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Nucleic Acid Isolation System

Nucleic Acid Isolation System

Operation Manual
Nucleic Acid Isolation System
Nucleic Acid Isolation System

Product Description
Thank you for buying the nucleic acid isolation system from Zybio Inc.
(hereinafter referred to as “Zybio”).
Before using this product, please read this operation manual carefully
to ensure proper use. Please keep this operation manual properly after
reading so that it will be readily available for reference.
Product: nucleic acid isolation system
Product Model: EXM6000, EXM6200
Serial number of product technical requirements/registration
certificate number: Chongqing Medical Device Registration No. 20200110
Production registration certificate number: Chongqing CFDA
Production Registration No. 20180001
Manufacturer: Zybio Inc.
Product structure: The nucleic acid isolation system is composed of a
mechanical part, electrical part and software part. It is designed for the
separation and extraction of nucleic acid from specimens when used
together with reagent kits. The mechanical part is composed of
enclosures, frames, motor motion components, magnetic rod components,
grab mechanisms and flapper mechanisms. The electrical part is
composed of display components, heating modules, ultraviolet (UV)
modules and negative pressure exhaust modules. The software
component of this product is an inbuilt software component. The software
component of this product is an inbuilt software component.

Scope of application: Nucleic acid isolation from clinical specimens.


Registrant / manufacturer Address: Floor 1 to Floor 4, Building 30,
No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou
District, Chongqing, China 400082.
Date of manufacture: shown on the nameplate of the isolation system
Service life: 6 years. This service life is determined by lifetime testing
of the product. During use, the user shall maintain, care and repair the
product in accordance with the requirements in the manual. Products that
are confirmed to maintain necessary safety and effectiveness after
maintenance, care and repair are available for normal use.
Issuance date of this operation manual: June 2020.
Nucleic Acid Isolation System

Intellectual Property Rights


The intellectual property rights of this operation manual and its
corresponding products belong to Zybio Inc. (hereinafter referred to as
“Zybio”).
© Zybio Inc. All rights reserved.

No individual or organization may duplicate, revise or translate any


part of this operation manual without Zybio’s written consent.
Zybio reserves the right of final interpretation of this operation manual.
Zybio reserves the right to modify the contents of the operation
manual without prior notice.
Zybio reserves the right to change the technology without prior notice.
Zybio reserves the right to modify the product specification without
prior notice.

is a registered trademark or brand of Zybio.

Statement

Zybio will be considered responsible for the safety, reliability and


performance of the product only if all of the following requirements are
met, namely:
 Assembly operation, expansion, readjustment, improvement and
maintenance shall be carried out by professionals approved by
Zybio;
 All parts, accessories and consumable materials involved in
maintenance are original or approved by Zybio;
 The relevant electrical equipment complies with the national
standards and the requirements of this operation manual;
 The product shall be operated in accordance with this operation
manual.

Warranty and Repair Services


The warranty period of the purchased product shall be subject to the
sales contract.
Nucleic Acid Isolation System

Consumable materials: refer to disposable materials or vulnerable


materials that need to be replaced regularly, consumable materials have
no warranty.
The warranty period starts from the “date of installation” set forth in
the “Instrument Warranty Card” accompanying the product, and the
“Instrument Warranty Card” is the only warranty certificate to
calculate the warranty period. To safeguard your rights and interests,
you’re expected to supervise and urge the installation personnel to return
the second copy of the “Instrument Warranty Card” to Zybio within 30
days from the date of installation; if the “Instrument Warranty Card”
corresponding to the product you purchased fails to be returned to Zybio
on time, the warranty period shall be counted from the 45th day following
the “date of shipment” shown on the packaging box of the system.
Products within the warranty period are entitled to after-sales service
free of charge; however, please pay attention to the following exceptions.
If the repair is attributed to any of the following circumstances, Zybio will
provide paid repair service, in which case you are required to pay for the
repair and replacement parts:
 Man-made damage;
 Improper use;
 Grid voltage exceeds the product’s specified voltage range;
 Force majeure such as natural disasters;
 Replacement or use of components, accessories or consumable
materials not approved by Zybio or any repair by personnel not
authorized by Zybio;
 Any malfunction not caused by the product itself.
After the warranty period expires, Zybio will continue to provide paid
repair service.
If you fail to pay for any paid repair service or delay such payment,
Zybio will suspend its repair service until your payment.

After-sales Service Provider


Company: Zybio Inc.
Address: Floor 1 to Floor 4, Building 30, No. 6 Taikang Road,Block C
of Jianqiao Industrial Park, Dadukou District, Chongqing,
China 400082
Nucleic Acid Isolation System

Website: www.zybio.com
24-hour service hotline: 400-056-7879
Tel: +86(0)23 6865 5509
Fax: +86(0)23 6869 9779
E-mail: info@zybio.com

Warning
 This system should only be operated by inspection
professionals, doctors and laboratory personnel trained by
Zybio or its agents.
 Failure of hospitals or institutions charged with use of this
system to prepare a complete set of satisfactory
maintenance/repair plans may result in abnormal
malfunction of this system and may jeopardize personal
health.
 Make sure that the system is used under the conditions
specified in the operation manual. If the conditions of use
are not met, the system may not function properly and may
also cause damage to its components and personal safety.

Attention
 This operation manual is intended for the following
professionals in clinical laboratory:
1. Personnel performing system routine operation;
2. Personnel performing system maintenance and
troubleshooting;
3. Personnel learning system operation.
目录
Chapter 1 Manual Overview...................................................................................................1

1.1 Overview..................................................................................................................... 1

1.2 Scope of Application................................................................................................. 1

1.3 Manual Guide.............................................................................................................1

1.4 Agreed Matters in the Manual................................................................................. 2

1.5 Common Operations.................................................................................................3

1.6 Symbol.........................................................................................................................3

Chapter 2 System Overview...................................................................................................6

2.1 Overview..................................................................................................................... 6

2.2 Product Model............................................................................................................ 6

2.3 Main Parameters and Performance....................................................................... 7

2.4 Working Principle.......................................................................................................7

2.5 Scope of Application................................................................................................. 8

2.6 Appearance of the System.................................................................................... 10

2.6.1 Front View............................................................................................................. 10

2.6.2 Rear View.............................................................................................................. 11

2.6.3 Left Side View.......................................................................................................12

2.6.4 Interior of Module Door....................................................................................... 13

2.7 Communication Interface....................................................................................... 13

2.8 Electromagnetic Compatibility...............................................................................14

Chapter 3 Unpacking and Preparation for Use.................................................................16

3.1 Unpacking Inspection............................................................................................. 16

3.2 Space Requirements.............................................................................................. 16

3.3 Working Environment Requirements................................................................... 17

3.4 Power Requirements.............................................................................................. 18

3.5 Grounding of the System....................................................................................... 19

3.6 Power Supply Check...............................................................................................20

Chapter 4 Operation Manual................................................................................................21

4.1 Preparations Before System Operation...............................................................21

4.2 Installation of Magnetic Rod Sleeves...................................................................22

4.3 Installation of Reagent Kits.................................................................................... 23


4.4 Software Operation................................................................................................. 24

4.4.1 Launch Screen......................................................................................................24

4.4.2 Functions of the Main Frame............................................................................. 25

4.4.3 Launch Screen - Quick Launch......................................................................... 27

4.4.4 Launch Screen - List Boot.................................................................................. 29

4.4.5 Program Run.........................................................................................................31

4.4.6 UV Sterilization..................................................................................................... 34

4.4.7 Program Management........................................................................................ 35

4.4.8 Setup...................................................................................................................... 40

4.4.9 Troubleshooting....................................................................................................44

Chapter 5 Cleaning and Maintenance................................................................................ 45

5.1 Maintenance and Servicing................................................................................... 45

5.2 Filter Screen Replacement.................................................................................... 45

5.3 Periodic Cleaning.................................................................................................... 46

5.4 Waste Disposal........................................................................................................ 47

5.5 Disposal of Scrapped isolation Systems............................................................. 48

Chapter 6 Transportation and Storage...............................................................................49

6.1 Transportation of the System................................................................................ 49

6.1.1 Graphic Illustrations of External Packaging.....................................................50

6.2 Transportation and Storage...................................................................................50

6.2.1 Transportation Instructions.................................................................................50

6.2.2 Storage Conditions.............................................................................................. 50

Chapter 7 Points of Attention............................................................................................... 52

7.1 Installation Attentions..............................................................................................52

7.2 Use Attentions..........................................................................................................52

7.3 Safety Attentions......................................................................................................52

7.4 Biological Safety...................................................................................................... 53

7.5 Replacement of Component Parts....................................................................... 54

7.5.1 Fuse Replacement...............................................................................................54

7.5.2 UV Lamp Replacement.......................................................................................55

Annex A Fault Information List............................................................................................. 56


Nucleic Acid Isolation System

Chapter 1 Manual Overview


1.1 Overview

This chapter teaches the reader how to use the operation manual of
the nucleic acid isolation system. This operation manual accompanying
the product describes in detail the intended use, functionality and
operation of the nucleic acid isolation system.
Before use, please read carefully and understand the contents of this
manual for proper use of the nucleic acid isolation system to realize its
optimal performance and ensure operator safety.

1.2 Scope of Application

This operation manual is intended for use by medical laboratory


professionals or trained physicians, nurses, or laboratory technicians.
Mainly used for the following purposes:
 Learning about the hardware and software of the nucleic acid
isolation system;
 Setting system parameters;
 Performing routine operations;
 Performing system maintenance and troubleshooting.

1.3 Manual Guide

This operation manual consists of 7 chapters and 1 annexes. The


operator is advised to look up the relevant chapter for the information
needed.
Chapter Introduction

This chapter tells the reader how to use the


1. Manual Overview
operation manual of the nucleic acid isolation

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Nucleic Acid Isolation System

system.

This chapter introduces the product structure


2. System Overview and measuring principle of the nucleic acid
isolation system.

This chapter introduces the environmental and


3. Installation and
installation requirements of the nucleic acid
Preparation for Use
isolation system.

This chapter introduces the operation


4. Operation Manual preparation, software interface and software
operation of the nucleic acid isolation system.

This chapter introduces the cleaning and


5. Cleaning and
maintenance process of the nucleic acid
Maintenance
isolation system.

This chapter introduces the transportation and


6. Transportation and
storage requirements of the nucleic acid
Storage
isolation system.

This chapter introduces the matters concerning


7. Points of Attention the installation, use, safety and parts
replacement of the nucleic acid isolation system.

Annex A List of This annex lists the malfunctions of the nucleic


Malfunction acid isolation system and the corresponding
Information solutions.

1.4 Agreed Matters in the Manual

This manual uses different fonts and formats to distinguish


information with special meanings.
Format Meaning

“××” ×× is the information displayed on the screen

All illustrations in this manual are provided as examples and should


not be used for other purposes. The graphics, settings or data shown in
the illustrations may not be exactly the same as the actual display you see
on the nucleic acid isolation system.

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1.5 Common Operations

Name Operation Executed

Click Press the “××” button

Click on the “××” edit box to move the cursor to that spot
Enter
and complete data entry with the soft keyboard

Click on the [←][→] keys on the touch screen to move the


cursor to the spot requiring deletion, and use the [X] key
Delete
on the soft keyboard to delete the character before the
cursor.

1.6 Symbol

Symbols used in the manual:

Symbol Meaning

The operator must follow the instructions


corresponding to this symbol or risk physical
Warning
injury.

The operator must follow the instructions


corresponding to this symbol or risk product
Caution
damage or malfunction, or inaccurate test results.

The operator must follow the instructions


corresponding to this symbol, the symbol
emphasizes important information in the
Attention
operation steps or the contents requiring
special attention.

The system contain the following symbols:

Symbol Meaning

Biological risk. The operator must follow the


instructions corresponding to this symbol or risk
biological infections.

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High temperature. Be careful not to burn your


hand.

Please refer to the accompanying document.

Electric shock. No one except authorized


maintenance personnel is allowed to
disassemble the analyzer panel when the
power supply is turned on; avoid any spill on
the panel. If any liquid infiltrates into the
analyzer, please turn off the power supply
immediately.

Protective grounding symbol

Alternating current symbol

On (power supply)

Off (power supply)

For in vitro diagnostic use only

Serial No.

Date of manufacture

Manufacturer

Refer to the operation manual

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Nucleic Acid Isolation System

Fuse

Ethernet port

USB

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Nucleic Acid Isolation System

Chapter 2 System Overview


2.1 Overview

This chapter mainly introduces the product model, main parameters,


performance structure and electromagnetic compatibility of the nucleic
acid isolation system.

2.2 Product Model

This product series include two models of the nucleic acid isolation
system which are exactly identical in terms of working principle, main
functionality, electrical structure and key components, and their only
difference lies in their functional configuration (refer to Table 2-1 for
details).

Table 2-1 Differences Between Two Models of Nucleic Acid Isolation System

Model number EXM6000 EXM6200


The mechanical part of the nucleic acid isolation
system is composed of enclosures, frames, motor motion
components, magnetic rod components, grab mechanisms
Product structure
and flapper mechanisms. The electrical part is composed
of display components, heating modules, ultraviolet (UV)
modules and negative pressure exhaust modules.

Operating mode nucleic acid isolation


Specimen throughput 1 - 96 specimens according to your choice
Processing volume 50 µL - 1000 µL

Cell lysis heating temperature Room temperature ~120℃

Elution heating temperature Room temperature ~120℃

Program management Not programmable Programmable


Reagent type Magnetic beads reagent kit
Abnormal alarm Support acoustic fault alarm

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Sterilization function UV Sterilization


Software of nucleic Software of nucleic
Software name
acid isolation system acid isolation system

Software model number EXM6000 EXM6200

Software released version V1 V1

This operation manual uses EXM6200 nucleic acid isolation system as


an example and applies to the EXM series. For other models of this series
(i.e., EXM6000), please refer to this operation manual.

2.3 Main Parameters and Performance

Table 2-2 Main Parameters


Principle Magnetic bead method
Specimen throughput 1 - 96
Processing volume 50 μL - 1000 μL
Quantity of magnetic rods 96
Recovery rate of magnetic
≥98%
beads
Coefficient of variant (well-
CV≤3%
well)
Cell lysis heating Room temperature ~120℃
Elution heating Room temperature ~120℃
Temperature accuracy ±1℃
Oscillation mixing Multi-mode, multi-level, adjustable
Operation interface 8.4″ large color touch screen
Internal programs Can store up to 50,000 programs
New, Edit, Save As, Delete programs, and
Program management
program shortcuts can be set
System expansion interface Standard USB, Ethernet
Sterilization and disinfection UV Sterilization
Exhaust Fan exhaust
Filtration HEPA filter screen
Max. input power 500VA
Dimension (L*W*H) 696mm*450mm*460mm
Weight 50 kg

2.4 Working Principle

This system uses the magnetic rods on the magnetic rod rack in the
experiment module to move magnetic beads absorbed with nucleic acid to
different reagent wells and mix liquid repeatedly and quickly with magnetic
rod sleeves so that the liquid and magnetic beads are mixed evenly. High

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purity nucleic acid is obtained after cell lysis, nucleic acid absorption,
magnetic bead transfer, washing and elution, as shown in the figure below.

Magnetic rod

Magnetic Magnetic
absorption absorption

Magnetic
rod sleeve
Transfer Transfer
Transfer
magnetic magnetic
magnetic
beads beads
beads

cell lysis Washing Elution

Magnetic beads

Figure 2-1 Schematic Diagram of Nucleic Acid Isolation System

2.5 Scope of Application

The nucleic acid isolation system can be widely used in such fields as
scientific research, clinical, disease control, food safety and forensics. The
user simply needs to add the specimens and magnetic-bead-based
nucleic acid extraction reagents, load the reaction consumable materials,
and the nucleic acid isolation system will complete the nucleic acid
isolation operation according to the experimental procedure. Matched with
different magnetic-bead-based nucleic acid extraction reagents, the
nucleic acid isolation system can quickly extract the DNA and RNA of
such specimens as plant and animal tissues, blood, body fluid and
specimens involved in criminal cases.
Zybio’s pre-packaged viral extraction kit, bacterial extraction kit,
whole blood genomic extraction kit, FFPE tissue nucleic acid extraction kit
and feces extraction kit, and other extraction kits of various specifications
are equipped with medical device registration certificates, and can be
utilized for the extraction of nucleic acid from specimens including whole
blood, serum, plasma, nose/throat swab, secretions, cast-off cells, urine,
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Nucleic Acid Isolation System

sputum, feces, FFPE tissues, plant/animal tissues, dried blood spots,


saliva and bronchoalveolar lavage fluid.
The pre-stored extraction program in the system can complete
nucleic acid extraction within 12~28 minutes when used with Zybio’s
magnetic-bead-based nucleic acid extraction reagents. Among which,
viral extraction time may be shortened to 12 minutes.

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2.6 Appearance of the System

2.6.1 Front View

Figure 2-2 Appearance Drawing of the Front


① Screen ② Door release handle ③ Transparent module
door

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Nucleic Acid Isolation System

2.6.2 Rear View

Figure 2-3 Appearance Drawing of the Rear


① Exhaust fan ② Power switch

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Nucleic Acid Isolation System

2.6.3 Left Side View


Figure 2-4 Appearance Drawing of the Left Side

① 1 network interface ② 2 USB interfaces

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Nucleic Acid Isolation System

2.6.4 Interior of Module Door



④ ⑤

Figure 2-5 Internal Structure Drawing of Module Door

① Magnetic rod rack and ② Magnetic rod ③ Guided positioning ④ Heating rod
magnetic rods sleeve rack rod for 96-well
reagent kit
⑤ Both-end positioning
rod for 96-well reagent
kit

2.7 Communication Interface

Interface name Interface type

Network interface RJ45 network port

USB interface USB 2.0 (2 interfaces)

Notes: (1) The network interface is used to connect to the computer for data transmission, and the
insulation resistance of the external circuit should be no less than 1MΩ.
(2) The 2 USB interfaces are used to connect to mouse, keyboard or USB flash disk during
debugging, maintenance and upgrading. Working voltage: DC 5V.

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Nucleic Acid Isolation System

Attention
 Do not use this system for other purposes. Incorrect use may
cause the system to be infected with a computer virus. The
computer virus may be transmitted through USB, programs,
networks, etc.

2.8 Electromagnetic Compatibility

 This system uses radio frequency energy for its internal functions.
Therefore, its radio frequency emission is very low, and it is very
unlikely to interfere with nearby electronic devices.
 Portable and mobile radio frequency communication equipment
may have a possible impact on the equipment, and other
equipment used concurrently in the vicinity of the equipment shall
meet the requirements related to electromagnetic compatibility.
 Suitable for use in all facilities not for household use and not
directly connected to the public low voltage power supply network
of domestic dwellings.
 Power sockets should have reliable protective grounding
measures, and the power cords, components and accessories
supplied with the product should be used.
 The floor shall be wood, concrete or tile, and if the floor is covered
with synthetic material, the relative humidity should be no less
than 30%.
 Grid power supplies should be of typical quality for use in
commercial or hospital environments.
 If users need to keep the system running continuously during a
power interruption, the utilization of uninterrupted power supply is
recommended.
 The power frequency magnetic field within the intended
installation site should be measured to ensure that the power
frequency is low enough. This system should be kept far away
from any power frequency magnetic field source. Under special

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Nucleic Acid Isolation System

circumstances, magnetic shielding materials shall be installed to


ensure normal operation of the system.
 This IVD equipment complies with the emission and immunity
requirements specified in IEC 61326-1-2013.

Warning
 In addition to the accessories and cables sold by the
manufacturer of the system as spare parts for internal
components, using accessories and cables other than those
specified may result in increased equipment emissions or reduced
immunity.
 This system should not be used in close proximity of or overlap
with other equipment, but if it must be used so, then it should be
observed and verified that the system can operate normally in
such environment.

Attention
 Do not use the system next to a strong radiation source (e.g., an
unshielded RF source), which may interfere with the normal
operation of the system.
 This system is designed and tested according to Category 1-A
devices in CISPR 11. In a home environment, this system is likely
to cause radio interference and protective measures are required.
 It is recommended that the electromagnetic environment be
assessed before using the system, and it is the responsibility of
the user to ensure that the electromagnetic environment is
compatible with the system.

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Nucleic Acid Isolation System

Chapter 3 Unpacking and Preparation


for Use
Before installation, the operator must ensure compliance with the
following requirements on space, power supply, environment and fuse.

Caution
 Unpacking or installation performed by any person other than
those authorized or trained by Zybio may cause personal injuries
or damage to the isolation system. Do not unpack the system or
install the isolation system before the arrival of Zybio’s authorized
personnel on site.

3.1 Unpacking Inspection

This system has been subjected to rigorous tests before shipment.


To avoid any collision in transit, this system has been carefully packaged
before transportation. Upon receiving the system, check the packaging
carefully to make sure that there is no physical damage, and if there is,
please notify Zybio’s after-sales department or its local agent
immediately.

Attention
 Carefully dismantle and avoid magnetic rods collision that will
damage the magnetic rods.

3.2 Space Requirements

This system is restricted to indoor use and the indoor environment


should be equipped with proper ventilation, free of corrosive gas and
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Nucleic Acid Isolation System

without strong magnetic field interference. Do not install the system at


any damp or dusty place. All openings in this system are for ventilation
and heat dissipation. Please do not block or cover these ventilation holes.
The distance between any ventilation hole of the system and the nearest
object should be at least 25cm during system operation so as not to
affect heat dissipation.
To ensure the space required for repair and maintenance, and
considering the system’s heat dissipation, the installation of the system
should meet the following requirements:
 The spacing between the left/right door of the system and the
wall ≥ 10 cm;
 The spacing between the rear panel of the system and the wall ≥
25 cm;
 The mounting surface or floor should be able to withstand a load
of at least 100 kg.

Attention
 Do not place the device in a position where it is difficult to turn off
the power switch.

3.3 Working Environment Requirements

Considering the system’s safety and performance, the installation


and working environment of the nucleic acid isolation system should
meet the following requirements:
 The working environment temperature is generally 5℃~40℃. If
the test has a higher requirement in regards of temperature, the
operating ambient temperature of the system must be 20℃~30℃;

 The relative humidity should be 30%~80% and the altitude should


be less than 3000 m;

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Nucleic Acid Isolation System

 The environment should be as far as possible, free of dust,


mechanical vibration, major noise source and power interference;
 It is advisable to assess the laboratory’s electromagnetic
environment before operating the system;
 Avoid direct exposure to sunlight or placing the system near any
heat and wind source;
 A well ventilated position should be selected;
 For indoor-use.

Warning
 The system should not be used in a combustible or explosive
environment.

Attention
 If the room temperature exceeds the system’s operating
temperature range, the extraction effect of the system will be
affected.

3.4 Power Requirements

 Power requirements: Before connecting to an alternating current,


make sure that the voltage of the power source is consistent with
the system’s required voltage (±10% deviation is permitted). Make
sure that the rated load of the power socket is not less than the
requirement of the system.
 Power cord requirements: As a rule, this system should use the
accompanying power cord. In case of any damage to such power
cord, it should be replaced with a power cord of the same
specification without delay. Don’t place any object on the power

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Nucleic Acid Isolation System

cord when using the system, don’t lay the power cord where
personnel tend to walk about.
 Plugging and unplugging of the power cord: The power cord must
be plugged or unplugged with hands. When connecting the
system to the power source, make sure that the plug is fully
inserted into the socket. Do not pull on the power cord forcefully to
unplug.

Warning
 The system must be used with good grounding in place.
 The operator must use a fuse of the given specification.
 Make sure that the output voltage of the power socket meets the
system’s requirements.
 If the fuse has to be replaced, please contact the after-sales
engineer.

3.5 Grounding of the System

 The power supply must be properly grounded, or else there is a


risk of electric shock.
 The ground resistance must be less than 10 mΩ. Poor grounding
will lead to unstable test results and electric leakage of the
enclosure, posing a risk of electric shock.

Attention
 Please place the system on a secure, flat surface and do not
place it near a centrifuge or any other vibration source.
 Do not place the system where it is prone to chemicals or
corrosive gases influence or strong electromagnetic interference.

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Nucleic Acid Isolation System

 Do not place the system at spots with direct sunlight, dampness or


high temperature.

3.6 Power Supply Check

 Check the power supply, confirm that the power supply is working
and can provide the correct voltage;
 Check the power cord of the system and confirm that it is firmly
connected with no looseness.

Caution
 The accompanying power cord should be used and the use of any
other power cord may damage the system.

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Nucleic Acid Isolation System

Chapter 4 Operation Manual


4.1 Preparations Before System Operation

Warning
 The specimens are likely to pose potential risks of biological
infection. When the operator is exposed to relevant substances
and areas in the laboratory, he/she should follow the laboratory
safety operation guidelines and put on such personal protective
equipment (PPEs)as laboratory protective clothing, gloves, masks,
etc.
 Please dispose of the specimens and used reagent kits, magnetic
rod sleeves, reagent strips and other consumable materials
according to the regulations of the local laboratory;
 This chapter sets forth the conventional method of performing
nucleic acid extraction with the nucleic acid isolation system.
 Before initial use, please read this section carefully.

Attention
 During the extraction, do not place the system under direct
sunlight, so as not to affect the performance of the system;
 Please do not use any reagent kit that is past its expiration date or
that has spoiled.

Before turning on the isolation system, the operator should check the
system according to the following requirements to ensure the system is
ready for operation.

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 Before turning on the system, the operator should check through


the transparent door to make sure that the interior of the system is
clean and free of foreign matter;
 The operator may carry out the cleaning and maintenance in line
with the relevant contents in “Chapter 5 Cleaning and
Maintenance”;
 The operator should turn on the system after closing the safety
door;
 Reagent kits and magnetic rod sleeves should be installed after
power-on self-test (POST).

4.2 Installation of Magnetic Rod Sleeves

This system adopts the automatic loading mode of magnetic rod


sleeves, and the user is required to place the magnetic rod sleeves in the
specified reagent kit according to the operation manual.
According to the positions of the magnetic rod sleeves and reagent kit
shown in the figure below, the magnetic rod sleeves should be placed in a
96-well reagent kit filled with magnetic beads in the direction indicated by
the arrow.

Magnetic
rod sleeve

Reagent
kit

Figure 4 -1 Installation of Magnetic Rod Sleeves

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4.3 Installation of Reagent Kits

Figure 4 -2 Installation of Reagent Kits

Open the module door, and the slots from left to right are the cell lysis
slot, magnetic bead slot, washing slot 1, washing slot 2 and elution slot
respectively. Put reagent kits in the 5 locating slots in the system
according to the operation manual and label of the reagent kits.

 Place the 96-well reagent kit loaded with magnetic rod sleeves in
the reagent kit locating slot second from the left;

 A stop block is placed on both sides of each locating slot filled


with 96- well reagent kit to assist the positioning, and there is a
spring piece on both sides to help fix the 96-well reagent kit;

 The first and fifth locating slots from the left are equipped with a
heating device;

 Insert the reagent kit into the reagent kit locating slot and ensure
that it is held in place;

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Attention

 The 96-well reagent kit may be installed only after power-on self-
test (POST);
 Make sure that the 96-well reagent kit is leveled and securely in
place before boosting the program.

4.4 Software Operation

4.4.1 Launch Screen

After turning on the power switch of the system, the display screen
shows the following boot screen.

Figure 4-3 Launch Screen

After launching and initialization, the system undergoes a self-test


with temperature control before proceeding to the quick launch screen.

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Attention
 When the system fails to pass the self-test, the screen displays an
error message. Please handle this error by referring to “Annex A
Fault Information List”.
 The motor runs throughout the self-test. The reagent kits and
magnetic rod sleeves should be installed after the system enters
the launch screen.

4.4.2 Functions of the Main Frame

Figure 4-4 Introduction of the Main Frame

The left side of the screen is the main frame of the system, which
contains the following key functions:

 “Run” subpage: jump to the quick launch/list launch screen;


 “Management” subpage: jump to the program management
screen;

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 “UV” subpage: jump to the UV sterilization screen;


 “Setup” subpage: jump to the setup screen;
 Shutdown key: close the system’s software interface;
 Exhaust Fan key: Click the fan icon to turn on/off the system’s
exhaust fan;
 Lighting Lamp key: Click the fan icon to turn on/off the system’s
lamp.

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4.4.3 Launch Screen - Quick Launch

Figure 4-5 Shortcut Launch Screen

If there are many programs, the operator may view them by using the
left and right page-turning keys at the lower left of the screen.

In the quick launch screen, click the program shortcut icon of the
proposed extraction item, and “Prompt” Dialog will pop up.

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Figure 4-6 Shortcut Launch - Confirmation Dialog

Before clicking on “Confirm”, please check and confirm that the


reagent kits and magnetic rod sleeves are securely installed in place and
the module door is closed.
 Click “Confirm”, and the system will run the selected program and
the running status screen will appear;
 Click “Cancel” to cancel the selected running program.

Attention
 Before launching the program, check if the reagent kits are
installed in place and if the magnetic rod sleeve is placed in the
reagent kit in the No.2 slot to avoid any extraction failure or
system contamination due to installation failure or forgetting to
install.

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4.4.4 Launch Screen - List Boot

The toggle key “Quick Launch/List Launch” on the top right corner of
the screen to switch between Quick Launch and List Launch of the launch
screen.

If there are many programs, the operator may view them by using the
page-turning keys at the right side of the operation table.
 Click the single-arrow page turning key once to flip one row of the
table; click the double-arrow page turning key once to flip a whole
page of the table.

Figure 4-7 List Launch Screen

In the list launch screen, click the row corresponding to the proposed
extraction item, and “List”will pop up.

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Figure 4-8 List Launch - Confirmation Dialog

Before clicking “Run”, please check and confirm that reagent kits are
installed in place, the magnetic rod sleeves are placed in the reagent kit in
the No.2 slot and the module door is closed.
 Click “Run”, and the system will run the selected program and the
running status screen will appear;
 If you want to run from a specified step, you may, in the dialog box,
select the row the corresponding step is in belongs (the color of
the row will change after it’s selected), and then click “Step Run”.
The system will skip the previous steps and start running from the
specified step, going on to complete the succeeding steps.
 Click “Cancel” to cancel the selected running program.

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4.4.5 Program Run

Figure 4-9 Running Screen

At the top of the screen is a progress bar, which shows the name of
the program, the progress of the running step and the remaining time.

1. At the upper part of the screen is the schematic diagram of the


reagent kit, which will simultaneously indicate the currently running
slot and real-time temperature.
 When the running program reaches a particular slot of the reagent
kit, the color of the slot corresponding to the schematic diagram
will change color while the other slots will remain gray.
 The temperature corresponding to the slots marked T1 and T2 on
the system will be displayed real-time below the slots to realize
temperature control with program settings.

2. There are “Stop” and “Pause” keys in the center of the screen.
 Click “Pause/Continue” to pause and resume program running.

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 Click “Stop”, and the “stop” prompt dialog box will pop up. Click
“Cancel”, and the program will continue to run. Click “OK” and
program running will return to the initial position, and the button
will switch from “Stop” to “Start”. Click “Start” to re-execute this
program.

3. At the lower part of the screen is a list of program steps, which shows
in detail the step, step name, well position, waiting time, mixing time,
magnetic absorption time, volume, mixing speed and temperature of
each program step.
 When the running program reaches a particular step, the color of
the row corresponding to that step will change.

During program running, the system will automatically move to the #2


slot to load magnetic rod sleeves. Upon the end of program running, the
magnetic rod sleeves will be returned to the #2 slot.

If the door of the system is opened during program running, a prompt


indicating abnormal door closing will pop up and the operation of the
system will pause immediately. The system will resume operation after its
module door is properly closed.

Attention
 Do not open the door while the program is running to avoid cross
contamination of the internal and external environment of the system.
 When the heating function is used during program running, do not touch
the heater strip to avoid burns.

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Figure 4-10 UV Sterilization Prompt

After the end of extraction, the UV sterilization prompt will pop up on


the system screen.

 If UV sterilization is not required after end of the extraction, click


the “Cancel” key.

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4.4.6 UV Sterilization

Click “UV Sterilization” on the left sidebar to jump to the UV


sterilization screen.

Figure 4-11 UV Sterilization Screen

The UV sterilization time can be changed before UV sterilization.


 Click the timing input box to enter the UV sterilization time.
 Alternatively, click “+” or “-” to adjust the sterilization time. Each
click adjusts the time by 1 minute.
 If no changes are made, UV sterilization will be carried out
according to the current time.

Click the UV sterilization icon (i.e., the round button in the center of
the screen) to turn UV sterilization on or off.
 Click the UV sterilization icon (i.e., the round button in the center
of the screen) to turn on the UV lamp and start the UV sterilization.
Meanwhile, the sterilization time countdown will begin.

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 Likewise, if you want to cancel a UV sterilization in progress, click


the UV sterilization icon (i.e., the round button in the center of the
screen) to turn off the UV lamp, and stop UV sterilization and its
countdown.
 You may tick “Shutdown after UV Sterilization”, and once ticked,
the system will be automatically shut down after the end of the UV
sterilization countdown.

If the system’s module door is opened during the sterilization, the UV


lamp will be automatically turned off and the sterilization will pause. The
UV lamp will be turned on and the sterilization resumed after the system’s
module door is closed.

4.4.7 Program Management

Click “Manage” on the left sidebar to jump to the “Manage” screen.

Figure 4-12 Program Management Screen

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In the program management list, you may set quick launch and
program lock.
 Click the “  ” of the “shortcut” column of the corresponding
program. When the clicked “” becomes “”, it indicates that the
program will appear in the shortcut list; if “” returns after “” is
clicked, it indicates that the program will not appear in the shortcut
list.
 In the Lock column, if the icon is a closed lock, it indicates that the
program is locked and cannot be edited, deleted or saved; if the
icon is an opened lock, it indicates that the program is unlocked
and can be edited.
 There are “New”, “Edit”, “Save As” and “Delete” keys at the lower
part of the screen.

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4.4.7.1 New Program

Click “New” on the “Manage” screen to jump to the New screen.

Figure 4-13 New Program Screen


The first step requires the user to enter the name of the new program.
 “Add”: Click “Add” to add a new step.
 “Insert”: Click the row of a particular step, and click “Insert” to
insert a new step below that step.
 “Delete”: Click the row of a particular step, click “Delete”, and a
prompt label will pop up. Click “OK” to delete the selected step;
click “Cancel” to keep the selected step.
 “Edit” : Click the row of a particular step, click “Edit” and “Step
Edit” screen will pop up, then edit the selected step row.
 Click “Save” and a prompt label will pop up. Click “OK” to save the
current program being edited; Click “Cancel” to give up saving the
current program being edited.

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 Click “Back” and the system will return to the “Manage” screen if
the newly added program has been saved. If the newly added
program has yet been saved, a prompt label will pop up. Click
“Yes”, and return to the “Manage” screen after the newly added
program is saved; Click “No”, and return to the “Manage” screen
with the newly added program unsaved. Click “Cancel”, and the
system will remain on the “New” screen.
 “Options”: Click “Options”, and the “Options” will pop up.

4.4.7.2 Steps
On the New Program screen, click the “Edit” key to jump to the Step
Edit screen.

Figure 4-14 Step Edit Screen

Enter the name of step at the “Step Name” spot.

Click “Pos.” to select the desired slot number.

Enter the value of “Mix_Time”, “Mag_Time”, “Wait_Time”, “Volume”


and “Mix_Speed” required for that step.

The system allows for the setting of the heating function in slots #1
and #5. When other slots are selected, the corresponding step row will

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have no “Temp” (Temperature) number box. The “Temp” (Temperature)


number box allows for the entry of the desired temperature value; if the
value “0” is entered, it indicates that the slot will not be heated when the
program runs to this step.

“Mix_Pos.”, “Mix_Range”, “Mag_Pos.” and “Mag_Speed” are


extended parameters which usually assume default values and require no
modification by ordinary users. If the user has any special requirement,
the relevant parameters may be adjusted according to actual conditions.

Click “Save” to save the step parameters.

Click “Cancel”, and the prompt box will pop up. The user may choose
not to save the current step being edited.

4.4.7.3 Options

Figure 4-15 Options Screen

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“Options” is the setting of a program, which usually takes a default


value and requires no modification by ordinary users. If the user has any
special requirement, the relevant parameter may be adjusted according to
actual conditions.

4.4.8 Setup

Click “Setup” on the left sidebar to jump to the “Setup” screen

Figure 4-16 Setup Screen

The Setup screen allows for the operation of “System Time”,


“About” ,“Import/Export”,“Service” and “Screen Cal.” (Screen Calibration).

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4.4.8.1 System Time Setup

Click “System Time” on the left sidebar to jump to the “System &
Date” screen.

Figure 4-17 Time Setup Screen


 The system’s current date and time can be modified, and the
values can be entered with the numeric keypad.
 The date format can be selected from a drop-down box.

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4.4.8.2 Import/Export
The system’s program can be imported/exported.

Figure 4-18 Import/Export Screen

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4.4.8.3 About

The system’s version information can be viewed.

Figure 4-19 About Screen

4.4.8.4 Screen Calibration

Click the “Screen Cal.” (Screen Calibration) icon to jump to the Touch
Screen Calibration Screen. Calibrate according to the operating
instructions on the calibration screen.

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4.4.9 Troubleshooting

If there is a system fault, the alarm prompt tone will be triggered.


Click any spot on the screen to turn off the alarm prompt tone. Meanwhile,
the fault prompt will appear at the lower right corner of the screen and the
name of the fault will be displayed within the orange area.

Figure 4-20 Fault Display Status Screen

Please click in the orange area to eliminate the fault with one click
according to the instructions in the pop-up box, or contact our after-sales
personnel/authorized dealer.

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Chapter 5 Cleaning and Maintenance


5.1 Maintenance and Servicing

1. Please read the operation manual carefully before using the


system;

2. During use, make sure that there is ventilation around the system;

3. Keep the experiment module’s internal environment dry and free


from water stain;

4. Don’t use the system when the voltage is unstable, too high or too
low;

5. After use, clean the experiment module with 75% ethanol, then
turn on the UV lamp for no less than 30 minutes for sterilization;

6. If the system is kept idle for long, unplug the system and cover it
with a dust cover to prevent the intrusion of dust;

7. If the system is kept idle for long, it is suggested that the system
be turned on for idle running every 30 days to ensure its reliable
performance.

Attention
 Do not perform any maintenance operation on the system while
the system is operating.

5.2 Filter Screen Replacement

This system is equipped with such functions as external-discharge


HEPA filter, negative pressure exhaust, etc., and this biological filter
screen can absorb aerosol to prevent cross contamination.

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To ensure reliable performance of the system, it is suggested that the


filter screen on the back of the system be replaced once every 3 months.
During replacement of filter screen, remove the 4 screws of each of the
two exhaust ports on the back of the system, then mount the new filter
screen, keeping the green surface of filter screen downward and close to
the fan, as shown in the graph below.

Filter Screen

Figure 5-1 Replacement of Filter Screen

5.3 Periodic Cleaning

The objects required to clean the system include: ① 75% ethanol;


②cleaning cloth.

Wash the cleaning cloth used during cleaning with liquid detergent,
rinse it with clean water then air-dry it for future use. Make necessary
replacement after long-term use.
1. Before cleaning, turn on the UV lamp and keep it on for at least 30
minutes.
2. After the end of each experiment and daily experimental work:

 Spray clean the wall of the experiment module and magnetic


rod rack with 75% ethanol;
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 Wipe the internal wall of the experiment module, the magnetic


rods and magnetic rod rack with a cleaning cloth moistened
with 75% ethanol, then dry them with a dry cleaning cloth;

 Turn on the UV lamp and keep it on for at least 15~ 30


minutes for sterilization.

Attention
 Pouring the solution directly into the experiment module is strictly
prohibited.

Warning
 Do not clean the system when it is powered;
 Do not wipe the system with gasoline, paint thinner, benzene
compounds and other organic solvents likely to corrode the
system;
 Cleaning cloth should be made from lint-free materials or be
disposable absorbent paper;
 A soft dry cloth or a soft cloth moistened with mild detergent may
be used to wipe and keep the system clean. It is advisable to wipe
the screen with a soft, wear-free cloth, and avoid washing the
screen with water.

5.4 Waste Disposal

Used disposable reagent kits, magnetic rod sleeves and other types
of used waste generated during normal operation of the system as well as
remaining extraction specimens may possibly contain biological
contaminants, and should be recovered and sterilized according to the
provisions of relevant national laws and regulations.

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Caution
The waste generated during the operation of the isolation system
poses a risk of biological and chemical contamination and should be
disposed of properly.

5.5 Disposal of Scrapped isolation Systems

When the system reaches its scrapping period, it should be disposed


of as medical device waste according to local regulation.

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Chapter 6 Transportation and Storage


6.1 Transportation of the System

1. The system adopts carton packaging for long-distance


transportation;
2. The system in transit should be protected against dampness, water,
violent vibration and squeezing. The system should be handled with care
during moving and loading/unloading.
3. If the system has to be moved, use cross-recessed head screws to
fix magnetic rod sleeve holders on the moving mechanism. After it is
being delivered to the designated point, the fixed cross-recessed head
screws should be removed before the installation and use of the system.
4. The user is expected to keep the system’s original packaging
material to facilitate the transportation of the system.

Attention
 During transportation, to avoid sampling component damage, you need
to fix moving components with clamps/cable ties.
 After the system is installed and works normally, it should not be moved
in order to avoid vibration and damage to the high-precision
components and vulnerable parts inside, thus affecting the normal
operation of the analyzer.
 If the system is to be moved, it must be placed in the packaging box,
and then carried by more than 2 person.

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6.1.1 Graphic Illustrations of External Packaging

“Upward”: The “Fragile Items” :


transportation Handle this
package should be transportation
kept straight up in package carefully
transit. and gently.

“Stacking Layer
“Avoid Rain” : This
Limit”: This
transportation
transportation
package is easily
package can be
damaged by
stacked in at most
rainwater.
two layers.

“Do Not Roll” : This


transportation
package cannot be
rolled.

6.2 Transportation and Storage

6.2.1 Transportation Instructions

The nucleic acid isolation system should be transported in package in


accordance with the requirements in the order contract, and should be
protected from severe shock, vibration, rain and snow splash and solar
exposure during transportation.

6.2.2 Storage Conditions

The packed nucleic acid isolation system should be stored in a clean


room with ambient temperature: -20°C ~ +55°C, relative humidity: 10% ~
90%, atmospheric pressure: 50.0 kPa ~ 106.0 kPa, without corrosive gas
and with good ventilation.

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Attention
 The operator should use the magnetic rod sleeves and reagent kits
designated by Zybio and store and use them in strict accordance with
the instructions for use of magnetic rod sleeves and reagent kits.

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Chapter 7 Points of Attention


7.1 Installation Attentions

Initial installation of the system should be performed by the


manufacturer’s service personnel and specially trained dealers.

7.2 Use Attentions

 Before turning on the system, make sure that the security panel is
closed.
 Do not use the system when the security panel is opened.
 Do not put your hands into the system through the opening below
the yellow line at the front end of the system.
 If the system stops running due to power failure or for any other
reason, all partly processed specimens should be discarded.
 Please make sure that all test tubes are accurately located to the
holder and are in contact with the bottom of the holder; otherwise,
liquid level detection and blood clot detection might fail to work
properly.

7.3 Safety Attentions

 Don’t open the enclosure at random, so as to avoid any


misoperation that may cause unnecessary personal injury or
system damage.
 Please pay attention to any sharp part of the system, so as to
avoid any personal injury including scratches and punctures
resulting from touch.
 When the system is operating, do not touch any of its moving
parts.
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 If the system is operating and accidentally disconnected from the


power supply, do not move the system or open the module door.
The system provides a power-off protection. When the power
supply is restored, you may choose to resume the program or re-
run the program according to software instructions.
 All test specimens, calibrators, quality control products and liquid
waste, as well as component parts contacting the foregoing
substances should be considered infectious, and the operators
should wear medical protective gloves when they have to contact
those objects and treat them as infection sources. During
maintenance and repair of the system, the operators should be
equipped with personal protective equipment.
 If any part of your body is contaminated by specimen solution, etc.,
you should rinse that part with clean water in time and perform
disinfection or other treatment.
 When unplugging the power plug, grip at the plug and avoid
pulling the power cord forcibly.
 Please note that ultraviolet rays are harmful to the human body

7.4 Biological Safety

 Operators should not eat, drink or smoke in the laboratory.


 Operators should wear lab coats and medical protective gloves
when operating the system.
 All specimens and components of reagent kits must be regarded
as reagents with potential hazards. Operators must be equipped
with relevant protective clothing, protective goggles and gloves.
 Measures are taken to prevent the splashing or spill of infectious
fluids that may touch any exposed part of the human body. If you
contact an infectious substance or surface by accident, you
should rinse your skin thoroughly with water and then follow the
disinfection procedure stipulated by your hospital or laboratory.
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 Be extremely careful when disposing of the patients’ specimens,


test cups and waste, for they might have been contaminated after
having contacted specimens and reagents.
 Tools and devices used in the test must be disinfected before they
are put back in place. In case of system failure, before
maintenance personnel make any repair, all components of the
system likely to be biologically contaminated should be ensured to
have been properly cleaned, disinfected and treated or have
taken necessary protection.
 All waste must be treated in accordance with applicable laws and
regulations and local stipulations.

7.5 Replacement of Component Parts

Among all component parts of this system, only the fuse and UV lamp
may be purchased and replaced by users on their own. All other component
parts must be provided by the manufacturer or authorized dealers. Users
must not replace those component parts on their own, and should instead
send such parts back to the manufacturer or authorized dealers for
replacement. The fuse should be replaced as follows:

7.5.1 Fuse Replacement

 The external fuse used in this system is F10AH250V, which will


melt in case of overcurrent.
 Fuse inspection method: Shut the system down and unplug the
power cord, then pry open the fuse base beside the power socket
of the system and remove the fuse. Use a multimeter to check if
the fuse is conductive. Conductive indicates that there is no
melting of fuse; otherwise, there is melting of fuse.
 Replacement method: If the fuse is melted, it will be replaced with
a new fuse of the same model. This is done simply by installing
the new fuse in the fuse holder.

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7.5.2 UV Lamp Replacement

 The model of the external UV lamp used in this system is


GPH135T5L-PRO. When the UV lamp is damaged, it will be
replaced with a new lamp tube.
 UV lamp inspection method: Turn on the UV lamp and visually
check if the UV lamp is lit. if the lamp is not lit, first cut off the
power supply and remove the UV lamp, then turn on the power
supply and use a multimeter to measure if the built-in contact
voltage of the UV lamp is normal. If the voltage is normal, then the
UV lamp is damaged. If that voltage is abnormal, please contact
our after-sales engineer for repair.
 Replacement method: Cut off the power supply, remove the
damaged UV lamp tube from the lamp shade, and replace it with
a new UV lamp tube of the same model.

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Annex A Fault Information List


Sequenc Fault
Cause Analysis Treatment Measure
e No. Description

Power cord is not Re-plug the power


properly plugged cord
The screen fails
to display any Replace a fuse of the
The fuse is faulty
1 content after the same model
power is being
turned on Contact our after-sales
Others engineer or authorized
dealers
Blank screen or Cut off the power supply
2 Improper use or misoperation
out of control and re-start the system

Abnormal contact of UV
Re-install the lamp tube
UV lamp/lighting lamp/lighting lamp
3
lamp is not lit Replace a lamp tube of the
UV lamp/lighting lamp failure
same model

Contact our after-sales


Magnetic rod sleeves are
engineer or authorized
not installed in place
dealers

Abnormal sound 96-well reagent kit is not Emplace the reagent


4
during operation placed correctly kit again

Contact our after-sales


Others engineer or authorized
dealers

Contact our after-sales


The door is not closed
engineer or authorized
properly
Cannot initiate dealers
5 program/program
interruption Contact our after-sales
Others engineer or authorized
dealers

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Temperature module is Temperature controller


not ticked is set as ON
Abnormal
6 Contact our after-sales
Temperature
Others engineer or authorized
dealers

Control the liquid


The liquid volume in the
volume in the reagent
reagent kit exceeds the
kit to be consistent
program extraction
with the required
Extraction results volume
7 show cross volume
contamination
Turn on the exhaust
Aerosol contamination filtration system in a
during extraction real-time manner
during extraction
Pause the program and
No lowering or rising
Abnormal reset
8 movement of The motor loses step, causing
magnetic rods Pause the program and
a deviation from the
reset
movement position

Abnormal contact of UV lamp Re-install the lamp tube


9 UV lamp is not lit
Damaged UV lamp Replace a new lamp tube

Contact our after-sales


Abnormal drip-
10 Abnormal movement of tray engineer or authorized
proof tray
dealers

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