Bolt VA08, User Manual

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B.O.L.T
User Manual
Model No: VA08
© Copyright 2016, All Rights Reserved. American Megatrends India Private Ltd. Page | 11
12.0 Certifications
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.
This device complies with the following normative documents:

EN ISO 10993-1:2009/AC: 2010 Biological evaluation of medical devices- Part1:
Evaluation and Testing with in a risk management process.

EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity

EN ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for
irritation and skin sensitization

EN ISO 80601-2-61:2011 Particular requirements for basic safety and essential
performance of pulse oximeter equipment

EN 80601-2-30:2010 Particular requirements for basic safety and essential
performance of automated non-invasive sphygmomanometers

EN 12470-5:2003 Clinical thermometers - Part 5: Performance of infra-red ear
thermometers

EN 60601-1:2012 General requirements for basic safety and essential performance

EN 60601-1-2-2007/AC: 2010 General requirements for safety -Collateral standard:
Electromagnetic compatibility.

EN 60601-1-6:2010 Collateral standard: Usability

IEC 60601-1-4:1996 General requirements for safety- Collateral standard:
Programmable electrical medical systems.