1001 Murry Ridge LaneRespironics DeutschlandM u r r y s v i l l e , PA 1 5 6 6 8Gewerbestrasse 17w w w. r e s p i r o n i c s . c o m8221 Herrsching, Germany1020121A M10404429/12/06E N - U S , F R - C A , E SJR- L A1/15/07, PT-BR
Important!Fill in the information below when you receive the REMstar Auto 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. 2007 Respironics, Inc. and itsaffiliates. 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.4-220.127.116.11 C-Flex Enabled.4-18.104.22.168 C-Flex Disabled.4-4REMstar Auto M Series User Manual
4.3.3 A-Flex Comfort Feature. 4-22.214.171.124 A-Flex Enabled. 4-126.96.36.199 A-Flex Disabled. 4-44.4 Changing the Device Settings. 4-54.4.1 Navigating the Display Screens. 4-188.8.131.52 Viewing Data on the Patient Data Screens. 4-184.108.40.206 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 . 6-26.3 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 Respironics1.1System ContentsYour REMstar Auto M Series system includes the following items:Carrying CaseUser ManualFlexible TubingSwivel(may not be included)Power SupplyReusable Gray FoamFilterFleDisposable Ultra-fineFilterxAC Power CordREMstar Auto M Series DeviceFigure 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 is lefton, oxygen delivered into the tubing may accumulate within the device’s enclosure. Oxygenaccumulated 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 (Part Number 302418)must be placed in-line with the patient circuit. Failure to use the pressure valve could resultin 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 befo