ComfortFusion - Philips Healthcare
Contents
1. your provider has disabled the resistance compensation you will not see this setting ComfortFusion 11 Removing the Headgear from the Mask Please use one of the following methods to remove he headgear from the mask Method 1 Undo the four headgear tabs Figure 2 on the Undo Headgear Tabs headgear and pull the straps out of the slots in the forehead support bracket and on the Quick Clips Method 2 Disconnect the Quick Clips Pull the Quick Clip ball up and away from the socket Figure 3 Do not pull he ball through the socket Leave the top headgear straps attached Pull the ball up and away from the socket not through the socket INSTRUCTIONS FOR USE 12 Disconnect the forehead support pad bracket Figure 4 from the forehead support arm by pressing in on the center of the forehead support pad and then squeezing the upper ribbed sides of the support arm together to disengage the forehead support pad Attaching the Headgear to Disconnect the Forehead the Mask Support Press center tab and squeeze ribbed 1 To reattach the headgear to the forehead sides of the support arm support arm thread the to pe into place Then connect pressing in on ComfortFusion and fold the tal 2 Attach the Qu he ball against he center o p headgear straps o the slots in the forehead support bracket bs to catch the headgear straps ick Clips to the mask by placing the socket2. 0768 ComfortFusion 0769 ComfortFusion 0770 ComfortFusion 0842 ComfortFusion 0843 ComfortFusion 0836 ComfortFusion 2205 ComfortFusion 2206 ComfortFusion 0840 Cushion and Re 0841 Cushion and Re 0773 Premium Forehe 0774 Premium Forehe 002720 Split Washer Kit 7041 Mask Swivel 008814 Retaining Ring 009723 Headgear Quick 0844 Fusion Headgear aining Ring S aining Ring M 23 Reorder Numbers as as as as as as as as ad ad 004395 Exhalation Elbow Kit wl wl wl wl wl No No No eadgear FitPack S M eadgear S Cushion eadgear M Cushion eadgear DuoPack S eadgear DuoPack M eadgear FitPack S M eadgear S Cushion eadgear M Cushion Support w Pad Blue Pad Blue 4 pack 5 pack 312 10 O Enrichment Attachment Clips 2 pack Visit wwwsleepapnea com for a complete list of products and reorder numbers or contact Customer Service at 1 800 345 6443 USA or Canada only or 1 724 387 4000 to obtain a product catalog REF 1027825 INSTRUCTIONS FOR USE 24 ComfortFusion
3. exhalation port However when the CPAP note places an machine is not operating enough fresh air will not emphasis on an be provided through the mask and exhaled air operating characteristic may be rebreathed This warning applies to most models of CPAP systems Rebreathing of exhaled air for longer circumstances If oxygen is us han several minutes can in some lead to suffocation ed with the device the oxygen flow must be turned off when the device is INSTRUCTIONS FOR USE not operating Explanation of the Warning When the device is not in operation and the oxygen flow is left on oxygen delivered into the ventilator tubing may accumulate within the device enclosure Oxygen accumulated in the device enclosure will create a risk of fire Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame At a fixed flow rate of supplemental oxygen flow the inhaled oxygen concentration will vary depending on the pressure settings patient breathing pattern mask selection and the leak rate This warning applies to most types of CPAP and bi level machines Some users may experience skin redness irritation or discomfort If this happens discontinue ues be inadequate to clear al may occur cracking crazing tears e as necessary Use of a nasal or full face aggravate an existing den symptoms occur f an additional exhalation need to adj
4. literature and other defects not related to materials or workmanship This warranty does not apply to any Product that may have been repaired or altered by anyone other than Respironics Respironics disclaims all liability for economic loss loss of profits overhead or indirect consequential special or incidental damages which may be claimed to arise from any sale or use of the Product Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you THIS WARRANTY IS GIVEN IN LIEU OF ALL OTHER EXPRESS WARRANTIES IN ADDI TION ANY IMPLIED WARRANTY INCLUDING ANY WARRANTY OF MERCHANTABIL ITY OR FITNESS FOR A PARTICULAR PURPOSE IS SPECIFICALLY DISCLAIMED SOME STATES DO NOT ALLOW DISCLAIMERS OF IMPLIED WARRANTIES SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS AND YOU MAY ALSO HAVE OTHER RIGHTS WHICH VARY FROM STATETO STATE To exercise your rights under this limited warranty contact your local authorized Respironics Inc dealer or Respironics Inc at 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 1 800 345 6443 USA and Canada only or 1 724 387 4000 Respironics StabilitySelector and Whisper Swivel are registered trademarks and Comfort Fusion Quick Clip DuoPack FitPack and Fusion Headgear are trademarks respectively of Respironics Inc and its affiliates Latex free ComfortFusion
5. restricts this device to sale by or on the order of a physician Intended Use The ComfortFusion Nasal Mask is intended to provide an interface for application of CPAP or bi level therapy to patients The mask is for single patient use in the home or multi patient use in the hospital institutional environment The mask is to be used on patients gt 66lbs 30kg for whom CPAP or bi level therapy has been prescribed Important Note An exhalation port is built into the ComfortFusion Nasal Mask so that a separate exhalation port is not required ComfortFusion Warnings This mask is n support ventil This mask is d ot suitable for providing life ation esigned for use with CPAP or IN Warning bi level systems recommended by your health care professio not wear this system is turn nal or respiratory therapist Do A warning indicates the mask unless the CPAP or bi level possibility of injury to ed on and operating properly Do the user or operator not block or try to seal the exhalation port A Explanation of the Warning CPAP systems are Caution intended to be used with special masks with connectors w continuous flow of air out of the mask When A caution indicates the hich have vent holes to allow possibility of damage to the CPAP machine is turned on and functioning thie device properly new air from the CPAP machine flushes 6 ote the exhaled air out through the attached mask
6. PHILIPS Respironics Inc i 1001 Murry Ridge Lane PHILIPS Murrysville PA 15668 USA 1067759 j i n urrysville ae ComfortFusion 2010 Koninklijke Philips Electronics N V All rights reserved i INSTRUCTIONS FOR USE RESPIRONICS ComfortFusion Nasal Mask Table of Contents O ONUA N E Co NUT UL NN CD N 22 23 Package Contents Intended Use Warnings Symbols Before Use Cleaning Instructions System One Resistance Control Removing the eadgear from the Mask Attaching the Headgear to the Mask Achieving the Right Fit Troubleshooting Leaks Removing the Headgear and Mask Assembling the Retaining Ring and Cushion Specifications Limited Warranty Reorder Information INSTRUCTIONS FOR USE Package Contents eG ComfortFusion nasal mask Note Not all packages Headgear contain listed items e Mask assembly Please contact your Cushion and Flap Home Care Provider or Instructions for use Respironics for additional e QuickStart fitting tips Mad DuoPacks and FitPacks may include extra cushion and flap with integrated retaining ring ComfortFusion ComfortFusion Nasal Mask o Figure 1 A Forehead pad B Headgear tab C Forehead support arm with StabilitySelector D Cushion E Exhalation port Do not block F Tubing connects to CPAP device G Quick Clip INSTRUCTIONS FOR USE CAUTION US federal law
7. ach alcohol cleaning solutions containing bleach or alcohol or cleaning solutions containing conditioners or moisturizers ComfortFusion 2 Rinse thoroughly with drinking quality water and air dry out of direct sunlight Make sure the mask is dry before use Lay the headgear flat or ine dry Do not place the headgear into the dryer 3 Inspect all parts for damage or wear replace any parts that have visibly deteriorated cracking crazing tears etc Replace the mask if the cushion becomes hardened For multi patient use in the hospital institutional environment use the Mask Cleaning and Disinfection Instructions to reprocess the mask between patients These instructions can be obtained by visiting www sleepapnea com or contacting Customer Service at 1 800 345 6443 USA or Canada or 1 724 387 4000 INSTRUCTIONS FOR USE 10 System One Resistance Control This mask uses the System One Resistance Control setting 1 X1 This symbol may appear on your therapy device This symbol represents the level of mask resistance compensation Match the setting to the mask if appropriate Important Notes Verify the System One setting if the mask or mask cushion changes The System One setting is not compatible with masks requiring a separate exhalation device If your provider has locked the resistance compensation setting you can view the setting but cannot change it and the screen will display a lock symbol If
8. and gently pressing he forehead support arm by f the forehead support pad and then squeezing the upper 13 sides of the support arm together and sliding the tabs into the forehead support pad until they latch into place Achieving the Right Fit 1 Open the headgear to a large setting and adjust the forehead arm Figure 5 to the Forehead Arm gently highest position To adjust gently squeeze squeeze the arms the arms of the StabilitySelector and slide the arm upwards 2 Disconnect one or both of the Quick Clips Hold the mask cushion over your nose Figure 6 and pull the headgear on over your head Connect the Quick Clips if detached gt Put on the mask INSTRUCTIONS FOR USE 14 3 Adjustthe top headgear strap Figure 7 using both hands and move the headgear tabs to a comfortable position The forehead pad should be touching the forehead lightly Adjust the bottom s rap so that the mask is sitting gently on the face 4 Connect or bi leve the mask he tubing included with your CPAP device to the swivel elbow on 5 Turn on the airflow 6 Lie down and breathe normally through your nose keeping your lips closed If the forehead support d oes not rest comfortably against your forehead tighten the top headgear strap ComfortFusio n Figure 7 Adjust the top strap 15 Troubleshooting Leaks You may need to adjust the fore
9. ce If used outside these specifications or if used with incompatible devices the mask may be uncomfortable the seal of the mask may not be effective optimum therapy may not be achieved and leak or variation in the rate of leak may affect device function Deadspace Volume S 130ml M 140ml Pressure Drop cm H O hPa 50 SLPM 100 SLPM S 01 0 4 M 01 0 4 ComfortFusion Intentional Leak 4 Whisper Swivel Wi ComfortFusion 2 2 d Pressure cm H O hPa Storage Conditions 4 to 140 F 20 to 60 C 15 to 95 RH non condensing INSTRUCTIONS FOR USE 21 22 LIMITED WARRANTY Respironics Inc warrants that its mask systems including mask frame and cushion the Product shall be free from defects of workmanship and materials for a period of ninety 90 days from the date of purchase the Warranty Period If the Product fails under normal conditions of use during the Warranty Period and the Product is returned to Respironics within the Warranty Period Respironics will replace the Product This warranty is non transferable and only applies to the original owner of the Product The foregoing replacement remedy will be the sole remedy for breach of the foregoing warranty This warranty does not cover damage caused by accident misuse abuse negligence alteration failure to use or maintain the Product under conditions of normal use and in accordance with the terms of the product
10. head support arm to reduce leaks or pressure points at the bridge of the nose or above the lip We offer these tips to adjust Fo for leaks r leaks around StabilitySelector Fo r leaks under the bridge of the nose or into the eyes gently squeeze the arms of the and adjust to a lower position he nose or near the lip gently squeeze the arms of the StabilitySelector and adj ust to a highe r position Recseat the mask by pulling it directly away from the face and gen ly setting it back into place INSTRUCTIONS FOR USE 16 Removing the Headgear amp Mask Disconnect one or both Quick Clips from the mask sockets e Grasp the body of the Quick Clip and gently pull it out of the socket away from the face After the Quick Clip is disengaged slide the mask over your head o Figure 8 To Remove disconnect a Quick Clip or both and slide mask over head ComfortFusion 17 Headgear Tightness The most common mistake is overtightening the headgear The headgear should fit loose and the mask and headgear should feel comfortable when worn e f your skin bulges around the mask loosen the headgear straps e f you see red marks or the mask leaves impressions on your skin loosen the headgear Troubleshooting Adjust straps the StabilitySelector to You should be able to easily run a finger under lessen leaks he headgear straps Comfort Tip Do not overtigh
11. ten the headgear straps Overtightening can cause or worsen leaks INSTRUCTIONS FOR USE 18 Assembling the Retaining Ring and Cushion To Remove Unhook the retaining clips Figure 10 on the bottom and the sides of the mask Step 1 Remove the retaining ring Step 2 Remove the cushion o Figure 10 Unhook the Retaining Clips Remove the retaining ring first then remove the cushion A Faceplate B Cushion C Retaining Clip ComfortFusion 19 To Attach First note the cutouts on the bottom of the cushion and the alignment marks Figure 11 on the bottom of the cushion faceplate and retaining ring Step 1 Place the cushion against the faceplate Step 2 Put the retaining ring around the cushion Press the ring Figure 12 firmly against the faceplate until all three sides click into place Gently tug on the cushion and the ring to make sure all of the parts are securely in place A Alignment Marks The mask faceplate and retaining ring are marked for easy assembly Figure 12 Press the Ring All three sides should click into place A Faceplate B Cushion C Retaining Clip INSTRUCTIONS FOR USE 20 Disposal Dispose of in accordance with local regulations Specifications A Warning The technical specifications of the mask are provided for your healthcare professional to determine if it is compatible with your CPAP or bi level therapy devi
12. ust the pressu he exhalation device ComfortFusion and contact your health care professional At low CPAP or EPAP pressures the flow through the exhalation port may exhaled gas from the tubing Some rebreathing Hand wash prior to first use Inspect the mask for damage or wear C Discard and replace any components mask may cause tooth gum or jaw soreness or al condition Consult your physician or dentist if device is added to the patient circuit you may re level to compensate for the additional leak of Symbols Symbol Description A General Caution or Warning BA Consult instructions for use X1 System One Resistance Control INSTRUCTIONS FOR USE Before Use Hand wash the mask Read and understand the instructions completely e Wash your face Remove the Quick Start fitting tips if attached to the headgear If you have sensitive skin you can condition the mask before use To condition create a bath of warm soapy water and soak the mask for 30 60 minutes Use a mild detergent free of conditioners moisturizers or bleaching agents Rinse thoroughly and air dry Cleaning Instructions Hand wash the mask before first use and daily The headgear should be hand washed weekly or as needed The headgear does not need to be removed for daily cleaning of the mask 1 Hand wash the mask and headgear in warm water with a mild liquid dish washing detergent Caution Do not use ble
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