Certifications - B.O.L.T BT4 User Manual

B.O.L.T User Manual
This graph shows plots of the error (SpO2 – SaO2) by SaO2 using the pulse oximeter (VA01-2)
with a linear regression fit and upper 95% and lower 95% limits of agreement. Each sample
data point is identified by subject from a clinical study in non-motion conditions.

20. Certifications

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.
This device complies with the following normative documents:
 IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance.

EN 60601-1-2:2015 Medical electrical equipment. General requirements for basic
safety and essential performance. Collateral Standard. Electromagnetic disturbances.
Requirements and tests.
 IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard:
Usability.

IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements
for basic safety and essential performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical systems used in the home
healthcare environment.

IEC 80601-2-30:2009/AMD1:2013
requirements for the basic safety and essential performance of automated non-
invasive sphygmomanometers.
 ISO 80601-2-61:2011 for use with IEC 60601-1:2005, COR1:2005, COR2:2007 Medical
electrical equipment. Particular requirements for basic safety and essential
performance of pulse oximeter equipment.
 ISO 80601-2-56:2009 Medical electrical equipment -- Part 2-56: Particular
requirements for basic safety and essential performance of clinical thermometers for
body temperature measurement.
 ASTM E1965 − 98 (Reapproved 2016) Standard Specification for Infrared
Thermometers for Intermittent Determination of Patient Temperature.
 EN 301489-1:V2.2.0:2017 Electro Magnetic Compatibility (EMC) standard for radio
equipment and services; - Part 1: Common technical requirements; Harmonised
Standard covering the essential requirements of article 3.1(b) of Directive
2014/53/EU and the essential requirements of article 6 of Directive 2014/30/EU.
 EN 301489-1:V3.2.0:2017 Electro Magnetic Compatibility (EMC) standard for radio
equipment and services; Part 17: Specific conditions for Broadband Data Transmission
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Medical electrical equipment. Particular
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