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-II-

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: 400-030-1573

Service fax: 0571-86483881

Zip code: 310021

E-mail: [email protected]

Website: http://www.bioanyu.com

Document No.

：

AG5.088Z.0000.SM1.Z

File version: 1

st

version1.1 September 21, 2020

All right reserved, the information herein is subject to change without notice.

Содержание AGS8830-16

Страница 1: ...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...

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Страница 4: ...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...

Страница 5: ...In Vitro Diagnostic IVD Medical Instrument Real time PCR Detection System Operation Manual Hangzhou AnYu Technologies Co Ltd...

Страница 6: ...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 Hangzh...

Страница 7: ...proper 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 Environmenta...

Страница 8: ...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 basi...

Страница 9: ...ipment 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 w...

Страница 10: ...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...

Страница 11: ...lug 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 instrume...

Страница 12: ...r 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 L...

Страница 13: ...5 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...

Страница 14: ...d 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...

Страница 15: ...maged 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 mainte...

Страница 16: ...s 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...

Страница 17: ...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...

Страница 18: ...eating 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 Line...

Страница 19: ...AGS8830 Operation manual 3 Hot lid component Shell component Thermal cycle component Photoelectric system Control system...

Страница 20: ...ion 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...

Страница 21: ...talled in a place with low humidity little dust and away from water sources such as a pool a water pipe etc the indoor ventilation shall be in desired condition and there is neither corrosive gas nor...

Страница 22: ...o keep the instrument stable Installation of the power cord The power cord an accessory to the instrument shall be used The power switch for the instrument shall be off during installation of the powe...

Страница 23: ...upply Confirm that the power plug is inserted into power socket in correct and reliable way Inspect whether working environment and location conditions of the instrument are in line with the requireme...

Страница 24: ...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 The mai...

Страница 25: ...n 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 to set the running parameters acco...

Страница 26: ...licking the in the front of the well position area Note The interface of 8 well position arrangement is shown in the figure below Functional Area You can edit experimental program parameters dyes samp...

Страница 27: ...t 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 Dye The dye setting includes the dye...

Страница 28: ...ion experimental results and Ct value ID consists of English characters and numbers up to 7 characters in length The dye shows the selected dye Testing item applies drop down list to select default te...

Страница 29: ...area Start To run the current file the hot lid temperature and gain settings need to be set before running and the uploaded data fluorescence data and temperature data after fitting need to be saved i...

Страница 30: ...ble you can check the experimental analysis results fluorescence curve and analyze the experimental results manually Click top left corner of the table can select all the wells or choose the certain w...

Страница 31: ...te manual analysis and select analysis algorithm algorithm provided and display of post analysis curves and results Channel Select the dye to be viewed analyze only the current selected dye display th...

Страница 32: ...al 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 Double...

Страница 33: ...DATE is also created and the upgrade software of the APP xxx tar you need to upgrade is put into this directory and the USB flash disk is inserted into the instrument Click APP Upgrade and Yes to star...

Страница 34: ...ing of year month day hour minute and second 4 Voice setting Click to activate key tone dialogue same as above for the setting of on and off mode default as on 5 User setting Click to activate languag...

Страница 35: ...AGS8830 Operation manual 19 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...

Страница 36: ...xclusive all selection and click Delete to activate the deletion dialogue by clicking confirm to delete Output To insert U drive and select the file multiple exclusive all selection by clicking Output...

Страница 37: ...l according to requirements of specific reagents Centrifugal processing Before inputting the instrument the tubes with prepared reagent samples should be centrifugally processed by the centrifuge so...

Страница 38: ...AGS8830 Operation manual 22 Transparent 8 strip 0 2ml tubes are recommended 4 2 Operational alarming Module sensors fails Module sensors Short circuit fault Temperature control fails...

Страница 39: ...AGS8830 Operation manual 23 Temperature Acquisition Fault Open circuit fault of hot lid sensor Short Circuit Fault of Hot Cap Sensor...

Страница 40: ...AGS8830 Operation manual 24 Hot lid temperature control failure Excessive temperature of radiator...

Страница 41: ...ped embedded control system software and there is no off the shelf software or safety software The hardware environment required for operation is a real time PCR detection system 5 3 Data and device i...

Страница 42: ...e and qualitative detection of nucleic acid samples RNA DNA from the human body in clinical practice including pathogens and human gene projects In terms of equipment maintenance this product is a pre...

Страница 43: ...avoid operational mistakes which may cause malfunctioning of the instrument 6 3 Analysis and handling of failure No Failure description Cause analysis Handling methods 1 During power on self test the...

Страница 44: ...anufacturer 5 Dramatic slow down of ramp up rate or inaccuracy of temperature control Vents blocked Clear up blockage of the vents Ceramic plate damaged Contact the distributor or manufacturer Air blo...

Страница 45: ...ompatible Checking the setting parameters of hot lid temperature and block temperature Make sure the hot lid temperature is higher than the block temperature 10 Inter channel signal crosstalk Objectiv...

Страница 46: ...IEC CISPR 11 2010 RF Emission Category A IEC 61000 3 2 2009 Harmonic emission Not Applicable IEC 61000 3 3 2013 Voltage fluctuation Not Applicable Form 2 Electromagnetic immunity Immunity test item St...

Страница 47: ...y magnetic fields IEC 61000 4 8 3A m 50Hz A DIPS Interrupts IEC 61000 4 11 1 Cycle 0 5 Cycles 40 25 Cycles 70 250 Cycles 5 B C C C Performance criteria A During the test the performance is normal with...

Страница 48: ...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 During the use the user shall maintain an...

Страница 49: ...AGS8830 Operation manual 33 9 Accessory list Item Name Unit Quantity Mainframe set 1 Power adapter piece 1 Electric wires piece 1 Document with the device set 1...

Страница 50: ...50 0 2 340mm USB 110 RVVP 2 0 2 180mm AF250 0 2 150mm RVVP 2 0 2 180mm AF250 0 2 160mm AF250 0 2 220mm AF250 0 2 160mm AF250 0 2 180 AF250 0 2 100mm AF250 0 2 110mm AF250 0 2 140mm 100mm SWITCH1 R13 8...

Страница 51: ...zhou 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 bio...

Страница 52: ...CE MARK Portable Fast Real time Fluerescence Quantitative PCR Instrument with Detection Kit for SARS CoV 2 RNA 3 Portable Real time PCR Instrument AGS8830 8 AGS8830 16...

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