Nippon Genetics FastGene qFYR Manual de usuario

Real-Time PCR System

FastGene®qFYR Real-Time PCR System

User Manual

Version 1.0

NIPPON Genetics EUROPE

®  

FastGene®qFYR Real-Time PCR Systems Installation, Use, and Maintenance Guide 2

The copyright of this manual is owned by NIPPON Genetics EUROPE GmbH. No individual or

organization shall, in any form, copy, edit, publish, or translate the contents of this manual

(including but not limited to words, trademarks, logos, keystroke icons, lists, images, data, etc.)

into other languages without the authorization or written permission of the company. In violation

of the above statement, the Company will investigate its relevant legal liability.

NIPPON Genetics EUROPE GmbH strives to ensure that the contents of this manual are correct

when printed, but the company still has the right to modify the contents of this manual at any

time without prior notice. The contents of the manual shall be subject to the changed contents.

User manual version number: V1.0

User manual revision time: September 2022

Type of instrument applicable: FastGene® qFYR Real-Time PCR System

Software Release Number: V 1.0

Instrument production date: See production label

®  

FastGene®qFYR Real-Time PCR Systems Installation, Use, and Maintenance Guide 3

Introduction

Welcome to the FastGene®qFYR Real-Time PCR System. Please read this instruction carefully

so that you can use this instrument correctly. After careful reading, please keep it for future

inquiry when necessary.

Product information

Description: Real-Time PCR System

Product model: FastGene®qFYR Realtime PCR System

Software Name: FastGene®qFYR Analysis Studio

Software Release Number: V1

Product Size: 350 x 520 x 370 mm (length x wide x height)

Net Weight: 25 Kg

®  

FastGene®qFYR Real-Time PCR Systems Installation, Use, and Maintenance Guide 4

Enterprise information

Statement of intended use:

This product is used to run real-time fluorescence PCR experiments (Real-time PCR) and to

analyze the experimental data. The instrument is operated in a laboratory with the corresponding

reagents, to carry out rapid and accurate quantitative and qualitative detection of target nucleic

acids sequences from human and animal samples (such as blood, oral swabs, nasopharyngeal

swabs, body fluids, etc.) or other analytes, or to conduct melting curves, genotype analysis, etc.

Special statement:

Before installing and using this instrument for the first time, please read the instructions in this

manual carefully. Please take into consideration the possible scope of maloperation or non-

recommended usage and pay special attention to the possible consequences.

Intended Usage:

This product is for Research-Use-Only (RUO).

User requirements:

This product must be operated by trained professionals, who have studied this user manual.

Table of Contents

Table of Contents 6

Chapter 1 Security and consideraons 10

1.1 Security Symbols and Markings 10

1.2 General Instrument Safety and Precauons 10

1.3 Personal Safety and Precauons 11

1.4 Electrical Safety and Precauons 11

1.5 Environmental Safety and Precauons  12

1.6 Biosafety and Precauons 13

1.7 Electromagnec Compability (EMC) Standards 13

Chapter 2 Product Overview 15

2.1 Scope of applicaon 15

2.1.1 Intended Use 15

2.1.2 Product Intended Use Environment 15

2.2 Applicaon Areas 15

2.3 Basic Principles  16

2.4 Main Funcons  16

2.5 Product Composion  16

2.6 Product Structure 17

2.7 Instrument Parameters and Characteriscs 19

2.7.1 Physical Specicaons 19

2.7.2 Instrument Technical Parameters 20

2.7.3 Soware Features 21

2.7.4 Chemistry Reagent Features 21

2.7.5 Consumables Specicaons 21

Chapter 3 Installaon and Transportaon of Instruments 22

3.1 Transport and Storage 22

3.2 Unboxing 22

3.3 Packing List 23

3.4 Installaon Requirements 23

3.4.1 Instrument Working Environment Requirements 23

3.4.2 Computer Conguraon Requirements 24

3.5 Equipment Installaon  25

3.5.1 Equipment Appearance 25

3.5.2 Release Instrument Transport Lock 27

3.5.3 First Installaon and Run Protocol 28

3.6 Instrument Soware Installaon 29

3.6.1 FastGene® qFYR Analysis Studio Soware Installaon 29

3.7 Pre-preparaon for boot 32

3.7.1 Instrument Self-inspecon 32

3.7.2 System Start-up 32

3.7.3 Experimental Preparaon 33

Chapter 4 Operaon to Run the Experiment 34

4.1 Soware Start 34

4.2 Create New Experiment 36

4.2.1 New Experiment or Loading exisng les 36

4.3 Experiment Properes  37

4.3.1 Name 37

4.3.2 Plasc Type 37

4.3.3 Experiment type 38

4.3.4 Chemistry 39

4.4 Experiment Method 40

4.4.1 Reacon volume 40

4.4.2 Thermal lid temperature 40

4.4.3 Basic seng 40

4.5 Plate Setup 42

4.5.1 Setup 42

4.5.2 Quick Setup 44

4.5.3 Remove Wells from the Reacon 44

4.6 Run an Experiment 45

4.6.1 Insert a Plate or Reacon tubes 45

4.6.2 Run the Experimental Program 45

4.7 Save Experiment 47

Chapter 5 Operaon of Dierent Experiment Types   48

5.1 Absolute Quancaon (Standard Curve) Experiment  48

5.1.1 Setup of a Standard curve     49

5.2 Experiment of Melng Curve     52

5.2.1 Setup of Melt Curve Analysis     52

5.3 Relave Quancaon Experiment（（（Cq（53

5.3.1 Setup of comparave Cq (（（Cq) Analysis   53

5.4 Genotyping Experiments     54

5.4.1 Set Up of a Genotyping analysis     54

5.4.2 Set Up of a High-Resoluon Melt Analysis (HRM)  55

5.5 Presence / Absence Experiments    56

5.5.1 Set Up of a Presence / Absence analysis    56

Chapter 6 Result Analysis and Data Export    57

6.1 Result Tab57

6.1.1 Buons in Toolbar      57

6.1.2 Other Toolbars       58

6.2 Result Overview      59

6.2.1 Amplicaon plot59

6.3.1 Plot Properes       59

6.2.2 Plot Sengs60

6.2.3 Threshold Sengs      60

6.2.4 Baseline Sengs      61

6.2.5 Target Sengs61

6.2.6 Results as Reacon Board     62

6.2.7 Results as List63

6.2.8 Raw Amplicaon Plot and Raw Melt Peak Plot   64

6.2.9 Standard Curve65

6.2.10 Melt Curve66

6.2.11 Gene Expression Map67

6.2.12 Analysis Sengs      68

6.2.13 Genotyping Maps69

6.2.14 Raw Melt Curves of the High-Resoluon Melt analysis  70

6.2.15 Aligned Melt Curves of the High-Resoluon Melt analysis 71

6.2.16 Dierence plot of the High-Resoluon Melt analysis  72

6.2.17 Presence/Absence Plot 74

6.2.18 QC Summary       75

6.3 Data Export       77

6.3.1 Toolbars in Export Tab77

6.3.2 Data Export       77

6.3.3 Printed report79

Chapter 7 Instruments Maintenance     81

7.1 Instrument Cleaning      81

7.1.1 Cleaning the Instrument     82

7.1.2 Clean Sample-tray and Reacon-holes    82

7.2 Instrument maintenance     83

7.2.1 Keep Air-Circulaon      83

7.2.2 Keep Stable Electricity Supply83

7.2.3 Keep Clean       83

7.2.4 Waste Disposal       83

7.2.5 Fuse Replacement      84

7.2.6 Overheang Protecon      84

Chapter 8 Troubleshoong      85

®  

FastGene®qFYR Real-Time PCR Systems Installation, Use, and Maintenance Guide 10

Safety markings used on instruments

Symbol Heading Description

Caution

This symbol is used to indicate that non-compliance with

instructions or procedures may lead to physical injury or even

death or could cause damage to the instrument. Consult the

Operator's Manual.

Biohazard This symbol is used to indicate that certain precautions must

be taken when working with potentially infectious material.

Hot surface Indicates the presence of a hot surface or other high-

temperature hazard and to proceed with appropriate caution.

Electricity hazard Indicates the presence of high voltage at the instrument.

Appliance class 1

Indicates that insulation of voltage-carrying parts (= basic

insulation) and connection of touchable metal parts to the

protective conductor (= grounding) protects against excessive

touch voltages

CE symbol This symbol indicates European conformity.

Serial number Identification of the serial number of the instrument.

Date of

Manufacturing The date of manufacturing will appear next to this symbol.

Manufacturer The name and the address of the manufacturer will appear

next to this symbol.

Disposal

Do not dispose of this product as unsorted municipal waste.

Follow local municipal waste ordinances for proper disposal

provisions to reduce the environmental impact

of waste

electrical and electronic equipment (WEEE).

1.2 General Instrument Safety and Precautions

The operator shall not disassemble the instrument, replace components or debug

the instrument without the authorization of our company. If one of the above is needed, it must

previously be approved by our company, and completed by trained professionals, otherwise

unexpected consequences will occur.

Please avoid collision, damage the instrument and store carefully.

The user should immediately unplug the instrument from the power outlet and contact the

supplier or ask our professional maintenance staff if one of the following is to happen:

•The instrument is subjected to rain or flooding.

•Abnormal sound or smell in the instrument.

•Collision or damage to the enclosure.

•The function of the instrument changed.

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