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E1 Minor Air Leakage | Higher leakage than normal but treatment still being delivered effectively ● Solution: The clinician or
distributor should advise patient at the next check-up, that it is important to adjust the Seal [20] and the Hose with Filter [24]
so that there is minimal leakage. Note: this error is only shown in the data log
E2 Major Air Leakage | Prolonged leakage, treatment is not being delivered ● Solution: Check that the Seal [20] is sealed air
tight to the bare leg, check that the Hose with Filter [24] is tightly connected to the hose connector [25], check that the air
vents [19] are correctly inserted into the holes in the PCH and adjust if necessary. Restart the device by pressing On/Off
Button [7]
E3 Low Air Volume | Not enough air to function (Low air volume) ● Solution: check for obstruction, e.g., kinked hose. Restart
the device by pressing On/Off Button [7]
E4 Data transfer error | Data not transferred, e.g., due to taking out USB Memory Stick [32] too early or software error ●
Solution: Switch off the device and try inserting the USB Memory Stick [32] into the Control Unit [4] again ● Note: if the
problem persists, contact the clinician or local distributor ● The Control Unit [4] can be reset by pressing On/Off button [7]
for 13 seconds.
COMPLAINTS AND ADVERSE EVENTS
Complaints about FlowOx™, including any adverse events experienced in its use, should be communicated to your distributor
or directly to Otivio at info@otivio.com. Serious adverse events should also be reported directly to Otivio at
and the relevant authorities where you live, contacts are shown below:
Belgium:
vigilance.meddev@fagg-afmps.be
Denmark:
med-udstyr@dkma.dk
Germany:
medizinprodukte@bfarm.de
Ireland:
devicesafety@hpra.ie
Italy:
dgfdm@postacert.sanita.it
Spain:
psvigilancia@aemps.es
France:
medicaldevicesvigilance@ansm.sante.fr
Luxembourg :
meddevices.vigilance@ms.etat.lu
Liechtenstein:
medical.devices@llv.li
Malta:
devices.medicinesauthority@gov.mt
The Netherlands:
meldpunt@igj.nl
Austria:
medizinprodukte@basg.gv.at
Sweden:
meddev.central@lakemedelsverket.se
Norway:
meddev-no@legemiddelverket.no
Classification of the FlowOx™ system: Class IIa in accordance with the Medical Devices Regulation (MDR 2017/745) ● Class A
in accordance with IEC 62304:2006+A1:2015, Software Safety Classification
Implemented Safety Standards: IEC 60601-1:2005+AMD1:2012+AMD2:2020 Ed. 3.2 Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance ● IEC 60601-1-2:2014+AMD1:2020 Ed.4.1 Medical electrical
equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic
disturbances - Requirements and tests ● IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Ed. 3.2 Medical electrical equipment -
Part 1-6: General requirements for basic safety and essential performance. Collateral standard: Usability ● IEC 60601-1-
11:2015+AMD1:2020 Ed. 2.1 General requirements for basic safety and
Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ● IEC
62304:2006+A1:2015 Medical device software – Software life-cycle processes ● BS EN ISO 14971:2019+A11:2021 Medical
devices – Application of risk management to medical devices ● BS EN ISO 10993:2020 Biological evaluation of medical devices
– Part 1: Evaluation and testing within a risk management process ● IEC 62366-1:2015+AMD1:2020 Ed. 1.1 Medical devices –
Application of usability engineering to medical devices ● BS EN ISO 15223-1: 2021 Medical devices - Symbols to be used with
610-00013 FLOWOX™ 2.0 Instructions for Use (IFU) Manual Rev 20
SPECIFICATIONS
8
essential performance. Collateral Standard:
Date of Issue: 09 OCT 2024
info@otivio.com
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