ResMed Mirage Activa, Mirage Kidsta, Mirage Series 2, Mirage Swift, Mirage Swift II, Mirage Vista, Ultra Mirage, Ultra Mirage II Option 1: Chemical Disinfection

Clinical Use Only

2

After disassembly, thoroughly disinfect or sterilize the mask components by

following the procedure for one of these methods:

•Chemical Disinfection

•Thermal Disinfection

•STERRAD™ Sterilization.

Option 1: Chemical 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, Aniosyme™ DDI or Alconox™).

Pay particular attention to all crevices and cavities.

3Rinse the components twice by agitating them vigorously in drinking quality

water (5 litres per mask) and allow them to air dry out of direct sunlight.

ResMed has tested the detergents Aniosyme DDI (diluted at 0.5% for 15

minutes) and Alconox (diluted at 1%).

Disinfection

1Soak the disinfectable mask components in a commercially available

solution of peracetic acid 0.15% (eg, Anioxyde™1000),

ortho-phthalaldehyde 0.55% (eg, CIDEX™ OPA) or glutaraldehyde 3.4%

(eg, CIDEX Plus™).

2Rinse the mask components in drinking quality water (5 litres per mask) and

allow them to air dry out of direct sunlight.

Testing by ResMed has shown that the mask components can withstand 15

cycles using solutions of peracetic acid (0.15% Anioxyde 1000 for 30 minutes),

ortho-phthalaldehyde (0.55% CIDEX OPA for 20 minutes) or glutaraldehyde

(3.4% CIDEX Plus for 20 minutes).

Note: If using the detergents and disinfectants listed above, the following

combinations should be followed:

•Detergent Aniosyme DDI with Anioxyde 1000 as the disinfectant

OR

•Detergent Alconox with disinfectant CIDEX OPA or CIDEX Plus.

Contents

Main ResMed Masks Disinfection/Sterilization Guide Clinical Use Only Disinfecting/Sterilizing the Mask or Nasal Pillows System between Patients WARNINGS AND CAUTIONS Option 1: Chemical Disinfection Pre-disinfection Disinfection Option 2: Thermal Disinfection Pre-disinfection Disinfection European Standards Regional Requirements Option 3: STERRAD Sterilization System Pre-sterilization Sterilization Inspection after Disinfection/Sterilization Parts not Validated for Multipatient Use The parts that cannot be disinfected or sterilized are listed in the following table. Page Desinfektion/Sterilisation der Maske oder des Nasenpolstersystems bei einem Patientenwechsel WARNUNGEN UND VORSICHTSMASSNAHMEN Option 1: Chemische Desinfektion Vordesinfektion Desinfektion Option 2: Thermale Desinfektion Vordesinfektion Desinfektion Europische Normen Regionale Anforderungen Option 3: STERRAD Sterilisationssystem Vorsterilisation Sterilisation Inspektion nach der Desinfektion/Sterilisation Nicht fr den Gebrauch durch mehrere Patienten geeignete Teile Page Dsinfection/Strilisation du masque ou du masque narinaire entre les patients AVERTISSEMENTS ET PRECAUTIONS Option 1 : Dsinfection chimique Pr-dsinfection Dsinfection Option 2 : Dsinfection thermique Pr-dsinfection Dsinfection Normes europennes Exigences rgionales Option 3 : Systme de strilisation STERRAD Pr-strilisation Strilisation Inspection aprs la dsinfection/strilisation Composants non valids pour une utilisation sur plusieurs patients Page Page Disinfezione/sterilizzazione della maschera o del cuscinetto nasale tra un paziente e laltro AVVERTENZE E PRECAUZIONI Opzione 1: Disinfezione chimica Pre-disinfezione Disinfezione Opzione 2: Disinfezione termica Pre-disinfezione Disinfezione Standard europei Requisiti regionali Opzione 3: Sistema di sterilizzazione STERRAD Pre-sterilizzazione Sterilizzazione Ispezione dopo la disinfezione/sterilizzazione Parti non approvate per luso multipaziente Le parti che non possono essere disinfettate o sterilizzate sono elencate nella seguente tabella. Page ADVERTENCIAS Y PRECAUCIONES Opcin 1: desinfeccin qumica Previo a la desinfeccin Desinfeccin Opcin 2: desinfeccin trmica Previo a la desinfeccin Desinfeccin Normas europeas Requisitos regionales Opcin 3: Sistema de esterilizacin STERRAD Previo a la esterilizacin Esterilizacin Inspeccin posterior a la desinfeccin o esterilizacin Piezas no validadas para el uso entre pacientes Las piezas que no pueden ser desinfectadas ni esterilizadas se enumeran en la tabla siguiente. Page Desinfeco/Esterilizao da Mscara ou do Sistema de Almofadas Nasais entre Pacien tes AVISOS E PRECAUES Opo 1: Desinfeco Qumica Limpeza antes da desinfeco Desinfeco Opo 2: Desinfeco Trmica Limpeza antes da desinfeco Desinfeco Normas Europeias Requisitos Regionais Opo 3: Sistema de Esterilizao STERRAD Limpeza antes da esterilizao Esterilizao Inspeco aps desinfeco/esterilizao Componentes no passveis de serem utilizados por vrios pacientes Os componentes que no podem ser desinfectados ou esterilizados so listados na tabela seguinte. Page WAARSCHUWINGEN EN OPMERKINGEN Optie 1: Chemische desinfectie Voorafgaand aan de desinfectie Desinfectie Optie 2: Thermische desinfectie Voorafgaand aan desinfectie Desinfectie Europese Normen Regionale vereisten Optie 3: STERRAD Sterilisatiesysteem Voorafgaand aan sterilisatie Sterilisatie Inspectie na desinfectie/sterilisatie Onderdelen die niet zijn goedgekeurd voor gebruik door meerdere patinten. De onderdelen die niet kunnen worden gedesinfecteerd of gesteriliseerd staan in de volgende tabel.