Users Manual Part 2

Wireless Digital Wireless Digital Flat Panel Detector Mars1417X
62 User
Manual of Mars1417X
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/AMD1:2012
Medical electrical equipment -- Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-2:2014/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
IEC 60601-2-54:2015/EN 60601-2-54:2015
Medical electrical equipment -- Part 2-54:
Particular requirements for the basic safety and
essential performance of X ray equipment for
radiography and radioscopy
IEC 62133-2:2017
Secondary cells and batteries containing alkaline
or other non-acid electrolytes - Safety requirements
for portable sealed secondary lithium cells, and for
batteries made from them, for use in portable
applications - Part 2: Lithium systems
ANSI/AAMI ES60601-
1:2005/(R)2012+A1:2012+C1:2009/(R)2012+A2:20
10/(R)2012
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD)
CAN/CSA-C22.2No.60601-1:14
Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance