REMstar Auto - Boardman Medical Supply

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REMstar AutoM Series with A-Flex 1050654JR 1/22/08EN-DOM

Important!Fill in the information below when you receive the REMstarAuto M Series system.Serial No.: (located on the bottom of the device)System Prescribed for:Date of Purchase or Rental:Pressure Setting: cm H2OMask Type:Mask Size:If you have any questions concerning the system, contact: Home Care Company:Telephone Number: Health Care Professional:Telephone Number: Respironics, Inc.1001 Murry Ridge LaneMurrysville, Pennsylvania15668-8550 USACustomer ServiceTelephone Number: 1-800-345-6443 (US and Canada) or 1-724-387-4000The REMstar Auto M Series with A-Flex system is covered by one or more of the following patents:5,148,802; 5,313,937; 5,433,193; 5,535,738; 5,632,269; 5,645,035; 5,794,615; 5,803,065; 5,970,975;6,029,664; 6,105,575; 6,286,508; 6,305,374; 6,539,940; 6,550,478; 6,609,517; 6,615,831; 6,752,150;6,837,260; 6,915,705; 6,920,877; 6,932,084; 7,100,607. Australian Patent Nos. 638054; 661575; 698519;723681; 734319; 733655; 766227. Canadian Patent Nos. 2,024,477; 2,162,981; 2,259,795. JapanesePatent Nos. 2137336; 2832812; 2926392; 3566285. EP Patent Nos. EP0425092; EP0714670; EP0612257.Other Patent Nos. FI 105650; DE 69231157; ES 2146591; IT 24310/BE. Other U.S. and foreign patentspending. REMstar, Whisper Swivel, Encore Pro, and Encore Pro SmartCard are trademarks of Respironics,Inc. NOTE: The C-Flex and A-Flex trademarks are used under license. 2008 Respironics, Inc. and its affiliates. All rights reserved.

Table of ContentsChapter 1: Introduction.1-11.1 System Contents.1-11.2 Intended Use.1-21.3 Warnings, Cautions, and Contraindications.1-21.3.1 Warnings.1-21.3.2 Cautions.1-41.3.3 Contraindications.1-41.4 System Overview.1-51.4.1 Breathing Circuit Overview.1-61.5 Glossary.1-71.6 Symbol Key.1-81.7 How to Contact Respironics.1-8Chapter 2: Device Controls and Displays.2-12.1 Controls and Displays.2-12.1.1 Control Panel Inactivity.2-22.2 Rear Panel.2-2Chapter 3: Setup.3-13.1 Installing the Air Filters.3-13.2 Where to Place the Device.3-23.3 Connecting the Breathing Circuit . .3-23.4 Supplying Power to the Device.3-43.4.1 Using AC Power . .3-43.4.2 Using DC Power.3-53.5 Complete Assembly Example.3-6Chapter 4: Device Operation.4-14.1 Available Therapies.4-14.2 Starting the Device.4-14.3 Using the Ramp and Flex Features.4-34.3.1 Ramp Feature.4-34.3.2 C-Flex Comfort Feature.4-34.3.2.1 C-Flex Enabled.4-34.3.2.2 C-Flex Disabled.4-4REMstar Auto M Series User Manuali

4.3.3 A-Flex Comfort Feature. 4-44.3.3.1 A-Flex Enabled. 4-44.3.3.2 A-Flex Disabled. 4-44.4 Changing the Device Settings. 4-54.4.1 Navigating the Display Screens. 4-54.4.1.1 Viewing Data on the Patient Data Screens. 4-64.4.1.2 Viewing and Modifying Patient Setup Screens. 4-84.5 Completing the FOSQ Questionnaire.4-114.6 Patient Reminder Screen.4-12Chapter 5: Device Alerts and Troubleshooting. 5-15.1 Device Alerts. 5-15.2 Troubleshooting. 5-4Chapter 6: Accessories. 6-16.1 Adding a Humidifier. 6-16.2 Using the SmartCard . 6-16.3 Adding Supplemental Oxygen. 6-2Chapter 7: Cleaning and Maintenance. 7-17.1 Cleaning the Device. 7-17.2 Cleaning or Replacing the Filters. 7-17.3 Cleaning the Tubing. 7-27.4 Service. 7-27.5 Traveling with the System. 7-27.5.1 International Travel. 7-2Chapter 8: Specifications. 8-1Appendix A: EMC Information.A-1iiREMstar Auto M Series User Manual

Chapter 1: IntroductionThis chapter provides information on: REMstar Auto M Series system contents Intended Use Warnings, cautions, and contraindications System overview Glossary and symbol key How to contact Respironics1.1 System ContentsYour REMstar Auto M Series system includes the following items:Carrying CaseUser ManualFlexible TubingPower SupplyReusable Gray FoamFilterxFleDisposable Ultra-fineFilterAC Power CordDeviceFigure 1–1 System ContentsNote:If your system includes a humidifier, you will receive additional items with yourpackage. See the instructions included with your humidifier for more information.Note:If any of the above items are missing, contact your home care provider.REMstar Auto M Series User Manual1-1

1.2Intended UseThe Respironics REMstar Auto M Series system is a CPAP (Continuous Positive Airway Pressure)device designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathingpatients weighing 66 lbs (30 kg).The device is to be used only on the instruction of a licensed physician. The system can deliverCPAP therapy or Auto-CPAP therapy. For enhanced pressure relief in CPAP mode, the REMstarAuto M Series can also deliver C-Flex. For enhanced pressure relief in Auto mode, the REMstarAuto M Series can deliver C-Flex or A-Flex. Your home care provider will make the correct pressure settings according to your health care professional’s prescription.When set in the Auto-CPAP therapy, the system will monitor your breathing as you sleep andautomatically adjust the pressure to meet your needs. When in CPAP therapy, the system willdeliver a continuous, set pressure during the night.Several accessories are available to make your OSA treatment with the REMstar Auto M Seriessystem as convenient and comfortable as possible. To ensure that you receive the safe,effective therapy prescribed for you, use only Respironics accessories.1.3Warnings, Cautions, and ContraindicationsCaution: U.S. federal law restricts this device to sale by or on the order of a physician.1.3.1 WarningsA warning indicates the possibility of injury to the user or the operator.1-2 This manual serves as a reference. The instructions in this manual are not intended to supersede the health care professional’s instructions regarding the use of the device. The operator should read and understand this entire manual before using the device. This device is not intended for life support. The device should be used only with masks and connectors recommended by Respironicsor with those recommended by the health care professional or respiratory therapist. A maskshould not be used unless the device is turned on and operating properly. The exhalationport(s) associated with the mask should never be blocked.Explanation of the Warning: The device is intended to be used with special masks or connectors that have exhalation ports to allow continuous flow of air out of the mask. When thedevice is turned on and functioning properly, new air from the device flushes the exhaled airout through the mask exhalation port. However, when the device is not operating, enoughfresh air will not be provided through the mask, and exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead tosuffocation.REMstar Auto M Series User Manual

If oxygen is used with the device, the oxygen flow must be turned off when the device is notin use.Explanation of the Warning: When the device is not in operation and the oxygen flow isleft on, oxygen delivered into the tubing may accumulate within the device’s 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 presenceof an open flame. When using oxygen with this system, a Respironics Pressure Valve must be placed in-linewith the patient circuit. Failure to use the pressure valve could result in a fire hazard. Do not use the device in the presence of a flammable anaesthetic mixture in combinationwith oxygen or air, or in the presence of nitrous oxide. Do not use this device if the room temperature is warmer than 95 F (35 C). If the device isused at room temperatures warmer than 95 F (35 C), the temperature of the airflow mayexceed 106 F (41 C). This could cause irritation or injury to your airway. Do not operate the device in direct sunlight or near a heating appliance because these conditions can increase the temperature of the air coming out of the device. Contact your health care professional if symptoms of sleep apnea recur. If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if the device or the power supply are dropped or mishandled, if wateris spilled into the enclosure, or if the enclosure is broken, discontinue use and contact yourhome care provider. Repairs and adjustments must be performed by Respironics-authorized service personnelonly. Unauthorized service could cause injury, invalidate the warranty, or result in costlydamage. Periodically inspect electrical cords, cables, and the power supply for damage or signs of wear.Discontinue use and replace if damaged. To avoid electric shock, unplug the device before cleaning it. DO NOT immerse the devicein any fluids. Pins of connectors identified with the ESD warning symbol ( )should not be touched.Connections should not be made to these connectors unless ESD precautionary proceduresare used. Precautionary procedures include methods to prevent build-up of electrostaticdischarge (e.g., air conditioning, humidification, conductive floor coverings, non-syntheticclothing), discharging one’s body to the frame of the equipment or system or to earth or alarge metal object, and bonding oneself by means of a wrist strap to the equipment or systemor to earth.REMstar Auto M Series User Manual1-3

1.3.2 CautionsA Caution indicates the possibility of damage to the device. The device may only be operated at temperatures between 41 F (5 C) and 95 F (35 C). If this device has been exposed to either very hot or very cold temperatures, allow it to adjustto room temperature before starting therapy. Condensation may damage the device. Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter. Do not place the device in or on any container that can collect or hold water. A properly installed, undamaged reusable foam inlet filter is required for proper operation. Tobacco smoke may cause tar build-up within the device, which may result in the devicemalfunctioning.Note:Additional warnings, cautions, and notes are located throughout this manual.1.3.3 ContraindicationsWhen assessing the relative risks and benefits of using this equipment, the clinician shouldunderstand that this device can deliver pressures up to 20 cm H2O. In the event of certain faultconditions, a maximum pressure of 30 cm H2O is possible. Studies have shown that the followingpre-existing conditions may contraindicate the use of CPAP therapy for some patients: Bullous Lung Disease Pathologically Low Blood Pressure Bypassed Upper Airway Pneumothorax Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pressure. Caution should be used when prescribing CPAP for susceptible patients such as thosewith: cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history ofhead trauma, and/or pneumocephalus. (Chest 1989; 96:1425-1426)The use of positive airway pressure therapy may be temporarily contraindicated if you exhibitsigns of a sinus or middle ear infection. Not for use with patients whose upper airways are bypassed. Contact your physician if you have any questions concerning your therapy.1-4REMstar Auto M Series User Manual

1.4 System OverviewThe REMstar Auto M Series device, shown in Figure 1–2, is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of Obstructive Sleep Apnea (OSA). It can deliverCPAP therapy or Auto-CPAP therapy.When prescribed for you, the device provides several special features to help make your therapymore comfortable. The ramp function allows you to lower the pressure when you are trying to fallasleep. The air pressure will gradually increase until your prescription pressure is reached. You alsohave the option of not using the ramp feature at all.Additionally, the C-Flex and A-Flex comfort features provide you with pressure relief when youexhale during therapy.Several accessories are also available for use with your REMstar Auto M Series device. Contactyour home care provider to purchase any accessories not included with your system.Figure 1–2 REMstar Auto M Series DeviceFigure 1–3 illustrates many of the device features, described in the table below.Ramp ButtonStart/StopButtonFlexButtonPower InletDisplay Screen(under door)MedicalEquipment Note(on bottom)Air OutletFilter AreaAccessoryModuleFigure 1–3 REMstar Auto M Series System OverviewREMstar Auto M Series User Manual1-5

Device FeatureAccessory ModuleDescriptionIf applicable, insert the optional accessory card here.Air OutletConnect the flexible tubing here.Flex ButtonThis button allows you to change the Flex comfort setting, ifFlex is prescribed for you. See Chapter 4 for more informationabout Flex.Display ScreenShows therapy settings, patient data, instructions, and errormessages.Filter AreaA reusable, gray foam filter must be placed in the filter area toscreen out normal household dust and pollens. An optional,white ultra-fine filter can also be used for more completefiltration of very fine particles.Medical Equipment NoteFor ease at airport security stations, there is a note on the bottom of the device stating that it is medical equipment. It mayhelp if you also take this manual with you when you travel.Power InletConnect the power cord here.Ramp ButtonThis button starts or restarts the ramp cycle.Start/Stop ButtonThis button starts or stops the airflow.1.4.1 Breathing Circuit OverviewThe patient breathing circuit, shown in Figure 1–4, consists of the following: Circuit tubing to deliver air from the device to your interface (e.g., mask) A mask or other patient interface device to deliver the prescribed pressure to your nose ornose and mouth, depending on which interface has been prescribed for you An exhalation device to vent exhaled air from the circuitPatient rcuitTubingCircuit with SeparateExhalation t with Mask withIntegrated Exhalation PortFigure 1–4 Typical Breathing CircuitsNote:1-6The exhalation port may be part of the interface or may be part of a separateexhalation device, but is required to minimize the potential for CO2 rebreathing.REMstar Auto M Series User Manual

1.5 GlossaryThe following terms and acronyms appear throughout this manual:Term/AcronymDefinitionActive StateThe state of the device when power is applied, the airflow is on, and thedevice is providing therapy.A-FlexA therapy feature that establishes a level of pressure relief taking place atthe end of inhalation and at the start of exhalation.ApneaA condition marked by the cessation of spontaneous breathing.Auto-CPAPAdjusts CPAP pressure automatically to improve patient comfort based onmonitoring of apnea and snoring events.Auto-OffWhen this feature is enabled, the device automatically discontinuestherapy whenever the mask is removed.Auto-OnWith this fea

Auto M Series can also deliver C-Flex. For enhanced pressure relief in Auto mode, the REMstar Auto M Series can deliver C-Flex or A-Flex. Your home care provider will make the correct pres-sure settings according to your health care professional’s prescription. When set in the Auto-CPAP therapy, the system will monitor your breathing as you .

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