ProfileLite CPAP/BiPAP Mask Instructions
Contents
1. 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 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 FORA 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 STATE TO 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 2010 Koninklijke Philips Electronics N V All rights reserved INSTRUCTIONS FOR USE 16 Reorder Informa2. place the mask into the water being careful to keep the water from spilling over Figure 7 minutes Using the tongs again grab the mask at the extension and remove it from the water Place ten seconds Re headstrap prevent irritatio Place the mas position you will be wearing it pressing comfortably against your face Figure 8 Slide the headgear over your head Note Be sure Caution Do not heat the mask by placing it into the microwave or conventional oven The mask will be damaged 11 Soak the mask for four the mask in cold water for connect the spacer and n or burning on your face in the o tighten the headgear to the tension you would normally use Wear the Note The mask mask and headgear for five minutes to allow can be reformed the mask to form to your face Remove the if necessary by mask and headstrap The mask will maintain repeating steps 1 its shape through 3 INSTRUCTIONS FOR USE 12 Comfort Tips e Clean your face and mask thoroughly before each use e Make sure the mask is the correct size for your face e Do not overtighten the headgear Overtightening can irritate your face increase leaks or cause damage to the mask e Replace the cushion and forehead gel spacer if they become hardened or deformed Disposal Dispose of in accordance with local regulations Specifications A Warning The technical specifications of the mask are provided for your c
3. 4000 INSTRUCTIONS FOR USE System One Resistance Control This mask uses the System One Resistance Control setting K X1 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 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 Putting on the Mask and Headgear 1 Hold the mask lightly against your face and slide the headstrap over your head Figure 2 2 Connect the flexible tubing to the ProfileLite exhalation elbow Turn the CPAP or Zi bi level system on B 3 Lie down and breathe normally through A your nose keeping your lips closed Unhook the straps and gradually tighten Figure 3 them until the mask has minimal leaks and fits comfortably A Use blue tabs for Note The headstrap has two sets of tabs for smaller sized heads better adjustment For larger size heads use B Use black tabs for the black tabs For smaller head sizes use the larger sized heads blue tabs Figure 3 The extra tabs can be rem
4. Provided for your reference by cpapXchange com RESPIRONICS Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 USA 1067778 Profile Lite JDH 04 9 2010 INSTRUCTIONS FOR USE 2010 Koninklijke Philips Electronics N V All rights reserved ProfileLite NEC TRE MERC Table of Contents 3 4 6 7 8 8 9 x x x Da ONNN Intended Use Warnings Symbols Cleaning Instructions System One Resistance Control Putting on the Mask and Headgear Removing the Mask and Headstrap Replacing the Gel Spacer Reforming the Mask Comfort Tips Disposal Specifications Limited Warranty Reorder Information INSTRUCTIONS FOR USE ProfileLite ProfileLite INEST MER Figure 1 Gel Forehead Spacer B Mask Cushion C Exhalation Port Do not block D Removable Port Cap CAUTION US federal law restricts this device to sale by or on the order of a physician Intended Use The Profile Lite Nasal Gel 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 The mask is to be used on patients gt 66lbs 30kg for whom CPAP or bi level therapy has been prescribed 6 Important Note An exhalation port is built into the Profile Lite Nasal Gel Mask so a separate exhalation port is not required INSTRUCTIONS FO
5. R USE 4 A Warnings e This mask is not suitable for providing life support ventilation e This mask is designed for use with CPAP or bi level aed recommended by your A Warning health care professional or respiratory A warning indicates the therapist Do not wear this mask unless the possibility of injury to CPAP or bi level system is turned on and operating properly Do not block or try to the user or operator seal the exhalation port Explanation of the Caution Warning CPAP systems are intended to be a used with special masks with connectors A caution indicates the which have vent holes to allow continuous possibility of damage to flow of air out of the mask When the the device CPAP machine is turned on and functioning 6 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 operating enough fresh air will not be provided through the mask and exhaled air may be rebreathed This warning 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 ote A note places an emphasis on an operating characteristic ProfileLite not operating Explanation of the Warning When the device is not in operation and the oxygen flow is left on o
6. TRUCTIONS FOR USE Symbols Description A General Caution or Warning CH Consult instructions for use x1 System One Resistance Control Note Does not contain natural rubber latex z Tip XS ProfileLite Cleaning Instructions Hand wash the mask before be hand washed weekly or a to be removed for daily clea 1 Hand wash the mask and liquid dish washing detergent Caution Do not use bleac or alcohol or cleaning solu Rinse thoroughly with dri rect sunlight Make sure the mas first use and daily The head s needed The headgear do ning of the mask headgear in warm water wi h ti nking quality water and air d is dry before use alcohol cleaning solutions con ons containing conditioners or di headgear flat or line dry dryer vi For multi patient use in the use Inspect all parts for damage or we sibly deteriorated cracking craz mask if the cushion becomes hardened nstitutional environment he Mask Cleaning and Disinfection Instructions to reprocess Do not p ar replace any part ing tears etc Repl hospital i tha mois ace the headgear into t gear should es not need mild aining bleach urizers ry out of Lay the he s that have ace the the mask between patients These instructions can be obtained by visiting www sleepapnea com or contacting Respironics Customer Service at 1 800 345 6443 USA or Canada or 1 724 387
7. linician to check that they are compatible with the CPAP or bi level device If used outside specification or if used with incompatible devices the seal and comfort of the mask may not be effective optimum therapy may not be achieved and leak or variation in the rate of leak may affect the CPAP or bi level device function ProfileLite Intentional Leak Pressure vs Leak Rate Leak Rate SLPM 0 4 8 12 16 Pressure cmH O hPa E Profile Lite Profile Lite w 22mm elbow 20 INSTRUCTIONS FOR USE 13 14 Pressure Drop cm H O hPa 50 SLPM 100 SLPM Large 0 1 0 3 Deadspace lt 281 cc Storage Conditions Temperature 4 F to 140 F 20 C to 60 C 15 to 95 RH non condensing ProfileLite 15 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 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
8. oved using a pair of scissors 4 DO NOT overtighten the straps Overtightening can cause or worsen leaks Removing the Mask and Headstrap Because the entire headstrap stretches you should not need to unfasten the straps to remove the headstrap Simply slide the mask and headstrap over your head If necessary unfasten either of the neck straps INSTRUCTIONS FOR USE Replacing the Gel Spacer 1 Replace the gel spacer if it is punctured CI eaking or damaged See the last page of these On instructions for order information 2 Before attaching a new gel spacer remove he headgear from the mask following the Figure 4 instructions below Slide the top tabs 1 on the gel spacer into the top headgear slot A Gel spacer Figure 4 then attach the bottom tabs 2 on B Headgear slots he gel spacer into the bottom headgear slot Reforming the Mask OPTIONAL If you are not able to minimize leaks you may want to reform the mask to fit your face more closely 1 Remove the headstrap and spacer from he mask Figure 5 and Figure 6 Fill a container with enough water to cover the entire mask DO NOT put the mask in he water at this time Place the container over heat and bring the water to a boil Remove the container from the heat Figure ProfileLite A ZX Warning Before placing the mask on your face be sure the mask has cooled enough to 3 Using tongs or a similar utensil slowly
9. tion 002849 i ask P 002850 file Li ask S 002370 i ask MS 002371 i ask M 002372 i ask MW 002374 i ask LN 002373 ite Mask L 004292 trofit Spacers S 004291 trofit Spacers L 008869 ofit Spacers XL 004086 i ask w headstrap P 004087 P i k w headstrap S 004088 i k w headstrap MS 004089 i w headstrap M 004110 file Li w headstrap MW 004112 i k w headstrap LN 004111 file Li k w headstrap L 004395 i bow Kit 002720 t 5 ea 7041 i For a complete list of products and reorder numbers or contact Customer Service at 1 800 345 6443 US or Canada only or 724 387 4000 to obtain a product catalog 1027825 or visit us online at www sleepapnea com ProfileLite
10. xygen 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 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 f 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 Hand wash prior to first use Inspect the mask for damage or wear cracking crazing tears or cushion damage resulting in gel exposure etc Discard and replace any components as necessary Carefully touch the mask cushion to be sure that it has cooled enough to prevent irritation or burning 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 INS
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