Declaration

Thank you for choosing our Microfluidic Fluorescence Immunoassy (FIA) panel disc Automated Analyzer. Please carefully read the contents of this manual before use.

This analyzer has a data storage function inside, and the company is free of responsibility for user losses caused by analyzer damage or data loss, which was caused by user operations.

Please do not disassemble or repair the analyzer without authorization, otherwise the post-sales service provided to you will be automatically terminated. Please use the reagents provided by our company, otherwise our company is free of responsibility for the wrong test results. The company has the right to change product design and specifications without prior notice. A slight difference between the picture and the actual product may occur due to the printing process of this manual, please refer to the actual product.

You need to ensure that the accessories expansion, re-commissioning or maintenance of the analyzer are carried out by the personnel approved by the company; the relevant electrical equipment conforms to the local standards; the operation is strictly followed to instruction described in this manual. Otherwise, the company is not responsible for the safety, reliability and performance of the device.

This manual is formed in accordance to the requirements of EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements, EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements, EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use, and point 20.1 of Annex I describe in Regulation EU 2017/746. This device meets the safety requirements specified in EN 61010-1:2010/A1:2019/AC:2019 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements, and EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment. This device also meets the electromagnetic compatibility requirements specified in EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements and EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment.

Analyzer Structure

This Microfluidic Fluorescence Immunoassy (FIA) panel disc Automated Analyzer consists of mainframe, power supply and random software (software release version number: DISKFLU.V1). The mainframe includes Photoelectric detection module (fluorescence), Scanning module, Data processing module, Information acquisition module, Reaction module, Incubation temperature control module, LCD module, Printer and the shell.

PRODUCT PARAMETER

ANALYSER INFORMATION
Principle	Microfluidic Immuno Fluorescence quantitative analysis	MODEL	DISKFLU
Storage	No less than 10,000 sample results	Maximum rotation frequency	6000rpm
Interface	USB, RS232, LAN, power supply	Repeatability	Coefficient of Variation (CV) ≤ 5%
Display	LCD	Linearity	Linear correlation coefficient (r) ≥ 0.99
Button	Capacitive touch screen	Stability	Relative deviation ≤±10％
Weight	3.7 Kg	Accuracy	Relative deviation ≤±10％
Voltage	100-240V～ 50/60Hz 1.5A Max	Temperature Accuracy and Temperature Fluctuation	The temperature deviation does not exceed ±2℃, and the temperature fluctuation does not exceed ±1℃
Size	300mm×200mm×230mm (Length × width × height)	Test Format	Cassette
Transport & Storage Temperature	-20℃～+55℃	Working Temperature	10℃～30℃
Relative humidity	≤85%	Service life	5 years
Use	IVD	Warranty	1 year
Certificate	CE/NMPA	Package	1 unit