Regulatory Information
10-4 Safety Standards & Specifications
• EN 60601-2-49: 2001, Medical electrical equipment - Part 2-49: Particular
requirements for the safety of multifunction patient monitoring
equipment
IEC 60601-2-49: 2001
• EN 60601-2-49: 2011 Medical electrical equipment - Part 2-49: Particular
requirements for the safety of multifunction patient monitoring
equipment
IEC 60602-2-49: 2011
• EN ISO 10993-1:2009 (for leadwires and pouch), Biological evaluation of
medical devices - Part 1: Evaluation and testing within a risk management
process
• EN 62304:2006, Medical device software - Software life-cycle processes
IEC 62304:2006
• EN 62366:2008, Medical devices - Application of usability engineering to
medical devices
IEC 62366:2007
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.
To Next Page
Loading...
Need help?
General
