Safety And Warnings - Otivio FLOWOX 2.0 Bedienungsanleitung

VIEWING TREATMENT DATA (CLINICIAN)
Note: Connecting a PC to the Control Unit may only be done by a trained professional. PC must only be connected to the
Control Unit outside of the patient area. Before connecting the Control Unit to a PC with the USB, make sure the PC has
the latest security updates and an up-to-date antivirus software installed.
Installing FlowOx™ Software: FlowOx™ Software enables the clinician to view the treatment data, get or delete treatment
data from the Control Unit [4], synchronize the Control Unit [4] time with the local time on the PC, and view the remaining
time available on the Control Unit [4]. To install the software, (a) Insert the red USB stick with the FlowOx™ Software [36]
supplied with the Control Unit [4] into the PC. (b) Copy the file "FlowOx-PC-SW" from the USB stick onto the PC. (c) Test the
software by opening the file. Note: FlowOx™ will still work in cases where software cannot be used.
Installing the driver: The communication with the Control unit requires that the specific driver is installed on the PC where
you are running the FlowOx 2 software. Note: You can read treatment data from the USB stick without installing the driver.
Only the connection to the Control unit requires the driver installation. Note: To install the driver you shall have the
administrator privileges. (a) Insert the red USB stick with FlowOx™ Software [36] into the PC. (b) The USB stick contains the
file with the name: InstallDriver. Double click the InstallDriver file and follow the installation instructions (c) Restart your PC
after installation. Stored treatment data can be viewed by (a) Launching the FlowOx™ Software (b) Clicking on the Folder
icon [37] and then on the desired file. The file can be found on the USB Memory Stick [32] (see section "Providing data to
your clinician") or in a previously created PC folder.
Direct Control Unit treatment data can be viewed in the following way: (a) Switch off the Control Unit [4]. (b) Connect the
PC with the USB Cable [11] to the USB Cable Port [13] on the Control Unit [4]. (c) Turn on the Control Unit [4]. (d) Launch the
FlowOx™ Software. (e) Click on the Cable icon [14] and then click on the Get Data icon [38]. ● The treatment data that is
stored on the Control Unit [4] can be deleted by pressing the Trashcan icon [39]. ● The time left on Timecard is shown on the
bottom right side "Control Unit Info" screen. ● Note: The USB Cable [11] can be used in locations where portable memory
devices are not permitted.
The treatment data is shown from 3 viewpoints (tabs), (a) The treatment summary shows the daily average treatment time,
average daily session length, days used, and total hours used for a specific period. (b) The treatment days shows the
accumulated daily usage divided into sessions for a specific period. (c) The treatment details show individual sessions per day,
at the specific time they occurred, along with any errors. ● In each of the viewpoints, it is possible to save data from a specified
timeperiod, save screen image or print. ● To close the software, select "X" on the right upper corner.

SAFETY AND WARNINGS

FlowOx™ is intended for indoor use only. Do not use in rooms where the device could get wet such as in a bathroom. FlowOx™
should only be used in the conditions specified in Environmental and handling conditions ● The FlowOx™ device should be
kept away from direct sources of heat such as an open fire ● Care should be taken to avoid tripping over the Hose with Filter
[24] and the External Power Supply [2] ● Caution should be taken to avoid accidental strangulation of yourself or others with
inappropriate use of the Hose with Filter [24] and the power cord ● Care should be taken with small parts to avoid accidental
ingestion as this could cause suffocation ● The power cable must never be attached to the wall power socket if it is
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 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
610-00013 FLOWOX™ 2,0 Instructions for Use (IFU) Manual Rev 16 Date of Issue: 28 APR 2022
6