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Alere Technologies GmbH

Löbstedter Straße 103-105


07749 Jena,
Pima Error Resolution Guide
Germany

Error Resolution Scripts

Revision date: 27-Feb-13

The information contained in this document is intended to guide Service and Repair activities.
For internal use only. Do not hand out to customers.

ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Revision Notification

The following changes have been made compared to the previous version of this document:

Revision of sections “Analyser does not charge”, “Analyser shuts down on its own account” and
“Storage Error - Storage medium lost”

P2
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Table of Scripts
ERROR 200 TEST ABORTED (SFDC: 3301) ................................................................................................................. 5

ERROR 201 VOLUME (SFDC: 3318) ........................................................................................................................... 6

ERROR 202 COLLISION (SFDC: 3317) ........................................................................................................................ 8

ERROR 203 EXPIRY DATE (SFDC: 3320)..................................................................................................................... 9

ERROR 205 LOST CARTRIDGE (SFDC: 3301) .............................................................................................................10

ERROR 206 MANUAL ABORT (SFDC: 3301)..............................................................................................................11

ERROR 207 NO RESULT VALUE AVAILABLE (SFDC: 3327) .........................................................................................12

ERROR 210, 220, 230 DEVICE APPLICATION (SFDC: 3302) .......................................................................................13

ERROR 211 TIME OUT ERROR (SFDC: 3301)............................................................................................................14

ERROR 300 - 399 ELECTRONICS ERRORS (SFDC: 3303).............................................................................................15

ERROR 810 CHANNEL FILLING (SFDC: 3304) ...........................................................................................................16

ERROR 820 FOCUS CONTROL (SFDC: 3305) .............................................................................................................18

ERROR 825 GRID DETECTION AT FOCUS CONTROL (SFDC: 3305).............................................................................19

ERROR 830 EXPOSURE TIME (SFDC: 3306) ..............................................................................................................20

ERROR 840 FOCUS RANGE (SFDC: 3307) .................................................................................................................22

ERROR 850 EXPOSURE POSITION CONTROL (SFDC: 3308) .......................................................................................24

ERROR 860 REAGENT CONTROL (SFDC: 3309) .........................................................................................................26

ERROR 870 CORRESPONDENCE CONTROL (SFDC: 3310) .........................................................................................27

ERROR 880 CELL MOVEMENT CONTROL (SFDC: 3311) ............................................................................................28

ERROR 910 IMAGE (SFDC: 3313) .............................................................................................................................30

ERROR 920 PLAUSIBILITY (SFDC: 3314) ...................................................................................................................32

ERROR 930 HOMOGENEITY (SFDC: 3315)................................................................................................................34

ERROR 940 GATING (SFDC: 3316) ...........................................................................................................................36

ERROR 0000 UNDEFINED ERROR (SFDC: 3317)........................................................................................................38

ANALYSER DISPLAY SHOWS BRIGHT VERTICAL LINES (SFDC: 3038) .........................................................................39

ANALYSER DOES NOT CHARGE (SFDC: 3036)...........................................................................................................40

ANALYSER DOES NOT DRAW IN TEST CARTRIDGES (SFDC: 3319) ............................................................................42

ANALYSER DOES NOT EJECT TEST CARTRIDGES (SFDC: 3317) ..................................................................................43

ANALYSER DOES NOT FINISH AN ANALYSIS (SFDC: 3321) .......................................................................................44

ANALYSER DOES NOT REACT TO KEYPAD ENTRIES (SFDC: 3019) .............................................................................45

ANALYSER EJECTS TEST CARTRIDGES BEFORE THE ANALYSIS IS FINISHED (SFDC: 3319) ..........................................46

ANALYSER FAILS TO START-UP (SFDC: 3039) ..........................................................................................................47


P3
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
ANALYSER SHUTS DOWN ON ITS OWN ACCOUNT (SFDC: 3036) .............................................................................49

ARCHIVE ERROR (SFDC: 3322) .............................................................................................................................51

BARCODE ERROR (SFDC: 3011) .............................................................................................................................52

ENTRY ERROR – OPERATOR ID ALREADY EXISTS (SFDC: 3323) ...............................................................................53

ENTRY ERROR – OPERATOR ID/SAMPLE ID (SFDC: 3323) ........................................................................................54

EXPORT ERROR – EXPORT FAILED (SFDC: 3214) ......................................................................................................55

EXPORT ERROR – NO RECOGNITION OF THE USB STORAGE MEDIUM (SFDC: 3214) ...............................................56

FAILURE WHILE DISPLAYING RESULT (SFDC: 3327) .................................................................................................57

INVALID BARCODE (SFDC: 3328) .............................................................................................................................58

POWER WARNING, POWER ERROR AND ERROR 0 (SFDC: 3324) .............................................................................59

PRINTER ERROR PAPER REQUIRED (SFDC: 3025).....................................................................................................61

PRINTER ERROR (SFDC: 3025) .............................................................................................................................62

SELECTION ERROR (SFDC: 3325) ............................................................................................................................64

STORAGE ERROR - STORAGE MEDIUM FULL (SFDC: 3214) ......................................................................................65

STORAGE ERROR - STORAGE MEDIUM LOST (SFDC: 3214) ......................................................................................66

UNEXPECTED EXCEPTION (SFDC: 3330) .................................................................................................................67

NOTE
For every Error Code or Error Message a suggestion is given for the most likely Primary Product
that needs to be named in SFDC when opening a complaint case. Follow these suggestions, but
review for correctness before closing a case in SFDC.

For every Error Code or Error Message a suggestion for a SFDC Trending Code is given.

P4
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Error 200 Test aborted (SFDC: 3301)
Primary Product: Pima Analyser
Description:
An Analysis was started, but not finished. In Analysers running software versions older than 0.39.1, this can
be caused intentionally by manually aborting the analysis or by a technical problem, causing an automatic
termination by the Analyser. In Analysers running software version 0.39.1 or higher Errors 205, 206 and 211
cover certain triggers previously causing Error 200.

Questions Coach

Q1: Have you manually aborted an If the answer is yes, advise the Operator that manually aborting
analysis? an analysis will trigger Error 200.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6079, 4019 [END OF SCRIPT]
If the answer is no, continue with Q2

Q2: Does the problem occur with If only Pima Bead Standard cartridges are affected, ask the
Pima CD4 test cartridges AND Operator whether the Bead Standard cartridges causing the
Pima Bead Standard cartridges? problem have been used for more than 6 months and refer to
the Pima Bead Standard User Guide regarding stability of the
product.
Advise the Operator to use a different set of Pima Bead
Standard cartridges and to report back should the problem
persist. Otherwise no action needs to be taken.
SFDC: 6029, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges are affected or the Bead Standard
cartridges are younger than 6 months, continue with Q3.

Q3: How often did the problem occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q4.

Q4: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
Refer to Pima Analyser User Guide Section 8.
If the answer is yes, advise the Operator to continue with the
measurements and to report back should the problem become
frequent.
SFDC: 6078, 4015, 4003 [END OF SCRIPT]
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

P5
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 201 Volume (SFDC: 3318)


Primary Product: Pima CD4 25X or 100X Cartridge Kit
Description:
The Pima Analyser checks whether sufficient sample was loaded onto the test cartridge.
An Error 201 can be caused by too little sample volume in the cartridge, unusual sample characteristics, the
use of control blood or a failure of the volume sensor of the Analyser. It regularly is triggered when a
cartridge is tested for the second time.

Questions: Coach

Q1: Was the particular cartridge that If the answer is yes, advise the Operator that a Pima CD4 test
caused the error tested for the cartridge is a single use device.
second time when the error Advise the Operator to continue with the measurements and to
occurred? report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q2.

Q2: How did you ensure that sufficient If the Operator cannot explain the steps outlined in the Pima CD4
sample was loaded onto the Cartridge Guide, reinforce the importance of proper sample
cartridge and the cartridge was loading and closing of the cartridge cap.
closed? Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6079, 5022, 4019, 4003 [END OF SCRIPT]
If the Operator can explain the process, continue with Q3.

Q3: Was the cartridge dropped before If the answer is yes, tell the Operator that filled cartridges
inserting it in the Pima Analyser? should not be processed after they were dropped.
SFDC: 6079, 4019 [END OF SCRIPT]
If the answer is no, continue with Q4.

Q4: Does the error occur with liquid If the answer is yes, explain to the Operator that certain liquid
control material? control materials trigger Error 201 due to their different color
compared to real blood. Error 201 with control blood can be
manually overruled. Advise the Operator to continue with the
measurements and to report back should the problem occur
with whole human blood samples as well.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q5.

Q5: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q6.

… continue with following page

P6
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q6: How old were the samples that If the samples were older than 36 hours and/or stored considerably
were used and how were they outside the recommended temperature of 18 – 28°C, explain to the
stored? Operator the importance of adhering to the recommended
storage conditions and refer to the Pima CD4 Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If age and storage condition can be ruled out as a cause, continue
with Q7.

Q7: Does the error occur with samples If only samples from a particular patient are affected, explain to the
from different patients? Operator that it is most likely a sample specific problem.
Advise the Operator to continue with the measurements and to
report back should the problem occur with other samples as
well.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If more than once, contact a higher level TS hub.
[END OF SCRIPT]

P7
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 202 Collision (SFDC: 3317)


Primary Product: Pima CD4 25X or 100X Cartridge Kit
Description:
Before starting an analysis the Pima Analyser reads the cartridge barcode by moving the cartridge along the
barcode reader. To do this, the Analyser uses all available space for cartridge movement.
An Error 202 is triggered if the cartridge physically collides with the cartridge slot door while the barcode is
read. This is in general caused by not properly closed cartridge caps.

Questions: Coach

Q1: Did the Analyser automatically If the answer is yes, continue with Q3.
eject the cartridge when
If the answer is no, continue with Q2.
displaying Error 202?

Q2: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
Refer to Pima Analyser User Guide Section 7.
If the answer is yes, continue with Q3.
If the answer is no, advise the Operator follow these
instructions:
Turn off the Pima Analyser as explained above.
Lift the cartridge slot door of the Pima Analyser. It may be
necessary to insert the blade of a knife or a screw driver
underneath the slot door to lift it up. CAUTION: Do not insert
the blade more than 2 mm underneath the door! Do not use
your fingernails!! Always wear gloves!!
Now restart the Analyser while lifting up the slot door. The
cartridge should now be ejected.
Continue with Q3.
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

Q3: How did you ensure that the If the Operator cannot explain the steps outlined in the Pima CD4
cartridge was closed? Cartridge Guide, reinforce the importance of proper closing of
the cartridge cap.
Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]

P8
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 203 Expiry date (SFDC: 3320)


Primary Product: Pima CD4 25X or 100X Cartridge Kit or Pima Bead Standard

Description:
The Pima Analyser detects a cartridge that is expired.

Questions: Coach

Q1: Are the cartridges you are using If the operator does not know where to find the expiry date of the
expired? cartridge, explain to the Operator where to find it on the
cartridge pouches.
If the answer is yes, tell the Operator that expired cartridges
cannot be used and advise to use a different cartridge lot.
SFDC: 6029, 4019 [END OF SCRIPT]
If the answer is no, continue with Q2.

Q2: Are date and time on your Pima If the answer is no, explain to the Operator how to change date
Analyser correct? and time on the Pima Analyser (refer to Pima Analyser User
Guide sections 6).
Advise the Operator to continue with the measurements and to
report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is yes, continue with Q3.

Q3: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q4.

Q4: What is the cartridge lot you If the operator does not know the cartridge lot, explain where to
encountered the error with? find it on the cartridge pouches.
Advise the operator to continue with the measurements and
report back should the problem persist.
Contact Alere Technologies at +49 3641 3111444 to enquire
whether the cartridge lot reported by the Operator is indeed expired
or has shown error 203 at other sites as well.
SFDC: 6078, 4019, 4003, 4024 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P9
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 205 Lost Cartridge (SFDC: 3301)


Primary Product: Pima Analyser
Description:
Pima Analyser lost contact with cartridge.
This error can only occur with instruments running software version 0.39.1 or higher.

Questions: Coach

Q1: Does the problem occur with If only Pima Bead Standard cartridges are affected, ask the
Pima CD4 test cartridges AND Operator whether the Bead Standard cartridges causing the
Pima Bead Standard cartridges? problem have been used for more than 6 months and refer to
the Pima Bead Standard User Guide regarding stability of the
product.
Advise the Operator to use a different set of Pima Bead
Standard cartridges and to report back should the problem
persist. Otherwise no action needs to be taken.
SFDC: 6029, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges are affected or the Bead Standard
cartridges are younger than 6 months, continue with Q2.

Q2: How often did the problem occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, contact a higher level TS hub.
[END OF SCRIPT]

P10
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Error 206 Manual Abort (SFDC: 3301)
Primary Product: Pima Analyser
Description:
An Analysis was manually aborted by the operator.
This error code is only displayed with instruments running software version 0.39.1 or higher.

Questions Coach

Q1: Have you manually aborted an If the answer is yes, advise the Operator that manually aborting
analysis? an analysis will trigger Error 206 in Pima Analyser running with
software version 0.39.1 or higher.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6079, 4019 [END OF SCRIPT]
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

P11
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Error 207 No Result Value Available (SFDC: 3327)
Primary Product: Pima Analyser
Description:
This error can only occur with instruments running software version 0.39.1 or higher.

Questions Coach

Q1: How often did the problem occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If the answer is no, continue with Q2

Q2: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
Refer to Pima Analyser User Guide Section 8.
If the answer is yes, advise the Operator to continue with the
measurements and to report back should the problem become
frequent.
SFDC: 6078, 4015, 4003 [END OF SCRIPT]
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

P12
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Error 210, 220, 230 Device Application (SFDC: 3302)
Primary Product: Pima Analyser

Questions: Coach

Q1: Was the problem alleviated by If the Operator does not know how to do this, refer to Pima
shutting down and restarting the Analyser User Guide Section 7. Then restart the Pima
Pima Analyser? Analyser.

If the answer is yes, continue with Q2.


If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

Q2: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, contact a higher level TS hub.
[END OF SCRIPT]

P13
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Error 211 Time Out Error (SFDC: 3301)
Primary Product: Pima Analyser
Description:
This error can only occur with instruments running software version 0.39.1 or higher.

Questions Coach

Q1: Was the problem alleviated by If the Operator does not know how to do this refer to Pima
shutting down and restarting the Analyser User Guide Section 7. Then restart the Pima
Pima Analyser? Analyser.

If the answer is yes, continue with Q2.


If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

Q2: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, contact a higher level TS hub.
[END OF SCRIPT]

P14
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Error 300 - 399 Electronics Errors (SFDC: 3303)
Primary Product: Pima Analyser

Questions: Coach

Q1: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
Refer to Pima Analyser User Guide Section 7.
If the answer is yes, continue with Q2.
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

Q2: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, contact a higher level TS hub.
[END OF SCRIPT]

P15
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 810 Channel Filling (SFDC: 3304)


Primary Product: Pima CD4 25X or 100X Cartridge Kit
Description:
Channel filling error: The Analyser has a maximum of 6 attempts to move the blood sample from the
cartridge capillary into the detection channel of the cartridge. This is performed by pressing the roller of the
Analyser against the cartridge tubing and gently moving the cartridge along the roller. At the outlet position
of the detection channel an image is taken and analyzed. If this image indicates no or insufficient channel
filling, Error 810 is displayed and the test will be aborted.
In most of the cases the error can be traced back to a cartridge that was not properly closed or to air bubbles
in the detection channel. It is also known that Error 810 may be sample dependent.

Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: Was Error 201 shown and have If the answer is yes, explain to the Operator that Error 201
you overruled it? indicates too little sample and should only be overruled under
certain circumstances. Continue with Script “Error 201
Volume”.
SFDC: 6079, 4019 [END OF SCRIPT]
If the answer is no, continue with Q3.

Q3: How did you ensure that sufficient If the Operator cannot explain the steps outlined in the Pima CD4
sample was loaded onto the Cartridge Guide, reinforce the importance of proper sample
cartridge and the cartridge was loading and closing of the cartridge cap.
closed? Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the Operator can explain the process, continue with Q4.

Q4: Was the particular cartridge that If the answer is yes, advise the Operator that a Pima CD4 test
caused the error tested for the cartridge is a single use device.
second time when the error Advise the Operator to continue with the measurements and to
occurred? report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q5.

… continue with following page

P16
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q5: How old were the samples that If the samples were older than 36 hours and/or stored considerably
were used and how were they outside the recommended temperature of 18 – 28°C, explain to the
stored? Operator the importance of adhering to the recommended
storage conditions and refer to the Pima CD4 Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If age and storage condition can be ruled out as a cause, continue
with Q6.

Q6: Does the error occur with samples If only samples from a particular patient are affected, explain to the
from different patients? Operator that it is most likely a sample specific problem.
Advise the Operator to continue with the measurements and to
report back should the problem occur with other samples as
well.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If samples from different patients are affected, continue with Q7.

Q7: Does the error also occur with a If the answer is yes, continue with Q8
different cartridge lot?
If the answer is no or no other cartridge lot is available, advise the
Operator to continue with the measurements and report back
should the problem persist.
Ask the Operator for the cartridge lot umber and contact Alere
Technologies at +49 3641 3111444 to enquire whether the
cartridge lot reported by the operator has shown error 810 at other
sites as well.
SFDC: 6078, 4003, 4024 [END OF SCRIPT]

Q8: Have you observed any error with If the answer is no, the reason is likely the formation of air
a Pima Bead Standard cartridge bubbles in the detection channel. Advise the Operator not to
during the last 10 runs? touch the channel lid of the cartridge or to rub it with cloth and
to pay particular attention to properly load and close the
cartridges.
Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is yes, contact a higher level TS hub.
[END OF SCRIPT]

P17
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 820 Focus Control (SFDC: 3305)


Primary Product: Pima CD4 25X or 100X Cartridge Kit or Pima Bead Standard

Description:
After autofocus of the optics, laser spots in the cartridge channel (red and green signals) are counted. More
than 10 red and green signals need to be detected. If the number is lower, Error 820 is triggered.

Questions: Coach

Q1: Does Error 820 occur with If only Pima Bead Standard cartridges are affected, advise the
Pima CD4 test cartridges AND Operator to check the channel lid of the Pima Bead Standard
Pima Bead Standard cartridges? cartridge for obvious damage or dirt.
Advise the Operator to clean the channel lid with a lint-free
cloth or use a different set of Pima Bead Standard cartridges
and to report back should the problem not be solved.
Otherwise no action needs to be taken.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges or both cartridge types are
affected, continue with Q2.

Q2: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q3.

Q3: Was the particular cartridge that If the answer is yes, advise the Operator that a Pima CD4 test
caused the error tested for the cartridge is a single use device.
second time when the error Advise the Operator to continue with the measurements and to
occurred? report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q4.

Q4: What is the cartridge lot you If the operator does not know the cartridge lot, explain where to find
encountered the error with? it on the cartridge pouches.
Advise the operator to continue with the measurements and
report back should the problem persist.
Contact Alere Technologies at +49 3641 3111444 to enquire
whether the cartridge lot reported by the Operator has shown
Error 820 at other sites as well.
SFDC: 6078, 4019, 4003, 4024 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P18
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 825 Grid Detection at Focus Control (SFDC: 3305)


Primary Product: Pima CD4 25X or 100X Cartridge Kit or Pima Bead Standard

Description:
After autofocus of the optics is completed, the Analyser verifies the focus level.
A segmentation image called FocusControl_grid.png of the focus position will be created where a minimum
of 17 signals have to be detected within a 5-by-5 grid. If less than 17 signals are found, Error 825 is
triggered.
This error can only occur with instruments running software version 0.39.1 and higher.

Questions: Coach

Q1: Does Error 825 occur with If only Pima Bead Standard cartridges are affected, advise the
Pima CD4 test cartridges AND Operator to check the channel lid of Bead Standard cartridge
Pima Bead Standard cartridges? for obvious damage or dirt.
Advise the Operator to clean the channel lid or use a different
set of Pima Bead Standard cartridges and to report back
should the problem not be solved. Otherwise no action needs
to be taken.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges or both cartridge types are
affected, continue with Q2.

Q2: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q3

Q3: Does the error also occur with a If the operator does not know the cartridge lot, explain where to find
different cartridge lot? it on the cartridge pouches.
Advise the operator to continue with the measurements and
report back should the problem persist.
Contact Alere Technologies at +49 3641 3111444 to enquire
whether the cartridge lot reported by the Operator has shown
Error 825 at other sites as well.
SFDC: 6078, 4019, 4003, 4024 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P19
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 830 Exposure Time (SFDC: 3306)


Primary Product: Pima CD4 25X or 100X Cartridge Kit
Description:
Exposure time is automatically adjusted for each test using the background signal of images filled with blood.
If exposure time adjustment fails Error 830 is displayed and the test is aborted.
Such an error can be caused by unusual sample characteristics or defect Analyser components.
Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: Was Error 201 shown and have If the answer is yes, explain to the Operator that Error 201
you overruled it? indicates too little sample and should only be overruled under
certain circumstances. Continue with chapter “Error 201
Volume” in the Error Resolution Guide.
SFDC: 6079, 4019 [END OF SCRIPT]
If the answer is no, continue with Q3.

Q3: Was the particular cartridge that If the answer is yes, advise the Operator that a Pima CD4 test
caused the error tested for the cartridge is a single use device.
second time when the error Advise the Operator to continue with the measurements and to
occurred? report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q4.

Q4: How old were the samples that If the samples were older than 36 hours and/or stored considerably
were used and how were they outside the recommended temperature of 18 – 28°C, explain to the
stored? Operator the importance of adhering to the recommended
storage conditions and refer to the Pima CD4 Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If age and storage condition can be ruled out as a cause, continue
with Q5.

Q5: Does the error occur with samples If only samples from a particular patient are affected, explain to the
from different patients? Operator that it is most likely a sample specific problem.
Advise the Operator to continue with the measurements and to
report back should the problem occur with other samples as
well.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If samples from different patients are affected, continue with Q6.

… continue with following page

P20
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q6: Does the error also occur with a If the answer is yes, continue with Q7
different cartridge lot?
If the answer is no or no other cartridge lot is available, advise the
Operator to continue with the measurements and report back
should the problem persist.
Ask the Operator for the cartridge lot umber and contact Alere
Technologies at +49 3641 3111444 to enquire whether the
cartridge lot reported by the operator has shown error 830 at other
sites as well.
SFDC: 6078, 4003, 4024 [END OF SCRIPT]

Q7: Have you observed any error with If the answer is no, the reason is likely the formation of air
a Pima Bead Standard cartridge bubbles in the detection channel. Advise the Operator not to
during the last 10 runs? touch the channel lid of the cartridge or to rub it with cloth and
to pay particular attention to properly load and close the
cartridges.
Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is yes, contact a higher level TS hub.
[END OF SCRIPT]

P21
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 840 Focus Range (SFDC: 3307)


Primary Product: Pima CD4 25X or 100X Cartridge Kit or Pima Bead Standard
Description:
For every test the autofocus of the instrument is adjusted to defined features on the Pima CD4 cartridge.
Therefore images on the bead focus position of the cartridge are taken. If an adjustment is not possible a
focus range Error 840 is displayed and the test will be aborted. In most cases focus errors are caused by
dirt on the cartridges and theoretically by defect cartridges. Other possible reasons are perhaps misaligned
optics or dirt and dust on the optics.

Questions: Coach

Q1: Does Error 840 occur with Pima If only Pima Bead Standard cartridges are affected, advise the
CD4 test cartridges AND Pima Operator to check the channel lid of the Pima Bead Standard
Bead Standard cartridges? cartridge for obvious damage or dirt.
Advise the Operator to clean the channel lid with a lint-free
cloth or use a different set of Pima Bead Standard cartridges
and to report back should the problem not be solved.
Otherwise no action needs to be taken.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges or both cartridge types are
affected, continue with Q2.
If both cartridge types are affected the Analyser may be defective,
contact a higher level TS hub.
[END OF SCRIPT]

Q2: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q3.

Q3: Was the particular cartridge that If the answer is yes, advise the Operator that a Pima CD4 test
caused the error tested for the cartridge is a single use device.
second time when the error Advise the Operator to continue with the measurements and to
occurred? report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q4.

… continue with following page

P22
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q4: What were the operating If the operating temperature reported by the Operator is outside the
conditions the Pima Analyser was recommended 10-40°C or the Analyser was exposed to direct
used at? sunlight, explain to the Operator the importance of adhering to
the recommended operating conditions.
Advise the Operator to continue with the measurements under
recommended operating conditions and report back should
the problem persist.
SFDC: 6039, 4019, 4003 [END OF SCRIPT]
If the operating conditions can be ruled out as a cause, continue
with Q5.

Q5: Does the error also occur with a If the answer is yes, continue with Q6
different cartridge lot?
If the answer is no or no other cartridge lot is available, advise the
Operator to continue with the measurements and report back
should the problem persist.
Ask the Operator for the cartridge lot umber and contact Alere
Technologies at +49 3641 3111444 to enquire whether the
cartridge lot reported by the operator has shown error 840 at other
sites as well.
SFDC: 6078, 4003, 4024 [END OF SCRIPT]

Q6: Have you observed any error with If the answer is no, advise the Operator to check the channel lid
a Pima Bead Standard cartridge of the Pima CD4 cartridge for obvious damage or dirt. Advise
during the last 10 runs? the Operator not to touch the channel lid of the cartridge or to
rub it with cloth and to pay particular attention to properly load
and close the cartridges.
Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is yes, contact a higher level TS hub.
[END OF SCRIPT]

P23
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 850 Exposure Position Control (SFDC: 3308)


Primary Product: Pima CD4 25X or 100X Cartridge Kit
Description:
Exposure time is automatically adjusted for each test using the background signal of images filled with blood.
If exposure time adjustment fails Error 850 is displayed and the test is aborted. Such an error can be caused
by air bubbles in the detection channel, instrument failures such as misaligned optics or defect Analyser
components.

Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: Was Error 201 shown and have If the answer is yes, explain to the Operator that Error 201
you overruled it? indicates too little sample and should only be overruled under
certain circumstances. Continue with chapter “Error 201
Volume” in the Error Resolution Guide.
SFDC: 6079, 4019 [END OF SCRIPT]
If the answer is no, continue with Q3.

Q3: Was the particular cartridge that If the answer is yes, advise the Operator that a Pima CD4 test
caused the error tested for the cartridge is a single use device.
second time when the error Advise the Operator to continue with the measurements and to
occurred? report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q4.

Q4: How did you ensure that sufficient If the Operator cannot explain the steps outlined in the Pima CD4
sample was loaded onto the Cartridge Guide, reinforce the importance of proper sample
cartridge and the cartridge was loading and closing of the cartridge cap.
closed? Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the Operator can explain the process, continue with Q5.

… continue with following page

P24
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q5: How old were the samples that If the samples were older than 36 hours and/or stored considerably
were used and how were they outside the recommended temperature of 18 – 28°C, explain to the
stored? Operator the importance of adhering to the recommended
storage conditions and refer to the Pima CD4 Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If age and storage condition can be ruled out as a cause, continue
with Q6.

Q6: Does the error occur with samples If only samples from a particular patient are affected, explain to the
from different patients? Operator that it is most likely a sample specific problem.
Advise the Operator to continue with the measurements and to
report back should the problem occur with other samples as
well.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If samples from different patients are affected, continue with Q7.

Q7: Does the error also occur with a If the answer is yes, continue with Q8
different cartridge lot?
If the answer is no or no other cartridge lot is available, advise the
Operator to continue with the measurements and report back
should the problem persist.
Ask the Operator for the cartridge lot umber and contact Alere
Technologies at +49 3641 3111444 to enquire whether the
cartridge lot reported by the operator has shown error 850 at other
sites as well.
SFDC: 6078, 4003, 4024 [END OF SCRIPT]

Q8: Have you observed any error with If the answer is no, the reason is likely the formation of air
a Pima Bead Standard cartridge bubbles in the detection channel. Advise the Operator not to
during the last 10 runs? touch the channel lid of the cartridge or to rub it with cloth and
to pay particular attention to properly load and close the
cartridges.
Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is yes, contact a higher level TS hub.
[END OF SCRIPT]

P25
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 860 Reagent Control (SFDC: 3309)


Primary Product: Pima CD4 25X or 100X Cartridge Kit
Description:
On every Pima CD4 test cartridge reagent control cells are deposited to test reagent functionality. At the end
of the experiment it is examined whether at least 21 CD3+CD4+ cells can be detected at the Reagent
Control position.
A reagent control error 860 can be caused by deteriorated freeze dried reagent in the cartridge or an air
bubble overlaying the reagent control image position.

Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: How were the Pima CD4 test If the storage conditions reported by the Operator are outside
cartridges stored? recommended 2-30°C for more than 1 week or in direct sunlight,
explain to the Operator the importance of adhering to the
recommended storage conditions outlined in the Pima CD4
Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist. Offer help with the
ordering process should this be necessary.
SFDC: 6039, 4019, 4003 [END OF SCRIPT]
If the storage conditions are within the recommended range,
continue with Q3.

Q3: What is the cartridge lot you If the operator does not know the cartridge lot, explain where to find
encountered the error with? it on the cartridge pouches.
Advise the operator to continue with the measurements and
report back should the problem persist.
Contact Alere Technologies at +49 3641 3111444 to enquire
whether the cartridge lot reported by the Operator is indeed expired
or has shown Error 860 at other sites as well.
SFDC: 6078, 4019, 4003, 4024 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P26
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 870 Correspondence Control (SFDC: 3310)


Primary Product: Pima CD4 25X or 100X Cartridge Kit or Pima Bead Standard
Description:
The individual characteristics of each Analyser optics are saved as a set of parameters on every Pima
Analyser. These are Analyser specific and essential when performing a Pima CD4 or Pima Bead Standard
test. In most of the cases correspondence control error 870 is triggered because of issues with a particular
test. If the error is persisting it could be indicative of an instrument hardware failure.
Questions: Coach

Q1: Does Error 870 occur with Pima If only Pima Bead Standard cartridges are affected, advise the
CD4 test cartridges AND Pima Operator to check the channel lid of Bead Standard cartridge
Bead Standard cartridges? for obvious damage or dirt.
Advise the Operator to clean the channel lid or use a different
set of Pima Bead Standard cartridges and to report back
should the problem not be solved. Otherwise no action needs
to be taken.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges are affected, continue with Q2.
If both cartridge types are affected the Analyser may be defective,
contact a higher level TS hub.
[END OF SCRIPT]

Q2: In case of Pima CD4 test If the answer is yes, advise the Operator that a Pima CD4 test
cartridges, was the particular cartridge is a single use device.
cartridge that caused the error Advise the Operator to continue with the measurements and to
tested for the second time when report back should the problem persist.
the error occurred? SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q3.

Q3: Does the error also occur with a If the answer is yes, continue with Q4
different cartridge lot?
If the answer is no or no other cartridge lot is available, advise the
Operator to continue with the measurements and report back
should the problem persist.
Ask the Operator for the cartridge lot umber and contact Alere
Technologies at +49 3641 3111444 to enquire whether the
cartridge lot reported by the operator has shown error 870 at other
sites as well.
SFDC: 6078, 4003, 4024 [END OF SCRIPT]

Q4: Have you observed any error with If the answer is no, the reason is likely the formation of air
a Pima Bead Standard cartridge bubbles in the detection channel. Advise the Operator not to
during the last 10 runs? touch the channel lid of the cartridge or to rub it with cloth.
Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is yes, contact a higher level TS hub.
[END OF SCRIPT]

P27
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 880 Cell Movement Control (SFDC: 3311)


Primary Product: Pima CD4 25X or 100X Cartridge Kit

Description:
For every Pima CD4 test the Analyser checks the remaining cell movement in the blood before starting the
analysis, to ensure reliable cell count. This Error is caused if the blood has not properly settled, or an air
bubble occurs close to the position where cell movement is checked.

Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: Do you hear the fan in the back of If the answer is yes, continue with Q3.
the Pima Analyser working after
If the answer is no, contact a higher level TS hub.
the instrument was running tests
[END OF SCRIPT]
for an hour?

Q3: What were the operating If the Analyser was placed on a vibrating surface or operated
conditions the Pima Analyser was outside the recommended temperature of 10-40°C or was exposed
used at? to direct sunlight, advise the Operator to ensure proper
installation of the Analyser, to avoid direct sunlight and
exposure to vibrations.
Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6039, 4019, 4003 [END OF SCRIPT]
If the operating conditions can be ruled out as a cause, continue
with Q4.

Q4: How did you ensure that sufficient If the Operator cannot explain the steps outlined in the Pima CD4
sample was loaded onto the Cartridge Guide, reinforce the importance of proper sample
cartridge and the cartridge was loading and closing of the cartridge cap.
closed? Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6079, 5022, 4019, 4003 [END OF SCRIPT]
If the Operator can explain the process, continue with Q5.

… continue with following page

P28
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q5: How old were the samples that If the samples were older than 36 hours and/or stored considerably
were used and how were they outside the recommended temperature of 18 – 28°C, explain to the
stored? Operator the importance of adhering to the recommended
storage conditions and refer to the Pima CD4 Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If age and storage condition can be ruled out as a cause, continue
with Q6.

Q6: Does the error occur with samples If only samples from a particular patient are affected, explain to the
from different patients? Operator that it is most likely a sample specific problem.
Advise the Operator to continue with the measurements and to
report back should the problem occur with other samples as
well.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If samples from different patients are affected, continue with Q7.

Q7: What is the cartridge lot you If the operator does not know the cartridge lot, explain where to find
encountered the error with? it on the cartridge pouches.
Advise the operator to continue with the measurements and
report back should the problem persist.
Contact Alere Technologies at +49 3641 3111444 to enquire
whether the cartridge lot reported by the Operator is indeed expired
or has shown Error 880 at other sites as well.
SFDC: 6078, 4019, 4003, 4024 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P29
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 910 Image (SFDC: 3313)


Primary Product: Pima CD4 25X or 100X Cartridge Kit

Description:
A test requires a minimum number of valid images. If this number cannot be reached Error 910 is given. The
validity of images is defined by the homogeneity of signal on an image.
An Error 910 can be caused by excessive amounts of air bubbles in the detection channel, by dust and dirt
on the cartridge channel lid or misaligned instrument optics.

Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: Was Error 201 shown and have If the answer is yes, explain to the Operator that Error 201
you overruled it? indicates too little sample and should only be overruled under
certain circumstances. Continue with chapter “Error 201
Volume” in the Error Resolution Guide.
SFDC: 6079, 4019 [END OF SCRIPT]
If the answer is no, continue with Q3.

Q3: Was the particular cartridge that If the answer is yes, advise the Operator that a Pima CD4 test
caused the error tested for the cartridge is a single use device.
second time when the error Advise the Operator to continue with the measurements and to
occurred? report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q4.

Q4: How did you ensure that sufficient If the Operator cannot explain the steps outlined in the Pima CD4
sample was loaded onto the Cartridge Guide, reinforce the importance of proper sample
cartridge and the cartridge was loading and closing of the cartridge cap.
closed? Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6079, 5022, 4019, 4003 [END OF SCRIPT]
If the Operator can explain the process, continue with Q5.

… continue with following page

P30
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q5: How old were the samples that If the samples were older than 36 hours and/or stored considerably
were used and how were they outside the recommended temperature of 18 – 28°C, explain to the
stored? Operator the importance of adhering to the recommended
storage conditions and refer to the Pima CD4 Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If age and storage condition can be ruled out as a cause, continue
with Q6.

Q6: Does the error occur with samples If only samples from a particular patient are affected, explain to the
from different patients? Operator that it is most likely a sample specific problem.
Advise the Operator to continue with the measurements and to
report back should the problem occur with other samples as
well.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If samples from different patients are affected, continue with Q7.

Q7: Does the error also occur with a If the answer is yes, continue with Q8
different cartridge lot?
If the answer is no or no other cartridge lot is available, advise the
Operator to continue with the measurements and report back
should the problem persist.
Ask the Operator for the cartridge lot umber and contact Alere
Technologies at +49 3641 3111444 to enquire whether the
cartridge lot reported by the operator has shown error 910 at other
sites as well.
SFDC: 6078, 4003, 4024 [END OF SCRIPT]

Q8: Have you observed any error with If the answer is no, the reason is likely the formation of air
a Pima Bead Standard cartridge bubbles in the detection channel. Advise the Operator not to
during the last 10 runs? touch the channel lid of the cartridge or to rub it with cloth and
to pay particular attention to properly load and close the
cartridges.
Advise the Operator to continue with the measurements and to
report back should the problem not be solved.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is yes, contact a higher level TS hub.
[END OF SCRIPT]

P31
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 920 Plausibility (SFDC: 3314)


Primary Product: Pima CD4 25X or 100X Cartridge Kit
Description:
Error 920 occurs because less CD3 carrying cells (i.e. lymphocytes; ‘CD3+CD4+’ plus 'CD3+CD4-') were
counted than monocytes (CD3-CD4+). This is a biologically implausible result and therefore invalid.

Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: Was the particular cartridge that If the answer is yes, advise the Operator that a Pima CD4 test
caused the error tested for the cartridge is a single use device.
second time when the error Advise the Operator to continue with the measurements and to
occurred? report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q3.

Q3: How were the Pima CD4 test If the storage conditions reported by the Operator are outside
cartridges stored? recommended 2-30°C for more than 1 week or in direct sunlight,
explain to the Operator the importance of adhering to the
recommended storage conditions outlined in the Pima CD4
Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist. Offer help with the
ordering process should this be necessary.
SFDC: 6039, 4019, 4003 [END OF SCRIPT]
If the storage conditions are within the recommended range,
continue with Q4.

Q4: How old were the samples that If the samples were older than 36 hours and/or stored considerably
were used and how were they outside the recommended temperature of 18 – 28°C, explain to the
stored? Operator the importance of adhering to the recommended
storage conditions and refer to the Pima CD4 Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If age and storage condition can be ruled out as a cause, continue
with Q5.

… continue with following page

P32
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q5: Does the error occur with samples If only samples from a particular patient are affected, explain to the
from different patients? Operator that it is most likely a sample specific problem.
Advise the Operator to continue with the measurements and to
report back should the problem occur with other samples as
well.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If samples from different patients are affected, continue with Q6.

Q6: What is the cartridge lot you If the operator does not know the cartridge lot, explain where to find
encountered the error with? it on the cartridge pouches.
Advise the operator to continue with the measurements and
report back should the problem persist.
Contact Alere Technologies at +49 3641 3111444 to enquire
whether the cartridge lot reported by the Operator is indeed expired
or has shown Error 940 at other sites as well.
SFDC: 6078, 4019, 4003, 4024 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P33
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 930 Homogeneity (SFDC: 3315)


Primary Product: Pima CD4 25X or 100X Cartridge Kit
Description:
Invalid test result due in-homogeneity of the image background. Error 930 can be caused by improper
dissolving of cartridge reagents during the initial mixing step.
This error is highly unlikely with instruments running software version 0.38k and higher.

Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent. Advise the Operator to consult the Pima Analyser
User Guide sections 8 and 9 first whenever they encounter an
error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: Was the particular cartridge that If the answer is yes, advise the Operator that a Pima CD4 test
caused the error tested for the cartridge is a single use device.
second time when the error Advise the Operator to continue with the measurements and to
occurred? report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q3.

Q3: How were the Pima CD4 test If the storage conditions reported by the Operator are outside
cartridges stored? recommended 2-30°C for more than 1 week or in direct sunlight,
explain to the Operator the importance of adhering to the
recommended storage conditions outlined in the Pima CD4
Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist. Offer help with the
ordering process should this be necessary.
SFDC: 6039, 4019, 4003 [END OF SCRIPT]
If the storage conditions are within the recommended range,
continue with Q4.

Q4: How old were the samples that If the samples were older than 36 hours and/or stored considerably
were used and how were they outside the recommended temperature of 18 – 28°C, explain to the
stored? Operator the importance of adhering to the recommended
storage conditions and refer to the Pima CD4 Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If age and storage condition can be ruled out as a cause, continue
with Q5.

… continue with following page

P34
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q5: Does the error occur with samples If only samples from a particular patient are affected, explain to the
from different patients? Operator that it is most likely a sample specific problem.
Advise the Operator to continue with the measurements and to
report back should the problem occur with other samples as
well.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If samples from different patients are affected, continue with Q6.

Q6: What is the cartridge lot you If the operator does not know the cartridge lot, explain where to find
encountered the error with? it on the cartridge pouches.
Advise the operator to continue with the measurements and
report back should the problem persist.
Contact Alere Technologies at +49 3641 3111444 to enquire
whether the cartridge lot reported by the Operator is indeed expired
or has shown error 930 at other sites as well.
SFDC: 6078, 4019, 4003, 4024 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P35
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 940 Gating (SFDC: 3316)


Primary Product: Pima CD4 25X or 100X Cartridge Kit

Description:
The software checks if different CD3+CD4+ sub-populations can be gated to avoid false positive counts.
An Error 940 can be caused by unusual sample characteristics, by dust and dirt on the cartridge channel lid
or miss-aligned instrument optics.

Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: Was the particular cartridge that If the answer is yes, advise the Operator that a Pima CD4 test
caused the error tested for the cartridge is a single use device.
second time when the error Advise the Operator to continue with the measurements and to
occurred? report back should the problem persist.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q3.

Q3: How old were the samples that If the samples were older than 36 hours and/or stored considerably
were used and how were they outside the recommended temperature of 18 – 28°C, explain to the
stored? Operator the importance of adhering to the recommended
storage conditions and refer to the Pima CD4 Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If age and storage condition can be ruled out as a cause, continue
with Q4.

Q4: Does the error occur with samples If only samples from a particular patient are affected, explain to the
from different patients? Operator that it is most likely a sample specific problem.
Advise the Operator to continue with the measurements and to
report back should the problem occur with other samples as
well.
SFDC: 6055, 4019, 4003 [END OF SCRIPT]
If samples from different patients are affected, continue with Q5.

… continue with following page

P36
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q5: How were the Pima CD4 test If the storage conditions reported by the Operator are outside
cartridges stored? recommended 2-30°C for more than 1 week or in direct sunlight,
explain to the Operator the importance of adhering to the
recommended storage conditions outlined in the Pima CD4
Cartridge Guide.
Advise the Operator to continue with the measurements and
report back should the problem persist. Offer help with the
ordering process should this be necessary.
SFDC: 6039, 4019, 4003 [END OF SCRIPT]
If the storage conditions are within the recommended range,
continue with Q6.

Q6: What is the cartridge lot you If the operator does not know the cartridge lot, explain where to
encountered the error with? find it on the cartridge pouches.
Advise the operator to continue with the measurements and
report back should the problem persist.
Contact Alere Technologies at +49 3641 3111444 to enquire
whether the cartridge lot reported by the Operator is indeed expired
or has shown error 940 at other sites as well.
SFDC: 6078, 4019, 4003, 4024 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P37
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Error 0000 Undefined Error (SFDC: 3317)


Primary Product: Pima Anaylser

Questions: Coach

Q1: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
If the answer is yes, continue with Q2.
If the answer is no, advise the Operator follow these
instructions:
Turn off the Pima Analyser as explained above.
Lift the cartridge slot door of the Pima Analyser. It may be
necessary to insert the blade of a knife or a screw driver
underneath the slot door to lift it up. CAUTION: Do not insert
the blade more than 2 mm underneath the door! Do not use
your fingernails!! Always wear gloves!!
Now restart the Analyser while lifting up the slot door. The
cartridge should now be ejected.
Advise the Operator to check whether the cartridge cap was
properly closed.
Explain to the Operator how to ensure proper cartridge loading
and closing of the cap which is indicated by a click sound.
Refer to the Pima CD4 Cartridge Guide.
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

Q2: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 6079, 4019, 4003 [END OF SCRIPT]
If more than once, contact a higher level TS hub.
[END OF SCRIPT]

P38
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Analyser display shows bright vertical lines (SFDC: 3038)


Primary Product: Pima Analyser

Questions: Coach

Q1: -- The Analyser needs to be sent back to a technical hub for


replacement of the GUI module.
[END OF SCRIPT]

P39
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Analyser does not charge (SFDC: 3036)


Primary Product: Pima Analyser

Questions: Coach

Q1: Do you see the battery status If the answer is yes, continue with Q4.
symbol in the status line of the
If the answer is no, continue with Q2.
Analyser display even when the
Analyser is connected to mains
A/C power?

Q2: Is the yellow charging status light Explain to the Operator that it may take several minutes before the
on the front of the Pima Analyser light becomes illuminated
flashing or constantly illuminated,
If the answer is yes, continue with Q5.
when the Pima Analyser is
connected to mains A/C power? If the answer is no, continue with Q3.

Q3: Please check whether the yellow If the answer is yes, contact a higher level TS hub.
charging status light is functioning: [END OF SCRIPT]
Is the yellow charging status light
If the answer is no, explain to the Operator that the light itself is
briefly flashing when the Pima
probably broken and that the functionality of the Analyser will
Analyser gets switched on?
not be affected. Advise the Operator to continue with the
measurements.
SFDC: 6078, 4019 [END OF SCRIPT]

Q4: Please check if the Pima Analyser If the Operator does not know how to connect the Pima Analyser to
is connected to mains A/C: mains A/C power, explain to the Operator how to connect the
Is the green light on the power Pima Analyser. Refer to Section 2 of the Pima Analyser Guide.
transformer illuminated when the
If the answer is no, advise the Operator to have facility
power cord is attached to the A/C
management check whether the outlet has power.
power outlet?
If there is power on the power outlet, advise the Operator to use a
power transformer and power cable from a different Pima
Anaylser (if available) to check whether the cable/transformer
or the Analyser is at fault.
CAUTION: no cables/transformers from different types of
instruments should be used!!
If the cable/transformer is at fault, exchange it for a new one.
SFDC: 6058 [END OF SCRIPT]
If all the above can be exclude and the answer is yes, continue
with Q5.

…continue with following page

P40
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q5: Is your Pima Analyser older than If the answer is yes, continue with Q6.
12 months?
If the answer is no, continue with Q7.

Q6: After having the Pima Analyser If the answer is yes, advise the Operator to continue with the
connected to mains A/C power measurements. The number of tests the Analyser is able to
overnight, does the instrument perform on a fully loaded battery is within the instrument
start up and perform at least 8 specifications.
tests within one working day when SFDC: 6048, 4019 [END OF SCRIPT]
NOT connected to mains power?
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

Q7: After having the Pima Analyser If the answer is yes, advise the Operator to continue with the
connected to mains A/C power measurements. The number of tests the Analyser is able to
overnight, does the instrument perform on a fully loaded battery is within the instrument
start up and perform at least 14 specifications.
tests within one working day when SFDC: 6048, 4019 [END OF SCRIPT]
NOT connected to mains power?
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

P41
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Analyser does not draw in test cartridges (SFDC: 3319)
Primary Product: Pima Analyser

Questions: Coach

Q1: Does the problem occur with If only Pima Bead Standard cartridges are affected, advise the
Pima CD4 test cartridges AND Operator whether the Bead Standard cartridges causing the
Pima Bead Standard cartridges? problem have been used for more than 6 months and refer to
the Pima Bead Standard User Guide regarding stability of the
product.
Advise the Operator to use a different set of Pima Bead
Standard cartridges and to report back should the problem not
be solved. Otherwise no action needs to be taken.
SFDC: 6029, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges are affected or the Bead Standard
cartridges are younger than 6 months, continue with Q2.

Q2: Have you inserted the test If the answer is yes, continue with Q3.
cartridge to the stop?
If the answer is no or if the Operator does not know, explain to the
Operator that the test cartridge needs to be inserted to the
stop. Point out that one may feel a first point of resistance that
needs to be overcome. The cartridge is fully inserted when it
cannot be pushed in any further.
SFDC: 6079, 4019 [END OF SCRIPT]

Q3: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
If the answer is yes, continue with Q4.
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

Q4: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, contact a higher level TS hub.
[END OF SCRIPT]

P42
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Analyser does not eject test cartridges (SFDC: 3317)
Primary Product: Pima Analyser

Questions: Coach

Q1: Does the Pima Analyser display If the answer is yes, continue with the respective Script for this
an Error Code when the problem Error Code.
occurs? [END OF SCRIPT]
If the answer is no, continue with Q2.

Q2: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
If the answer is yes, advise the Operator to continue with the
measurements and to report back should the problem become
frequent.
SFDC: 6079, 4015, 4003 [END OF SCRIPT]
If the answer is no, advise the Operator follow these
instructions:
Turn off the Pima Analyser as explained above.
Lift the cartridge slot door of the Pima Analyser. It may be
necessary to insert the blade of a knife or a screw driver
underneath the slot door to lift it up. CAUTION: Do not insert
the blade more than 2 mm underneath the door! Do not use
your fingernails!! Always wear gloves!!
Now restart the Analyser while lifting up the slot door. The
cartridge should now be ejected.
Advise the Operator to check whether the cartridge cap was
properly closed.
Explain to the Operator how to ensure proper cartridge loading
and closing of the cap which is indicated by a click sound.
Refer to the Pima CD4 Cartridge Guide.
Advise the Operator to continue with the measurements and to
report back should the problem reappear.
SFDC: 6079, 4019, 4003 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P43
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Analyser does not finish an analysis (SFDC: 3321)


Primary Product: Pima Analyser

Questions: Coach

Q1: Have you entered Operator and If the answer is yes, continue with Q2.
Sample ID?
If the answer is no, explain to the Operator that as analysis will
only be finished after Operator and Sample ID are inserted.
Advise the Operator to consult the Pima Analyser User Guide
sections 3 on how to enter Operator and Sample ID.
SFDC: 6079, 4019 [END OF SCRIPT]

Q2: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
If the answer is yes, continue with Q3.
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

Q3: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, contact a higher level TS hub.
[END OF SCRIPT]

P44
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Analyser does not react to keypad entries (SFDC: 3019)


Primary Product: Pima Analyser

Questions: Coach

Q1: Is the problem transient, meaning If the answer is yes, explain to the Operator that the computer in
the keypad shows delayed the Pima Analyser may be too busy at certain times (especially
response to entries? right after a cartridge was inserted), so that the response to a
keypad entry may be delayed. Advise the Operator to wait
approximately 30 seconds after the cartridge has been
inserted, before typing. If the keypad acknowledges the entry
with a «beep» sound, the key does not need to be pushed
again even if the character does not appear on the display.
Advise the Operator to continue with the measurements and to
report back should the problem become frequent.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q2.

Q2: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
If the answer is yes, continue with Q3.
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

Q3: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, contact a higher level TS hub.
[END OF SCRIPT]

P45
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Analyser ejects test cartridges before the analysis is finished


(SFDC: 3319)
Primary Product: Pima Analyser

Questions: Coach

Q1: Does the Pima Analyser display If the answer is yes, continue with the respective Script for this
an Error Code when the problem Error Code.
occurs? [END OF SCRIPT]
If the answer is no, continue with Q2.

Q2: Does the problem occur with If only Pima Bead Standard cartridges are affected, ask the
Pima CD4 test cartridges AND Operator whether the Bead Standard cartridges causing the
Pima Bead Standard cartridges? problem have been used for more than 6 months and refer to
the Pima Bead Standard User Guide regarding stability of the
product.
Advise the Operator to use a different set of Pima Bead
Standard cartridges and to report back should the problem not
be solved. Otherwise no action needs to be taken. Offer help
with the ordering process should this be necessary.
SFDC: 6029, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges are affected or the Bead Standard
cartridges are younger than 6 months, continue with Q3.

Q3: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
If the answer is yes, continue with Q4.
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

Q4: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, contact a higher level TS hub.
[END OF SCRIPT]

P46
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Analyser fails to start-up (SFDC: 3039)


Primary Product: Pima Analyser

Questions: Coach

Q1: Have you pressed the Power If the answer is yes, continue with Q2.
On/Off button on the back of the
If the answer is no, advise the Operator to follow the start-up
Pima Analyser for approximately
procedure as described in Section 2 of the Pima Analyser User
10 seconds to start the Analyser?
Guide. Press and hold the Power On button until you hear a
triple «beep» and the appearance of “Pima” on the screen
confirms that the Analyser is now switched On. Advise the
Operator to continue with the measurements.
SFDC: 6079, 4019 [END OF SCRIPT]

Q2: Was the Pima Analyser properly If the answer is yes, continue with Q3.
shut down before observing the
If the answer is no, advise the Operator to press and hold the
problem?
Power On button on the back of the Pima Analyser until a long
«beep» is audible, confirming that the Analyser is now
switched Off. Then restart the Pima Analyser.
SFDC: 6079, 4019 [END OF SCRIPT]

Q3: Does the Pima Analyser start-up If the Operator does not know how to connect the Pima Analyser to
when connected to mains A/C mains A/C power, explain to the Operator how to connect the
power for at least 30 minutes Pima Analyser. Refer to Section 2 of the Pima Analyser Guide.
before trying to start-up?
If the answer is yes, continue with Q4.
If the answer is no, continue with Q5.

Q4: Does the Pima Analyser start-up If the answer is yes, advise the Operator to continue with the
when NOT connected to mains measurements.
power after the Analyser was SFDC: 6048, 4019 [END OF SCRIPT]
connected to mains A/C power for
If the answer is no, contact a higher level TS hub.
8 hours?
[END OF SCRIPT]

Q5: Does the display of the Pima If the answer is yes, continue with Q6.
Analyser stay black?
If the answer is no, continue with Q7.

Q6: When connected to mains A/C If the answer is yes, contact a higher level TS hub.
power for at least 30 minutes, is [END OF SCRIPT]
the yellow charging status light on
If the answer is no, continue with Q8.
the front of the Pima Analyser
flashing or constantly illuminated?

Q7: Does the “Run test” window If the answer is yes, advise the Operator to continue with the
appear on the display after measurements.
approximately 2 minutes? SFDC: 6048, 4019 [END OF SCRIPT]
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]
… continue with following page

P47
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q8: Please check if the Pima Analyser If the Operator does not know how to connect the Pima Analyser to
is connected to mains A/C: mains A/C power, explain to the Operator how to connect the
Is the green light on the power Pima Analyser. Refer to Section 2 of the Pima Analyser Guide.
transformer illuminated when the
If the answer is no, advise the Operator to have facility
power cord is attached to the A/C
management check whether the outlet has power.
power outlet?
If there is power on the power outlet, advise the Operator to use a
power transformer and power cable from a different Pima
Anaylser (if available) to check whether the cable/transformer
or the Analyser is at fault.
CAUTION: no cables/transformers from different types of
instruments should be used!!
If the cable/transformer is at fault, exchange it for a new one.
SFDC: 6058 [END OF SCRIPT]
If all the above can be exclude and the answer is yes, contact a
higher level TS hub.
[END OF SCRIPT]

P48
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Analyser shuts down on its own account (SFDC: 3036)


Primary Product: Pima Analyser

Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: Did the Pima Analyser re-start on If the answer is yes, contact a higher level TS hub.
its own account after it shut [END OF SCRIPT]
down?
If the answer is no, continue with Q3.

Q3: Do you hear the fan in the back of If the answer is yes, continue with Q4.
the Pima Analyser working after
If the answer is no, contact a higher level TS hub.
the instrument was running tests
[END OF SCRIPT]
for an hour?

Q4: What were the operating If the operating temperature reported by the Operator is outside the
conditions the Pima Analyser was recommended 10-40°C or the Analyser was exposed to direct
used at? sunlight, explain to the Operator the importance of adhering to
the recommended operating conditions.
Advise the Operator to continue with the measurements under
recommended operating conditions and report back should
the problem persist.
SFDC: 6039, 4019, 4003 [END OF SCRIPT]
If the operating conditions can be ruled out as a cause, continue
with Q5.

Q5: Was a ‘Power Warning’ or ‘Power If the answer is yes, continue with Q6.
Error’ given by the Pima Analyser
If the answer is no, contact a higher level TS hub.
before it shut down?
[END OF SCRIPT]

Q6: Did the problem occur when the If the answer is yes, explain to the Operator that the Analyser
Pima Analyser was running on should be connected to mains A/C power after the first ‘Power
battery power? Warning’ is given.
Advise the Operator to continue with the measurements and to
consult the Pima Analyser User Guide sections 8 and 9 first
whenever they encounter an error.
SFDC: 6079, 4019 [END OF SCRIPT]
If the answer is no or the Analyser was plugged in as reaction to the
‘Power Warning’, continue with Q7.

… continue with following page

P49
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q7: Could there have been a power If the answer is yes, advise the Operator to continue with the
outage when the problem measurements and to report back should the problem become
occurred? frequent.
SFDC: 6048, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q8.

Q8: Is the yellow charging status light If the answer is yes, contact a higher level TS hub.
on the front of the Pima Analyser [END OF SCRIPT]
flashing or constantly illuminated,
If the answer is no, explain to the Operator that it may take a
when the Pima Analyser is
couple of minutes before the yellow light becomes illuminated
connected to mains A/C power?
after the Analyser is connected to mains A/C power.
If the answer is still no, continue with Q9.

Q9: Do you see the battery status If the answer is yes, continue with Q10.
symbol in the status line of the
If the answer is no, contact a higher level TS hub.
Analyser display even when the
[END OF SCRIPT]
Analyser is connected to mains
A/C power?

Q10: Please check if the Pima If the Operator does not know how to connect the Pima Analyser to
Analyser is connected to mains mains A/C power, explain to the Operator how to connect the
A/C: Pima Analyser. Refer to Section 2 of the Pima Analyser Guide.
Is the green light on the power
If the answer is no, advise the Operator to have facility
transformer illuminated when the
management check whether the outlet has power.
power cord is attached to the A/C
power outlet? If there is power on the power outlet, advise the Operator to use a
power transformer and power cable from a different Pima
Anaylser (if available) to check whether the cable/transformer
or the Analyser is at fault.
CAUTION: no cables/transformers from different types of
instruments should be used!!
If the cable/transformer is at fault, exchange it for a new one.
SFDC: 6058 [END OF SCRIPT]
If all the above can be exclude and the answer is yes, contact a
higher level TS hub.
[END OF SCRIPT]

P50
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Archive Error (SFDC: 3322)


Primary Product: Pima Analyser
Description:
If the storage capacity of the archive is reached, the screen will display the «Archive full» window. No further
analyses can be performed by the Analyser until data has been downloaded and the archive emptied.

Questions: Coach

Q1: How many tests are currently in If the Operator cannot offer a number, explain how to find the
the archive? archive and ask for the test ID of the last entry in the archive.
If the reported number of tests in the archive is greater than
999, the archive is most likely full and the operator needs to
delete all/some of the stored tests from the archive. Refer to
section 5 in the Pima Analyser User Guide. Make sure the
Operator understands that once the tests are deleted, they
CANNOT be retrieved anymore. An export of the data may be
advisable (also described in section 5).
SFDC: 6048, 4019 [END OF SCRIPT]

P51
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Barcode Error (SFDC: 3011)


Primary Product: Pima CD4 25X or 100X Cartridge Kit or Pima Bead Standard
Description:
The Pima Analyser is unable to identify a barcode on the cartridge.
Questions: Coach

Q1: Does the Barcode Error occur If only Pima Bead Standard cartridges are affected, ask the
with Pima CD4 test cartridges Operator to check the Bead Standard cartridge barcodes for
AND Pima Bead Standard obvious damage.
cartridges? Advise the Operator to use a different set of Pima Bead
Standard cartridges and to report back should the problem not
be solved. Otherwise no action needs to be taken.
SFDC: 6021, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges or both cartridge types are
affected, continue with Q2.

Q2: Were you able to manually enter If the answer is yes, give the following advice to the Operator:
the cartridge barcode into the Avoid scratching or damaging the cartridge barcode
Pima Analyser? Do not write on the cartridge barcode
Avoid toughing the barcode if you may have blood on your
gloves
Check whether this could be the cause for the error
Continue with Q3.
If the answer is no, explain to the Operator how to manually
enter a barcode (described in section 9 of the Pima Analyser
User Guide).
If it is still not possible to enter the barcode, contact a higher level
TS hub.
[END OF SCRIPT]

Q3: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q4.

Q4: What is the cartridge lot you If the operator does not know the cartridge lot, explain where to find
encountered the error with? it on the cartridge pouches.
Advise the operator to continue with the measurements and
report back should the problem persist.
Contact Alere Technologies at +49 3641 3111444 to enquire
whether the cartridge lot reported by the Operator is indeed expired
or has shown Barcode Errors at other sites as well.
SFDC: 6078, 4019, 4003, 4024 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P52
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Entry Error – Operator ID already exists (SFDC: 3323)


Primary Product: Pima Analyser
Description:
Should a new Operator ID be entered into the Operator list, but an Operator with the same name / number
already exists in the list, the “Invalid Entry” error message will appear.

Questions: Coach

Q1: -- Explain to the Operator how to edit an existing Operator ID.


Advise the Operator to delete Operators from the Operator list
if they are not used anymore. The Operator my chose to
amend his/her ID by a number or letter. Refer to section 3 of
the Pima Analyser User Guide.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6079, 4019 [END OF SCRIPT]

P53
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Entry Error – Operator ID/Sample ID (SFDC: 3323)


Primary Product: Pima Analyser
Description:
It is mandatory to enter an Operator ID to view a test results. Attempting to confirm «blank» entry fields for
Operator ID will trigger the “Invalid Entry” error messages.

Questions: Coach

Q1: -- Explain the Operator that it is mandatory to enter an Operator


and Sample ID before a result can be viewed. Refer to the Pima
Analyser User Guide Section 3.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6079, 4019 [END OF SCRIPT]

P54
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Export Error – Export failed (SFDC: 3214)


Primary Product: Pima Analyser

Description:
If the «Export failed» window appears, an unspecified error has occurred during export of results. This may
have been caused by either the USB storage medium or the Analyser.

Questions: Coach

Q1: Was the export successful after If the answer is yes, advise the Operator to continue as usual
several attempts? and to report back should the problem not be resolved by
repeating of the export attempt.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q2

Q2: Does the Error occur only when If the answer is yes, advise the Operator to export one result
ALL results from the archive get first, before attempting to export all results.
exported at the same time? Advise the operator to continue with the measurements and
report back should the problem persist.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q3.

Q3: Is the problem alleviated when the If the answer is yes, advise the Operator to continue with the
USB storage medium is measurements and to report back should the other USB port
connected to the other USB port also becomes affected.
of the Pima Analyser? SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q4.

Q4: Is the problem alleviated when a If the answer is yes, advise the Operator that it is possible that
different USB storage medium is certain USB storage media have difficulties connecting with
connected to the Pima Analyser? the Pima Analyser and that he/she should continue with the
one that works.
SFDC: 6089, 4019 [END OF SCRIPT]
If the answer is no or the Operator has no other storage medium at
hand, continue with Q5.

Q5: Is it possible to print results with If the answer is yes, advise the Operator that the USB storage
the Pima Printer? medium is most likely at fault and that another medium needs
to be tested.
SFDC: 6089, 4019 [END OF SCRIPT]
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

P55
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Export Error – No recognition of the USB storage medium


(SFDC: 3214)
Primary Product: Pima Analyser

Description:
The following questions should be asked if the Pima Analyser does not recognize the presence of a USB
storage medium.

Questions: Coach

Q1: Do you use a USB storage device If the answer is yes, advise the Operator that only USB storage
of the generation USB 3.0? devices of generation USB 2.0 and lower are compatible with
the Pima Analyser.
SFDC: 6089, 4019 [END OF SCRIPT]
If the answer is no, continue with Q2.

Q2: How often did the error occur? If only once, advise the Operator to continue as usual and to
report back should the problem become frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q3

Q3: Is the problem alleviated when the If the answer is yes, advise the Operator to continue with the
USB storage medium is measurements and to report back should the other USB port
connected to the other USB port also becomes affected.
of the Pima Analyser? SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q4.

Q4: Is the problem alleviated when a If the answer is yes, advise the Operator that it is possible that
different USB storage medium is certain USB storage media have difficulties connecting with
connected to the Pima Analyser? the Pima Analyser and that he/she should continue with the
one that works.
SFDC: 6089, 4019 [END OF SCRIPT]
If the answer is no or the Operator has no other storage medium at
hand, continue with Q5.

Q5: Is it possible to print results with If the answer is yes, advise the Operator that the USB storage
the Pima Printer? medium is most likely at fault and that another medium needs
to be tested.
SFDC: 6089, 4019 [END OF SCRIPT]
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

P56
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Failure while displaying result (SFDC: 3327)


Primary Product: Pima Analyser

Description:
This problem occurs when an analysis is spontaneously aborted very early after its start. This leads to an
archive entry but without a defined error code.

Questions: Coach

Q1: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q2.

Q2: Does the problem occur with If only Pima Bead Standard cartridges are affected, ask the
Pima CD4 test cartridges AND Operator whether the Bead Standard cartridges causing the
Pima Bead Standard cartridges? problem have been used for more than 6 months and refer to
the Pima Bead Standard User Guide regarding stability of the
product.
Advise the Operator to use a different set of Pima Bead
Standard cartridges and to report back should the problem not
be solved. Otherwise no action needs to be taken.
SFDC: 6029, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges are affected or the Bead Standard
cartridges are younger than 6 months, contact a higher level TS
hub.
[END OF SCRIPT]

P57
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Invalid Barcode (SFDC: 3328)


Primary Product: Pima Analyser

Description:
If the cartridge barcode does not encode for a test type uploaded onto the Analyser.
Currently all Pima Analysers have analysis software for all available test types on-board. Should the error
occur it is related to a faulty barcode or a software problem.

Questions: Coach

Q1: Does the Error occur with Pima If only Pima Bead Standard cartridges are affected, advise the
CD4 test cartridges AND Pima Operator to check the channel lid of the Pima Bead Standard
Bead Standard cartridges? cartridge for obvious damage.
Advise the Operator to use a different set of Pima Bead
Standard cartridges and to report back should the problem not
be solved. Otherwise no action needs to be taken.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If only Pima CD4 test cartridges or both cartridge types are
affected, continue with Q2.

Q2: How often did the error occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q3.

Q3: What is the cartridge lot you If the operator does not know the cartridge lot, explain where to find
encountered the error with? it on the cartridge pouches.
Advise the operator to continue with the measurements and
report back should the problem persist.
Contact Alere Technologies at +49 3641 3111444 to enquire
whether the cartridge lot reported by the Operator is indeed expired
or has shown this error at other sites as well.
SFDC: 6078, 4019, 4003, 4024 [END OF SCRIPT]
If the problem persists, contact a higher level TS hub.
[END OF SCRIPT]

P58
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Power Warning, Power Error and Error 0 (SFDC: 3324)


Primary Product: Pima Analyser
Description:
The «Warning Recharge battery» window appears indicating that the Analyser's integrated battery is low.
The «Recharge battery» window appears if the power level of the integrated battery is too low to conduct
another analysis. No further analyses can be performed by the Analyser until the battery is recharged or the
Analyser is connected to A/C power.
«Error 0» is shown if the Analyser initiates a controlled shut down due to critically low battery charge. This
error may occur following the «Recharge battery» message or upon start up on an empty battery. The
Analyser needs to be connected to A/C power for any further action.

Questions: Coach

Q1: Did the problem occur when the If the answer is yes, explain to the Operator that the Analyser
Pima Analyser was running on should be connected to mains A/C power after the first ‘Power
battery power? Warning’ is given.
Advise the Operator to continue with the measurements and to
consult the Pima Analyser User Guide sections 8 and 9 first
whenever they encounter an error.
SFDC: 6079, 4019 [END OF SCRIPT]
If the answer is no or the Analyser was plugged in as reaction to the
‘Power Warning’, continue with Q2.

Q2: Could there have been a power If the answer is yes, advise the Operator to continue with the
outage when the problem measurements and to report back should the problem become
occurred? frequent.
SFDC: 6048, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q3.

Q3: Is the yellow charging status light If the answer is yes, contact a higher level TS hub.
on the front of the Pima Analyser [END OF SCRIPT]
flashing or constantly illuminated,
If the answer is no, explain to the Operator that it may take a
when the Pima Analyser is
couple of minutes before the yellow light becomes illuminated
connected to mains A/C power?
after the Analyser is connected to mains A/C power.
If the answer is still no, continue with Q4.

… continue with following page

P59
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Q4: Please check if the Pima Analyser If the Operator does not know how to connect the Pima Analyser to
is connected to mains A/C: mains A/C power, explain to the Operator how to connect the
Is the green light on the power Pima Analyser. Refer to Section 2 of the Pima Analyser Guide.
transformer illuminated when the
If the answer is no, advise the Operator to have facility
power cord is attached to the A/C
management check whether the outlet has power.
power outlet?
If there is power on the power outlet, advise the Operator to use a
power transformer and power cable from a different Pima
Anaylser (if available) to check whether the cable/transformer
or the Analyser is at fault.
CAUTION: no cables/transformers from different types of
instruments should be used!!
If the cable/transformer is at fault, exchange it for a new one.
SFDC: 6058 [END OF SCRIPT]
If all the above can be exclude and the answer is yes, contact a
higher level TS hub.
[END OF SCRIPT]

P60
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Printer Error Paper required (SFDC: 3025)
Primary Product: Pima Printer

Description:
Should the Pima Printer run out of paper, the «Paper Required» window is displayed. There is a possibility
that there is a different underlying reason for the error.

Questions: Coach

Q1: -- If the Operator does not know how to change printer paper, explain
to the Operator how to do it and refer to the Pima Printer User
Guide.
SFDC: 6079, 4019 [END OF SCRIPT]

P61
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Printer Error (SFDC: 3025)


Primary Product: Pima Printer

Description:
Should the Operator attempt to print results with no Pima Printer attached to the Analyser the «Printer Error»
window is displayed. There is a possibility that there is a different underlying reason for the error.
Questions: Coach

Q1: Do you experience a paper jam, If the answer is yes, advise the Operator to remove the paper
slow print speed and/or roll from the printer and to tighten the width of the roll by
compressed print? pushing it against a flat surface like a table-top. Then re-insert
the paper roll as described in the Pima Printer User Guide and
continue.
SFDC: 6089, 4019 [END OF SCRIPT]
If the answer is no, continue with Q2.

Q2: Do you have a Pima Printer If the answer is yes, continue with Q3.
connected to the USB port on the
If the answer is no, explain to the Operator how to connect the
back of the Pima Analyser?
Pima Printer to the Pima Analyser. Refer to the Pima Analyser
User Guide Section 9 and the Pima Printer User Guide.
Emphasize that only Pima Printers can be connected to the
Pima Analyser.
SFDC: 6079, 4019 [END OF SCRIPT]

Q3: How often did the error occur If only once, advise the Operator to continue as usual and to
during the last 20 attempts? report back should the problem become frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q4

Q4: Was the Pima Printer connected If the answer is yes, continue with Q5.
to the Pima Analyser before the
If the answer is no, advise the Operator to unplug the Pima
Analyser was switched on?
Printer from the Analyser and reconnect it.
If the problem persists, advise the Operator to turn off the Pima
Analyser via the main menu route and restart the Analyser with
the Pima Printer connected.
Advise the Operator to continue as usual and to report back
should the problem become frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If the problem persists, continue with Q5.

… continue with following page

P62
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts
Q5: Is the problem alleviated when the If the answer is yes, advise the Operator to continue with the
printer is connected to the other measurements and to report back should the other USB port
USB port of the Pima Analyser? also becomes affected.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q6.

Q6: Is the problem alleviated when a If the answer is yes, the Pima Printer needs to be exchanged.
different Pima printer is connected SFDC: 6058 [END OF SCRIPT]
to the Pima Analyser?
If the answer is no, continue with Q7.

Q7: When connected to the Pima If the Operator does not know where to find the Pima Printer Status
Analyser, is the Status light of the light, explain to the Operator where to find it and refer to the
Pima Printer: Pima Printer User Guide.
Green, If the answer is Green, the Operator should turn off the Pima
Analyser via the main menu route and restart the Analyser with
Yellow,
the Pima Printer connected.
Red, Advise the Operator to continue as usual and to report back
OR should the problem become frequent.
Advise the Operator to consult the Pima Analyser User Guide
Off? sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If the problem persists, continue with Q9.
If the answer is Yellow, advise the Operator to keep the Pima
Printer connected to the Analyser and allow the Printer battery
to recharge for at least 10 minutes before attempting to print.
IMPORTANT: The Pima Analyser needs to be connected to
mains A/C power at this point.
If the problem persists, continue with Q9.
If the answer is Red, continue with Q8.
If the answer is Off, continue with Q9.

Q8: Is the lid of the printer paper If the answer is yes, continue with Q9.
compartment properly closed?
If the answer is no, explain to the Operator how to close the
paper compartment lid of the Pima Printer. Refer to the Pima
Printer User Guide.
SFDC: 6079 [END OF SCRIPT]
If the problem persists, continue with Q9.

Q9: Is the Pima Printer directly If the answer is yes, continue with Q10.
connected to one Pima Analyser
If the answer is no, explain to the Operator that the Pima Printer
USB port (no USB hub
needs to be directly plugged into the Pima Analyzer.
interlinked)?
Advise the Operator to continue as usual and to report back
should the problem persist.
SFDC: 6079, 4003 [END OF SCRIPT]

Q10: Is it possible to export result files If the answer is yes, the Pima Printer needs to be exchanged.
onto a USB memory stick via the SFDC: 6058 [END OF SCRIPT]
USB ports of the Pima Analyser?
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

P63
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Selection Error (SFDC: 3325)


Primary Product: Pima Analyser
Description:
Should the Operator attempt to Print, Export, Export and Delete or Delete stored test results without
selecting a result prior to executing the command the “Invalid Selection” error message is displayed.

Questions: Coach

Q1: -- Explain to the Operator that it is necessary to select at least


one test to execute one of the processes. Refer to the Pima
Analyser User Guide Section 5.
SFDC: 6079, 4019 [END OF SCRIPT]

P64
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Storage Error - Storage medium full (SFDC: 3214)


Primary Product: Pima Analyser
Description:
If, during export, the storage capacity of the storage medium is reached, the “Storage medium full” window
appears.

Questions: Coach

Q1: -- Advise the Operator to empty the USB storage medium or use
a different storage medium.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6079, 4019 [END OF SCRIPT]

P65
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Storage Error - Storage medium lost (SFDC: 3214)


Primary Product: Pima Analyser

Description:
If, during export, the storage medium is removed from the USB port, the “Storage medium lost” window
appears.

Questions: Coach

Q1: Does the error occur when this If the answer is yes, advise the Operator to wait for two minutes
particular USB storage medium when a USB storage medium was connected to the Pima
was connected to the Pima Analyser for the first time and continue as usual and to report
Analyser for the first time? back should the problem become frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If the answer is no, continue with Q2

Q2: Was the export successful after If the answer is yes, advise the Operator to continue as usual
several attempts? and to report back should the problem not be resolved by
repeating of the export attempt.
SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q3

Q3: Is the problem alleviated when the If the answer is yes, advise the Operator to continue with the
USB storage medium is measurements and to report back should the other USB port
connected to the other USB port also becomes affected.
of the Pima Analyser? SFDC: 6078, 4019, 4003 [END OF SCRIPT]
If the answer is no, continue with Q4.

Q4: Is the problem alleviated when a If the answer is yes, advise the Operator that it is possible that
different USB storage medium is certain USB storage media have difficulties connecting with
connected to the Pima Analyser? the Pima Analyser and that he/she should continue with the
one that works.
SFDC: 6089, 4019 [END OF SCRIPT]
If the answer is no or the Operator has no other storage medium at
hand, continue with Q5.

Q5: Is it possible to print results with If the answer is yes, advise the Operator that the USB storage
the Pima Printer? medium is most likely at fault and that another medium needs
to be tested.
SFDC: 6089, 4019 [END OF SCRIPT]
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

P66
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN
Pima Error Resolution Scripts

Unexpected Exception (SFDC: 3330)


Primary Product: Pima Analyser

Questions: Coach

Q1: How often did the problem occur If only once, advise the Operator to continue with the
during the last 20 runs? measurements and to report back should the problem become
frequent.
Advise the Operator to consult the Pima Analyser User Guide
sections 8 and 9 first whenever they encounter an error.
SFDC: 6078, 4003 [END OF SCRIPT]
If more than once, continue with Q3.

Q2: Was the problem alleviated by If the Operator does not know how to do this, tell the Operator to
shutting down and restarting the press and hold the Power On button on the back of the
Pima Analyser? Analyser until the screen turns black and a long «beep» is
audible, confirming that the Analyser is now switched Off.
Then restart the Pima Analyser.
If the answer is yes, advise the Operator to continue with the
measurements and to report back should the problem become
frequent.
SFDC: 6078, 4015, 4003 [END OF SCRIPT]
If the answer is no, contact a higher level TS hub.
[END OF SCRIPT]

P67
Revision date: 27-Feb-13 Alere Technologies GmbH ERG-PIMA-01-06-EN

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