ResMed Mirage Swift II Option 2 Thermal Disinfection, European Standards, Regional Requirements

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Clinical Use Only

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, Neodisher™ Medizyme 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 Branson™ LTH 1828-24 hot water bath.

English

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Contents ResMed Masks English Pre-disinfection Option 1 Chemical DisinfectionDisinfection European Standards Option 2 Thermal DisinfectionRegional Requirements Option 3 Sterrad Sterilization System Inspection after Disinfection/SterilizationParts not Validated for Multipatient Use Pre-sterilizationClinical Use Only Clinical Use Only Warnungen UND Vorsichtsmassnahmen DeutschVordesinfektion Option 1 Chemische DesinfektionDesinfektion Europäische Normen Option 2 Thermale DesinfektionRegionale Anforderungen Option 3 Sterrad Sterilisationssystem Inspektion nach der Desinfektion/SterilisationVorsterilisation SterilisationMirage Full Face Maske NV ohne Luftauslassöffnungen Serie Nur zur klinischen Behandlung Avertissements ET Precautions FrançaisPré-désinfection Option 1 Désinfection chimiqueDésinfection Normes européennes Option 2 Désinfection thermiqueExigences régionales Option 3 Système de stérilisation Sterrad Inspection après la désinfection/stérilisationPré-stérilisation StérilisationEnsemble tuyau à air court Utilisation clinique uniquement Avvertenze E Precauzioni ItalianoPre-disinfezione Opzione 1 Disinfezione chimicaDisinfezione Standard europei Opzione 2 Disinfezione termicaRequisiti regionali Opzione 3 Sistema di sterilizzazione Sterrad Ispezione dopo la disinfezione/sterilizzazioneParti non approvate per l’uso multipaziente Pre-sterilizzazioneNessuna Solo per uso clinico Advertencias Y Precauciones EspañolPrevio a la desinfección Opción 1 desinfección químicaDesinfección Normas europeas Opción 2 desinfección térmicaRequisitos regionales Opción 3 Sistema de esterilización Sterrad Inspección posterior a la desinfección o esterilizaciónPiezas no validadas para el uso entre pacientes Previo a la esterilizaciónSistema de Almohadillas Nasales Mirage Swift Solamente para uso clínico Avisos E Precauções PortuguêsLimpeza antes da desinfecção Opção 1 Desinfecção QuímicaDesinfecção Normas Europeias Opção 2 Desinfecção TérmicaRequisitos Regionais Opção 3 Sistema de Esterilização Sterrad Inspecção após desinfecção/esterilizaçãoLimpeza antes da esterilização EsterilizaçãoApenas para uso clínico Apenas para uso clínico Waarschuwingen EN Opmerkingen NederlandsVoorafgaand aan de desinfectie Optie 1 Chemische desinfectieDesinfectie Optie 2 Thermische desinfectie Voorafgaand aan desinfectieEuropese Normen Regionale vereistenOptie 3 Sterrad Sterilisatiesysteem Inspectie na desinfectie/sterilisatieVoorafgaand aan sterilisatie SterilisatieAlleen voor gebruik in de ziekenhuissituatie Alleen voor gebruik in de ziekenhuissituatie