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

GENIE®II Mk2/ eazyReportTM software
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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.