Orion Diagnostica QuikRead go Instrument User manual

QuikRead go®
Instrument
145841-6
• English
• Español

2
Explanation of symbols Explicación de los símbolos
In vitro diagnostic medical device Producto sanitario para diagnóstico in vitro
Catalogue number Número de catalogo
Manufacturer Fabricante
Date of manufacture Fecha de fabricación
Contents Contenido
Instrument Equipo
Power supply Fuente de alimentación
Power cable / Mains cable Cable de poder
Consult instructions for use Consultar las instrucciones de uso
Caution Precaución
Biological risks Riesgos biológicos
Temperature limit Límite de temperatura
Fragile, handle with care Frágil, manejar con cuidado
Keep dry Manténgase seco
China RoHS GB/T 26572 China RoHS GB/T 26572
For prescription only Solamente para uso con receta
15
Rx only

3
Cat. No. 145218
Instructions for use • English 4
Instrucciones de uso • Español 34
English
Rx only

4
CONTENTS
1 INTENDED USE ............................... 5
2 FUNCTION OF THE
QUIKREAD GO INSTRUMENT ........ 5
3 INSTALLATION PROCEDURES
AND REQUIREMENTS..................... 5
Safety information ....................................... 5
Unpacking ................................................... 5
Parts of the QuikRead go instrument............ 6
Lifting/transporting the instrument............... 8
Location and environment............................ 8
During use............................................. 8
During transport and storage................. 8
Power cable and battery pack ...................... 9
Connectors and cables........................... 9
Plugging in the power supply cable........ 9
Inserting a battery pack........................ 10
External devices ................................... 10
Use of the touchscreen...............................11
Set-up wizard............................................. 12
Language............................................. 13
Date and time...................................... 14
Screen brightness................................. 14
Audio volume ...................................... 15
Finishing the set-up process ................. 15
4 PRINCIPLES OF OPERATION ......... 15
Power (on, off or sleep mode) .................... 15
Turning the power on .......................... 15
Turning the power off.......................... 15
Sleep mode ......................................... 15
User interface in general ............................ 16
Layout .................................................... 17
Structure of the user interface.................... 18
Settings .................................................... 18
Personal settings.................................. 19
Measurement flow............................... 20
Maintenance settings........................... 22
Admin settings..................................... 23
Internal clock ....................................... 23
LIS settings........................................... 23
Factory reset ........................................ 23
Manufacturer settings.......................... 23
Profiles................................................. 23
Basic settings ....................................... 23
5 PERFORMANCE CHARACTERISTICS
AND SPECIFICATIONS................... 24
Declaration of conformity .................... 24
Technical specification.......................... 24
Photometer.......................................... 24
Touchscreen display ............................. 24
Dimensions and power requirements ... 24
Instrument software............................. 24
Instrument identifier ............................ 24
Memory............................................... 24
Power supply ....................................... 24
Serial connection ................................. 24
LAN connection ................................... 24
USB connection ................................... 24
6 OPERATING INSTRUCTIONS......... 25
Performing an assay............................. 25
Performing an assay in basic
measuring mode.................................. 25
Quality control ..................................... 26
Other measuring modes....................... 27
Results................................................. 27
7 CALIBRATION PROCEDURES........ 28
8 PRECAUTIONS AND RESTRICTIONS
ON OPERATION............................ 28
Precautions and restrictions.................. 28
Warranty.............................................. 28
Recycling ............................................. 28
9 TROUBLESHOOTING .................... 29
10 SERVICE AND MAINTENANCE
INFORMATION ............................. 32
CONTENTS
English

5
1 INTENDED USE
Orion Diagnostica QuikRead go®is an in vitro diag-
nostic test system. The QuikRead go instrument has
been designed to measure quantitative test results
from patient samples using QuikRead go reagent kits.
Not for point-of-care use.
2 FUNCTION OF THE
QUIKREAD GO INSTRUMENT
QuikRead go is a photometer capable of reporting
quantitative measurements. The instrument has
been designed and calibrated for both photometric
and turbidimetric measurements. It guides the user
through the assay procedure by means of a series
of messages and animations shown on the display.
3 INSTALLATION PROCEDURES
AND REQUIREMENTS
Safety information
For your own safety, comply with all warning and
caution statements. To alert you to potential electri-
cal or operation-related hazards, warning and cau-
tion statements are provided where applicable.
Before beginning to use QuikRead go, please read
the Precautions and restrictions on operation in
Chapter 8 carefully.
Unpacking
Open the packaging box and check that it contains
all the necessary items:
●Instrument
●Instructions for use
●Power supply
●Power 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 supplier.
INTENDED USE, FUNCTION, INSTALLATION

6
Parts of the QuikRead go instrument
The QuikRead go components are shown below,
in Image 1 (instrument from above), Image 2
(instrument from the rear), and Image 3 (instrument
from below).
Image 1
1. Measurement well for cuvette
2. Touchscreen display
3. Power button
4. USB port 1 (Type A)
INSTALLATION PROCEDURES AND REQUIREMENTS
1
3
2
4

7
Image 2
1. USB port 2 (Type A)
2. USB port 3 (Type A)
3. USB port 4 (Type B)
4. RJ45 port
5. Connector for power supply
Image 3
1. Battery unit cover
2. Instrument label, with serial number
3. Warranty seal
INSTALLATION PROCEDURES AND REQUIREMENTS
4
5
1
2
3
1
23
---- ---
-- ----

8
Lifting/transporting the instrument
When lifting or transporting the QuikRead go
instrument, always handle it carefully. At the back of
the instrument is a handle, enabling lifting with one
hand (Image 4).
A recess is added to the instrument side surfaces to
help the grasp (Image 5).
Location and environment
During use
The instrument should be placed on a flat, clean,
horizontal surface, and the following restrictions
should be observed:
●Altitude up to 6,500 feet (2,000 m)
● Ambient temperature between 59 °F (15 °C)
and 95 °F (35 °C)
● Maximum relative humidity 80% for tempera-
tures up to 87 °F (31 °C), decreasing linearly to
67% at 95 °F (35 °C)
● Power-supply voltage fluctuations of no more
than ±10% of the nominal voltage
● Installation category II (2,500 V transient)
● Do not expose the instrument to direct sunlight
●Do not use this device in close proximity to
sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these may
interfere with the proper operation
● Do not move the instrument while it is perform-
ing measurements
● Noise level generated is <85 dB (A)
● Environmental limit of Pollution Degree 2
During transport and storage
●The ambient temperature must be between 36
°F (2 °C) and 95 F (35 °C)
●Protect from rain and humidity
●Handle the instrument with care
Image 4
Lifting the instrument with one hand.
Image 5
Lifting the instrument with two hands.
INSTALLATION PROCEDURES AND REQUIREMENTS

9
Power cable and battery pack
The QuikRead go instrument can be used with either
the power-supply cable or an optional battery pack.
The battery pack is charged automatically when the
power cable is plugged in.
Connectors and cables
On the back of the instrument are five connection
slots, with symbols describing their use. One USB
port can be found on the right side of the instru-
ment. All of the symbols are described in Image 6.
The RJ45 connector can be used for serial and LAN
connections.
Plugging in the power supply cable
Plug in the power-supply cable, using the marked
connection at the back of the instrument. Plug in
the other end of the cable to a power outlet.
USB
RJ-45
Consult instructions
for use
Constant force,
motion or flow
On-Off switch
Image 7
Connection of the power supply cable
Image 6
Symbols on QuikRead go
INSTALLATION PROCEDURES AND REQUIREMENTS

10
Inserting a battery pack
Follow the steps below to insert a battery pack into
the QuikRead go instrument.
1. Make sure the instrument is turned off
2. Unplug the power-supply cable
3. Place the instrument on its side on a table
4. Open the battery compartment, removing the
cover
5. Attach the battery connector to the battery pack
6. Press the battery pack into place and ensure
that it is positioned properly
7. Attach the battery-compartment cover
8. Place the instrument back in the upright, opera-
tion position
External devices
Barcode reader
An external barcode reader can be connected
to the QuikRead go instrument. A list of com-
patible barcode reader devices can be found via
www.quikread.com.
Connect the compatible barcode reader to a USB
port and follow the instructions on the display.
Printer
The instrument can be connected to an external
printer. A list of compatible printers and configu-
ration parameters can be found on the QuikRead
website, www.quikread.com.
Connect the compatible printer to a USB port and
follow the instructions on the display.
INSTALLATION PROCEDURES AND REQUIREMENTS
Image 8
1. Battery-compartment cover
2. Battery-pack connector
3. Battery pack
4. Clock battery
2
1
3
4

11
Use of the touchscreen
The QuikRead go instrument has a color touch-
screen. The user operates it by touching the virtual
buttons with the fingers. The screen can be used
either with bare fingers or with gloves. The touch-
screen does not require much pressure, and pressing
too hard or operating it with sharp items could dam-
age the screen.
There is always multimodal feedback to touching
a button: the button press is indicated both with a
change in appearance and via an audible signal.
A command is registered when the finger is released
from the button touched. If the release occurs out-
side the initial button area, no command is issued.
Image 9
Using the touchscreen by pressing gently with a finger.
INSTALLATION PROCEDURES AND REQUIREMENTS

12 INSTALLATION PROCEDURES AND REQUIREMENTS
Set-up wizard
When starting up the QuikRead go instrument for
the first time, you will be asked to follow a set-up
wizard. During the set-up process, you will be asked
to select the language and to set the date and time.
The default language is English. The interface lan-
guage can be changed in the first step presented by
the set-up wizard.
The wizard is activated by choosing Start (see
Image 10).
Note
The set-up wizard can be started also manually,
from Settings –> Measurement flow –> Mainte-
nance –> Basic Settings.
Image 10
To start the set-up wizard, choose Start from the
set-up screen.
Welcome to QuikRead go!
To start using the instrument we kindly ask you to complete
the following setup. This will take only a few minutes.
On the next screen you are asked to choose the language
for the instrument.
Please choose Start below to start the set-up.
WELCOME
Set-up
LIS ON
10:30
Start

13
Language
Choose the language you wish to use with the
instrument.
You will then be asked to confirm your language
choice. The confirmation request is shown in the
chosen language and, if that is not English, in Eng-
lish also.
If the chosen language is desired, choose Yes,
if not, choose No.
The chosen language can be changed later, at any
time.
Image 11
The first step in the set-up process is to choose the
interface language for the QuikRead go instrument.
INSTALLATION PROCEDURES AND REQUIREMENTS
SL
FR
NO
CZ
ES
SR
EN
FI
SK
PT
HR
DE
SV
HU
NL
EL
IT
DA
PL
More languagesBack
Set-up LANGUAGE
LIS ON
10:30

14
Date and time
The second step presented by the set-up wizard is
to adjust the date and time. To do this, follow the
instructions below:
1. Choose Edit on the Time row
2. Adjust the time with the arrow buttons
3. Choose between a 12-hour and 24-hour clock
4. Accept the selection by choosing OK
5. Choose Edit on the Date row
6. Indicate the date with the arrow buttons
7. Select a date format
8. Accept by selecting OK
9. Select Next to continue
10. Choose Next
Screen brightness
The third step in the set-up process is to adjust
screen brightness. To do this, follow the instructions
below:
1. Adjust the screen’s brightness level with the
arrow buttons.
2. Accept the selection by choosing Next.
Image 12
The second step presented by the set-up wizard is
to adjust a time and date for the instrument.
INSTALLATION PROCEDURES AND REQUIREMENTS
NextBack
LIS ON 10:30
Set-up
Edit
Edit
Time:
Date:
10:30 am
2014-05-03
Edit time and date. The instrument does not automatically
take daylight saving time into account but it should be
adjusted manually.
DATE & TIME

15
Audio volume
The fourth step presented by the set-up wizard is to
adjust the volume levels:
1. Adjust the keypad tone volume with the arrow
buttons.
2. The volume of these sounds can be tested with
the Test button.
3. Adjust the volume for the alert tones by using
the arrow buttons.
4. The sound volume can be tested by means of
the Test button.
5. Accept the selection by choosing Next.
Power save
Adjust the power save time to reduce power con-
sumption when the instrument is being powered
from the battery pack. A lower time increases the
operation time.
1. Choose the time after which the QuikRead go
instrument will enter sleep mode (hibernate)
2. Choose the functionality of the sleep mode.
Finishing the set-up process
You have now completed the set-up process.
You may start using the instrument or make
additional settings from Advanced set-up which takes
you to Measurement flow where you can adjust labo-
ratory or work-routine settings.
PRINCIPLES OF OPERATION
4 PRINCIPLES OF OPERATION
The QuikRead go instrument measures the absor-
bance of the cuvette contents and converts the re-
sulting figure into a concentration value on the basis
of pre-set test-calibration data. The calibration data
defining the overall assay curve are encoded on each
cuvette label. This information is transferred to the
QuikRead go instrument automatically during the
measurement.
Assays are performed in accordance with the user
instructions accompanying the QuikRead go reagent
kit. The results are available within minutes.
The instrument can be operated using a mains pow-
er supply or a battery pack. It has USB sockets for an
external printer or barcode reader.
The QuikRead go instrument can be connected to
a remote laboratory or hospital information system
(LIS/HIS). The instrument uses a standards-compliant
data-transfer protocol. Contact your supplier for
more details.
Power
(on, off or sleep mode)
The QuikRead go instrument can be in any of the
three modes: on, off or sleep mode.
Turning the power on
To turn on the instrument, press the Power button
on the front panel. A light on the button is illumi-
nated when the instrument is powered on.
If nothing happens, ensure that the power is con-
nected or, if the instrument is operating from a bat-
tery pack, that the battery pack is charged.
After the Power button is pressed, the backlight of
the display comes on, the instrument starts up, and
the main menu appears.
Starting the QuikRead go instrument for the first
time opens a set-up wizard (see the “Set-up wiz-
ard” section).
Turning the power off
To turn the instrument off, press the Power button
and hold for approximately two seconds. The instru-
ment requests you to confirm the shutdown, ask-
ing, “Do you want to shut down?” If Yes is chosen
on the touchscreen display, the instrument will turn
off. If a cuvette was inside the instrument when the
shutdown command was given, the cuvette will be
raised and the instrument will ask you to remove it.
Sleep mode
The purpose of sleep mode is to prolong the bat-
tery life while the unit is being powered from the
battery pack (available separately). Sleep mode is
activated when the instrument has been inactive for
longer than the time indicated in the personal set-
tings (see the section on Settings > Power save). The
sleep mode’s functionality can be “Full standby” or
“Close lid only”.
The instrument indicates that it is in sleep mode via
blinking of the Power button light.
To wake the instrument up, press the Power button.

16
21 3 4 5 6 7 8
PROFILE LIS ON 10:30
Measure
Quality control Results
Settings Profiles
Image 13
The main menu and the symbols used by the system.
User interface in general
The QuikRead go instrument is used via a graphical
user interface. This section of the manual explains
the main principles of the user interface.
Main menu
All the features of the user interface can be accessed
via the main menu (see Image 13).
Status area symbols
The status area may contain the following symbols
or indicators (see Image 13):
1. Profile name
2. USB storage
3. External keyboard
4. Barcode reader
5. Printer
6. LIS status
7. Battery level
8. Time
PRINCIPLES OF OPERATION

17
PRINCIPLES OF OPERATION
Image 14
1
2
3
4
5New measurementExit Print
PROFILE LIS ON 12:20
RESULT
Measure
Patient ID: Measurement time:
xxxxxxxxxx 2014-05-03 12:19
mg/L
20
CRP
Choose Result info to view result information.
Remove cuvette to perform a new measurement.
Result info
Test:
CRP
Layout
The screen area of the user interface is divided
into five sections by function (see Image 14):
1. Status area
This indicates the status of the QuikRead
go instrument via symbols.
2. Notification area
Here, information is given, with the color
indicating the current stage of the pro-
cess. The default color is gray, while green
means that something is currently being
done, yellow means that a user action is
required, and red indicates an error.
3. Content area
The actual data are at the center of the
screen.
4. Information area
Most views provide the user with
additional information or guidance.
5. Navigation area
Standard buttons for navigation can be
found at the bottom of the screen.

18
Structure of the user interface
The user interface features a menu system with
five main sections under the main menu (see
Image 15):
1. Measurement
2. Quality control
3. Results
4. Profiles
5. Settings
Settings
QuikRead go system settings can be configured
from the touchscreen display. The settings are di-
vided into five main categories:
• Personal settings
• Measurement flow
• Maintenance
• Admin settings
• Manufacturer settings (for manufacturer use
only)
Saving changes to the personal settings and mea-
surement flow settings is done by saving them as pro-
files, which can be brought into use later on through
application of the desired profile after start-up.
Changes from the factory settings are made with
the set-up wizard. When started for the first time,
the instrument uses the factory settings.
PRINCIPLES OF OPERATION
Measure
Results
Last results
Last QC results
LIS offline results
Delete result
history
Quality Control
Settings
Personal settings
Measurement flow
Admin settings
Manufacturer
settings
Main menu
Profiles
Apply profile
Save as profile
Basic settings Maintenance
Image 15
The user interface’s menu system.
Directly under the main manu are Measurement,
Quality control, Results, Profiles and Settings.

19
Personal settings
From Personal settings,the operator can set lan-
guage, screen, volume, and power-saving options.
These can be chosen for temporary use (that is, un-
til powering down of the instrument) or for further
use, in which case the settings need to be saved to
a profile. Settings for continuous use should be con-
figured with the set-up wizard: Settings > Measure-
ment flow > Maintenance > Basic settings.
Language
The language is selected with the set-up wizard.
From here, it is possible to change the language
by choosing Language and then selecting the
desired language. Accept the selection with Yes, or
reject it with No.
Screen
Screen brightness can be adjusted from Screen. To
increase or decrease the brightness of the screen,
use the arrow buttons. Accept with OK, or reject by
selecting Cancel.
Volume
Sound volume can be adjusted from Volume.
Adjust the keypad tone volume and the alert tone
volume by using the arrow buttons. Accept the se-
lection with OK, or reject it with Cancel.
PRINCIPLES OF OPERATION
Image 16
The Personal settings menu
LIS ON 10:30
Cancel Measurement flow Save
PROFILE
Settings
Language
Screen
Volume
Power save
PERSONAL SETTINGS
Modify personal settings. Changes in measurement flow
and personal settings can be saved as a profile.

20
Power-save operation
The time after which the QuikRead go instrument
closes the lid – without entering sleep mode – can
be adjusted from Power save > Close lid only; adjust
the delay value with the arrow buttons. The instru-
ment will close the lid if it hasn’t been used for the
amount of time specified, without entering sleep
mode (activating the hibernation function). This
mode does not disrupt any LIS/HIS connection.
The time after which the QuikRead go instrument
enters sleep mode can be adjusted from Power save
> Full standby; adjust the delay value with the arrow
buttons. The instrument goes from idle mode into
sleep mode if it hasn’t been used for the amount
of time indicated. Entering sleep mode breaks any
active LIS/HIS connection.
Accept the settings with OK, or reject with Cancel.
Saving changes to personal settings
After all desired adjustments to personal settings
have been made, choose Save.
Saving setting to profiles for further use
From the main menu screen, choose Profiles.
Choose Save as profile, and select either use of a
new profile or a profile you’d like to copy and then
modify. Supply a name for the profile, and accept
with OK.
PRINCIPLES OF OPERATION
Measurement flow
With the measurement flow settings, the operator
can adjust laboratory- or work-routine-oriented set-
tings such as operator and patient IDs, printing, LIS
transfer, and some test-specific parameters.
These settings can be selected for temporary use
(use until power-down) with Save after you make
the desired changes.
For further use, the settings need to be saved to a
profile. Settings for continuous use should be con-
figured with the set-up wizard.
Operator ID
... is an identifier of the user.
• Operator ID OFF: The instrument does not re-
quest an Operator ID.
• Operator ID ON: An Operator ID has to be given
before every sample measurement. That ID is
paired with the test result.
• Operator ID ON + Propose previous: The instru-
ment suggests a previous ID for use, but a dif-
ferent ID can be supplied.
Patient ID
... provides identification of the patient sample.
• Patient ID OFF: The instrument does not request
a Patient ID.
• Patient ID ON: A patient ID has to be supplied
before every measurement, and that ID is pre-
sented with the test result.
Test parameters
The unit of results can be chosen here. The change
requires the administrator’s password, which is QR-
GOSET. Choose
...
and the options will be shown.
To make settings permanent, they should be config-
ured with the set-up wizard.
Printing
• Printing OFF: The instrument does not prompt
for printing. It is nevertheless possible to print
the result if one chooses Print from the Measure
/ Result screen.
• Printing ON: After lifting the cuvette, the instru-
ment asks “Print current result?”. Accept print-
ing by choosing Yes. Cancel printing by choos-
ing No.
• Printing ON + Automatic: The instrument prints
every measurement result automatically.
LIS transfer
• LIS transfer OFF: The instrument does not send
the results to the Laboratory Information System.
• LIS transfer ON: After printing, if activated, the
instrument asks: “Send result to LIS?” Accept
sending by choosing Accept. Reject by choosing
Reject.
• LIS transfer ON + Automatic: The instrument
sends the measurement result automatically to
the LIS.