PHILIPS Respironics ComfortGel Instructions For Use Manual
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PHILIPS Respironics ComfortGel Instructions For Use Manual

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Respironics Inc.
1001 Murry Ridge Lane
Comfor tGel
Murrysville, PA 15668 USA
1067752
JDH 3/3/2010
INSTRUCTIONS FOR USE

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Summary of Contents for PHILIPS Respironics ComfortGel

  • Page 1 Respironics Inc. 1001 Murry Ridge Lane Comfor tGel Murrysville, PA 15668 USA 1067752 JDH 3/3/2010 INSTRUCTIONS FOR USE...

  • Page 2: Table Of Contents

    Cleaning Instructions System One Resistance Control Removing and Attaching the Headgear Achieving the Right Fit Removing the Headgear and Mask Customizing the ComfortGel Cushion Removing and Attaching the Flap and Integrated Ring Specifications Reorder Information Limited Warranty Instructions for Use...

  • Page 3: Package Contents

    Package Contents • ComfortGel nasal mask • Premium headgear w/ EZPeel tabs • Mask assembly • Gel cushion • Comfort flap • Instructions for use • Quick fit tips • Comfort Guide DVD Note: Visit www.respironics.com for a complete list of products...
  • Page 4 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 &...

  • Page 5: Intended Use

    Intended Use The 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 environment.

  • Page 6: Warnings

    Warnings • This mask is not suitable for providing life Warning! support ventilation. A warning indicates the • This mask is designed for use with CPAP or possibility of injury to the bi-level systems recommended by your health user or operator. care professional or respiratory therapist.
  • Page 7 applies to most models of CPAP systems. Rebreathing of exhaled air for longer than several minutes can, in some circumstances, lead to suffocation. • 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.
  • Page 8 • 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.

  • Page 9: Symbols

    Symbols Symbol Description Symbol Description Does not contain Warning or natural rubber Caution latex Does not contain DeHP Note (bis (2-ethylhexyl) phthalate) System one resistance Control Setting Consult Prescription instructions required for use C o m f o r t G e l...

  • Page 10: Before Use

    Before Use • Hand wash mask. • Read and understand the instructions completely. • Remove protective coverings. • Wash face. • 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 minutes.
  • Page 11 Cleaning the Mask It is not necessary to disconnect the headgear for daily use Note: and cleaning. Hand wash mask in warm water with a mild dishwashing detergent. Do not use bleach, alcohol, or cleaning solutions Caution: containing bleach or alcohol, or cleaning solutions containing conditioners or moisturizers.

  • Page 12: System One Resistance Control

    System One Resistance Control This mask uses the System One Resistance Control setting 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: •...

  • Page 13: Removing And Attaching The Headgear

    Removing and Attaching the Headgear Please use one of the following methods to remove the headgear from the mask. Method 1 Figure 2 Undo the EZPeel tabs (Figure 2) on the A = Forehead Pad Slot headgear and pull them through the slots in the B= EZPeel Tab forehead support and through the slots on the Quick Clips.
  • Page 14 Method 2 Disconnect the Quick Clips and Forehead Support Arm from the Forehead Support. Pull the Quick Clip ball up and away from the socket (Figure 3). Figure 3 Do not pull the ball through the socket. Disconnect Quick Clips Press in on the center tab of the forehead support (Figure 4) and then squeeze the upper sides of the support arm together to disengage...
  • Page 15 Attach the Quick Clips to the mask by placing the ball against the socket and gently pressing into place. Then connect 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 and sliding the tabs into the forehead support pad until they latch into place.
  • Page 16 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.

  • Page 17: Achieving The Right Fit

    Achieving the Right Fit Open the headgear to a large setting and adjust the forehead arm (Figure 6) to the highest position. To adjust, gently squeeze the arms of the StabilitySelector and slide the arm upwards. Figure 6 To make it easier to place the mask and Adjust the forehead arm headgear, we recommend disconnecting to the highest position.
  • Page 18 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.
  • Page 19 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: • 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...
  • Page 20 Reseat the mask by pulling it directly away from the face and gently setting it back into place. 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...

  • Page 21: Removing The Headgear And Mask

    Removing the Headgear and Mask First remove one (or both) Quick Clips from the mask sockets (Figure 12). Grasp the ball 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 head. Figure 12 A = Quick Clip Ball B = Faceplate Slot...

  • Page 22: Customizing The Comfortgel Cushion

    Customizing the ComfortGel Cushion Tools Needed • A clean pan to boil water • A clean container for cold water • Tongs or utensil to remove cushion from the hot water (optional) Preparation Disconnect the bottom neckstraps by using the Quick Clips so the headgear does not get wet.
  • Page 23 When the water reaches a boil, turn off the heat. : Do not place the gel cushion into Caution the microwave. Hold the forehead support pad (or use tongs) and submerge the mask cushion into the hot water for 4 minutes. Carefully remove the mask from the hot Figure13 water and submerge into the cold water...

  • Page 24: Removing And Attaching The Flap And Integrated Ring

    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. Wear the mask for 5 minutes to allow the gel cushion to set. Remove the mask and headgear or connect the therapy device and use as directed.
  • Page 25 To Attach Note the cutout on the top of the flap ring. Place the cushion against the faceplate. Place the gel cushion into the faceplate. Figure 14 Put the flap with ring around the cushion and press the connection points (Figure Loosen the bottom and 15) firmly against the faceplate until the sides of the retaining ring.

  • Page 26: Specifications

    Operating and Storage Conditions Operating: 41º to 104º F (+5º to +40º C) 15% to 95% relative humidity, non-condensing Storage: -4º to 140º F (-20º to +60º C) 15% to 95% relative humidity, non-condensing Specifications : The technical specifications of the mask are provided Warning for your healthcare professional to determine if it is compatible with your CPAP or bi-level therapy device.
  • Page 27 Intentional Leak Whisper Swivel II ComfortGel 60.0 50.0 40.0 30.0 20.0 10.0 Pressure cm H O (hPa) Pressure Drop cm H O (hPa) 50 SLPM 100 SLPM All mask sizes: 0.25 Deadspace Petite Cushion: 83.6 cc Small Cushion: 111.4 cc Medium Cushion: 121.3 cc...
  • Page 28 Reorder Numbers 1009040 ComfortGel mask with Premium Headgear, P (petite) 1009041 ComfortGel mask with Premium Headgear, S (small) 1009042 ComfortGel mask with Premium Headgear, m (medium) 1009043 ComfortGel mask with Premium Headgear, l (large) 1010518 ComfortGel mask, P 1010519 ComfortGel mask, S...
  • Page 29 Reorder Numbers 1009109 Silicone flap, l 1018401 forehead Support and Pad 1009722 Silicone forehead Pads, 4 pack 1010646 Diffusion elbow with exhalation Kit 7041 mask Swivel 1009723 Headgear Quick Clips, 2 pack 1002720 Split Washer Kit 312710 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).

  • Page 30: Limited Warranty

    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.
  • Page 31 THIS WARRANTY IS GIVEN IN LIEU OF ALL OTHER EXPRESS WARRANTIES. IN ADDITION, ANY IMPLIED WARRANTY, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IS SPECIFI- CALLY 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.
  • Page 32 Instructions for Use...
  • Page 33 ©2010 Koninklijke Philips electronics N.V. All rights reserved. C o m f o r t G e l...

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