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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.
Statement
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
1.6 Symbol.........................................................................................................................3
2.1 Overview..................................................................................................................... 6
4.4.6 UV Sterilization..................................................................................................... 34
4.4.8 Setup...................................................................................................................... 40
4.4.9 Troubleshooting....................................................................................................44
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.
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system.
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Click on the “××” edit box to move the cursor to that spot
Enter
and complete data entry with the soft keyboard
1.6 Symbol
Symbol Meaning
Symbol Meaning
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On (power supply)
Serial No.
Date of manufacture
Manufacturer
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Fuse
Ethernet port
USB
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Nucleic Acid Isolation System
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
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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
Magnetic beads
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
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①
②
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①
②
③
④ ⑤
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
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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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.
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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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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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.
Attention
Carefully dismantle and avoid magnetic rods collision that will
damage the magnetic rods.
Attention
Do not place the device in a position where it is difficult to turn off
the power switch.
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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.
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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.
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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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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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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Magnetic
rod sleeve
Reagent
kit
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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;
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.
After turning on the power switch of the system, the display screen
shows the following boot 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.
The left side of the screen is the main frame of the system, which
contains the following key functions:
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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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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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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.
In the list launch screen, click the row corresponding to the proposed
extraction item, and “List”will pop up.
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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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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.
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.
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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4.4.6 UV Sterilization
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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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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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.
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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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
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4.4.8 Setup
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Click “System Time” on the left sidebar to jump to the “System &
Date” screen.
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4.4.8.2 Import/Export
The system’s program can be imported/exported.
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4.4.8.3 About
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
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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2. During use, make sure that there is ventilation around the system;
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.
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Filter Screen
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:
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.
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.
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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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“Stacking Layer
“Avoid Rain” : This
Limit”: This
transportation
transportation
package is easily
package can be
damaged by
stacked in at most
rainwater.
two layers.
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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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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.
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:
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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
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