Otivio FLOWOX 2.0 Mode D'emploi page 4

Clock Set symbol [12] is lit. Time is shown on the Multi Screen [8] after it is set. The Control Unit [4] shuts downs
automatically in 15 seconds. |f| Disconnect the USB Cable [11] at both ends.
Refer to the drawings from the cover page of this instruction manual. In all the following steps, the clinician should train the
patient. The clinician will assess whether the patient will need someone to help them with using FlowOx™. FlowOx™ is a
sophisticated medical device. It may take the patient several training sessions to become familiar enough to use the device
routinely.
(A) Preparing FlowOx™: (a) Insert the Positioner [16] into the Pressure Chamber [1] and align its grooves with the ridges on
the floor of the Pressure Chamber [1]. The Positioner [16] is adjustable forwards and backwards and for left or right foot
usage. The foot shall be placed on the Positioner, so the foot alignment matches the Left Foot symbol [57] or Right Foot
symbol [58]. (b) Insert the Padding [17] into the Pressure Chamber [1] so that the Fastening Band [18] is towards the
top. Start by pushing its two Air Vents [19] into the holes on the inside of the Pressure Chamber [1]. Attach the 5 holes
on the Fastening Band [18] of the Padding [17] to the 5 studs on the inside of Pressure Chamber neck. (c) Place the Seal
[20] around the top of the Pressure Chamber [1]. The Seal has a hole in the front section which should be placed on the
Stud [21] on the front top of the Pressure Chamber [1]. Note: The Seal Seam [22] should be on the outside (d) Place one
of the holes of the Strap [23] over the same stud that the Seal [20] is fastened to. Wrap the Strap [23] around the Seal
[20] edges and secure it by placing the other Strap [23] hole over the same Stud [21] (e) Connect the Hose with Filter
[24] to the Hose Connector [25] on the Control Unit [4]. Note: Ensure that the connection is tight. (f) Connect the External
Power Supply [2] to the Power Supply Port [3] on the Control Unit [4] and then to an electrical socket. Note: No other
power supply can be used.
(B) Fitting FlowOx™. (a) Check that the Pressure Chamber [1] fits the patient and is comfortable. Only the arch of the foot
should rest lightly on the top of the Positioner [16]. Note: The foot should not touch the bottom of the Pressure Chamber
[1]. The Positioner [16] is not a weight bearing support device. (b) The Seal [20] should be comfortable on the bare calf.
(c) Ask the patient to put their Pressure Chamber [1] on and take it off several times. Check that the patient can do this
without harming the skin or disrupting any wound dressings. Note: It is recommended that a non-shedding sock/tubular
bandage is used to cover any wound dressings and the areas of the leg which touch the Padding [17] and Positioner [16].
(d) If the test was OK, the patient can use the device alone as instructed in the section "Daily Use of FlowOx™". Note:
training should include: how to set up the device at home, put on and take off the Pressure Chamber [1], operating the
system, cleaning, and how to care for the device, adding time with Time Card [5], and discussion of hazards, e.g. tripping
and disposal of small parts.
(A) Putting on the Pressure Chamber [1]: Once the system has been assembled (see "Preparing FlowOx™ above), (a) Roll
down the Seal [20] over the Pressure Chamber [1] neck to allow the leg to be put into the opening. (b) While sitting on
a chair, insert the foot to be treated into the Pressure Chamber [1]. (c) Make sure that the Positioner [16] is correctly
placed for the foot to be treated as advised by clinician. (d) Roll the Seal [20] up over the leg and make sure it fits snugly
around the bare leg. Note: Physical contact should only occur between the patient's leg, the Positioner [16], the Padding
[17] and the Seal [20] and caution should be taken to avoid pressure points between the leg and the device.
(B) Treatment: (a) Place the leg into the Pressure Chamber [1] and press the On/Off Button [7] on the Control Unit [4] to
start the treatment. (b) Make sure the leg and foot are centrally placed inside the Pressure Chamber [1] and not touching
the outside walls during inflation of the Padding [17] (10-15 sec). See image [41]. (c) Treatment begins. Time counts
upwards on the Multi Screen [8]. The Treatment Ongoing symbol [27], along with a progress bar (shown first minute
only) will appear on the Multi Screen [8]. (d) Place the Pressure Chamber [1] at a comfortable distance from the chair
and if needed, change position of the Pressure Chamber [1] during treatment to increase comfort. Note: The patient
should remain seated during treatment ● After 2 hours a Smiley Face symbol [9] becomes lit on the Multi Screen [8] ●
All treatment use is recorded on the device ● The FlowOx™ continues working for 12 hours unless it is stopped ● If
condensation appears on the inside of the Pressure Chamber [1] when in use, insert 1-2 Absorbgel Pouches [26] into
the Pressure Chamber [1] floor. Note: An Absorbgel Pouch [26] should be used for a maximum of 10 days, or earlier
depending on humidity level and temperature. Thereafter it must be disposed of. ● The treatment can be stopped and
restarted any time by pressing the On/Off Button [7].
(C) Taking off the Pressure Chamber [1]: (a) Turn off the Control Unit [4] by pressing the On/Off Button [7]. (b) Roll down
the Seal [20] around the neck of the Pressure Chamber [1] shell. (c) Push the Release Valve Button [28] to deflate the
Padding [17]. Note: In case the Release Valve Button [28] does not work, the Air Deflation Cover [29] can be pulled off
to deflate the Padding [17]. (d) Gently remove the leg from the Pressure Chamber [1] after deflation of the Padding [17].
(e) Roll up the Seal [20] from the Pressure Chamber neck to release it from tension. Do not leave the Seal [20] stretched
over the Pressure Chamber neck.
(D) After daily treatment: If possible, leave the Pressure Chamber [1] and Control Unit [4] in place for daily treatment
procedures. If the Control Unit [4] and Pressure Chamber [1] are left in place, make sure they are close to each other, to
FLOWOX™ 2,0 Patient IFU (610-00013) Rev 9
FIRST TIME FITTING
DAILY USE OF FLOWOX™
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