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Disinfection And Sterilization Guide

Disinfection And Sterilization Guide

Disinfection And Sterilization Guide

Product catalog summary
Overview: This guide provides instructions for the disinfection and sterilisation of ResMed full face masks, nasal masks, and nasal pillows systems used in clinical settings. It is intended for multipatient use in sleep labs, clinics, or hospitals and complies with ISO17664 standards.
Specifications: The guide lists specific masks validated for reprocessing between patients, detailing parts that need replacement and the number of validated disinfection cycles. It includes high-level thermal and chemical disinfection methods, as well as sterilisation procedures.
Disinfection and Sterilisation Procedures: Three main procedures are outlined: high-level thermal disinfection, high-level chemical disinfection, and sterilisation. Each procedure includes detailed steps for disassembly, cleaning, drying, and inspection of mask components.
Cleaning Instructions: Specific cleaning agents and methods are recommended for different mask components. The guide emphasizes thorough cleaning, rinsing, and air drying out of direct sunlight.
Warnings and Cautions: The guide warns against deviations from the recommended procedures, such as exceeding the number of reprocessing cycles, and advises against using autoclave or ethylene-oxide gas sterilisation. It also cautions against ironing the headgear due to heat sensitivity.
Additional Information: The document provides alternative disassembly instructions for certain mask models and specifies that some components do not require disinfection but should be thoroughly washed between patients.
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Catalog excerpts

Disinfection And Sterilization Guide-1

Disinfection and sterilisation guide This guide is intended for multipatient use of a ResMed full face mask, nasal mask or nasal pillows system ('mask') in a sleep lab, clinic or hospital. If you use the mask as a single user in the home, refer to the User Guide for cleaning instructions. This guide describes ResMed's recommended and validated procedures for cleaning, disinfection and sterilisation of the mask in accordance with IS017664. Note: Only masks listed in the table below have been validated for reprocessing between patients Replace these parts between High level thermal disinfection European regional requirements High level chemical disinfection Peracetic acid CIDEX™ Plus Gluta raldehyde

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Disinfection And Sterilization Guide-2

Replace these parts with new parts between patients High level thermal disinfection EN ISO 15883-1 70°C-100 min; 75°C-30 min 80°C-10 min; 90°C-1 min European regional requirements 93°C-10 min High level chemical disinfection Anioxyde™ 1000 Peracetic acid 0.15% for 30 minutes CIDEX™ OPA Orthophthalaldehyde 0.55% for 20 minutes CIDEX™ Plus Glutaraldehyde 3.4% for 20 minutes Mirage Vista Swivel, inlet tube Ultra Mirage Non-vented Mirage Non-vented Swivel, short tubing Swift FX Nano / Swift FX Nano for Her Nasal pillows systems Swift FX / Swift FX for Her / None Swift FX Bella / Swift FX Bella Gray...

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Disinfection And Sterilization Guide-3

Validated disinfection and sterilisation procedures In the procedures below, only one of the following three disinfection or sterilisation procedures needs to be performed. High level thermal disinfection Disassembly High level chemical disinfection Disassemble the mask according to the instructions in the User Guide. 1. Clean the individual parts of the mask with a soft bristle brush for one minute while soaking them in one the following detergents or disinfectants according to manufacturer’s instructions. Pay particular attention to all crevices and cavities. • neodisher MediZym (concentration...

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Disinfection And Sterilization Guide-4

Disassembling the masks before cleaning Cleaning other components These instructions apply only to: These instructions apply only to: • Mirage Quattro • AirFit N10 / AirFit N10 for Her - Soft sleeves • Mirage Micro • AirFit F10 / AirFit F10 for Her - Frame, Soft sleeves • Quattro Air / Quattro Air For Her / Quattro Air NV - Frame • Mirage SoftGel. • Quattro FX / Quattro FX for Her - Spring frame, Soft sleeves As an alternate to the disassembly instructions shown in the relevant user guide for removing the forehead support and dial from the mask frame, you can disassemble these components as follows:...

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