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Domus 4/English
1. Introduction
This manual should be used for initial set up of the system and for reference purposes.
General Information
1.1.
The system is a high quality and affordable mattress system suitable for treatment
and prevention of pressure ulcers. The system has been tested and successfully
approved to the following standards:
IEC/EN 60601-1
IEC/EN 60601-1-2
IEC/EN 61000-3-2 Class A
IEC/EN 61000-3-3
CISPR 11 Group 1, Class B
E348970
53DG
The product has been tested with medical equipment and complies with ANSI/AAMI ES60601-1 &
CAN/CSA C22.2 No.601.1. standards preventing electric shock, fire and the risk of physical injury.
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical
devices to the EN 60601-1-2. These limits are 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 guarantee that
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 by one
or more of the following measures:
◼
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
device(s) are connected.
◼
Consult the manufacturer or field service technician for help.
Intended Use
1.2.
This product is intended to help and reduce the incidence of pressure ulcers while
optimizing patient comfort. It also provides following purposes:
◼
to help and reduce the incidence of pressure ulcers while optimizing patient comfort.
◼
for long term care patients suffering from pressure ulcers.
◼
for pain management as prescribed by a physician.
The product can only be operated by personnel who are qualified to perform general
nursing procedures and have received adequate training in knowledge of prevention
and treatment of pressure ulcer.
NOTE: Equipments are not suitable for use in the presence of
flammable anesthetic mixture with air or with oxygen or nitrous
oxide.
MEDICAL EQUIPMENT- AIR PUMP
WITH RESPECT TO ELECTRICAL SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI ES60601-1(2005, 3rd ed.)
AND CAN/CSA C22.2 NO.60601-1(2008, 3rd ed.)
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