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

PHILIPS Respironics ComfortGel Full Instructions For Use Manual

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Respironics Inc.
1001 Murry Ridge Lane
Comfor tGel Full
Murrysville, PA 15668 USA
INSTRUCTIONS FOR USE
1067744
JAW 04/08/2010
©2010 Koninklijke Philips Electronics N.V. All rights reserved.

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  • Page 1 Respironics Inc. 1001 Murry Ridge Lane Comfor tGel Full Murrysville, PA 15668 USA INSTRUCTIONS FOR USE 1067744 JAW 04/08/2010 ©2010 Koninklijke Philips Electronics N.V. All rights reserved.

  • Page 2: Table Of Contents

    ComfortGel Full Full Face Mask Table of Contents Package Contents Intended Use Warnings Contraindications Before Use and Disposal Symbols Cleaning Instructions Removing the Headgear from the Mask Attaching the Headgear to the Mask Achieving the Right Fit Troubleshooting Tips Removing the Mask and Headgear...

  • Page 3: Package Contents

    Package Contents Note: Not all packages contain • ComfortGel Full Face Mask listed items. Please -includes gel cushion and Comfort Flap with contact your Home Care Sure Seal Technology (SST) Provider or Respironics for • additional items. ComfortGel Full Headgear •...

  • Page 4: Intended Use

    Intended Use The ComfortGel Full 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 (>66lbs/30kg) who are appropriate candidates for noninvasive ventilation.

  • Page 5: Warnings

    A note places an air may be rebreathed. This warning applies to emphasis on an operating most models of CPAP systems. Rebreathing of characteristic. exhaled air for longer than several minutes can, in some circumstances, lead to suffocation. ComfortGel Full...
  • Page 6 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.

  • Page 7: 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 patient is uncooperative, obtunded, unresponsive, or unable to remove the mask by themselves. ComfortGel Full...

  • Page 8: Symbols

    Symbols Symbol Description Symbol Description Does not contain Warning or natural rubber Caution latex System One Note Resistance Control Setting Consult instructions for use INSTRUCTIONS FOR USE...
  • Page 9 CPAP or bi-level Do not block or device should flow into the mask. If the flapper try to seal the does not close or does not function properly, entrainment valve or replace the mask. the exhalation vents. ComfortGel Full...

  • Page 10: Cleaning Instructions

    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. Hand wash the mask and headgear in warm water with a mild liquid dish washing detergent.
  • Page 11 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...

  • Page 12: Replacing The Forehead Pad

    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...
  • Page 13 (Figure 6). Figure 6 ComfortGel Full...
  • Page 14 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.
  • Page 15 Follow these tips to adjust for leaks. • For leaks around the bridge of the nose or into the eyes, gently squeeze the arms of the StabilitySelector and adjust to a lower Figure 8 position (Figure 8). ComfortGel Full...
  • Page 16 • 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). •...
  • Page 17 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...
  • Page 18 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.

  • Page 19: Specifications

    Intentional Leak 60.0 50.0 40.0 30.0 20.0 10.0 ComfortGel Full...
  • Page 20 Pressure Drop cm H O (hPa) 50 SLPM 100 SLPM All mask sizes: Deadspace Small 260 mL Medium 280 mL Large 300 mL X-Large 320 mL Disposal Dispose of in accordance with local regulations. Storage Conditions -4º to 140º F (-20º to +60º C) 15% to 95% relative humidity, non-condensing INSTRUCTIONS FOR USE...

  • Page 21: Limited Warranty

    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...
  • Page 22 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.
  • Page 23 Reorder Numbers 1040135 S ComfortGel Full Face Mask w/ Headgear 1040136 M ComfortGel Full Face Mask w/ Headgear 1040137 L ComfortGel Full Face Mask w/ Headgear 1062004 XL ComfortGel Full Face Mask w/ Headgear 1040568 S ComfortGel Full Face Mask w/o Headgear...
  • Page 24 Reorder Numbers 1040795 RP S ComfortGel Full Face Mask Flap 1040796 RP M ComfortGel Full Face Mask Flap 1040797 RP L ComfortGel Full Face Mask Flap 1062031 RP XL ComfortGel Full Face Mask Flap 1040138 RP ComfortGel Full Headgear 1040139...
  • Page 25 ComfortGel Full...

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