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Regulatory Information; Software Hazard Prevention; Ac Power Source; Industrie Canada Compliance (canada) - Philips IntelliVue MX40 Instructions For Use Manual

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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:
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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
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 Commerical 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 SpO
EN ISO 10993-1:2003 Biocompatibility
EN ISO 10993-1:2003 Biocompatibility (for leadwires and pouch)
Pulse Oximeters
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