ComfortGel Full - Philips Healthcare
Contents
1. hiatal hernia It should not be used if the patient is uncooperative obtunded unresponsive or unable to remove the mask by themselves ComfortGel Full Symbols Description Symbol Warning or Caution Consult instructions for use Description Does not contain natural rubber latex System One Resistance Control Setting INSTRUCTIONS FOR USE Before Use Hand wash the mask to remove any dust that accumulated during shipping or storage Read and understand the instructions completely Verify that the air entrainment valve functions correctly Wash the patient s face Remove the Quick Start fitting tips if attached to the headgear Entrainment Valve The entrainment valve consists of an air inlet and a flapper With the airflow turned off verify that the elbow with the flapper is lying flat Figure 2 so that room air can flow in and out through the air inlet Next with the airflow on the flapper should now cover the air inlet 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 ComfortGel Full Figure 2 A Flapper is lying flat B Flapper is covering the air inlet N Warning Do not block or try to seal the entrainment valve or the exhalation vents Cleaning Hand wash the washed weekly nstructions mask before first use and2. daily The headgear should be hand 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 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 ake sure the mask is dry before use 3 Lay the headgear flat or line dry Do not place the headgear into the dryer 4 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 D isinfection Instructions to reprocess the mask between patients These instructions can be obtained by visiting www sleepapnea com contacting Respironics 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 i amp X 1 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
3. 01 Murry Ridge Lane Murrysville Pennsylvania 15668 1 800 345 6443 USA and Canada only or 1 724 387 4000 INSTRUCTIONS FOR USE Reorder Numbers 040135 S ComfortGel Full Face Mask w Headgear 040136 ComfortGel Full Face Mask w Headgear 040137 L ComfortGel Full Face Mask w Headgear 062004 XL ComfortGel Full Face Mask w Headgear 040568 S ComfortGel Full Face Mask w o Headgear 040569 ComfortGel Full Face Mask w o Headgear 040570 L ComfortGel Full Face Mask w o Headgear 062003 XL ComfortGel Full Face Mask w o Headgear 044861 RP S ComfortGel Full Flap and Cushion 044862 RP M ComfortGel Full Flap and Cushion 044863 RP L ComfortGel Full Flap and Cushion 062032 RP XL ComfortGel Full Flap and Cushion 040798 RP S ComfortGel Full Face Mask Cushion 040799 RP M ComfortGel Full Face Mask Cushion 040800 RP L ComfortGel Full Face Mask Cushion 062030 RP XL ComfortGel Full Face Mask Cushion ComfortGel Full 040795 040796 040797 062031 040138 040139 040114 049398 23 Reorder Numbers RP S ComfortGel Full Face Mask Flap RP M ComfortGel Full Face Mask Flap RP L ComfortGel Full Face Mask Flap RP XL ComfortGel Full Face Mask Flap RP ComfortGel Full Headgear RP Mushroom Swivel Clips Blue RP Silicone Pillow Forehead Pad RP ComfortGel Full Entrainment Valve Swivel Blue INSTRUCTIONS FOR USE 24 ComfortGel Full
4. Face 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 and multi patient use in the hospital institutional environment The mask is to be used on patients gt 66lbs 30kg who appropriate candidates for noninvasive ventilation Important Note An exhalation port is built into the ComfortGel Full Face Mask so a separate exhalation port is not required AN Caution US Federal law restricts this device to sale by or on the order of a physician INSTRUCTIONS FOR USE Warnings e his mask is not suitable for providing life support ventilation his mask is designed for use with CPAP or A bi level systems recommended by your health Warning care professional or respiratory therapist Do A warning indicates the not wear this mask unless the CPAP or bi level possibility of injury to the system is turned on and operating properly Do user or operator not block or try to seal the exhalation port Explanation of the Warning CPAP systems are intended to be used with special masks with A connectors which have vent holes to allow Caution continuous flow of air out of the mask When caution indicates the he CPAP machine is turned on and functioning possibility of damage to properly new air from the CPAP machine the device flushes the exhaled air out through the attached mask exhalation port However when the CPAP machine
5. PHILIPS Respironics Inc 1001 Murry Ridge Lane PHILIPS Murrysville PA 15668 USA i ComfortGel Full instructions ror use ud jwoweno RESPIRONICS 2010 Koninklijke Philips Electronics All rights reserved ComfortGel Full Full Face Mask Table of Contents 2 Package Contents 4 Intended Use 5 Warnings 7 Contraindications 8 Before Use and Disposal 9 Symbols 10 Cleaning Instructions 11 Removing the Headgear from the Mask 12 Attaching the Headgear to the Mask 14 Achieving the Right Fit 17 Troubleshooting Tips 20 Removing the Mask and Headgear 21 Tubing Quick Release 22 Replacing the Forehead Pad 23 Cushion and Flap Assembly 24 Specifications 26 Limited Warranty 28 Reorder Information INSTRUCTIONS FOR USE Package Contents Com inclu Sure Com Instructions for Use Quid fortGel Full Face Mask Seal Technology SST fortGel Full Headgear Start Fitting Tips ComfortGel Full des gel cushion and Comfort Flap with Note Not all packages contain listed items Please contact your Home Care Provider or Respironics for additional items Figure 1 A Forehead Support Slots B Forehead Bracket C StabilitySelector D Forehead Pad E Exhalation Port Do not block F Pick Off Port G Entrainment Valve inside mask elbow H Quick Clip Swivel Swivel Release Intended Use The ComfortGel Full
6. 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 Intentional Leak Jy Whisper Swivel Il H ComfortGel Full amp E m g 9 ri a e 5 E d x n 16 20 24 Pressure cm H O hPa ComfortGel Full 19 Pressure Drop cm H O hPa 50SLPM 100 SLPM All mask sizes 4 1 0 Deadspace Small 260 mL Medium 280 mL Large 300 mL X Large 320 mL Disposal Dispose of in accordance with local regulations Storage Conditions 4 to 140 F 20 to 60 C 1526 to 9576 relative humidity non condensing INSTRUCTIONS FOR USE 20 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 th
7. e 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 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 ComfortGel Full 21 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 10
8. is not operating enough fresh air will N te not be provided through the mask and exhaled air may be rebreathed This warning applies to A note places an most models of CPAP systems Rebreathing of emphasis on an operating exhaled air for longer than several minutes can characteristic in some circumstances lead to suffocation ComfortGel Full Warnings cont If oxygen is used with the device the oxygen flow must be turned off when the device 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 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 f this happens discontinue use and contact your healthcare professional The patient s physician should be contacted if the patient experiences the following symptoms while using the mask or after removing it Unusual chest discomfort shortness of breath stomach d
9. istension belching or severe headache drying of the eyes eye pain or eye infections blurred vision Consult an ophthalmologist if symptoms persist 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 INSTRUCTIONS FOR USE Warnings cont e Aminimum of 3cm H O hPa must be maintained when using this mask This mask should not be used for patients who are uncooperative obtunded unresponsive or unable to remove the mask This masks is not recommended for patients who are taking a prescription drug that may cause vomiting When including an additional exhalation device to the patient circuit you may need to adjust the pressure level to compensate for the additional leak of the exhalation device The gel mask is not customizable Do not attempt to heat Hand wash prior to first use Inspect the mask If any visible deterioration of a system component is apparent cracking crazing tears or cushion damage resulting in gel exposure etc the component should be discarded and replaced Using a mask may cause tooth gum or jaw soreness or aggravate an existing dental condition If symptoms occur consult your physician or dentist Contraindications This mask may not be suitable for persons with the following conditions impaired cardiac sphincter function excessive reflux impaired cough reflex and
10. mask cushion changes 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 ComfortGel Full 11 Replacing the Forehead Pad The forehead pad will slide off and on the track of the forehead pad bracket Figure 3 The forehead pad is strong and will stretch without tearing Figure 3 A Forehead Pad Tab B Forehead Pad Slot C StabilitySelector D Forehead Support Arm E Forehead Bracket F Headgear Bracket Slot G Forehead Pad Note Do not detach the StabilitySelector from the faceplate rail INSTRUCTIONS FOR USE 12 Removing and Attaching the Headgear and Mask Method 1 Brackets a Removing Undo the four headgear tabs on the headgear Figure 4 and pull the straps out of the forehead bracket slots and on the Quick Clips b Reattaching Thread the top headgear straps into the slots in the forehead bracket and the Quick Clips The headgear tabs fold back to catch the headgear straps Method 2 Ball Sockets a Removing Disconnec forehead support arm Pull the Quick Clip ball up and away from the socket Figure 5 Do not pull the ball through the socket Next disconnect the f
11. orehead bracket from the fore head support arm by pressing in on the center of the forehead bracket and then squeezing the upper sides of the support arm together to disengage the forehead bracket Figure 6 ComfortGel Full the Quick Clips and Figure 5 13 b Reattaching Place the ball against the socket and gently press the ball into the socket Press in on the center of the forehead bracket and then squeeze the upper sides of the support arm together Slide the tabs into the forehead bracket until they latch into place Mask Use and Fit 1 Open the headgear to a large size setting and adjust the forehead arm to the highest position To adjust gently squeeze the arms of the StabilitySelector and slide the arm upwards 2 Disconnect one or both of the Quick Clips Place the mask cushion against the face by first setting the base of the cushion under the lower lip then roll the cushion up the nose Be sure the mouth remains slightly open Pull the headgear on over your head Connect the Quick Clips if detached 3 Using both hands adjust the top headgear strap first by using the headgear tabs on the headgear The forehead pad should be touching your forehead lightly Adjust the INSTRUCTIONS FOR USE bottom strap so that the mask is sitting gently on your face 4 Connect the tubing that is included with your CPAP or bi level device to the swivel elbow on
12. the mask Figure 7 5 Turn on the airflow 6 Lie down and breathe normally Be sure the mouth remains slightly open If the forehead pad does not rest comfortably against your forehead Tighten the top headgear strap If there are any air leaks make any final adjustments Some air leakage is normal Do not overtighten the headgear Comfort Tips Adjust the StabilitySelector on the forehead support arm to reduce leaks or reduce pres sure points at the bridge of the nose or above the lip Follow these tips to adjust for leaks Forleaks around the bridge of the nose or into the eyes gently squeeze the arms of the StabilitySelector and adjust to a lower position Figure 8 ComfortGel Full For leaks around or below the mouth gently squeeze the arms of the StabilitySelector and adjust to a higher position Re seat the mask by pulling it directly away from the face and gently setting it back into place Figure 9 The most common mistake is overtightening the headgear The headgear should fit loose and comfortable If your skin bulges around the mask loosen the headgear straps If you see red marks or the mask leaves impressions on your skin loosen the headstraps Figure 10 INSTRUCTIONS FOR USE 15 16 Taking Off the Headgear and Mask 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 p
13. ull the ball out of the socket away from your face After the Quick Clip is disengaged slide the mask over your face Figure 11 By using the Quick Clip you ll be able to maintai gear adjustments every Tubing Quick Release to remove your mask n your mask and head day The mask elbow is equipped with a tubing quick release Simply squeeze the quick release tabs and the blue swivel will disengage from the mask and come loose with the tubing Figure 12 Note to Home Care Providers If a nasogastric tube or similar device is in place use an optional nasogastric 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 ComfortGel Full 17 Assembling the Cushion and Flap Remove the Gel cushion by detaching the comfort flap with its integrated retaining ring from the faceplate Do this by pressing on the faceplate tabs at the bottom of the mask Clean or discard the cushion as necessary First place the Gel cushion onto the faceplate Figure 13 Then put the Comfort Flap over the Gel cushion and push the retaining ring onto the faceplate until the connection tabs click into place Gently tug on the cushion to make sure all of the parts are securely in place o Figure 13 A Mask Faceplate B Gel Cushion C ComfortFlap with Retaining Ring INSTRUCTIONS FOR USE 18 Specifications AN
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