Abbott m-PIMA User manual

m-PIMA™ANALYSER
USER GUIDE
EN

The m-PIMA™ Analyser is a portable automated bench-top analyzer for
processing m-PIMA™ test cartridges and may be used in any laboratory and
non-laboratory environment that meets the requirements specied in this
document.
The m-PIMA™ Analyser can be operated on external power, with an internal
rechargeable baery protecng it against power uctuaons and is also
suitable for near-paent tesng.
For more product informaon about the m-PIMA™ Analyser and available test
cartridges please go to www.abbo.com/poct
m-PIMA™ Analyser
Index of Symbols
CE Mark Manufacturer
In vitro diagnosc
medical device Serial number
Catalogue number Direct current (DC)
Lithium-Ion Baery To keep dry
This product must be
recycled or discarded
according to applicable
local and naonal
regulaons.
Aenon symbol.
Indicates important
informaon.
Read the accompanying
text carefully.
Temperature limitaon Consult instrucons for use
Don’t pull on cord Pull at plug
50ºC
2ºC

m-PIMA™ ANALYSER USER GUIDE 3
1
2
3
4
5
6
7
8
9
10
1 INTRODUCTION
2 GETTING STARTED
3 HOME
4 RUNNING A TEST
5 ARCHIVE
6 SETTINGS
7 DEVICE
8 POWER OFF & STORAGE
9 TECHNICAL SUPPORT & ERROR CODES
10 WARNINGS & ERROR MESSAGES

4
6 1 INTRODUCTION
6 Intended Use
6 User Prole
6 Test Principle
6 Data Handling
7 m-PIMA™ Analyser Specicaons
8 Declaraon of Conformity
8 Unpacking, Installaon and Transport
8 Calibraon
9 Maintenance and Cleaning
9 Components and oponal items
10 Safety Warnings and Precauons
12 The m-PIMA™ Analyser at a Glance
13 2 GETTING STARTED
13 Seng up the m-PIMA™ Analyser
14 Charging the m-PIMA™ Analyser
15 m-PIMA™ Analyser Status Lights
15 Power Status Light
16 Charging Status Light
16 Process Status Light
17 m-PIMA™ Analyser User Interface
17 m-PIMA™ Analyser Display
18 Navigaon
18 Explanaon of Icons
19 Data Entry
19 Screen Type Descripon
21 The Baery Symbol
22 3 HOME
22 Menu Overview
23 4 RUNNING A TEST
23 How to iniate a Test
24 How to insert an m-PIMA™ Test Cartridge
25 How to enter an Operator
27 How to enter a Sample ID
28 Analysis in Progress
28 Analysis Completed
29 Prinng Results immediately aer Analysis
30 The m-PIMA™ Test Report
31 During Analysis
31 How to Change Operator and Sample ID
32 How to Abort an Analysis
TABLE OF CONTENTS

m-PIMA™ ANALYSER USER GUIDE 5
34 5 ARCHIVE
35 View Results
35 Select Results
36 Acon Menu
36 Acon Menu: Print
38 Acon Menu: Export
38 Export Opons
41 Acon Menu: Delete
42 6 SETTINGS
42 Operator List
43 Enter an Operator
44 Delete an Operator
45 Date and Time
46 Languages
47 Advanced Sengs
48 Connecvity
48 Calibrate Screen
50 Test Mode
53 Signal Tone
54 7 DEVICE
54 Device Info
56 Service Export
58 Soware Update
59 8 POWER OFF & STORAGE
60 Deinstallaon
60 m-PIMA™ Analyser Storage and Recharging Intervals
61 9 TECHNICAL SUPPORT & ERROR CODES
61 Technical Support
62 Error Codes
66 10 WARNINGS & ERROR MESSAGES
66 Archive Informaon
67 Power Warnings
68 Export Errors
70 Printer Warning
70 Printer Error

1
1 INTRODUCTION
6
1 INTRODUCTION
Intended Use
The m-PIMA™ Analyser is a portable automated bench-top analyser for
processing m-PIMA™ test cartridges. The m-PIMA™ Analyser is suited to be
used in laboratory as well as in non-laboratory environments.
The instrument is classied as in vitro diagnosc device.
User Prole
User proles are described in detail in the respecve Package Inserts (PI) of the
m-PIMA™ test cartridges.
Test Principle
An m-PIMA™ test consists of a disposable test cartridge containing both dried
reagents and liquid buer and the m-PIMA™ Analyser.
Depending on the test cartridge used, appropriate volumes of test sample are
applied onto the cartridge.
During processing of the test, data is recorded, analysed and interpreted using
soware embedded within the instrument. Upon compleon of the test the
cartridge is removed from the m-PIMA™ Analyser and a test result is displayed.
For detailed informaon on the test principle of the individual assay, please
refer to the respecve Cartridge Guides.
Data Handling
The m-PIMA™ Analyser provides for data entry (Operator, Sample ID), archiving
and connecvity to printers, data storage media and remote FTP servers.
You can save all results in the on-board archive and retrieve or download and
export them at any me aer the test.
Addionally, you can print a Test Report using the aached external USB
Printer.

m-PIMA™ ANALYSER USER GUIDE 7
1
m-PIMA™ Analyser Specicaons
Device
Dimensions W 20 cm × H 22 cm × D 31 cm
Weight 8 kg
Detecon system LED illuminaon and CCD-based detecon
Controls
sample detecon, control of cartridge
expiry date, automated cartridge
idencaon, internal process controls
Display graphical display, colour, VGA 480 × 640 pixel
User interface touch screen (resisve)
Languages (display) English, French, German, Portuguese, Spanish
Memory data storage capacity of 1000 tests
Protecon class III
Degree of protecon IP 20
Climate condions
Operang 10 – 40 °C at max. 85 % humidity, altude
0 – 2000 m NN (0 – 6500 feet), 800 – 1013 hPa
Storage 2 – 50 °C
Transport 2 – 50 °C at max. 95 % humidity
Environment no direct sunlight, humidity and dust
Power
Mains power 110 – 220 V (A / C) at 47 – 63 Hz, max. 4 A
Power supply DC 24 V/ 6 A/ 144 W
Overvoltage category II
Internal baery rechargeable Lithium-Ion baery
Power supply type PMP 220 SF-14 (protecon class II)

1
1 INTRODUCTION
8
Declaraon of Conformity
The m-PIMA™ Analyser complies with Direcves 98/79/EC and 2011/65/EU
and was tested according to IEC 61010-1, IEC 61010-2-101, IEC 61326-1 and
IEC 61326-2-6.
Unpacking, Installaon and Transport
Unpack the m-PIMA™ Analyser and place it safely on a clean, at, level and
stable surface. Inspect for any obvious sign of damage. Report any damage
immediately to your local distributor.
Allow 5 – 10 cm space on the back of the instrument to ensure free venlaon.
Please use the device handle to li the instrument, considering the instrument
weight. If you transported or moved the m-PIMA™ Analyser to areas with
dierent climac condions, allow temperature equilibraon for at least
30 minutes before turning on the instrument.
Note: Keep the original m-PIMA™ Analyser box in case you need to transport
the instrument. Throw the main power switch on the back of the
instrument to posion ( O ) to prevent accidental start up during
transport.
Calibraon
The m-PIMA™ Analyser is factory calibrated and does not require any further
calibraon. However, upon switching on the m-PIMA™ Analyser performs an
internal roune to verify calibraon and pre-set instrument parameters.

m-PIMA™ ANALYSER USER GUIDE 9
1
Maintenance and Cleaning
The m-PIMA™ Analyser requires no user related maintenance.
If outer cleaning is required, use cleaning soluon 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.
Do not use cleaning soluons containing chlorine bleach or organic
solvents other than alcohol.
Never clean the inside of the m-PIMA™ Analyser.
Always turn o the m-PIMA™ Analyser and disconnect it from any external
power source and accessories before cleaning.
Follow the instrucons on the clearance cercate included in the instrument
box before shipping the m-PIMA™ Analyser to a third party.
Components and oponal items
The following items are supplied with your m-PIMA™ Analyser (catalogue no.
27030R001):
• Power transformer
• Power cord (EU, UK, AUS/ASIA, SA)
• m-PIMA™ Analyser User Guide
The following oponal items are also available for your m-PIMA™ Analyser:
• USB Printer (catalogue no. 27040R007)
• Printer Paper I (catalogue no. 26040R009)
• Printer Paper II (catalogue no. 26040R010)
• PowerDrum (catalogue no. 27040R004)
• Connecvity Pack IV (catalogue no. 260400059)
• CONNECT Universal Gateway (catalogue no. AC-EU-01/ AC-US-01)

1
1 INTRODUCTION
10
Safety Warnings and Precauons
Please read the following safety instrucons carefully to avoid any misuse.
Only use the m-PIMA™ Analyser as described in this document.
Only use the Power transformer and A/C power cord supplied with the
m-PIMA™ Analyser. Any other power supplies can damage the instrument
and may cause hazards.
The m-PIMA™ Analyser is designed to be used in combinaon with
m-PIMA™ test cartridges only. Do not insert any other cartridges, test strips
or devices into the instrument.
Plug in the power cord only in grounded power sockets.
Place the m-PIMA™ Analyser where you can easily disconnect it from mains
A/C power at any me.
Turn the back of the m-PIMA™ Analyser to the front for easy access to
ports and main switch. Do not lt forward the instrument for beer access
since this may result in considerable damage to the front door and housing.
Do not open the m-PIMA™ Analyser. Any unauthorized opening of the
instrument can cause potenal hazards and will invalidate warranty claims.
Only insert the USB Printers or other authorized devices, e.g. Connecvity
Packs IV into the USB ports of the m-PIMA™ Analyser.
Use only one USB storage device at a me.
Only use FAT32 formaed storage/ export devices.
Do not plug in bulky USB devices next to each other since this may damage
the USB ports.

m-PIMA™ ANALYSER USER GUIDE 11
1
To ensure proper venlaon do not cover the instrument while switched on.
Only trained and authorized personnel may use the m-PIMA™ Analyser.
Abbo is not responsible for any injury or damage caused by improper use.
The m-PIMA™ Analyser must not be moved while an analysis is in progress.
Do not autoclave the m-PIMA™ Analyser!
Follow proper infecon control guidelines for handling all human
specimens and related items.
Do not dispose of the m-PIMA™ Analyser with domesc waste.
For informaon regarding disposal of the m-PIMA™ Analyser please contact
your local distributor.
Operang the m-PIMA™ Analyser at atmospheric pressures outside the
specicaons (page 7) may result in increased numbers of instrument
induced test terminaons. Please refer to secon 9 for respecve Error
Codes and acons.
m-PIMA™ test cartridges are for single use only and need to be discarded
as biohazard waste aer removal. Do not reuse test cartridges.

1
1 INTRODUCTION
12
m-PIMA™ Analyser at a Glance
Touch screen
Device handle
Power On
m-PIMA™ Analyser door
Power Status Light
Charging Status Light
Process Status Light
LAN port
8
9
10
11
Main power switch
2 × USB ports
Power connector port

m-PIMA™ ANALYSER USER GUIDE 13
2
2 GETTING STARTED
To prevent undesired discharge of the internal baery an energy preservaon
mode (EP-mode) is implemented by the manufacturer. Before starng to work
with your m-PIMA™ Analyser see the following instrucons.
Seng up the m-PIMA™ Analyser
• Connect the instrument to A/C power or a compable external energy
source as listed in “Components and oponal items” (page 9) before
switching on your m-PIMA™ Analyser. When using external power sources
also refer to their respecve handling instrucons.
• Insert the A/C power cord into the power transformer.
• Connect the power transformer to the power connector port located at
the back of the instrument. Please note that the power plug can only be
inserted in one parcular direcon. Make sure that the arrow on the at
side of the plug is facing the main power switch (see graphic).
• Connect the power cord to the corresponding A/C power socket.
Illuminaon of the power supply LED indicates the connecon to mains
power.
• Switch on your m-PIMA™ Analyser using the main power switch on the
back of the instrument (posion ( I )).
Power connector Power transformer A/C power cord
plus tag

2
14 2 GETTING STARTED
Note: Make sure to remove all storage devices before you switch on the
m-PIMA™ Analyser.
• Then press the grey Power On buon located on the front of the
m-PIMA™ Analyser. The EP-mode of the internal baery is now deacvated.
An automated inializaon procedure
commences and may last for approximately
one minute. The screen changes automacally
during this procedure.
Please refer to secon 8 to learn more about
shung down the m-PIMA™ Analyser and
re-acvaon of the EP-mode. If the
m-PIMA™ Analyser fails to correctly inialize,
an Error Code or an Error Message will
be displayed.
Please refer to secon 9 to learn more about
Error Codes and respecve acons.
The m-PIMA™ Analyser is ready for use when
the «HOME» screen is displayed.
Charging the m-PIMA™ Analyser
Your m-PIMA™ Analyser is supplied with a partly charged baery secured
within the instrument to cover power outages. Once the m-PIMA™ Analyser
is set up and the baery EP-mode is deacvated the baery will be
automacally charged while the instrument is running and connected to an
external power supply.
Ensure the baery is fully charged before you iniate a test run.
Please refer to secon 7 for more informaon about the baery status.
POWER OFF
HOME
2019-11-07 14:51
ARCHIVE
SETTINGS DEVICE
RUN TEST

m-PIMA™ ANALYSER USER GUIDE 15
2
Power Status Light
The green power status light on the front of the instrument indicates whether
the m-PIMA™ Analyser is turned on and ready to operate.
The appearance of the solid green power status light conrms that the
m-PIMA™ Analyser is switched on.
m-PIMA™ Analyser OFF O
m-PIMA™ Analyser startup/ shut down Flashing
m-PIMA™ Analyser ON Solid
m-PIMA
Power Status Light
Charging Status Light
Process Status Light
m-PIMA™ Analyser Status Lights
Your m-PIMA™ Analyser is equipped with a number of LED indicators to
inform you about the current state of the instrument.

2
16 2 GETTING STARTED
Charging Status Light
Once the instrument is connected to an external power source and turned on
the yellow charging status light located on the front of the instrument will be
illuminated, indicang the charging status of the internal baery.
The charging status light will only be illuminated when the m-PIMA™
Analyser is connected to an external power source and turned on. It may
take several minutes unl the instrument displays the correct charging
status.
In order to ensure maximum baery life, charge the internal m-PIMA™
Analyser baery whenever possible.
To recharge an empty baery takes approx. 90 minutes.
When your m-PIMA™ Analyser is running on baery power, the baery
status is indicated by the baery symbol within the display status line (see
page 21).
Process Status Light
On the right side of the m-PIMA™ Analyser door you nd the process status
light. It is only illuminated during an acve analysis process.
No cartridge inserted/
m-PIMA™ Analyser o
O
Analysis in progress Solid
Analysis done Flashing
m-PIMA™ Analyser not connected to external power O
m-PIMA™ Analyser baery charging Flashing
m-PIMA™ Analyser baery fully charged Solid

m-PIMA™ ANALYSER USER GUIDE 17
2
Result in 45 minutes.
m-PIMA HIV-1/2 VL
Sample ID
07-11-2019-ABC
ANALYSIS
14:562019-11-07
m-PIMA™ Analyser Display (example)
Status Line
Date and me are displayed.
Title Line
Display of screen type and currently
acve menu or sub menu.
Message Line
Area to display menu items, test results, error
codes, device acvies and messages.
Navigaon Line
Provides access to the various test funcons
and menu opons.
Please nd a more detailed descripon of the icons on page 18.
m-PIMA™ Analyser User Interface
Your m-PIMA™ Analyser is equipped with a resisve touch screen for displaying
informaon and to interact with the instrument. The touch screen is
precalibrated and you may use it with bare or gloved hands alike.
In case the touch screen loses its calibraon go to page 49 to learn more about
how the touch screen of your m-PIMA™ Analyser can be re-calibrated.

2
18 2 GETTING STARTED
Explanaon of Icons
guides you directly to the «Home»
screen where you get access to
various menu funcons
to scroll through menu lists,
archive entries and Test Reports
to scroll through menu lists,
archive entries and Test Reports
to conrm all entries or selecons
or to conrm a message
(Informaon, Warning, Error)
to go back to the previous screen
to abort an acve process
to access the print, export, delete
and select all opon
to open a Test Report in the
m-PIMA™ Analyser archive
to print m-PIMA™ Test Reports
to delete entries in the Operator
List
Home Cancel
Up Acon
Down View
Conrm Print
Back Delete
Navigaon
The touch screen user interface facilitates
easy navigaon between the various
menu opons.
Acvate specic funcons by pressing the
respecve eld on the screen.
Use the scroll opon for accessing data that is
stored in a list format.
ARCHIVE
14:51
32
15
8
2019-11-06
89-FG
1-AH-35
62-GU-1
Sample ID# View
Date
2019-11-06
2019-11-05
2019-11-05
2019-11-04
2019-11-02
2019-10-30
123456789-ABD-576123
106
105
75
107 06-11-2019-ABC
2019-11-07
12345-ABG-123
123456789-ABF

m-PIMA™ ANALYSER USER GUIDE 19
2
The majority of screens displayed are Menu
screens. Their header is blue.
They display menus and sub menus, lists,
acons in progress and results.
SETTINGS
14:56
Operator List
Date and Time
Language
Advanced Settings
2019-11-07
Screen Type Descripon
Throughout the m-PIMA™ Analyser menu structure dierent types of screens
will be displayed.
You will nd a brief overview in the following.
The dierent screen types can easily be disnguished by the color of their
tle/ status line (header). Examples for every screen type are shown below.
Data Entry
Use the alpha-numeric keypad to enter test related data, e. g. Sample IDs.
Switch between capital and lower case leers by pressing or to special
characters by pressing [#?+], respecvely.
1234567890
QWERTYUIOP
ASDFGHJKL-
ZXCVBNM._
#?+
1 23456 7890
=/~+“{}<>@
*#%&
§^[]-
\,():!?._
ABC
$

2
20 2 GETTING STARTED
Cancel current process?
CONFIRMATION
15:332019-11-07
YES
NO
ERROR
15:33
PRINTING FAILED
2019-11-07
Informaon screens with white headers
appear when pressing an inacve grey icon.
An icon turns grey if the underlying acon is
not available at that stage, e.g. the gicon
will turn or remain grey as long as no printer is
connected to the m-PIMA™ Analyser.
Informaon screens provide you with further
details to connue with your processes.
As a precauonary measure your m-PIMA™
Analyser will ask you to conrm certain
decisions, like cancelling acve processes.
Conrmaon screens are displayed with a
yellow header.
Choose either zor yto connue.
Error screens are displayed completely in red.
They contain either Error Messages or Error
Codes.
Conrming Error screens with iwill lead you
either back to the previous screen or will open
a m-PIMA™ Test Report.
INFORMATION
15:33
Connect to USB Printer.
2019-11-07