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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 of the area of the leg resting or pushing on the Pressure Chamber
[1] ● 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, resulting in tissue injury or disturbance to wound dressings
● The inside of the Pressure Chamber [1] needs to be visually inspected both prior to and after use for any contamination
such as wound exudate, dirt, and fibres ● Clean the Pressure Chamber [1], Padding [17], Seal [20], and Positioner [16] in
accordance with 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-use life ● Do not attempt to modify the FlowOx™ Control Unit.
The Control Unit cannot be serviced. 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 should 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 the Control Unit is to dispose of it as electrical waste●
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 as per the National Waste
Guidelines. Not doing so could risk spreading diseases to others● Visual inspection of the Absorgel Pouch [26] should be done
prior to use to ensure that there is no rupture on it
CARE AND MAINTENANCE
Maintenance: The operator is not required to perform any preventive maintenance on the equipment. In the event of a fault,
please contact your clinician or your distributor.
Cleaning: The FlowOx™ device can be cleaned if needed with wipes moistened with water and/or alcohol impregnated wipes.
Note: Do not get the Control Unit [4] wet ● Do not use any abrasives or oxidizing agents such as detergents or hypochlorite
(bleach) if the FlowOx™ system is to be used for further treatment.
Recyclability: Used Pressure Chambers should be cleaned with hypochlorite solution prior to disposal as per the National
Waste Guidelines. Not doing so could risk spreading diseases to others ● Do not dispose of the Control Unit [4] with your
general waste. It contains a battery and other electronic components and must be disposed as electronic waste. When its
end-of-life is reached, contact Otivio or your authorized distributor ● The Pressure Chamber [1] is a disposable item and has
a lifetime of one year.
Replacement parts: Please contact your clinician or distributor if you need replacement parts., i.e., Padding (900-00024) [17],
Seal (900-00026) [20], 2x Absorgel Pouch (900-00025) [26], Refurbishment Kit (900-00028) containing 1x Padding [17] and 2x
Seal [20] and/or the Strap (900-00029) [23]. These spare parts/consumables are not covered by the MDR 2017/745
certification.
TROUBLE SHOOTING
If an error occurs, the Treatment Ongoing symbol [27] disappears from the Display [10], Error code is shown on the Multi
Screen [8] and a General Error symbol [35] or Air Leakage symbol [40] is shown. If an error code appears on the Multi Screen
[8], it should be documented, and the clinician or distributor informed as soon as possible. Error Codes:
610-00013 FLOWOX™ 2.0 Instructions for Use (IFU) Manual Rev 20
Date of Issue: 09 OCT 2024
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