How It Works; Intended Use And Contra-Indications - Otivio FLOWOX 2.0 Manual De Uso

FlowOx™ is a medical device according to the Medical Device Directive 93/42/EEC, that improves blood flow to your lower
limb. The patented technology is based on several years of research and development.
Please read carefully this instruction manual before using the device. The Quick Guide [0] should be kept handy.
Otivio and its distributors decline any responsibility for any use of FlowOx™ that does not comply with this instruction manual.
The user puts the foot and leg into a Pressure Chamber [1] which is connected to a pump. The pump creates a pre-set cycle
of 10 seconds with negative pressure of -40 mmHg and 7 seconds with normal air pressure. The negative pressure facilitates
blood flow down into the limb and to the skin.
Use FlowOx™ as recommended by your clinician, normally for 2 hours daily, divided into at least two sessions. Follow up your
clinician recommendations for treatment modalities.

INTENDED USE AND CONTRA-INDICATIONS

FlowOx™ should be used by adults for the following indications: Peripheral arterial disease (PAD) ● Diabetic and non-diabetic
foot and leg ulcers caused by arteriopathy ● Intermittent claudication and rest pain ● Foot and lower leg ulcers of mixed
aetiology associated with immobility such as paraplegia following spinal injury.
A clinician will prescribe FlowOx™ treatment and monitor the patient's healing progress. It is only intended to be used by the
patient themselves if they can put on and take off their own shoes. FlowOx™ is intended to be used in a clinical or in a home
environment, as a supplement to standard of care.
Contra indication: Patients with uncontrolled infection ● People younger than 18 years of age ● Patients with varicose veins,
eczema or psoriasis.
Note: If any medical conditions become aggravated, stop treatment and contact the responsible clinician.
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). The applied parts of the
system are the Positioner [16], Padding [17] and Seal [20]. The materials chosen for the applied parts are non-allergic.
(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. Type of the 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) Activate FlowOx™ with the time card: The FlowOx™ Control Unit [4] can only be operated when it has been activated
with a Time Card [5]. To add time, do the following: |a| Check that the Control Unit [4] is switched off. |b| Insert the
Time Card [5] into the Time Card Port [6]. |c| Press the On/Off Button [7]. When the Control Unit [4] has read the Time
Card [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 Time Card
[5] from the Control Unit [4] and dispose of it immediately. Note: Time Cards [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] becomes lit. 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 FlowOx™ Software |e| The Control Unit [4] adopts the local time from the PC and the
FLOWOX™ 2,0 Patient IFU (610-00013) Rev 9
INSTRUCTION MANUAL [EN]
WELCOME

HOW IT WORKS

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