LEVITAS DOMUS 3 Series, Instruction Manual

Page: 20 / 36

20
ENGLISH
2. The devices in question ARE NOT MEASUREMENT DEVICES
3. The devices in question ARE NOT INTENDED FOR CLINICAL INVESTIGATION
4. The devices in question are sold in NON STERILE packing
5. The devices in question should be considered as belonging to class I
6. DO NOT use/install the devices in question for any other purpose than that expressly
indicated by Moretti S.p.A.
7. Moretti S.p.A. maintains and submits the documentation certifying conformity with
Directive 93/42/EEC to the proper authorities and further modifications
8. The devices mentioned are manufactured using materials in accordance with
Directive 2011/65/UE – ROHS2
5. STANDARDS
The system has been tested and successfully approved to the following standards:
EN 60601-1
EN 60601-1-2
EN 55011 Class B
EN 61000-3-2 Class A
EN 61000-3-3
6. GENERAL WARNINGS
• For proper use of the device, refer to the following manual carefully
• Advise with physician or therapist to determinate the correct adjustment and the correct
use of the device
• Keep the packed kit away from heat sources
• SERVICE LIFE- the device use limit is defined by the wear of the parts
• DO NOT allow children to play on or operate the pump
6.1 Electromagnetic compatibility warnings
This equipment has been tested and it complies with medical devices limits belonging to EN
60601-1-2:2007. These limits have been designed to provide reasonable protection against
harmful interference in a typical medical installation. This equipment generates, uses and
can radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to other devices in the vicinity. However,
there is no guaranteed that the interference will not occur in a particular installation. If this
equipment does cause harmful interference to other devices, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference
following one or more of the suggestions below:
• Reorient or relocate the receiving device
• Increase the separation between the equipment
• Connect the equipment into an outlet on a circuit different from that to which the other
devices are connected
• Consult the manufacturer or field service technician for help