User's Manual

Table Of Contents
24
273
24Specifications
The specifications in this section apply to the MP2 patient monitor.
Indications for Use
The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring
the physiological parameters of patients.
The monitor is intended to be used for monitoring and recording of, and to generate alarms, for,
multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use
by trained healthcare professionals in a hospital environment.
The monitor is also intended for use during patient transport inside and outside of the hospital
environment.
The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic
device. The monitor is for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed
morphology of complex cardiac complexes (according to AAMI EC 11).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for
use with neonatal and pediatric patients.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years)
patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.
Use Environment
Hospital Environment
The monitor is suitable for use in all medically used rooms which fulfill the requirements regarding
electrical installation according to IEC60364-7-710 "Requirements for special installations or locations
- Medical locations", or corresponding local regulations.
EMC Environment
All measurements (except the sidestream CO
2
measurement with M2741A sensor) and system
interfaces (except short range radio and wireless LAN) are, in addition, suitable for use in
establishments directly connected to the public low-voltage supply network that supplies buildings
used for domestic purposes (see table in “Electromagnetic Emissions” on page 300).
The monitor is indicated for use by health care professionals whenever there is a need for monitoring
the physiological parameters of patients.