Alere Afinion ™ as100 Analyzer us


INFORMATION CODES AND TROUBLESHOOTING



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  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

GALLERY OF ICONS

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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