Prevena Plus™ 125 Therapy Unit Electromagnetic Compatibility - Acelity KCI PREVENA PLUS Mode D'emploi

PREVENA PLUS™ 125 THERAPY UNIT ELECTROMAGNETIC
COMPATIBILITY
The following are guidance and manufacturer's declarations regarding EMC for the PREVENA PLUS™
125 Therapy Unit.
•
The PREVENA PLUS™ 125 Therapy Unit needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the following pages.
WARNING: This equipment is intended for use by healthcare professionals only. As with all
electrical medical equipment, this equipment may cause radio interference or may disrupt
the operation of nearby equipment. It may be necessary to take mitigation measures
such as re-orienting or relocating the PREVENA PLUS™ 125 Therapy Unit or shielding the
location.
•
Portable and Mobile RF communications equipment, RFID readers, electronic article surveillance
(anti-theft) equipment and metal detectors can affect the performance of the PREVENA PLUS™
125 Therapy Unit. Please use the guidelines and recommendations specified in Tables 204 and
206.
•
Other medical equipment or systems can produce electromagnetic emissions and therefore can
interfere with the functionality of the PREVENA PLUS™ 125 Therapy Unit. Care should be used
when operating the PREVENA PLUS™ 125 Therapy Unit adjacent to or stacked with other equip-
ment. If adjacent or stacked use is necessary, the PREVENA PLUS™ 125 Therapy Unit and the other
equipment should initially be observed to verify normal operation in the configuration in which
it will be used.
• The electrical cables, external power supplies and accessories listed or referenced in this manual
have been shown to comply with the test requirements listed in the following tables. Care should
be taken to use only manufacturer-recommended cables, power supplies and accessories with
the PREVENA PLUS™ 125 Therapy Unit. If a third-party supplier offers cables, external power
supplies and electrical accessories for use with the PREVENA PLUS™ 125 Therapy Unit and they
are not listed or referenced in this manual, it is the responsibility of that third-party supplier to
determine compliance with the standards and tests in the following tables.
• The use of electrical cables and accessories other than those specified in this manual or refer-
enced documents may result in increased electromagnetic emissions from the PREVENA PLUS™
125 Therapy Unit or decreased electromagnetic immunity of the PREVENA PLUS™ 125 Therapy
Unit.
•
Portable and mobile RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the
PREVENA PLUS™ 125 Therapy Unit including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result. More precisely, the minimum
recommended separation distance should be calculated from the equation applicable to the
frequency of the transmitter, as noted in the guidance below.
• NOTE: This equipment has been tested and found to comply with the limits for medical devices
to IEC 60601-1-2: 2014 4th edition. These limits and test levels are intended to provide reasonable
safety with regard to electromagnetic disturbances when the device is used in a typical medical
installation.
32