MICROPOINT qLabs Vet User manual

EN
REF QV-1
Vet
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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)
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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
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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.
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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®Vet.
• Standard AA batteries can also be used for qLabs®Vet.
• The qLabs®eStation can be purchased separately from Micropoint
Biotechnologies, Inc. Please contact your local distributor for
ordering information.
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
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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
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4. Operation Summary
Operation
Preparation
Meter Setup
Performing a Test
Reviewing Previous
Results
Power ON Time Setting
Date Setting Normal Range
Setting
Collect Sample Test Sample
Review QC Data Review Patient Data
Patient ID
Lot Number
Language
Upload Data Print DataDelete Data
Enter Patient ID and
or Strip Lot Number Select Species
5. Before Testing
Before using qLabs®Vet to do a test, you will need:
• qLabs®Vet test strip
• 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
• 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
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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® Vet’s test results should
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.
6.1 Care of Your qLabs®Vet
• The qLabs®Vet is a delicate instrument and should be handled
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®Vet below -10 ºC or above 40 ºC.
• DO NOT use the qLabs®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.
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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.
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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®Vet power supply jack. Alternatively, the qLabs®Vet can use 4
standard AA batteries (See Section 12.2).
The messages on the four-cell grid displayed at the
bottom of the screen provide hints for the functions of the
buttons.
7.2 Powering the qLabs®Vet On
OK
NEXT
-+
DD/MM/YY HH:MM
01/02/12
12:00
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
SET MEM
OFF
VER
Press the “OK” button to view the prompt to
insert a test strip.
When qLabs®Vet is in the standby mode, you have two choices to power
on the monitor:
1) Press and hold the “Power” button for 2 seconds to turn on the
qLabs®Vet, or
2) Insert a fresh test strip if you are ready to perform a test. The
qLabs®Vet will then prompt you to conrm the strip code.
Turning the qLabs®Vet ON in CHOICE 1, allows the user to:
• Perform a test, or
• Check the version of the software and the manufacturer information
by pressing “VER” button, or
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V8.0.02
MICROPOINT
S/N
023300E1200001
• Enter Setup mode by pressing “SET” button to change the Vet
setting, or
• Enter Memo mode by pressing “MEM” button to review previous
results.
Turning the qLabs®Vet ON in CHOICE 2, allows the user to:
• Perform a test.
See the appropriate sections of this User’s Manual for
complete information for all of these options.
7.3 Powering the qLabs®Vet Off
SET MEM
OFF
VER
In the interface where the monitor prompts
you to insert a test strip, press the functional
“OFF” button to enter the shut down mode.
SHUT DOWN
BACK
OFF
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®Vet if not in use to conserve the
batteries.
• If the qLabs®Vet is left idle for about 5 minutes, it will turn off
automatically and enter standby mode.
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8. qLabs®Vet Settings
Follow the steps below to set up the qLabs®Vet.
8.1 Enter Setup Mode
OK
NEXT
-
+
DD/MM/YY HH:MM
01/02/12
12:00
When the qLabs®Vet is turned on for the rst
time, it will automatically enter to the Setup
Mode.
SET MEM
OFF
VER
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
OK
NEXT
-+
DD/MM/YY HH:MM
01/02/12
12:00
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.
OK
NEXT
-
+
DD/MM/YY HH:MM
01/02/12
12:00
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.
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8.3 Setting the Time
The time is in 24-hour format: “HH:MM” (Hour: Minute)
OK
NEXT
-
+
DD/MM/YY HH:MM
01/02/12
12:00
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.
OK
NEXT
- +
DD/MM/YY HH:MM
01/02/12
12:00
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.
NORMAL RANGE
OK
NEXT
-+
5
CANINE
PT
APTT
16
15 43
LO HI
First, use “+” or “-” buttons to select the
species.
Press”NEXT” to accept. The next settable
item will be highlighted
NORMAL RANGE
OK
NEXT
-+
5
CANINE
PT
APTT
16
15 43
LO HI
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.
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8.5 Patient ID Setup
PATIENT ID
OK
NEXT
-
+
ON
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.
8.6 Lot Number Setup
LOT NUMBER
OK
NEXT
-
+
ON
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
LANGUAGE
√ENGLISH
FRANçAIS
DEUTSCH
ITALIANO
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.
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9. Perform a Test
9.1 Entering Test Mode
SET MEM
OFF
VER
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.
PATIENT ID
ON
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
PATIENT ID
ON
The Patient ID can be composed of numbers
or letters, with a length of no more than 16
digits.
Press “ ” to manually input the Patient ID
or press “ ” to input Patient ID via barcode
scanner.
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9.3.1 Manual Input
PATIENT ID
NEXT
OK
-+
----------
A000
-
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.
Do not stare directly at the laser beam.
9.4 Conrming the Patient ID
PATIENT ID
OK
NEXT
ON
0123456789
If the Patient ID is entered correctly, press
“OK” button to conrm.
Otherwise, press “ ” or “ ” to repeat
Section 9.3 until all numbers are correctly
entered.
9.5 Selecting the Species
SPP:
OK
-+
√CANINE
FELINE
OTHER
Use “+” and “-” buttons to switch highlighted
item in the species list. Select the species
you are testing. Press ”OK” to conform.
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9.6 Entering the Strip Code and Lot Number (if enabled)
STRIP CODE
OK
ON
PT/APTT
471213408
LOT: 3052E0503
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 “ ” to manually input the strip code
or use “ ” to enter the code via barcode
scanner. Press “OK” button to conrm the
code after the strip code is correctly entered.
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.
9.6.1 Manual Input
STRIP CODE
OK
NEXT
ON
PT/APTT
P
471213408
LOT: 3052E0503
-+
Use “+” and “-” buttons to change the rst
digit highlighted.
STRIP CODE
OK
NEXT
ON
PT/APTT
P
471213408
LOT: 3052E0503
-+
Press “NEXT” button to accept and advance
to next digit.
To change numbers more quickly, hold down the functional “+” and “-”
buttons.
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9.6.2 Auto Scan
User can also use the built-in barcode
scanner to scan the strip code on the pouch.
9.7 After Conrming the Code
EXPIRED STRIP!
OK
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.
9.8 Heating Up
HEATING
After conrming the code, the qLabs®Vet will
heat up automatically for the test.
ADD BLOOD
When qLabs®Vet is ready for sample testing,
it will beep and prompt the user to apply a
blood sample.
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.
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NOTE:
• 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.
TESTING
67s
After the blood sample is added, the qLabs®
Vet will perform the test automatically.
ADD BLOOD
120s
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.
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.
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21.6 APTT
8.2 PT
PID0002
-+
When testing is complete, the qLabs®Vet
will beep and the test results will appear on
the screen along with the patient ID and test
time.
CODE: 471213408
LOT: 3052E0503
01/05/2014 14:30
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.
SET MEM
OFF
VER
When the “ ” button is pressed, the qLabs®
Vet will prompt the user to remove the test
strip.
NOTES:
• Test results are automatically stored in the qLabs®Vet memory
including all the information of the test (See Section 10 for reviewing
past results).
• The qLabs®Vet can store up to 200 test results. If the memory is
full, the new test result will overwrite the oldest test.
9.11 Results and Explanation
Please read qLabs®Vet test strips package inserts for detailed explanation
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®Vet when it is
not in use.
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