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Mirage TM Quattro Full Face Mask Elbow to Frame Interface - Overcoming objections related to leak and noise Mirage and Mirage Quattro are trademarks of ResMed Ltd and Mirage is registered in the U.S. Patent and Trademark Office Confidential – Not for distribution 1 Mirage Quattro Sizing & Fitting Training © ResMed 2008 July 110182/1 Global leaders in sleep and respiratory medicine Mirage Quattro Elbow to Frame Leak and Noise In September 2007, the Mirage Quattro frame design was modified to reduce the magnitude of leak and noise at the elbow-to-frame interface. – Product Bulletin: #513 – Implementation date: September 2007 – Lot number cut in: Various – refer to Product Bulletin – Description of change: The frames were modified to reduce the clearance between the contact surfaces of the elbow and frame. The image shows the area of the frame that was modified (ring shown is on inside surface of mask frame). Confidential – Not for distribution 2 Mirage Quattro Sizing & Fitting Training © ResMed 2008 July 110182/1 Mirage Quattro Elbow to Frame Leak Comparison - After Frame Design Fix Product Leak at Elbow (non-vent flow) UMFFM 6.5 l/min Quattro at launch 9.0 l/min Quattro (after frame modification - PB#513) 5.5 l/min The result of the frame modification was to successfully reduce the leak at the elbow interface from 9.0 litres per minute to 5.5 litres per minute. Confidential – Not for distribution 3 Mirage Quattro Sizing & Fitting Training © ResMed 2008 July 110182/1 Mirage Quattro Elbow Design Enhancement Leak at the elbow-to-frame interface has been further reduced though a design change to the elbow. The new elbow design incorporates a much larger sealing area which not only reduces leak but makes the elbow much less likely to leak under extreme elbow loads (tube drag). Old elbow – Product Bulletin: #538 Sealing area on elbow – Implementation date: August 2008 (elbow spares only) Mask system introduction date TBA – Lot number cut in: 205281 (61294 & 61282 only) Mask system lot number cut in TBA – Description of change: The elbow design has been modified at the point where it connects to the mask frame. The image shows the detail of the change. Confidential – Not for distribution 4 Mirage Quattro Sizing & Fitting Training © ResMed 2008 July 110182/1 New elbow Mirage Quattro Elbow to Frame Leak Comparison – New Elbow Design Product Leak at Elbow (non-vent flow) UMFFM 6.5 l/min Quattro at launch 9.0 l/min Quattro (after frame modification - PB#513) 5.5 l/min Quattro (after elbow modification - PB#538) 2.0 l/min Confidential – Not for distribution 5 Mirage Quattro Sizing & Fitting Training © ResMed 2008 July 110182/1 FAQs Q. Why have we continued to see a low rate of returns for elbow leak since September 2007? A. In almost all cases since September 2007 where mask product has been returned to ResMed for investigation of elbow leak the frame has been found to have been manufactured prior to the design change described in PB#513. Confidential – Not for distribution 6 Mirage Quattro Sizing & Fitting Training © ResMed 2008 July 110182/1 FAQs Q. Why has the elbow design been modified given the success of the change to the mask frame in reducing elbow-to-frame leak? A. The current elbow design relies very heavily on maintaining tight clearances between the elbow and the mask frame to keep leak at an acceptable level. In an effort to make the design less susceptible to manufacturing variation and to further reduce the level of leak between the elbow and the frame the elbow design has been improved. The design change significantly increases the sealing area between the elbow and the frame and makes the elbow very resistant to leak even under side loading conditions (tube drag). Confidential – Not for distribution 7 Mirage Quattro Sizing & Fitting Training © ResMed 2008 July 110182/1 FAQs Q. Can the new elbow design be retrofitted to masks already in the field in order to overcome leak or noise issues? A. Yes. If you are still experiencing leak on existing Mirage Quattro masks in the field, it is possible to supply the new elbow to overcome the problem. The new elbow design is currently available in the following accessory product codes; 61294 – Elbow assembly 61282 – Elbow spare Production tooling is currently being modified to support the capacity requirements for implementation of this change on the assembly line. The planned date for unlimited release of Mirage Quattro mask products containing the new elbow to the field is fourth quarter 2008. Confidential – Not for distribution 8 Mirage Quattro Sizing & Fitting Training © ResMed 2008 July 110182/1 FAQs Q. When will the new elbow design be made available on all Mirage Quattro mask systems? A. Production tooling is currently being modified to support the capacity requirements for implementation of this change on the assembly line. The planned date for unlimited release of Mirage Quattro mask products containing the new elbow to the field is fourth quarter 2008. Confidential – Not for distribution 9 Mirage Quattro Sizing & Fitting Training © ResMed 2008 July 110182/1