Drawell Gentier 96E User manual

User Manual
Please read the manual before installation and operation.
Drawell International Technology Limited
Chongqing Drawell Instrument CO,.Ltd
Add:Suite 2705,Building No.12,Shiyou Road No.1,Yuzhong District, Chongqing,China
Tel: [phone]
Shanghai Drawell Scientific Instrument Co.,Ltd
Add : Suite 1117,Lane561XiuChuan Rd.,PuDong New Area,Shanghai,China
Web : www.drawell.com.cn
Email : [email protected]

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Gentier Real-Time PCR System
Gentier Real-Time PCR System
User Manual
Drawell International Technology Limited

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Gentier Real-Time PCR System
User Manual Version: V1.8
User Manual Revision Time: 08-Apr - 2019
Suitable Instrument Model: Gentier 96E, Gentier 96S, Gentier 96R, Gentier 96C
Medical Device Manufacturing Enterprise License:
Shaanxi FDA Production License No. 20170023
is a registered trademark for Drawell International Technology Limited
Intended Use
The Gentier real-time PCR system (hereinafter referred to as Gentier instrument)
is intended for performing rapid, accurate polymerase chain reaction (PCR),
meanwhile real-time measuring nucleic acid signals from DNA-binding
fluorescent dyes or labeled probes and converts them to comparative quantitative
readouts of DNA or reverse transcribed RNA.
Special Declaration
Before installing and operating the Gentier instrument, please read this manual
carefully, observe the warnings and non-recommended functions. Also bear mind the
potential scope for misuse; it is advisable to draw attention to the possible
consequences.
Contraindication
This product belongs to IVD diagnostic medical device, no contraindications.
User Requirements
The Gentier instrument must only be used by laboratory professionals trained in
laboratory techniques, who have carefully read this manual.

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Gentier Real-Time PCR System
Safty Labels on Transport Package
Label Description
Fragile: the items inside are fragile, please handle with care.
This Side Up: indicates the upward side ofthe transport package.
Keep Dry: keep the transport package away from rain or any liquid.
IVD Instrument: the product belongs to In Vitro Diagnostic equipment.
Temperature Limit: indicates the temperature limits for the storage and
transportation of package.
Humidity Limit: indicates the humidity limits for the storage and transportation of
package.
Atmospheric Pressure Limit: indicates the atmospheric pressure limits for the
storage and transportation of package.
Max 4 Packages: it is prohibited to stack more than 4 layers for the storage and
transportation of packages.
Recycle: indicates the packaging materials are recyclable.
Safty Labels on Gentier Instruemt
Label Description
Biohazard: indicates that a certain area of the Gentier instrument can be easily
contaminated with biological reagents or samples. Reminding user to timely
disinfect this area, keep necessary precautions during operation and take
corresponding protective measures at the same time.
High Temp.: indicates that a certain area of the Gentier instrument may produce
high temperature. Reminding user to pay attention and be careful for burns.
Moving Part: indicates that a certain moving part of the Gentier instrument may
cause personal injury. Reminding user to proceed with appropriate caution.
IVD Equipment: The Gentier instrument belongs to In Vitro Diagnostic equipment.

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Gentier Real-Time PCR System
Symbols Used in This Manual
Symbol Description
Caution: reminding uesrs to pay attention to a certain operation. Operating the
Gentier instrument in any manner unspecified in this manual may results in
instrument damage or abnormal function.
Reminding: providing important informations regarding the Gentier instrument
operation and successful application, including the information explained in further
detail elsewhere in this manual.
Prohibit: prohibiting uesrs from a certain dangerous operation. Otherwise it may
results in instrument damage or abnormal function, even constitutes a personal
injury hazard.
Conventions Used in This Manual
Convention Meaning
Ordered list Procedure steps must be performed follow the list order.
(Double) Click A Click Aon the application software.
Click A > B Click Bin menu Aon the application software.
Press A Press Akey on the instrument system sofware.
Italic + Bold Refers to the instructions/options of the application software.
< Italic + Bold > Refers to the keys/icons of the application software.
Bold Refers to the instructions/options ofthe instrument system sofware.
< Bold > Refers to the keys/icons of the instrument system sofware.
[ ] Refers to the keys on computer keyboard.
italic + Blue Indicate the reference chapter.

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Gentier Real-Time PCR System
Safety and Regulatory Compliance
The operation, maintenance and repair of Gentier instrument shall strictly follow the safety
specifications listed in this section and through this manual. The design of Gentier instrument
has fully considered its biological contamination protection, electrical safety protection and
mechanical motion protection. Non-observance of the instructions or performing any
operations not stated herein may affect the safety protection provided, and may also destroy the
safety standards of design and manufacture as well as the expected application scope of the
Gentier real time PCR system.
XATL Co., Ltd. will not be responsible for any possible consequence caused by either not read or
violate the instructions mentioned herein.
Caution: please carefully read this manual before operating the Gentier instrument.
Incorrect understanding or operations may result in instrument damage or inefficiency
usage, laboratory damage, even personal injury.
Reminding: please pay attention to the descriptions with ‘Caution’, ‘Reminding’, ‘Prohibit’
symbols, and the safety labels on the instrument and transport package.
I. General Instrument Safeties and Precautions
Caution: no person except the XATL Co., LTD professional engineers are allowed to open
the instrument, to replace any component or to debug the Gentier instrument.
Caution: do not drop or damage the Gentier instrument, please handle it with care.
Caution: in case of any following conditions, immediately cut off the power supply and
contact the distributor or manufacturer to ask for professional engineer for processing.
Any liquid has entered into the Gentier instrument;
Abnormal sound or smell appears while the Gentier instrument is running;
Gentier instrument is soaked with water or rain;
Obvious functional changes of the Gentier instrument.
Prohibit: never handling or move the Gentier instrument while it is running.
Caution: for protection against overheating hazards, the openings on the instrument are
designed for ventilation. Please do not block these openings nor cover the instrument with
dust cover and other materials while it is running.

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Gentier Real-Time PCR System
Caution: Gentier instrument installation and transportation should be perfomed by
professional engineer or under professional guidelines.
Caution: please remove the transport lock after instrument installation and reserve the
transport lock for future use.
Caution: please confirm you have removed the transport lock before power on the
instrument.
Caution: do not open the loading platform while the instrument is running, this may break
the biological safety and electromagnetic radiation protection measures ofthe instrument.
Caution: do not force to place unmatched consumables into the sample block.
II. Personal Safeties and Precautions
Caution: Gentier instrument is heavy, please adopt appropriate tools and methods, or
cooperate with other people to complete the lifting or moving of the instrumnet. Move or
lift the instrument in an improper way may result in bodily injury, pain, or instrument
damage.
Prohibit: never touch the plug, the power cord or the power switch with wet hands.
High Temp.: do not directly touch the sample block and the hot lid while the instrument is
still running, they may generate enough heat to cause serious burns. Please wait the sample
block to return to idle temperature before opening the loading platform.
III. Electrical Safeties and Precautions
Prohibit: the voltage of Gentier instrument can cause harms to human body, please cut off
the power supply before opening the instrument shell, and it is prohibited to replace any
part of the instrument while it is electrified.
Caution: Gentier instrument should be properly grounded, any damage of the internal or
external grounding path may cause dangerous.
Caution: in case of electric leakage, immediately unplug the Gentier instrument and stop
using.
Caution: please unplug the power cord before moving the Gentier instrument.

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Gentier Real-Time PCR System
Reminding: under normal circumstances, please use the instrument attached power cord.
If the original power cord is destroyed, please substitute it with an equal one.
Caution: for protection against electric shock hazards, the Gentier instrument must be
grounded properly. The power cord provided is a standard three-pin plug, please plug it
into an appropriate three-wire grounded receptacle for operation safety.
Caution: the power grid environment of Gentier instrument must have ground wire.
Caution: please check the power connection carefully. Hold the power plug when you plug
the power cord and make sure the power plug is perfectly inserted into the socket, do not
pull the power cord to pull out the plug.
Caution: please keep the power cord away from heater or other high temperature objects.
Please do not put anything on the power cord and keep it away from places where people
move around.
Caution: the fuse tube type of the Gentier instrument is 250V~/F10AH, located in the fuse
tube box near the power outlet at the rear of the instrument. Use improper fuse tube may
lead to circuit system damage. Please check and make sure that the fuse tube has been
properly installed before switch on the instrument.
Caution: before replacing the fuse tube, please cut off the instrument power supply, unplug
the power plug and use a screwdriver to pry open the fuse box. Then substitute the old fuse
tube with an equal one.
IV. Environmental Safeties and Precautions
Caution: Gentier instrument is for indoor use only, the room should be well ventilated and
without corrosive gas.
Prohibit: never run the Gentier instrument in places that have or may have flammable and
explosive gas.
Prohibit: spraying liquid on electrical parts may cause a short circuit and result in fire, do
not use sprays in vicinity of the Gentier instrument.
Reminding: the working environment temperature of Gentier instrument should be
between 10°C~30°C, and the relative humidity should be between 20%~85%.

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Gentier Real-Time PCR System
Reminding: the working environment of the Gentier instrument should be under normal
atmosphere (the altitude should below 2000m).
V. Biological Safety and Precautions
Biohazard: the sample objects of the Gentier instrument are nucleic acids, please consider
all samples are with potential biohazard, and please take applicable safety protection
measures and wear appropriate protective goggles, clothing and gloves while processing
the samples.
Biohazard: in case of any liquid overflows during the operation, please immediately
disinfect the contaminated area with appropriate detergent to avoid the spreading of
contaminant, prevent the laboratory or instrument from biohazards.
Biohazard: please comply with the local or national applicable regulations to complete the
disposal of waste samples and contaminated materials.
Biohazard: user should consider the abandoned Gentier instrument as biological
contaminated material and comply with the local or national applicable regulations to
complete the instrument disposal. Before disposal or recycle the instrument, please
completely clean and disinfect the instrument.
Biohazard: user should only use reagents and consumables that are within their expiration
date.

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Gentier Real-Time PCR System
Content
A. OVERVIEW......................................................................................................................................... 1
1. APPLICATION FIELDS........................................................................................................................... 1
2. PRODUCT CONSTITUTE AND INSTRUMENT STRUCTURE.......................................................................... 1
2.1 Product Constitute..................................................................................................................... 1
2.2 Instrument Structure................................................................................................................. 1
3. PRODUCT INTRODUCTION.................................................................................................................... 2
3.1 Instrument Parameters and Characters...................................................................................2
3.1.1 Instrument General Parameters.......................................................................................2
3.1.2 Instrument Technical Parameters....................................................................................4
3.1.3 Instrument Characters...................................................................................................... 6
3.2 Software Characters.................................................................................................................. 6
3.3 Reagent Specifications...............................................................................................................7
3.4 Consumable Specifications........................................................................................................ 7
B. GENTIER INSTRUMENT INSTALLATION...................................................................................... 8
1. UNPACKING INSTRUCTIONS.................................................................................................................. 8
1.1 Unpacking Steps.........................................................................................................................8
2. WORKING ENVIRONMENTAL REQUIREMENTS......................................................................................10
2.1 Instrument Space Requirements............................................................................................. 10
2.2 Instrument Power Requirements............................................................................................ 11
3. INSTRUMENT INSTALLATION.............................................................................................................. 12
3.1 Remove Transport Lock...........................................................................................................12
3.2 External Device Connection.....................................................................................................14
3.3 Application Software Installation........................................................................................... 14
3.4 Computer Network Setting......................................................................................................14
C. THE PREPARATION BEFORE EXPERIMENT.............................................................................. 16
1. INSTRUMENT SELF INSPECTION..........................................................................................................16
2. REAGENT PREPARATION....................................................................................................................16
3. INSTRUMENT LOADING...................................................................................................................... 16

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Gentier Real-Time PCR System
D. APPLICATION SOFTWARE OPERATION.................................................................................... 18
1. STARTUP APPLICATION SOFTWARE.................................................................................................... 18
2. QUICK START BAR............................................................................................................................ 19
3. MAIN INTERFACE.............................................................................................................................. 22
3.1 Menu Bar..................................................................................................................................23
3.2 Tool Bar....................................................................................................................................35
3.3 Operation Area.........................................................................................................................36
3.3.1 Run Setting....................................................................................................................... 38
3.3.2 Sample Setting................................................................................................................. 48
3.3.3 Run Monitoring................................................................................................................55
3.3.4 Analysis............................................................................................................................ 60
3.3.4.1 Abs Quant.................................................................................................................. 61
3.3.4.2 Rel Quant................................................................................................................... 73
3.3.4.3 Melting Curve............................................................................................................77
3.3.4.4 High Resolution Melting.......................................................................................... 81
3.3.4.5 Genotyping................................................................................................................ 86
3.3.4.6 End Point Fluorescence........................................................................................... 90
E. INSTRUMENT SOFTWARE OPERATION..................................................................................... 93
1. BOOT SCREEN & MAIN MENU INTERFACE.......................................................................................... 93
2. INSTRUMENT SOFTWARE OPERATION AREA....................................................................................... 95
2.1 Experiment File........................................................................................................................ 95
2.2 Run Setting...............................................................................................................................98
2.2.1 Temperature Setting....................................................................................................... 99
2.2.2 Fluorescence Setting..................................................................................................... 110
2.3 Run Monitoring......................................................................................................................111
2.4 General Setting...................................................................................................................... 114
2.4.1 Instrument Sub-tab....................................................................................................... 114
2.4.2 Configuration Sub-tab...................................................................................................116
2.4.3 Service Sub-tab.............................................................................................................. 118

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Gentier Real-Time PCR System
F. INSTRUMENT CLEANING AND MAINTENANCE....................................................................... 120
1. INSTRUMENT CLEANING OPERATION INSTRUCTIONS......................................................................... 120
1.1 Clean Instrument Shell.......................................................................................................... 120
1.2 Clean Touch Screen................................................................................................................121
1.3 Clean Loading Platform and Sample Block.......................................................................... 121
2. INSTRUMENT MAINTENANCE OPERATION INSTRUCTIONS.................................................................. 122
2.1 Maintain Sufficient Air Flow................................................................................................. 122
2.2 Maintain Stable Power Supply.............................................................................................. 122
2.3 Maintain Instrument Cleanliness.......................................................................................... 122
2.4 Replace Fuse Tube................................................................................................................. 123
2.5 Replace Dust Filter Foam...................................................................................................... 123
3. TRANSPORTATION OR RETURN TO FACTORY.....................................................................................124
3.1 Instrument Disinfection.........................................................................................................124
3.2 Install Transport Lock........................................................................................................... 125
3.3 Product Packaging................................................................................................................ 126
4. TROUBLESHOOTING.........................................................................................................................128
G. CONTACT INFORMATION........................................................................................................... 130

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Gentier Real-Time PCR System
A. Overview
1. Application Fields
The Gentier real-time PCR system is intended for performing rapid, accurate polymerase chain
reaction (PCR), meanwhile real-time measuring the nucleic acid signals from DNA-binding
fluorescent dyes or labeled probes and converts them to comparative quantitative readouts of
DNA or reverse transcribed RNA.
The Gentier real-time PCR system can be used in medical institution laboratories and clinical
laboratories for infectious pathogens (such as viruses, bacteria, mycoplasma, chlamydia, etc.)
detection; or multiple tumor marker tests of neoplastic diseases, etc. For scientific research, it
could be used for the fluorescence quantitative or qualitative analysis of genetic materials
DNA/RNA in fields of immunology, molecular biology, forensic science, genetics, archeology,
zoology, phytology, etc.
2. Product Constitute and Instrument Structure
2.1 Product Constitute
The Gentier real-time PCR system is mainly consisted of control system, power system,
temperature control system, detection system, man-machine interface system and instrument
shell, etc.
Among them, the temperature control system includes Peltier heating module, sample block and
hot lid, etc; the detection system includes LED excitation light source, photodiodes and light
filter, etc; the man-machine interface system includes data acquisition and analysis software,
which is mainly responsible for real-time data collection, fluorescence diagram formation, data
processing and diagram analysis, in order to quantify or characterize the target nucleic acid and
obtain other test report information, etc.
2.2 Instrument Structure
The structure of Gentier instrument is shown in figure A-1.

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Gentier Real-Time PCR System
Figure A-1. Gentier Instrument Stucture
1. Touch screen
4&5. Cooling fan
8. Fuse tube box
11. Internet access
3. Loading platform
7. Power switch
10&12. USB interface
13. Removable air vent cover
3. Product Introduction
3.1 Instrument Parameters and Characters
3.1.1 Instrument General Parameters
▶Instrument Specification:
Dimension: 475mm(L) × 355mm (W) × 484mm (H);
Weight: 30kg;
2. Sample block
6. Air vent
9. Power socket

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▶Package Specification:
Dimension: 690mm(L) × 580mm (W) × 720mm (H);
Weight: 42kg;
▶Power Specification:
Voltage: AC 100~240V;
Frequency: 50~60Hz;
Rated power: 900VA;
▶Power Cord:
less than 3 meters;
▶Network Cable:
Cat 5e FTP cable with length less than 3 meters;
▶Communication Specification:
Network port: TCP/IP protocol;
Ethernet connection;
Gentier Real-Time PCR System
USB interface;
Reminding: Connected to IEC/EN 60950-1 approved computer host and mouse.
▶Application Environment:
Temperature: 10°C ~30°C;
Relative humidity: 20%~85%, non-condensing;
Atmospheric pressure: 85.0kPa~106.0 kPa;
Altitude: below 2000m;
▶Storage and Transportation Enviroment:
Temperature: -20°C~55°C, with transport package;
Relative humidity: less than 90% ;
▶Running Noise:
While the instrument is running, the maximum noise does not exceed 65 decibel.

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Gentier Real-Time PCR System
3.1.2 Instrument Technical Parameters
Thermal Parameters
▶Temperature Accuracy: ≤ 0.1°C;
▶Temperature Uniformity: ± 0.1°C;
▶ Temperature Precision : ≤ 0.1°C;
▶Max Heating and Cooling Ramp: 6.1°C/s
Optical Parameters
▶Excitation Light Source: LED light sources;
▶Detect System: photodiodes;
▶Optical Channel:
Dyes
Instrument Models
96E
96S
96R
96C
1
FAM, SYBR Green I ,etc.
2
VIC, HEX, TET, JOE, etc.
3
ROX, Texas Red, etc.
4
Cy5, etc.
5
Alexa Fluor 680, etc.
6
FRET Probe
Reminding: channel 6 is for FRET probe, which takes the report group of channel 1 as the
energy donor and the report group of channel 2 as the energy receptor.
Detective Parameters
▶Throughputs: simultaneously detect 96 samples.
▶ Repeatability : CV ≤ 0.5%.
▶ Linear Correlation : │ r │ ≥ 0.999, within the scope of no less than ten magnitudes
concentration gradients.
▶Throughputs: simultaneously detect 96 samples.

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Gentier Real-Time PCR System
Man-machine Interactive System Parameters
▶
▶
▶
Touch Screen: with built in 10.4’ inches color touch screen, providing more simple
operation. The instrument can run alone without the control computer. The stand-alone
running saves more space and energy.
USB interface: the USB interface of Gentier instrument is only used to connect USB disk,
mouse, keyboard and bar code scanner.
Prohibit: the USB interface of Gentier instrument can not be used for charging.
Reminding: the rated output voltage ofthe USB interface is 5±5%;
Reminding: the rated output voltage ofthe USB interface is 500mA.
Reminding: please format the USB disk as FAT32 format before connect it to the Gentier
instrument.
Reminding: please make sure that there is at least 1GB space left in the USB disk before
connect it to the Gentier instrument.
Main Control Computer: the recommend configurations of main control computer are
listed as below.
Computer Processors: quad core CPU;
Internal Storage: 8GB;
Hard Disk: 500GB;
Network Card: 10M/100M adaptive network card;
Display Resolution: 1440 x 900 or higher;
Operating System: Windows 7_ 64bit/32bit, Windows 10 _ 64bit/32bit;
Necessary Software: Office/Excel 2010
Caution: the main control computer of the Gentier instrument is not designed for online
use, connect it to internet may cause risks of computer virus infection or hacker attacks.
XATL Co., LTD. will not be responsible for any damages caused by.
Caution: it is not recommended to install other software on the main control computer of
the Gentier instrument. Otherwise there may be potential risks of software module conflict,
and may also influences the results reliability.
Caution:XATL Co., LTD. will not provide anti-virus software. Therefore, if necessary,
please take preventive measures to prevent the main control computer from virus.

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Gentier Real-Time PCR System
3.1.3 Instrument Characters
▶Touch Screen Operation: Gentier instrument possesses a built-in 10.4’-inches colored
touch screen, very easy for operation. It can run independently from the computer;
▶Independent Temperature Control: Gentier instrument adopts independent temperature
control technology and high repeatability temperature zone. Truly realize the optimization
of PCR;
▶Loading Platform: the Gentier instrument possesses loading platform that can be ejected,
very convenient for sample loading and reduce the experiment environment contamination.
▶Concealed Hot Lid: Gentier instrument possesses a constant pressure, thermostatic
concealed hot lid. This unique design could avoid the possible contact between user and the
hot lid, therefore ensure the operation safety;
▶Power-off Protection: Gentier instrument possesses instantaneous power-off protection
function which can protect all configuration settings in case of power off and the
interrupted experiment can continue after power on.
▶Multiple PCR Step Modes: Gentier instrument provides multiple PCR step modes, such as
touchdown step, long step, gradient step, melting step and so on.
Reminding: Gentier 96S/96C instrument model cannot support gradient PCR step mode.
▶Network Control: one computer can connect with 10 Gentier instruments at the same time,
user can remote control the experiment and truly realize the network centralized control.
▶Remote Running: user could edit experiment settings on control computer and command
the connected Gentier instrument, truly realize the remote running control and real-time
monitoring.
▶Lis System: the Gentier instrument can be connected to hospital Lis system.
3.2 Software Characters
▶Software Interface: wizard-style interface, intuitive layout and program setting, very easy
for operation.
▶Software Language: with switchable multiple languages. Default languages are Chinese
and English.

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Gentier Real-Time PCR System
▶Multiple Functions: the software possesses multiple analysis functions that can adapt to a
variety of experimental requirements. Such as absolute quantification analysis, relative
quantification analysis, melting curve analysis, high resolution melting (HRM) analysis,
genotyping analysis, end point fluorescence analysis, etc.
▶Data Transmission: data can be transmitted between the Gentier instrument and the
control computer. In the process of experiment, Gentier instrument will real-time
transmitting the experiment data to the control computer.
▶Data Storage: the Gentier instrument can store over 1000 experiment setting /experiment
data files.
▶Program Setting: each Stage can contain 99 steps, and the maximum cycle number is 99.
User can set the program for low temperature long-term preservation after the experiment.
▶Report Template Design: the unique universal report function is designed by XATL Co.,
LTD. for user to customize their own report form, more suitable for the personal needs of
all user.
3.3 Reagent Specifications
▶PCR Reagent: open platform for all qualitative and quantitative PCR reagent.
▶Dye: FAM/SYBR Green I, VIC/HEX/TET/JOE, ROX/Texas Red, Cy5, Alexa Fluor 680, etc.
Reminding: Gentier 96R/96C instrument model cannot support Alexa Fluor 680 or similar
fluorescence reagent.
Biohazard: user should only use reagents and consumables that are within their expiration
date.
3.4 Consumable Specifications
▶ 0.2mL single PCR tube (clear, white or frosted), clear tube cap.
▶ 0.2 ml 8-strip PCR tube (clear, white or frosted), clear tube cap.
▶ 0.2 ml 96-well no skirt PCR plate (clear, white or frosted ).

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Gentier Real-Time PCR System
B. Gentier Instrument Installation
1. Unpacking Instructions
The Gentier transport package is as shown in figure B-1. The Gentier instrument and its
accensories are well preserved in a carton case. In order to prevent the collision and oscillation
during transportation, the Gentier instrument is sealed with plastic bag and well supported by
protective foams.
Figure B-1. Package Details
1.1 Unpacking Steps
The unpacking of the Gentier transport package mainly includes 3 steps, as shown in figure B-2.
The specific operation method is as follow.
1stStep: please cut off the packing belt and unseal the transpot package, as shown in figure
B-2a. Then remove the top protective foam, as shown in figure B-2b.
2ndStep: please remove the four plastic buckles on both sides of the package, as shown in figure
B-2c. Grasp the handles and remove the top half carton, as shown in figure B-2d.