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
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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

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1 INTRODUCTION
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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
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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)

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1 INTRODUCTION
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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
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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)

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1 INTRODUCTION
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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.