Technical Description - GCE MediVital E Bedienungsanleitung

9.5. ENVIRONMENT
There are not any know risks related to disposing the of Medivital®E device at the end of its
lifetime. The battery and electronics must be disposed of in a special recycling centre. Other
components may be disposed of in a standard way.

10. TECHNICAL DESCRIPTION

THE DEVICE MEDIVITAL®E COMPILES WITH THE FOLLOWING ELECTRICAL STANDARDS
Electric safety:
Electromagnetic compatibility:
Medical devices used in the home care conditions:
Degrees of protection:
10.1. EMC CONDITIONS
The Medivital®E combination valve is adequate for use in homes, hospital and ambulance care,
etc. Avoid use near devices with high intensity of electromagnetic disturbance, such as magnetic
resonance, VF surgical tools, etc. The device does not included any wires or transmitters which
would lead to an increase of EM emissions or decrease EM resistance of the device.
Essential performance of the device may be worsened by the electromagnetic disturbance.
Medical electrical devices require special safety measures concerning electromagnetic
compatibility and it is necessary to install them and put them into operation according to the
information on electromagnetic compatibility stated in this document.
Portable and mobile radio frequency communication equipment may negatively affect
medical devices.
Medivital®E may be interfered by other equipment, even though they meet the conditions for
radiation according to the CISPR requirements.
Medivital®E should not be used in vicinity to other equipment or placed on that equipment. If it
cannot be avoided, the valve with E-GAUGE should be tested in normal operation composed
in configuration as it will be used.
It should be avoided to use Medivital®E next to or in a block with other devices because
it could cause incorrect operation. If such use is necessary, Medivital®E and other devices
should be observed to prove that they function normally.
The E-GAUGE ensures indication only and is not intended for assurance of monitoring or
alarm functions in the context of permanently sustainable lifetime. The monitoring functions
may fail, without this failure being connected with an unacceptable risk, and therefore this
equipment does not state any technical parameters whose maintaining in a failure condition
is requested.
Transportable RF communication device (including end devices such as antenna cables
and external antenna) should not be used closer than 30 cm from any part of Medivital®E.
Otherwise it could lead to worsening the functionality of such device.
EN60601-1:2006 as amended
EN60601-1-2:2015 as amended
EN60601-1-11:2015 as amended
EN 60529 2015 as amended, IP55
25/108
EN