Sleepnet MP126 Minime 2 Nasal Mask Instruction Manual
- June 1, 2024
- Sleepnet
Table of Contents
Sleepnet MP126 Minime 2 Nasal Mask
This guide is intended for multi-patient use of MiniMe® 2 Pediatric Vented / Non-Vented Nasal Mask in the hospital, or other clinical settings, where proper disinfection/sterilization of the device must occur between patients. If contaminated with blood, please replace the contaminated component between patients.
Mask Components| Thermal Disinfection
In line with EN ISO 15883, the uncertainty range for disinfection temperature is -0°C and +5°C
|
Chemical Disinfection
|
Sterilization
|
Validated number of cycles
---|---|---|---|---
1min at 90 °C (194 °F)
|
10mins at 80 °C (176 °F)
|
30mins at 75 °C (167 °F)
| CIDEX ® OPA 1,
MetriCide™ OPA Plus 2 or
Rapicide ® OPA/28 3.
|
Sterrad ®4.
MiniMe® 2 Pediatric Vented / Non-Vented Nasal Mask
(excluding headgear)
| | | |
(Replace mask if discolours)
|
–
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25
MiniMe® 2 Pediatric Vented / Non-Vented Nasal Mask Headgear *
| | | |
–
|
–
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25
MiniMe® 2 Pediatric Vented / Non-Vented Nasal Mask Tubing *|
–
|
–
| |
–
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–
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25
Validated disinfection and sterilization procedures
Point of Use| Remove any gross soiling on the mask by wiping or
rinsing in potable water.
---|---
Disassembly| Disassemble the mask according to the Disassembling your
Mask and the Advanced Assembly/Disassembly instructions provided in the Guide.
Cleaning
| ****
Disassemble the mask according to the Disassembling Your Mask instructions and the advance instructions below. Soak all processable parts of the mask and headgear assembly in a solution of mild alkali, anionic detergent e.g. Alconox™ 5 according to the manufacturer’s instructions (at 1%concentration and 50°C for 10mins), ensuring that no air bubbles are present on the device surface. Using a soft non-metallic brush (e.g. medium-hard toothbrush)*, vigorously brush the mask parts for no less than 10 seconds and headgear for no less than 30 seconds.
Brush until visibly clean paying close attention to crevices, cavities and corners, such as the join between the silicone seal and plastic housing. Rinse headgear under running water for at least 30 seconds, intermittently wringing the fabric. Submerge headgear and mask parts separately in 5 litres of demineralised water each, agitating the mask parts for at least 10 seconds and agitating and squeezing headgear for at least 30 seconds. Repeat submerged rinse. Repeat as necessary to ensure that all detergent residue is removed. Ensure mask components are air-dried thoroughly before continuing.
*An additional thin bottle brush is required to access the inside of the mask tube.
Drying| ****
Disinfection or Sterilization
| Thermal Disinfection| Chemical Disinfection| Sterilization
---|---|---|---
For all processable components:
Run a disinfection cycle in an automatic washer-disinfector using one of the
time/temperature combinations shown on the front page of this guide. These
time/temperature combinations are consistent with EN ISO 15883 and are
equivalent in terms of known thermal inactivation kinetics of vegetative
micro-organisms, meeting an A0 of 600.| 1. Immerse completely in an
undiluted bath of CIDEX® OPA, MetriCide™ OPA Plus or Rapicide® OPA/28 at 20 °C
(68 °F) for 12 minutes, ensuring that no air bubbles are present on the device
surface.
2. Rinse thoroughly following the manufacturer’s rinsing instructions.
| –
Drying| Allow all components to air dry out of direct sunlight.
Inspection
| Before each use, inspect the mask for deterioration. If any visible
deterioration of a mask component is apparent, the mask component should be
discarded and replaced. Some discolouration may occur after reprocessing which
is acceptable.
Reassembly| Reassemble the mask according to the Assembling Your Mask
and the Advanced Assembly/Disassembly instructions given in the Guide.
Storage| Ensure the mask is completely dry before storing. Store in
clean conditions out of direct sunlight. Storage temperature: -20 °C to 50 °C
(-4 °F to 122 °F).
General Warnings and Cautions
| The instructions provided above have been validated as being capable of preparing the masks for re-use. Fisher & Paykel Healthcare does not recommend any deviations from the recommended method of reprocessing. The following actions may deteriorate or damage the mask and shorten its life:
• Do not iron the headgear
• Do not clean the mask with products containing alcohol, anti-bacterial agents, antiseptic, bleach, chlorine or moisturizer.
• Do not wash the mask in a dishwasher.
• Do not store or dry the mask in direct sunlight.
- Cidex is a registered trademark of Advanced Sterilization Products, a division of Ethicon Inc., a Johnson & Johnson Company. Product of Metrex™ Research, LLC.
- MetriCide is a registered trademark of Metrex Research
- Rapicide is a registered trademark of Medivators Inc.
- Sterrad is a registered trademark of Advanced Sterilization Products, a division of Ethicon Inc., a Johnson & Johnson Company
- Alconox is a trademark of Alconox, Inc.
Sleepnet Corporation
5 Merrill Industrial Drive
Hampton, NH 03842 USA
Tel: 603-758-6600
Fax: 603-758-6699
Toll Free: 1-800-742-3646 (USA AND
CANADA ONLY)
www.sleepnetmasks.com