ResMed 608133/1 manual Option 2 Thermal Disinfection, European Standards, Regional Requirements

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Option 2: Thermal Disinfection

Pre-disinfection

1Disassemble the mask.

2Clean the individual parts of the mask with a soft bristle brush for one minute while soaking them in detergent (eg, NeodisherMedizyme or Alconox). Pay particular attention to all crevices and cavities.

3Rinse the components twice by agitating them vigorously in drinking quality water and allow them to air dry out of direct sunlight.

ResMed has tested the detergents Neodisher Medizyme (concentration at 2% for 30 minutes) and Alconox (diluted at 1%).

Disinfection

Using a certified hot water disinfection system, soak the disinfectable mask components using one of the temperature-time combinations listed in the following sections.

European Standards

Based on prEN ISO 15883-1, the mask has been tested at the following temperature-time combinations:

70°C for 100 minutes

75°C for 30 minutes

80°C for 10 minutes

90°C for 1 minute.

Regional Requirements

Due to specific regional requirements, the mask has also been tested for disinfection at the following temperature-time combination:

93°C for 10 minutes.

Testing by ResMed has shown that the mask components can withstand 15 cycles of thermal disinfection using the above temperature-time combinations. The device used for testing was BransonLTH 1828-24 hot water bath.

English

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Contents ResMed Masks Page English Disinfection Option 1 Chemical DisinfectionPre-disinfection Regional Requirements Option 2 Thermal DisinfectionEuropean Standards Inspection after Disinfection/Sterilization Option 3 Sterrad 100S Sterilization ProcessParts not Validated for Multipatient Use Pre-sterilizationEnglish Page Deutsch Warnungen UND VorsichtsmassnahmenDesinfektion Option 1 Chemische DesinfektionVordesinfektion Regionale Anforderungen Option 2 Thermale DesinfektionEuropäische Normen Inspektion nach der Desinfektion/Sterilisation Option 3 Sterrad 100S SterilisationsverfahrenVorsterilisation SterilisationDeutsch Page Français Avertissements ET PrecautionsDésinfection Option 1 Désinfection chimiquePré-désinfection Exigences régionales Option 2 Désinfection thermiqueNormes européennes Inspection après la désinfection/stérilisation Option 3 Procédé de stérilisation Sterrad 100SPré-stérilisation StérilisationFrançais Page Italiano Avvertenze E PrecauzioniDisinfezione Opzione 1 Disinfezione chimicaPre-disinfezione Requisiti regionali Opzione 2 Disinfezione termicaStandard europei Ispezione dopo la disinfezione/sterilizzazione Opzione 3 Processo di sterilizzazione Sterrad 100SParti non approvate per l’uso multipaziente Pre-sterilizzazioneMaschera nasale non ventilata Ultra Mirage Page Español Advertencias Y PrecaucionesDesinfección Opción 1 desinfección químicaPrevio a la desinfección Requisitos regionales Opción 2 desinfección térmicaNormas europeas Inspección posterior a la desinfección o esterilización Opción 3 proceso de esterilización Sterrad 100SPiezas no validadas para el uso entre pacientes Previo a la esterilizaciónConjunto de tubo corto Page Português Avisos E PrecauçõesDesinfecção Opção 1 Desinfecção QuímicaLimpeza antes da desinfecção Requisitos Regionais Opção 2 Desinfecção TérmicaNormas Europeias Inspecção após desinfecção/esterilização Opção 3 Processo de Esterilização Sterrad 100SLimpeza antes da esterilização EsterilizaçãoPortuguês Page Svenska Varningar OCH SäkerhetsföreskrifterFöre desinfektionen Alternativ 1 Kemisk desinfektionLokala/regionala krav Alternativ 2 VärmedesinfektionEuropeiska standarder Inspektion efter desinfektionen/steriliseringen Alternativ 3 Sterrad 100S steriliseringFöre steriliseringen SteriliseringSvenska Page Nederlands Waarschuwingen EN OpmerkingenDesinfectie Optie 1 Chemische desinfectieVoorafgaand aan de desinfectie Voorafgaand aan desinfectie Optie 2 Thermische desinfectieEuropese Normen Regionale vereistenInspectie na desinfectie/sterilisatie Optie 3 Sterrad 100S SterilisatieprocesVoorafgaand aan sterilisatie SterilisatieNederlands