Quo-Test

User Manual

SCIENCE MADE SIMPLE

Copyright © 2008 - 2015 Quotient
Diagnostics Ltd
No part of this publication may be
reproduced, transmitted, transcribed, stored
in any retrieval system or translated into any
human or computer language by any means
or in any form, without the prior written
permission of Quotient Diagnostics Ltd.

Part Number: 3120-9001-0124

Quo-Test User Manual – EU-EN
Date: July 2015 Russell House
Molesey Road
Issue: IFU0108.EU-EN.02.02 Walton on Thames
For use with Firmware version 2.xx Surrey
Printed in Germany KT12 3PE
United Kingdom

T +44 (0)1932 220 124

info@ekfdiagnostics.com
www.ekfdiagnostics.com

An ISO 13485:2003/2012 Certified Company

produced for Quotient Diagnostics Ltd. by

EKF-diagnostic GmbH
Ebendorfer Chaussee 3
39179 Barleben
Germany

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

 Contents
Section 1 Safety Precautions
Section 2 Introduction
General Information
Unpacking
Warnings and Precautions
Intended Use
Quo-Test System Description
Measurement Principle
Section 3 Setting up the System
Setting the Language
Setting the Time
Setting the Date
Setting the Identification (ID) Options
Calibration
Reported Units
Functional Checking
Section 4 Running a Test
Preparing to Run a Test
Running the Test
Collecting the Sample
Scanning Operator and Patient ID
The Test Result
Printing the Test Result
Retrieving a Result from the Analyzer Memory
Running a Quality Control Sample
Section 5 Maintenance
Section 6 Troubleshooting Guide and Error Messages
Operational Error Messages
Section 7 Customer Support
Warranty
Disposal of the Analyzer
Returning an Analyzer
Section 8 Technical Specifications
Quo-Test Analyzer
Accessories
Section 9 Packaging Symbols and their Meaning
Section 10 Certificate of Conformance
Section 11 Change History

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

 Section 1 Safety Precautions
Basic safety precautions must always be taken, including all those listed below.
Danger - Misuse of electrical equipment can cause electrocution, burns,
fire and other hazards.
Close supervision is necessary when the system is used, on, or near children,
or vulnerable persons.

Read the following instructions before using the system

1) Connect the analyzer to the mains supply. The mains outlet must have an earth
connection.
2) If the system is not going to be used for an extended period of time, unplug
the analyzer from the mains supply.
3)  Do not place the system in liquid, or put it where it could fall into liquid.
If the equipment becomes wet, unplug from the mains supply before touching it.
4) Use the system only for the purpose described in this User Manual.
5)  Do not use accessories which are not supplied or recommended by the
manufacturer.
6)  Do not use the system if it is not working properly or if it has suffered any
damage, for example;
a) damage to the flexible supply cord or its plug.
b) damage caused by dropping the system.
c) damage caused by dropping the system into liquid or splashing liquid on to it.
7)  Do not let the equipment or the flexible cords come into contact with surfaces
which are too hot to touch.
8)  Do not block air openings or place the system on a soft surface. Keep air
openings free from debris.
9) Do not place anything on top of the system.
10) Do not drop or put anything into any opening in the equipment, unless
instructed by this User Manual.
11) Do not use the system where aerosol sprays are used, or where oxygen is
administered.
12) Do not use the system out of doors.
13) Do not use the system in close proximity to sources of strong electromagnetic
radiation, as these may interfere with the proper operation of the analyzer. An
evaluation of the electromagnetic environment should be undertaken before
using the system.

Section 1 - Page 1 of 1 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

 Section 2 Introduction
General Information
IVD Please read these instructions in full before performing a test

The Quo-Test Analyzer is for in vitro diagnostic use only.

The Quo-Test Analyzer is for use at the point of care.
Only Quo-Test Cartridges can be used with the Quo-Test Analyzer.

Unpacking
Unpack the system and check that the following components are present in the pack.
If there is anything missing contact your local distributor or customer support.
• Quo-Test Analyzer
• Barcode Scanner
• Mains Power Cable
• Power Supply
• User Manual
It is recommended to keep the packaging to transport your analyzer. If the optional
printer has been purchased, it will be delivered in a separate box.

Warnings and Precautions

• T here are no user serviceable parts inside the analyzer. Call your local distributor or
customer support if you have any problems that are not resolved by following the
Troubleshooting Guide and Error Messages section of this User Manual.
• Place the system on a clean, dry, flat and level surface away from direct sunlight
in a room with a temperature range of 18 to 30 °C (64 to 86 °F). An analyzer which
has been stored at a temperature above or below the working temperature will take
longer to exit the Analyzer Warm Up screen when the system is first powered on.
• Place the system away from draughts, or other sources that may cause sudden
changes in temperature e.g. air flow from air conditioning units.
• The system must be within easy reach of a mains supply outlet with a protective
earth connection.
• The system has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case you may need to take
measures to mitigate the interference.
• Ensure that the analyzer and cartridges have reached room temperature before
using the system.
• The analyzer must be used in accordance with the instructions stated in this User
Manual.
• Used cartridges must be treated and disposed of as clinical waste.
Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 2 - Page 1 of 3
Intended Use
The Quo-Test A1C System is intended for the in vitro quantitative determination of
glycated hemoglobin (HbA1c) in whole blood obtained from a finger prick or venous
whole blood sample collected into EDTA tubes.
The Quo-Test A1C System is indicated in the management and treatment of diabetes
mellitus and for monitoring long term glycemic control in patients diagnosed with
diabetes.
The Quo-Test A1C System is designed for professional use only.
Quo-Test Quality Controls are intended to check the correct operation of the Quo-Test
A1C System.

Quo-Test System Description

The Quo-Test A1C System consists of the Quo-Test Analyzer, Quo-Test A1C Test
Cartridges, Quo-Test A1C Control Kit and Thermal Label Printer (optional).
Quo-Test A1C Test Cartridges can only be run on the Quo-Test Analyzer.
Figure 1 shows the main parts of the analyzer.

Rear Connection Panel

(see Figure 2 in Section 3 - Setting up the System)

Display Screen
Door

Key Pad

Slide
Test Chamber

Figure 1: The Quo-Test Analyzer

Section 2 - Page 2 of 3 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015
Read the Instructions For Use that come with the Test Cartridges. Refer to the
Instructions For Use on how to prepare and perform the test. The Quo-Test Analyzer
will provide on screen instructions at each stage of performing the test. At the end
of the test the result is displayed on the screen, stored in the analyzer memory and
can be printed on to a label with the optional printer.
The Quo-Test Analyzer is calibrated by the manufacturer and there are no user-
serviceable parts.
The analyzer performs optical, electronic and mechanical checks on the test
cartridge throughout the test procedure and if a problem is detected the analyzer
stops the test and an error message is displayed on the screen. If this happens,
then consult the Troubleshooting Guide and Error Messages section of this User
Manual.

Measurement Principle
The arrangement of the two light sources and associated detectors allows the
Quo-Test Analyzer to be used as a dual channel spectrophotometer / fluorimeter.
This allows the Quo-Test Analyzer to be used either to measure changes in optical
density as used in Immunoturbidimetric assays or changes in light transmission from
specific fluoriphores as they interact with analytes of interest e.g. HbA1c.

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 2 - Page 3 of 3

 Section 3 Setting up the System
Connect the barcode scanner and the printer (optional) to the analyzer by pushing
the cables into the connectors on the rear panel. Make sure the printer and barcode
scanner are connected to the correct ports as shown in Figure 2 below. If the printer
is no longer required, disconnect it from the analyzer.
Barcode Printer DC
Scanner Port Port Power Supply

WEEE
USB Port Directive Mark

Model No.
Serial No.
Manufacturer
CE Mark

Figure 2: Connection panel on the rear of the analyzer.

Connect the power supply to the analyzer and plug the supply cord into the
mains supply (100-240v AC 50-60Hz). Ensure that the supply has a protective
earth connection.

Once the analyzer has warmed up the

Quo-Test screen will show the Quo-Test logo, this
is the home screen. The keypad under
11:32 21/06/13 the blue screen has three buttons. The
Setup File
text on the screen immediately above
each button shows the function of
that button. If there is no text above
a button, then it has no function.
The functions of the buttons change,
depending on which screen is displayed.

Section 3 - Page 1 of 6 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

When the analyzer is first switched on, you must set the local language, time, date, ID
options and reported units before you perform a test. You only need to do this once.
The analyzer should be switched off at the mains supply or unplugged when not
required for long periods. Otherwise the analyzer should be left on, but must be
powered down and restarted once a week, to perform the self-check procedure.
Ensure that the analyzer is displaying the home screen before powering the system
down.
Press the button labelled Setup to start the setup process.

Setting the Language

Language The default language for the analyzer
is English. To change to a different
English language, press the Change button
OK Change and use the up/down arrow buttons to
select the required language from the
list. Press the OK button to confirm the
selection.

Setting the Time

Time The analyzer has a clock that keeps track
of the date and time. Whenever a test is
11:32 performed, the result is recorded in the
24 hr Change analyzer memory with the date and time
that it was run. Choose Change on the
time screen to set the time.
Choose either the 24 hr or 12 hr clock
by pressing one of the buttons. Set the
hours and minutes by using the up/
down arrow buttons. Press OK when
Hour correct.
11:32 Note: The clock can only be set
OK am pm
+/- 30 hrs from default setting.
If the 12 hr clock is selected, then set
either am or pm. Press OK to confirm
the settings.
The time will then be displayed. Either
press the OK button to move on to
setting the date, see next section, or
press the Change button to go back
to setting the time.

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 3 - Page 2 of 6

 Setting the Date
Year To set the date, use the up/down
arrow and OK buttons to set the year,
2013 month and day as required. Press the
OK OK button to save the selection.
Note: The Date can only be set
+/- 30 hrs from the default time.
Choose the date format, either dd/mm/
yy or mm/dd/yy. Press the OK button
to save the selection. The date will then be displayed.
Either press the OK button to move on to setting the ID options, see next section, or
press Change to go back to setting the date.
Note: The analyzer will automatically adjust the time and date for leap years.
 

Setting the Identification (ID) Options

The Quo-Test Analyzer allows for operator and patient identification (ID) to be entered
via the supplied barcode scanner. This feature allows recording of the ID of the person
who ran the test and the person who was tested in the analyzer memory and on the
result print-out (if the optional printer is attached). These features can be switched on
or off. The operator has the option to skip the ID entry when analysing a cartridge if
the feature is turned on. Having the operator and patient ID stored or printed with the
test result, will aid identification of the result at a later date.
Barcode lengths up to 18 characters in Code 128, Code 39, NW7/Codabar and 2
of 5 Interleaved formats are supported. It is strongly recommend that users do not
use 2 of 5 interleaved as this format carries a risk of character substitution. Attempting
to scan a barcode in excess of 18 characters will result in the code being shortened
to 18 digits.

Users must verify that the Patient or

Patient ID ON Operator ID scanned matches the one
displayed on the Quo-Test.
Operator ID ON Press the Patient and Operator buttons
OK Patient Operator to switch these features on. Press the
buttons again to switch the features off.
Finally, press OK to move on to setting
the reported units.

Section 3 - Page 3 of 6 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

Calibration
The Quo-Test A1C System is certified by the NGSP and IFCC.
The Quo-Test Analyzer and A1C Test Cartridges have been calibrated using samples
provided by the European Reference Laboratory via the NGSP network.
Results obtained using the Quo-Test A1C System are traceable to the IFCC reference
method.

Reported Units
The Quo-Test A1C assay reports results in up to two user selectable units: % DCCT,
mmol/mol IFCC, % JDS, eAG mg/dl or eAG mmol/l.

mmol/mol IFCC = (% DCCT - 2.15) x 10.929

% JDS = (0.09274 x mmol/mol IFCC) + 1.724
eAG mg/dl = (28.7 x % DCCT) – 46.7
eAG mmol/l = (1.59 x % DCCT) – 2.59

eAG values are based on a correlation study linking % DCCT to the patient’s average
glucose concentration, resulting in published formula to derive the eAG.

eAG values may differ significantly from a patients glucose level measured at the
same time.

The Quo-Test Analyzer allows the user to select dual reporting (two different
measument units can be displayed) or single reporting. Users should refer to national
guidance when setting up reported units.

% DCCT is the default primary unit, to change the primary reported unit press Change

Primary Units
DCCT
OK Change

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 3 - Page 4 of 6

 The first screen allows you to select
Primary Units DCCT (%), IFCC (mmol/mol) or select
More to see additional units.

DCCT IFCC More

If you select More, JDS (%) or More

Primary Units are the options. If you select More you
are returned to the first menu screen.
Once a Primary reportable unit is
JDS More selected you can select a Secondary
Reportable unit to ‘Dual Report’.

IFCC (mmol/mol) is the default

Secondary Units secondary reportable unit. To select an
alternative secondary unit or switch off
IFCC dual reporting select Change.
OK Change

The first screen allows you to select

Secondary Units DCCT (%), IFCC (mmol/mol) or select
More to see additional units.

DCCT IFCC more

If you select More, JDS (%), None or

Secondary Units More are the options. Selecting None
switches off dual reporting. Selecting
More will forward you to the eAG
JDS None more options.

Section 3 - Page 5 of 6 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

 eAG can be reported in either mmol/l or
Secondary Units mg/dl to match the units used to report
glucose measurments locally.
eAG eAG Selecting More will return you to the first
(mmol/l) (mg/dl) More secondary units screen.
Once a secondary unit (or none) has
been selected, then setup is complete
and the analyzer is ready to run a test.
Note: Changing the secondary reported unit will also change the secondary reported
units on previously run samples held in the memory of the analyzer, as these are
calculated each time they are displayed. Changing the primary reported unit will not
alter the primary units reported on previously run samples.

Functional Checking
Each time the Quo-Test Analyzer is switched on it performs a series of functional
checks of the system and optics. The analyzer must be powered off and powered on
at least once a week to allow the analyzer to perform the internal self-checks.
Refer to the Troubleshooting Guide and Error Messages section of this User Manual
to diagnose any problems, if they occur.
Correct operation of the system may be confirmed by running Quo-Test A1C Control
samples.
To run a control, read the Instructions For Use supplied with your Quo-Test A1C
Control Kit in combination with the Running a Quality Control section of this User
Manual.

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 3 - Page 6 of 6

 Section 4 Running a Test
Please read the Instructions For Use supplied with your Test
Cartridges.
Always use protective gloves when handling blood samples.

Preparing to Run a Test

Step 1
When the Quo-Test Analyzer
displays the home screen
with ‘Quo-Test’, the time and
date, the analyzer is ready
to run a test.

Step 2
Before using a new lot of test cartridges,
scan the calibration barcode that is
printed on the inner flap of the carton,
indicated by the CAL symbol.
Place the barcode scanner over the
calibration barcode and press the
barcode scanner button until you hear
a beep. The analyzer will confirm that
the data has been accepted, along with
displaying the lot number and expiry
date.
2
 

Section 4 - Page 1 of 8 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

Step 3
Remove a pouched cartridge from the
carton and place it next to the analyzer.
Allow at least 40 minutes for it to
equilibrate to the analyzer’s environmental
temperature before use, even if previously
stored at room temperature. When ready
to perfom the analysis, carefully open the
pouch and remove the Test Cartridge.
Check the indicator color of the silica gel
(see test Instructions For Use).
Do not handle the lower part of the
carrtridge containing the liquid. 3
Do not use the cartridge if condensation
is present.

Collecting the Sample

Step 4
The Quo-Test can be used with either
venous whole blood collected with EDTA
or with a finger prick blood sample.
For fringer prick sample collection, the
patient’s finger must be warm, dry and
clean, including being free of substances
such as hand cream. Use a single use
lancet (not provided) on the patient’s
finger to get a droplet of blood about the
same width as the Blood Collector. 4
For venous samples previously collected
into EDTA tubes, ensure that the sample
is thoroughly mixed and use standard
equipment to place a droplet of blood,
approximately 10 to 20 µl, onto a non-
metallic and non-absorbant surface such
as Parafilm® M.
Do not attempt to sample directly from
the tube.
Note: Parafilm® M is a trademark of
Pechiney Plastics Packaging.

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 4 - Page 2 of 8

 Step 5
Lightly touch the pointed tip of the
Blood Collector to the top surface of the
droplet of blood, as per the image.
The blood will be taken up by the
collector.
The blood must completely fill the slot.
Note: Avoid taking up air bubbles and
excess sample on the outside of the tip
X of the Blood Collector.
Do not wipe excess blood from the
5 collector.

Step 6
Place the Blood Collector into the free
cavity on the top of the Test Cartridge,
making sure that the Blood Collector is
flush with the top of the Test Cartridge
and is not sticking out.
Note: Do not push the Blood
Collector into the Test Cartridge, as
this may cause an error message to be
displayed instead of a result. Refer to
the Troubleshooting Guide and Error
Messages section of this User Manual
6 for further details.

Running a Test
Step 7
After the Test Cartridge is prepared,
open the door of the analyzer and place
the cartridge into the test chamber,
making sure that the Test Cartridge is
firmly seated. The Test Cartridge must be
inserted into the analyzer within 1 minute
of the blood sample being collected.

Section 4 - Page 3 of 8 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

Step 8
Pull the red slide towards the front of
the analyzer and close the door. The test
will start automatically.
You will be prompted to scan the
Operator and Patient ID, if these
features have been activated.
Note: If the analyzer displays “Scan
Lot ****** Data Card” then scan the
calibration barcode (see Step 2).

Step 9
When the test has finished the result will
be displayed on the screen and printed
on the (optional) printer, if connected.
Open the door and push the red slide
towards the rear of the analyzer. Remove
the used cartridge and dispose of it as
clinical waste.
Upon closing the analyzer door, the
display will return to the home screen
and the analyzer will be ready to run
another sample.
9
Note: See Section 4 - Retrieving a
Result from the Analyzer Memory

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 4 - Page 4 of 8

 Scanning Operator and
Scan Operator ID Patient ID
If the Operator and/or Patient ID features
are enabled (see section 3), when the
analyzer door is closed to start the test the
Skip screen will request that the user scans the
Operator and/or Patient ID, depending
upon which features have been activiated
in the analyzer setup.
Please note that when using the system in
Scan Patient ID QC mode the system will only request the
operator ID to be scanned, as the system
automatically uses the Patient ID for the
Control Lot number.
When requested to scan the ‘ID’, place
Skip
the barcode scanner over the Operator or
Patient ID barcode and press the barcode
scanner button.

When the analyzer has recorded the barcocde a beep will sound and the ID is
displayed on the screen. Confirm the displayed ID matches the barcode scanned. If
you do not have an Operator or Patient ID barcode label available, press the Skip
button to exit the screen. The test result will not be displayed until the requested ID’s
have been scanned or the screens have been exited. If an error occurs, the analyzer
will abort the request to scan the Operator and/or Patient ID if not already completed.

Section 4 - Page 5 of 8 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

The Test Result
When the test is finished, the result will be displayed on the screen in the specified
units (Section 3 - Reported Units). The image below shows an example of the result
of a Quo-Test A1C Test. In this case, the test result was 7.1 % A1C. The letters “DCCT”
below the test result show the selected primary reported units of the test at the time
it was run. Important: make a note of the calibration scheme in order to accurately
compare results. Below the main result is a derived result showing the equivalent value
in mmol/mol IFCC units.
The result will stay on the screen until
the analyzer door is opened. The result
7.1% A1C is stored in the analyzer memory (see
Section 4 - Retrieving a Result from the
DCCT Analyzer Memory). On removal of the
54 mmol/mol IFCC used cartridge, the analyzer will be ready
to perform another test.

Printing the Test Result

Quo-Test A1C If you have the optional printer
Time: 11:34 connected, the result will be printed
Date: 21/06/13 when the test has finished. The result is
printed onto a self-adhesive label to be
Result: 7.1 % A1C DCCT
kept with the patients’ records.
54 mmol/mol IFCC
Lot: 020130
Inst ID: 021132
Test ID: 00053
Patient: xxxxxxxxxxxxxxxx
Operator: xxxxxxxxxxxxxxxx

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 4 - Page 6 of 8

Retrieving a Result from the Analyzer Memory
The results of the most recent 7,000 tests run on the analyzer are recorded in the
memory. Only the most recent 1,000 test results can be viewed on the analyzer. Press
the File button on Quo-Test home screen. The most recently performed test result
will be shown on the screen.

The sequential number of the test (in the

Test 00053 example below it is Test 53) will be shown
11.34 pm 21/06/13 together with the time and date the test
7.1% A1C DCCT was started along with the result. If the
54 mmol/mol IFCC OK button is pressed a second page will
OK
be shown which includes the Operator
and Patient IDs and the cartridge lot
number.

Press the Print button for a printed

Test 00053 copy of the result, if the optional printer
Lot: 020130 is attached, or press the Exit button to
Pat ID: return to the home screen. Press the Back
Op ID: button to return to the memory file.
Print Exit Back
The most recent 1,000 test results may
be accessed using the up/down arrow
buttons on the result screen as shown
above. To find earlier test results contact
your local distributor or customer support.

Note: Changing the secondary reported unit (see Section 3 - Report Units) will also
change the secondary reported units on previously run samples held in the memory
of the analyzer, as these are calculated each time they are displayed. Changing
the primary reported unit will not alter the primary units reported on previously run
samples.

Section 4 - Page 7 of 8 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

Running a Quality Control Sample
The Quo-Test A1C Control Kit must be used with Quo-Test A1C Test Cartridges to
ensure that the system is operating correctly.

Only Quo-Test A1C Controls should be used with the Quo-Test A1C Test.

Please read the Instructions For Use included with each Quo-Test A1C Control Kit to
ensure that the correct procedure is used.

Quality controls should be run:

• With each new lot of Test Cartridges.
• With each new shipment of Test Cartridges.
• At any time there is concern that the result may be wrong, the Test Cartridges
may not have been stored correctly, the user is unfamiliar with the test procedure
or the user may be performing the test incorrectly.

Use the Quo-Test A1C Control Kit according to the quality standards set by the
organisation or laboratory and according to local and national regulations.

If the controls do not give results within the range stated in the Instructions For Use,
contact your local distributor or customer support.

The quality control result is stored in the memory of the analyzer. The lot number of
the Quo-Test A1C Control Kit used is stored under the Patient ID field.

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 4 - Page 8 of 8

 Section 5 Maintenance
Other than restarting the system once a week to allow the system
to perform a self check, no routine maintenance of the Quo-Test
Analyzer other than cleaning is required.

• C leaning may be carried out by wiping the analyzer with a non-abrasive lint
free cloth. Use a mild detergent or commercially available disinfectant, such as
“Virkon®”, if necessary. Do not use bleach (Hypochlorite).
• Always power off the analyzer by unplugging the power supply when performing
any cleaning operation.
• Always power off the analyzer on a weekly basis. Leave off for a minimum of 10
seconds, then the analyzer may be powered on in order to perform the internal
self-checks. To power off the system, the Quo-Test should be in the home screen,
then either switch off at the mains supply or disconnect the power cable from the
power socket on the analyzer.
• Do not clean inside the cartridge test chamber. Contact your local distributor or
customer support for advice.
• If you spill liquid inside the cartridge test chamber, call your local distributor or
customer support for advice.
• If the instrument is stored when not in use, ensure that the mains cord is not liable
to damage or kinking.
• The analyzer is calibrated by the manufacturer and there are no user-serviceable
parts.

Virkon® is a trademark of Antec International Limited.

Section 5 - Page 1 of 1 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

 Section 6 Troubleshooting Guide and Error Messages
Operational Error Messages
To access the log files listing results or error messages please refer to the
Retrieving a Result from the Analyzer Memory section of this User Manual.
MESSAGE OR
DESCRIPTION RESOLUTION
PROBLEM

Analyzer warming Wait for the analyzer to

The analyzer is warming up
up warm up

Screen shows ‘Insert

The door switch in the analyzer Check the cartridge barcode
New Cartridge’ and
may be faulty, or the analyzer label for damage and that the
‘Close Door’ even
may not be able to read the door is properly closed and that
when the door has
barcode on the cartridge there is nothing in the way*
been closed

Screen shows ‘Pull Make sure the cartridge is sitting

Either the red slide has not been
Slide Forward’ even correctly and the red slide is
pulled far enough forward, or it
after the slide has correctly pulled forward. Then
is faulty
been pulled forward close the analyzer door*

Screen shows
Remove cartridge, close the door
‘Remove Old Either a used cartridge has been
and allow the system to return
Cartridge’ when inserted or the test cartridge is
to the home screen. Repeat test
a new cartridge faulty
with a new cartridge.*
is inserted.

The analyzer temperature sensor Contact your local distributor or

Error 01
has failed customer support

Do not turn off the analyzer.

Ambient
Make sure that the room
temperature The temperature of the room is
temperature is within
outside analyzer outside the analyzer’s working
18 to 30°C (64 to 86°F)
operating range range of 18 to 30°C (64 to 86°F)
(Error 02) Once achieved the home screen
will be displayed automatically*

Turn off the analyzer, allow it to

reach room temperature and
The analyzer temperature is
Error 03 turn it on again. Make sure that
unstable
the analyzer is sited away from
draughts*

Power off the analyzer, wait 10

seconds, and power on again.
Error 04 / 05 Part of the optical system has failed Remove the old cartridge, if
present, close the door and allow
the analyzer to return to the
home screen*

* If the problem continues, contact your local distributor or customer support.

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 6 - Page 1 of 4

 MESSAGE OR
DESCRIPTION RESOLUTION
PROBLEM

The x- or z-axis motor has

Error 06 / 07
failed

Error 08 The stirrer motor has failed Power off the analyzer, wait 10
seconds, and power on again
The internal fan Remove the old cartridge, if
Error 09
has failed present, close the door and allow
the analyzer to return to the home
The x- or z-axis motor has screen*
Error 10/11
jammed

The stirrer motor has

Error 12
jammed

The measurement system

Error 98
has failed Contact your local distributor or
customer support
Error 99 The analyzer memory is full

Door Opened The analyzer door was

Do not open the analyzer door whilst
Assay Abandoned opened before the test had
a test is running*
(Error 101) finished

Reagent Out of
Remove cartridge and repeat test
Range The test cartridge is faulty
with a new cartridge*
(Error 102 / 103)

Either the blood sample had

a low level of hemoglobin,
Too Little Blood the blood collector was
under filled or the filled Remove cartridge and repeat test
(Error 104) blood collector was pushed with a new cartridge, making sure
into the cartridge prior to that the blood collector is filled
running the test correctly and that it is carefully
placed into the cartridge*
Either the blood sample had (see Section 4 - Running a Test)
Too Much Blood a high level of hemoglobin,
(Error 104) or blood collector was
overfilled

Blood Mix Failure The blood sample did not

Remove cartridge and repeat test
form a homogenous solution
(Error 105) with a new cartridge*
with the buffer

Invalid Result
(2)/(1) A result was not able to be Remove the cartridge and repeat
calculated with a new cartridge*
(Error 106)

* If the problem continues, contact your local distributor or customer support.

Section 6 - Page 2 of 4 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

 MESSAGE OR
DESCRIPTION RESOLUTION
PROBLEM

Remove the cartridge and repeat

with a new cartridge.
107 errors are most commonly seen
when a cold cartridge is used with
the system Make sure the cartridge
has sufficient time to reach the same
temperature as the analyzer before
Invalid Result use
(2)/(1) A result was not able to be 107 errors can sometimes occur
calculated when the analyzer is working at the
(Error 107)
bottom of it’s temperature range
and the blood volume/hemoglobin
concentration is towards the bottom
of the acceptable range. Make sure
that the temperature is within the
working range of the analyzer and
that the collected sample fills the slot
on the blood collector*

Calibration Barcode: re-scan the

calibration barcode or scan a barcode
Invalid Barcode from a different carton.
Format The calibration barcode has
not been recognized Cartridge Lot Barcode: open and close
(Error 108)
the analyzer door. If the error is still
displayed, use a different cartridge*

High Background
Fluorescence The test cartridge is faulty
(Error 110)

Curve Fit Fail A result was not able to be

(Error 112) calculated Remove cartridge and repeat test
with a new cartridge*
Invalid Result (2)
(Error 120, 121, A result was not able
122, 123,124, to be calculated
125 or 126)

Remove cartridge, close the door

Mix Motor Stall Mixer Motor has failed to start and allow the system to return to the
(Error 128) during the assay home screen. Repeat the test with a
new cartridge*

* If the problem continues, contact your local distributor or customer support.

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 6 - Page 3 of 4

Please contact your local supplier:

Customer support
+44 (0) 1932 220124
support@quotientdiagnostics.co.uk

Section 6 - Page 4 of 4 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

 Section 7 Customer Support
If you cannot resolve your problem Quotient Diagnostics Ltd shall not be
by reference to the Troubleshooting liable to the purchaser or any third party
Guide, contact your local distributor for any loss, inconvenience, or damage,
or customer support on the telephone whether direct, incidental, consequential
number or email address listed below or otherwise, resulting in any breach of
for advice and technical assistance. this warranty.
Provide the following information when
contacting customer support:
• Analyzer serial number (SN) (found Disposal of the Analyzer
on the rear panel label), see Section 3. The Quo-Test analyzer has been
• Test Cartridge lot number. designed for a long and fault-free
• Quality Control Kit lot number and life. However, excessive wear on
results, if available. the mechanisms may result in error
conditions and may indicate that the
analyzer has reached the end of its
Reporting Test System Problems useful life.
Users should report problems with The analyzer must then be disposed
their Quo-Test Analyzer, its reagents or of according to local regulations
controls to the local distributor concerning the disposal of electronic
and/or direct to Quotient Diagnostics items in general.
customer support.

The WEEE Directive 2002/96/

Phone: +44 (0) 1932 220124
EC defines the basis for
Email: support@quotientdiagnostics.
regulations in the EU.
co.uk
Contact your local distributor
or customer support for advice
Warranty on collection and disposal.
Quotient Diagnostics Ltd warrants to
the original purchaser, for a period of 12
months from the date of invoice, that the
Quo-Test Analyzer System is free from
defects in materials and workmanship.
In the event of failure within the warranty
period, Quotient Diagnostics Ltd will
repair or replace the system, or part
thereof, at their discretion, provided it
has not been subjected to accident,
alteration, misuse or abuse.

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 7 - Page 1 of 2

Returning an Analyzer
A signed certificate of decontamination must be completed and a
‘Return Authorization Number’ is required from Quotient Diagnostics Ltd before
returning an analyzer for investigation.
Contact your local distributor to obtain a Return Authorization Number and
decontamination certificate. When returning the analyzer, include a copy of the
details of the problem along with your contact details, the Return Authorization
Number and decontamination certificate.
Return the analyzer in its original packaging with sufficient protective material
to protect the analyzer from further damage during transit. Analyzers damaged
in transit are not covered by the terms of the warranty.

Ship to your local distributor or

directly to:

Customer Support
Quotient Diagnostics Ltd
Russell House,
Molesey Road
Walton on Thames,
Surrey, KT12 3PE
UK
Phone: +44 (0) 1932 220124
Email: support@quotientdiagnostics.co.uk

Upon receipt of the analyzer, it will be investigated and providing it is within warranty
and the tamper proof quality control label on the rear of the system is intact,
Quotient Diagnostics Ltd will promptly repair or replace the analyzer.
Analyzers that have not been maintained in accordance with the operating
instructions, which have been misused or abused or which are no longer under
warranty will be repaired and returned with a service charge.

Section 7 - Page 2 of 2 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

 Section 8 Technical Specifications
Quo-Test Analyzer
ANALYZER

Size 205mm(h) x 205mm(w) x 135mm(d)

Weight 1.3kg

Blue LCD backlit monochrome display 128x64 pixels.

Display
Visible area 70x39mm

Connections USB 2.0 (slave), Printer (RS232), Barcode Scanner (PS2)

Data Memory Capacity 7,000 data records

POWER SUPPLY

Mains Adapter Separate AC to DC mains adapter

Input 100-240 V AC, 50-60 Hz, 30 W

Output 24 V DC, 1.25A

BATTERY

CR1225, Lithium, non-rechargeable / non-replaceable.

Type Used to maintain the date, time and memory
of the analyzer

BARCODE READER

Barcode T8-W CCD Hand Scanner

Scanner Part No. 0108-0035

Width of Field 80 mm
Accessories
Interface Keyboard PS2

Supported Barcode
Code 128, Code 39, NW7 / Codabar, 2 of 5 interleaved
Formats

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 8 - Page 1 of 2

 OPERATING
CONDITIONS

18 to 30 °C (64 to 86 °F) or according to Test Cartridge

Temperature
temperature range

Relative Humidity 10 to 80 %, non condensing

Location Clean, dry, horizontal surface and away from direct sunlight

STORAGE &
TRANSPORT

Temperature -20 to 50 °C (-4 to 122 °F)

Relative Humidity 10 to 93 % at 40 °C (104 °F)

Accessories
PRINTER (OPTIONAL)

Seiko SLP-440
Label Printer
Part No. 0108-0002

Seiko SLP-650E
New Label Printer Part No. 0108-0035
Power supply provided with printer

Thermal Label Rolls SLP-DRL

Paper Type
Part No. 0108-0006

Interface Serial

SHOULDER BAG

Shoulder Bag Part No. 0108-0008

Section 8 - Page 2 of 2 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

 Section 9 Packaging Symbols and their Meaning
A number of symbols are used on the Quo-Test Analyzer, Test Cartridges and their
packaging. The following table lists the symbols used and their meaning.

SYMBOL MEANING

Consult Instructions For Use / User Manual

IVD In vitro Diagnostic Medical Device

LOT Batch or Lot Number

CAL Calibration Barcode

REF Product Reference

CONTROL Control

Storage Temperature

Contents Sufficient for “Σ” Number of Tests

Expiry Date (Year-Month)

Manufacturer

SN Serial Number

  DC Polarity on Rating Label

 
Printer Connector

USB Connector

Barcode Scanner Connector

When the end-user wishes to discard this product, it must be sent to

separate collection facilities for recovery and recycling

Caution

Conformity to the European Directive 98/79/EC

on in vitro Diagnostic Medical Devices

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 9 - Page 1 of 1

 Section 10 Certificate of Conformance

Product Code:
0108-0000
Description:
Quo-Test Analyzer System

Refer to the Certificate of Conformance

provided with the Analyzer

Russell House, Molesey Road

Walton on Thames, Surrey
KT12 3PE
United Kingdom
T +44 (0)1932 220 124

info@ekfdiagnostics.com
www.ekfdiagnostics.com

An ISO 13485:2003/2012 Certified Company

Section 10 - Page 1 of 1 Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

 Section 11 Change History
Revision Changes

IFU0108.EU-EN.02.02 July 2015 New printer Seiko SLP-650E Part No. 0108-0032
replacing Seiko SLP-440 Part No. 0108-0002 and
new power supply
New barcode Scanner T8-W CCD Hand Scanner
minor formatting changes

IFU0108.EU-EN.02.01 February 2013 New manual all pages, replacing MS0040.01

Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 Section 11 - Page 1 of 1

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NOTES Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015

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Quo-Test User Manual IFU0108.EU-EN.02.02 July 2015 NOTES

Part Number: 3120-9001-0140