Covvi - Technical Manual, EU

Partners in Prosthetics

Partners in Prosthetics

17.0 Symbols Used

18.0 EC Declaration of Conformity

EC Declaration of Conformity We, COVVI Ltd. , Direct House (Unit 4), Quayside Business Park, George Mann Road, Leeds, LS10 1DJ, United Kingdom declare under our sole responsibility that the product to which this declaration relates is in conformity with the following standard(s) or other normative document(s) and proves the conformity of the designated product with the provisions of the EC Directive(s): Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

• United States/FCC ID: A8TBM71S2 • Canada IC: 12246A-BM71S2 • Europe/CE • China/SRRC: CMIIT ID: 2016DJ5890

R 005-101150

Name

Type or Model

MSIP-CRM-mcp-BM71BLES1FC2

COVVI Hand

CVXXXQXXXXXXXX(+00001)

CCAN16LP0011T7

Standards Applied • BS EN 60601-1-2 2015 - Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests • BS EN 60601-1 2006+A12 2014 - Medical Electrical Equipment Part1 • BS EN 50419 2006 - Marking of electrical and electronic equipment in accordance with Article 11(2) of directive 2002-96-EC (WEEE) • BS EN ISO 15223-1 2016- Medical Devices - symbols • BS EN ISO 14971 2012 - Medical Devices - Application of Risk Management to medical devices • EN 300328 v2.1.1 (2016 11) Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band • Directive 2014/53/EU Radio Equipment Directive

注意 ! 依據 低功率電波輻射性電機管理辦法 第十二條 經型式認證合格之低功率射頻電機, 非經許可, 公司、商號或使用者均不得擅自變更頻率、加大 功率或變更原設計 之特性及功能。 第十四條 低功率射頻電機之使用不得影響飛航安 全及干擾合法通信; 經發現有干擾現象時,應立即停用,並改善至無 干擾時方得繼續使用。 前項合法通信,指依電信規定作業之無線電信。 低功率射頻電機須忍受合法通信或工業、科學及

醫療用電波輻射性 電機設備之干擾。

Conformity Assessment Procedure: Device Classification Annex I (Annex IX rule 12) VII

Edward Varley, Chief Technical Officer November 8th 2019

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 | Page 52

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 | Page 53

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