Software Hazard Prevention
Potential hazards arising from errors in the software program have been
identified. Mitigations applied to reduce the associated risk of such hazards
are included as part of the Risk Management, Clinical Evaluation, and
Verification and Validation phases of the product's development.
AC Power Source
The system is not intended for connection to the public mains as defined in
Industrie Canada Compliance (Canada)
This Class B ISM device complies with Canadian ICES-001.
Cet ISM de la classe B est conforme à la norme NMB-001 du Canada.
The device complies with the following safety requirements for medical
Safety Standards & Specifications
EN 60601-1:1990 + A1:1993 + A2:1995 +A11:1993 +A12:1993 + A13:1996
General Requirements for Safety (with worldwide deviations, including
CSA C22.2 #601.1:1992 Medical Electrical Equipment - General Safety
UL 60601-1 Medical Electrical Equipment - General Safety
UL 2054 Standards for Household and Commerical Batteries
EN 60601-1-1:2006 System Requirements
EN 60601-1-4:2000 Safety Requirements for Programmable Electronic
EN 50371:2005 Low Power Electronic and Electronic Apparatus
EN ISO 9919:2005 Requirements for SpO
EN ISO 10993-1:2003 Biocompatibility
EN ISO 10993-1:2003 Biocompatibility (for leadwires and pouch)