ResMed Mask Materials January 2009

Transcription

1 ResMed Mask s January 2009 PRODUCT BULLETIN Bulletin Number: 590 Month/Year: January 2009 Distribution: Global Date of implementation: Immediately Replaces Product Bulletin #578 Following are details of the materials contained in ResMed mask/pillow systems. Please note some products may not be available in all regions. As a manufacturer of medical devices, ResMed s products are subject to strict regulation. One of the requirements in this regard is to demonstrate an appropriate level of biocompatibility for every material to which a patient is exposed. To this end, the biocompatibility of each of the materials listed below has been confirmed by ResMed. ResMed mask cushions are made from silicone which is a hypoallergenic material used in medical appliances and devices. True allergic reactions to silicone are extremely rare. In fact, skin irritation, sores (pressure sores) and blisters are more commonly caused by other associated factors rather than the silicone material itself. Further information and advice regarding skin irritation resulting from the use of CPAP masks can be found at the following website: Mirage Activa LT Nasal Mask Clear Dial Dial - Sleep Lab Kit 15% PTFE in 15% PTFE in Clip Polyester Forehead Pad Headgear Assembly Elastomer Layer: Open cell Polyurethane Loop : /Spandex Fastener Tabs: Polycaproloctam (Polyamide Family) Cloth Label: Rayon acetate satin

2 Swift LT for Her Nasal Pillows System (Pillows) Headgear Assembly Headgear Straps: Foam Layer: Open cell Polyurethane Buckles: Thermoplastic Polyester Elastomer (TPE) Inlet Tube Thermoplastic Polyester Elastomer (TPE) Assembly / Plastic Tube Retainer Thermoplastic Polyester Elastomer (TPE) Soft Wraps Polyester Swift LT Nasal Pillows System (Pillows) Headgear Assembly Headgear Straps: Foam Layer: Open cell Polyurethane Buckles: Thermoplastic Polyester Elastomer (TPE) Inlet Tube Thermoplastic Polyester Elastomer (TPE) Assembly / Plastic Tube Retainer Thermoplastic Polyester Elastomer (TPE) Mirage Micro Nasal Mask Clear Dial Dial - Sleep Lab Kit Forehead Pad Headgear Assembly 15% PTFE in 15% PTFE in Elastomer Layer: Open cell Polyurethane Loop : /Spandex Fastener Tabs: Polycaproloctam (Polyamide Family) Cloth Label: Rayon acetate satin

3 Mirage Liberty Full Face Mask Pillows Valve Valve Clip Short Tube Tube: Polyolefin Plastomer (POP) Cuff: SEBS Based Thermoplastic Elastomer Light Grey Assembly / Headgear Foam Layer: Open cell Polyurethane Loop : /Spandex Fastener Tabs: Polycaprolactam Upper Upper Clips: Assembly Foam Layer: Open cell Polyurethane Stitching: Anefil Lower Mirage Quattro Full Face Mask Clip 15% PTFE in Pad Dial Dial - Sleep Lab Kit 15% PTFE in Mask Valve Valve Clip Headgear Foam Layer: Open cell Polyurethane Loop : /Spandex Fastener Tabs: Polycaprolactam (Polyamide Family).

4 Mirage Swift and Mirage Swift II Nasal Pillows System Clip Seal Ring Inlet Tube Polyolefin Plastomer (POP) Tube Retainer Foam Layer: Open cell Polyurethane Loop : /Spandex Fastener Tabs: Polycaprolactam Assembly / Snap Plug Headgear Assembly Headgear Straps: Foam Layer: Open cell Polyurethane Headgear Buckle: Mirage Kidsta Nasal Mask Short Tube Assembly Exhaust Vent Headgear Assembly Tube: Polyolefin plastomer (POP) Cuff: SEBS Based Thermoplastic Elastomer Light Grey / Headgear Straps: Foam Layer: Open cell Polyurethane : Ladder Lock: Crossover: Strap Loop: Headgear Label: Rayon acetate satin Mirage Activa Nasal Mask Vent Clip Polyester Polyester Forehead T-Bar Short Tube Tube: Polyolefin Plastomer (POP) Cuff: SEBS Based Thermoplastic Elastomer Light Grey Assembly / Forehead Pads Cloth Label Rayon acetate satin Loop : /Spandex Fastener Tabs: Polycaprolactam (Polyamide Family)

5 Ultra Mirage Full Face Mask Clip Lower Housing Clip Retainer Forehead Pads Grommet Valve Membrane Loop : /Spandex Fastener Tabs: Polycaprolactam (Polyamide Family) Non-Vented Ultra Mirage Full Face Mask Clip Retainer Forehead Pads Loop : /Spandex Fastener Tabs: Polycaproloctam (Polyamide Family) Stiffening ribbon: Satin polyester ribbon sewn inside Mirage Vista Nasal Mask Short Tube Assembly Exhaust Vent Headgear Assembly Tube: Polyolefin plastomer (POP) Cuff: SEBS Based Thermoplastic Elastomer Light Grey / Headgear Straps: Foam Layer: Open cell Polyurethane : Ladder Lock: Crossover: Strap Loop: Headgear Label: Rayon acetate satin

6 Mirage Full Face Mask Series 2 (Vented and Non-vented) Grommet Clip Lower Housing Clip Retainer Forehead Pad Clip Luer Lock NV components Valve Membrane Forehead Pad Shallow Forehead Pad Deep Cloth Label Rayon acetate satin NV Cloth Label NV Headgear Assembly Loop : /Spandex Fastener Tabs: Polycaprolactam (Polyamide Family) NV Assembly: Satin tape sewn inside Ultra Mirage /Ultra Mirage II Nasal Mask (Vented and Non-vented) Vent Cover Clip Clip NV components 15% PTFE in Standard Forehead Pad Cloth Label Rayon acetate satin NV Cloth Label NV Headgear Assembly Loop : /Spandex Fastener Tabs: Polycaproloctam (Polyamide Family) NV Assembly: Satin polyester ribbon sewn inside

7 Mirage Nasal Mask (Vented and Non-vented) Connector Pipe T-bar Actuator Arm Small-Bore Tubing Polyolefin Small Bore Adapter NV s Grommet Standard Forehead Pads Cloth Label Rayon acetate satin NV Cloth Label NV Headgear Assembly Loop : /Spandex Fastener Tabs: Polycaprolactam (Polyamide Family) NV Assembly: Satin tape sewn inside Disposable Mask Systems ResMed Hospital Disposable Non-Vented Full Face Mask Clip Port Cap Headgear Top layer: Polyester Underside: Polyester Foam Layer: Open cell Polyurethane Finished fabric: Pressure lamination of the three layers of material using an acrylic adhesive. ResMed Hospital Non-Vented Full Face Mask Clip Headgear Top layer: Underside: Foam Layer: Open cell Polyurethane Finished fabric: Pressure lamination of the three layers of material using an acrylic adhesive.

8 ResMed Hospital Disposable Full Face Mask Distal Pressure Port Anti-asphyxia Valve Clip Headgear Top layer: Polyester Underside: Polyester Foam Layer: Open cell Polyurethane Finished fabric: Pressure lamination of the three layers of material using an acrylic adhesive ResMed Hospital Nasal Mask Clip Assembly Lower : : Headgear White Elastic Button Hole Tape 70% Polyester 30% non Latex elastomer For further information, please contact your nearest ResMed office. See for details. Mirage, Ultra Mirage, Mirage Vista, Kidsta, Activa, Mirage Swift, Swift, Mirage Quattro, Mirage Liberty and Mirage Micro are trademarks of ResMed Ltd. Velcro is a registered trademark of Velcro Industries B.V ResMed Ltd /