Electromagnetic Compatibility - KCI CelluTome Système de prélèvement de cellules épidermiques Manuel D'utilisation

ELECTROMAGNETIC COMPATIBILITY

Although this equipment conforms to the intent of the 2004/108/EC EMC Directive, all medical equipment
has the potential to cause electromagnetic interference or be susceptible to electromagnetic interference.
The following are guidance and manufacturer's declarations regarding EMC for the CelluTome™ Epidermal
Harvesting System.
•
The CelluTome™ Epidermal Harvesting System 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 CelluTome™ Epidermal Harvesting System 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 CelluTome™
Epidermal Harvesting System. Please use the guidelines and recommendations in the following
pages.
•
Other medical equipment or systems can produce electromagnetic emissions and therefore can
interfere with the functionality of the CelluTome™ Epidermal Harvesting System. Care should be
used when operating the CelluTome™ Epidermal Harvesting System adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the CelluTome™ Epidermal Harvesting
System 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
CelluTome™ Epidermal Harvesting System. If a third-party supplier offers cables, external power
supplies and electrical accessories for use with the CelluTome™ Epidermal Harvesting System and
they are not listed or eferenced 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 referenced
documents may result in increased electromagnetic emissions from the CelluTome™ Epidermal
Harvesting System or decreased electromagnetic immunity of the CelluTome™ Epidermal
Harvesting System.
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The CelluTome™ Epidermal Harvesting System is intended for use in the electromagnetic environment
specified below. The customer or the end user of the CelluTome™ Epidermal Harvesting System should
assure that it is used in such an environment.
Emission Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Compliance
The CelluTome™ Epidermal Harvesting System uses RF
Group 1 energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Class A
The CelluTome™ Epidermal Harvesting System is
suitable for use in all establishments other than
Class A
domestic and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes.
Complies
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Electromagnetic environment - guidance