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Due to increased blood flow to the treated area, ulcers may experience increased exudate production or bleeding.
Should these occur, a super absorbent dressing may be required and/or dressings may need to be changed more often
or treatment terminated.
Underlying conditions and co-morbidities should be stabilised and under control prior to treatment to be compatible
with the treatment period.
If any medical conditions become aggravated, treatment should be stopped, and medical advice obtained.
Some patients may face challenges in tolerating FlowOx treatment, as it necessitates extended periods of sedentary
activity, and initial treatment may exacerbate feelings of discomfort, pain, and spasticity. In such instances, it is advisable
to discontinue the treatment.
Treatment Period:
FlowOx™ use is recommended for 2 hours per day and clinical improvement in symptoms usually requires a minimum of 8
weeks treatment. Treatment is applied whilst the patient is seated, and it does not interfere with other activities normally
enjoyed whilst seated.
INITIAL SETUP OF FLOWOX™ BY CLINICIAN
Please read this FlowOx™ instruction manual and refer to the drawings at the beginning of the instruction manual.
(A) Unpack and verify that all items are provided and free from damage (see overview picture). If any parts are missing or
damaged, please contact your clinician or distributor. The Control Unit box contains the Quick Guide [0], Instructions for
use (IFU) Manual [0], the Control Unit [4], the power supply [2], Timecard [5] (if supplied), USB drive with FlowOx™
Software [32] data transfer cable [11]. The Pressure Chamber box contains the Quick Guide [0], Instructions for use (IFU)
Manual [0], the PCH [1], 2x Absorbgel pouch [26], Positioner [16], Padding [17], 2x Seal [20] and Strap [23]. The Positioner
[16], Padding [17], Seal [20], and Strap [23] are applied parts of the system and the materials are non-allergenic.
(B) Connect the External Power Supply [2] to the Power Supply Port [3] on the Control Unit [4] and plug into an electrical
socket. Note: Use of external power supply [2] other than that specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation. The type of External Power Supply [2] is Meanwell GSM60B24-P1L. Note:
Make sure the External Power Supply [2] can easily be disconnected from the Control Unit [4] during use.
(C) Check FlowOx™ Control Unit for the timecard: To check if the Control Unit [4] is activated with a Timecard, press the
On/Off Button [7]. A timecard is activated if the Control Unit [4] starts the treatment. If instead, the Control Unit Display
[10] shows the text "0h" and a General Error symbol [35], then no Timecard [5] is yet activated. The FlowOx™ Control
Unit [4] can only be operated when it has been activated with a Timecard [5]. To add time, do the following: |a| Check
that the Control Unit [4] is switched off. |b| Insert the Timecard [5] into the Timecard Port [6]. |c| Press the On/Off
Button [7]. When the Control Unit [4] has read the Timecard [5], an hourglass symbol, along with total time left, will be
displayed on the Multi Screen [8] and the Smiley Face symbol [9] will appear on the Display [10]. The Control Unit [4]
will shut down automatically. |d| Remove the Timecard [5] from the Control Unit [4] and dispose of it immediately.
Note: Timecards [5] come with varying amounts of hours.
(D) Set time (hours). Time is set manually on Control Unit [4] or by synchronizing with a Personal Computer (PC) using the
USB Cable [11]. USB cable supplied with the Control Unit is a 2 m long, black type A-B USB cable. Manual time setup:
|a| Push the On/Off Button [7] for 10 seconds. The Clock Set symbol [12] lights up. The hour blinks on the Multi Screen
[8] |b| Press the On/Off Button [7] repeatedly until the correct local hour is set. Note: minutes do not have to be set.
|c| Wait for 10 seconds. The local time will be briefly displayed. |d| The Control Unit [4] shuts down automatically
afterwards. Synchronized PC time setup: See section "Viewing Treatment Data (Clinician)" for information on how to
setup the software |a| Connect the USB Cable [11] to the USB Cable Port [13] on the Control Unit [4] and then to the PC
|b| Start the FlowOx™ Software |c| Press the On/Off Button [7] on the Control Unit [4] |d| Click on the Cable icon [14]
and then the Clock Set icon [15] in the FlowOx™ Software |e| The Control Unit [4] adopts the local time from the PC and
the Clock Set symbol [12] is lit. The 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.
610-00013 FLOWOX™ 2.0 Instructions for Use (IFU) Manual Rev 20
FIRST TIME FITTING
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Date of Issue: 09 OCT 2024
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