ComfortFull 2 - Sherman Oaks Medical
Contents
1. Tips You may need to adjust the StabilitySelector on the forehead support arm Figure 13 to reduce leaks or reduce pressure points at the bridge or above the lip Follow these tips to adjust for leaks e For leaks around the bridge of the nose or into the eyes gently squeeze the arms of the StabilitySelector and adjust to a lower position Figure 13 For leaks around or below the mouth gently AE He StabilitySelector squeeze the arms of the StabilitySelector and fo lassen Jeaks adjust to a higher position Reseat the mask by pulling it directly away from the face and gently setting it back into place INSTRUCTIONS FOR USE 22 Replacing the Forehead Pad If you need to replace the forehead pad Figure 14 follow these instructions To remove Slide the pad outward toward one edge of the forehead support and lift it upward so the connection track on that side is released from the plastic connection slot Next pull the pad in the opposite direction to release the connection track on the other side from its connection slot Figure 14 Replace the forehead pad A Connection Track B Connection Slot C Forehead Support D Forehead Pad ComfortFull 2 To attach Slide one of the new pad s connection tracks on the new pad into its connection slot on the support Pull the pad in the opposite direction toward the center and slide the other connection track into its conne2. block or try to seal the large y 8 opening or the exhalation ports on the valve Z Warning Ensure that the valve is not blocked Fisure igure with secretions and that the flapper is dry Chek h eck the entrainment valve INSTRUCTIONS FOR USE 16 ext with the airflow on Figure 6B the apper should now cover the large opening and air from the CPAP or bi level device should flow into the mask If the flapper does not close or does not function properly replace the mask 3 Put on the mask Figure 7 Simply hold the mask cushion gently over your nose and mouth Pull the headgear on over your head Connect the Quick Clip if detached Figure 7 Put on the Mask ComfortFull 2 17 First adjust the top headgear straps evenly and at the same time using the EZPeel tabs on the headgear The forehead pad should be touching your forehead lightly Adjust the bottom strap so that the mask is sitting gently on your face The headgear should stay loose Do not overtighten You should be able to run a finger under the headgear straps Figure 8 Figure 8 Run a finger under the headgear to make sure it is loose to start INSTRUCTIONS FOR USE 18 5 Connect the tubing Figure 9 that is included with your CPAP or bi level device to the swivel elbow on the mask 6 Tum on the airflow 7 Lie down and breathe normally th
3. 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 66 Ibs 30 kg for whom CPAP or bi level therapy has been prescribed Important Note An exhalation port is built into the ComfortFull 2 Full Face Mask so a separate exhalation port is not required ComfortFull 2 A Warnings support level sys professional or respiratory therapist this mas turned on and o This mask is designed for use with C ventilation ems recommended by your unless the CPAP or bi level This mask is not suitable for providing life PAP or bi health care Do not wear system is perating properly Do not block or try to seal the exhalation port Explanation of the Warning CPAP systems are intended used wi vent ho h special masks with connec the mask When the CPAP machine ors whi es to allow continuous flow of air ou o be ch have of is turned on and functioning properly new air from the C machine flushes the exhaled air out tl hrough PAP he attached mask exhalation port However when the CPAP machine is not operating enough fresh air will not be provided through the mask and exhal may be rebreathed This warning applies to most models of CPAP systems Rebreathing of ex air for longer than several minutes can in some circumstances lead to suffocation If oxy
4. 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 INSTRUCTIONS FOR USE 28 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 STATE TO 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 ComfortFull 2
5. NN RESPIRONICS Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 USA 1067749 y DHOO ComfortFull 2 2010 Koninklijke Philips Electronics N V All rights reserved INSTRUCTIONS FOR USE ComfortFull 2 Full Face Mask Table of Contents Package Con Intended Use Warnings Contraindica Symbols Before Use ents ions and Disposal Cleaning Instructions System One Resistance Control Removing and Attaching the Headgear Achieving the Right Fit Removing the Headgear and Mask Tubing Quick Replacing the Specifications Release Troubleshooting Leaks Forehead Pad Reorder Information Limited Warranty INSTRUCTIONS FOR USE Package Contents ComfortFull 2 mask e Headgear Mask assembly e Instructions for use Quick Start fitting tips Note Not all packages contain listed items Please contact your Home Care Provider or Respironics for additional items or replacement parts ComfortFull 2 ComfortFull 2 Full Face Mask Figure 1 A StabilitySelector B Exhalation Port Do not block C Entrainment Valve D Elbow Swivel E Tubing Quick Release F Quick Clip Socket G Port Cap H Cushion Forehead Support INSTRUCTIONS FOR USE A Caution US federal law restricts this device to sale by or on the order of a physician Intended Use The ComfortFull 2 Full Face Mask is intended to provide an interface for application of CPAP or bi level
6. ar replace any parts that have visibly deteriorated cracking crazing tears etc Replace the mask if the cushion becomes hardened ComfortFull 2 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 11 12 System One Resistance Control This mask uses the System One Resistance Control setting X11 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 e The System One setting is not compatible with masks requiring a separate additional 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 your provider has disabled the resistance compensation you will not see this setting ComfortFull 2 13 Removing and Attaching the Headgear Please use one of the following methods to remove or attach the headgear Figure 2 e Method One Undo the four EZPeel tabs Undo EZPeel Tabs Figure 2 on the headgear and pull the st
7. ction slot to lock the pad into place 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 device 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 23 Note for Home Care Providers If a nasogastric NG tube or similar device is in place use the optional NG tube sealing pad Position the pad so that its flat surface is against the user s face and the C shaped opening surrounds the tube INSTRUCTIONS FOR USE 24 Intentional Leak Whisper Swivel II E ComfortFull 2 Exhaust Leak Rate SLPM 4 8 12 20 Pressure cm H20 hPa 30 Pressure Drop cm H O hPa 50 SLPM 100 SLPM All mask sizes 0 4 1 0 Deadspace Small 280 cc Medium 392 cc Large 434 cc ComfortFull 2 Storage Conditions 4 to 140 F 20 to 60 C 15 to 95 relative humidity non condensing INSTRUCTIONS FOR USE 25 Reorder Numbers 004880 Co fortFull 2 Mask with Premium Headgear S 004872 ComfortFull 2 Mask with Premium Headgear M 004950 ComfortFull 2 Mask with Premium Headgear L 010868 ComfortFull 2 Mask only S fo fo iu 010869 C
8. gen is used with this device the oxygen flow must be turned off when the machine is 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 ed air haled A Warning Indicates the possibility of injury to the user or operator A Caution Indicates the possibility of damage to the device e Note A note places an emphasis on an operating characteristic INSTRUCTIONS FOR USE 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 he presence of an open flame Ata 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 or bi level machines Some users may experience skin redness irritation or discomfort If this happens discontinue use and contact your healthcare professional e The patient s physician should be contacted if the patient experiences the following symptoms while using the masks or after removing it Unusual chest discomfort shortness of breath stomach distension belching or sever headache drying of the eyes eye pain or eye infections blurred vision Consult an ophthalmologist if symptoms pers
9. ist At low CPAP or EPAP pressures the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing Some rebreathing may occur A minimum of 3 cm H O hPa must be maintained when using this mask This mask should not be used on patients who are uncooperative obtunded unresponsive or unable to remove the mask This mask is not recommended if the patient is taking a prescription drug that may cause vomiting e If an additional exhalation device is added to the patient circuit you may need to adjust the pressure level to compensate for the additional leak of the exhalation device ComfortFull 2 e Hand wash prior to first use Inspect the mask for damage or wear cracking crazing tears etc Discard and replace any components as necessary e Use of a nasal or full face mask may cause tooth gum or jaw soreness or aggravate an existing dental condition Consult your physician or dentist if symptoms occur Do not block or try to seal the entrainment valve Contraindications This mask may not be suitable for persons with the following conditions impaired cardiac sphincter function excessive reflux impaired cough reflex and hiatal hernia It should not be used if the person is uncooperative obtunded unresponsive or unable to remove the mask by themselves Disposal Dispose of in accordance with local regulations INSTRUCTIONS FOR USE Symbols Symbol Description Con
10. o Full 2 Mask only M 010870 Co Full 2 Mask only L 033678 Premium Headgear with EZPeel tabs 014333 ComfortHeadgear t5 2040 G Tube Sealing Pad 10 pack 018401 Forehead Support and Pad 009722 Silicone Forehead Pads 4 Pack 009723 Quick Clips 2 pack 004871 Entrainment Valve Swivel 010872 Portcap 5 pack Visit www sleepapnea 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 1027825 ComfortFull 2 27 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 literature and other defects not related to materials or
11. raps out of the slots in the forehead support and on the Quick Clips e Method Two Disconnect the Quick Clips and Forehead Support Arm Pull the Quick Clip ball up and away from the socket Figure 3 Do not pull the ball through the socket Figure 3 Pull the ball up and away and not through the socket A Quick Clip Ball B Faceplace Socket INSTRUCTIONS FOR USE 14 Next disengage the forehead support pad Figure 4 from the forehead support arm by pressing in on the center of the forehead support pad and then squeezing the upper sides of the support arm together to disengage the forehead support pad To attach press the ball into the socket Figure 4 Disconnect the Forehead Support Press center tab and squeeze ribbed sides of the support arm ComfortFull 2 15 Achieving the Right Fit 1 Open the headgear to a large setting and adjust the forehead arm Figure 5 to the highest position To adjust gently squeeze the arms of the StabilitySelector and slide the arm upwards To make it easier to place the mask and Adjust the headgear on your face we recommend forehead arm disconnecting one of the Quick Clips 2 Check the Entrainment Valve located inside he mask elbow With the airflow turned off verify that the entrainment valve flapper is lying flat so that room air can flow through the large opening in he valve Figure 6A B f A Warning Do not
12. rough your nose keeping your lips closed If the forehead support does not rest comfortably against your forehead tighten the top headgear strap Figure 9 Connect the tubing to the swivel elbow ComfortFull 2 Assume different sleeping positions Figure 10 and move your head around If there are any air leaks make any final adjustments Some air leakage is normal Do not overtighten the headgear Overtightening the headgear may cause discomfort or irritation Q Comfort Tip Keep the headgear loose The improved headgear keeps its elasticity longer and better Figure 10 Lie down and assume different sleeping positions Make any minor adjustments but DO NOT overtighten the headgear INSTRUCTIONS FOR USE 19 20 Removing the Mask and Headgear To take off the mask and headgear first remove one or both Quick Clips from the mask sockets Grasp the body of the Quick Clip and gently pull the ball out of the socket away from your face After the i Figure 11 Quick Clip is disengaged slide the mask over your Disengage the Quick head Figure 11 Clips and slide mask off Tubing Quick Release The mask elbow is equipped with a Tubing Quick Release Figure 12 Simply squeeze the quick release tabs and the grey swivel will disengage from the mask and come loose with the tubing Figure 12 Tubing Quick Release ComfortFull 2 21 Q Comfort
13. sult instructions for use General caution or warning Tip System One Resistance Control ComfortFull 2 Before Use Hand wash the mask to remove particles that may have accumulated during shipping or storage Read and understand the instructions completely Verify that the entrainment valve functions correctly e Wash face e Remove the quick fit tips Comfort Tip 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 INSTRUCTIONS FOR USE 10 Cleaning Instructions Hand wash the mask before first use and daily The 6 Note headgear should be hand washed weekly or as It is not necessary to needed The headgear does not need to be removed disconnect the headgear for daily cleaning of the mask for daily use and cleaning 1 Hand wash the mask and headgear in warm water with a mild liquid dish washing detergent A Caution Do not use bleach alcohol cleaning solutions containing bleach or alcohol or cleaning solutions containing conditioners or moisturizers 2 Rinse thoroughly with drinking quality water and air dry out of direct sunlight Make sure he mask is dry before use Lay the headgear at or line dry Do not place the headgear into he dryer 3 Inspect all parts for damage or we
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