User's Manual

“More than just Digital” Page 70 of 81
Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM
Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1)
Annex . 5 Regulatory Information
1. Medical equipment safety standards
 Medical Equipment Classification
Type of protection against electrical shock
Class Ⅰ equipment
Internally Powered
Degree of protection against electrical shock Type B applied parts
Degree of protection against ingress of water IPXO
Mode of operation Continuous operation
Flammable anesthetics
NOT suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous
oxide
 Product Safety Standards
 U.S.A and Canada
IEC 60601-1(ed.2 am1+am2+ co1) Medical electrical equipment-Part1: General requirements for
safety
UL 60601-1(ed.1)
CSA-C22.2 No. 601-1-M90(R2006) (R2006) Medical electrical equipment –Part1: General re-
quirements for safety (adopted amendment 2:1995 to IEC
601-1:1990)
IEC 60601-1-2: 2007(ed.3) Medical electrical equipment-Part 1-2: Collateral standard:
Electromagnetic compatibility
IEC 62304:2006-Ed.1.0 Medical device software-software life cycle processes
EN ISO 14971:2012 Medical Device-Application of risk management to medical
devices