AGS AGS8830-8 Manual
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AGS AGS8830-8 Manual

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

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Summary of Contents for AGS AGS8830-8

  • Page 1 1 Portable Real time PCR Instrument: AGS8830-8/AGS8830-16 PRESENTATION Portable Fast Real-time Fluerescence Quantitative PCR Instrument with Detection Kit for SARS-CoV-2 RNA...
  • Page 4 2 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...
  • Page 5 In Vitro Diagnostic (IVD) Medical Instrument Real-time PCR Detection System Operation Manual Hangzhou AnYu Technologies Co., Ltd.
  • Page 6 All right reserved, the information herein is subject to change without notice. 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.
  • Page 7 AGS8830 Operations Manual Important Notes Symbols The Operations Manual must be consulted in all cases where this symbol is marked. It must be consulted in all cases where symbol Caution marked, in order to find out the nature of the potential HAZARDS and any actions which have to be taken to avoid them.
  • Page 8 Protective The position with the symbol attached to the conductor terminal instrument indicates the grounding terminal. The AGS8830-8, AGS8830-16 Real-Time Detection System is comply with the requirements of CE technology symbol. The AGS8830-8, AGS8830-16 Real-Time...
  • Page 9 AGS8830 Operations Manual 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.
  • Page 10 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.
  • Page 11 AGS8830 Operations Manual 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.
  • Page 12 AGS8830 Operations Manual 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.
  • Page 13 AGS8830 Operations Manual 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.
  • Page 14 AGS8830 Operations Manual j) Warning sign 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! 3 Instrument maintenance...
  • Page 15 AGS8830 Operations Manual 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 ...

  • Page 16: Table Of Contents

    AGS8830 Operation manual 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............

  • Page 17: Overview

    AGS8830 Operation manual 1. Overview 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.

  • Page 18: Basic Parameters And Specifications

    AGS8830 Operation manual 1.2.2 Basic parameters and specifications Sample size 8×0.1ml/0.2ml centrifugal 16×0.1ml/0.2ml centrifugal tub (5-100μL), adapted tube (5-100μL), adapted to 8 to 8 strip PCR tubes strip PCR tubes Dynamic testing range 10-10 Copies F1：FAM、SYBR GreenⅠ etc. F2：HEX、VIC、JOE etc. Fluorescence channel F3: ROX、TEXAS RED etc.
  • Page 19 AGS8830 Operation manual Hot lid component Shell component Photoelectric system Thermal cycle component Control system -- 3 --...

  • Page 20: Basic Functions Of The Software

    AGS8830 Operation manual Display screen Wind outlet Power switch USB interface Power socket Upgrade switch RS232 interface 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.

  • Page 21: Installation

    AGS8830 Operation manual 2. Installation 2.1 Environmental requirement for the instrument 2.1.1 Transportation and storage conditions Storage conditions: Avoid splashing water and direct sunlight Operation ambient temperature: -20~55℃ Operation relative humidity: 10 - 85% , without condensation Violent vibration, collision, impact and drop are strictly forbidden in loading and unloading.

  • Page 22: Requirements For The Power Supply

    AGS8830 Operation manual 2.1.3 Requirements for the power supply Input power：24VDC 47-63Hz 9.2A The power socket shall be 3-pin and the reliable grounding shall be ensured. 2.2 Instrument installation The instrument shall be installed in line with 2.1.2 Field and ...

  • Page 23: Start-Up

    AGS8830 Operation manual 3. Start-up 3.1 Inspection before start-up The checklists below shall be confirmed before the power turns on: Inspect whether the power supply is in line with system requirements  (Refer to 2.1.3 Requirements for the power supply). Confirm that the power plug is inserted into power socket in correct ...

  • Page 24: Introduction To The Operation Interfaces

    AGS8830 Operation manual The “*.agi” file is used to store the data produced by the   software of AGS8830-8. The “*.agd” file is used to store the data produced by the  software of AGS8830-16. 3.3 Introduction to the operation interfaces 3.3.1 Introduction of the main interface...
  • Page 25 AGS8830 Operation manual DNA button Click "DNA" to enter the DNA detection project and quickly run the DNA detection program for detection. RNA button Click "RNA" to enter the RNA detection project and quickly run the RNA detection program for detection. Customize button Click "Custom"...

  • Page 26: Introduction To The Parameters Setting Interface

    AGS8830 Operation manual 3.3.2 Introduction to the parameters setting interface The parameters setting interface includes well display area, functional area and button bar. Well display area Functional area Button bar Well display area Well locations can be selected by clicking. Select all wells by clicking the in the front of the well position area.
  • Page 27 AGS8830 Operation manual +Cycle：To increase the cycle step, the max cycle is 99. Overlap or nesting between 2 cycles is not allowed. +Temp：to increase the temperature step. Delete： To delete the temperature or cycle steps. Speed：To set the ramp rate. Read: To set fluorescence collecting step.
  • Page 28 AGS8830 Operation manual Gain setting: Set the gains of the selected dye. Sample parameters setting: The option mainly includes: well location, sample ID, dye, testing item, sample type, concentration, experimental results and Ct value. ID consists of English characters and numbers up to 7 characters in length. The dye shows the selected dye.

  • Page 29: Launch

    AGS8830 Operation manual Regarding the adding of “Delete” button in the sample setting bar, the button is available when selected and not available in other status. Ct displays the post-analysis Ct value of specific channels. Functional button Functional button includes “New”, “Start”, “Open”, “Save”, “Clear”...
  • Page 30 AGS8830 Operation manual Click the curve option to run the program to collect fluorescence, the real-time fluorescence curve, running time, remaining time, module temperature and cycle times of the current experiment can be viewed, and the displayed dye and dye fluorescence color can be set. When the experimental results are available, you can check the experimental analysis results, fluorescence curve, and analyze the experimental results manually.

  • Page 31: Analysis

    AGS8830 Operation manual performed; if not, the analysis is not applicable; then the interface will be redirected to the sample interface. After abnormal power failure during operation, the system will prompt whether to continue the experiment after restart. 3.3.4 Analysis Analysis interface 1) Automatic analysis and manual analysis are mutually exclusive and only one can be selected at the same time.
  • Page 32 AGS8830 Operation manual Judgement standard Negative and positive judgement: based on Ct method and fluorescence method. Functional keys “Add”, “Delete”, “Confirm” and “Cancel”. Add: Single click “Add” to add another row below the present judgement standards; the key-in of testing items is English, numbers and characters applicable only.
  • Page 33 AGS8830 Operation manual “Confirm” to save the judgement standard added; single click “Cancel” not to save. Delete: To delete the selected judgement standard. Ct method: Ct range: 1-99. Fluorescence method: value:20-1200. About Click to activate about product dialogue for the display of instrument version and two options (APP upgrade and Firmware upgrade): To upgrade the software, you need to use a USB flash disk, and under the folder named 8830 and 8830 on the USB flash disk, a new folder named UPDATE...
  • Page 34 AGS8830 Operation manual Time setting Click to activate time setting dialogue for the value setting of year, month, day, hour, minute and second. Voice setting Click to activate key tone dialogue (same as above) for the setting of on and off mode (default as on). User setting Click to activate language setting dialogue (design different layouts) for the setting of English or Chinese (default as Chinese).

  • Page 35: File Management

    AGS8830 Operation manual 3.3.6 File Management Click “file” button on the main interface to enter the file management interface, which including DNA,RNA, Custom and Standard Curve. -- 19 --...
  • Page 36 AGS8830 Operation manual Open: To select the file (exclusive selection only) and click “Open” to  open the experiment file Delete: To select the file (multiple/exclusive/all selection) and click  “Delete” to activate the deletion dialogue; by clicking “confirm” to delete.

  • Page 37: Running Of Detection Program Files

    AGS8830 Operation manual 4. Running of detection program files 4.1 Preparation of sample reagents 4.1.1 Basic requirements for the detection of reagent samples Reagent preparation ------Real-time PCR detection system applies  transparent centrifugal tubes of 0.2ml, and the liquid adding should be proper within 5-100μl according to requirements of specific reagents.

  • Page 38: Operational Alarming

    AGS8830 Operation manual Transparent 8-strip 0.2ml tubes are recommended.  4.2 Operational alarming Module sensors fails.  Module sensors Short-circuit fault.  Temperature control fails.  -- 22 --...
  • Page 39 AGS8830 Operation manual Temperature Acquisition Fault.  Open circuit fault of hot lid sensor.  Short Circuit Fault of Hot Cap Sensor.  -- 23 --...
  • Page 40 AGS8830 Operation manual Hot lid temperature control failure.  Excessive temperature of radiator.  -- 24 --...

  • Page 41: Network Security Related Description

    AGS8830 Operation manual 5. Network security related description 5.1 Network security type From the perspective of data security, the real-time PCR detection system control software is only used to control the operation of the equipment and collect the original test data of the experiment, without the function of user management. However, the test data involves patient privacy information, so the data type of medical devices belongs to "health data".
  • Page 42 AGS8830 Operation manual 5.6 Application From the perspective of clinical application, the product is based on fluorescence polymerase chain reaction (PCR) and is used in conjunction with supporting nucleic acid detection reagents to conduct quantitative and qualitative detection of nucleic acid samples (RNA/DNA) from the human body in clinical practice, including pathogens and human gene projects.

  • Page 43: Maintenance

    AGS8830 Operation manual 6. Maintenance 6.1 Regular cleaning Clean the shell part on a regular basis with 75% medical alcohol; Do not drip the liquid into the instrument when cleaning; Use the accompanying brush dipped with absolute alcohol for the regular cleaning of module holes. 6.2 Software upgrade Upgrade of lower instrument should be performed by ...
  • Page 44 AGS8830 Operation manual manufacturer. Start-up failure when The power supply is Check the power supply and connected power switch is turned activate it. electricity. The actual temperature Module temperature display is abnormal sensor failure and Contact the distributor or  automatic instrument manufacturer.
  • Page 45 AGS8830 Operation manual Wells Fluorescence intensity Clear up the pollutants. or background of each polluted. well Check the suitability of gains Gains set too high and Without tubes differs and automatic gains signals saturated. greatly. recommended. Check the quality of the consumables.
  • Page 46 AGS8830 Operation manual The instrument complies with the emission and immunity requirements specified in IEC 61326-1：2012 Form 1: Electromagnetic emission Emission test Conformity IEC/CISPR 11: 2010 RF Emission Group 1 IEC/CISPR 11: 2010 RF Emission Category A 61000-3-2:2009 Harmonic Not Applicable emission 61000-3-3:2013 Voltage...
  • Page 47 AGS8830 Operation manual Electrical Fast Transien Power IEC 61000-4-4 t (EFT) line:±1kV(5/50ns,5kHz) Line-to-earth: ±2kV Surge IEC 61000-4-5 Line-to-line: ±1kV Power line: 3V/m， Radio frequency IEC 61000-4-6 150kHz～80MHz， conduction 80%AM Power frequency IEC 61000-4-8 3A/m，50Hz magnetic fields 1 Cycle 0%； 5 Cycles 40%； DIPS/Interrupts IEC 61000-4-11 25 Cycles 70%；...

  • Page 48: Service Life Of The Instrument

    AGS8830 Operation manual 8. Service life of the instrument Production date of the instrument Please refer to the nameplate on the back of the instrument for the date of production. Service lift of the instrument The normal use of this product is valid for 5 years. The service life of the product is determined according to the fatigue test method.

  • Page 49: Accessory List

    AGS8830 Operation manual 9. Accessory list Item Name Unit Quantity Mainframe Power adapter piece Electric wires piece Document with the device -- 33 --...

  • Page 50: Appendix A - Wiring Layout

    AGS8830 Operation manual Appendix A – Wiring layout 125℃ 温度保险丝 恒温加热片 U2(PCB5) LED组件 热 盖 加 温 LED1_A LED1_K PCB4 LED2_A AG5.084Z.9804_PD2 AF250-0.2-160mm LED2_K 红 SWITCH1 J3-1_+24V R13-87 J3-2_NC DC插座 黑 J3-3_0V +12V 18AWG-1-?mm 红 PCB2 PCB3 RVVP-2-0.2-180mm AG9.084Z.9802_HXB J1-1_3.3VGND AG9.084Z.9803_PD1 AF250-0.5-200mm J1-2_PGA_A0...
  • Page 51 Hangzhou AnYu Technologies Co., Ltd. ================================================ Hangzhou AnYu Technologies Co., Ltd. Room 607, 6th Floor, Building 2, No. 1216 Da Nonggang Road Jianggan District, Hangzhou, Zhejiang, China Hotline: 400-030-1573 Fax: 0571-86483881 Zip Code: 310021 E-mail: service@bioanyu.com Website: http://www.bioanyu.com...
  • Page 52 3 Portable Real time PCR Instrument: AGS8830-8/AGS8830-16 CE MARK Portable Fast Real-time Fluerescence Quantitative PCR Instrument with Detection Kit for SARS-CoV-2 RNA...

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Ags8830-16

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