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Total Face CPAP Mask User Instructions

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1. A Faceplate block opening B Entrainment Valve Do not block C Accessory Swivel D Exhalation Ports E Pressure Pickoff Port Cap F Headgear Hooks ry Swivel valve flapper internal blue disk should be open allowing the user to breathe room air Figure 1 D Turn the unit On The flapper should close allowing the user to receive airflow from the unit If the valve still does not function properly notify your home care dealer Do not block the opening on the entrainment valve Check the valve before each use for dysfunction or any blockage by patient secretions To ensure proper entrainment valve function verify that the flapper is free moving and dry Leak Symbol and Port Settings Some ventilators may incorporate the use of a leak symbol and value in the mask selection setup procedures The leak characteristics of this mask is leak symbol 4 The leak symbol and value represents the intentional leak characteristics of the interface On ventilators equipped with a Mask Selection control enter the leak symbol value Ci k 4 that corresponds with the leak symbol value on the mask Achieving the Right Fit 1 Set up the CPAP or BiPAP unit and patient circuit according to the unit s instruction manual 2 To ensure a proper fit place the patient s chin in the mask first then lightly press the mask against the patient s face 3 Pull the headgear straps around each side of the head and secure them to the mask G
2. 1629 al EC REP vee JAW 06 25 2010 2010 Koninklijke Philips Electronics N V All rights reserved
3. Note Do not overtighten the straps Overtightening can cause or worsen leaks 4 Connect the circuit tubing to the mask swivel Figure 2 C Turn the CPAP or BiPAP unit on 5 Verify that there is only minor lifting of the mask from the patient s face approximately 1 4 to 1 2 during a full respiratory cycle Have the patient assume various sleeping positions e g supine lateral prone with the mask in place Readjust the straps if necessary If the inner flap covers the mouth readjust the mask fit Removing the Mask and Headgear To remove the mask quickly pull on the quick release cord away from the patient s face and remove the mask The mask and headgear can also be removed by detaching the headgear straps from the tabs on the mask comfort Tips e Clean the mask thoroughly before every use including first time usage e Clean the patient s face thoroughly before each use e Make sure the mask and headgear are the correct size for the patient s face If excessive discomfort is experienced have the mask readjusted or consider an alternative mask Do not overtighten the headgear Overtightening can irritate the patient s face increase leaks or cause damage to the cushion Disposal Dispose of in accordance with local regulations 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 ther
4. RESPIRONICS Instructions for Use Provided for your reference by Total Face Mask cpapXchange com Intended Use The Total 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 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 amp Important An exhalation port is built into the Total Face Mask so a separate exhalation port is not required A Caution U S federal law restricts this device to sale by or on the order of a physician Symbols Warning or A Consult instructions Leak symbol Aim Note r Ba for use F and value Does not contain Contains PHT natural rubber latex phthalates Warnings e This mask is not suitable for providing life support ventilation e 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 flow of air out of the mask When the CPAP machine is turned on and functioning properly new air from the CPAP m
5. achine 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 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 operation and the oxygen flow is left on oxygen delivered into the ventilator tubing may accumulate within the device enclosure Oxygen accumulated in the device enclosure will create a risk of fire e Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame e Ata 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 If this happens discontinue use and contact your healthcare professional e The entrainment valve contains a magnet Do not use this mask in or near magnetic resonance imaging MRI equipment e The patient s physician should be contacted if the patient experiences the following symptoms while
6. apy 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 100 80 Respironics Total Face Mask Flow 60 with Disposable Circuit Respironics Total F Mask slpm 49 gt ath Whisper Swivel S Respironics Total Face Mask 20 Whisper Swivel II 0 0 25 5 10 15 20 Pressure cm H20 Deadspace The total volume of the mask is 1500 cc The volume of the area around the nose piece and entrainment valve where most of the gas exchange occurs is 80 cc Disinfection Clean all parts of the mask before disinfecting it as described below Pasteurization Temperature 70 C Exposure time 30 minutes Result High level disinfection Maximum allowable cleaning cycles 10 e Ifthe swivel does not move freely after disinfection replace the sealing ring part no 452072 e Verify function of the flapper valve after processing If the flapper does not move freely replace the mask Inspect the mask after processing If any componenets are damaged replace the mask CIDEX Exposure time 45 minutes Rinse Per manufacturer s instructions Result High level disinfection Maximum allowable cleaning cycles 10 e Ifthe swivel does not move freely after disinfection replace the sealin
7. g ring part no 452072 e Verify function of the flapper valve after processing If the flapper does not move freely replace the mask e Inspect the mask after processing If any componenets are damaged replace the mask e Slight discoloration of the mask cushion after processing is normal CIDEX O P A Exposure time 12 minutes Rinse Per manufacturer s instructions Result High level disinfection Maximum allowable cleaning cycles 10 If the swivel does not move freely after disinfection replace the sealing ring part no 452072 Verify function of the flapper valve after processing If the flapper does not move freely replace the mask Inspect the mask after processing If any componenets are damaged replace the mask Slight discoloration of the mask cushion after processing is normal STERRAD System 100 Exposure time Machine controlled Result Sterilization Maximum allowable cleaning cycles 10 If the swivel does not move freely after disinfection replace the sealing ring part no 452072 Verify function of the flapper valve after processing If the flapper does not move freely replace the mask Inspect the mask after processing If any componenets are damaged replace the mask A slight odor may be present after processing This is normal Respironics Inc Respironics Deutschland 100 Murry Ridge Lane Gewerbestrasse 7 Murrysville PA 15668 USA 82211 Herrsching Germany 107
8. liqu 2 Hand wash the mask with a soft bristle detergent not use bleach alcohol or cleaning solutions containing bleach or alcohol or cleaning solutions containing conditioners or moisturizers Rinse thoroughly Air dry Make sure the mask is dry before use f any parts are damaged or can not be cleaned replace the mask Cleaning Instructions for the Headgear 1 2 and or machine wash with a standard aundry detergent and warm water Rinse thoroughly Do not use bleach ine dry or machine dry at the medium heat setting Verifying Entrainment Valve Function Wi th the unit turned off the entrainment r use on patien parts of the mask daily Clean the if needed Remove headgea 1 reflex or o isinfection brush in co Figure A Entrainment Valve Do not B Entrainment Valve Flapper C Flapper Closed D Flapper Open E Accesso cian o leak of the exhalation device m or jaw soreness or aggravate an r dentist if symptoms occur hich may cause adverse health effects healthcare professional before use ts with the following conditions glaucoma ng hiatal hernia impaired cardiac sphincter n patients unable to remove the mask instructions later in this document headgear at least once each week or more often r before cleaning ol tap water with a mild dishwashing id dishwashing detergent only Do 1 Figure 2
9. using the masks or after removing it Unusual chest discomfort shortness of breath stomach distension belching or severe PH i LI PS Contraindicati This mask may not be suitable fo recent eye surgery or dry eyes nocturnal vomiti headache drying of the eyes eye pain or eye infections blurred vision Consult an ophthalmologist if symptoms persist 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 A minimum of 5 cm H O hPa must be maintained when using this mask This mask should not be used on patients who are uncooperative obtunded unresponsive or unable to remove the This mask is not recommended if the patient is taki vomiting mask ng a prescription drug that may cause If an additional exhalation device is added to the patient circuit youmay need to adjust the pressure level to compensate for the add Use of a nasal or full face mas existing den Do not bloc This produc itiona may cause tooth gu tal condition Consult your physi k or try to seal the entrainment valve t may contain chemcials phthala es w If you are pregnant or breast feeding contact your ons function excessive reflux impaired cough by themselves Cleaning Instructions for the Mask For Multi Patient Use Reusable See the d Clean a A Caution Use a mild

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