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Idiomas disponibles
Idiomas disponibles
Contrindications and Warnings
• Contraindication: Sensitivity to silver.
• As with any prescription medical device, failure to carefully read and follow all instructions
and safety information prior to use may lead to improper product performance.
• Bleeding: With or without using the Prevena
patients are at risk of bleeding complications due to the operative procedure or
concomitant therapies and/or comorbidities. If bleeding develops suddenly or in large
amounts during therapy, leave Prevena
Therapy Unit and seek immediate emergency medical assistance.
• If you experience any of the following, you should call your treating physician right away
as your incision may have become infected: you become feverish and/or there is an
increase in soreness, redness, swelling, itching, warmth, or if there is pus or a bad odor.
Your physician will advise you as to whether Prevena
• Magnetic Resonance Imaging (MRI): Do not take the Prevena
MR environment. The Prevena
Incision Dressing can typically remain with minimal risk in
™
an MR environment.
• Hyperbaric Oxygen Therapy (HBO): Do not take the Prevena
Prevena
Incision Dressing into the hyperbaric oxygen chamber, it is not designed for this
™
environment and should be considered a fire hazard.
• If defibrillation is required in the area of Prevena
dressing should be removed before defibrillation, follow clinician's instructions.
• If at any time while using Prevena
full of fluid other than blood, indicated by a "Maximum Capacity" alert or visual
inspection, turn therapy unit off and contact the treating physician.
• The Prevena
Incision Dressing has an acrylic adhesive coating and a skin interface
™
layer with silver, which may present a risk of an adverse reaction in patients who are
allergic or hypersensitive to acrylic adhesives or silver. If a patient has a known allergy
or hypersensitivity to these materials, do not use the Prevena
System. If any signs of allergic reaction, irritation or hypersensitivity develop, such as
redness, swelling, rash, urticaria, or significant pruritus, patient should consult a physician
immediately. If bronchospasm or more serious signs of allergic reaction appear, the
patient should turn off the Prevena
medical asistance.
Contact Information
For additional information concerning the Prevena
your local KCI representative, visit www.kci1.com or call 1-800-275-4524.
™
Incision Management System, certain
Incision Dressing in place, turn off Prevena
™
™
Therapy should be discontinued.
125 Therapy Unit into the
™
125 Therapy Unit or
™
™
Incision Dressing placement, the
Incision Management System, the canister becomes
™
Incision Management
™
Therapy Unit and seek immediate emergency
™
Incision Management System, contact
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Conforms with the Medical Device
Directive (93/42/EEC) and has been
subject to the conformity procedures
laid down in the council directive
Consult Instructions for Use
™
Sterile using Radiation
Class II Device
Single Use Only
Latex Free
Latex
Expiration
Date
Non Sterile
Environmental Conditions:
Storage Conditions:
Temperature Range:
-4ºF (-20ºC) to 140ºF (60ºC)
Relative Humidity Range: 0-95%, non-condensing
Equipment not suitable for use in presence of flammable anesthetic mixture with air, oxygen or nitrous oxide.
IPX4 - Ingress Protection Level
Electromagnetic Compatibility:
Electromagnetic Interference - Although this equipment conforms with the intent of the directive 89/336/EEC in relation to
Electromagnetic Compatibility (EMC), all electrical equipment may produce interference. If interference is suspected, move
equipment away from sensitive devices or contact the manufacturer.
KCI USA, Inc.
San Antonio, TX
78219 USA
Prevena
and KCI are trademarks of KCI Licensing, Inc. © 2011 KCI Licensing, Inc.
™
Symbols Used
This product is designated for separate
collection at an appropriate collection
point. Do not dispose of as household
waste.
ETL Listed, Conforms to UL Std.
60601-1 certified to CAN/CSA
CM
C22.2 Std. No. 601.1.
3182664
Authorized Representative in the
European Community
Refer to
Clinician Guide
Do not
Resterilize
Type B Applied
Part
Keep Dry
Rx only
Federal (USA) law restricts this device to sale by or on the
order of a physician.
Specifications
Operating Conditions:
Temperature Range:
Altitude Range for
Optimum Performance: -50 to 8000 ft (-15.24 m to 2438 m)
Manufacturer Information
KCI Medical Products (UK) Ltd.
Wimborne, Dorset, BH21 7SH
United Kingdom
www.kci-medical.com
All rights reserved. 390152-WEB C 01/2011
Date of Manufacture
Manufacturer
Do not use if package
is damaged or open
Fragile
41ºF (5ºC) to 122ºF (50ºC)
®
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