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
50
º
C
2
º
C
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.
m-PIMA™ ANALYSER USER GUIDE
11
1
To ensure proper venlaon 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 infecon control guidelines for handling all human
specimens and related items.
Do not dispose of the m-PIMA™ Analyser with domesc waste.
For informaon regarding disposal of the m-PIMA™ Analyser please contact
your local distributor.
Operang the m-PIMA™ Analyser at atmospheric pressures outside the
specicaons (page 7) may result in increased numbers of instrument
induced test terminaons. Please refer to secon 9 for respecve Error
Codes and acons.
m-PIMA™ test cartridges are for single use only and need to be discarded
as biohazard waste aer 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 baery an energy preservaon
mode (EP-mode) is implemented by the manufacturer. Before starng to work
with your m-PIMA™ Analyser see the following instrucons.
Seng up the m-PIMA™ Analyser
• Connect the instrument to A/C power or a compable external energy
source as listed in “Components and oponal items” (page 9) before
switching on your m-PIMA™ Analyser. When using external power sources
also refer to their respecve handling instrucons.
• 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 parcular direcon. 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.
Illuminaon of the power supply LED indicates the connecon to mains
power.
• Switch on your m-PIMA™ Analyser using the main power switch on the
back of the instrument (posion ( 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 buon located on the front of the
m-PIMA™ Analyser. The EP-mode of the internal baery is now deacvated.
An automated inializaon procedure
commences and may last for approximately
one minute. The screen changes automacally
during this procedure.
Please refer to secon 8 to learn more about
shung down the m-PIMA™ Analyser and
re-acvaon of the EP-mode. If the
m-PIMA™ Analyser fails to correctly inialize,
an Error Code or an Error Message will
be displayed.
Please refer to secon 9 to learn more about
Error Codes and respecve acons.
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 baery secured
within the instrument to cover power outages. Once the m-PIMA™ Analyser
is set up and the baery EP-mode is deacvated the baery will be
automacally charged while the instrument is running and connected to an
external power supply.
Ensure the baery is fully charged before you iniate a test run.
Please refer to secon 7 for more informaon about the baery 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 conrms 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, indicang the charging status of the internal baery.
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 unl the instrument displays the correct charging
status.
In order to ensure maximum baery life, charge the internal m-PIMA™
Analyser baery whenever possible.
To recharge an empty baery takes approx. 90 minutes.
When your m-PIMA™ Analyser is running on baery power, the baery
status is indicated by the baery 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 acve 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 baery charging Flashing
m-PIMA™ Analyser baery 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
acve menu or sub menu.
Message Line
Area to display menu items, test results, error
codes, device acvies and messages.
Navigaon Line
Provides access to the various test funcons
and menu opons.
Please nd a more detailed descripon of the icons on page 18.
m-PIMA™ Analyser User Interface
Your m-PIMA™ Analyser is equipped with a resisve touch screen for displaying
informaon 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 calibraon 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
Explanaon of Icons
guides you directly to the «Home»
screen where you get access to
various menu funcons
to scroll through menu lists,
archive entries and Test Reports
to scroll through menu lists,
archive entries and Test Reports
to conrm all entries or selecons
or to conrm a message
(Informaon, Warning, Error)
to go back to the previous screen
to abort an acve process
to access the print, export, delete
and select all opon
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
Acon
Down
View
Conrm
Print
Back
Delete
Navigaon
The touch screen user interface facilitates
easy navigaon between the various
menu opons.
Acvate specic funcons by pressing the
respecve eld on the screen.
Use the scroll opon 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,
acons in progress and results.
SETTINGS
14:56
Operator List
Date and Time
Language
Advanced Settings
2019-11-07
Screen Type Descripon
Throughout the m-PIMA™ Analyser menu structure dierent types of screens
will be displayed.
You will nd a brief overview in the following.
The dierent screen types can easily be disnguished 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 leers by pressing or to special
characters by pressing [#?+], respecvely.
1
2 3 4 5 6
7
8 9 0
Q W E R T Y U I O P
A S D F G H J K L -
Z
X
C V B N
M
.
_
#?+
1
2
3 4 5 6
7
8 9 0
=
/ ~ + “
{
}
< >
@
*
#
% &
§
^
[ ]
-
\
,
( )
:
!
?
.
_
ABC
$
2
20
2 GETTING STARTED
Cancel current process?
CONFIRMATION
15:332019-11-07
YES
NO
ERROR
15:33
PRINTING FAILED
2019-11-07
Informaon screens with white headers
appear when pressing an inacve grey icon.
An icon turns grey if the underlying acon is
not available at that stage, e.g. the g icon
will turn or remain grey as long as no printer is
connected to the m-PIMA™ Analyser.
Informaon screens provide you with further
details to connue with your processes.
As a precauonary measure your m-PIMA™
Analyser will ask you to conrm certain
decisions, like cancelling acve processes.
Conrmaon screens are displayed with a
yellow header.
Choose either z or y to connue.
Error screens are displayed completely in red.
They contain either Error Messages or Error
Codes.
Conrming Error screens with i will 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
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