Otivio FLOWOX 2.0 Manual De Uso página 6

disconnected from the Control Unit ● Do not use with equipment not specified in the instruction manual, doing so could harm
the operator ● Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result
in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that
they are operating normally ● Portable RF communications equipment, such as mobile phones or other mobile devices
equipped with WIFI or Bluetooth, should not be used closer than 30 cm (12 inches) to any part of the Control Unit [4] or
External Power Supply [2] and its cables ● Use the system only with cables and other electrical accessories provided by the
manufacturer. Using other cables or accessories could result in increased electromagnetic emissions or decreased
electromagnetic immunity and result in improper operation ● Keep the FlowOx™ system away from children and pets ● Make
sure that the positioner is installed correctly inside the Pressure Chamber to avoid any pressure points on the foot ● Make
sure that there are no pressure points on the foot or leg from the Positioner, Seal, Padding, or Pressure Chamber ● Do not
try to run the Control Unit for more than 12 hours a day ● The clinician and patient should be trained before using FlowOx™
● The Pressure Chamber [1] is a single patient use device. Do not share the Pressure Chamber [1] with different patients since
this could lead to cross contamination ● Do not rest or push the non-treated leg on the Pressure Chamber [1] shell during
treatment. Doing so could cause damage to the skin surface on the area of the leg where it is resting ● Be sure that your foot
and leg are placed properly in the Pressure Chamber [1] without touching the Pressure Chamber [1] shell. Touching the inside
surface could cause a pressure point and result in tissue injury or disrupt wound dressings ● The inside of the Pressure
Chamber [1] needs to be visually inspected both prior to use and after for any contamination such as wound exudate, dirt
and fibres ● Clean the Pressure Chamber [1], Padding [17], Seal[20], and Positioner [16] according to section "Cleaning", if
visible contamination is present ● Check that the Hose with Filter [24] is visibly clean. Do not use the Pressure Chamber [1],
if the Hose with Filter [24] contains any blood or liquid, in this case discard the Pressure Chamber [1] and use a new one ●
Care should be taken when putting on and taking off the Pressure Chamber [1], so as not to disturb wound dressings ● Do
not use with uncovered wounds ● A non- shedding sock/tubular liner should be worn over all dressings and between the leg
and the Positioner [16] and Padding [17] contact areas ● Shedding socks should not be used as they potentially clog the
pneumatic circuits and reduce in service-life ● Do not attempt to modify the FlowOx™ Control Unit. It is not a serviceable
unit. When broken or malfunctioning, contact your clinician. Modifying the unit could harm the operator ● Remain seated.
Standing up or walking could lead to injury ● Use of FlowOx™ has been reported in patient studies to be relaxing and injury
may result if you are not adequately supported in case you fall asleep ● Do not attempt to lift FlowOx™ if you have reduced
strength. It could fall out of your hands and injure you or someone else ● Patients with a rapidly deteriorating condition
should not start using FlowOx™ ● FlowOx™ should be used in addition to standard of care in all cases ● System parts must be
verified before usage ● In case of system failure, contact the clinician ● USB should not be removed until device is correctly
powered off● Correct disposal of Control Unit shall be done as electrical equipment● Used Pressure Chambers should either
be cleaned with hypochlorite solution prior to disposal as non-hazardous domestic waste or be disposed of as hazardous
waste in a hospital or professional healthcare setting. Not doing so could risk spreading diseases to others● Visual inspection
of the Absorbgel Pouch [26] should be done prior to use to ensure that there is no rupture on it ● Discontinue use if any
conditions worsen during treatment. ● Patients with varicose veins which may be irritated or aggravated by contact with the
Pressure Chamber [1] should discontinue treatment.
Known clinical challenges: ● Patients with uncontrolled infection should not use FlowOx™ ● Several patients have reported
altered sensation in the toes ● Patients condition should be stable before treatment starts, as at least 8 weeks of treatment
time is usually necessary ● Reperfusion pain is experienced by some patients ● Increased exudate production may occur, and
a more frequent dressing change may be necessary. A highly absorbent super absorbent dressing may be necessary. ●
Increased bleeding from an ulcer has been reported ● Note: Should any of these issues occur, a clinician should be consulted.
Your clinician should determine whether a check-up is necessary. Monitor the progress and keep close contact with your
clinician to ensure that the condition does not get worse due to use of the FlowOx™
FLOWOX™ 2,0 Patient IFU (610-00013) Rev 9
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