ComfortLite 2 - Philips Healthcare
Contents
1. OO Figure 5a Simple cushion A Simple Cushion B Ball amp Socket Connector C Exhalation vent Do not block D Elbow 13 Q Comfort Tips e The Simple cushion should cover but not obstruct the nostrils e Pivot the Simple cushion to angle it to your features and to correct leaks Sizing the Direct Seal Cushion To determine the correct size start with the largest Direct Seal cushion Figure 6a in the package The bulbs of the Direct Seal cushion should rest on the edge of the nostrils blocking the ends Figure 6b The bulbs should not be inserted into the nostrils Figure 6c Therefore choose a cushion with bulbs larger than your nostrils Figure 6a Direct Seal cushion A Direct Seal Bulb B Metal Support C Exhalation Vent Do not block D Elbow INSTRUCTIONS FOR USE 14 Figure 6b Correct fit bulbs rest against the nostrils Figure 6c Incorrect fit bulbs 4 inside the nostrils ComfortLite 2 15 Attaching the Cushion to the Vertical Tube After you have chosen the proper cushion size and type align the vertical tube knob with the notch in the rim of the exhalation elbow Simple cushion or cradle Pillows amp Direct Seal cushions Slide the two pieces together and turn the cushion until it clicks into place Figure 7 Figure 7 Connecting the cushion to the vertical tube A Vertical Tube Knob B Vertical Tube C Exhalatio2. machine is not operating enough fresh air will not be provided through the mask and exhaled air may be rebreathed This warning applies models of CPAP systems Rebreathing of to most exhaled air for longer than several minutes can in some circumstances lead to suffocation 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 an emphasis on an operating characteristic INSTRUCTIONS FOR USE If oxygen is used the device is no the ventilator tu accumulated in Oxygen suppor or in the presence of At a fixed flow rate of supplemental oxygen concentration wi pattern mask se bing WI th the device the oxygen flow must be t urned off when operating Explanation of the Warning When the device is not in operation and the oxygen flow is left on oxygen delivered into ned 5 CO ll va ect of CPAP and bi Some users may happens disconti At low CPAP or be inadequate may occur If an additional need to adjust Oc evel machines experience skin nu EPAP pressures exhalation device he pressure level the exhalation device Hand wash prior to first use Inspect the mask for damage o c Discard and re crazing tears ComfortLite 2 e use and con ear all exhaled may accumulate within the devi evice encl
3. Lite 2 Direct Seal Cushion Sizing Gauge 20 pk Simple Direct Seal 021835 PETITE 1021802 SIZE1 1021816 SIZE 5 021830 SMALL 1021806 SIZE2 1021817 SIZE 6 021823 MEDIUM 1021807 SIZE 3 021821 LARGE 1021815 SIZE 4 Visit wwwsleepapnea com for a complete list of products and reorder numbers or contact Customer Service 5 6443 US and Canada or 1 724 387 4000 to obtain a product catalog 1027825 at 1 800 34 Comfo rtLite 2
4. RESPIRONICS Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 USA 1067728 i 7 an ComfortLite 2 2010 Koninklijke Philips Electronics N V All rights reserved INSTRUCTIONS FOR USE ComfortLite 2 Nasal Mask Table of Contents Package Contents Intended Use Warnings Symbols Before Use Cleaning Instructions System One Resistance Control Sizing amp Attaching the Cushion Achieving the Right Fit Removing the the Mask from the Headgear Specifications Disposal Limited Warranty Reorder Information INSTRUCTIONS FOR USE N ComfortLite 2 Nasal Mask Figure 1 A Crown Swivel Connector B Top Connection Point C Middle Connection Point ComfortLite 2 D Upper Strap E Back Strap F Lower Strap behind or over ears G Front Connection Point H Metal Support Band Pillows or Direct Seal Cradle J Vertical Tube K Vertical Tube Adjustment L Angular Adjustment Package Contents s ComfortLite 2 nasal interface assembly e Headgear e Cushions NOTE Additional accessories and replacement parts are available Please see the reorder box located in the back of these instructions Figure 2 Nasal interface assembly headgear amp cushions e Instructions for use e Quick fit tips INSTRUCTIONS FOR USE Intended Use The ComfortLite 2 Nasal Mask is intended to provide an interface for application of CPAP or bi level therapy
5. 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 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 1 800 345 6443 USA and Canada only or 1 724 387 4000 INSTRUCTIONS FOR USE 24 030493 025111 025127 025225 030494 030495 025112 025113 025114 025117 027999 032007 031154 018624 018665 Cushions 030502 030503 030504 030505 Combo Packs Replacement Parts ComfortLi ComfortLi ComfortLi Reorder Numbers e 2 w Headgear S M L Pillows Cushion e 2 w Headgear S M L Simple Cushion e 2 w Headgear 4 5 6 Direct Seal Cushion Sub assembly w Headgear No Cushions Comfor Comfort ComfortLi Com ComfortLi ComfortLt Small Accessory Pouch ComfortLt Comfor Comfor Comfor 1 pk Pillows PETITE SMALL MEDIUM LARGE Lite 2 Combo w Headgear S M Pillows amp Simple Cushions ij Lite 2 Combo w Headgear M L Pillows amp Simple Cushions i I e 2 Combo w Headgear 4 5 Direct Seal SM Simple Cushions Lite 2 Combo w Headgear 5 6 Direct Seal M L Simple Cushions e 2 Headgear strap only e 2 Headgear w Strap e 2 Pillows Sizing Gauge 5 pk ite 2 Pillows Sizing Gauge 20 pk Lite 2 Simple Cushion Sizing Gauge 20 pk
6. them outward or i Figure 9 To move the cushion up or down twis dial on the vertical tube adjustment un cushion is at the proper height Figure Bend the metal support band to adjus Pillows or Direct Seal bulbs to the wid your nostrils Figure 11 Angular adjustment nward the il the 10 the h of Note Do not squeeze the metal band Pillows and Direct Seal cushi ons to move the on the Figure 10 cushion up or down always use the angular and or vertical tube adjustment Vertical tube adjustment INSTRUCTIONS FOR USE 18 Figure 11 Metal support band U adjustment 7 Connect the tubing of the CPAP or bi level device to the crown swivel connector Figure 12 Turn on the device and adjust the LAT ComfortLite 2 to correct any leaks Troubleshooting Leaks p B e Try a different size cushion a e Use the angular and vertical tube adjusters to change the cushion position Figure 12 e Tighten or loosen the headgear Ifyou are using the Simple Cushion verify that it Connect the is properly connected to the exhalation elbow ComfortLite 2 to the Verify that the front of the headgear rests on CPAP or bilevel device the brow line Figure 8b E S S er Connector ComfortLite 2 19 Removing the Mask from the Headgear First unfasten the white retaining strap from the crown swivel Squeeze the clear tabs behind the angular adjuster Figure 13
7. 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 66lbs 30kg for whom CPAP or bi level therapy has been prescribed 5 Important Notes e An exhalation port is built into the ComfortLite 2 Nasal Mask so a separate exhalation port is not required e Device pressures should be verified when used by other vendor s auto titrating devices ComfortLite 2 has been validated to work with all Respironics CPAP and bi level therapy devices A Caution U S federal law restricts this device to sale by or on the order of a physician ComfortLite 2 A Warnings support ventilation This mask is designed for use wi bi level systems recommended care professional or respiratory not wear this mask unless the CPAP or bi system is turned on and operating proper halation port not block or try to seal the exl This mask is not suitable for providing therap ife ith CPAP or by your health ist Do evel y Do Explanat intended connectors which have vent ho continuo the CPA ion of the Warning CPAP sys to be used with special masks wi es to al us flow of air out of the mask new air from the CPAP machine low When P machine is turned on and functi ems are h oning flushes properly the exha ed air ou through the attached exhalation port However when the CPAP mask
8. R USE 10 Direct Seal Pillows Simple s1 e E E Pa Sizing amp Attaching the Cushion The ComfortLite 2 may come with an assortment of nasal interface cushions in multiple sizes Figure 3 Figure 3 Cushion assortment A Pillows Cushion A B Simple Cushion C Direct Seal Cushion oe ot 4 Comto Ite 11 Sizing the Pillows Cushion To determine the proper size Figure 4a select the Pillows cushion that fills the nostrils without any gaps between the cushion and the nostril walls Figure 4b amp c Figure 4a Pillows cushion A Elbow B Pillows C Exhalation Vent Do not block D Metal Support AN Figure 4c S Figure 4b ike Incorrect fit lt Correct fit Pillows outside nostrils Pillows inside nostrils INSTRUCTIONS FOR USE 12 Sizing the Simple Cushion To determine he proper size start with the smallest Simple cushion in the package Choose the size that fits over the entire nose wi Slide the smaller opening of the Simple cushion over the ball and socket connector Figure 5a Tip Posi ion the Simple cushion so the narrower end fits over the bridge of the nose and the wider end is under the nostrils Figure 5b Correct fit cushion fits over the nose Incorrect fit cushion is placed too high amp blocks the nostrils ComfortLite 2 b hout blocking the nostrils CR L Figure 5b amp c
9. and slide them up and off the track This will completely remove the assembly from the headgear Figure 13 Headgear removal A Crown Swivel B White Retaining Strap INSTRUCTIONS FOR USE 20 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 Intentional Leak 60 50 D Simple 40 E Pillows Direct Seal 30 S B Whisper Swivel Il 20 Exhaust Leak Rate SLPM 4 8 12 16 20 30 Pressure cm H O hPa ComfortLite 2 21 Deadspace Volume Pillows cushion 19 36cc Simple cushion 27 65cc Direct Seal cushion 14 38cc Storage Conditions 4 F to 140 F 20 C to 60 C 15 to 95 relative humidity non condensing Disposal Dispose of in accordance with local regulations INSTRUCTIONS FOR USE 22 LIMITED WARRANTY Respironics Inc warrants that tts 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 und
10. dry Do cl r cleaning solutions contai eaning solutions containing bleach ning conditioners or moisturizers water and air dry out of direct fore use Lay the headgear flat or Inspect all parts for damage or wear replace any parts that have visibly deteriorated becomes ha ComfortLite 2 cracking crazing tears rdened c Replace the mask if the cushion 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 wwwsleepapnea com or contacting Customer Service at 1 800 345 6443 USA or Canada or 1 724 387 4000 System One Resistance Control This mask uses the System One Resistance Control setting 1 X 1 This symbol may appear on your therapy device mask resistance compensation Match the set Important Notes s Verify the System One setting if the mas The System One setting is not compatib additional exhalation device tting to tl or mas If your provider has locked the resistance co This symbol represents the level of he mask if appropriate k cushion changes e with masks requiring a separate mpensati on 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 FO
11. er 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 workmanship This warranty does not apply to any Product that may have been repaired or altered by anyone other than Respironics d U ComfortLite 2 23 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 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 SPECIFICALLY DISCLAIMED SOME STATES DO NOT ALLOW DISCLAIMERS OF IMPLIED WARRANTIES SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU
12. n Elbow INSTRUCTIONS FOR USE 16 Achieving the Right Fit TN The headgear and mask only require a one time S sizing and fitting RS 1 Place the headgear against your forehead and pull the straps over your head Figure 8a 2 Tighten the lower strap to provide a firm yet comfortable level of stability The bottom edge of the headgear should rest just above the Figure 8a eyebrows Figure 8b The back strap of the headgear should be pulled down toward the Pull the straps over back of the neck for maximum support The your head straps can be worn behind or over the ears 3 Adjust the upper strap if necessary to improve the fit of the headgear over the top of he head Do not overtighten the upper strap Overtightening may cause the headgear to rise off of the head Note If the headgear slides on your head or irritates your ears move the upper strap to different upper or middle connection S Figure 8b Proper position of mask on head ComfortLite 2 Q To do tab pu point and refasten hi Note rests on the brow line s simply unfasten the hook and loop he strap through the connection ake sure the front of the headgear 17 Comfort Tip Wear the backstrap under your hair if it is long or silky Figure 9 To move the cushion closer to or farther from your face squeeze the tabs on the angular adjustment and pull
13. osure will crea mbustion Oxygen shou an open flame act your he flow t gas from redness irritation or disco is added to the pa e a risk of fire d not be used hrough the exhal the tubi ient circ o compe nsate for the add mfort Ift healthcare professional ng Some rebreathi ce enclosure Oxygen while smoking ow the inhaled oxygen ry depending on the pressure settings ion and the leak rate This warni patient breathing ng applies to mos types hi S ation port may ng uit you may itional leak of r wear cracking place any components as necessary Symbols This table defines the symbols used on the ComfortLite 2 mask and or in these instructions Description A Warning or Caution EA System One Control Note Q Tip INSTRUCTIONS FOR USE Before Use Hand wash the mask and cushions Read and understand the instructions completely Wash your face 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 i Hand wash the mask and headgear in warm water with a mild liquid dish washing detergent A Caution Do not use bleach alcohol or alcohol o Rinse thoroughly with drinking quality sunlight Make sure the mask is dry be not place the headgear into the dryer line
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