Orion Diagnostica QuikRead go User manual

QuikRead go®
Instrument
135936-5
• English
• Deutsch
• Français
• Italiano

2
Explanation of symbols Zeichenerklärung Explication des symboles Spiegazione dei simboli
In vitro diagnostic medical device In-vitro-Diagnostikum Dispositif médical de diagnostic in vitro Dispositivo medico-diagnostico in vitro
Serial number Seriennummer Numéro de série Numero di serie
Catalogue number Bestellnummer Référence du catalogue Riferimento di Catalogo
Manufacturer Hersteller Fabricant Fabbricante
Date of manufacture Herstellungsdatum Date de fabrication Data di fabbricazione
Contents Inhalt Contenu Contenuto
Instrument Gerät Appareil Strumento
Power supply Netzteil Alimentation Alimentatore
Mains cable Netzkabel Câble d’alimentation Cavo di collegamento alla rete
Consult instructions for use Gebrauchsanweisung beachten Consulter la notice d’utilisation Consultare le istruzioni per l’uso
Caution Achtung Attention Attenzione
Biological Risks Biogefährdung Risques biologiques Rischio biologico
Temperature limitation Temperaturbegrenzung Limites de température Limiti di temperatura
Fragile, handle with care Zerbrechl ich, mit Sorgfalt behandeln Fragile, manipuler avec
précautions Fragile, maneggiare con cura
Keep dry Vor Nässe schützen Conserver au sec Conservare a secco
China RoHS GB/T 26572 China RoHS GB/T 26572 China RoHS GB/T 26572 China RoHS GB/T 26572
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Cat. No. 133893
Cat. No. 149915
Instructions for use • English 4
Bedienungsanleitung • Deutsch 36
Mode d’emploi • Français 70
Istruzioni per l’uso • Italiano 104
English

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CONTENTS
1 INTRODUCTION.............................. 5
Intended use ................................................ 5
QuikRead go instrument .............................. 5
Safety information ....................................... 5
Precautions and limitations .................... 5
2 GETTING STARTED ......................... 6
Unpacking ................................................... 6
Accessories .................................................. 6
QuikRead go parts ....................................... 6
Lifting/transporting the instrument............... 8
Location and environment............................ 8
During use............................................. 8
During transport and storage................. 8
Power supply cable & accumulator unit ........ 9
Connectors and cables........................... 9
Plugging the power supply cable............ 9
Inserting the accumulator unit ............. 10
Power (on, off, sleep mode) ....................... 11
Turning power on ................................ 11
Turning power off................................ 11
Sleep mode.......................................... 11
Use of the touch screen..............................11
Set-up wizard............................................. 12
Language............................................. 13
Date and time...................................... 14
Screen brightness................................. 14
Audio volume ...................................... 15
Power save .......................................... 15
Finishing the Set-up wizard.................. 15
User interface in general ............................ 16
Main menu.......................................... 16
Status area symbols ............................. 16
Layout ................................................. 17
Structure of the user interface.............. 18
3 USAGE .......................................... 19
Performing an assay ................................... 19
Basic measuring mode ......................... 20
Quality control ..................................... 21
Other measuring modes ...................... 21
Results .................................................... 21
Viewing results .................................... 21
Deleting result history .......................... 21
Printing results ..................................... 21
Transferring results to USB-storage....... 21
Sending offline results to LIS/HIS .......... 21
Settings .................................................... 22
Personal settings.................................. 22
Measurement flow............................... 23
Maintenance settings........................... 25
Admin settings..................................... 25
Manufacturer settings.......................... 27
Profiles .................................................... 27
Creating a profile................................. 27
Applying a profile ................................ 27
Basic settings ....................................... 27
4 MAINTENANCE ............................ 27
Instrument calibration ................................ 27
Cleaning the instrument............................. 27
Software update ........................................ 27
Changing the clock battery ........................ 27
5 TROUBLESHOOTING .................... 28
6 INSTRUMENT SPECIFICATION ...... 31
Declaration of conformity........................... 31
Technical specification ................................ 31
Photometer.......................................... 31
Touch screen display ............................ 31
Dimensions & power requirements....... 31
Software update .................................. 31
Instrument identifier ............................ 31
Memory............................................... 31
Power supply ....................................... 31
LIS connection ..................................... 31
USB connection ................................... 31
Service .................................................... 32
Warranty.................................................... 32
Recycling.................................................... 32
QuikRead go user levels and rights
when Security login is enabled ................... 33
CONTENTS
English

5
1 INTRODUCTION
Intended use
Orion Diagnostica QuikRead go®is an easy to
use in vitro diagnostic test system. It has been
designed to measure various analytes from pa-
tient samples needed as an aid in diagnosis and
treatment monitoring. The system consists of the
QuikRead go Instrument and the QuikRead go
reagent kits.
QuikRead go instrument
QuikRead go is a photometer capable of pro-
ducing quantitative and qualitative results. The
instrument has been designed and calibrated
for both photometric and turbidimetric measure-
ments. The instrument will guide you through
the assay procedure by means of a series of mes-
sages and animations shown on the display.
The QuikRead go instrument measures the ab-
sorbance of the cuvette contents and converts
the absorbance value into a concentration value
or positive/negative result on the basis of preset
test calibration data. The calibration data defin-
ing the overall assay curve or cut-off value for
each test is encoded on each cuvette label. This
information is transferred to the QuikRead go in-
strument automatically during the measurement.
The assays are performed according to the user
instructions accompanying each QuikRead go
reagent kit. The results are available in minutes.
The instrument can be operated on the mains
power or with an accumulator unit, it has USB
connections for an external printer or keyboard,
or barcode reader.
The QuikRead go instrument can be connected
to a remote Laboratory and Hospital Information
System (LIS/HIS). The instrument uses a standard-
ised data transfer protocol. Contact your local
supplier for more details.
Safety information
For your own safety, comply with all warning and
caution statements. To alert you to potential elec-
trical or operational hazards, warning and cau-
tion statements are provided where applicable.
Before taking QuikRead go into use, please read
the following precautions and limitations carefully.
Precautions and limitations
• Do not spill any liquids or drop any objects
onto or into the instrument.
• Spillage of potentially infectious material
should be wiped off immediately with ab-
sorbent paper tissue and the contaminated
areas swabbed with a standard disinfectant
or 70% ethyl alcohol. Material used to clean
spills, including gloves, should be disposed of
as biohazardous waste.
• Read beforehand and carefully follow the
QuikRead go reagent instructions for use sup-
plied with each reagent kit.
• Only QuikRead go reagents can be used.
• Do not mix components with different lot
numbers or different assays.
• Never place a cuvette without a tightly placed
cap into QuikRead go.
• Ensure that the cuvette sealing foil is totally
removed.
• Use only the power supply supplied with the
instrument and make sure that the plug is
placed so that it is removable.
• Use only the official QuikRead go accumula-
tor supplied by Orion Diagnostica.
• Do not put your fingers or any external devices
into the QuikRead go during measurement.
• Do not remove or shut down a USB-device
during data transfer.
• Do not open the instrument’s covers by open-
ing any screws. If the warranty seal is broken,
the instrument warranty is not valid.
• Use a secure internal network or Virtual Pri-
vate Network (VPN) when connecting the
QuikRead go to a LIS/HIS using LAN.
• Do not use or connect the instrument to LAN
if the warranty seal is broken.
INTRODUCTION

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2 GETTING STARTED
Unpacking
Open the packaging box and check that it con-
tains all the necessary items:
• Instrument
• Instructions for use
• Power supply
• Mains cable
• Certificate of analysis
Carefully examine the instrument to ascertain
that it has not been damaged during shipment.
If damage has occurred or any parts are missing,
immediately notify your local supplier.
Accessories
Printer
The instrument can be connected to an external
printer. A list of compatible printers and
configuration parameters can be found at
www.quikread.com.
Connect the compatible printer to a USB port
and follow the instructions on the display.
Barcode reader
An external barcode reader can be connect-
ed to the QuikRead go instrument. A list of
compatible barcode readers can be found at
www.quikread.com.
Connect the compatible barcode reader to a USB-
port and follow the instructions on the display.
Picture 1
1. Measurement well for cuvette
2. Touch display
3. Power button
4. USB-port 1 (type A)
GETTING STARTED
QuikRead go parts
The components of QuikRead go are shown in
Picture 1 (instrument from above), Picture 2
(instrument from the rear) and Picture 3
(instrument from below).
1
3
2
4
WLAN adapter
For a wireless network connection. Use only
an adapter supplied by Orion Diagnostica.
Insert the adapter to any free USB port.

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Picture 2
1. USB-port 2 (Type A)
2. USB-port 3 (type A)
3. USB-port 4 (Type B)
4. RJ-45 port
5. Connector for power supply
Picture 3
1. Accumulator unit cover
2. Instrument label with serial number
3. Warranty seal
GETTING STARTED
4
5
1
2
3
1
23
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Lifting/transporting
the instrument
When lifting or transporting the QuikRead go in-
strument, always handle it carefully. In the back
of the instrument there is a handle to enable lift-
ing it by one hand (Picture 4).
A recess is added to the instrument side surfaces
to help the grasp (Picture 5).
Picture 4
Lifting the instrument by one hand.
Picture 5
Lifting the instrument by two hands.
Location and environment
During use
The instrument should be placed on a flat clean,
horizontal surface, and the following points
should be observed:
• Indoor use
• Altitude up to 2000 m
• The ambient temperature must be between
15°C and 35°C.
• Maximum relative humidity 80 % for temper-
atures up to 31°C decreasing linearly to 67 %
relative humidity at 35°C (non-condensing).
• Mains supply voltage fluctuations up to
±10 % of the nominal voltage.
• Installation category II (2500 V transient).
• Do not place the instrument in direct sunlight.
• Do not place the instrument into a strong
magnetic or electric field.
• Do not move the instrument while a test is
being measured.
• Do not measure in a moving vehicle.
• Pollution degree 2.
During transport and storage
• The ambient temperature must be between
2°C and 35°C.
• Protect from rain and humidity.
• Handle the instrument with care.
GETTING STARTED

9
Power supply cable &
accumulator unit
The QuikRead go instrument can be used either by
the power supply cable or the accumulator unit.
The accumulator unit is charged automatically
when the power cable is plugged in.
Connectors and cables
In the back of the instrument there are five
connectors with symbols describing their use.
One USB connector is placed on the right side
of the instrument. All symbols are described in
Picture 6.
The RJ-45 connector can be used for serial and
LAN connections. Wiring diagram of the cable is
described at www.quikread.com.
USB
RJ-45
Please consult
instructions for use
Power
On-Off switch
Picture 7
Connecting Power Supply Cable
Picture 6
Symbols on QuikRead go
GETTING STARTED
Plugging the power supply cable
Plug the power supply cable into the back of the
instrument. Plug the power supply into a power
outlet.

10 GETTING STARTED
Picture 8
1. Accumulator unit cover
2. Accumulator connector
3. Accumulator unit
4. Clock battery
Inserting the accumulator unit
Please follow carefully the steps below for insert-
ing the accumulator unit to the QuikRead go
instrument.
1. Turn off the instrument (if on).
2. Unplug the power supply cable.
3. Turn the instrument onto its side on a table.
4. Open the accumulator unit cover.
5. Attach the accumulator connector to the ac-
cumulator unit.
6. Press the accumulator unit into its place and
ensure that it is placed properly.
7. Close the accumulator unit cover.
8. Turn the instrument back to a standing
position.
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1
3
4