Tianlong Gentier Series User manual

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Gentier Real-Time PCR System
Gentier Real-Time PCR System
User Manual
Xi’an TianLong Science and Technology Co., LTD.
Bring Technology to Life

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Gentier Real-Time PCR System
Disclaimer and Copyright
Copyright © 2017 Xi’an TianLong Science and Technology Co., Ltd. (hereinafter referred to as
XATL Co., Ltd.). All rights reserved.
All contents of this manual (including but not limited to text, trademark, logo, buttons icons,
graphics, tables, data, etc.) are subject to the copyright and other intellectual property rights of
XATL Co., Ltd. These materials shall not be reproduced in any form, neither mechanical nor
electronic, nor translated into any other languages without the express written permission of
XATL Co., Ltd.
Every effort has been made to ensure that all the information contained in this manual is correct
at the time of publishing. However, XATL Co., Ltd. reserves the right to make any changes
necessary. The contents of this manual are subject to change without prior notice at any time, and
the updated revision prevails.
User Manual Version:V1.2
User Manual Revision Time: 23 –May –2019
Suitable Instrument Model:Gentier 48E, Gentier 48S, Gentier 48R
Medical Device Manufacturing Enterprise License:
Shaanxi FDA Production License No. 20123142

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Gentier Real-Time PCR System
is a registered trademark for Xi’an TianLong Science and
Technology corporate 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.
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 of the transport package.
Keep Dry: keep the transport package away from rain or any liquid.
IVD Instrument: the instrument 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
European Community Representative:indicates the authorized representative of
this instrument in European.
CE Mark: indicates this instrument is in conformity with the essential health and
safety requirements set out in European directives.
Serial Number: indicates the serial number of this instrument.
Manufacturer: indicates the manufacture of this instrument.
Caution: indicates the “caution”of this instrument .
Manufacture Date: indicates the manufacture date of this instrument.
Consult Instructions for Use: indicates the consult instructions for the use of this
instrument.
Separate Collection for this Equipment: indicates that this instrument is reusable
and not contaminated at the end of the instrument life.

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Gentier Real-Time PCR System
Symbols Used in User 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 User Manual
Convention
Meaning
Ordered list
Procedure steps must be performed follow the list order.
(Double) Click A
Click A on the application software.
Click A > B
Click B in 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 of the 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: do not open the top lid while the instrument is running, this may break the biological
safety and electromagnetic radiation protection measures of the 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 top lid.
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.
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: the power grid environment of Gentier instrument must have ground wire.

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Gentier Real-Time PCR System
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: 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 F10AH250V, 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%.
Reminding:the working environment of the Gentier instrument should be under normal
atmosphere (the altitude should below 2000m).

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Gentier Real-Time PCR System
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.....................................................................................................3
3.1.3 Instrument Characters...........................................................................................................................5
3.2 Software Characters .................................................................................................................................................5
3.3 Reagent Specifications.............................................................................................................................................6
3.4 Consumable Specifications.....................................................................................................................................6
B. GENTIER INSTRUMENT INSTALLATION..............................................................................................7
1. UNPACKING INSTRUCTIONS.........................................................................................................................................7
1.1 Unpacking Steps..........................................................................................................................................................7
2. WORKING ENVIRONMENTAL REQUIREMENTS.........................................................................................................9
2.1 Instrument Space Requirements.........................................................................................................................9
2.2 Instrument Power Requirements........................................................................................................................9
3. INSTRUMENT INSTALLATION ...................................................................................................................................10
3.1 External Device Connection................................................................................................................................10
3.2 Application Software Installation ...................................................................................................................10
3.3 Computer Network Setting.................................................................................................................................11
C. THE PREPARATION BEFORE EXPERIMENT.....................................................................................13
1. INSTRUMENT SELF INSPECTION ..............................................................................................................................13
2. REAGENT PREPARATION...........................................................................................................................................13
3. INSTRUMENT LOADING .............................................................................................................................................13

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Gentier Real-Time PCR System
D. APPLICATION SOFTWARE OPERATION ........................................................................................... 14
1. STARTUP APPLICATION SOFTWARE........................................................................................................................14
2. QUICK START BAR......................................................................................................................................................15
3. MAIN INTERFACE........................................................................................................................................................18
3.1 Menu Bar..................................................................................................................................................................... 19
3.2 Tool Bar....................................................................................................................................................................... 31
3.3 Operation Area......................................................................................................................................................... 32
3.3.1 Run Setting ...............................................................................................................................................34
3.3.2 Sample Setting ........................................................................................................................................44
3.3.3 Run Monitoring ......................................................................................................................................51
3.3.4 Analysis......................................................................................................................................................56
E. INSTRUMENT SOFTWARE OPERATION ............................................................................................ 89
1. BOOT SCREEN &MAIN MENU INTERFACE.............................................................................................................89
2. INSTRUMENT SOFTWARE OPERATION AREA.........................................................................................................91
2.1 Experiment File........................................................................................................................................................ 91
2.2 Run Setting................................................................................................................................................................. 94
2.2.1 Temperature Setting ............................................................................................................................95
2.2.2 Fluorescence Setting ......................................................................................................................... 105
2.3 Run Monitoring......................................................................................................................................................106
2.4 Result Anlysis...................................................................................................................................................109
2.5 General Setting.......................................................................................................................................................111
2.5.1 Instrument Sub-tab............................................................................................................................ 111
2.5.2 Configuration Sub-tab....................................................................................................................... 113
2.5.3 Service Sub-tab.................................................................................................................................... 115
F. INSTRUMENT CLEANING AND MAINTENANCE.............................................................................116
1. INSTRUMENT CLEANING OPERATION INSTRUCTIONS....................................................................................... 116
1.1 Clean Instrument Shell .......................................................................................................................................116
1.2 Clean Touch Screen..............................................................................................................................................117

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Gentier Real-Time PCR System
1.3 Clean Sample Block ............................................................................................................................................. 117
2. INSTRUMENT MAINTENANCE OPERATION INSTRUCTIONS.............................................................................. 118
2.1 Maintain Sufficient Air Flow ........................................................................................................................... 118
2.2 Maintain Stable Power Supply....................................................................................................................... 118
2.3 Maintain Instrument Cleanliness.................................................................................................................. 118
2.4 Replace Fuse Tube................................................................................................................................................ 119
3. TRANSPORTATION OR RETURN TO FACTORY..................................................................................................... 119
3.1 Instrument Disinfection..................................................................................................................................... 119
3.2 Product Packaging .............................................................................................................................................. 120
4. TROUBLESHOOTING ................................................................................................................................................ 122
G. AFTER-SALE SERVICE COMMITMENTS .......................................................................................... 124
1. WARRANTY SERVICE .............................................................................................................................................. 124
2. RESPONSE TIME ...................................................................................................................................................... 125
3. CONTACT INFORMATION........................................................................................................................................ 125

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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&11. Top lid
2&10. Top lid handle
3. Radiator air vent
4. Power air vent
5. Power socket
6. Fuse tube box
7. Power switch
8&12.USB interface
9. Internet access
13.Hot lid
14.Sample block
15. Touch screen
3. Product Introduction
3.1 Instrument Parameters and Characters
3.1.1 Instrument General Parameters
▶Instrument Specification:
Dimension: 400mm(L) x 260mm (W) x 260mm(H);
Weight: 11kg;

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Gentier Real-Time PCR System
▶Package Specification:
Dimension: 500mm(L) ×350mm (W) ×360mm (H);
Weight: 13kg;
▶Power Specification:
Voltage: AC 100-240V;
Frequency: 50-60Hz;
Rated power: 600VA;
▶Communication Specification:
Network port: TCP/IP protocol;
Ethernet connection;
▶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 93%;
▶Running Noise:
While the instrument is running, the maximum noise does not exceed 65 decibel.
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:8°C/s

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Gentier Real-Time PCR System
Optical Parameters
▶Excitation Light Source: LED light sources;
▶Detect System: photodiodes;
▶Optical Channel:
Dyes
Instrument Models
48E
48S
48R
1
FAM, SYBR Green I ,etc.
√
√
√
2
VIC, HEX, TET, JOE, etc.
√
√
√
3
ROX, Texas Red, etc.
√
√
×
4
Cy5, etc.
√
√
×
Detective Parameters
▶Throughputs: simultaneously detect 48 samples;
▶Repeatability: CV ≤0.5%;
▶Linear Correlation:│r│≥0.999, within the scope of no less than five magnitudes
concentration gradients.
Man-machine Interactive System Parameters
▶Touch Screen: with built-in 7.0’inches full 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.
▶Main Control Computer:the recommend configurations of main control computer are listed
as below, customs are allowed to purchase by themselves.
CPU: 2.4GHz, dicaryon;
Internal Storage: ≥2G;
Hard Disk: 500G hard disk is recommended;
Operating System: applicable for Windows XP, Windows 7, Windows 8, etc.
▶Network Control: one computer can be connected with 10 Gentier instruments at the same
time, user can remote control the experiment and truly realize the network centralized
control.

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Gentier Real-Time PCR System
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.
3.1.3 Instrument Characters
▶Touch Screen Operation: Gentier instrument possesses a built-in 7.0’-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;
▶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: the Gentier 48S instrument model cannot support gradient PCR step mode.
▶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: 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.

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Gentier Real-Time PCR System
▶Software Language: with switchable multiple languages. Default languages are Chinese and
English.
▶Multiple Functions: Gentier 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: 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, etc.
Reminding: Gentier 48R instrument model cannot support ROX/Texas Red, Cy5 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.
▶0.2 ml 8-strip PCR tube.