REMstar - Boardman Medical Supply (BMS)

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REMstar M Series1050727JR 1/22/08EN-DOM

Important!Fill in the information below when you receive theREMstar 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 or 1-724-387-4000The REMstar M Series system is covered by the following patent: 6,622,724. Other patents pending.REMstar and Whisper Swivel are trademarks of Respironics, Inc. 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.1-31.3.3 Contraindications.1-41.4 System Overview.1-41.4.1 Breathing Circuit Overview.1-61.5 Glossary.1-61.6 Symbol Key.1-71.7 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 Starting the Device.4-14.2 Using the Ramp Feature.4-24.3 Changing the Device Settings.4-24.3.1 Navigating the Display Screens.4-24.3.1.1 Viewing the Patient Data Screens.4-34.3.1.2 Viewing and Modifying Patient Setup Screens.4-44.4 Reporting Your Therapy By Phone.4-6REMstar M Series User Manuali

Chapter 5: Alerts and Troubleshooting. 5-15.1 Device Alerts. 5-15.2 Troubleshooting. 5-2Chapter 6: Accessories. 6-16.1 Adding a Humidifier. 6-16.2 Adding Supplemental Oxygen. 6-1Chapter 7: Cleaning and Maintenance. 7-17.1 Cleaning the Device. 7-17.2 Cleaning or Replacing the Filters. 7-17.3 Cleaning the Tubing. 7-37.4 Service. 7-37.5 Traveling with the System. 7-47.5.1 International Travel. 7-4Chapter 8: Specifications. 8-1Environmental. 8-1Physical. 8-1Standards Compliance. 8-1Electrical. 8-1Pressure. 8-2Disposal. 8-2Appendix A: EMC Information.A-1iiREMstar M Series User Manual

Chapter 1: IntroductionThis chapter provides information on: System contents Intended use Warnings, cautions, and contraindications System overview Glossary and symbol key How to contact Respironics1.1 System ContentsYour REMstar M Series system includes the following items:Carrying CaseUser ManualFlexible TubingPower SupplyReusable Gray FoamFilterDisposable 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 M Series User Manual1-1

1.2 Intended UseThe Respironics REMstar M Series system is a CPAP (Continuous Positive Airway Pressure)device designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathingpatients weighing more than 66 lbs (30 kg).The device is to be used only on the instruction of a licensed physician. Your home care providerwill make the correct pressure settings according to your health care professional’s prescription.1.3Warnings, Cautions, and ContraindicationsCaution: US 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. 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.1-2 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.REMstar M Series User Manual

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. Using this device at an incorrect elevation setting could result in airflow pressures higher thanthe prescribed setting. Always verify the elevation setting when traveling or relocating. 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.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. Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter. Condensation may damage the device. Always allow the device to reach room temperaturebefore use. 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.REMstar M Series User Manual1-3

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.1.4 System OverviewThe REMstar M Series device, shown in Figure 1–2, is a sleep apnea therapy system thatdelivers Continuous Positive Airway Pressure (CPAP). CPAP maintains a constant level of pressure throughout the breathing cycle.When prescribed for you, the device provides a special feature to help make your therapy morecomfortable. 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.Figure 1–2 REMstar M Series Device1-4REMstar M Series User Manual

Figure 1–3 illustrates many of the device features, described in the table below.Ramp ButtonStart/StopButtonDisplay Screen(under door)MedicalEquipment Note(on bottom)Power InletAir OutletFilter AreaFigure 1–3 System OverviewDevice FeatureAir OutletDescriptionConnect the flexible tubing here.Display ScreenShows therapy settings and patient data.Filter AreaA reusable, gray foam filter must be placed in thefilter area to screen out normal household dust andpollens. An optional, white ultra-fine filter can alsobe used for more complete filtration of very fineparticles.Medical Equipment NoteFor ease at airport security stations, there is a noteon the bottom of the device stating that it is medicalequipment. It may help if you also take this manualwith 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.REMstar M Series User Manual1-5

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 sk'sConnectorCircuitTubingCircuit with SeparateExhalation DeviceFlexibleTubingConnectorCircuit with Mask withIntegrated Exhalation PortFigure 1–4 Typical Breathing CircuitsNote:The 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.1.5 GlossaryThe following terms and acronyms appear throughout this manual:Term/Acronym1-6DefinitionActive StateThe state of the device when power is applied, the airflow is on, and thedevice is capable of providing therapy.AltitudeAllows the user to modify the altitude setting. Can be set to 1, 2, or 3 corresponding to low, medium, and high altitudes, respectively.ApneaA condition marked by the cessation of spontaneous breathing.BPMBreaths Per MinuteComplianceCheck ValueRepresents a code used by the provider to determine the accuracy ofreported therapy data.CPAPContinuous Positive Airway PressureHours ofPatient UseThe total amount of time that the blower has been on .LPMLiters Per MinuteOSAObstructive Sleep ApneaREMstar M Series User Manual

Term/AcronymDefinitionPatient DataModeThe display mode in which the patient can view certain stored information,such as session count.Patient SetupModeThe display mode in which the patient can change patient-adjustabledevice settings such as the ramp starting pressure.RampA feature that may increase patient comfort when therapy is started. Theramp feature reduces pressure and then gradually increases the pressure tothe prescription setting so patients can fall asleep more comfortably.Safe StateThe state in which the device does not provide therapy. The device entersthis state if a fault is detected.Standby StateThe state of the device when power is applied but the airflow is turned off.Therapy HoursThe total amount of time that the blower is on and patient breathing isdetected.1.6 Symbol KeyThe following symbols appear on the device and power supply:SymbolDefinitionConsult accompanying instructions for use.DC PowerType BF Applied PartClass II (Double Insulated)IPX1Drip Proof EquipmentElectrostatic DischargeCanadian/US CertificationTUV Safety Standard ComplianceUL Recognized for Canada and the United StatesNo User Serviceable PartsREMstar M Series User Manual1-7

1.7 How to Contact RespironicsTo have your device serviced, contact your home care provider. If you need to contact Respironicsdirectly, call the Respironics Customer Service department at 1-800-345-6443 (US and Canadaonly) or 1-724-387-4000.You can also use the following address:Respironics1001 Murry Ridge LaneMurrysville, Pennsylvania15668-8550 USAVisit Respironics web site at: www.respironics.com1-8REMstar M Series User Manual

Chapter 2: Device Controls and DisplaysThis chapter describes the device’s control buttons and displays, patient circuit connections, andrear panel connections.2.1Controls and DisplaysFigure 2–1 shows the two primary control buttons on the REMstar M Series device.Figure 2–1 Primary Control ButtonsThese buttons are described below.ButtonDescriptionRamp – When the airflow is on, this button allows you to activate or restart theramp function. Ramp lowers the airflow pressure and then gradually increases it,allowing you to fall asleep more easily.Start/Stop – This button starts the device’s airflow and places the device in the Active state, or stops the airflow, and places the device in Standby. You can also pressthis button to e

Your REMstar M Series system includes the following items: Device Flexible Tubing Reusable Gray Foam Filter Disposable Ultra-fine Filter Power Supply AC Power Cord Carrying Case User Manual fgi U R E 1–1 sy s t E M Co n t E n t s Note: If your system includes a humidifier, you will receive additional items with your package.

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