Manamed PlasmaFlow - PlasmaFlow Labeling Information; Indications for Use; Contraindications; Warnings

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PlasmaFlow Labeling Information
Indications for Use
PlasmaFlow model PF0001 is intended to be an easy-to-use portable system, prescribed by a physician, for use in the home
or in a clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating
muscle contractions). This device can be used to:
 s!IDINTHEPREVENTIONOF$64
 s%NHANCEBLOODCIRCULATION
 s$IMINISHPOSTOPERATIVEPAINANDSWELLING
 s2EDUCEWOUNDHEALINGTIME
 s!IDINTHETREATMENTANDHEALINGOFSTASISDERMATITISVENOUSSTASISULCERSARTERIALANDDIABETICLEGULCERS
chronic venous insufficiency and reduction of edema in the lower limbs.
 s
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Contraindications
PlasmaFlow must not be used to treat the following conditions:
 s0ERSONSWITHSUSPECTEDACTIVEORUNTREATEDDEEPVEINTHROMBOSISISCHEMICVASCULARDISEASESEVERE
arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis or an active infection.
 s/NALEGWHERETHECUFFSWOULDINTERFEREWITHTHEFOLLOWINGCONDITIONSVEINLIGATIONGANGRENEDERMATITIS
open wounds, a recent skin graft, massive edema or extreme deformity of the leg on patients.
 s/NPATIENTSWITHNEUROPATHY
 s/NEXTREMITIESTHATAREINSENSITIVETOPAIN
 s7HEREINCREASEDVENOUSORLYMPHATICRETURNISUNDESIRABLE
Warnings
Do not attempt to repair the device or open or remove covers. Do not remove the pump unit from the cuff. Do not
ATTEMPTTOMODIFYORCHANGETHEDEVICE.%6%2ATTEMPTANYSERVICEWHILETHEDEVICEISINUSE0LASMA&LOWISA-EDICAL
%LECTRICAL$EVICE4HEFOLLOWINGAREPRECAUTIONSSPECIFICTO-EDICAL%LECTRONIC$EVICES
 s$ONOTOPERATEINAWETENVIRONMENT
 s$ONOTIMMERSEINANYLIQUIDFORANYREASON&ORCLEANINGANDDISINFECTINGINSTRUCTIONSREFERTO
“Cleaning and Disinfecting” section.
 s$ONOTPLACETHEDEVICEINAUTOCLAVEFORANYREASON
 s.OTSUITABLEFORUSEINTHEPRESENCEOFAFLAMMABLEANESTHETICMIXTUREWITHAIRORWITHOXYGENORNITROUSOXIDE
 s)FEXPOSEDTOTEMPERATURESBELOWO&O#ALLOWTHEDEVICETOWARMUPTOROOMTEMPERATURE
 s$ONOTSUBJECTTHEDEVICETOEXTREMESHOCKSSUCHASDROPPINGTHEPUMP
 s0ORTABLEANDMOBILE2ADIO&REQUENCY#OMMUNICATION%QUIPMENTCANBAFFECTEDBY-EDICAL%LECTRICAL$EVICES
Cautions
4HEDEVICEISTOBESOLDBYORONTHEORDEROFTHEPHYSICIAN/PERATIONOFTHEDEVICECANBEDONEBYTHEPATIENT4HE0LASMA&LOW
CUFFSAREDESIGNEDFORSINGLEPATIENTUSE4HEDEVICEMUSTBE/.,9USEDFORITSINTENDEDUSEBYTHEPATIENTPRESCRIBED4HEDEVICE
must not be transferred to another patient. Stop using the device if swelling, skin irritation or any other unpleasant or painful
SENSATIONOCCURS#ONSULTYOURPHYSICIAN,OOSENCUFFSIMMEDIATELYIFPULSATIONORTHROBBINGOCCURSASTHECUFFSMAYBEWRAPPEDTOO
TIGHTLY0ATIENTSWITHDIABETESORVASCULARDISEASEREQUIREFREQUENTSKINASSESSMENT#ONSULTYOURPHYSICIAN0ATIENTSWHOUSE
WARMINGDEVICESINCOMBINATIONWITHCUFFSREQUIREFREQUENTASSESSMENTASSKINIRRITATIONMAYOCCUR#ONSULTYOURPHYSICIAN0ATIENTS
POSITIONEDINTHESUPINELITHOTOMYPOSITIONWITHORWITHOUTCUFFSFORANEXTENDEDPERIODOFTIMEREQUIRESPECIALATTENTIONTOAVOID
extremity compartment system. Consult your physician.