Specifications; Electromagnetic Compatibility - Acelity Prevena Incision Management System Application Instructions

Specifications

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™ Therapy System is classified as a Type BF applied part under IEC 60601-1:2005 (3rd
Edition).
IP24 - Protection against solid objects greater than 12.5 mm and against liquid water sprays for
short periods of time.
All alerts are classified as low priority according to IEC 60601-1-8:2006.

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.
Portable and mobile RF communications equipment can affect medical electrical equipment.
Medical electrical equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information in the following tables.
The following tables document compliance levels and guidance from the IEC 60601-1-2:2007
Standard, for the electromagnetic environment in which the Prevena™ 125 Therapy Unit
should be used. The Prevena™ 125 Therapy Unit also meets the standard for electromagnetic
compatibility related to use in the home care environment (IEC 60601-1-11:2010).
Guidance and manufacturer's declaration - electromagnetic emissions
The Prevena™ 125 Therapy Unit is intended for use in the electromagnetic environment specified
below. The customer or user of the Prevena™ 125 Therapy Unit 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 Prevena™ 125 Therapy Unit uses RF energy only for internal
Group 1 function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
Class B
Not applicable
Not applicable
to 700 hpa (9878 ft / 3010 m)
Electromagnetic environment
Battery operated device
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