amplex GENIE II User manual

GENIE®II Mk2/ eazyReportTM software
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GENIE®II Mk2 device with
eazyReportTM software
Instructions for use
In vitro diagnostic medical device

GENIE®II Mk2 device with eazyReportTM software
REF: 7500
language: English
valid from: 2021/02/18

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TABLE OF CONTENTS
Chapter 1: INTRODUCTION
INTENDED USE..................................................................................................... 4
SAFETY NOTICES................................................................................................. 4
Chapter 2: GETTING STARTED
THE FIRST STEPS:................................................................................................ 6
UNPACKING:.......................................................................................................... 6
SITE PREPARATION: ............................................................................................ 7
CONNECTIONS: .................................................................................................... 8
USER INTERFACE................................................................................................. 9
GENIE®II Mk2 WELCOME SCREEN..................................................................... 9
SET DATE AND TIME: ......................................................................................... 10
USER MANAGEMENT: ........................................................................................ 11
SELECT THE LANGUAGE:.................................................................................. 13
Chapter 3: HOW TO TAKE CARE OF THE SYSTEM
Chapter 4: RUN A TEST
START A TEST RUN:........................................................................................... 16
STOP A TEST RUN:............................................................................................. 18
ADDING INFORMATION TO A TEST RUN:......................................................... 19
RESULTS: ............................................................................................................ 19
PRINT RESULTS:................................................................................................. 20
CREATE A PDF:................................................................................................... 20
EXPORT A PDF:................................................................................................... 21
CREATE A CSV FILE:.......................................................................................... 24
START A SECOUND RUN:.................................................................................. 24
Chapter 5: RESULTS
FINDING LOG - FILES:......................................................................................... 25
Chapter 6: TROUBLESHOOTING
PROBLEM TO POWER UP:................................................................................. 28
ERROR MESSAGES:........................................................................................... 28
BEEPING DURING THE RUN:............................................................................. 28
QUESTIONABLE RESULTS:................................................................................ 28

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Chapter 7: NICE TO KNOW
SCREEN BRIGHTNESS CONTROL .................................................................... 29
POWER SETTINGS:............................................................................................. 29
ZOOMING FUNCTION: ........................................................................................ 30
SELECTION OF GRAPHS:................................................................................... 30
SCREENSHOT:.................................................................................................... 31
UTILITIES:............................................................................................................ 32
TOUCHSCREEN CALIBRATION: ........................................................................ 33
Chapter 8: MAINTENANCE
CLEANING AND DECONTAMINATION:.............................................................. 34
BATTERY AND CHARGING:................................................................................ 34
STAND BY MODE: ............................................................................................... 35
SELF TEST:.......................................................................................................... 36
PERFORMANCE CHECK:.................................................................................... 36
RECALIBRATING LID SENSORS:....................................................................... 37
DETAILS OF SERVICE AND REPAIR: ................................................................ 39
ORGANISING SERVICE AND REPAIR:............................................................... 39
GENIE®II Mk2 SOFTWARE UPDATES:.............................................................. 40
Chapter 9: ADDITIONAL INFORMATIONS
GENIE®II Mk2 TECHNICAL SPECIFICATION..................................................... 42
WARRANTY: ........................................................................................................ 43
DISPOSAL:........................................................................................................... 43
EXPLANATION OF SYMBOLS:............................................................................ 43
DOCUMENT REVSION:....................................................................................... 43

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Chapter 1: INTRODUCTION
INTENDED USE
The intended use of the Genie®II Mk2 device (with eazyReport™ software) is to perform
isothermal amplification with real-time detection of target nucleic acid. The Genie®II
Mk2 device (with eazyReport™ software) is designed for in vitro diagnostic use in
combination with eazyplex® kits manufactured by AmplexDiagnostics GmbH. Up to two
eazyplex® tests can be performed in parallel.
Additional information concerning the test procedure can be found in the IFU of the
respective eazyplex test.
Only qualified laboratory personnel trained by AmplexDiagnostics GmbH or one of its
distributors should operate this device.
SAFETY NOTICES
Please read the following notices carefully before using the Genie®II Mk2 device.
The equipment supplied has been designed to be completely safe to use. However to avoid
any risk to the safety of the equipment, operator, or anybody in the vicinity of the equipment,
please read this chapter carefully before unpacking and using the device. The advice given
in this manual is intended to supplement, not supersede, the normal safety requirements
prevailing in the user’s country. If there is any doubt as to the correct use of the equipment,
contact your local supplier.
Notices
Using the device in a manner not specified by Amplex may result in personal injury or
damage to the device.
Always ensure that the surface on which the device is placed is level and stable and
will not cause the device to topple over. Ensure that the surface is suitable for the
weight and size of the device. If the device is dropped it may be damaged.
The device should never be lifted by its covers. Always ensure that the base or sides
are used as the lifting point.
The device is electrically powered. Please ensure that the correct voltage settings have
been applied before applying power to the device. If in doubt consult a qualified electrician.
The device has a rating label affixed to the rear. Please consult this if needed.
Never try to open the case of the device or to interfere with objects in the device!

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While every effort has been made to protect the inside of the device against splashes,
the device carries no IP rating. If fluids are spilt on the device they may cause damage
and cause an electrical hazard.
If a spill occurs, remove power from the device. Do not touch the device or any fluid
flowing from it while it is connected to the mains supply. Always follow local health and
safety guidelines.
Disconnection Method
Genie®II Mk2 is disconnected by removal of incoming mains power source to the unit.
Following disconnection the unit should be left for a period of at least 5 minutes before
any internal assemblies are removed or examined.
When in use the heating blocks and heated lids are hot, so allow to cool before
touching the surfaces.
Safe removal of fluids from Genie®II Mk2 will depend on the chemistry used. This will also
require knowledge of the fluids used in the system to adhere with local health and safety
and COSHH regulations. If in doubt, consult the person responsible for the equipment in the
laboratory.

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Chapter 2: GETTING STARTED
THE FIRST STEPS:
After receiving a new device, please proceed the following steps:
•UNPACKING
•SITE PREPARATION
•Read this IFU thoroughly, especially “HOW TO TAKE CARE OF THE DEVICE”,
“TROUBLESHOOTING” and “MAINTENANCE” to be well-prepared for the training by a
representative of your local distributor or AmplexDiagnostics GmbH. The trainer will take care
of the initial settings and instruct you about the usage of the device as well as the eazyplex®
tests.
UNPACKING:
Open the packaging box and check that it contains allof the necessary items:
•Genie®II Mk2 device
•Power supply
•Power lead
•USB connection lead
•Stylus
•Cooling block A and B
•Optional accessory (not included): USB barcode scanner
•Optional accessory (not included): printer DYMO®Labelwriter 450 (Dymo) with labels
54x101mm
Carefully examine the device to ascertain that it has not been damaged during shipment.
If damage has occurred or any parts are missing, notify your local supplier or [e-mail]
immediately.

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SITE PREPARATION:
The laboratory bench should be level and stable. The device should be placed centrally on the lab
bench and the surfaces surrounding the device must be clear of obstructions at all times. In the event
of an emergency or under abnormal operating conditions the location should provide, at any time,
enough space to allow easy disconnection of the device.
Care must be taken not to unduly restrict the air at the front of the device and the outlet vents at the
rear. Restricting airflow may impede operation and could affect performance.
Electrical points should be close to the device to avoid injury from trailing wires.
It is recommended that the device is kept away from sinks and other wet areas. Genie®II Mk2 is an
electrical device and care should be taken not to operate if there is a risk of water damage.
The Genie®II Mk2 device is a highly sensitive and precise optical instrument. Results can be affected
by vibration if the instrument is used too close to a vibrating machine.
IMPORTANT! If a Genie®II Mk2 device is kept in a very cold environment, the battery will not
begin charging until the internal temperature has reached 15°C.

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CONNECTIONS:
Genie®II Mk2 is ready to use straight out of the box without any external connections. It can be
operated standalone, taking power from its internal battery. In order to charge the battery, some
connections must be made.
Attach the power supply plug to the supply and connect the power cable into the back of the device.
When you switch on the Genie®II Mk2 will it will start immediately a self-check of the optics and the
heating.
NOTE To maintain the battery life as long as possible, disconnect the device from time to time and
leave the battery almost completely discharge during operation (battery symbol red). Only then
reconnect the device to the mains.
ATTENTION The battery only charges when the device is switched on via the main switch on the
back. To save energy, switch the device to standby mode (page 35) or turn it off completely when not
in use.
Power InLet
USB (To PC)
Power Switch

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USER INTERFACE
Genie®II Mk2 uses a touchscreen for viewing and inputting data.
Touch the screen gently and press the appropriate keys when required. The touch screen can be
operated while wearing protective gloves or by using the stylus included with the device.
IMPORTANT! Do not use a pen or any other sharp implements to touch the screen.
GENIE®II Mk2 WELCOME SCREEN
When switching on the Genie (at
the back), the LED above the
screen will be amber in colour.
Please wait for the light to change
to green ( ),
THEN touch the Screen to access
the main menu.
→eazyplex® IFU 8.1
Login
with your User ID
and your password
IMPORTANT! When running for the first time check that the date and time on the status bar are
correct. These can be changed as follows.

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SET DATE AND TIME:
To manage date and time please
open the software by clicking the
little “tool” ( ) at the bottom task
bar
Choose the tap “Utilities” and
enter the date and time
management area by clicking the
“Date & Time” button ( )
Please type the correct date and
time into the regarding fields and
tip the “Set” buttom.
Leave this software area by
tipping the red cross in the upper
right corner.

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USER MANAGEMENT:
To manage (add, delete or edit)
the users, please open the
software by clicking the little “tool”
( ) at the bottom taskbar
! The user management is not
allowed in the “user” mode, for
this purpose you need access as
supervisor.
Choose the tap “Utilities” and
enter the user management area
by clicking the “Admin” button.
Choose the “User” tap and the
mask will open.
To edit or delete a user, please
activate the data entry by clicking
on the corresponding user name;
it will be highlighted in blue. Then
click the “Edit” or “Delete” button.
If you would like to add a user,
click the “Add” button.

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The mask for the data entry will
open.
Please fill in all required data.
Don’t forget to assign the relevant
authority (User or Supervisor) by
choosing it from the drop down
menue. To open it, tip the triangel
next to the text field ( ).
And don’t forget to save.
The new user will appear in the
list.
Leave this software area by
tipping the green close button in
the upper right corner.

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SELECT THE LANGUAGE:
To select a language, please
open the software by clicking the
little “tool” ( ) at the bottom task
bar.
! The language selection is not
allowed in the “user” mode, for
this purpose you need access as
supervisor.
Choose the “Utilities” tap and
open the admin area by tipping
the “Admin” button.
Please open the drop down
menue by tipping the triangel next
to the text field ( ).

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Choose the desired language.
The language will change
promptly.
Leave this software area by
tipping the green close button in
the upper right corner.

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Chapter 3: HOW TO TAKE CARE OF THE SYSTEM
•IMPORTANT! For the daily or weekly disinfection of the surfaces of the Genie®II Mk2, the
touch screen and the wire the disinfectant Meliseptol®Wipes sensitive from B. Braun
Melsungen AG or something comparable is suitable. Due to the use of those wipes the
chance of bringing liquids to the optics is minimized.
•IMPORTANT! It is absolutely necessary to prevent the penetration of liquids into the
optics. Therefrom it is not allowed to pipet with inserted tubes. All pipetting steps have to be
made outside the Genie®Mk2 device. In case of liquid entry into the optical unit, contact
AmplexDiagnostics GmbH to schedule maintenance or repair of the Genie®II Mk2 device.
•IMPORTANT! Any unauthorized modification of the device as well as damages caused by
wrong handling entails the invalidity of the warranty.
•IMPORTANT! Genie®II Mk2 uses a proprietary tube strip that maximises optical and
thermal efficiencies. Other tubes and strips will not fit.
•IMPORTANT! Forcing non-supported consumables will cause damage to the instrument
and invalidate the warranty.
•IMPORTANT! The shape of the tubes is such that they will only fit in one way round. The
locating pins on the block have corresponding holes in the strips.
•IMPORTANT! Gently lift the lids upwards. Close the lids by lowering gently. Care must be
taken to ensure that objects are not obstructing the lids when trying to close it and under no
circumstances should the lids be forced open or closed.
•IMPORTANT! To maintain the battery life as long as possible, disconnect the device from
time to time and leave the battery almost completely discharge during operation (battery
symbol red). Only then reconnect the device to the mains.
•IMPORTANT! The battery only charges when the device is switched on via the main
switch on the back. To save energy, switch the device to standby mode (page 35) or turn it off
completely when not in use.

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Chapter 4: RUN A TEST
START A TEST RUN:
To start a test run,
touch the “Test Run”
button
Choose the favoured test
For this, tip into the text field and
activate it (red framed) and scan
the barcode. You also can type in
the barcode via keyboard.
If applicable for the selected test,
please choose the relevant
sample material from the
appearing text field.

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Enter sample ID
Touch the field to activate
it (if not already red framed) and
enter the ID via the keypad *or
scan the barcode
Confirm your data entry with
“enter”
*! Please don’t use punctuation
marks or special characters; these
can cause problems with the file
creation and leads to incorrect
files.
Perform the test pretreatment
according the instruction for use
→eazyplex® IFU 8.2
Start test run by
touching the “Start” button
→eazyplex® IFU 8.3.
Select block A or B
! If one block is already in use, it
is blocked and the free block is
automatically chosen.
Insert the strip and close the lid
THEN
Start test run with “YES”

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The window opens with the
amplification screen / tap open.
Signalling starts after 3 min
The green LED is flashing to
signal that the device is running.
Chart can be minimized by tipping
the green close button in the
upper right corner (e.g. to start a
second test run, as stated below)
If the second block is not in use, a
second test run can be initiated:
(Re-maximizing the screen of the
running test is possible by
touching the chart again).
Choose “Test Run” and repeat the
instructions made above for the
first run.
After completion of the test run close the run file by tipping the green close button in the upper right
corner. Open the lid and remove the test strip (Attention, block could still be hot!)
!Never open a test strip after use! Danger of contamination!
For details and “Trouble Shooting” see eazyplex® IFU.
STOP A TEST RUN:
The ‘Stop’ button ( …..) will abort
a run in progress!
A confirmation pop-up box will
prompt ‘Yes’ or ‘No’.
!If you stop a run the result chart
won’t be filled!

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ADDING INFORMATION TO A TEST RUN:
If you would like to add some
notes to the sample or the
patient, please open the “Notes”
sheet.
Type it in via the key pad and
confirm with “return”.
! Caution if you activated the
capital letters the return button
will be a X.
RESULTS:
The amplification shows the
fluorescence data that is being
acquired during the amplification
phase of the experiment.
To see the result table, tip the
“Result” tab.
! The result table will be filled
AFTER the test run.
The times in the column
“Amplification” are the time points
when the results are given out as
positive / valid.
All results are saved as .gen file at the device (LOG) and can be opened every time (Please have a
look at page 25).

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PRINT RESULTS:
You can print the results via the
“Print” ( ) button if you have
connected a printer (DYMO®
Labelwriter 450 (Dymo) with
labels 54x101mm).
→eazyplex® IFU 4.2
CREATE A PDF:
You can save the results as a run
report via the PDF ( ) button.
It will be automatically stored in
the “Report” folder at the Genie.