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1. Introduction
This manual should be used for initial set up of the system and for reference purposes.
1.1. General Information
The system is a high quality mattress system suitable for treatment and prevention of pressure
injury.
The system has been tested and successfully approved to the following standards:
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.
1.2. Intended Use
This product is intended to help and reduce the incidence of pressure injury while optimizing
patient comfort. It also provides following purposes:
for long term home care of patients suffering from pressure injury.
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 injury.
NOTE: Equipment is not suitable for use in the presence of flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
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
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