26
Patient and control results records
The patient and control results are stored in the memory of the Alere Afinion™ AS100 Analyzer. The last 500 patient results and the
last 500 control results are saved in separate records. When exceeding the capacity of 500 results, the oldest result will be deleted.
The following parameters are listed for each run: Date and time, run number, patient ID/control ID, operator ID, lot number of Test
Cartridge and the test result.
View, print and export patient and control results
1
Main menu
Touch
to enter patient results.
Touch
to enter control results.
2
The last patient result or control is displayed.
To view more results touch
or
If a printer is connected, touch
to print the result.
Result records may be exported if a USB flash (FAT 32 formatted) is inserted into the Alere Afinion™ USB port.
Touch
to export the results. The results will be stored on the USB in a .txt file for each assay tested on the Alere Afinion™
AS100 Analyzer. These files may be opened in e.g. Microsoft Excel for further processing.
Caution
When you export data that contains patient information, it is your responsibility to comply with your local regulations on
protection of personal health information.
TESTING PROCEDURES
27
When an information code appears
Information codes that might appear during use of the Alere Afinion™ AS100 Analyzer refer to specific information messages.
The code numbers, the possible causes and actions to take are listed below.
If the Analyzer detects a problem during processing of a Test Cartridge, the test will automatically be aborted and the Test Cartridge
will be safely moved to the cartridge chamber. Proceed as follows:
1
Record the code number (#) and touch
to accept.
The lid opens automatically.
2
Remove the Test Cartridge.
If the Test Cartridge is not ejected, restart the Analyzer.
Do not re-use the Test Cartridge.
3
Look up the possible cause from the table below, and take actions to solve the problem.
If the problem persists, contact your local Alere Afinion™ supplier (see “Service information” page 29).
Do not re-use a Test Cartridge that has been rejected by the Analyzer. Collect a new sample and repeat the test
with a new Test Cartridge.
Information codes caused by assay specific limitations
[#]
Cause
Action to take
103
Hemoglobin too low
Consult the Alere Afinion™ HbA1c
Package Insert, section Test result reporting.
104
Hemoglobin too high
Consult the Alere Afinion™ HbA1c Package Insert, section Test result reporting.
105
HbA1c too low
Consult the Alere Afinion™ HbA1c Package Insert, section Test result reporting.
106
HbA1c too high
Consult the Alere Afinion™ HbA1c Package Insert, section Test result reporting.
107
Creatine too high
Consult the Alere Afinion™ ACR Package Insert.
108
Blood in urine
Consult the Alere Afinion™ ACR Package Insert.
INFORMATION CODES AND TROUBLESHOOTING
28
INFORMATION CODES AND TROUBLESHOOTING
Information codes caused by sample or Test Cartridge failure
[#]
Cause
Action to take
201
Insufficient sample volume:
- Empty capillary
- Air bubble in capillary
- Capillary incompletely filled
Repeat the test with a new sample and Test Cartridge.
Ensure that the capillary is completely filled with no air bubbles.
202
Excess sample on the sampling
device exterior
Repeat the test with a new sample and Test Cartridge.
Ensure that only the tip of the capillary is in contact with the sample.
203
Wrong sample material
Repeat the test with a new sample and Test Cartridge. Ensure that proper sample
material is used (see Package Insert for the Alere Afinion™ test in use, section
Specimen collection and storage).
204
Coagulated sample
Repeat the test with a new sample and Test Cartridge.
The time from filling the capillary until analyzing the Test
Cartridge should be as short as possible.
Hemolysed blood sample
(Alere Afinion™ HbA1c)
Consult the Alere Afinion™ HbA1c Package Insert.
Repeat the test with a new sample and Test Cartridge.
Test Cartridge or Analyzer failure Repeat the test with a new sample and Test Cartridge.
If the problem persists, restart the Analyzer and run controls.
205
Capillary cracked or damaged
Repeat the test with a new sample and Test Cartridge.
Inspect the sampling device before use and handle with care.
206
Barcode label not readable
(dirty or damaged)
Repeat the test with a new sample and Test Cartridge.
If the problem persists, restart the Analyzer and run controls.
207
No
sampling device inserted
Repeat the test with a new sample and Test Cartridge.
Used sampling device belongs
to another Alere Afinion™ test
Repeat the test with a new sample and Test Cartridge. Ensure that the sampling device
and Test Cartridge have the same label color.
Label on sampling device not
readable (dirty or damaged)
Repeat the test with a new sample and Test Cartridge. Ensure that the label is clean.
208
Test Cartridge previously used
Repeat the test with a new sample and Test Cartridge.
209
Test Cartridge has passed
expiration date
Check expiration date on the Cartridge pouch or box.
Repeat the test using a new sample and a new Test Cartridge from another lot.
The date in the Analyzer is
incorrectly set
Check the date in the Analyzer to make sure it is set correctly.
Repeat the test with a new sample and Test Cartridge.
210
Test Cartridge temperature too
low
Repeat the test with a new sample and a new Test
Cartridge within recommended
operating temperature range (see Package Insert for the Alere Afinion™ test in use).
211
Test Cartridge temperature too
high
Repeat the test with a new sample and a new Test Cartridge within recommended
operating temperature range (see Package Insert for the Alere Afinion™ test in use,
section Test procedure).
212
Test Cartridge not recognized
by the Analyzer
The software version required for this test is not installed.
Contact your local supplier for assistance.
213
214
215
Test Cartridge or Analyzer failure Repeat the test with a new sample and Test Cartridge.
If the problem persists, restart the Analyzer and run controls.
217
Test Cartridge or Analyzer failure Repeat the test with a new sample and Test Cartridge.
If the problem persists, restart the Analyzer and run controls.
218
Condensation
detected on
cartridge
Run a new test cartridge, ensure that the cartridge is equilibrated to room temperature
before the foil pouch is opened.
Information codes or messages caused by Analyzer failure
[#]
Cause
Action to take
301
Self-test failed
Restart the Analyzer.
302
Analyzer failure
Restart the Analyzer and run controls.
Repeat the test with a new sample and Test Cartridge.
303
Analyzer temperature is too high Ensure that the operating temperature is within recommended range (15-32°C, 59-89°F).
Wait until the Analyzer has cooled down. Repeat the test with a new sample and Test
Cartridge.
304
Analyzer temperature is too low
Ensure that the operating temperature is within recommended range for the Alere
Afinion™ test in use (see Package Insert). The Analyzer temperature is displayed in the
Start-Up menu (see page 13). Repeat the test with a new sample and Test Cartridge.
305
- Printer improperly connected
- Malfunction of the printer
Power off the Analyzer, reconnect the printer and restart the Analyzer.
If the message persists, see the printer User Manual.