Introduction; General Information - Drive Harmony 14200 Guide D'utilisation

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 Tri-Therapy mattress replacement system including alternating pressure,
pulsation and true low air loss. These therapies are intended for the prevention and
treatment of all stages of pressure injuries.
The system has been tested and successfully approved with the following standards:
EN 60601-1
EN 60601-1-2
EN 55011 Class B
IEC61000-3-2
IEC 61000-3-3
FOR US AND CANADA ONLY
The product was tested with medical equipment and meets AAMI STD. ES60601-1 &
CSASTD. C22.2 NO. 60601-1. preventing electric shock, fire and 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. Howev-
er, 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 inter-
ference by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation distances between the equipments.
• Connect the equipment into an outlet on a circuit different from that to which the
other device is connected.
• Consult the manufacturer or field service technician for help.
4