General Information; Intended Use - Apex Digital DOMUS 2+ User Manual

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1. INTRODUCTION
English
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 and affordable mattress system suitable for treatment and
prevention of pressure ulcers.
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
EN60601-1-2:2007. 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:

to help and reduce the incidence of pressure ulcers while optimizing patient comfort.

for long term home care of patients suffering from pressure ulcers.

for pain management as prescribed by a physician.
The product can only be operated by personnels who are qualified to perform general nursing
procedures and has received adequate training in knowledge of prevention and treatment of
pressure ulcer.
EN 60601-1
EN 55011 Class B
EN 61000-3-3
IEC 61000-4-3
IEC 61000-4-5
IEC 61000-4-8
NOTE - Equipment not suitable for use in the presence of flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
EN 60601-1-2
EN 61000-3-2 Class A
IEC 61000-4-2
IEC 61000-4-4
IEC 61000-4-6
IEC 61000-4-11
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