Abbott Pima ANALYSER User manual

PimaTM ANALYSER
USER GUIDE
EN

Pima™Analyser
2
Li-Po Lithium-Polymer
Li-Ion Lithium-Ion
Baery
Serial Number
pTo keep dry
This unit must be recycled
or discarded according to
applicable local and naonal
regulaons.
Index of Symbols
CE Mark
In vitro diagnosc
medical device
Manufacturer
Catalogue Number
Aenon symbol.
Indicates special problems
or important informaon.
Read the accompanying text
carefully.
Direct current (DC)
The Pima Analyser employs the same stac image analysis and counng
principles as exisng cell enumeraon technologies, in a compact, portable
and robust package. Designed equally to suit the needs of the healthcare
professional in the eld or in the laboratory the Pima Analyser is an
aordable, eecve and valuable point-of-care diagnosc 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 informaon about Pima: www.globalpointofcare.abbo

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Pima™ ANALYSER USER GUIDE 3
1 INTRODUCTION
2 GETTING STARTED
3 RUNNING A TEST
4 ANALYSIS MENU
5 MAIN MENU: RESULTS
6 MAIN MENU: SETTINGS
7 MAIN MENU: POWER OFF
8 ERROR CODES & TECHNICAL SUPPORT
9 ERROR WARNINGS & MESSAGES

4
6 1 INTRODUCTION
6 Intended Use
6 Test Principle
6 Data Handling
7 Pima Analyser Specicaons
7 Declaraon of Conformity
8 Pima Analyser Recharging Intervals during Storage
8 Unpacking, Installaon & Transport
8 Pima Analyser Calibraon
9 Maintenance & Cleaning
9 Components and Oponal Items
10 Safety Warnings
11 Pima Analyser at a Glance
12 2 GETTING STARTED
12 Pima Analyser Status Lights
12 Pima Analyser Display
13 Charging the Pima Analyser
13 Charging Status Light
14 Switching On the Pima Analyser/Power Status Light
15 User Interface
15 Navigaon
16 3 RUNNING A TEST
16 Iniang a Test
17 Inserng the Pima Test Cartridge
18 Operator ID Entry
18 Sample ID Entry
18 Analysis in Progress
19 Analysis Complete
20 Prinng Results immediately aer Analysis
22 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
TABLE OF CONTENTS

Pima™ ANALYSER USER GUIDE 5
24 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
31 6 MAIN MENU: SETTINGS
31 Sengs
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 Connecvity
36 Local Network
37 7 MAIN MENU: POWER OFF
37 Turning O the Pima Analyser
38 8 ERROR CODES & TECHNICAL SUPPORT
38 Error Code Window
38 Technical Support
39 Error Codes
40 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 Selecon Error
44 Storage Errors
45 Undened Errors
46 Volume Error

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6
Intended Use
The Pima Analyser is a portable bench-top xed volume cytometer used for
the processing and analysis of a Pima CD4 test cartridge.
For in vitro diagnosc use. 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 baery.
The Pima Analyser requires no maintenance.
Test Principle
The Pima test consists of a disposable Pima test cartridge, containing dried
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 Pima Analyser and the sample
sealed within the cartridge is processed. During the course of test processing,
data is recorded, analyzed and interpreted using soware embedded in the
Pima Analyser.
Upon compleon of the test the cartridge is removed from the Pima Analyser
and a test result is displayed.
Data Handling
The Pima Analyser provides for data entry (Operator ID, Sample ID),
archiving and connecvity to printers and data storage media.
All results are saved in an on-board archive and may be retrieved and
downloaded by the operator at any me aer the test.
A Pima Test Report may also be printed using an aached external USB Printer.
1 INTRODUCTION
1 INTRODUCTION

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Pima™ ANALYSER USER GUIDE 7
Pima Analyser Specicaons
Pima Analyser
Dimensions D 22 cm × W 13 cm × H 16 cm
Weight 2.54 kg
Detecon System LED illuminaon and CCD-based detecon
Controls sample volume control; reagent control;
automac control of cartridge expiry date;
internal process controls; automac test
idencaon
Display graphical display, monochrome, 128 × 64 pixel
User Interface 16 buon keypad
Languages (Display) English
Memory data storage capacity of approx. 1000 tests
Operang Condions
Operang Temperature 10 - 40 °C
Altude 0 - 2000 m
Relave Humidity 10 - 95 % (no condensaon)
Transport/Storage Temperature 2- 40 °C
Environment protect from direct sunlight, humidity and dust
Power
Power Supply DC 18 V/ 3.5 A
Mains Power 100 - 240 V + 10 % (A/C) at 47 - 63 Hz
Declaraon of Conformity
The Pima Analyser complies with the Essenal Requirements of the Direcve
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.

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Unpacking, Installaon & Transport
Unpack the Pima Analyser and place safely on a clean, at, 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.
Inspect for any obvious sign of damage. Report any damage immediately to
your local distributor. Allow temperature equilibraon for at least 30 minutes
to ensure that the Pima Analyser has reached surrounding temperature.
When using the Pima Bag for transportaon, take out the Pima Analyser and
place safely on a clean, at, level and stable surface for tesng.
If the Pima Analyser was transported or moved to areas with dierent climac
condions, allow temperature equilibraon for at least 30 minutes.
Note: Keep the original Pima Analyser box in case the instrument needs to
be shipped for repair or the like.
Pima Analyser Calibraon
The Pima Analyser is factory calibrated and does not require any further
calibraon and vericaon operaons. However, a daily performance check
using Pima Bead Standard is recommended. If the Pima Analyser was
transported or moved, a test with the Pima Bead Standard may be run to ensure
proper funconality. Please refer to the Pima Bead Standard User Guide
(UG-PIMA-03) for more informaon on this product.
Pima Analyser Recharging Intervals during Storage
During long term storage below 30 °C, the Pima Analyser should be connected
to mains A/C power and the baery recharged overnight at least once per
year. During long term storage at 30 - 40 °C the baery needs to be recharged
at least 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
baery. Therefore, always recharge the baery before long term
storage.
1 INTRODUCTION

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Pima™ ANALYSER USER GUIDE 9
Maintenance & Cleaning
The Pima Analyser is a maintenance free instrument and has no serviceable
parts. In the case of encountered Pima Analyser failures or damages, contact
your local distributor.
Use cleaning soluons containing alcohol (for example 70 % Ethanol or
Isopropanol). Soak a paper towel or clean cloth with cleaning soluon and wipe
the outside of the instrument. In case of using a liquid reagent, turn o the
Pima Analyser and disconnect it from mains A/C power.
Do not try to open the Pima Analyser for cleaning.
Do not spray directly onto or inside of the instrument.
Do not use cleaning soluons containing chlorine bleach or organic solvents
other than alcohol.
Follow instrucons on clearance cercate included in the Pima Analyser
box before shipping the instrument to a third party.
Components and Oponal Items
The following items are supplied with your Pima Analyser
(catalogue no. 260300003):
• Power transformer (18 V)
• Power cable (EU)
• Pima Analyser User Guide
• Pima Bead Standard (catalogue no. 260400011)
The following oponal items are also available for your Pima Analyser:
• Pima Bag (catalogue no. 260400001)
• USB Printer (catalogue no. 27040R007)
and Printer Paper I (catalogue no. 26040R009)
and Printer Paper II (catalogue no. 26040R010)
• Connecvity Pack IV (catalogue no. 260400059)

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10
Safety Warnings
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.
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
liquids of any kind.
Do not open the Pima Analyser. Any unauthorized opening of the instrument
can cause potenal hazards and will invalidate warranty claims.
Only use the Pima Analyser as described in this document.
Only insert USB Printers, USB storage devices or other authorized devices
into the USB ports of the Pima Analyser. Do not use USB 3.0 storage devices.
Placement of the Pima Analyser should allow easy disconnecon from mains
A/C power at any me.
To ensure proper venlaon do not cover the instrument while switched on.
Perform scan on USB storage devices for viruses on a regular basis.
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 infecon control guidelines for handling all blood specimens and
related items.
For disposal of the Pima Analyser please contact your local distributor.
1 INTRODUCTION

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Pima™ ANALYSER USER GUIDE 11
Power On
2 × USB ports
Both Pima USB ports are
designed to be used with USB
storage media, USB Printers or
other authorized devices only.
Power connector port
Display
Keypad
Cartridge slot door
Pima Analyser at a Glance

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12 2 GETTING STARTED
Status Line
Date and me are displayed.
Baery Status
The Baery Status symbol indicates the charging status when the Pima
Analyser is not connected to mains A/C power.
Title Line
Display of currently acve 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, Pima Analyser acvies and
funcon messages.
2020-11-01
PIMA CD4
Analysing
67352
time—to—result:
11:14
11:00
Power Status Green
Charging Status Yellow
2 GETTING STARTED
Pima Analyser Status Lights
Symbol Colour
Pima Analyser Display

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Pima™ ANALYSER USER GUIDE 13
Charging the Pima Analyser
Your Pima Analyser is supplied with a parally charged baery secured within
the analyzer. To charge the analyzer baery connect the Pima Analyser to
mains A/C power as follows:
Charging Status Light
Upon connecng to mains A/C power the yellow charging status light located
on the front of the Pima Analyser will be illuminated, indicang the charge
state of the analyzer baery.
• Insert the A/C power cable into the power transformer.
• Connect the power transformer to the power connector port located at the
back of the Pima Analyser.
• Connect the power cable to the corresponding A/C power socket.
Power connector Power transformer A/C power cable
Pima Analyser baery fully charged Solid
Pima Analyser baery charging Flashing

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14
Switching On the Pima Analyser/Power Status Light
The green power status light located on the front of the Pima Analyser
displays its power status.
Press and hold the Power On buon unl you hear a triple "beep" and the
appearance of «pimaTM» on the screen conrms that the Pima Analyser is now
switched on.
An automated inializaon and self-test procedure is acvated which may last
for approximately two minutes. During this me the screen changes and the
funcon of the cartridge slot door is tested.
If the Pima Analyser fails correct inializaon and self-test, an error code is
displayed. It may not be possible to turn the Pima Analyser o via the route
described in secon 7. In such a case press and hold the Power On
buon on the back of the Pima Analyser unl the screen turns black and you
hear a single "beep", conrming that the Pima Analyser is now switched o.
Restart the Pima Analyser as described above. Refer to secon 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.
Pima Analyser On On
Pima Analyser Off O
The charging status light will only be illuminated when connected to main
A/C power. It may take several minutes unl the correct charging status is
displayed.
In order to ensure maximum baery life charge the analyzer baery fully
overnight (8 -10 hours) before running the Pima Analyser on baery power.
When running the Pima Analyser on baery power, the baery status is
displayed by the baery status symbol within the display status line.
2 GETTING STARTED

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Pima™ ANALYSER USER GUIDE 15
User Interface
All operator interac ons with the Pima Analyser are performed using the
analyzer keypad.
Naviga on
⌱ (UP) key to navigate menus, operator and result lists
⌲(DOWN) key to navigate menus, operator and result lists
〈(OK) key to con rm selected menu items and entered text
⌨(BACK) key to cancel a par cular ac on and to go back to
previous screen
⌧(CLEAR) key to delete entered text
⌰(MODE) key to switch from numbers to le ers and special characters
on the keypad
Text edit keys to enter numbers, le ers and special characters
Press a number key to enter the respec ve number. Press ⌰once to switch
back and forth between numbers and le ers and special characters,
respec vely. Press respec ve keys repeatedly un l the desired character
appears in the order as printed on the keys. If the next le er you want to
enter is located on the same key as the present one, wait un l the cursor
appears and enter the le er.
«Dash» and «Underscore» are located on the (0) key.
«Space» is located on the (1) key.

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16 3 RUNNING A TEST
Iniang a Test
The Pima test consists of a disposable Pima CD4 test cartridge, containing dried
reagents, and the Pima Analyser.
Pima test cartridges are supplied in boxes containing a product insert detailing
instrucons for sample collecon as well as the test specic performance
characteriscs.
Before performing a Pima test, carefully read the Pima CD4 cartridge guide
for details on sample applicaon and cartridge handling.
Check correct local date and me before running a test.
• To iniate a test run and open the
cartridge slot door press 〈when
prompted by the following screen.
• The cartridge slot door opens and
the Pima Analyser prompts the
operator to insert a cartridge.
• The cartridge slot door can be
closed by pressing ⌨returning
the operator to the «Run test»
window.
If no cartridge is inserted within 30 seconds, the cartridge slot door closes
automacally and the display returns to the «Run test» window.
3 RUNNING A TEST
11:052020-11-01
Insert new
cartridge
11:052020-11-01
Run test
press OK

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Pima™ ANALYSER USER GUIDE 17
Inserng the Pima Test Cartridge
Insert cartridge into the Pima Analyser in the direcon indicated by the arrow
on the cartridge.
The Pima Analyser is designed to be used in combinaon with the Pima
test cartridge only. No other cartridges, test strips or devices should be
inserted into the Pima Analyser.
Do not discard the cartridge pouch unl the Pima Analyser has
successfully started the analysis. In case of a barcode error, the informaon
printed on the cartridge pouch can be used to enter the barcode manually
(refer to p. 40 for Barcode Error message).
• Upon inserng the Pima test
cartridge a sensor in the Pima
Analyser recognizes that a
cartridge has been inserted and
automacally starts the analysis
process by fully drawing the
cartridge into the Pima Analyser
and closing the cartridge slot door.
• The display screen changes briey
to «Reading cartridge» at this
moment.
• 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 connues in the background.
While it is not necessary to enter Operator and Sample ID before starng
the analysis, the Pima Analyser will NOT display a result unl both
Operator and Sample ID have been entered.
2020-11-01 11:05
ANALYSIS
Reading
cartridge

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18
Operator ID Entry
The «Operator List» is displayed with all archived operators in alphabecal
order.
• Select an operator from the list by
using ⌱and ⌲ and conrm the
selecon with 〈.
Or, if the operator is not yet in the
list, select «New Operator» to enter
a new operator into the list.
Refer to secon 6 for instrucons on how to enter a new Operator ID into the
Operator List.
Sample ID Entry
Aer entering an operator, the «Enter Sample» window is displayed on the
screen.
• A Sample ID of up to 20 characters
may be entered using the keypad.
Enter Sample ID and conrm
with 〈.
Analysis in Progress
• Aer Operator and Sample ID have
been entered successfully,
the «Analysis in Progress» window
appears.
The ID of the sample currently
analysed and an esmated me to
compleon are shown.
2020-11-01 11:05
ENTER SAMPLE
67
2020-11-01
PIMA CD4
Analysing
67352
time—to—result:
11:14
11:00
11:052020-11-01
OPERATOR LIST
New Operator
Anton
Chris
Karin
3 RUNNING A TEST

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Pima™ ANALYSER USER GUIDE 19
Analysis Complete
• Aer the analysis has been
successfully completed, the
«Analysis done. Remove cartridge»
window appears and prompts the
operator to remove the cartridge
from the Pima Analyser.
• Once the cartridge has been
removed, the Pima Analyser
automacally displays the rst of
four result windows, showing the
Sample ID and test result.
• Addional test related parameters can be viewed using ⌲and ⌱.
A Pima Test Report may be printed at this me (see "Prinng results
immediately aer 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 secon 5.
• Press ⌨ to return to the inial
«Run test» window and start
the analysis.
11:252020-11-01
ANALYSIS
Analysis done.
Remove
cartridge
2020-11-01 11:25
Sample
CD3 CD4
PIMA CD4
BACK PRINT
67352
11:252020-11-01
Run test
press OK

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20
Prinng Results immediately aer Analysis
This opon is only available if a USB Printer is aached to the Pima
Analyser via the USB port. For informaon on Pima accessories,
please view www.globalpointofcare.abbo and refer to the USB Printer
User Guide (UG-m-PIMA-02).
• A Pima Test Report can be printed
from any of the four Pima test
result windows by pressing 〈.
• The «Print» window appears
and «YES» is selected by default.
Conrm with 〈and the current
result is printed. Press ⌨or
select «NO» to exit this window and
return tothe Pima test
result window.
•The prinng status is indicated
by a progress bar. Prinng can
be aborted at any me this window
is shown on the screen.
Refer to secon 4 on how to abort
prinng.
2020-11-01 11:25
Sample
CD3 CD4
PIMA CD4
BACK PRINT
67352
2020-11-01 11:25
Do you want to
print the
current result?
PRINT
YES
NO
2020-11-01 11:25
Printing
results
PRINT RESULTS
TOTAL:
3 RUNNING A TEST