The electronic sphygmomanometers corresponds to the below
standards:
IEC 60601-1 Edition 3.1 2012-08 / EN 60601-1: 2006 / A1: 2013
(Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance),
IEC60601-1-2: 2014 / EN 60601-1-2: 2015
(Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral standard: Electro-
magnetic compatibility - Requirements and tests),
IEC 80601-2-30: 2009 + AMD1: 2013 / EN 80601-2-30: 2010 / A1: 2015
(Medical electrical equipment - Part 2-30: Particular requirements for
the basic safety and essential performance of automated non-inva-
sive sphygmomanometers),
EN 1060-1: 1995 + A2: 2009 (Non-invasive sphygmomanometers -
Part 1: General requirements),
EN 1060-3: 1997 + A2: 2009 (Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems),
ISO 81060-2: 2013 (Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type).
1. Product name: Blood pressure monitor
2. Model: PC-BMG 3018 (KD-738BR)
3. Classification: Internally powered, Type BF applied part, IP22 (1.
Safeguard against touching with a finger and penetration of for-
eign objects with Ø ≥ 12.5 mm; 2. Safeguard against falling drip
water when the casing is sloped at an angle of up to 15 °),
No AP or APG, Continuous operation
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PC-BMG 3018_IM_new
Specifications
08.07.19