User's Manual

Regulatory Information
15-2 Safety Standards & Specifications
Regulatory Information
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
CISPR-11.
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.
Safety Standards
The device complies with the following safety requirements for medical
electrical equipment:
 EN 60601-1:1990 + A1:1993 + A2:1995 +A11:1993 +A12:1993 + A13:1996
General Requirements for Safety (with worldwide deviations, including
U.S. deviations)
 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 Commercial Batteries
 EN 60601-1-1:2006 System Requirements
 EN 60601-1-4:2000 Safety Requirements for Programmable Electronic
Medical Systems
 EN 50371:2005 Low Power Electronic and Electronic Apparatus
Electromagnetic Exposure
 EN ISO 9919:2005 Requirements for SpO2 Pulse Oximeters
 EN ISO 10993-1:2003 Biocompatibility
 EN ISO 10993-1:2003 Biocompatibility (for leadwires and pouch)
 EN ISO 9919:2005 Pulse Oximeters