ComfortGel - Philips Healthcare
Contents
1. Note the cutout on the top of the flap ring 1 Place the cushion against the faceplate 2 P 3 Put the flap with ring around the cushion Figure 14 s ace the gel cushion into the faceplate nd press the connection points Figure 5 firmly against the faceplate until the des click into place Loosen the bottom and sides of the retaining ring SA 4 Gently tug on the cushion and the ring to make sure all of the parts are securely in place i Figure 15 A Forehead pad B Faceplate Connection Point C Gel Cushion D Flap with Integrated Retaining Ring COMFORTGEL 25 Operating and Storage Conditions Operating 41 to 104 F 5 to 40 C 15 to 95 relative humidity non condensing Storage 4 to 140 F 20 to 60 C 15 to 95 relative humidity non condensing Specifications 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 Instructions for Use 26 Intentional Leak Whisper Swivel Il m ComfortGel Exhaust Leak Rate SLPM Pressure cm H20 hPa2. Figure 7 Simply hold he mask cushion ge headgear and mask i ntly over nose and pull the headgear on over head Then reconnect the Quick Clip when the s on 3 Adjust the top Figure 8 headgear strap COMFORTGEL first by using the EZPeel tabs on the headgear The forehead pad should be ouching the forehead lightly Adjust the Figure 6 Adjust the forehead arm to the highest position Put on the mask 17 bottom strap so that the mask is sitting gently on the face Connect the flexible tubing Figure 9 included with the CPAP or bi level device to the swivel on the mask elbow Turn on the airflow Figure 8 Lie down Figure 10 and breathe normally through nose keeping lips closed Adjust the top strap If the forehead support does not rest comfortably against the forehead tighten the top headgear strap on the mask Figure 9 Connect the flexible tubing to the mask swivel The mask swivel connects to the mask elbow Instructions for Use 18 Figure 10 Lie down Breathe normally with lips closed Troubleshooting Leaks Adjust the forehead support arm 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 Figure 11 of the StabilitySelector and adjust to a lower position Troubleshooti
3. Pressure Drop cm H O hPa 50 SLPM__100 SLPM All mask sizes 0 1 0 25 Deadspace Petite Cushion 83 6 cc Small Cushion 111 4 cc Medium Cushion 121 3 cc Large Cushion 142 6 cc COMFORTGEL 1009040 1009041 1009042 medium 1009043 1010518 1010519 1010640 1010641 1033678 1002800 1009048 1009049 1009050 1009051 1009052 1009053 1009054 27 Reorder Numbers ComfortGel Mask with Premium Headgear P petite ComfortGel Mask with Premium Headgear S small ComfortGel Mask with Premium Headgear M ComfortGel Mask with Premium Headgear L large ComfortGel Mask P ComfortGel Mask S ComfortGel Mask M ComfortGel Mask L Premium Headgear w EZPeel tabs Deluxe Headgear Gel Cushion P Gel Cushion S Gel Cushion M Gel Cushion L Silicone Flap P Silicone Flap S Silicone Flap M Instructions for Use 28 1009109 1018401 1009722 1010646 7041 1009723 1002720 312710 Reorder Numbers Silicone Flap L Forehead Support and Pad Silicone Forehead Pads 4 pack Diffusion Elbow with Exhalation Kit Mask Swivel Headgear Quick Clips 2 pack Split Washer Kit O Enrichment Attachment Visit www respironics com for a complete list of products and reorder numbers or contact Customer Service at 1 800 345 6443 USA or Canada only or at 1 724 387 4000 to obtain a product catalog REF1027825 COMFORTGEL 29 LIMITED WARRANTY Respironics Inc warrants that tts mask systems inclu
4. set aside 3 Filla pan with enough water to cover the entire mask cushion Place the pan over medium heat and bring the water to a boil Instructions for Use 22 When the water reaches a boil turn off the heat Caution Do not place the gel cushion into the microwave 4 Hold the forehead support pad or use tongs and submerge the mask cushion into the hot water for 4 minutes 5 Carefully remove the mask from the hot water and submerge into the cold water Figure 13 for 10 seconds to cool the cushion Figure 13 Cool the Cushion Submerge for 10 seconds 6 Remove the mask from the cold water and shake off excess water A Warning Carefully touch the mask cushion 8 y to be sure that it has cooled enough to prevent irritation or burning COMFORTGEL 23 7 To form the gel cushion position the mask over nose and press the mask cushion gently against face Pull the headgear over head and connect the Quick Clips Do not apply excessive pressure to the cushion 8 Wear the mask for 5 minutes to allow the gel cushion to set 9 Remove the mask and headgear or connect the therapy device and use as directed Removing and Attaching the Flap and Integrated Ring To Remove 1 Loosen the bottom and the sides of the retaining ring Figure 14 2 Remove the Comfort Flap with the integrated retaining ring 3 Remove the cushion Clean or replace the cushion as needed Instructions for Use 24 To Attach
5. PHILIPS Respironics Inc 1001 Murry Ridge Lane l PHILIPS Murrysville PA 15668 USA ins ComfortGel ee JDH 3 3 2010 INSTRUCTIONS FOR USE RESPIRONICS COMFORTGEL Nasal Mask Table of Contents Package Contents Intended Use Warnings Symbols Before Use Cleaning Instructions System Remov Achievi Remov One Resistance Control ing and Attaching the Headgear ng the Right Fit ing the Headgear and Mask Customizing the ComfortGel Cushion Remov ing and Attaching the Flap and Integrated Ring Specifications Reorder Information Limited Warranty Instructions for Use Package Contents ComfortGel nasal mask e Premium headgear w EZPeel tabs Mask assembly e Gel cushion e Comfort flap Instructions for use e Quick fit tips e Comfort Guide DVD Note Visit www respironics com for a complete list of products and reorder numbers or contact Customer Service at 1 800 345 6443 USA or Canada only or at 1 724 387 4000 to obtain a product catalog REF 1027825 COMFORTGEL Figure 1 A Forehead Pad B Forehead Support Arm with Stability Selector C Exhalation Port DO NOT BLOCK D Mask Swivel Connects to Tubing E Tubing Connects to CPAP Device F Quick Clip G Gel Cushion amp Comfort Flap H EZPeel Tab Instructions for Use A Caution US federal law restricts this device to sale by or on the order of a physician Intended Use Th
6. PRESS WARRANTIES ADDITION ANY IMPLIED WARRANTY INCLUDING ANY WARRANTY OF RCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IS SPECIFI LLY DISCLAIMED SOME STATES DO NOT ALLOW DISCLAIMERS OF LIED WARRANTIES SO THE ABOVE LIMITA S WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS AND YOU MAY ALSO VE OTHER RIGHTS WHICH VARY FROM STATE TO STATE ON MAY NOT APPLY TO YOU o exercise your rights under this limited warranty contact your local authorized Respironics Inc dealer or Respironics Inc at 1001 Murry Ridge Lane Murrysville 5668 1 800 345 6443 USA and Canada only or 1 724 387 4000 RTGEL Instructions for Use 31 32 COMFORTGEL 2010 Koninklijke Philips Electronics N V All rights reserved
7. care professional ssures the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing Some rebreathing may occur COMFORTGEL e Hand wash prior to first use Inspect the mask for damage or wear cracking crazing tears cushion damage resulting in gel exposure etc Discard and replace any components as necessary 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 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 Disposal Dispose of in accordance with local regulations Instructions for Use Symbols Symbol Description Symbol Description Does not contain natural rubber latex Does not contain DEHP bis 2 ethylhexyl phthalate X Xx x1 R Warning or Caution System One Resistance Control Setting Consult I f Prescription instructions j ONLY required for use COMFORTGEL Before Use Hand wash mask e Read and understand the instructions completely Remove protective coverings e Wash face e Remove the quick fit tips If the wearer has sensitive skin condition the mask cushion and forehead pad before use To condition create a bath of warm soapy water and soak the cush ion and pad for 30 60 minu
8. ding 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 he Product under conditions of normal use and in accordance with the terms of he product literature and other defects not related to materials or workman ship 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 imitation of incidental or consequential damages so the above limitation or exclu sion may not apply to you Instructions for Use 30 1 a O prm I Pennsylvania COMFO SWARRANTY IS GIVEN IN LIEU OF ALL OTHER EX
9. e ComfortGel 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 patients gt 66lbs 30 been prescribed environment The mask is to be used on g for whom CPAP or bi level therapy has Important Note An exhalation port is built into the ComfortGel Nasal required ask so a separate exhalation port is not Important Note The ComfortGel mask is designed to fit comfortably on most adults However because of differences in facial features some users need a customized fit You can customize this mask by re forming the gel to fit your face COMFORTGEL A Warnings This mask is not suitable for providing life support ventilation This mask is designed for use with CPAP or bi level systems recommended by your health care professional or respiratory therapist Do not wear this mask unless the CPAP or bi level system is turned on and operating properly Do not block or try to seal the exhalation port Explanation of the Warning CPAP systems are intended to be used with special masks with connectors which have vent holes to allow continuous ow of air out of the mask When the CPAP machine is turned on and functioning properly new air from the CPAP machine flushes the exhaled air out through the attached mask exhalation port However when the CPAP machine is not operati
10. ng Adjust For leaks under the nose or near the lip re ah ai to essen I dKS COMFORTGEL 19 gently squeeze the arms of the StabilitySelector and adjust to a higher position Reseat the mask by pulling it directly away from the face and gently setting it back into place Q Comfort Tip If not able to minimize the air leaks and obtain a comfortable fit follow the directions for Customizing the ComfortGel Cushion Instructions for Use 20 Removing the Headgear and Mask 1 First remove one or both Quick Clips from the mask sockets Figure 12 2 Grasp the ball of the Quick Clip and gently pull it out of the socket away from the face 3 After the Quick Clip is disengaged slide the mask over head Figure 12 A Quick Clip Ball B Faceplate Slot To Remove Disconnect a Quick Clip or both and slide the mask over head COMFORTGEL 21 Customizing the ComfortGel Cushion Tools Needed e A clean pan to boil water A clean container for cold water e Tongs or utensil to remove cushion from the hot water optional Preparation 1 Disconnect the bottom neckstraps by using the Quick Clips so the headgear does not get wet Although the headgear is water resistant it may be uncomfortable to wear while customizing the gel cushion Caution The headgear must be partially disconnected before customizing the gel cushion 2 Filla bowl with enough cold water to cover the entire mask cushion and
11. ng enough fresh air will not be provided through the mask and exhaled air may be rebreathed This warning A Warning A warning indicates the possibility of injury to the user or operator A Caution A caution indicates the possibility of damage to the device Note A note places emphasis on an operating characteristic Instructions for Use applies to most models of CPAP systems Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation e 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 oxygen delivered into the device enclosure Oxygen create a risk of fire e Oxygen supports combus smoking or in the presence of an open flame Ata fixed flow rate of sup concentration will vary de breathing pattern mask se to most types of CPAP and bi level machines operation and the oxygen flow is left on ventilator tubing may accumulate within the accumulated in the device enclosure will ion Oxygen should not be used while plemental oxygen flow the inhaled oxygen pending on the pressure settings patient ection and the leak rate This warning applies Some users may experience skin redness irritation or discomfort If this happens discontinue use a At low CPAP or EPAP pre nd contact your health
12. port arm together to disengage or re engage the forehead support pad Figure 4 Press Center Tab Squeeze ribbed sides of the support arm to engage and disengage Instructions for Use 14 Attach the Quick Clips to the mask by placing the ball against the socket and gently pressing into place Then connect the forehead upport arm by pressing in on the center of the forehead support pad and then squeezing the upper sides of the support arm together and sliding the tabs into the forehead support pad until they latch nto place wn COMFORTGEL 15 Getting the Right Cushion Size Identify the areas of the face Figure 5 A sides of the nostrils B bridge of the nose and C below the nose tip and above the lip Use the sizing gauge integrated into the product bag to get the right size cushion Choose the smallest size mask cushion that is wide enough to extend beyond the nostrils but does not obstruct breathing Figure 5 Areas of the Face A Sides of nostrils B Bridge of nose zone C Below the nose tip above the lip Instructions for Use 16 Achieving the 1 Open the headgear Right Fit o a large setting and adjust the forehead arm Figure 6 to the he arm upwards To make it easier to highest position To adjust gently squeeze he arms of the StabilitySelector and slide place the mask and headgear we recommend disconnecting one of the Quick Clips 2 Put on the mask
13. tes Use a mild liquid detergent free of conditioners moisturizers or bleaching agents Rinse thoroughly and air dry Cleaning Instructions For Multi Patient Use Visit www respironics com or contact Respironics Customer Service at 1 800 345 6443 USA or Canada only or at 1 724 387 4000 to obtain Mask Disinfection Instructions REF 1011138 For Home Use The mask and tubing should be cleaned daily Instructions for Use 10 Cleaning the Mask Note It is not necessary to disconnect the headgear for daily use and cleaning 1 Hand wash mask in warm water with a mild dishwashing detergent a Caution Do not use bleach alcohol or cleaning solutions containing bleach or alcohol or cleaning solutions containing conditioners or moisturizers 2 Rinse thoroughly Pat with a towel and air dry completely before use 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 Cleaning the Headgear The headgear should be cleaned weekly by hand or machine wash in the gentle cycle Lay the headgear flat or line dry Do not place the headgear into the dryer COMFORTGEL 11 System One Resistance Control This mask uses the System One Resistance Control setting Ko X11 This symbol may appear on your therapy device This symbol represents the level of mask resistance compensation Match the set
14. ting to the mask if appropriate 6 Important Notes e 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 Instructions for Use Removing and Attaching the Headgear Please use one of the following methods to ar BHS remove the headgear from the mask o Method 1 Figure 2 Undo the EZPeel tabs Figure 2 on the headgear and pull them through the slots in the A Forehead Pad Slot B EZPeel Tab forehead support and through the slots on the Quick Clips To reattach the headgear to the forehead support arm thread the top headgear straps through the slots in the forehead support and through the slots on the Quick Clips Fold the EZPeel tabs to latch onto the headgear straps COMFORTGEL 13 Method 2 Disconnect the Quick Clips and Forehead Support Arm from the Forehead Support sd Pull the Quick Clip ball up and away from the Figure 3 Disconnect Quick Clips socket Figure 3 Do not pull the ball through the socket Press in on the center tab of the forehead support Figure 4 and then squeeze the upper sides of the sup
Download Pdf Manuals
Related Search