AGS AGS8830-8 User manual

PRESENTATION
Portable Fast Real-time Fluerescence
Quantitative PCR Instrument
with Detection Kit for SARS-CoV-2 RNA
1 Portable Real time PCR Instrument:
AGS8830-8/AGS8830-16

INSTRUCCIONS FOR USE
Portable Fast Real-time Fluerescence
Quantitative PCR Instrument
with Detection Kit for SARS-CoV-2 RNA
2 Portable Real time PCR Instrument:
AGS8830-8/AGS8830-16

In Vitro Diagnostic (IVD) Medical Instrument
Real-time PCR Detection System
Operation Manual
Hangzhou AnYu Technologies Co., Ltd.

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The text contains the patent data protected by copyright, with all rights reserved. Any part in the
document shall never be copied, remade or translated into other languages without the prior
written approval of Hangzhou AnYu Technologies Co., Ltd.
Express our sincere thanks to you for choosing our products.
Please make sure to read the operations manual carefully before
you use the instrument for the first time!
Software version number: V1
：Hangzhou AnYu Technologies Co., Ltd.
Room 607, 6th Floor, Building 2, No. 1216 Da Nonggang Road, Jianggan District, Hangzhou,
Zhejiang, China
After-sales Service: Hangzhou AnYu Technologies Co., Ltd.
Service phone: [phone]
Service fax: [phone]
Zip code: 310021
E-mail: [e-mail]
Website: http://www.bioanyu.com
Document No.：AG5.088Z.0000.SM1.Z
File version: 1st version1.1 September 21, 2020
All right reserved, the information herein is subject to change without notice.

AGS8830 Operations Manual
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Important Notes
1Symbols
Caution
The Operations Manual must be consulted in all cases
where this symbol is marked.
It must be consulted in all cases where symbol is
marked, in order to find out the nature of the potential
HAZARDS and any actions which have to be taken to
avoid them.
Caution, possibility
of electric shock
The improper operation may result in electric shock or
damage to the instrument.
Warning;
Hot surface
The improper operation may result in scald.
Hint

The hint includes several operation tips and reasonable
methods for setting and using the instrument.
Environmental
Protection Use
Period
The EPUP (Environmental Protection Use Period)
symbol is prepared according to Measures for the
Control of Pollution from Electronic Information
Products and Marking for Control of Pollution Caused
by Electronic Information Products (SJ/T11363-2006)
and is suitable for the electronic information products
sold in China.
Biological risks
The reagent used in the position with the symbol
attached to the instrument may result in biohazard, and
thus, the protection shall be concerned.

AGS8830 Operations Manual
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Caution
The real-time fluorescence quantitative PCR
instrument conforms to the electromagnetic
compatibility requirements of IEC 61326-1：2012 and
IEC 61326-2-6：2012 standards.
The equipment is designed and tested according to
class A equipment in IEC/CISPR 11：2010.
In the home environment, the device may cause radio
interference, and protective measures should be taken.
Do not use the device near the source of strong
radiation, otherwise it may interfere the normal
operation of the device.
It is recommended that the electromagnetic
environment be evaluated before the equipment is
used.
Protective
conductor terminal
The position with the symbol attached to the
instrument indicates the grounding terminal.
CE symbol
The AGS8830-8, AGS8830-16 Real-Time PCR
Detection System is comply with the requirements of
CE technology symbol.
The AGS8830-8, AGS8830-16 Real-Time PCR
Detection System is comply with the standard 61010-1
IEC/EN and standard IEC 60601-1-2.
2 Safety
The basic safety measures below must be observed during operation,
maintenance, and repair of the instrument. If the notes, warnings, or cautions
specified in the manual are neglected, the basic protection provided by the
instrument may be affected. Meanwhile, it may also damage the safety level of
instrument design and manufacture and the anticipated application scope.
It is not allowed to change the parts of the instrument without permission,
and the inspection and maintenance of the instrument must be completed by
engineers authorized by Hangzhou AnYu Technologies Co., Ltd.. If the
equipment is not used in the way specified in this manual, the protection provided
by the equipment may be damaged.
Hangzhou AnYu Technologies Co., Ltd. never assumes any result caused by
the user who disobeys the requirements below.

AGS8830 Operations Manual
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The AGS8830-8,AGS8830-16 Real-Time PCR Detection System
is comply with the Standard IEC61010-1：2010, and the protection
degree is IP20.
It is intended for indoor use and applied to an elevation below
2,000 meters.
It is an in vitro diagnostic (IVD) medical equipment which is
comply with the standard IEC 61010-2-101: 2015.
a) Instrument grounding
WARNING: To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
The mains plug or appliance coupler is intended to be used as disconnecting
device from mains supply, not to position the equipment so that it is difficult to
operate the disconnecting device.
Please use the equipment in a manner specified by the manufacturer, or the
protection provided by the equipment will be impaired.
The input power cord for the instrument must be grounded reliably so as to
avoid electric shock. The instrument is equipped with 3-pin plug with a grounding
pin, and only mated with a grounding power socket. If the plug cannot be inserted
into the socket, please ask an electrician to install the right socket but never make
the grounding plug lose its safety protection function.
Warning: Against replacing detachable MAINS supply cords by
inadequately RATED cords.
Warning: please use parts supplied only by the manufacturer or his
agent.
b) Keep away from the circuits when the power is on.
The operator shall never remove the protection device, replace a component,
or adjust the instrument. If it is required, the manufacture shall complete it and it
is forbidden to replace any component when the power is on.
c) Attention to the power supply
Before AC power is applied, make sure that the power voltage is in line with
the value required by the instrument (24VDC 47-63Hz 9.2A).

AGS8830 Operations Manual
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The connection to the external circuit shall not: a) cause the accessible parts
of the external circuit to become dangerously live under normal conditions and
single fault conditions; B) or make the accessible parts of the equipment
dangerously live under normal conditions and single fault conditions.
Requirements for the power supply
Model
Input power
AGS8830-8
24VDC 47-63Hz 9.2A
AGS8830-16
24VDC 47-63Hz 9.2A
NOTE: The device is connected to the network power supply through
the adapter, and the adapter has met the corresponding standard
IEC60601-1.
NOTE: The overvoltage category parameter of the adapter is
105%-135%.
The connection of instrument, adapter and network power is shown in the
figure below.
①Instrument ②Adapter output terminal ③Adapter ④Adapter power input terminal ⑤Power
plug ⑥Network power supply
This surface facing down
To insert the plug, pinch the rubber end of the plug in the right direction and
push until a click is heard, which means the plug and socket are locked. Inserting
the plug in the wrong direction may cause damage to the instrument, whether or

AGS8830 Operations Manual
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not the power is switched on! If you pinch the elastic shell of the plug and insert it,
you cannot push the plug into the lock.
If you want to pull out the plug, you need to hold the upper and lower sides
of the elastic shell. When the elasticity reaches the maximum, the plug will be
automatically unlocked and then pulled out. Holding the rubber part to pull out or
using pry, shaking and other actions to pull out the plug may cause damage to the
instrument!
d) Attention to the power cord
The instrument shall adopt the power cord attached with the machine. If the
power cord is damaged, a power cord of the same type and same specification
shall be used to replace the old one and the repair shall never be conducted. It is
forbidden to put anything on the power cord or lay the power cord in a crowded
place when the instrument is in operation.
e) Plugging and unplugging of the power cord
When the power cord is plugged or unplugged, hold the plug, not the cord,
tightly, ensure that the plug is fully and firmly inserted into the socket when
plugging, but never drag the cord when unplugging.
f) Attention to the location for installing the instrument
There is a power switch on the back side of the instrument. The instrument
should be placed in such a way that it can be easily turned on or off. Do not place
the device in a position where it is difficult to operate the disconnect device.
The instrument shall be laid in the place with low humidity, little dust and
away from water source (such as a poll, a water pipe, etc.), the indoor ventilation
shall be in desired condition, and there is neither corrosive gas nor strong
magnetic field interference. Please never install the instrument in the place full of
humidity or dust.
The openings of the instrument are designed for ventilation circulation so as
to prevent the machine from overheating and the vents shall never be blocked or
covered, and shall be at least 30cm away from the nearest object when the
instrument is used alone. The distance between the instruments shall never be less
than 50cm when more instruments are used at the same time. Please pay attention

AGS8830 Operations Manual
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to the risk of electric shock since there are electrical circuits in all ventilation
holes.
The high temperature environment may affect the test performance of the
instrument or cause malfunctioning. Never use the instrument directly exposed to
the sun or intense light sources so as to ensure fluorescence detection accuracy of
the instrument. Keep it away from heaters, stoves, or other heat sources.
There is an over-temperature protection device built in the instrument.
When the detected temperature exceed the over-temperature protection threshold,
the software will alarm automatically. The over-temperature protection device will
be disconnected and the instrument stops working.The instrument will be
self-checked when it is started up. The self-check indicates that the
over-temperature protector is normal and the instrument can operate normally.
Please turn off the power supply when run is over, unplug the power plug,
and cover the instrument with soft cloth or plastic film so as to prevent dust or
impurities.
Sound pressure level ≤55 dB
g) Attentions during operation
Only use consumables within their expiration date.
Please make sure the instrument is in good condition and safe before
operation.
Liquid shall never drip on the instrument under test. The consumables,
reagents and other wastes shall be disposed according to the local directive but
never discarded or dumped arbitrarily.
If there is harmful substance under test, the operation cannot be performed
until the related training is obtained.
The harmful substances after use shall be handled or stored properly
according to their operations manual.
The operator must obtain the related training and qualification.
For personal safety, do not open the hot-lid when the program is running.
which is hot and there is a risk of scalding. During the operation of the machine, it
is forbidden to touch the hot-lid or the test hole with the power cord and other
non-experimental items.
During the following situations, turn off the power, unplug the
power plug from the socket, and contact the distributor or
manufacturer for troubleshooting.
● Liquid splashes into the instrument;
● The instrument is caught in rain or watered;
●The instrument is malfunctioning, and especially there occurs any

AGS8830 Operations Manual
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h) Transportation symbols
This way up
Indicate that the correct position of the
transport package is vertically upward.
Handle with care
Please put the package carefully during
transportation.
Keep away from
moisture
The package shall never be caught in rain.
Pile limit
There are at most 3 pile for the same
package.
Temperature limit
Indicate that the temperature range for the
transport package is from -20℃ to 55℃.
i) Second transportation
After the instrument is used up, it should be cut off in time before it is
stopped and re-transported. If the instrument is to be transported again, the
instrument and its wells shall be cleaned completely and the sterilization shall be
conducted with UV-light.
Please refer to Chapter 2 Installation for locating the transport
abnormal sound or odor.
● The instrument falls or the shell is damaged;
● The instrument performance is obviously degraded.
During the disposal of infectious substance (such as human
body sample or reagent), if the skin may be touched, the protective
gloves or other protective measures are required.

AGS8830 Operations Manual
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j) Warning sign
3 Instrument maintenance
The wells and hot lid of the instrument should be periodically cleaned with
special brushes dipped with a little absolute alcohol to guarantee the complete
contact between the tubes and the wells and high thermal conductivity while free
from pollution.
Using soft fabric to do the daily maintenance for cleaning the surface and
wells. If there is any stain on the surface, you can wipe it with a dust-free cloth
with 75% alcohol. Do not use chlorine disinfectants, moisturizing or antibacterial
soaps, aromatic solutions, propanol or isopropanol to clean the equipment, since
this kind of cleaning agent or disinfectant is easy to have chemical reaction with
equipment parts or materials contained in the equipment and cause danger.
Only carry out the maintenance mentioned in this manual. Before using any
cleaning and disinfection method not described in this document, please contact
the technical support personnel of the Company or authorized agency to ensure
that the method used will not damage the instrument. If you have any questions
about the compatibility of disinfectants or cleaning agents with equipment parts or
materials contained in the equipment, please consult the Company or an
authorized agency.
Be sure that the power is off while the instrument is being
cleaned.
Never drip the cleaner into the hole when cleaning each well
of the module.
Never clean the instrument surface with corrosive cleaner.
In case of stains or leakage of dangerous substances on the surface or in the
wells of the instrument, it can be cleaned with soft cloth with cleaning cream or
wiped with 75% alcohol.
4 After-sales service
The specific warranty terms and period are shown in the warranty list.
2 parts of this instrument are pasted with "pay attention to high
temperature" sign. The metal parts (module, hot cover) near this
sign are strictly prohibited to touch by any part of the body during
the operation or within a period of time after the operation, so as
to avoid burns!

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After the packaging box of the instrument is opened, check
the instrument and its accessories immediately according
to its checklist. If any item is damaged or missing, please
contact the distributor or manufacture immediately.
Please conserve the packaging box and packaging
materials in a safe place after the packaging box is opened
for future maintenance. As for the damage to the
instrument incurred during any transportation to our
maintenance department, Hangzhou AnYu Technologies
Co., Ltd. shall never assume any responsibility.

AGS8830 Operation manual
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Contents
1. Overview............................................................................................................... - 1 -
1.1 Main applications and characteristics of the AGS8830-8, AGS8830-16
Real-Time PCR Detection System.....................................................................- 1 -
1.2 Model information and basic parameters and performance indicators........- 1 -
1.2.1 Model information.................................................................................... - 1 -
1.2.2 Basic parameters and specifications......................................................... - 2 -
1.3 Structure composition.................................................................................. - 2 -
1.4 Basic functions of the software....................................................................- 4 -
2. Installation............................................................................................................ - 5 -
2.1 Environmental requirement for the instrument............................................- 5 -
2.1.1 Transportation and storage conditions...................................................... - 5 -
2.1.2 Field and environmental requirements......................................................- 5 -
2.1.3 Requirements for the power supply.......................................................... - 6 -
2.2 Instrument installation................................................................................. - 6 -
3. Start-up................................................................................................................. - 7 -
3.1 Inspection before start-up............................................................................ - 7 -
3.2 Start-up interface..........................................................................................- 7 -
3.3 Introduction to the operation interfaces....................................................... - 8 -
3.3.1 Introduction of the main interface.............................................................- 8 -
3.3.2 Introduction to the parameters setting interface......................................- 10 -
3.3.3 Launch.....................................................................................................- 13 -
3.3.4 Analysis.................................................................................................. - 15 -
3.3.5 System setting......................................................................................... - 15 -
3.3.6 File Management.................................................................................... - 19 -
4. Running of detection program files.................................................................. - 21 -
4.1 Preparation of sample reagents.................................................................. - 21 -
4.2 Operational alarming................................................................................. - 22 -
5. Network security related description............................................................... - 25 -
6. Maintenance........................................................................................................- 27 -
6.1 Regular cleaning..................................................................................... - 27 -
6.2 Software upgrade.................................................................................... - 27 -
6.3 Analysis and handling of failure............................................................. - 27 -
8. Service life of the instrument.............................................................................- 32 -
9. Accessory list.......................................................................................................- 33 -
Appendix A – Wiring layout................................................................................. - 34 -

AGS8830 Operation manual
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1. Overview
1.1 Main applications and characteristics of the AGS8830-8,
AGS8830-16 Real-Time PCR Detection System
The product is based on fluorescent polymerase chain reaction (PCR) and is
used in conjunction with supporting nucleic acid detection reagents for the
quantitative and qualitative detection of nucleic acid samples (RNA/DNA) from
the human body, including pathogens and human gene projects.
Attentions: When the instrument is used in the clinical detection, the used
reagent must be in the period of validity and in line with the local laws and
regulations. Positive quality sample and negative quality sample and critical
positive quality sample should be tested in each experiment, when the quality
control sample results meet the requirement of quality control, the experiment is
efficient.
The instrument is characterized as follows:
Advanced semiconductor refrigeration technology is used to control the
temperature accurately;
7-inch LCD screen, user-friendly operation interface, simple operation;
With the power off protection function, continue to complete the
unfinished procedures after the resumption of power supply;
USB 2.0 interface supports U disk to store data;
Huge data storage, and can store more than 1000 files.
1.2 Model information and basic parameters and
performance indicators
1.2.1 Model information
Model:

AGS8830 Operation manual
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1.2.2 Basic parameters and specifications
Sample size
8×0.1ml/0.2ml centrifugal
tub (5-100μL), adapted
to 8 strip PCR tubes
16×0.1ml/0.2ml centrifugal
tube (5-100μL), adapted to 8
strip PCR tubes
Dynamic testing range
10-1010Copies
Fluorescence channel
F1：FAM、SYBR GreenⅠ etc.
F2：HEX、VIC、JOE etc.
F3: ROX、TEXAS RED etc.
F4: Cy5 etc.
Full plate detection time
＜3s
Temperature range
30-100℃
Uniformity
±0.2℃ (@55℃)
Precision of temperature
±0.1℃ (@55℃)
Heating rate（average）
≥3.1℃/s
Cooling rate（average）
≥2.7℃/s
Hot-lid temperature range
30-110℃
Repeatability of fluorescent
intensity detection
CV≤3%
Repeatability of sample
detection
CV≤3%
Sample linearity
Linear regression coefficient r ≥ 0.98
Fluorescent linearity
Linear regression coefficient r ≥ 0.99
Instrument communication
interface
USB2.0
Input power
100-240VAC 50/60Hz 220VA
Boundary dimension（mm）
300×260×180（L×W×H）
Net weight（Kg）
5.5
1.3 Structure composition
The instrument is mainly composed of control system, photoelectric system,
thermal cycle component, hot lid component, shell component and random
software. The structure is shown in the following figure:

AGS8830 Operation manual
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Hot lid component
Shell component
Thermal cycle
component
Photoelectric system
Control system

AGS8830 Operation manual
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1.4 Basic functions of the software
Program setting for the PCR and fluorescence detection.
Real-time display of detection data.
After the current run is completed, the detection data can be analyzed
directly.
The software functions above are only used as the reference
and subject to change without notice.
USB interface
Power switch
Power socket
RS232 interface
Upgrade switch
Display screen
Wind outlet