using this system, take special note of CAUTIONS throughout this User’s Manual.

As with all diagnostic tests, qLabs be scrutinized in light of a specic patient’s condition and anticoagulant therapy. Any results exhibiting inconsistency with the patient’s clinical status should be repeated or supplemented with additional test data or repeated with other testing methods.

Vet’s test results should

6.1 Care of Your qLabs

• The qLabs

Vet is a delicate instrument and should be handled

Vet

with care. Dropping or other mishandling may cause malfunction of qLabs® Vet.

• The qLabs

Vet should be transported in a carrying case or a

secure container.

• DO NOT spill any liquid on the qLabs

Vet. If it happens, immediately contact local distributor from Micropoint Biotechnologies, Inc.

• DO NOT store the qLabs

• DO NOT use the qLabs

Vet below -10 ºC or above 40 ºC.

Vet for any other types of test strips not

provided by Micropoint Biotechnologies, Inc.

6.2 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.

6.3 Performing a Test

• The qLabs

Vet 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

Vet in your hands

during the testing.

• The blood sample must be applied to the test strip immediately

after collection. Otherwise, the blood sample may begin clotting, causing inaccurate results.

• DO NOT move or touch the qLabs

Vet during testing.

DO NOT switch power supplier from adapter to battery or

vice versa during testing!

6.4 Collecting Blood Sample

• Use only fresh non anti-coagulated whole blood and citrated whole

blood. Do not use plasma.

• The drop of blood must be a minimum of 10 μL.

• Hematocrit ranges between 30% and 55% will not affect test

results.

6.5 Electromagnetic Compatibility

• This equipment has been tested and found to comply with

applicable EMC emission requirements as specied in EN 61326-1: 2006 and EN 61326-2-6: 2006, 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 damage static discharges in a dry environment. That may cause incorrect operation or damage to the device. The

recommended humidity operating range is 10% to 90%.

• Do not use this instrument near cellular or cordless telephones,

walkie talkies, garage door openers, radio transmitters, or other electrical or electronic equipment that are sources of electromagnetic radiation, as these may interfere with the proper operation of the instrument.

DD/MM/YY HH:MM

01/02/12

12:00

SET MEM

OFF VER

7. Powering the qLabs® Vet ON and OFF

7.1 Power Connection

The qLabs® Vet comes with a power supply which must be plugged into

the qLabs standard AA batteries (See Section 12.2).

Vet power supply jack. Alternatively, the qLabs® Vet can use 4

bottom of the screen provide hints for the functions of the buttons.

7.2 Powering the qLabs® Vet On

The messages on the four-cell grid displayed at the

When the qLabs® Vet is initially powered on, it will beep and automatically enter Setup mode. In the Setup mode you can change the qLabs® Vet settings, or

Press the “OK” button to view the prompt to insert a test strip.

When qLabs on the monitor:

Turning the qLabs

1) Press and hold the “Power” button for 2 seconds to turn on the qLabs

2) Insert a fresh test strip if you are ready to perform a test. The qLabs

• Perform a test, or

• Check the version of the software and the manufacturer information

by pressing “VER” button, or

Vet is in the standby mode, you have two choices to power

Vet, or

Vet will then prompt you to conrm the strip code.

Vet ON in CHOICE 1, allows the user to:

V8.0.02

MICROPOINT

S/N

023300E1200001

• Enter Setup mode by pressing “SET” button to change the Vet

SET MEM

OFF VER

SHUT DOWN

BACK

OFF

setting, or

• Enter Memo mode by pressing “MEM” button to review previous

results.

Turning the qLabs

• Perform a test.

Vet ON in CHOICE 2, allows the user to:

ENENEN

complete information for all of these options.

7.3 Powering the qLabs® Vet Off

In the interface where the monitor prompts

See the appropriate sections of this User’s Manual for

you to insert a test strip, press the functional “OFF” button to enter the shut down mode.

In shut down mode, the user can:

• Press the functional “OFF” button to

turn off and enter standby mode, or

• Press functional “BACK” button to

return to the previous interface.

NOTES:

• Manually turn off the qLabs

batteries.

• If the qLabs

automatically and enter standby mode.

Vet is left idle for about 5 minutes, it will turn off

Vet if not in use to conserve the

8. qLabs® Vet Settings

DD/MM/YY HH:MM

01/02/12

12:00

SET MEM

OFF VER

DD/MM/YY HH:MM

01/02/12

12:00

DD/MM/YY HH:MM

01/02/12

12:00

Follow the steps below to set up the qLabs® Vet.

8.1 Enter Setup Mode

When the qLabs® Vet is turned on for the rst

time, it will automatically enter to the Setup Mode.

When the qLabs® Vet is powered on from standby mode, a prompt to insert a test strip will appear. Press the functional “SET” button to enter the Setup Mode.

8.2 Setting the date

The date format is DD/MM/YY. The rst set of digit (YY) will be highlighted. Use the functional “+” and “-”buttons to change the date.

Press functional “NEXT” button to go to the second digit (MM) after a correct date is selected. Change the month and the date using the same method.

8.3 Setting the Time

DD/MM/YY HH:MM

01/02/12

12:00

- +

DD/MM/YY HH:MM

01/02/12

12:00

NORMAL RANGE

CANINE

PT APTT

LO HI

NORMAL RANGE

CANINE PT APTT

LO HI

The time is in 24-hour format: “HH:MM” (Hour: Minute)

After the day setting, the setting option will prompt you to the hour setting mode. The hour will be highlighted on the display. Use “+” and “-” functional buttons to adjust the hour. Press “NEXT” functional button when you have the correct hour on the display.

The minute will be highlighted on the display. Use “+” and “-” buttons to change the minute. Press “NEXT” button when you have the correct minute on the display.

8.4 Normal Range Setup

An target range of PT and APTT for each supported aminal species may be set to alert the user when the results are out of range.

First, use “+” or “-” buttons to select the species.

Press”NEXT” to accept. The next settable item will be highlighted

Then, use “+” or “-” buttons to set the low and high limit of PT and APTT for the selected species. Press “NEXT” to accept current setting and go to the next item.

8.5 Patient ID Setup

PATIENT ID

LOT NUMBER

LANGUAGE

√ ENGLISH FRANçAIS DEUTSCH

ITALIANO

8.6 Lot Number Setup

You can use “+” or “-” buttons to set the

input of Patient ID ON or OFF. If you set the Patient ID ON, the meter will prompt you to input the Patient ID before you process a patient test. Press “Next” button to enter the QC Lockout Setup interface. Press “OK” button to return to main menu.

You can press the functional “+” and “-” buttons to enable or disable the LOT NUMBER input function. If the LOT NUMBER input function is enabled, you will be asked to enter the Lot Number before performing each test. The Lot Number contains the expiration date of the strip or liquid control. The meter will check whether the strip is expired. If it is expired, the meter will report an error.

NOTE: Please make sure the date setting is correct if you want to use the input function of LOT NUMBER.

8.7 Selecting Language

You can use right button “ ” or left button “ ” to select desired language and then press “OK” button to return to main menu.

NOTE:

• The language option may be different, depending on the software

conguration.

9. Perform a Test

SET MEM

OFF VER

PATIENT ID

9.1 Entering Test Mode

When the qLabs® Vet is turned on by pressing the “OK” button, the display screen will prompt the user to insert a test strip. Go to Section 9.2 for test strip insertion.

When the qLabs® Vet is turned on by inserting a new test strip, the display screen will prompt the user to enter patient ID or enter the strip code if patient ID function is turned off.

9.2 Insert a Test Strip

Remove a fresh test strip from its foil pouch. Insert the strip into the test strip guide.

The following two observations indicate that you inserted the strip correctly:

1) The electrode leads go in rst.

2) You can read test strip name clearly on the end of strip, left to right.

If the input of patient ID is set to ON, go to Section 9.3 for entering the patient ID; otherwise, jump directly to Section 9.5 for entering the strip code.

9.3 Entering the Patient ID

The Patient ID can be composed of numbers

or letters, with a length of no more than 16 digits.

Press “ or press “ ” to input Patient ID via barcode scanner.

” to manually input the Patient ID

9.3.1 Manual Input

PATIENT ID

----------

A000

PATIENT ID

0123456789

SPP:

√ CANINE

FELINE OTHER

Use “+” and “-” buttons to change the highlighted digit. Press “NEXT” button to accept and advance to next digit. If the input of the Patient ID is completed, press “OK” button to accept.

9.3.2 Auto Scan

In the Patient ID INPUT/SCAN interface, press “SCAN” and scan the patient barcode from a distance of approx. 15cm (6 inches).

The meter beeps once the barcode has been read successfully. The barcode information appears in the CONFIRM interface.

If a barcode is not scanned, the scanner turns off after 10 seconds.

ENEN

Do not stare directly at the laser beam.

9.4 Conrming the Patient ID

If the Patient ID is entered correctly, press “OK” button to conrm.

Otherwise, press “ Section 9.3 until all numbers are correctly entered.

9.5 Selecting the Species

” or “ ” to repeat

Use “+” and “-” buttons to switch highlighted item in the species list. Select the species you are testing. Press ”OK” to conform.

9.6 Entering the Strip Code and Lot Number (if enabled)

STRIP CODE

PT/APTT

471213408

LOT : 3052E0503

STRIP CODE

PT/APTT

471213408

LOT: 3052E0503

STRIP CODE

PT/APTT

471213408

LOT: 3052E0503

NOTES:

• If the Lot Number Input function is enabled, you will be asked to input the strip code and the lot number; otherwise, you just need to input the lot number.

• The Strip Code contains information of the type of test. After you entered the Strip Code, the test name will be recognized automatically and displayed on the screen.

• A different type of test may have different length of code. Make sure both the length and each digit are exactly the same with those on the pouch.

If the displayed strip code and lot number

(if enabled) match those on the strip pouch, press “OK” button to conrm. Otherwise, you

can use “ or use “ ” to enter the code via barcode scanner. Press “OK” button to conrm the code after the strip code is correctly entered.

” to manually input the strip code

9.6.1 Manual Input

To change numbers more quickly, hold down the functional “+” and “-”

buttons.

Use “+” and “-” buttons to change the rst digit highlighted.

Press “NEXT” button to accept and advance to next digit.

9.6.2 Auto Scan

EXPIRED STRIP!

HEATING

ADD BLOOD

User can also use the built-in barcode scanner to scan the strip code on the pouch.

9.7 After Conrming the Code

If you input the lot number, the meter will

automatically check whether the strip is expried after conrming the code is correctly entered. If it is expired, an error will be reported. As a result, you need to use strips within the expiration date to perform the test. If you didn’t input the lot number, the meter will skip the expiration date inspection and start the test directly.

ENEN

9.8 Heating Up

9.9 Collecting a Sample

After the heating is complete, collect whole blood samples and run test. Refer to the test strip insert for detailed sample collecting procedures.

After conrming the code, the qLabs® Vet will heat up automatically for the test.

When qLabs® Vet is ready for sample testing, it will beep and prompt the user to apply a blood sample.

NOTE:

TESTING

67s

ADD BLOOD

120s

• To avoid mechanical hemolysis of the blood sample,

nonheparinized syringe with 21 gauge needle or larger is highly recommended.

• Since the interstitial uid (thromboplastin) will accelerate the clotting process, vascular puncture action is preferably a one-time action so as to minimize the interstitial uid from entering into the blood sample.

• Excitement of the patient should be minimized when collecting the sample. The clotting reaction and test results will be affected when the patient is extremely exciting. Sedatives and analgesics can also affect the blood clotting process.

• When collecting the sample, follow the guidelines and procedures for blood collection as instructed by the veterinary clinic.

9.10 Performing the Test

Disuse the rst drop of blood needle disuse, then apply a total of about 10-20 microliter blood sample to sample well of the strip. Make sure to apply the blood sample directly on the sample well of the strip. DO NOT move the qLabs

Vet while adding the blood to the strip.

NOTES:

• There is a 10 minutes time limit for the user to apply the blood sample.

When the time limit is reached, the qLabs® Vet will display an error code.

After the blood sample is added, the qLabs® Vet will perform the test automatically.

If insufcient blood sample is added, the qLabs® Vet will not begin its testing and will continue to prompt the user to add blood sample.

21.6

AP TT

8.2

PID0002

When testing is complete, the qLabs® Vet

CODE: 471213408 LOT: 3052E0503

01/05/2014 14:30

SET MEM

OFF VER

will beep and the test results will appear on the screen along with the patient ID and test time.

If the test results need to be reported instantly, press “ ” button to print or

upload the results.

NOTE:

• A qLabs® eStation or qLabs® eCable is needed to support the upload/print function.

NOTES:

• Test results are automatically stored in the qLabs

including all the information of the test (See Section 10 for reviewing past results).

• The qLabs

9.11 Results and Explanation

Please read qLabs of test results.

9.12 Finishing the Test

Remove and discard the used test strip into a sharps or other puncture proof container. It is recommended to power off the qLabs

full, the new test result will overwrite the oldest test.

Vet can store up to 200 test results. If the memory is

Vet test strips package inserts for detailed explanation

not in use.

When the “ ” button is pressed, the qLabs® Vet will prompt the user to remove the test strip.

Vet memory

Vet when it is

21.6

AP TT

8.2

PID0002

SET MEM

OFF VER

Before turning off the meter, press the “ ” button to return to the test mode.

Remove the test strip from the meter. To perform another test, please use a fresh test strip. Please use a different nger for a new test.

SET MEM

OFF VER

RESULTS

BACK

PATIENT TESTS

QC TESTS

NO RECORD

13.1

N-1

28.4

10. Reviewing Previous Results

Follow these steps to review previous results that are stored in the meter memory.

In the Test Mode where the display prompts the user to insert a test strip. Press “MEM” button.

Select the type of results you want to view: Display QC TEST results Display PATIENT TEST results

10.1 Displaying QC Test Results

The meter stores up to 12 QC results chronologically. The most recent result is named “N-1”. The least recent result is named “N-12”.

If no results exist, the meter will prompt “NO RECORD”.

Press the “+” and “-” buttons to switch between QC result. Press “ ” button to exit.

10.2 Displaying Patient Test Results

03/08 a010010001

03/08 a010010013 02/08 a010040215 02/08 a030010005

21.6

AP TT

8.2

PID0002

CODE: 471213408 LOT: 3052E0503

01/05/2014 14:30

Whenever a test is successfully performed, the result is automatically stored in the meter memory along with the date of the test. The meter memory will store up to 200 results.

Press the “á” button to select previous results. Each page lists four results; use the functional “â” button to scroll down to review the next four results.

Press the “ Mode.

Press the “OK” button to view the detailed

information of the selected test including PT, and/or APTT, QC results, and Patient ID. Use the “+” and “-” buttons to scroll through the detailed results. Press the “

Press the “ ” button to view more detailed information and operation options.

” button to return to the Test

” button to exit.

10.2.1 Deleting Patient Test Results

Press the “

Use “+” and “-” buttons to toggle between deleting all results or the current result.

” button to enter “delete setting” interface.

8.1

DELETE

CURRENT

8.1

DELETE

ALL

Press the “OK” button to conrm or press “ ” button to exit.

DELETED

NO RECORD

OK?

If the option to delete the current result is selected, the “DELETED” symbol will ash on the display for a short time, the subsequent results will be displayed.

If the option to delete all results is selected, the display will show “NO RECORD”.

10.2.2 Printing Patient Test Results

Press the “

NOTE:

”button to enter “print setting” interface.

In print setting interface, press the “ ” and “ ” to set up the number of test results will

be printed. Press “OK” to conrm printing.

eStation is required for printing the test results.

• A qLabs

10.2.3 Uploading Patient Test Results

Press the “ ” button to upload the selected results to the qLabs® Data manager.

11. Quality Control

11.1 Onboard QC Test

The qLabs® Vet also measures the clotting time in the Quality Control (QC) zone of PT or APTT strip. If the QC result fails to fall within a predetermined range, the qLabs® Vet will display an error code rather than give a possible erroneous PT or APTT result.

This safety measure guards the user against situations in which the qLabs temperatures or humidity (which could happen if the foil pouch is torn or punctured).

11.2 Liquid QC Test

Micropoint Biotechnologies, Inc. has optional liquid controls for qLabs® Vet system. The qLabs® PT and APTT liquid controls are used with qLabs® PT and APTT test strips to verify the qLabs® system performance, respectively. It is recommended that two levels of liquid controls are used to perform the test. The qLabs® PT and APTT liquid controls can be purchased separately from Micropoint Biotechnologies, Inc. Please refer to the qLabs® PT and APTT liquid controls package insert for detailed operation instructions.

PT or APTT test strip may have been subjected to very high

QC test.

Only use qualied qLabs® PT and APTT Controls for

12. Maintenance

12.1 Care and Cleaning of Your Screen

Follow these steps for cleaning the qLabs Vet:

NOTE:

• No maintenance is required other than routine cleaning.

• Clean display screen with a clean damp cloth. If necessary, a mild detergent or disinfectant (such as 5% bleach solution or 70%

isopropyl alcohol) may be used.

• Clean the area around the test strip guide with a swab or a pad that has been dampened with alcohol or 5% bleach solution.

12.2 Installing/Replacing Batteries

Follow these steps to install/replace the batteries:

1) Turn the qLabs

Vet upside down.

2) Remove the battery cover screw.

3) Remove the battery cover by pressing down on the battery cover release, remove the old batteries.

4) Replace with 4 standard AA batteries. Follow the direction for battery placement (+ and – ends) inside the battery compartment.

5) Fasten the battery cover. Tighten the battery cover screw.

NOTE:

• Turning the qLabs

Vet off manually when it is not being used will

help conserve the battery power.

• Settings for date, time, and target range will not be saved if

batteries are replaced, though past test results will be saved.

• If storing the Vet for an extended period, completely remove the

batteries before the next use.

Dispose of the batteries in compliance with local regulations.

12.3 Servicing

All servicing and adjustment must be performed by Micropoint Biotechnologies, Inc.’s service engineers only.

13. Troubleshooting

ERROR CODE DISCRIPTION

qLabs® ElectroMeter is not connected to qLabs eStation.

The qLabs® eStation is Out of thermal paper.

NO COAG

The meter did not detect coagulation.

CORRECTIVE

ACTIONS

Connect the qLabs ElectroMeter to the qLabs eStation properly.

Replace the thermal paper.

Retest with a new strip. If this error message appears again, the result must be checked using another method.

E001 Low battery power.

E002 Heating process timeout.

The ambient temperature is

E003

E004

E005

outside of the operational temperature range.

Insufcient blood was added to the sample well.

Internal QC check out of specications.

Replace batteries or use power adapter as a power source.

Turn off the meter and let it equilibrate at ambient temperature (10-35°C) for at least 5 minutes before performing additional tests.

Move the meter and strip to a location that is within the operational range of 10 °C to 35 °C and repeat the test.

Retest with a new strip and make sure one big drop of blood is correctly added to the sample well.

1. Make sure the strip is within the expiry date.

2. Make sure the Strip Code is entered correctly.

3. Retest with a new strip.

ERROR CODE DISCRIPTION

E006

E008 Barcode scanner error. Restart the meter and retry.

E010 The operation has timed out.

E011

External liquid QC check out of specications.

You inserted a used test strip, or you applied a blood sample to the test strip before the meter warm-up was complete.

CORRECTIVE

ACTIONS

1. Make sure the strip and liquid controls are within the expiry date.

2. Make sure the Strip Code is consistent with the code printed on the liquid controls vial label.

3. Retest with a new strip.

Please ensure the sample is added within 2 minute after the 'add sample' indicator is ashing

Retest with a new strip. Make sure to add sample within 2 minutes after the 'add blood' indicator is ashing.

E013

E014

E02x

The strip is defective or improperly operated when adding sample.

The value of HCT may be out

of range 30%-55%.

There is an error when calculating PT or APTT.

Retest using a new strip. Make sure the operation of adding sample is exactly correct according to the user manual guidance.

Patients with abnormal HCT value may be recommended to test the PT and/or APTT using another method.

Retest with a new strip.

14. Symbols

SYMBOLS EXPLANATION SYMBOLS EXPLANATION

Caution. Read

Carefully

Avoid Liquid

Spills

Separate

Collection

Temperature

Limitation

Laser Radiation

Risk

Lot Number

Expiry Date

Fragile

Biological Risk

DO Not Reuse

Manufacturer

Consult

Instructions For

Use

Catalog Number

Serial Number

15. Performance Characteristics & Product Specications

15.1 Operation Condition

Temperature

Humidity 10% and 90%

Atmospheric Pressure 700 hPa and 1060 hPa

15.2 Product Specications

CPU 32 V1 ColdFire

Display screen 128×96 LCD

Test memory 200 test results

Barcode scanner

Power

between 10ºC and 35ºC (50ºF and 95ºF)

Laser Class 2, according to EN 60825-1:2007

Battery: 4 X AA batteries Supply: Input: 110-240 VAC,

50-60 Hz Output: 7 VDC Power: 6 W

Size

Weight 154 g (without batteries)

Warranty period 2 years

135mm x 65mm x 34.5mm (L× W × H)

16. Warranty

Use of the qLabs® Vet

The qLabs

Vet (the “Meter”) is designed for individual point-of-care coagulation test. Proper adherence to the instructions in the User’s Manual and package insert is critical to proper operation.

WARNING: Failure to comply with the user manual could lead to inaccurate results and incorrect medication dosing which could result in injury or death.

Limited Warranty

Micropoint Biotechnologies, Inc. guarantees to the original purchaser of the Meter that the Meter is free from material defects in material and workmanship for two years from the date of purchase. This warranty does not guarantee the uninterrupted operation of the meter.

Micropoint Biotechnologies, Inc.’s only liability and purchaser’s only remedy under this warranty is that during the warranty period Micropoint Biotechnologies, Inc. shall replace or repair, at no charge, any Meter component with defects in material or workmanship. MICROPOINT BIOTECHNOLOGIES, INC. MAKES NO OTHER WARRANTIES AND EXPRESSLY EXCLUDES ANY IMPLIED WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT OR FITNESS FOR A PARTICULAR USE.

The only user serviceable parts of the Meter are the battery, the cleaning door and the battery door. Tampering with any other portion of the Meter, abusing the Meter or using the Meter in a manner inconsistent with its user manual will void this warranty. This warranty does not apply to any component that is damaged by improper storage or accident or that is subject to alteration, misuse, tampering or abuse. Before returning any defective components, you must obtain a “Return Material Authorization” number and return instructions from Micropoint Biotechnologies, Inc. Technical Support by calling +86 755 86296766.

MICROPOINT BIOTECHNOLOGIES, INC. ENTIRE LIABILITY IN CONNECTION WITH THE METER, REGARDLESS OF THE LEGAL OR EQUITABLE BASIS OF ANY CLAIM, IS LIMITED TO THE PURCHASE PRICE OF THE METER. IN NO EVENT WILL MICROPOINT BIOTECHNOLOGIES, INC. BE LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL, CONSEQUENTIAL, OR PUNITIVE LOSS OR DAMAGES IN ANY WAY RELATED TO THE METER, OR ANY THIRD PARTY CLAIMS, EVEN

IF MICROPOINT BIOTECHNOLOGIES, INC. OR ITS DISTRIBUTORS ARE AWARE OF THE POSSIBILITY OF SUCH CLAIM OR DAMAGES AND NOTWITHSTANDING THE ESSENTIAL PURPOSE OF ANY REMEDY.

17. Contact Address and phone

number

Customer Service and Technical Support

Available 8:30 AM to 5:30 PM (Beijing Standard Time), Monday-Friday.

Tel: +86 755 86296766

Micropoint Biotechnologies, Inc.

6F, No.3, Industry 5 Road, Shekou, Shenzhen, Guangdong 518067, China Tel: +86 755 86296766 Fax: +86 755 86673903 www.micropointbio.com

qLabsqLabs

Micropoint Biotechnologies, Inc.

6F, No. 3, Industry 5 Road

Shekou, Shenzhen, Guangdong

Tel. : +86 755 86296766

Fax : +86 755 86673903

E-mail : info@micropointbio.com

www. micropointbio.com

qLabs

and Micropoint® are registered trademarks of Micropoint Bioscience, Inc.

China, 518067

P/N MP400401 Rev. A4

MICROPOINT QLABS VET User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual