Otivio FLOWOX 2.0 Bedienungsanleitung Seite 8

COMPLAINTS AND ADVERSE EVENTS
Complaints about FlowOx™, including any adverse events experienced in its use, should be commiunicated 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 Directive (MDD 93/42) ● Class A in
accordance with 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 ● 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 Rev 1.0: 2015 + A1: 2017 Medical devices – Application of usability engineering to medical devices ● BS EN ISO 15223-
1: 2021 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 ● BS EN ISO 20417: 2021 Medical devices — Information to be supplied by the
manufacturer ● 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
610-00013 FLOWOX™ 2,0 Instructions for Use (IFU) Manual Rev 16
SPECIFICATIONS
8
info@otivio.com
Date of Issue: 28 APR 2022