29
INFORMATION CODES AND TROUBLESHOOTING
[#]
Cause
Action to take
Touch
screen
error
Touch screen failure/ Touch
screen buttons do not respond
accurately
Restart instrument and realign screen. If the problem persists, contact your local
Alere Afinion™ distributor.
27
28
29
Start-up procedure failed
Contact your local Alere Afinion™ supplier for assistance.
Self-test
error.
Analyzer
in non-
operative
mode
Analyzer failure
Restart analyzer. If the problem persists, contact your local Alere Afinion™ supplier.
Other information codes
[#]
Cause
Action to take
401
No registered supervisors in
operator list
At least one supervisor is required in the operator list when the instrument is
configured to operator ID verified (see page 14 and 15)
402
Cannot delete last
supervisor
At least one supervisor is required in the operator list when the instrument is
configured to operator ID verified (see page 14 and 15).
403
This assay type is not
accessible to the operator
The operator logged in does not have access to run this assay type. Please contact
your supervisor.
404
Operator ID is not found in
operator list
When configured to required the operator ID entered is required to be present in the
operator list. Please contact your supervisor.
[#]
Cause
Action to take
501
The control lot has passed
expiry date
Check the expiry date on the control lot package insert or kit box. Repeat the test
using a sample for a new control lot.
502
Alere Afinion™ Control
Data is not recoginzed and
is not stored in control lot
database
Re-enter the Alere Afinion™ Control Data (see page 17).
503
Control verificaton aborted.
The Alere Afinion™ Control Data entered was not recognized. The control test was
aborted by the operator. Test result was not stored. Run new control test to reset
QC lockout interval.
504
Required control test interval
has expired. Patient testing
is disabled for this assay.
A passed control run must be performed according to configuration to unlock this
assay for patient testing.
[#]
Cause
Action to take
601
Operator list or control lot
database is full
The operator list can store 500 operators and the control lot database can store 100
control lots. Delete an operator or control lot to enter a new item
Service information
The laboratory must notify the manufacturer of this test system of any performance, perceived or validated,
that does not meet the performance specifications as outlined in the instructions.
The manufacturer provides a toll free line for technical support.
1.866.216.9505
The toll free number is available for use only in the United States of America.
Before asking for assistance, please record the following information:
• Alere Afinion™ AS100 Analyzer serial number (SN) – see page 1
• Software version number – see page 1 or start-up menu
• Alere Afinion™ test type
• Test Cartridge lot number – see foil pouch or kit container
• Control name and lot number – see vial label
• Control results obtained
• Description of the problem with reference to information codes or messages
30
MAINTENANCE AND WARRANTY
Cleaning and maintenance
No maintenance of the Alere Afinion
TM
AS100 Analyzer is required other than cleaning the exterior and cartridge chamber.
Cleaning the exterior
Cleaning the exterior of the Alere Afinion
TM
AS100 Analyzer should be performed whenever necessary. Most spills and stains can be
removed with water or a mild detergent.
- Power off the Analyzer. Unplug the power supply when the shut down procedure is completed.
- Clean the outside of the Analyzer and the touch display with a clean, lint-free and non-abrasive cloth dampened in water
or a mild detergent.
- To disinfect the exterior of the instrument, first remove as much as possible of the spilled material with a cloth dampened
in the disinfectant (2% glutaraldehyde or 0.5% sodium hypochlorite). The surface of the Analyzer should be exposed to
the disinfectant for at least 10 minutes.
1
- Allow the Analyzer to air dry.
- Plug in the power supply and power on the Analyzer.
• The Analyzer must be powered off and unplugged before cleaning.
• Do not use any cleaning liquid or equipment other than those recommended above.
• Do not immerse the Analyzer in water or other liquids.
Cleaning the cartridge chamber
The Alere Afinion
TM
AS100 Analyzer Cleaning Kit (
1116048) should always be used for cleaning the cartridge chamber.
The cartridge chamber should be cleaned immediately if materials or liquids are spilled in the cartridge chamber.
For regular maintenance (removal of dust particles etc.), the cartridge chamber should be cleaned every 30 days.
- Touch
to open the lid.
- Unplug the power supply.
- Wet a Cleaning Swab with 3 drops of water or a disinfectant (2% glutaraldehyde or 0.5% sodium hypochlorite).
Do not soak.
- Carefully remove spills and particles from the cartridge chamber using the moistened swab.
- To disinfect the cartridge chamber, the surface of the chamber should be exposed to the disinfectant
for at least 10 minutes.
1
- Wipe off any residual liquid from the cartridge chamber using a new, dry Cleaning Swab.
- Close the lid.
- Plug in the power supply and power on the Analyzer.
• The Analyzer must be unplugged before cleaning.
• Do not use any cleaning liquid or equipment other than those recommended above.
• Do not allow liquid to drip off the Cleaning Swab into the Analyzer. If liquid drips into the Analyzer,
optics can be destroyed.
• Do not immerse the Analyzer in water or other liquids.
• Do not move or tilt the Analyzer when cleaning the cartridge chamber.
Disposal of the Analyzer
For correct disposal according to the Directive 2012/19/EU (WEEE), contact your local Alere Afinion™ supplier.
Software upgrade
Consult the Alere Afinion™ AS100 Analyzer SW Upgrade Package Insert.
1
Clinical and Laboratory Standards Institute (CLSI) Guideline M29-A3: ”Protection of Laboratory Workers From Occupationally
Acquired Infections; Approved Guideline - Third Edition”. ISBN 1-56-238-567-4
31
MAINTENANCE AND WARRANTY
Warranty
Alere Technologies AS warrants solely to the Buyer that the Alere Afinion™ AS100 Analyzer will be free from defects in materials
and workmanship, when given normal, proper and intended usage, and will perform in accordance with Alere Technologies AS’s
specifications for a period of twelve months from the date of delivery.
At its expense, Alere Technologies AS agrees to repair, or at Alere Technologies AS’s option, replace with a new or recon ditioned
unit, any Alere Afinion™ AS100 Analyzer which is under warranty and not performing substantially in accordance with applicable
product specifications, provided that the Buyer has given Alere Technologies AS notification of such warranty claim within the
warranty period. If Alere Technologies AS is unable after reason able efforts to repair or replace the Alere Afinion™ AS100 Analyzer
not performing substantially in accordance with applicable product specifications, the Buyer’s sole remedy shall be the refund of
an amount not to exceed the actual purchase price paid by the Buyer for the Alere Afinion™ AS100 Analyzer. All repairs will be
done during normal working hours. All replaced parts shall become Alere Technologies AS’s property. Alere Technologies AS may
require the Buyer to ship the Alere Afinion™ AS100 Analyzer to Alere Technologies AS or elsewhere at Alere Technologies AS’s
expense, for warranty service to be performed.
Notwithstanding the foregoing, Alere Technologies AS shall have no obligation to make repairs, replacements or corrections which
result, in whole or in part, from (i) an act of God or other unforeseen catastrophe, (ii) any error, omission or negligence of the Buyer,
(iii) improper or unauthorized use of the Alere Afinion™ AS100 Analyzer, (iv) operating errors or the disregard of warnings and pre-
cautions described in this Alere Afinion™ AS100 Analyzer User Manual; (v) repairs performed to the Alere Afinion™ AS100 Analyzer
by any person other than an authorized Alere Technologies AS service representative; (vi) use of the Alere Afinion™ AS100 Analyzer
in a manner for which it was not designed, (vii) causes external to the Alere Afinion™ AS100 Analyzer such as, but not limited to,
power failure or electric power surges, or (viii) use of the Alere Afinion™ AS100 Analyzer in combination with equipment, compo-
nents or software not supplied by Alere Technologies AS.
EXCEPT AS STATED IN THIS SECTION OF THE USER MANUAL, ALERE TECHNOLOGIES AS DISCLAIMS ALL WARRANTIES,
WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, WITH RESPECT TO THE ALERE AFINION™ AS100 ANALYZER,
INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. ALERE TECHNOLOGIES
AS’S MAXIMUM LIABILITY ARISING OUT OF THE SALE OF THE ALERE AFINION™ AS100 ANALYZER OR ITS USE, WHETHER
BASED UPON WARRANTY, CONTRACT, TORT OR OTHERWISE, SHALL NOT EXCEED THE ACTUAL PURCHASE PRICE PAID BY
THE BUYER FOR THE ALERE AFINION™ AS100 ANALYZER. IN NO EVENT SHALL ALERE TECHNOLOGIES AS BE LIABLE FOR
SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS, LOSS OF
DATA OR LOSS OF USE DAMAGES, ARISING HEREUNDER OR FROM THE SALE OF THE ALERE AFINION™ AS100 ANALYZER.
THIS WARRANTY MAY NOT BE TRANSFERRED BY THE BUYER.
The acknowledgement of claims shall be reported to your Technical Care Specialist at 1.866.216.9505
32
TECHNICAL SPECIFICATIONS
Alere Afinion
TM
AS100 Analyzer
Analyzer
Size
13,4 x 6,7 x 7,4 in. / 340 x 170 x 190 mm
Weight
11 lbs. / 5 kg
Display
Standard LCD color display with back light and integrated touch panel.
Resolution: 240 x 320 pixels. Visible area: 2.3 x 3.0 in. / 58 x 77 mm.
Camera
640 x 480 pixels
Capacity of result records
500 patient results and 500 control results
Capacity of operator list
500 operators
Capacity of control lot database
100 control lots
SW update
via USB flash drive
Communication interface
RS 232C, USB 1.1
Power supply
Power cord adapter
Separate AC to DC power cord adapter. Double insulated.
Input
100-240 VAC, 50/60 Hz, 42 W
Output
24 VDC ± 5%, 1.75A
Output connector
0.2 x 0.1 in. / 5.5 x 2.5 mm plug. Positive (+) on inner pin.
Adapter standards
IEC/EN-60950/UL 1950 (USA and Europe). EN-60601/UL 2601
(Japan). Approved for in vitro diagnostic medical devices.
Operating conditions
Temperature
15-32ºC (59-89ºF)
Relative humidity
10-90%, non-condensing
Location
Dry, clean, horizontal surface. Avoid direct sunlight.
Test Cartridge temperature
According to specifications for the Alere Afinion
TM
test in use.
Storage and transport (in the original container)
Temperature
-40 to 70ºC (-40 to 158ºF)
Relative humidity
10-93% at 40ºC (104ºF)
Additional equipment
For information regarding recommended barcode reader, printer, The Alere Afinion
TM
AS100 Analyzer Cleaning Kit, USB flash drive
or Alere Afinion™ Data Connectivity Converter, please call 1.866.216.9505.
33
The touch buttons and their function
Touching a button on the screen will activate the function of this button. All the touch buttons that may appear during operation of
the Alere Afinion™ AS100 Analyzer are explained below by their function.
Menu
Touch button
Name
Function
Start-up menu
Patient sample mode
Select patient sample mode.
Control mode
Select control mode.
Main menu
Enter main menu (operator ID, patient records, control records
and configuration menu).
QC lockout status
Enabled-unlocked
All controls are within the configured interval. It is possible to
run patient tests for all assays.
QC lockout status
Warning-unlocked
All controls are within the configured interval. When one or
more of the assays has 10 % or less of the configured interval
remaining the warning icon will be displayed. It is possible to
run patient tests for all assays.
QC lockout status
Expired-locked
One or more controls have expired according to the configured
interval. Patient testing on the expired assay has been locked.
Operator logout
button
Manual operator logout button.
Main menu
Patient records
View patient result records. View, print or export patient
results.
Control records
View control result records. View, print or export control
results.
Configuration menu
Enter configuration menu (language, patient ID on/off, date/
time and screen/volume).
Configuration
menu
Patient ID
configuration
Configure patient ID function.
Operator menu
Configure operator function.
Language
Enter language selection.
Screen/Beeper volume
menu
Configure screen and beeper volume settings
(screen contrast, screen adjustment and beeper volume).
Date/Time menu
Enter date/time settings (date and time).
QC lockout menu
Configure QC lockout function.
Patient ID menu
Patient ID disabled
Patient ID disabled.
Patient ID enabled
Patient ID enabled and required.
Operator menu
Operator ID
configuration
Configure operator ID function.
Automatic operator
logout
Configure number of minutes before automatic logout of
operator.
Operator list
Manage operator list. View, add, edit and delete operators.
Patient and
control records
Print
Print result on connected printer.
Result records export
Export result records to connected USB flash.
Universial
buttons
Patient ID
Enter patient ID.
Control ID
Enter control ID.
Enter
Enter and return to previous view.
Backspace
Delete previous character.
Increase
Increase contrast/volume.
Decrease
Decrease contrast/volume.
34
GALLERY OF ICONS
Menu
Touch button
Name
Function
Scroll up
View previous
Scroll down
View next
Exit
Exit current menu and return to previous screen view.
Accept
Accept (a setting or a test result).
Abort
Abort the test result or cancel operation.
Add button
Add new operator or control lot.
Delete button
Delete operator or control lot.
Edit button
Edit QC lockout interval or operator ID.
Operator ID
configuration
Operator ID disabled
Operator ID function is disabled.
Operator ID enabled
Operator ID is required to be entered to run an Alere Afinion™
Test Cartridge
Operator ID enabled
with verification
Operator ID is required to be entered to run an Alere Afinion™
Test Cartridge. The operator ID is verified against the
instrument operator list.
Screen/Beeper
volume menu
Screen contrast
Enter screen contrast setting.
Screen alignment
Enter screen alignment function.
Beeper volume
Enter beeper volume setting.
Date/Time menu
Date
Enter date setting.
Time
Enter time setting.
QC lockout
menu
QC lockout
Enable/disable QC lockout function.
QC lockout interval
Configure QC warning and lockout interval.
Control lot information
View, add or delete control lots stored on instrument.
Operator list
Operator list export
Export operator list from instrument to USB flash.
Operator list import
Import operator list from USB flash to instrument.
QC lockout
QC lockout disabled
QC lockout is disabled for this test.
QC lockout enabled
One passed control run of either C I or C II is required to reset
QC lockout interval.
QC lockout enabled
Two passed control runs, C I and C II is required to reset QC
lockout interval.
QC lockout
interval
Interval by number of
patient tests
QC reminder and lockout active after a configured set of
patient tests.
Interval by number of
hours
QC reminder and lockout active after a configured set of
hours.
35
GALLERY OF ICONS
Other symbols and signs
Other symbols, signs and abbreviations that may appear during operation of the Alere Afinion™AS100 Analyzer are explained
below. These symbols or signs are only informative and can not be activated like the buttons.
Symbol
Meaning
Appears when?
Wait!
Hour-glass icon that appears in the start-up procedure.
Information code
Icon used along with a code number [#] that corresponds to code specific information
messages [#] (see “Information codes and troubleshooting”).
Operator ID
Icon illustrates the operator ID.
Patient ID
Icon illustrates the patient ID.
Control ID
Icon illustrates the control ID.
Quality control pass
Control result is within acceptable range.
Quality control failed Control result is outside acceptable range.
Result is above
acceptable range
The displayed control result is above acceptable range.
Result is below
acceptable range
The displayed control result is below acceptable range.
C
Control
The letter C will appear on the screen when the control mode is selected.
O-ID
Operator ID
Abbreviation used in the patient and control records.
P-ID
Patient ID
Abbreviation used in the patient records.
C-ID
Control ID
Abbreviation used in the control records.
RUN#
Run number
Abbreviation used in the patient and control records for the run number of the
analysis. This numbering is reset each day at midnight.
LOT#
Lot number
Abbreviation used in the patient and control records for the lot number of the Test
Cartridge.
USER
User
Operator with user privileges.
SUPERVISOR
Supervisor
Operator with supervisor privileges.
36
The following symbols and abbreviations are used in the product labelling and instructions for the Alere Afinion™ AS100 Analyzer System.
Symbol/Abbreviation
Explanation
Conformity to the European directive 98/79/EC on in vitro diagnostic medical devices
In Vitro Diagnostic Medical Device
Catalog number
Lot number
Serial number
Test Cartridge
CONTROL C I
Control C I
CONTROL C
II
Control C II
CLEANING KIT
Cleaning kit
Waste Electrical and Electronic Equipment (WEEE)
Contents sufficient for ”
Σ” number of tests
Expiry date (year-month)
Storage temperature limitations
Manufacturer
Fragile, handle with care
Keep away from sunlight
Keep dry
Operator’s handling
Warnings and precautions
Consult the Alere Afinion™ user instructions
Direct current
USB port
IOIOI
Serial port
Double insulation
LED
Light Emitting Diode
PC
Personal Computer
ID
Identification
HIS
Hospital Information System
LIS
Laboratory Information System
LCD
Liquid Crystal Display
AC
Alternating Current
DC
Direct Current
SYMBOLS AND ABBREVIATIONS
37
1116227 Rev
. A 2014/07
www
.signatur
.no - 140325
Alere Technologies AS
Kjelsåsveien 161
P.O. Box 6863 Rodeløkka
NO-0504 Oslo, Norway
www.alere.com
ISO 9001 and ISO 13485 certified company
© 2014 Alere. All rights reserved.
The Alere Logo, Alere and Afinion are trademarks of the Alere group of companies.
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