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PREVENA™ 125 Therapy System

Symbols Used

Refer to Clinician Guide
Do Not Resterilize
Date of Manufacture
Single Use Only
Consult Instructions for Use
Do not use if package is
damaged or open
Use By
Manufacturer
Lot Number
Temperature Limits
This product is designated for separate collection at an appropriate collection point.
Do not dispose of as household waste.
Rx Only
CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician.
Fragile
IP24
Ingress Protection
MR Unsafe
Type BF Applied Part
Keep Dry
Sterile Using Radiation
Authorized Representative in the
European Community
Content Information
Catalog Number
Specifications
Environmental and Storage Conditions
Temperature Range: ....................................................................................-4˚F (-20˚C) to 140˚F (60˚C)
Relative Humidity Range: ..........................................................................15%-95%, non-condensing
Operating Conditions
Temperature Range: .......................................................................................41˚F (5˚C) to 104˚F (40˚C)
Atmospheric Pressure Range: ................................................................ 1060 hpa (-1253 ft/-381.9 m)
(for optimum performance)
Equipment not suitable for use in presence of flammable anesthetic mixture with air, oxygen or
nitrous oxide.
The PREVENA™ 125 Therapy Unit is classified as a Type BF applied part under IEC 60601-1.
IP24 - Protection against solid objects greater than 12.5mm and against liquid water sprays for
short periods of time.
All alerts are classified as low priority according to IEC 60601-1-8.
Conforms to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11.
Disposal
The therapy unit and dressing should be removed by your doctor. Do not discard these items
with household trash. This could violate local laws regarding hazardous waste.
Electrical Equipment Interference
Cell phones or similar products could affect the therapy unit. Move the therapy unit away from
these devices if interference is suspected.
to 700 hpa (9878 ft/3010 m)
7