ResMed MAP Series Respiratory Product User Manual


 
Disposal
The Silent Papillon nasal mask, AeroFix II
headgear, and AeroFix plus tubing clip contain
no toxic substances. Dispose of the nasal mask
in accordance with applicable national laws and
regulations. Except where stipulated otherwise,
before being taken to a recycling center the
nasal mask should be cleaned in accordance
with the procedures described in this Instruction
Manual.
Statutory Warranty
A two-year statutory warranty applies for
manufacturing defects. The statutory warranty
does not cover normal wear and tear. For further
details, see the MAP Medizin-Technologie GmbH
General Terms and Conditions of Business.
MAP shall not be liable for any impairments to
the safety, reliability, or performance of the
product caused by:
use other than that specified in the
Instruction Manual
use in conjunction with other products not
designed for this purpose
any technical alterations made to the
product.
The nasal mask must always be cleaned and
disinfected before being returned for servicing.
On completion of the above procedure, dry
the mask and pack it in a sealable padded
mailing bag.
Symbols
Attention: consult accompanying
documents (Instruction Manual)
Warning: failure to comply with the
instructions could pose a health risk.
REF Part number
Lot number
Date of manufacture (month, year)
Washing temperature 30 °C
Do not use chlorine bleach
Do not iron
Do not tumble dry
Technical Data
Standards
CE labeling in accordance with EC directive
93/42/EEC, class IIa
Quality Management: development,
manufacture, sale, and service certified in
accordance with ISO 13485:2003
quality management principles
EN ISO 17510-2
(Sleep apnea respiratory therapy, Part 2: masks and
application accessories)
Validated Cleaning and Disinfection
The general suitability of the Silent Papillon nasal mask
for effective cleaning and disinfection using the
procedures specified in this Instruction Manual has been
established by an independent accredited test laboratory.
Flow Resistance
Pressure drop measured with mask cushion size 2
at 50 l/min = max. 0.1 hPa
at 100 l/min = max. 0.4 hPa
Tubing Connection
22 mm for elastomer tubing
Weight
Approx. 92 g
Therapeutic Pressure
4 to 20 hPa
Storage Temperature
- 20 °C to + 60 °C
Operating Temperature
+ 5 °C to + 40 °C
Materials Used
Mask (latex-free): silicone, PSU, PC
Headgear (neoprene-free): nylon, lycra, spandex,
polyurethane, polyester
Cleaning of Headgear
Pressure/Flow Curve
Mean flow [l/min]
Pressure Units
1 hPa = 1 mbar = approx. 0.98 cm H
2
O
P [hPa]
GB
560 186 11.2005 (3) Copyright 2005 by MAP Medizin-Technologie GmbH