Pima™ Analyser User Guide

English
Pima Analyser
The Pima Analyser employs the same static image analysis and counting
principles as existing cell enumeration technologies, in a compact, portable
and robust package.
Designed equally to suit the needs of the healthcare professional in the field
or in the laboratory the Pima Analyser is an affordable, effective and valuable
point-of-care diagnostic tool.
The following cartridges can be used together with the Pima Analyser:

Pima CD4 test cartridges: 25 individually pouched test cartridges

(catalogue no. 260100025) or
100 individually pouched test cartridges
(catalogue no. 260100100)

Pima Bead Standard: box incl. 2 bead cartridges "Low" and "Normal"
(catalogue no. 260400011)

For more information about Pima: www.AlereHIV.com

Index of Symbols

CE Mark Li-Po Lithium-Polymer

In vitro diagnostic medical device Li-Ion Lithium-Ion

Manufacturer Battery

Catalogue number Serial number

Attention symbol.
Indicates special problems or p To keep dry

important information. Read the

accompanying text carefully.
 his unit must be recycled or
T
Direct current (DC) discarded according to applicable
local and national regulations.

2
 1 Introduction 1

2 Getting Started 2

3 Running a Test 3

4 Analysis Menu 4

5 Main Menu: Results 5

6 Main Menu: Settings 6

7 Main Menu: Power Off 7

8 Error Codes & Technical Support 8

9 Error Warnings & Messages 9

Pima Analyser User Guide 3

Table of Contents

1 Introduction
6 Intended Use
6 Test Principle
6 Data Handling
7 Analyser Specifications
7 Declaration of Conformity
8 Pima Analyser Recharging Intervals during Storage
8 Unpacking, Installation & Transport
8 Analyser Calibration
9 Maintenance & Cleaning
9 Components and optional items
10 Safety Warnings
11 Pima Analyser at a Glance

2 Getting Started
12 Analyser Status Lights
12 Analyser Display
13 Charging the Pima Analyser
13 Charging Status Light
14 Switching On the Pima Analyser/Power Status Light
15 User Interface
15 Navigation

3 Running a Test
16 Initiating a Test
17 Inserting the Pima Test Cartridge
18 Operator ID Entry
18 Sample ID Entry
18 Analysis in Progress
19 Analysis Complete
20 Printing Results immediately after Analysis

4 Analysis Menu
22 Changing Operator and Sample ID during a Test Run
22 Analysis Menu
22 Change Operator ID
22 Change Sample ID
23 Abort Analysis

4
 5 Main Menu: Results
24 View Results from Archive
25 Print Results from Archive
26 Export Results from Archive
28 Export and Delete Results from Archive
29 Delete Results from Archive

6 Main Menu: Settings

31 Settings
31 Enter an Operator ID
32 Edit an Operator ID
33 Delete an Operator ID
33 Date
34 Time
34 Service Export
35 Device Info
36 Connectivity
36 Local Network

7 Main Menu: Power Off

37 Turning Off the Pima Analyser

8 Error Codes & Technical Support

38 Error Code Window
38 Technical Support
39 Error Codes

9 Error Warnings & Messages

40 Archive Error
40 Barcode Errors
41 Entry Errors
42 Export Error
42 Power Warning
43 Power Error
43 Printer Errors
44 Selection Error
44 Storage Errors
45 Undefined Errors
46 Volume Error

Pima Analyser User Guide 5

 1  Introduction
Intended Use
1
The Pima Analyser is a portable bench-top fixed volume cytometer used for the
processing and analysis of a Pima test cartridge. For in vitro diagnostic use.

2 Designed to perform in a laboratory as well as in non-laboratory environments,

the Pima Analyser can be operated on external power or by using an on-board
rechargeable battery. The Pima Analyser requires no maintenance.

3
Test Principle

The Pima test consists of a disposable Pima test cartridge, containing dried
4 reagents, and the Pima Analyser. A low sample volume of approx.
25 microliters (µL) of capillary or venous whole blood is collected into the test
cartridge, which is then capped.
The Pima test cartridge is inserted into the Analyser and the sample sealed within
5
the cartridge is processed. During the course of test processing, data is recorded,
analysed and interpreted using software embedded in the Analyser.
Upon completion of the test the cartridge is removed from the Analyser and
6 a test result is displayed.

Data Handling
7
The Pima Analyser provides for data entry (Operator ID, Sample ID), archiving
and connectivity to printers and data storage media.

8 All results are saved in an on-board archive and may be retrieved and
downloaded by the Operator at any time after the test.

A Pima Test Report may also be printed using an attached external Pima Printer.
9

6 1 Introduction
 Analyser Specifications
1
Analyser
dimensions D 22 cm × W 13 cm × H 16 cm
weight 2.54 kg
2
detection system LED illumination and CCD-based detection
controls sample volume control; reagent control;
automatic control of cartridge expiry date;
internal process controls; automatic test 3
identification
display graphical display, monochrome, 128 × 64 pixel
user interface 16 button keypad 4
languages (display) English
memory data storage capacity of approx. 1000 tests

5
Operating conditions
operating temperature 10–40 °C
altitude 0-2000 m
6
relative humidity 10-95% (no condensation)
transport/storage temperature 2 – 40 °C
environment protect from direct sunlight, humidity and dust
7

Power
power supply DC 18 V/ 3.5 A
mains power 100–240 V + 10% (A/C) at 47–63 Hz 8

9
Declaration of Conformity

The Pima Analyser complies with the Essential Requirements of the Directive 98/79/
EC Annex I and was tested according to EN 61010-1, EN 61010-2-101, EN 61326-1
and EN 61326-2-6.

Pima Analyser User Guide 7

 Pima Analyser Recharging Intervals during Storage
1
During long term storage below 30°C, the Pima Analyser should be connected to
mains A/C power and the battery recharged overnight at least once per year.
During long term storage at 30-40°C the battery needs to be recharged at least
2 once every 6 months. If long term storage temperatures exceed 40°C,
the recharge intervals may need to be considerably shorter.

Note: It is not recommended to store the Pima Analyser with an empty battery.
3 Therefore, always recharge the battery before long term storage.

Unpacking, Installation & Transport

4
Unpack the Pima Analyser and place safely on a clean, flat, level and stable
surface. Do not put the Pima Analyser on surfaces that may vibrate, e.g. the top
of a freezer or refrigerator or next to a laboratory centrifuge.
5
Inspect for any obvious sign of damage. Report any damage immediately to
your local distributor. Allow temperature equilibration for at least 30 minutes to
ensure that the Analyser has reached surrounding temperature.
6
When using the Pima Bag for transportation, take out the Analyser and place
safely on a clean, flat, level and stable surface for testing.
If the Pima Analyser was transported or moved to areas with different climatic
7 conditions, allow temperature equilibration for at least 30 minutes.

Note: Keep the original Analyser box in case the instrument needs to
be shipped for repair or the like.
8

Analyser Calibration
9
The Pima Analyser is factory calibrated and does not require any further
calibration and verification operations.
However, a daily performance check using Pima Bead Standard is
recommended. If the Analyser was transported or moved, a test with the
Pima Bead Standard may be run to ensure proper functionality.
Please refer to the Pima Bead Standard User Guide (UG-PIMA-03) for more
information on this product.

8 1 Introduction
Maintenance & Cleaning
1
The Pima Analyser is a maintenance free instrument and has no serviceable
parts. In the case of encountered Analyser failures or damages, contact your
local distributor.
Use cleaning solutions containing alcohol (for example 70% Ethanol or 2
Isopropanol). Soak a paper towel or clean cloth with cleaning solution and wipe
the outside of the instrument. In case of using a liquid reagent, turn Off the
Analyser and disconnect it from mains A/C power.
3
Do not try to open the Analyser for cleaning.
Do not spray directly onto or inside of the instrument.
Do not use cleaning solutions containing chlorine bleach or organic solvents
other than alcohol.
4
Follow instructions on clearance certificate included in the Analyser box
before shipping the instrument to a third party.
5
Components and optional Items

The following items are supplied with The following optional items may also 6
your Pima Analyser: be supplied with your Pima Analyser:

• Power transformer • Pima Bag

• Power cable
• Pima Analyser User Guide
• Pima Bead Standard
• Pima Printer and printer paper 7
• Alere Connectivity Pack I and II
• Alere Connectivity Pack III
• Alere Power Pack
• Alere Solar Panel 8
• Alere Solar Solution

Pima Analyser User Guide 9

 Safety Warnings
1
Only use the Power transformer and A/C power cable supplied with the
Pima Analyser. Any other power supplies can damage the instrument and may
cause possible hazards.
2
Plug in power cable only in grounded power sockets.

Use Pima Analyser indoors when connected to A/C power.

When used outdoors disconnect from mains and avoid direct contact with
3 liquids of any kind.

Do not open the Pima Analyser. Any unauthorized opening of the instrument
can cause potential hazards and will invalidate warranty claims.
4
Only use the Pima Analyser as described in this document.

Only insert Pima Printers, USB storage devices or other authorized devices
5 into the USB ports of the Pima Analyser. Do not use USB 3.0 storage devices.

Placement of the Pima Analyser should allow easy disconnection from mains
A/C power at any time.

6 To ensure proper ventilation do not cover the instrument while switched on.

Perform scan on USB storage devices for viruses on a regular basis.

7 Do not plug in bulky USB devices next to each other since this may damage
the USB ports.

When using the Pima Analyser together with the Pima CD4 cartridge follow
proper infection control guidelines for handling all blood specimens and
8 related items.

For disposal of the Pima Analyser please contact your local distributor.

10 1 Introduction
Pima Analyser at a Glance
1

9
Display Power On
Keypad 2  × USB ports
Cartridge slot door Both Pima USB ports are
designed to be used with USB
storage media, Pima Printers or
other authorized devices only.
Power connector port

Pima Analyser User Guide 11

 2  Getting Started
Analyser Status Lights
1

2
Symbol Colour

Power Status Green

3
Charging Status Yellow

5 Analyser Display

2012-11-01 11:14
pima cd4
6 Analysing
67352

7 time—to—result: 11:00

 Status Line
Date and time are displayed.
8
Battery Status
The Battery Status symbol indicates the charging status when the
Analyser is not connected to mains A/C power.
9 Title Line
Display of currently active menu or sub-menu. During analysis and in the
result windows, the name of the test is displayed here.

Message Lines
Area to display menu items, test results, Analyser activities and function
messages.

12 2  Getting Started
Charging the Pima Analyser
1
Your Pima Analyser is supplied with a partially charged battery secured within
the Analyser. To charge the Analyser battery connect the Pima Analyser to
mains A/C power as follows:
• Insert the A/C power cable into the power transformer. 2
• Connect the power transformer to the power connector port located at the
back of the Analyser.
• Connect the power cable to the corresponding A/C power socket.
3

7
Power connector Power transformer A/C power cable

8
Charging Status Light

Upon connecting to mains A/C power the yellow charging status light located
9
on the front of the Analyser will be illuminated, indicating the charge state of
the Analyser battery.

Analyser battery fully charged Solid

Analyser battery charging Flashing

Pima Analyser User Guide 13

 The charging status light will only be illuminated when connected to main
A/C power. It may take several minutes until the correct charging status is
1 displayed.

In order to ensure maximum battery life charge the Analyser battery fully
overnight (8–10 hours) before running the Analyser on battery power.
2
When running the Analyser on battery power, the battery status is displayed
by the battery status symbol within the display status line.

Switching On the Pima Analyser/Power Status Light

4 The green power status light located on the front of the Analyser displays its
power status.

5 Analyser ON On
Analyser OFF Off

• Press and hold the Power On button until you hear a triple "beep" and the
appearance of «pimaTM» on the screen confirms that the Analyser is now
7 switched On.

An automated initialisation and self-test procedure is activated which may last

for approximately two minutes. During this time the screen changes and the
8 function of the cartridge slot door is tested.

• If the Analyser fails correct initialisation and self-test, an error code is dis-
played. It may not be possible to turn the Analyser off via the route
9
described in section 7. In such a case press and hold the Power On
button on the back of the Analyser until the screen turns black and you hear
a single "beep", confirming that the Analyser is now switched Off.
Restart the Pima Analyser as described above. Refer to section 8 and 9 for
details on error codes and contact your local distributor or Technical
Support, if necessary.

It is recommended to shutdown the Pima Analyser at least once per month.

14 2  Getting Started
User Interface
1
All Operator interactions with the Pima Analyser are performed using the
Analyser keypad.

5
Navigation

⌱ (UP) key to navigate menus, Operator and result lists 6

⌲ (DOWN) key to navigate menus, Operator and result lists
〈 (OK) key to confirm selected menu items and entered text
⌨ (BACK) key to cancel a particular action and to go back to previous screen
⌧ (CLEAR) key to delete entered text 7
⌰ (MODE) key to switch from numbers to letters and special characters on
the keypad
Text edit keys to enter numbers, letters and special characters
8
Press a number key to enter the respective number. Press ⌰ once to switch
back and forth between numbers and letters and special characters, respectively.
Press respective keys repeatedly until the desired character appears in the order
9
as printed on the keys. If the next letter you want to enter is located on the same
key as the present one, wait until the cursor appears and enter the letter.
«Dash» and «Underscore» are located on the (0) key.
«Space» is located on the (1) key.

Pima Analyser User Guide 15

 3  Running a Test
Initiating a Test
1
The Pima test consists of a disposable Pima CD4 test cartridge, containing
dried reagents, and the Pima Analyser.

2 Pima test cartridges are supplied in boxes containing a product insert detailing
instructions for sample collection as well as the test specific performance
characteristics.

3
Before performing a Pima test, carefully read the Pima CD4 cartridge guide
for details on sample application and cartridge handling.

4 Check correct local date and time before running a test.

5
• To initiate a test run and open the 2012-11-01 11:05
cartridge slot door press 〈 when
prompted by the following screen.
6 Run test
press OK
• The cartridge slot door opens and
the Analyser prompts the Operator
7 to insert a cartridge.
2012-11-01 11:05

• The cartridge slot door can be

8 closed by pressing ⌨ returning Insert new
the Operator to the «Run test»
cartridge
window.

If no cartridge is inserted within 30 seconds, the cartridge slot door closes

automatically and the display returns to the «Run test» window.

16 3  Running a test
Inserting the Pima Test Cartridge
1
Insert cartridge into the Pima Analyser in the direction indicated by the arrow
on the cartridge.

The Pima Analyser is designed to be used in combination with the Pima test 2
cartridge only. No other cartridges, test strips or device should be inserted
into the Analyser.

Do not discard the cartridge pouch until the Pima Analyser has 3
successfully started the analysis. In case of a barcode error, the information
printed on the cartridge pouch can be used to enter the barcode manually
(refer to p. 40 for Barcode Error message).
4

• Upon inserting the Pima test

cartridge a sensor in the Analyser
5
recognizes that a cartridge has
been inserted and automatically
starts the analysis process by
fully drawing the cartridge into the 6
Analyser and closing the cartridge
slot door.

• The display screen changes briefly 2012-11-01 11:05 7

to «Reading cartridge» at this Analysis
moment.
Reading
cartridge 8

9
• Once the Pima Analyser has accepted the cartridge it will prompt the
Operator to enter both the Operator and Sample ID.
During data entry the test analysis continues in the background.

While it is not necessary to enter Operator and Sample ID before starting

the analysis, the Pima Analyser will NOT display a result until both Operator
and Sample ID have been entered.

Pima Analyser User Guide 17

 Operator ID Entry
1
The «Operator List» is displayed with all archived Operators in alphabetical
order.

2
• Select an Operator from the list by 2012-11-01 11:05
using ⌱ and ⌲ and confirm the Operator list
selection with 〈. New Operator
3 Or, if the Operator is not yet in the Anton
list, select «New Operator» to enter Chris
a new Operator into the list. Karin
4
Refer to section 6 for instructions on how to enter a new Operator ID into the
Operator List.
5
Sample ID Entry

6 After entering an Operator, the «Enter Sample» window is displayed on

the screen.

• A Sample ID of up to 20 characters 2012-11-01 11:05

7 may be entered using the keypad. enter sample
Enter Sample ID and confirm
with 〈.
67
8

Analysis in Progress
9
• After Operator and Sample ID 2012-11-01 11:14
have been entered successfully, pima cd4
the «Analysis in Progress» window Analysing
appears. The ID of the sample 67352
currently analysed and an estimated
time to completion are shown. time—to—result: 11:00

18 3  Running a test
Analysis Complete
1
• After the analysis has been 2012-11-01 11:25
successfully completed, the analysis
«Analysis done. Remove cartridge»
window appears and prompts the Analysis done. 2
Operator to remove the cartridge Remove
from the Analyser.
cartridge

• Once the cartridge has been 2012-11-01 11:25

removed, the Pima Analyser pima cd4
automatically displays the first of 4
Sample 67352
four result windows, showing the
CD3 CD4
Sample ID and test result.

BACK PRINT 5
Additional test related parameters
can be viewed using ⌲ and ⌱.

A Pima Test Report may be printed at this time (see "Printing results immediately 6
after Analysis" for details).

All results data is stored in the data archive. Archived results can be viewed
under «Results» in the «Main Menu». For details see section 5. 7

• Press ⌨ to return to the initial 2012-11-01 11:25

«Run test» window and start 8
the analysis.
Run test
press OK
9

Pima Analyser User Guide 19

 Printing Results immediately after Analysis
1
This option is only available if a Pima Printer is attached to the Pima
Analyser via the USB port. For information on Pima accessories, please view
www.AlereHIV.com and refer to the Pima Printer User Guide (UG-PIMA-02).
2
• A Pima Test Report can be printed 2012-11-01 11:25
from any of the four Pima test pima cd4
result windows by pressing 〈.
3 Sample 67352
CD3 CD4

BACK PRINT
4
• The «Print» window appears 2012-11-01 11:25
and «YES» is selected by default. Print
Confirm with 〈 and the current
5 Do you want to
result is printed. Press ⌨ or
print the
select «NO» to exit this window and YES
current result?
return to the Pima test NO
6 result window.

• The printing status is indicated 2012-11-01 11:25

7 by a progress bar. Printing can Print Results
be aborted at any time this window
Printing
is shown on the screen.
results
Refer to section 4 on how to abort
8 printing. TOTAL:

20 3  Running a test
 1
• The «Pima Test Report» (example shown below) contains all information
displayed on the result windows of the Pima Analyser. After successful
printing, the Analyser returns automatically to the Pima test result window.
2

Pima Analyser User Guide 21

 4  Analysis Menu
Changing Operator and Sample ID during a Test Run
1
Should the Operator discover that an error has been made in the entry of
Operator and / or Sample ID, these entries can be changed as long as the
cartridge is not removed from the Analyser.
2
After removal of the cartridge no changes to the selected Operator or
entered Sample ID are possible anymore.

3 Changes to Operator and Sample ID can be made through the «Analysis

Menu» which is accessed by pressing ⌨.

Analysis Menu
4
The «Analysis Menu» can only be 2012-11-01 11:05
accessed while an analysis is in analysis Menu
progress and allows the Operator to
5 Operator
change the Operator and Sample ID Sample ID
as well as abort the test run. Abort Analysis

Change Operator ID
7
• To change the Operator ID during the analysis, select «Operator» from the
«Analysis Menu» and confirm with 〈. Select a different Operator from the
«Operator List» or select «New Operator» to enter a new Operator. Any new
8 Operator will be automatically added to the «Operator List». Confirming the
Operator with 〈 will re-open the «Analysis in Progress» window.

9
Change Sample ID

• To change a Sample ID during the analysis, select «Sample ID» from the
«Analysis Menu» and confirm with 〈. This opens the «Enter Sample»
window and the Sample ID can be edited. Confirming the edited Sample ID
with 〈 will re-open the «Analysis in Progress» window.

22 4  Analysis Menu
Abort Analysis
1
• Select «Abort Analysis» in the «Analysis Menu» and confirm with 〈.

Note that cartridges CANNOT be re-used after an analysis is aborted.

2

• The «Abort Analysis» window 2012-11-01 11:05

appears and «NO» is selected by abort analysis
default. Press either 〈 or ⌨ 3
Do you want to
to exit this window and to return
abort the
to the «Analysis Menu». analysis ? YES
NO
4

• Select «YES» and confirm with 〈. 2012-11-01 11:05

The Analyser will abort the current abort analysis 5
analysis.
Do you want to
abort the
analysis ? YES
NO 6

• The Operator is prompted to 2012-11-01 11:05 7

remove the cartridge. The following PIMA CD4
error code is displayed in the first Sample: 67352
result window. Press ⌨ to return to
Manual abort 8
the initial «Run test» window and to Error 206
start the next analysis. _________________________________________
BACK X PRINT

9
To abort the export, deletion or printing of results, proceed in the same
manner. Press ⌨ to open the «Abort process» window. «NO» is selected by
default. Select «YES» and confirm with 〈.
The Analyser will abort the current process.

Pima Analyser User Guide 23

 5  Main Menu: Results
The «Main Menu» window can only be selected, if there is no analysis currently
1 in progress.

View Results from Archive

2
• To view the result options, select 2012-11-01 11:30
«Results» from the «Main Menu» MAIN MENU
and confirm with 〈.
3 Results
Settings
Power Off

4
• A list of all available result options is 2012-11-01 11:30
displayed. Use ⌱ and ⌲ to scroll Results
the complete list. To view Results View
5
select «View» from the «Results» Print
window. Export
Export and Delete
Delete
6

• The «View Results» window with all 2012-11-01 11:30

archived Sample IDs is displayed VIEW RESULTS
7 by Test ID in reverse chronologi- 36 67352
cal order. The last archived result is 35 55687
selected by default. Use ⌱ and ⌲ 34 48951
to select a result of interest and 33 37756
8 confirm with 〈.
32 23544

• This opens the first result window 2012-11-01 11:25

9
for the selected Sample ID. pima cd4
Sample 67352
Additional test related parameters
CD3 CD4
can be viewed using ⌲ and ⌱.

BACK PRINT
• Press ⌨ to return to the «View
Results» window.

24 5  Main Menu: Results

Print Results from Archive
1
For printing, a Pima Printer needs to be attached to the Pima Analyser
via the USB port.

• To print results select «Print» from 2012-11-01 11:30 2

the «Results» window and confirm Results
with 〈. View
Print
Export 3
Export and Delete
Delete
• The «Print Results» window with all 2012-11-01 11:30
archived Sample IDs is displayed PRINT RESULTS 4
by Test ID in reverse chronological Print All
order. Select results to be printed Print Selected
and confirm with 〈. Confirmed 36 67352
35 55687 5
results are marked by a (x).
34 48951
If only one result is selected, printing will start immediately after initial
confirmation. 6

• If more than one result was 2012-11-01 11:30

selected, the «Print» window Print
appears and «NO» is selected by Do you want to 7
default. Select «YES» and confirm print 2
with 〈 to print selected results results ? YES
from the Analyser archive. NO
8
Press ⌨ or select «NO» to exit this
window and return to the «Print
Results» window.
9
The printing status is indicated by a progress bar.

The «Pima Test Report» contains all information displayed on the four result
windows of the Pima Analyser.

After successful print, the display automatically returns to the «Results»

window.

Pima Analyser User Guide 25

 Export Results from Archive
1
• To export results select «Export» 2012-11-01 11:30
from the «Results» window and Results
confirm with 〈. View
2 Print
Export
Export and Delete
Delete
3

• The Analyser prompts the Operator 2012-11-01 11:30

4 to insert a storage medium into one
of the two USB ports on the back
of the Analyser. Insert
storage
5 medium

• The storage medium is recognised 2012-11-01 11:30

by the Analyser and displayed. select storage
7 This may take up to one minute. Storage device 2 GB
Use ⌱ and ⌲ to select a storage Mobile Modem
medium and confirm with 〈. LAN Adaptor
8

• In case the USB storage medium is not recognised, please refer to p. 42 for
Export Error message.
9
In case a mobile modem is used, please refer to “AlereTM Connectivity
Pack I and II – Annex to Pima Analyser User Guide UG-PIMA-01”.
In case a LAN adaptor is used please refer to “AlereTM Connectivity Pack III
– Annex to Pima Analyser User Guide UG-PIMA-01”.

26 5  Main Menu: Results

• The «Export Results» window with 2012-11-01 11:30
all archived Sample IDs is displayed eXPORT RESULTS 1
by Test ID in reverse chronological Export All
order. Export Selected
36 67352
35 55687 2
34 48951

• Either select «Export All» to export

all results in the list, 3
or use ⌱ and ⌲ to select a result
2012-11-01 11:30
of interest and confirm with 〈.
Confirmed results are marked by
Export Results
a (x). Export All 4
Export Selected
36 67352
• After selecting one or more 35 55687
individual results, select «Export 34 48951 5
Selected» and confirm with 〈 to
export results onto the
storage medium.
6
• If only one result is selected, export will start immediately after initial
confirmation. If more than one result was selected, the «Export» window
appears and «NO» is selected by default. Select «YES» and confirm
with 〈 to export selected results from the Analyser archive. 7
Press ⌨ or select «NO» to exit this window and return to the «Export
Results» window.

Pima Analyser User Guide 27

 • The exporting status is indicated 2012-11-01 11:30
1 by a progress bar. Exporting can be Export Results
aborted at any time this window is Exporting
shown on the screen. results
TOTAL
2

3 • Successful export is indicated 2012-11-01 11:30

by this message. Remove storage
medium or press 〈 or ⌨
to continue. Remove
4 storage
medium

5
Note: The storage medium does not need to be removed to continue,
however, removal is recommended, especially when the Pima Analyser is
6 operated on the integrated battery.

Export and Delete Results from Archive

7
• To export and delete results at 2012-11-01 11:30
the same time, select «Export and Results
Delete» from the «Results» window View
8 and confirm with 〈. Print
Select results of interest in the same Export
way as described in the previous Export and Delete
section for result export. Delete
9
After export, the Operator will be prompted to confirm deletion of results.

28 5  Main Menu: Results

• The «Delete» window appears and 2012-11-01 11:30
«NO» is selected by default. DelEte 1
Press either 〈 or ⌨ to exit this Do you want to
window and return to the «Export
delete 35
Results» window.
exported YES
results ? NO 2

• Select «YES» and confirm with 〈 2012-11-01 11:30 3

and selected results are deleted DelEte
from the Analyser archive after Do you want to
their export onto the storage
delete 35 4
medium. All other results remain
exported YES
in the archive. The process status
results ? NO
is indicated by a progress bar.
5
After successful completion, the display automatically returns to the «Results»
window.

Delete Results from Archive

• To delete results select «Delete» 2012-11-01 11:30 7

from the «Results» window and Results
confirm with 〈. View
Print
Export 8
Export and Delete
Delete

9
• The «Delete Results» window 2012-11-01 11:30
with all archived Sample IDs is DElete RESULTS
displayed by Test ID in reverse Delete All
chronological order. Select results Delete Selected
to be deleted as described in the 36 67352
section for result export.
35 55687
34 48951

Pima Analyser User Guide 29

 • The «Delete» window appears and 2012-11-01 11:30
1 «NO» is selected by default. DelEte
Press either 〈 or ⌨ to exit this Do you want to
window and return to the «Delete
delete 35
Results» window. results ? YES
2 NO

3 • Select «YES» and confirm with 〈 2012-11-01 11:30

and selected results are deleted DelEte
from the Analyser archive. Do you want to
All other results remain in the delete 35
4 archive. results ? YES
NO
The deleting status is indicated by
a progress bar.
5
After successful deletion, the display automatically returns to the «Results»
window.
6

30 5  Main Menu: Results

6  Main Menu: Settings
Settings
1
• To change general Analyser 2012-11-01 11:05
settings, select «Settings» from the MAIN MENU
«Main Menu» and confirm with 〈. Results
Settings 2
• A list of all available settings is Power Off
displayed. Use ⌱ and ⌲ to scroll
the complete list.
3

Enter an Operator ID
4
• Select «Operator» from the 2012-11-01 11:05
«Settings List» and confirm Settings list
with 〈. Operator 5
Date
Time
Service Export
Device Info
6

• This opens the «Operator List» 2012-11-01 11:05

window. Select «New Operator» to Operator list
enter a new Operator into the list. 7
New Operator
Confirm with 〈.

• Enter a new Operator using the 2012-11-01 11:05

keypad and confirm with 〈. new Operator 9
Press 〈 again to save new
Operator.
Karin
The «Operator List» now
contains an Operator.
Continue as described above to
enter more Operators.

Pima Analyser User Guide 31

 Edit an Operator ID
1
Editing of existing Operators is only possible when no analysis is running.
Select «Operator» from the «Settings List » and confirm with 〈 to enter the
«Operator List».
2

• Select the Operator that needs to 2012-11-01 11:05

be edited. Confirm with 〈. Operator list
3
New Operator
Karin
Anton
Chris
4

• The «Operator ID» window opens. 2012-11-01 11:05

Select «Edit Operator» and confirm Operator id
5
with 〈. Edit
Delete

• The «Edit Operator» window opens 2012-11-01 11:05

7 and the entry can be edited. EDIT Operator
Confirm with 〈 when finished
and the «Edit Operator» Menu is
displayed. ANTO
8

9 Press 〈 to save edited Operator. 2012-11-01 11:05

Selecting «Cancel» and confirm EDIT Operator
with 〈 re-opens the unchanged Save
«Operator List». Cancel

32 6  Main Menu: Settings

• After confirmation, the edited 2012-11-01 11:05
Operator is displayed in the Operator list 1
«Operator List». New Operator
Karin
Anto
Chris 2

Delete an Operator ID 3

• Select «Delete» in the «Operator ID» 2012-11-01 11:05

window and confirm with 〈. Operator id
The Operator is now deleted from
4
Edit
the «Operator List». Delete

6
Date

• Select «Date» from the «Settings 2012-11-01 11:05

List» and confirm with 〈 to set Settings list 7
the date on the Analyser. Operator
Date
Time
Service Export 8
Device Info

• Use ⌱ and ⌲ to select the 2012-11-01 11:05

9
desired number and confirm with set date
〈, entering the year first, followed
by month and day. Confirm the 2013—02—02
correct date with 〈.

Pima Analyser User Guide 33

 Time
1
• Select «Time» from the «Settings 2012-11-01 11:05
List» and confirm with 〈 to set Settings list
the time on the Analyser. Operator
2 Date
Time
Service Export
Device Info
3
• Use ⌱ and ⌲ to select the 2012-11-01 11:05
desired number and confirm set time
with 〈, entering the hours first,
4 followed by minutes. Confirm the
13 53
correct time with 〈.

Service Export
6
• Select «Service Export» from 2012-11-01 11:05
the «Settings List» and confirm Settings list
with 〈 to export encrypted Operator
7 data from the last analysis or Date
the last 10 analyses. Follow Time
the on-screen instructions and Service Export
proceed in similar fashion as
Device Info
8 described for "Export Results
from Archive".

9
Note: The Service Export tool is meant to assist Technical Support in trou-
ble shooting the Pima Analyser. Service Export files can only be read using
matching decrypting software. Service Exports may take up to an hour,
depending on the number of files needed to be exported and the USB
storage medium used.

34 6  Main Menu: Settings

Device Info
1
The Device Info window provides a quick overview of some important Analyser
characteristics.

2
• Select «Device Info» from the 2012-11-01 11:05
«Settings List» and confirm with Settings list
〈 to view Analyser status data. Operator
Date 3
Time
Service Export
Device Info
4
• The following information can be 2012-11-01 11:30
obtained: Device Info
DEVICE: PIMA-D-000552 5
SOFTWARE: 0.39.1
BATTERY: 60%
ARCHIVE: 37 RESULTS
CONNECTIVITY: UC864, CT63

Category Information 7

Device: Serial Number of the Pima Analyser

Software: Software version installed on the Pima Analyser 8

Battery: Current charging status of the internal battery

9
Archive: Number of results stored in the archive

Connectivity: Mobile modems that can be used with this Pima Analyser

Pima Analyser User Guide 35

 Connectivity
1
• This option is only available in 2012-11-01 11:05
combination with the respective Settings list
hardware and Pima software Date
2 version 0.39.1 or higher. Time
For wireless connectivity please Service Export
refer to “AlereTM Connectivity Pack Device Info
I and II – Annex to Pima Analyser Connectivity
3 User Guide UG-PIMA-01” or
contact your local distributor.

4
Local Network

• This option is only available in 2012-11-01 11:05

5
combination with the respective Settings list
hardware and Pima software
Time
version 0.40.0 or higher. Service Export
6 Device Info
For more information about LAN Connectivity
connectivity please refer to Local Network
“AlereTM Connectivity Pack III –
7 Annex to Pima Analyser
User Guide UG-PIMA-01” or
contact your local distributor.

36 6  Main Menu: Settings

7  Main Menu: Power Off
Turning Off the Pima Analyser
1
• To turn off the Pima Analyser 2012-11-01 11:05
select «Power Off» from the «Main MAIN MENU
Menu» and confirm with 〈.
Results
Settings 2
Power Off

• The «Power Off» window appears 2012-11-01 11:05

4
and, as a safety measure, «NO» is power off
selected by default. Do you want to
turn power off ?
YES 5
NO

6
• If «Yes» was selected and 2012-11-01 11:05
confirmed with 〈, the screen
will indicate that the Analyser is
shutting down. This may take up Shutdown 7
to one minute. After the shutdown
Please wait
sequence is completed, the
Analyser will turn itself Off, the
screen will turn black and a "beep" 8
is audible.

9
Remove any storage media from the USB port before shutting down
the Analyser.

Pima Analyser User Guide 37

 8  Error Codes & Technical Support
Note: If the Analyser does not react to any input from the keypad, press and
1 hold the Power On button on the back of the Analyser until the screen turns
black and you hear a long single "beep", confirming that the Analyser is now
switched Off. Restart the Pima Analyser.

2
Error Code Window

The Pima Analyser performs a series of checks to ensure that all steps of the
3 analysis process are completed successfully.

Should one of these checks discover 2012-11-01 11:05

4 an error, the test will be aborted PIMA CD4
automatically, the cartridge ejected Sample: 67352
and an error code displayed on the
Invalid Test
screen (an example is shown to the Error 810
5
right). _________________________________________
BACK X PRINT

6
Technical Support

For Technical Support please contact your local distributor or call the
7 respective number for your region:

Europe: +44 161 483 9032 EMEproductsupport@alere.com

Africa: +27 21 5315 999 Afrisupport@alere.com
8 Asia Pacific: +61 7 3363 7166 au.techsupport@alere.com
India: +91 11 45089400 technical.service@alere.com
Latin America: +57 2 6618916, la.techsupport@alere.com
+57 2 6618797
9
Russia & CIS: +972 8 9429 683 Tsupport@orgenics.co.il

38 8  Error Codes & Technical Support

Error Codes
1
Error Code Action
Switch Off the Analyser via Main Menu and restart.
200
If Error persists contact your local distributor.
2
Check cartridge control window was fully filled.
201
Repeat test with new cartridge.
Check cartridge cap was completely closed.
202
Repeat test with new cartridge. 3
Check cartridge expiry date.
203 Check correct date on the Pima Analyser.
Repeat test with valid cartridge.
205 Contact your local distributor.
4
206 Analysis aborted by operator. No further action required.
Repeat test with new cartridge.
207
If Error persists contact your local distributor. 5
Repeat test with new cartridge.
210, 220, 230
If Error persists contact your local distributor.
Switch Off the Analyser via Main Menu and restart. 6
211
If Error persists contact your local distributor.
300-399 Contact your local distributor.
810
7
820
825
830
840
8
850
860 Repeat test with new cartridge.
870 If Error persists contact your local distributor. 9
880
910
920
930
940

Pima Analyser User Guide 39

 9 Error Warnings & Messages
Archive Error
1
If the storage capacity of the 2012-11-01 11:05
archive is reached, the screen will FAILURE
display the «Archive full» window.
2 No further analyses can be
Archive full
performed by the Analyser until
data has been downloaded and
the archive emptied.
3

Even if the storage capacity is reached, all menu functions are still active.

Barcode Errors
5
In the unlikely event that the Analyser 2012-11-01 11:05
has difficulties reading the cartridge FAILURE
barcode, the «Barcode error»
6 window appears. Barcode
error

7 • Press 〈 or ⌨ and enter the

number printed below the barcode
on the cartridge pouch (circled in
image). Press 〈 to confirm
8 and continue.

The barcodes (and their respective

numbers) carry important cartridge
9
specific information and may differ
from cartridge to cartridge.

• Press ⌨ instead of entering a barcode and the «Abort Analysis» window

opens.

Check cartridge barcode for damage or marks.

40 9  Error Warnings & Messages

 DO NOT use the barcode from a different cartridge when manually
entering the barcode. Manual input of barcodes will be documented on 1
the test result pages.

• If the cartridge barcode does not 2012-11-01 11:05

encode for a test type uploaded FAILURE 2
onto the Analyser, the following
window is displayed. Invalid
barcode
3

For information regarding available test software please contact your

local distributor.
4

Entry Errors 5
It is mandatory to enter Operator 2012-11-01 11:05
and Sample ID to view a test result. Invalid entry
Attempting to confirm «blank» 6
entry fields for either Operator or Operator is
Sample ID will trigger the following required
error messages.
7
• Enter valid Operator and Sample 2012-11-01 11:05
ID to continue. Invalid entry
Sample ID 8
Should a new Operator ID be entered is required
into the Operator list, but an Operator
with the same name / number already
9
exists in the list, the following window 2012-11-01 11:05
is displayed. Invalid entry
• Press 〈 or ⌨ and pick a Operator
different name / number for already
the new Operator. exists

Pima Analyser User Guide 41

 Export Error
1
If the «Export failed» window 2012-11-01 11:05
appears, an unspecified error has FAILURE
occurred during export of results.
2 This may have been caused by either Export
the storage medium or the Analyser. failed

3
• Press 〈 or ⌨ and remove the storage medium. Repeat export of results.
Should this fail a second time insert a different USB storage medium and
export results.
4

5 Power Warning

The «Warning Recharge battery» 2012-11-01 11:05

window appears indicating that the warning
6 Analyser's integrated battery is low.
This Warning can appear at any Recharge
time, even during an active analysis. battery
At this point the Analyser is fully
7 functional and the analysis can
be continued.

8 It is recommended to connect the Pima Analyser to A/C power before

starting another analysis.

• Press 〈 or ⌨ to continue.
9

42 9  Error Warnings & Messages

Power Error
1
The «Recharge battery» window 2012-11-01 11:05
appears if the power level of the
integrated battery is too low to
conduct another analysis. No further Recharge 2
analyses can be performed by the battery
Analyser until the battery is recharged
or the Analyser is connected to A/C
power. 3

• Menu functions may still be active at this point. Press 〈 or ⌨ to continue.

It is recommended to connect the Pima Analyser to A/C power before the

4
integrated battery is completely discharged.

5
Printer Errors

Should the Operator attempt to print 2012-11-01 11:05

results with no Pima Printer attached Failure 6
to the Analyser the «Failure» window
Printer error
is displayed.
Abort printing ?
YES
NO 7

Should the Pima Printer run out

of paper, the following window
is displayed. 8
2012-11-01 11:05
After a new roll of paper has been Failure
inserted, confirm continuation of Paper required 9
printing with 〈. In case the error Abort printing ?
occurred during the printing of a YES
Pima Test Report, the last report will NO
be printed again.

For more information on the Pima Printer, please refer also to the Pima Printer
User Guide (UG-PIMA-02).

Pima Analyser User Guide 43

 Selection Error
1
Should the Operator attempt to Print, 2012-11-01 11:05
Export, Export and Delete or Delete Invalid selection
stored test results without
2 selecting a result prior to executing No test
the command the following window selected
is displayed.

3 • Press ⌨ and select one or more

tests before pressing 〈.

4
Storage Errors

If, during export, the storage 2012-11-01 11:05

5
capacity of the storage medium FAILURE
is reached, the following window
appears. Storage
6 medium full
• Press 〈 or ⌨ and remove the
storage medium. Insert another
storage medium with adequate
7 storage capacity and try to
export again.

If, during export, the storage medium 2012-11-01 11:05

8 is removed from the USB port, the FAILURE
following window appears.
Storage
• 
Press 〈 or ⌨, re-insert the medium lost
9
storage medium and attempt to
export again.

44 9  Error Warnings & Messages

Undefined Errors
1
It is possible that an undefined error occurs while operating the Pima Analyser.

This error message may appear if 2012-11-01 11:05

the Analyser unexpectedly aborted FAILURE 2
start up.
Unexpected
• Press and hold the Power On exception
button on the back of the Analyser 3
until the screen turns and remains
black. Then restart the Analyser.

4
This error message may appear 2012-11-01 11:05
at any time. Depending on what FAILURE
triggered the error, the Operator
5
may still be able to navigate through
Error 0000
the Analyser menus and to start
a new test.
6

• In case the error caused the Analyser to stall, press and hold the Power
On button on the back of the Analyser until the screen turns and remains
black. Then restart the Analyser. 7

This error message may appear

during the initial booting procedure 8
and will cause the Analyser to stall. pima
• Press and hold the Power On
Hardware failed 9
button on the back of the Analyser
until the screen turns and remains
black.
Then restart the Analyser.
If Error persists contact your local distributor.

Pima Analyser User Guide 45

 Volume Error
1
2012-11-01 11:05
Before each analysis, the Analyser FAILURE
checks the sample volume loaded on
2
No sample
the Pima test cartridge. If the Analyser
detected
detects insufficient volume the
Error 201
following window is displayed.

3 • Press 〈 or ⌨ and the «Abort

Analysis» window opens.

• The Operator can overrule this error message by selecting «NO» in the
4 «Abort Analysis» window and the analysis process will continue.

Overruling Error 201 will be documented on the result pages.

5

46 9  Error Warnings & Messages

Alere Technologies GmbH
Loebstedter Str. 103–105
D-07749 Jena, Germany
www.AlereHIV.com

© 2013 Alere. All rights reserved. UG-PIMA-01-07-EN

AlereTM and PimaTM are trademarks of the Alere group of companies. Revision date: 12-Dec-2013