295
31
31Installation and Specifications
Intended Use
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 in a hospital environment. The
MP5 and MP5T monitors are also intended for use during patient transport inside the hospital
environment; only the MP5 monitor for use during patient transport outside of the hospital
environment. The monitor is intended for use by health care professionals.
The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic
device.
Rx only: U.S. Federal Law restricts this device to sale by or on the order of a physician.
ST segment monitoring is intended for use with adult patients only and is not clinically validated for
use with neonatal and pediatric patients.
The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital
environment.
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).
The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients
receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV
measurement has been validated only for adult patients.
NOTE1 Hospital Environment
The monitor is suitable for use in all medically used rooms which fulfil the requirements regarding
electrical installation according to IEC60364-7-710 “Requirements for special installations or locations
- Medical locations”, or corresponding local regulations.
NOTE2 EMC Environment
The following measurements and system interfaces 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 321):
•ECG/Respiration, NBP, SpO
2
, Pressure, Temperature, CO
2
(only Mainstream Sensor M2501A and
Microstream CO
2
)
• LAN, Video Out, Battery, Nurse Call, RS232, and recorder interfaces
The monitor is indicated for use by health care professionals whenever there is a need for monitoring
the physiological parameters of patients.
To Next Page
Loading...
Need help?
General
