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H-02-70-01-1056-00 [A] nucleic acid isolation system EXM3000

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Nucleic Acid Isolation System
Operation Manual
Zybio Inc.
Product Description
Thank you for purchasing Zybio.Inc (hereinafter referred to as “Zybio”) Nucleic
Acid Isolation System. Allow us to express our appreciation.
Please read this operation manual carefully before using the product.
The pictures in this operation manual are used for illustration or example only
and are not intended for other purposes. Please consult the actual product for accurate
display.
Please consult this operation manual whenever necessary.
Product Name: Nucleic Acid Isolation System.
Specifications and Models:EXM 3200,EXM 3000.
Administration Class: The administration category is class I.
Manufacturer: Zybio.Inc.
Product composition: The product is composed of a mechanical part, an
electrical part and a software part. It is used in conjunction with the kit to achieve the
separation and extraction of nucleic acids in the sample. The mechanical part is
composed of the shell (including the warehouse door), the frame, the motor
movement component, the magnet rob component, and the heat transfer component.
The electrical part is composed of display screen assembly, heating module,
ultraviolet module, lighting module and negative pressure exhaust module. The
software of this product is an embedded software.
Scope: Used to extract nucleic acid from clinical samples.
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
Production date: refer to product label
Service life: 6 years, as determined by lifetime testing. During use, you shall
maintain, care and repair this product in accordance with the requirements in this
manual to ensure the safety and effectiveness.
Operation manual issued date: 2020-5
I
Intellectual Property
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.
Nobody can use, disclose or permit others to obtain all or part of the information
in this operation manual without the prior written permission of Zybio. Nobody shall,
in whole or in part, including but not limited to, take photographs, make copies,
reproduce or translate into other languages of this operation manual.
is a registered trademark or brand of Zybio.
Statement
Zybio has the final right to interpret this manual.
Zybio will be responsible for the safety, reliability and performance of this
product only if all of the following requirements are met, namely:
1) The installing, debugging, expanding, and maintaining of this product shall be
carried out by personnel approved by Zybio;
2) All parts, accessories and consumables for maintenance shall be produced or
approved by Zybio;
3) The operation of this product shall be carried out in accordance with this
operation manual;
4) The relevant electrical equipment shall comply with the national standards and
the requirements of this operation manual.
Warranty and Services
The warranty period of your analyzer shall be subject to the sales contract.
Consumable materials: refer to disposable materials or materials that need to be
replaced regularly, consumable materials have no warranty.
The warranty period starts from the “Date of installation” filled in the “Warranty
Card” attached to this product. The “Warranty Card” is the only warranty
certificate, and must not be lost. In order to protect your rights and interests, please
urge the installation personnel to return the second copy of the Warranty Card to the
II
company within 30 days from the date of installation; If the "Warranty Card"
corresponding to the product you purchased fails to be returned to the company on
time, the warranty period will be extended from the "out-of-stock date" of the
equipment packaging box by 45 days.
During the warranty period, you can enjoy free service; but please note that even
during the warranty period, Zybio will charge for the situation that the product needs
to be repaired due to the following reasons.

Human error;

Improper use;

Voltage mismatch;

Force majeure such as natural disasters;

Replace or use parts, accessories, consumables not approved by Zybio or
repaired by non-Zybio authorized personnel;

Other non-product issues.
After the warranty period expires, Zybio can continue to provide repair services
for a fee.
If you do not pay or delay the payment of the paid maintenance service fee,
Zybio will temporarily suspend the maintenance service until you pay it.
Service Provider
Company Name: Zybio Inc.
Address: Floor 1-4, Building 30, No. 6 Taikang Road, C Zone, Jianqiao
Industrial Park, Dadukou District, Chongqing
Website: www.zybio.com
24-hour service phone: 400-056-7879
Tel: +86(0)23 6865 5509
Fax: +86(0)23 6869 9779
E-mail: info@zybio.com
III

Warning
Your analyzer should only be operated by professionals, doctors and
laboratory personnel trained by Zybio or its agents.

Failure to prepare a complete set of maintenance/repair plans may
result in product fault or personal safety issues.

Failure to operate your product under the conditions specified in this
operation manual may result in product fault, unreliable test results,
product damage or personal safety issues.

Attention
This operation manual is intended for the following personnel:
1.
Operators;
2.
Maintenance staff;
3.
Trainees.
IV
Content
CONTENT.......................................................................................................................................V
CHAPTER 1 OVERVIEW............................................................................................................. 1
1.1 OVERVIEW............................................................................................................................... 1
1.2 SCOPE.......................................................................................................................................1
1.3 READING GUIDE.......................................................................................................................1
1.4 DECLARATION..........................................................................................................................2
1.5 COMMON OPERATIONS............................................................................................................ 2
1.6 SYMBOLS................................................................................................................................. 2
CHAPTER 2 SYSTEM OVERVIEW............................................................................................5
2.1 OVERVIEW............................................................................................................................... 5
2.2 MODEL.....................................................................................................................................5
2.2.1 Mechanical Part...............................................................................................................6
2.2.2 Electrical Part..................................................................................................................6
2.3 MAIN INDICATORS AND PERFORMANCE.................................................................................. 6
2.4 WORKING PRINCIPLE............................................................................................................... 7
2.5 SCOPE.......................................................................................................................................8
2.6 STRUCTURE..............................................................................................................................8
2.6.1 Front Diagram................................................................................................................. 8
2.6.2 Back Diagram.................................................................................................................. 9
2.6.3 Side Diagram................................................................................................................... 9
2.6.4 Iternal Diagram............................................................................................................. 10
2.6.5 Communication Interface...............................................................................................10
2.7 ELECTROMAGNETIC COMPATIBILITY.....................................................................................11
CHAPTER 3 INSTALLATION AND USE PREPARATION.................................................. 13
3.1 OPEN INSPECTION.................................................................................................................. 13
3.2 SPACE REQUIREMENTS.......................................................................................................... 13
3.3 WORKING ENVIRONMENT REQUIREMENTS............................................................................14
3.4 POWER REQUIREMENTS......................................................................................................... 15
3.5 GROUNDING........................................................................................................................... 16
3.6 CHECK THE POWER SUPPLY.................................................................................................. 16
CHAPTER 4 OPERATION GUIDE........................................................................................... 17
4.1 PRE-OPERATION..................................................................................................................... 17
V
4.2 REAGENT KIT INSTALLATION................................................................................................ 18
4.3 MAGNETIC SLEEVE INSTALLATION....................................................................................... 19
4.4 SOFTWARE OPERATION..........................................................................................................19
4.4.1 Start-up Interface........................................................................................................... 19
4.4.2 Main Function................................................................................................................ 20
4.4.3 Shortcut Start-up............................................................................................................ 21
4.4.4 List Start-up....................................................................................................................22
4.4.5 Program Running...........................................................................................................24
4.4.6 Ultraviolet sterilization.................................................................................................. 26
4.4.7 Program Management................................................................................................... 27
4.4.7.1 New Program........................................................................................................................... 28
4.4.7.2 Step Edit...................................................................................................................................29
4.4.7.3 Options..................................................................................................................................... 30
4.4.8 Settings........................................................................................................................... 30
4.4.8.1 System Time Setting................................................................................................................ 31
4.4.8.2 Language Settings.................................................................................................................... 32
4.4.8.3 About........................................................................................................................................32
4.4.8.4 Screen Calibration....................................................................................................................33
4.4.8.5 Upgrade....................................................................................................................................33
CHAPTER 5 PREVENTIVE MAINTENANCE........................................................................34
5.1 CARE AND MAINTENANCE.....................................................................................................34
5.2 FILTER COTTON REPLACEMENT............................................................................................ 34
5.3 CLEANING.............................................................................................................................. 35
5.4 DISPOSAL OF OPERATING MATERIAL.................................................................................... 36
5.5 DISPOSAL OF THE ISOLATION SYSTEM.................................................................................. 36
CHAPTER 6 TRANSPORT AND STORAGE...........................................................................37
6.1 TRANSPORT............................................................................................................................37
6.1.1 Packaging Illustration....................................................................................................37
6.2 TRANSPORT AND STORAGE....................................................................................................38
6.2.1 Transport Conditions..................................................................................................... 38
6.2.2 Storage Conditions.........................................................................................................38
CHAPTER 7 PRECAUTIONS.....................................................................................................39
7.1 INSTALLATION PRECAUTIONS................................................................................................ 39
7.2 PRECAUTIONS FOR USE..........................................................................................................39
7.3 SAFETY PRECAUTIONS........................................................................................................... 39
7.4 BIOSECURITY......................................................................................................................... 40
7.5 PARTS REPLACEMENT............................................................................................................40
7.5.1 Fuse Replacement.......................................................................................................... 40
VI
7.5.2 UV Lamp Replacement...................................................................................................41
7.6 CONTRAINDICATIONS.............................................................................................................41
APPENDIX A TROUBLESHOOTING...................................................................................... 42
APPENDIX B PACKING LIST...................................................................................................44
VII
Chapter 1 Overview
1.1 Overview
This chapter describes how to use the manual of Nucleic Acid Isolation System.
This manual is attached with a detailed description of the use, function and operation
of the Nucleic Acid Isolation System.
Before using the Nucleic Acid Isolation System, please read and understand the
contents carefully to ensure that the Nucleic Acid Isolation System can be used
correctly and to ensure the operator’s safety.
1.2 Scope
This operation manual is intended for medical laboratory professionals or trained
physicians, nurses, or experimenters, for the use of:

Learning to use the hardware and software of EXM3X00;

Setting system parameters;

Performing routine operations;

Performing system maintenance and troubleshooting.
1.3 Reading Guide
This manual contains 7 main chapters and 2 appendices. The operator searches
for the corresponding chapter according to the required information.
Please refer to…
1. Overview
2. System Overview
3. Installation and Use
Preparation
4. Operation Guide
5. Preventive Maintenance
When you need to…
Learn how to use the Nucleic Acid Isolation System operation
manual.
Learn the composition and measurement principle of Nucleic
Acid Isolation System
Learn the environment and installation requirements of the
Nucleic Acid Isolation System.
Learn the operation preparation, software interface and software
operation of the Nucleic Acid Isolation System.
Learn the cleaning and maintenance process of the Nucleic Acid
Isolation System.
1
Learn the transportation and storage conditions of the Nucleic
6. Transport and Storage
Acid Isolation System.
Learn the matters related to the installation, use, safety and parts
7. Precautions
replacement of the Nucleic Acid Isolation System.
Appendix A Fault
Learn the faults and treatment methods of the Nucleic Acid
Information Table
Isolation System.
Appendix B Accessories List
Learn the main accessories of the Nucleic Acid Isolation
System.
1.4 Declaration
In this manual, different fonts and formats are used to distinguish the content
with special meaning in the text.
Format
“××”
Meaning
×× is the information displayed on the screen interface
All illustrations provided in this manual are examples only, please do not use
them for other purposes. The graphics, settings, or data in the illustration may not
exactly match the actual display you see on the Nucleic Acid Isolation System.
1.5 Common Operations
Name
Click
Input
Operations
Press the "××" button
Click the "××" edit box to move the cursor to that place, and use the
soft keyboard to complete the data input
Click the [←] [→] key on the touch screen to move the cursor to the
Delete
place to be deleted, and then use the [X] key on the soft keyboard to
delete the character before the cursor.
1.6 Symbols
Symbols used in this manual
Symbol
Meaning
Please follow the instructions corresponding to this symbol or
risk biological infections.
2
High temperature, be careful with your hands.
High intensity Ultraviolet Light, Please protect your eye and
skin.
Please refer to the document attached with your equipment.
Warning! Handle carefully.
Electric shock
No one except an authorized maintenance personnel is allowed
to disassemble the equipment panel when the power supply is
turned on; avoid spilling liquid on the equipment, if any liquid
enters the equipment, please immediately turn off the power
supply, and contact Zybio service team or its local agent as
soon as possible.
Protective grounding
Alternating current
On (power supply)
Off (power supply)
For in vitro diagnostic use only
Serial No.
Date of manufacture
3
Manufacturer
Please refer to the operation manual.
4
Chapter 2 System Overview
2.1 Overview
Mainly introduce the model, main indicators, performance structure and
electromagnetic compatibility.
2.2 Model
There are two models of this series of products. The working principle, main
functions, electrical structure and key components of each model are exactly the same,
the only difference is that the function configuration is different. (See Table 2-1
below for details).
Table 2-1 Model Differences
EXM 3200
EXM 3000
Model
The Nucleic Acid Isolation System is divided into mechanical
part and electrical part. The mechanical part is composed of a
Structure
shell, a frame, a motor moving component, a magnetic rob
component, and a heat transfer component. The electrical part is
composed of a display screen, a heating module, an ultraviolet
module and a negative pressure exhaust module.
Operating Mode
Nucleic Acid Isolation System
Sample Size
1-32 samples optional
Processing Volume
30 µL — 1000 µL
Cell Lysis Heating
Temperature
Room temperature-105℃
Elution Heating
Temperature
Room temperature-105℃
Program Management
Not programmable
Programmable
Reagent
Magnetic bead kit
Alarm
Support sound alarm
Sterilization
Ultraviolet sterilization
This operation manual takes the EXM 3200 Nucleic Acid Isolation System as an
example, and is applicable to the EXM series. For other models (EXM 3000), please
refer to this operation manual.
5
2.2.1 Mechanical Part
The mechanical part is composed of a shell, a frame, a motor moving component,
a magnetic rob component, and a heat transfer component.

There is a transparent door on the shell to observe the equipment internal
condition. And the door has a sealing strip to separate the equipment inside
and outside to prevent environmental pollution.

The frame is used to support the motor moving component and the magnetic
rod.

The motor movement component is composed of a motor, a magnetic rod
frame and a magnetic sleeve frame. The motor drives the magnetic rod frame
and the magnetic sleeve frame to move, and is used to complete the magnetic
attraction and mixing.

The heat transfer component is located on the bottom plate in the equipment
and is used to assist the temperature conduction of 'Cell lysis and Elution'.
2.2.2 Electrical Part
The electrical part is composed of a display screen, a heating module, an
ultraviolet module and a negative pressure exhaust module.

The display screen supports touch operation and human-computer interaction
with the equipment through touch screen software.

The heating module is used to realize the heating requirements of program
running.

The ultraviolet module is on the equipment compartment top and can be
switched by software. It is used for ultraviolet sterilization after nucleic acid
extraction.

The negative pressure exhaust module is located on the equipment back and
is composed of a negative pressure exhaust fan and a HEPA filter cotton, it
can be switched by software. Used to exhaust the air in the instrument and to
prevent pollution to the external environment.
2.3 Main Indicators and Performance
Table2-2 Main indicators
Principle
Sample Size
Sample Volume
Number of Magnets
Magnetic bead method
1-32
30 μL—1000 μL
32
6
Magnetic Bead Recovery
Extraction Hole CV
Lysis Heating
Elution Heating
Temperature Accuracy
Oscillating Mixing
Operation Interface
Internal Program
≥98%
CV≤3%
Room temperature to 105℃
Room temperature to 105℃
±1℃
Multi-mode and multi-speed adjustable
8.4 inch color touch screen
Can store 500 programs
Create, edit, save, and delete programs, and can set
shortcut programs
Standard USB, Ethernet
Ultraviolet sterilization
Fan exhaust
HEPA filter
Storable, Built-in SD card
500VA
375mm*415mm*440mm
27 kg
Program Management
Expansion Interface
Sterilization
Exhaust
Filter
Data Storage
Maximum input power
Dimensions (L*W*H)
Weight
2.4 Working Principle
Use the magnetic rod on the magnetic rod holder of the experiment cabin to
move the magnetic beads adsorbed with nucleic acid to different reagent holes. The
magnetic sleeve repeatedly and rapidly stirs the liquid to evenly mix the liquid and the
magnetic beads, after cell lysis, nucleic acid adsorption, magnetic bead transfer,
washing and elution, high purity nucleic acid is finally obtained, as shown in the
figure2-1.
Figure2-1 Schematic diagram
7
2.5 Scope
The Nucleic Acid Isolation System can be widely used in scientific research,
clinical, disease control, food safety, forensic and other fields. Users only need to add
samples, nucleic acid extraction reagents, reaction consumables, the Nucleic Acid
Isolation System will complete all operations in accordance with the experimental
procedures. Combined with different magnetic bead nucleic acid extraction reagents,
the Nucleic Acid Isolation System can quickly extract DNA and RNA from animal
and plant tissues, blood, body fluids, and criminal samples.
2.6 Structure
2.6.1 Front Diagram
①
②
③
Figure2-2 Frontal structure
① Touch screen
② Door handle
8
③ Transparent hatch
2.6.2 Back Diagram
①
②
Figure2-3 Posterior structure
① Exhaust fan
② Power switch
2.6.3 Side Diagram
①
②
Figure 2-4 Left side structure
① 1 network port
②2 USB ports
9
2.6.4 Iternal Diagram
①
②
③
④
⑤
⑥
Figure 2-5 Structure inside the door
①Magnetic rod holder and magnetic rod
②Magnetic sleeve holder
⑤96-hole kit positioning strip
⑥96-hole kit middle guide
③96-hole kit Edge guide ④Heating bar
2.6.5 Communication Interface
Name
Type
Network Interface
RJ45 network port plug
USB interface
USB 2.0 (2)
Note: (1) The network interface is used to connect the computer for data transmission, and the
insulation value of the external circuit should not be less than 1MΩ
(2) 2 USB ports for external mouse, keyboard or U disk during debugging and maintenance
upgrade. The working voltage is DC 5V.
Attention

Do not use this Isolation System for other purposes. Incorrect use may cause
the equipment to be infected with viruses. Computer viruses may spread
through USB, programs, and networks.
10
2.7 Electromagnetic Compatibility

The radio frequency emission of the equipment is very low, and the
possibility of interference with nearby electronic equipment is very low.

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.

Be Suitable to 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 shall have reliable protective grounding measures and use
matching power cords, components and accessories.

The floor shall be wood, concrete or tile, and if the floor is covered with
synthetic material, the relative humidity shall be at least 30%.

Grid power supplies should be of typical quality for using in commercial or
hospital environments.

If you need to keep the equipment running continuously during a power
interruption, it is recommended that you use uninterrupted power supply.

This IVD equipment complies with the emission and immunity requirements
specified in IEC 61326.

The power frequency magnetic field in the intended installation site should
be measured to ensure that it is sufficiently low. This equipment should be
far away from the power frequency magnetic field source. In special cases,
magnetic shielding materials should be installed to ensure the normal
operation of the equipment.
Warning

In addition to accessories and cables sold by the manufacturer of the
equipment as spare parts for internal components, using accessories and
cables other than those specified may result in increased equipment
11
emissions or reduced.

This equipment should not be used in close proximity or overlap with other
equipment, and if it must be used in close proximity or overlap, it should be
verified to operate normally in the configuration that it uses.
Attention

Do not use the equipment next to a strong radiation source (e.g., an unshielded
RF source), which may interfere with the normal operation of the equipment.

In a domestic environment, this equipment may cause radio interference. Need
to take protective measures.

It is recommended that the electromagnetic environment should be assessed
before using the equipment, and it is the responsibility of you to ensure that
the electromagnetic environment is compatible with the equipment.
12
Chapter 3 Installation and Use Preparation
Before installation, please ensure that the following space, power, and
environmental requirements are met.
Caution

Unpacking or installation by personnel not authorized by Zybio may cause
personal injury or equipment damage. Please do not unpack or install without
Zybio authorized personnel.
3.1 Open Inspection
All products have passed strict inspection from Zybio before shipment. Upon
receiving your analyzer, please examine carefully before opening the packing box,
and pay attention to the damage, and please notify Zybio or its local agent as soon as
the damage is found.
Attention
During the unpacking process, take care to avoid damage to the magnetic rod
After opening the box, please carefully examine your equipment’s appearance
and verify completeness with the packing list. In case of transportation damage or
missing components, please immediately declare to Zybio or its local agent.
3.2 Space Requirements
This equipment is limited to indoor use, with good indoor ventilation, no
corrosive gas, and no strong magnetic field interference. Please do not place the
equipment in a humid or dusty place. The openings on this equipment are designed
for ventilation and heat dissipation. Please do not block or cover these ventilation
holes. When the equipment is running, the distance between the equipment ventilation
hole and the nearest object should not be less than 25cm to avoid affecting the heat
dissipation.
To ensure the space required for repairs and maintenance, considering the
equipment heat dissipation, the equipment installation must meet:
13

The reserved space between the equipment left and right side doors and the
wall ≥ 10 cm;

The reserved space between the equipment back panel and the wall≥ 25 cm;

The installation table (or floor) can bear a weight of at least about 40 kg.
Attention
Do not place the equipment in a position where it is difficult to disconnect the
power switch.
3.3 Working Environment Requirements
Considering the equipment safety and performance, the installation environment
and working environment of the nucleic acid should meet the following conditions:
 The general working environment temperature is 5 ℃ ~ 40 ℃, if the
experiment requires high temperature, the operating temperature must be 20 ℃
~ 30 ℃;
 The relative humidity should be 30%~80%, and the altitude is less than 3000m;
 The environment should be as dust-free, no mechanical vibration, no large noise
source and no power source interference as possible;
 It is recommended to evaluate the laboratory electromagnetic environment
before operating the equipment;
 Avoid direct sunlight or heat and wind;
 Good ventilate;
 Indoor use.
Warning

The instrument cannot be used in a flammable and explosive environment
14
Attention
If the room temperature exceeds the normal equipment operating temperature
range, causing the equipment temperature to exceed the limit, it will affect the
extraction effect.
3.4 Power Requirements
1.
100V~240V, 50Hz/60Hz, correctly grounded, grounding resistance less than 10
mΩ.
2.
Power supply: Before connecting the AC power supply, please make sure that the
power supply voltage is consistent with the voltage required by the equipment
(tolerable deviation of ±10%). And ensure that the power socket rated load is not
less than the equipment requirements.
3.
Power cord: Use the attached power cord. If the power cord is damaged, replace
the power cord with the same specifications in time. When the equipment is
running, do not put anything on the power cord, and do not place the power cord
where people walk around.
4.
Insert and unplug the power cord: be sure to hold the plug when inserting and
unplugging the power cord. Make sure the plug is fully inserted into the socket
when inserting the power cord and do not pull the power cord vigorously when
unplugging.
Warning

The equipment must be used under good grounding conditions.

The operator must use the specified fuse.

Confirm that the input voltage meets the equipment requirements.

If the fuse needs to be replaced, please contact a service engineer.
15
3.5 Grounding
1) The power supply must be properly grounded, otherwise there will be an
electric shock risk.
2) The grounding resistance must be less than 10mΩ. Poor grounding can lead
to unstable measurement results and housing leakage, and cause an electric
shock risk.
Attention

Please place the equipment on a stable, flat surface, and do not put it with
vibration sources such as centrifuges.

Do not place the equipment where it may be affected by chemicals, corrosive
gases, or strong electromagnetic interference.

Please do not place the equipment in direct sunlight, humidity or high
temperature.
3.6 Check the Power Supply

Check the power supply to confirm it has power and can provide the correct
voltage;

Check the power cord to make sure it is firmly connected and not loose.
Caution

Please use the supplied power cord. Other power cords may damage the
instrument.
16
Chapter 4 Operation Guide
4.1 Pre-operation
Waring

The samples may have potential biological infectious hazards. Operators
should observe the laboratory's safe operation regulations and wear personal
protective equipment (such as laboratory protective clothing, gloves, masks,
etc.).

Please dispose of samples and discarded reagent kits, magnetic sleeve, reagent
strips and other consumables in accordance with local laboratory regulations;

This chapter introduces the routine nucleic acid extraction method in this
Nucleic Acid Isolation System. Please read it carefully before the first use.
Warning

Do not place the equipment in direct sunlight during extraction, so as not to
affect the equipment performance.

Do not use kits beyond the expiration date or deterioration.
Before turning the equipment power on, the operator must check the following
requirements to ensure that the system is ready.

Before starting the equipment, check the equipment is clean and no dirt
through the transparent door

Care and maintain in accordance with the relevant content in " Chapter 5
Preventive Maintenance".

After closing the safety door, power on again.

After the power-on self-test, install the kit and magnetic sleeve.
17
4.2 Reagent Kit Installation
Open the door, first place the 96-well reagent kit with the sample in the
positioning strip, and then press the 96-well reagent kit into the positioning strip. Pay
attention to its direction, and its chamfer should be in the lower left corner. After the
96-well kit is installed in place, install the magnetic sleeve.
Reagent Kit
Figure 4-1 Reagent kit installation.

There are four heating blocks on the plate where the 96-hole reagent kit is
placed, and there is a limit block on each side to assist positioning. At the same
time, there is a shrapnel on each side to fix it

Note: The 96-hole kit can only be placed after power-on self-test;

It is important to ensure that the 96-hole kit is flat and in place before starting
the program.
18
4.3 Magnetic Sleeve Installation
Magnetic Rod
Cover
Figure 4-2 Install magnetic sleeve
Insert the magnetic sleeve completely into the fixing groove of the Magnetic rod
holder. And install the magnetic sleeve according to the kits number.
4.4 Software Operation
4.4.1 Start-up Interface
After turning on the equipment’s power switch, the following startup interface
appears.
Figure 4-3 Start-up Interface
19
Then enter the quick start interface.
Warning

When the self-test fails, prompts the error message, please refer to "Appendix
Troubleshooting Table" to deal with.

The self-test process accompanies the motor movement. Please install the reagent
kit and magnetic sleeve after the equipment enters the startup interface.
4.4.2 Main Function
Figure 4-4 Main Function Interface
The left side of the interface is the main fuction botton, including the key
functions:

"Run": Enter the quick start/list start interface;

"Manage": Enter the program management interface;

"UV": Enter the ultraviolet sterilization interface;

"Setup": Enter the setup interface;

"Shutdown": Close the software interface;

"Exhaust Fan": Click the fan icon to turn on/off the exhaust fan;

"Lighting lamp": Click on the lamp icon to turn on/off the equipment's
lighting lamp.
20
4.4.3 Shortcut Start-up
Figure 4-5 Shortcut Start-up Interface
If there are a large number of programs, you can operate the page turning keys at
the bottom left to check.
In the Shortcut start-up interface, click the currently extracted item’s shortcut
icon, and a'shortcut start-up confirmation dialog' will pop up.
Figure 4-6 Shortcut Start-up Confirmation Dialog
21
Before clicking to confirm the operation, please check that the reagent kit and
magnetic sleeve are well installed, and close the door.

Click ‘Confirm’, the equipment will run the selected program, and appear the
running status on the interface.

Click ‘Cancel’ to cancel currently running program.
Warning
Before starting the program, please check whether the reagent kit and the

magnetic sleeve are installed, to avoid extraction failure or instrument
contamination due to installation failure or not installation.
4.4.4 List Start-up
On the upper right corner of the page, there is a "Shortcut/List" switch button,
which can be used to switch between the shortcut star-upt and list start-up.
If there are a large number of programs, you can operate the page turning key on
the right to view.

Single arrow page turning key, turn one table at a time; double arrow page
turning key, turn entire page at one time.
Figure 4-7 List Start-up Interface
22
In the list display interface, click on the corresponding line of the currently item,
and a'List start-up confirmation dialog' will pop up.
Figure 4-8 List start-up confirmation
Before clicking to confirm the operation, please check that the reagent kit
and magnetic sleeve are well installed, and close the door.

Click ‘Run’, the equipment will run the selected program, and appear the
running status on the interface.

If you want to run from the specified step, you can select the corresponding
step row in the dialog box (the line changes color after selection), and click
‘Step Run’, Then skip the previous steps, start running from the specified
step, and complete the subsequent steps.

Click ‘Cancel’ to cancel currently running program.
23
4.4.5 Program Running
Figure 4-9 Running interface
At the top of the interface is the progress bar, which displays the program
name, the running step progress, and the remaining time.
At the top of the interface is the reagent kit schematic diagram, which will
simultaneously display the corresponding hole-position and real-time
temperature status of the current operation.

When the program runs to the reagent kit certain column, the corresponding
column on the schematic will change color, and the remaining columns
remain gray.

The temperature corresponding to the hole-position in the T1, T2, T3, T4, T5,
T6, T7, and T8 columns marked on the instrument will be displayed in real
time above the column, and the temperature will be controlled with the
program settings.

Click "Pause/Run" to interrupt and continue the program.

Click "Stop", a prompt dialog box will pop up. Click "Cancel", the program
continues to run, click "OK", the program runs back to the initial position,
24
and the button changes from "Stop" to "Start". Click "Start" to re-execute this
program.
At the bottom of the interface is a program steps list, which shows the steps,
step name, hole-position, waiting time, mixing time, magnetic time, volume,
mixing speed and each step program temperature in detail.

When a step is run, the list line corresponding to the step will change color.
If the equipment door is opened while the program is running, it will prompt
‘Please close the door’ and the equipment will immediately pause. When the door
is closed again, it continues to operate.
Warning

Do not open the door while the program is running, to avoid crosscontamination of the equipment internal and external environment.

When the heating function is running in the program, please do not touch the
heating bar to avoid burns!
25
4.4.6 Ultraviolet Sterilization
Click "UV" in the left to enter the ultraviolet Sterilization interface.
Figure 4-11 Ultraviolet sterilization interface
Before ultraviolet sterilization, please modify the ultraviolet sterilization
time.

Click the timing input box to enter the ultraviolet sterilization time. Or

Click "+" "-" to adjust the sterilization time, adjust 1 minute for each click.

If not modified, ultraviolet sterilization will be performed according to the
current time.

Click the ultraviolet sterilization icon (circular button in the middle of the
page) to turn on the ultraviolet lamp, start ultraviolet sterilization and
countdown from the sterilization set time.

If you want to stop during the sterilization process, click the ultraviolet
sterilization icon, turn off the ultraviolet lamp, to stop UV sterilization and
countdown.
26
If the equipment door is opened during the sterilization process, the
ultraviolet lamp will automatically turn off, and suspend sterilization. Close the
instrument door, the ultraviolet lamp will turn on, and continue sterilization.
4.4.7 Program Management
Click "Manage" in the left to enter the "Program Management" interface.
Figure 4-12 Program management interface.
In the program management list, you can set up a shortcut start-up or lock
the program.

Click "" in the "Shortcut Start-up" column of the corresponding program.
When "" changes to "", this program will appear in the shortcut list; if
click "", it will change back to "", indicating that this program does not
appear in the shortcut list.

In the lock column, when the icon is a locked lock, it means that the program
is locked and cannot be edited, deleted, or saved as; when the icon is an open
lock, it means that the program is unlocked and it can be edited, deleted, or
saved as.
27

At the bottom of the page there are buttons for "New", "Edit", "Save As", and
"Delete".
4.4.7.1 New Program
Click "New" in the "Program Management" interface.
Figure 4-13 New program interface.

Enter the entire program name.

"Add": Click "Add" to add a new step.

"Insert": Click on a step, click "Insert" to insert a new step below it.

"Delete": Click on a step, click "Delete", pop up a confirmation prompt,
Click "OK" to delete the selected step; click "Cancel" to not delete.

"Edit": Click on a step, click "Edit" to pop up the "step editing interface" to
edit the selected step.

"Save", Click "Save", pop up a prompt. Click "OK" to save the currently
edited program; click "Cancel" to not save.

Click "Back", if the new program has been saved, return to the "Program
Management" interface. If the new program has not been saved, it will pop
28
up a prompt, click "Yes", and the new program will be saved and return to
the "program management" interface; click "No", the new program will not
be saved and return to "Program management" interface, click "Cancel" to
stay in the new program interface.

"Options": Click "Options" to pop up the "Options interface".
4.4.7.2 Step Edit
Click ‘Edit’ on the new program interface to enter the step editing interface.
Figure 4-14 Step editing interface
Enter the step name in "Step Name".
Click "Pos." to select the desired hole-position.
Enter the "mixing time", "magnetic time", "waiting time", "volume", and
"mixing speed" for current step.
Only The heating function of 1, 6 holes can be set, when select other holes,
there is no “temperature” in the corresponding step row, and in which you can
enter the temperature number you want; If you enter "0", it means that the hole is
not heated when the program runs to this step.
29
"Mixing position", "Mixing range", "Magnetic position" and "Magnetic
speed" are extended parameters, which are generally default values and don’t
need to be modified. If there are special needs, you can adjust them according to
the actual situation.
Click "Save" to save the step parameters.
Click "Back" to not save the currently edited step.
4.4.7.3 Options
"Options" is used to set a program, which are generally default values and
don’t need to be modified. If there are special needs, you can be adjust them
according to the actual situation.
Figure 4-15 Options interface
Among them, when click related position of heating module, if ""
becomes "", it means that this program is running, the corresponding heating
module will not run. Generally all are in "" state.
4.4.8 Settings
Click "Setup" in the left column to enter the "Setup" interface.
30
Figure 4-16 Setup interface
In the setup interface, you can set "System Time", "Language", "About", and
"Screen Calibration".
4.4.8.1 System Time Setting
Click "System Time Setting" to enter the "Time & Date" interface.
Figure 4-17 System time setting interface

You can modify the current date and time, and use the numeric
keyboard to enter the value.
31

You can select the date format through the drop-down box.
4.4.8.2 Language Settings
You can modify the equipment language.
Figure 4-18 Language setting interface
4.4.8.3 About
You can view the equipment version information.
Figure 4-19 ‘About’ interface
32
4.4.8.4 Screen Calibration
Click "Screen Calibration" to enter the touch screen calibration interface.
Follow the operation prompts on the calibration interface to perform the
calibration.
4.4.8.5 Upgrade
Support to use U disk to upgrade equipment software.
33
Chapter 5 Preventive Maintenance
This chapter gives instructions on all maintenance work to be performed in order
to keep the Nucleic Acid Isolation System in good working condition.
5.1 Care and Maintenance
1.
Before using the equipment, please carefully read this operation manual.
2.
When using, please ensure that the equipment environment is ventilated;
3.
Keep the equipment experiment cabin environment dry and free of water
stains.
4.
Please do not use the equipment when the voltage is unstable, too high or too
low;
5.
At the end of the experiment, use 75% ethanol to clean the equipment
experiment cabin, and turn on the ultraviolet lamp to irradiation sterilization
for more than 30 minutes;
6.
When the equipment is not used for a long time, please unplug the power
cord and cover the equipment with a dust cover to prevent dust.
7.
When the equipment is not used for a long time, to ensure its stable
performance, it is recommended to turn on the equipment and run it every 30
days.
Attention

It is forbidden to maintain the equipment during operation.
5.2 Filter Cotton Replacement
To ensure stable performance of the instrument, it is recommended to
replace the filter cotton on the back of the instrument every 3 months.When
replacing the filter cotton, please remove the 4 screws at the exhaust port on the
back of the equipment, remove the old filter cotton, install a new one, put its
green side down, and close to the fan.
34
Filter cotton
Figure5-1 Filter cotton replacement
5.3 Cleaning
Cleaning Agent:①75% Ethanol ;②lint-free tissue.
After using the lint-free tissue, please clean and dry it for the next use.
After long-term use, replace as necessary.
1. Turn on the ultraviolet lamp to irradiate sterilization for more than 30
minutes before cleaning.
2. After a single experiment and before get off work:

Use 75% ethanol to spray the experiment cabin and magnetic rod
holder;

Wipe the experiment cabin, magnetic rod, and magnetic rod holder
with a lint-free tissue moistened with 75% ethanol, and then wipe dry
with a dry one;
3. Turn on the ultraviolet lamp to irradiate sterilization for 15~30 minutes.
Attention

It is strictly prohibited to pour the solution directly into the experiment
cabin.
35
Warning

Do not clean the equipment when it is powered on;

Do not wipe the equipment with organic solvents such as gasoline, paint
thinner, or benzene compounds;

The lint-free tissue should be made not easy falling down materials or
disposable absorbent paper;

Wipe the equipment with a soft dry cloth or a soft cloth moistened with
mild detergent. Wipe the screen with a soft and non-abrasive cloth, do
not clean it with water.
5.4 Disposal of Operating Material
The used wastes such as disposable kits, magnetic sleeve, and remaining
samples may contain biological contaminants. Please recycle and sterilize them in
accordance with relevant national laws and regulations.
Caution
The waste generated by the equipment has the biological and chemical
pollution risk, please handle it properly.
5.5 Disposal of the Isolation System
After the equipment expires, stop using it or use it after comprehensive
inspection and maintenance by Zybio.
36
Chapter 6 Transport and Storage
6.1 Transport
1. Carton packaging for long-distance transportation;
2. Prevent moisture, water, severe vibration and squeezing during
transportation. Handle with care when handling and loading.
3. If you need to transport, please use the cross screw to fix the magnetic rod
sleeve on the motion mechanism. After transportation to the designated place,
you need to remove the fixed cross screw before installation.
4. Please save the original packaging materials to facilitate the transportation
of the equipment.
Attention
 During transportation, in order to avoid the damage of the sampling
component, it is necessary to fix the moving component with a clip/tie.
 After the equipment is in normal operation, it should not be moved in general
to prevent the high-precision components and Fragile parts inside the
equipment from being damaged by vibration
 If you really want to move the equipment, you must put the it in the packing
box, and then carry it together by more than two people.
6.1.1 Packaging Illustration
"Fragile
"Upward": The
items": Handle
transport package
the transport
should be upright
package with
when transported.
care.
"No
"Fear of rain":
stacking": The
The transport
transport package
package is afraid of
can only be
rain.
placed in a single
layer.
37
"Rolling
prohibited": The
transport package
cannot be rolled.
6.2 Transport and Storage
6.2.1 Transport Conditions
The Nucleic Acid Isolation System is transported according to the order
contract in the packaging state. During the transportation, the ambient
temperature: -20℃~+55℃, relative humidity: 10%~90%, atmospheric pressure:
50.0kPa~106.0kPa, must be prevented Subjected to severe shock, vibration, rain,
snow and exposure.
6.2.2 Storage Conditions
The packaged Nucleic Acid Isolation System should be stored in a clean
room with ambient temperature: -20℃~+55℃, relative humidity: 10%~90%,
atmospheric pressure: 50.0kPa~106.0kPa, no corrosive gas and good ventilation.
Attention

The operator should use the magnetic sleeve and kit specified by Zybio, and
strictly follow the instructions for storage and use.
38
Chapter 7 Precautions
7.1 Installation Precautions
The equipment initial installation can only be carried out by Zybio service
personnel and specially trained distributors.
7.2 Precautions for Use

Before starting the equipment, make sure that the safety board is turned off.
Never use it with the safety panel open.

Do not reach into the equipment through the opening under the yellow line
on the front of it.

If the equipment is stopped due to power failure or other reasons, all
processing samples should be abandoned.

Please make sure that all test tubes are accurately positioned on the shelf and
touching the bottom of the shelf, otherwise the liquid level detection and clot
detection may not work correctly.
7.3 Safety Precautions

Please do not open the shell at will to avoid unnecessary man-machine injury
caused by improper operation.

Please pay attention to the equipment sharp parts to avoid human injuries
such as scratches and punctures.

When the equipment is in operation, never touch its moving parts.

All test samples, calibrators, quality control, waste liquid, etc., including the
parts that have been in contact with them, should be considered as infectious,
medical protective gloves should be worn when in contact and handled them
as infection source. During the maintenance and repair of the equipment, the
operator needs safety protection.

If samples or other items accidentally contaminate any part of the body,
please rinse with water and disinfect or other treatment in time.

When unplugging the power plug, hold the plug instead of pulling the power
cord.

Pay attention to the harm of ultraviolet rays.
39
7.4 Biosecurity

Operators are not allowed to eat, drink or smoke in the equipment room.

Please wear lab coat and medical protective gloves when operating the
equipment.

All samples and test kit components must be considered potentially
hazardous reagents. The operator must wear appropriate protective clothing,
goggles and gloves.

Avoid splashing and spilling of infectious fluids, resulting in contact with
any exposed parts of the body. If you accidentally come into contact with
infectious substances, immediately wash your skin thoroughly with water,
and then follow the disinfection procedures prescribed by your hospital or
laboratory.

Be extremely careful when handling patient samples, test cups, and waste,
because they may be contaminated with the samples and reagents that have
been in contact.

The tools used in the inspection must be sterilized before putting back .
Before performing repairs, Maintenance personnel should ensure the parts
that may have biological contamination on the equipment are properly
cleaned and disinfected, and wear the necessary protection clothing.

All waste must be disposed of in accordance with local regulations.
7.5 Parts Replacement
Among all the parts of the instrument, only fuse and UV lamp can be purchased
and replaced by yourself. Any other parts can only be provided and replaced by Zybio
or authorized agent, it is strictly forbidden to replace it by yourself. The fuse and UV
lamp replacement method is as follows:
7.5.1 Fuse Replacement
a) The external fuse used in this equipment is F10AH250V. When the
overcurrent occurs, the fuse blows.
b) Check the fuse: firstly disconnect the power cord, then pry the fuse holder next
to the power cord socket, take out the fuse, use a multimeter to measure
whether it is continuity, if it is continuity, it is not fused, otherwise it is fused.
40
c) Replacement method: if it has been fused, replace it with a same model fuse
and install it into the fuse holder.
7.5.2 UV Lamp Replacement
a) The model of the UV lamp used in this equipment is GPH135T5L-PRO.
When the UV lamp is damaged, replace it with a new lamp.
b) Check the UV lamp: turn on the UV lamp switch, visually check whether the
UV lamp is on, if not, first turn off the power, remove the UV lamp and use
multimeter to measure whether the UV lamp electric shock voltage
is
normal, if it is normal, the UV lamp is damaged, if not, please contact Our
Service Engineer.
c) Replacement method: disconnect the power supply, remove the damaged UV
lamp from the lampshade, and replace it with the same type .
7.6 Contraindications
None.
41
Appendix A Troubleshooting
No.
Malfuction
1
The screen does
not display after
turning on the
power
Result
The power cord is not
plugged in
The fuse is broken
Black screen or
out of control
3
UV
lamp/lighting
lamp is not on
4
Abnormal sound
during operation
Replug the power cord
Replace a new fuse of the
same type
Contact Zybio service team
Others
2
Measures
or authorized agent
Improper use or operation
error
Poor contact of UV
lamp/lighting lamp
UV lamp/lighting lamp
damaged
The magnetic sleeve
Restart the equipment after cutting
off the power
Reinstall the lamp
is not inserted in
Reinsert the magnetic sleeve
Replace a new lamp of the same
model
place
96-hole kit is placed
incorrectly
Contact Zybio service team
others
5
Program cannot
start/program is
interrupted
or authorized agent
The safety door is not
Contact Zybio service team
closed
or authorized agent
Contact Zybio service team
Others
6
Abnormal
temperature
Replace the kit
or authorized agent
Temperature module
Set the temperature controller
is not checked
on
Contact Zybio service team
Others
or authorized agent
The liquid volume in
7
Crosscontamination in
extraction
results
the kit and the
Control the liquid volume in
volume extracted by
the kit to be consistent with
the program are
the required volume
inconsistent
42
Aerosol
contamination during
extraction
8
Abnormal
magnet action
Open the real-time exhaust
filter system during extraction
Not falling or rising
Pause the program, reset again
Motor abnormality causes
the magnet action position Pause the program,reset again
not to be in place
43
Appendix B Packing List
No.
Material Name
Quantity
Unit
1
Nucleic Acid Isolation System
1
Set
2
Power Cable
1
pcs
3
Operation Manual
1
pcs
4
Warranty Card
1
page
5
Packing List
1
page
44
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