User's Manual

6. Regulatory Information
User Manual of Mars1717X 77
6. Regulatory Information
6.1 Medical Equipment Safety Standards
Medical equipment classification
Protection type against electrical shock Class I equipment, using medically approved adaptor
supply
Internally powered equipment, using battery power
supply
Protection degree against electrical shock B Type
Protection degree against water
penetration
IP56 (Detector)
IP20 (Charger-Combo)
Mode of operation Continuous operation
Flammable anesthetics Not suitable for use in situation with flammable
anesthetic mixture with air, oxygen or nitrous oxide
Not suitable for use in oxygen-rich situation
The detector has two power supply modes (power adaptor and battery pack) and a single way for
signal transmission (wireless)
Safety standards reference
Wireless detector safety standards cover the detector, charger, battery pack and other accessories.
IEC 60601-1:2005+A1:2012
Medical electrical equipment -- Part 1: General
requirements for basic safety and essential performance
EN 60601-1: 2006+A1:2013 +A11:2011+A12:2014
Medical electrical equipment -- Part 1: General
requirements for basic safety and essential performance
CAN/CSA-C22.2No.60601-1:14
Medical electrical equipment Part 1: General
requirements for basic safety and essential performance
ANSI/AAMI ES60601-1:2005+A2 (R2012)+A1
C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated
Text) Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
(IEC 60601-1:2005, MOD)
KS C IEC 60601-1:2013;
Medical electrical equipment Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-2:2014
Medical electrical equipment Part 1-2: General
requirements for basic safety and essential performance
Collateral standard: Electromagnetic disturbances
Requirements and tests
EN60601-1-2:2015
Medical electrical equipment Part 1-2: General
requirements for basic safety and essential performance
Collateral standard: Electromagnetic disturbances
Requirements and tests
CAN/CSA-C22.2 No. 60601-1-2:16
Medical electrical equipment Part 1-2: General
requirements for basic safety and essential performance
Collateral standard: Electromagnetic disturbances