AMERICAN MEGATRENDS INDIA PRIVATE LIMITED AMI-BU-2 User Manual
B.O.L.T User Manual
Model No: VA06
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© Copyright 2015, All Rights Reserved. American Megatrends India Private Ltd.
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.
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