Care And Maintenance - Otivio FLOWOX 2.0 Manual De Uso

CARE AND MAINTENANCE

Maintenance: The operator is not required to perform any preventive maintenance on the equipment. In the event of a fault,
please contact your clinician or your distributor.
Cleaning: The FlowOx™ device can be cleaned if needed with wipes moistened with water and/or alcohol impregnated wipes.
Note: Do not get the Control Unit [4] wet ● Do not use any abrasives or oxidizing agents such as detergents or hypochlorite
(bleach) if the FlowOx™ system is to be used for further treatment.
Recyclability: Used Pressure Chambers should either be cleaned with hypochlorite solution prior to disposal as non-hazardous
domestic waste or be disposed of as hazardous waste in a hospital or professional healthcare setting. Not doing so could risk
spreading diseases to others ● Do not dispose of the Control Unit [4] with your general waste. It contains a battery and other
electronic components and must be disposed as electronic waste. When its end-of-life is reached, contact Otivio or your
authorized distributor ● The Pressure Chamber [1] is a disposable item and has a lifetime of one year.
Replacement parts: Please contact your clinician if you need replacement parts, i.e. Padding (810-00002) [17], Seal (810-
00003) [20], and/or the Absorbgel Pouch (431-00002) [26].
TROUBLE SHOOTING
If an error occurs, the Treatment Ongoing symbol [27] disappears from the Display [10], Error code is shown on Multi Screen
[8] and a General Error symbol [35] or Air Leakage symbol [40] is shown. If an error code appears on the Multi Screen [8], it
should be documented, and the clinician informed as soon as possible. Error Codes:
E1 Minor Air Leakage | Higher leakage than normal but treatment still being delivered effectively ● Solution: Clinician should
advise patient at 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 only shown in data log
E2 Major Air Leakage | Higher leakage than normal and treatment not being delivered ● Solution: Check the Seal [20], Hose
with Filter [24] 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 clinician or local distributor ● The Control Unit [4] can be reset by pressing On/Off button [7] for 13
seconds
SPECIFICATIONS
Classification of the FlowOx™ system: Class IIa according to the Medical Devices Directive (MDD 93/42) ● Class A according
to EN ISO 62304: 2006, Software Safety Classification
Implemented Safety Standards: IEC 60601-1 Rev 3.1: 2012 Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance ● IEC 60601-1-2 Rev 4.0: 2014 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 Rev 3.0 + A1: 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance. Collateral standard: Usability ● IEC 60601-1-11 Rev 2.0: 2015 General requirements for basic safety
and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment ● EN ISO 62304 Rev 1.1: 2015 Medical device software – Software life-cycle
processes ● EN ISO 14971 Rev 4: 2012 Medical devices – Application of risk management to medical devices ● EN ISO 10993
Rev 4: 2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ● IEC
62366 Rev 1.0: 2015 + A1: 2017 Medical devices – Application of usability engineering to medical devices ● ISO 15223-1: 2012
Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General
requirements ● ISO 15223-2 Rev 1.0: 2010 Medical devices. Symbols to be used with medical device labels, labelling and
information to be supplied. Part 2 ● EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices ● EN
15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing
phthalates
Manufacturing Standards used: ISO 13485 Rev 3.0, 2016 Medical devices – Quality management systems – Requirements for
regulatory purposes
FLOWOX™ 2,0 Patient IFU (610-00013) Rev 9
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