ResMed P10 User's Manual
Contents
1. do not have internet access please contact your ResMed representative Troubleshooting Problem possible cause Solution Pillows won t seal properly mask is uncomfortable or causes red marks Pillows may have been fitted Check that the nasal pillows with the incorrectly adjusted incorrectly left L and right R indicators are or the headgear is fitted inserted correctly L into your left incorrectly nostril R into your right nostril Carefully follow the fitting instructions Readjust the headgear to ensure it is fitted comfortably Inner wall position of one or both Squeeze pillow sides to release inner pillows is incorrect wall The correct position is shown in the reassembly instructions Pillows are the wrong size Talk to your clinician Pillows may be dirty Clean pillows according to the instructions Headgear is too loose Wash headgear to help it return to its original form Follow the washing instructions Adjust the headgear split straps Problem possible cause Vent is blocked or dirty discolored Vent is wet Mask too noisy System is assembled incorrectly System is leaking air Technical specifications Solution If the vent requires cleaning use a soft bristle brush The vent may discolor over time and this is not a safety concern Follow the cleaning instructions in this guide to maintain performance and safety of the mask Ensure the vent is dry after cleaning and in the case of2. e If you experience nasal dryness or irritation using a humidifier is recommended Fitting 1 Hold the pillows away from your nose ensuring that the pillow size eg M with the left L and right R indicators are correctly facing towards you then guide the nasal pillows into your nostrils L into your left nostril R into your right nostril Pull the headgear over your head by holding the bottom strap and stretching it around the back of your head The top strap should sit comfortably on top of your head Tip There are raised logos on top of the frame so you can feel the correct way up when fitting in the dark 2 Move the mask away from your face then place it back to get a comfortable fit Ensure the nasal pillows fit securely into your nostrils with both pillows positioned upright English 3 SA Finally connect the end of the mask tubing into your device air tubing Your mask is now fitted and ready to use When the device is running a light breeze should be felt through the vent To inspect the vent place a finger close but not over the entire vent area Adjustment To achieve a comfortable fit adjust the split straps by spreading them apart to loosen or draw them closer together to tighten Removal To take off your mask system pull the mask and headgear by the split strap up and over your head Disassembly T 2 Holding the top of the mask tubing squeeze and pull the pillows away from the mask fra
3. excess condensation Disassemble the mask then reassemble according to the instructions Refit or reposition your mask Adjust your headgear Check your mask is assembled correctly Pressure flow curve The mask contains passive venting to protect against rebreathing As a result of manufacturing variations the vent flow rate may vary Pressure Flow PE cm H O L min 4 20 A 8 29 2 12 37 16 43 20 49 Eo gt 0 4 6 8 10 12 14 16 18 20 Mask pressure cm H O Dead space Physical dead space is the empty volume of the information mask to the end of the swivel Using the large pillows it is 123 mL Therapy pressure 4 to 20 cm H20 English 1 Resistance Drop in pressure measured nominal at 50 L min 0 4 cm H20 at 100 L min 1 4 cm H20 Sound DECLARED DUAL NUMBER NOISE EMISSION VALUES in accordance with ISO 4871 The A weighted sound power level of the mask is 21 dBA with uncertainty of 3 dBA The A weighted sound pressure level of the mask at a distance of 1 m is 13 dBA with uncertainty of 3 dBA Environmental Operating temperature 5 C to 40 C conditions Operating humidity 1596 to 9596 non condensing Storage and transport temperature 20 C to 60 C Storage and transport humidity up to 9596 relative humidity non condensing Gross dimensions Large 590 mm H x 149 mm W x 30 mm D Mask frame system no headgear Mask setting options For S9 Select Pillows For other devices Select SWIFT if
4. Med locations worldwide For patent information see www resmed com ip AirFit is a trademark C of ResMed Ltd 2013 ResMed Ltd 0123
5. User Guide English AirFit P10 Nasal Pillows System Fitting Anlegen Mise en place Applicazione Removal Abnehmen Retrait Rimozione Reassembly Zusammenbau Remontage Riassemblaggio English AirFit P10 NASAL PILLOWS SYSTEM Thank you for choosing the AirFit P10 This document provides the user instructions for the AirFit P10 and AirFit P10 for Her masks referred to collectively as AirFit P10 throughout this manual AirFit P10 has blue headgear while AirFit P10 for Her has pink headgear Using this guide Please read the entire guide before use When following instructions refer to the images at the front and back of the guide Intended Use The AirFit P10 channels airflow noninvasively to a patient from a positive airway pressure PAP device such as a continuous positive airway pressure CPAP or bilevel device The AirFit P10 is e tobe used by patients gt 30 kg for whom positive airway pressure has been prescribed e intended for single patient re use in the home environment and multipatient re use in the hospital institutional environment GENERAL WARNINGS e he mask must be used under qualified supervision for users who are unable to remove the mask by themselves The mask may not be suitable for those predisposed to aspiration e The vent must be kept clear e he mask should only be used with CPAP or bilevel devices recommended by a physician or respiratory therapis
6. available otherwise select MIRAGE as the mask option Notes The mask system does not contain PVC DEHP or phthalates e This product is not made with natural rubber latex The manufacturer reserves the right to change these specifications without notice Storage Ensure that the mask is thoroughly clean and dry before storing it for any length of time Store the mask in a dry place out of direct sunlight Disposal This mask does not contain any hazardous substances and may be disposed of with your normal household refuse Symbols The following symbols may appear on your product or packaging REF Catalog number LOT Batch code CATALOG BATCH HUMEBEFZ CODE E sn e Humidity limitation z Temperature limitation LIMITATI ir Fragile handle with care X KS eine RAGE TUDE rubber latex H PATH CAFE EER LATIN European Authorised Manufacturer Representative EN Keep away from rain t t This way up aie Indicates a Warning or Caution and alerts you to a possible injury or explains special measures for the safe and effective use of the device Caution consult accompanying documents Polypropylene recyclable Consumer Warranty ResMed acknowledges all consumer rights granted under the EU Directive 1999 44 EG and the respective national laws within the EU for products sold within the European Union English 9 Mask components Maskenkomponenten Composants du masque Componenti della maschera A Headg
7. ear Kopfband Harnais Copricapo 1 Split strap headgear Geteiltes Kopfband Harnais avec sangle lani re double Copricapo con cinghia con fenditura 2 Buttonhole Knopfloch Boutonni re Asola 3 Fabric end Textilende Extr mit en tissu Estremit in tessuto B Pillows Nasenpolster Coussins Cuscinetti 4 Nasal pillows Nasenpolster Coussins narinaires Cuscinetti nasali C Frame Maskenrahmen Entourage rigide Telaio 5 Stabiliser Stabilisator Stabilisateur Stabilizzatore 6 Node Anschluss N ud Nodo 7 Vent Ausatem ffnung Orifice de ventilation Dispositivo di esalazione 8 Mask tubing Maskenschlauch Circuit du masque Tubo della maschera Pillows system Nasenpolstermaske Masque narinaire Cuscinetti nasali Complete system Komplettes System Syst me complet Maschera con tutti i componenti XS Extra Small Extra Small Tr s petit Extra Small S Small Small Petit Small M Medium Medium M dium Medium L Large Large Grand Large AEI P10 ResMed Global leaders in sleep and respiratory medicine www resmed com 618265 1 2013 10 ud Manufacturer ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Distributed by ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA ResMed UK Ltd 96 Jubilee Ave Milton Park Abingdon Oxfordshire OX14 4RW UK See www resmed com for other Res
8. me Remove the headgear from the stabilisers by holding the fabric end of each strap and pulling out to reveal the buttonhole then sliding over the node and off the end of each stabiliser Your mask is now disassembled Reassembly iR With the gray side facing out insert each end of the headgear strap over the stabilisers through the buttonholes Secure in place by wrapping each strap end up and around the nodes Holding the split straps pull the headgear from the stabiliser to ensure it is tightly secure around the nodes Ensure the headgear strap is not twisted Attach the pillows to the mask frame by inserting the top and bottom clips into the correct slots shorter clip into top slot longer clip into bottom slot on the mask frame Your mask is now reassembled Ensure the inner walls of the nasal pillows are not compressed or collapsed If they are squeeze each nasal pillow so they return to the correct shape Cleaning your mask at home Your mask and headgear should only be gently handwashed The mask vent may discolour over time due to dust Follow the cleaning instructions in this guide to maintain performance and safety of the mask WARNING Always follow cleaning instructions and use mild soap Some cleaning products may damage the mask its parts and their function or leave harmful residual vapours that could be inhaled if not rinsed thoroughly CAUTION e If any visible deterioration of a system component is ap
9. parent cracking crazing tears etc the component should be discarded and replaced e Avoid connecting flexible PVC products eg PVC tubing directly to any part of the mask Flexible PVC contains elements that can be detrimental to the materials of the mask and may cause the components to crack or break Daily After each use e Disassemble the pillows from the frame according to the disassembly instructions e Thoroughly clean the separated mask components excluding headgear by gently rubbing in warm approximately 30 C water using mild soap e To optimise the mask seal facial oils should be removed from the pillows after use e Use a soft bristle brush to clean the vent e Inspect each component and if required repeat washing until visually clean e Rinse all components well with drinking quality water and allow to air dry out of direct sunlight Dry the vent by wiping with a cloth English 5 e When all components including the vent are dry reassemble according to the reassembly instructions Weekly e Handwash the headgear in warm approximately 30 C water using mild soap It may be washed without being disassembled Rinse well and allow it to air dry out of direct sunlight Reprocessing the mask between patients This mask should be reprocessed when used between patients Cleaning disinfection and sterilisation instructions are available from the ResMed website www resmed com masks sterilization If you
10. t e he mask should not be used unless the device is turned on Once the mask is fitted ensure the device is blowing air Explanation CPAP and bilevel devices are intended to be used with special masks or connectors which have vent holes to allow continuous flow of air out of the mask When English 1 the device is turned on and functioning properly new air from the device flushes the exhaled air out through the mask vent holes However when the device is not operating insufficient fresh air will be provided through the mask and the exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation This applies to most models of CPAP or bilevel devices Follow all precautions when using supplemental oxygen Oxygen flow must be turned off when the CPAP or bilevel device is not operating so that unused oxygen does not accumulate within the device enclosure and create a risk of fire Oxygen supports combustion Oxygen must not be used while smoking or in the presence of an open flame Only use oxygen in well ventilated rooms At a fixed rate of supplemental oxygen flow the inhaled oxygen concentration varies depending on the pressure settings patient breathing pattern mask point of application and leak rate This warning applies to most types of CPAP or bilevel devices The technical specifications of the mask are provided for your clinician to check that
11. they are compatible with the CPAP or bilevel 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 bilevel device function Discontinue using this mask if you have ANY adverse reaction to the use of the mask and consult your physician or sleep therapist Using a mask may cause tooth gum or jaw soreness or aggravate an existing dental condition If symptoms occur consult your physician or dentist As with all masks some rebreathing may occur at low CPAP pressures e Refer to your CPAP or bilevel device manual for details on settings and operational information e Remove all packaging before using the mask Using your mask When using your mask with ResMed CPAP or bilevel devices that have mask setting options refer to the Technical specifications section in this user guide for mask selection options For a full list of compatible devices for this mask see the Mask Device Compatibility List on www resmed com on the Products page under Service amp Support If you do not have internet access please contact your ResMed representative Notes This mask is not compatible for use with ResMed AutoSet CS 2 and VPAP Adapt SV devices e SmartStart may not operate effectively when using this mask with some CPAP or bilevel devices that have this feature
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