General Information; Intended Use - Apex Sedens 500 Instructions D'utilisation

Sedens500/English
1. INTRODUCTION
This manual should be used for initial set up of the system and for reference purposes.

1.1 General Information

The device is a high quality, affordable pressure relief seat cushion system for wheelchair
users. It helps to decrease the concentrated pressure, distribute the pressure over the entire
contact interface and stimulate capillary blood flow for the 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
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 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.
NOTE: Equipments are not suitable for use in the presence of flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
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