Acelity KCI PREVENA Plus 125 Guia página 7

PREVENA PLUS™ 125 Therapy Unit
Explanation of Symbols Used
Do not use if package is damaged or open
IP22
Ingress Protection
Type BF applied part
Sterile using radiation
Date of Manufacture
Manufacturer
Fragile
Keep Dry
Content Information
Class II Device
Temperature Limits
MR Unsafe
No Bathing or Showering
CAUTION: Federal (US) law restricts this
Rx only
device to sale by or on the order of a
physician.
Consult Instructions for Use
Refer to Clinician Guide
Single Use Only
Authorized Representative in the
European Community
Tripping Hazard
Use By
Catalog Number
Lot Number
2
Do Not Resterilize
STERILE
This product is designated for separate
collection at an appropriate collection
point. Do not dispose of as household
waste.
Contains Phthalates
(SENSAT.R.A.C.™ Pad Tubing)
Electrical Safety/Electromagnetic Compatibility Information
Electrical Safety
• Do not operate this product if it has a damaged power cord, power supply or plug. If these
components are worn or damaged, contact KCI.
• The PREVENA PLUS™ Incision Management System is classified as a Type BF applied part
under IEC 60601-1.
• It provides IP22-Protection level against ingress of solid foreign objects and liquids.
• All alerts are classified as low priority according to IEC 60601-1.
• Conforms to: IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-1-8.
Electromagnetic Compatibility
The PREVENA PLUS™ 125 Therapy Unit needs special precautions regarding EMC.
WARNING: As with all electrical medical equipment, the therapy unit 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 including cell phones and similar
devices, RFID readers, electronic article surveillance (anti-theft) equipment and metal
detectors can affect the performance of the PREVENA PLUS™ 125 Therapy Unit.
• 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 equipment. 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 cable, external power supply and accessories provided by the manufacturer
have been shown to comply with the test requirements. Use only the manufacturer-supplied
electrical cable, power supply and accessories with 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 power cord and power
supply provided by the manufacturer. Otherwise, degredation of the performance of this
equipment could result.
• 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.
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