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Intended Use Statement; Indications For Use - Philips IntelliVue MX40 Instructions For Use Manual

Wearable patient monitor.
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EN ISO 9919:2005 Pulse Oximeters
IEC 60601-1-2:2001 Electromagnetic Compliance
IEC 60601-1-4:1999 +A1 Requirements for Programmable Electrical
Medical Systems
IEC 60601-1-6:2006 General requirements for basic safety and essential
performance - Collateral standard: Usability
IEC 60601-1-8:2006 General Requirements for Safety for Alarm Systems
IEC 60601-2-49:2001 Particular Requirements for Safety for Patient
Monitoring Equipment
IEC 60601-2-27:2005 Particular Requirements for Safety for
Electrocardiograph Monitoring Equipment
IEC 62133:2002 Safety Requirements for Portable Sealed Secondary Cells
(alkaline, lithium-ion)
AAMI EC 13:2007 Performance Standard, Cardiac Monitors
AAMI EC 53:1995 (R) 2001 ECG Cables/Leadwires (excluding 4.2.1)

Intended Use Statement

Intended for monitoring and recording of and to generate alarms for,
multiple physiological parameters of adults and pediatrics in a hospital
environment and during patient transport inside hospitals. Not intended
for home use. Intended for use by health care professionals.

Indications for Use

Indicated for use by health care professionals whenever there is a need for
monitoring the physiological parameters of patients. Intended for
monitoring and recording of, and to generate alarms for, multiple
physiological parameters of adults and pediatrics in hospital environments
and during transport inside hospitals.
Safety Standards & Specifications
13-3

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