Abbott m-PIMA Manuale utente
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 specied in this
document.
The m-PIMA™ Analyser can be operated on external power, with an internal
rechargeable baery protecng it against power uctuaons and is also
suitable for near-paent tesng.
For more product informaon 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 diagnosc
medical device Serial number
Catalogue number Direct current (DC)
Lithium-Ion Baery To keep dry
This product must be
recycled or discarded
according to applicable
local and naonal
regulaons.
Aenon symbol.
Indicates important
informaon.
Read the accompanying
text carefully.
Temperature limitaon Consult instrucons 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 Prole
6 Test Principle
6 Data Handling
7 m-PIMA™ Analyser Specicaons
8 Declaraon of Conformity
8 Unpacking, Installaon and Transport
8 Calibraon
9 Maintenance and Cleaning
9 Components and oponal items
10 Safety Warnings and Precauons
12 The m-PIMA™ Analyser at a Glance
13 2 GETTING STARTED
13 Seng 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 Navigaon
18 Explanaon of Icons
19 Data Entry
19 Screen Type Descripon
21 The Baery Symbol
22 3 HOME
22 Menu Overview
23 4 RUNNING A TEST
23 How to iniate 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 Prinng Results immediately aer 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 Acon Menu
36 Acon Menu: Print
38 Acon Menu: Export
38 Export Opons
41 Acon Menu: Delete
42 6 SETTINGS
42 Operator List
43 Enter an Operator
44 Delete an Operator
45 Date and Time
46 Languages
47 Advanced Sengs
48 Connecvity
48 Calibrate Screen
50 Test Mode
53 Signal Tone
54 7 DEVICE
54 Device Info
56 Service Export
58 Soware Update
59 8 POWER OFF & STORAGE
60 Deinstallaon
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 Informaon
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 classied as in vitro diagnosc device.
User Prole
User proles are described in detail in the respecve 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 buer 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
soware embedded within the instrument. Upon compleon of the test the
cartridge is removed from the m-PIMA™ Analyser and a test result is displayed.
For detailed informaon on the test principle of the individual assay, please
refer to the respecve Cartridge Guides.
Data Handling
The m-PIMA™ Analyser provides for data entry (Operator, Sample ID), archiving
and connecvity 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 aer the test.
Addionally, you can print a Test Report using the aached external USB
Printer.
m-PIMA™ ANALYSER USER GUIDE 7
1
m-PIMA™ Analyser Specicaons
Device
Dimensions W 20 cm × H 22 cm × D 31 cm
Weight 8 kg
Detecon system LED illuminaon and CCD-based detecon
Controls
sample detecon, control of cartridge
expiry date, automated cartridge
idencaon, internal process controls
Display graphical display, colour, VGA 480 × 640 pixel
User interface touch screen (resisve)
Languages (display) English, French, German, Portuguese, Spanish
Memory data storage capacity of 1000 tests
Protecon class III
Degree of protecon IP 20
Climate condions
Operang 10 – 40 °C at max. 85 % humidity, altude
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 baery rechargeable Lithium-Ion baery
Power supply type PMP 220 SF-14 (protecon class II)
1
1 INTRODUCTION
8
Declaraon of Conformity
The m-PIMA™ Analyser complies with Direcves 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, Installaon 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 venlaon.
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
dierent climac condions, allow temperature equilibraon 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 posion ( O ) to prevent accidental start up during
transport.
Calibraon
The m-PIMA™ Analyser is factory calibrated and does not require any further
calibraon. However, upon switching on the m-PIMA™ Analyser performs an
internal roune to verify calibraon 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 soluon containing alcohol (for
example 70% ethanol or isopropanol). Soak a paper towel or clean cloth with
cleaning soluon and wipe the outside of the instrument.
Do not use cleaning soluons 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 instrucons on the clearance cercate included in the instrument
box before shipping the m-PIMA™ Analyser to a third party.
Components and oponal 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 oponal 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)
• Connecvity Pack IV (catalogue no. 260400059)
• CONNECT Universal Gateway (catalogue no. AC-EU-01/ AC-US-01)
1
1 INTRODUCTION
10
Safety Warnings and Precauons
Please read the following safety instrucons 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 combinaon 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 beer 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 potenal hazards and will invalidate warranty claims.
Only insert the USB Printers or other authorized devices, e.g. Connecvity
Packs IV into the USB ports of the m-PIMA™ Analyser.
Use only one USB storage device at a me.
Only use FAT32 formaed storage/ export devices.
Do not plug in bulky USB devices next to each other since this may damage
the USB ports.
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