Regulatory Information
Safety Standards & Specifications 15-3
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.
Intended Uses of MX40
The MX40 is to be used primarily as a traditional telemetry medical device.
It connects to the IntelliVue Information Center by way of a wireless
network. When the MX40 is connected the IntelliVue Information Center
the IntelliVue Information Center provides the primary patient monitoring
and alarming function. The MX40 does not automatically provide local
monitoring or alarming when connected to the Information Center.
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