User Manual - Sleep Restfully, Inc
www .respir onics.comCPAP SystemUser Manual1007167LK 5/12/01
Table of ContentsSymbol Key . 2Intended Use . 3Specifications . 4Warnings & Cautions . 5Unpacking the System . 6System Features . 7First Time Setup . 8Installing the Filter .9Device Settings . 11Assembling the Circuit . 15Accessories . 16Adding a Humidifier . 16Adding Oxygen . 16Using DC Power . 17Using an Ultra-fine Filter . 17Carrying Case . 17Routine Use . 18Connecting the Circuit . 18Adjusting the Circuit . 18Starting Ramp . 19Turning the System Off . 19Helpful Hints . 19Screen Messages . 20Traveling with the System . 22Routine Maintenance . 23Filter . 23Cleaning . 24Reordering . 24Service . 24Troubleshooting . 26Warranty . 28REMstar Pro User Manual 1
SymbolsPressure ON / OFFRampHeated Humidifier ON / OFFDC PowerType BF Applied PartClass II (Double Insulated)IPX0 Ordinary EquipmentAttention, consultaccompanying documentsEuropean CE Marking0123This CPAP System is the subject of U.S. patent #5239995 andother pending U.S. and foreign patents.REMstar is a trademarkof Respironics, Inc. Respironics, Inc. 20012 REMstar Pro User Manual
Intended UseIntended UseThe Respironics Pro System is a continuous positive airway pressure(CPAP) device designed for the treatment of adult Obstructive SleepApnea (OSA) only.The REMstar Pro is to be used only on the instruction of a licensedphysician. Your home care provider will make the correct pressuresettings according to your physician’s prescription.Several accessories are available to make your OSA treatment with theREMstar Pro system as convenient and comfortable as possible. Toensure that you receive the safe, effective therapy prescribed for you,use only Respironics accessories.IMPORTANT!Read and understand the entire user’s manual before operating thissystem. If you have any questions concerning the use of this system,contact your home care provider or doctor.Contraindications Studies have shown that the following preexisting conditions maycontraindicate the use of positive airway pressure therapy for somepatients: Bullous Lung Disease Pathologically Low Blood Pressure Pneumothorax Pneumocephalus has been reported in a patient using nasalContinuous Positive Airway Pressure. Caution should be used whenprescribing CPAP for susceptible patients such as those with:cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate,prior history of head trauma, and/or pneumocephalus.(Chest 1989; 96:1425-1426)The use of positive airway pressure therapy may be temporarilycontraindicated if you exhibit signs of a sinus or middle ear infection.Not for use with patients whose upper airways are bypassed. Contactyour physician if you have any questions concerning your therapy.REMstar Pro User Manual 3
SpecificationsDevice SizeProduct Use,Transport, andStorageStandardsComplianceDimensions:Weight:9 1/2” x 6 7/8” x 4 3/4” (24 x 17 x 12 cm)4 lbs. (1.8 kg)OperationTemperature:41 to 95 F (5 to 35 C)Humidity:15 to 95% Non-condensingAtmospheric Pressure: 82.8 to 102 kPascalsTransport & Storage-4 to 140 F (-20 to 60 C)15 to 95% Non-condensing50 to 102 kPascalsThis device is designed to conform to the following standards:IEC 60601-1 Medical Electrical Equipment General Requirements for SafetyIEC 60601-1-2 Electromagnetic CompatibilityUS Deviations (UL 2601-1:1997)Canada Deviations (CAN/CSAC22.2 No. 601.1-M90)Mode of OperationContinuousPower RequirementsAC Power Consumption:DC Power Consumption:100 to 240 VAC, 50/60 Hz, 1.0 A max.12 VDC, 3.0 A max.Class II EquipmentType of ProtectionAgainst Electric ShockType BF Applied PartDegree of ProtectionAgainst Electric ShockIPX0 - Ordinary EquipmentDegree of ProtectionAgainst Ingress of WaterPressure Range4 REMstar Pro User Manual4 to 20 cm H2O (in 1 cm increments)
Warnings & CautionsCAUTION! US federal law restricts this device to sale by or on the order of aphysician.WARNING! The instructions in this manual are not intended to supersedeestablished medical protocols.Indicates thepossibility forinjury to the useror the operator. This device is intended for adult use only. This device is not intended for life support. CPAP devices have the potential to allow rebreathing of exhaled air. Toreduce this potential, observe the following:- Use only Respironics circuit accessories.- Do not wear the mask and headgear for more than a few minutes.while the device is not operating.- Do not block or try to seal the vent holes in the exhalation portAs with most CPAP devices: At low CPAP pressures, some exhaled gas(CO2) may remain in the mask and be rebreathed. Do not use this device if the room temperature is warmer than 95 F(35 C). If this device is used at room temperatures warmer than 95 F(35 C), the temperature of the airflow may exceed 106 F (41 C).This could cause irritation to your airway. This equipment is not suitable for use in the presence of a flammableanaesthetic mixture in combination with oxygen or air, or in thepresence of nitrous oxide. To avoid electrical shock, disconnect the power cord before cleaning.DO NOT immerse the device in any fluids Contact your doctor if symptoms of sleep apnea recur.CAUTION!Indicates thepossibility ofdamage to thedevice. If you notice any unexplained changes in the performance of thisdevice, if it is making unusual or harsh sounds, if it has been droppedor mishandled, if the enclosure is broken, or if water has entered theunit, discontinue use and contact your home care provider. Tobacco smoke may cause tar build-up within the REMstar Pro thatmay result in the REMstar Pro malfunctioning.Additional warnings and cautions are located throughout this manualas they apply.REMstar Pro User Manual 5
Unpacking the SystemAfter unpacking the system, check to make sure you have everythingshown here:REMstar Prowith ltersUserFlexible Tubing6 ft. (1.83 m)ManualPowerCordIMPORTANT!If any of the above parts are missing, contact your home care provider.***The Encore SmartCard is a new feature which records the CPAP usage. Anothernew feature is the FOSQ “Quality of Life” questionnaire. Your doctor or homecare provider may ask you to periodically complete this questionnaire and sendyour answers (recorded on the SmartCard). The FOSQ questionnaire is detailedin the enclosed “Sleep Solutions” brochure.6 REMstar Pro User ManualSleepSolutionswww.respironics.com
System FeaturesDisplayScreenSmartCardHumidifierButtonAC InletPressureRampDC InletMedicalOn/Off ButtonButtonEquipmentNote (on bottom)Filter andFilter CapAir OutletUserCommunicationsButtonsConnectorAC Inlet . Connect the power cord here.Air Outlet . Connect the flexible tubing here.Communications Connector . For clinical use with the Encore Data Management Software or an IEC950 approved device. Connect the communications cable here.DC Inlet . Connect the optional DC power cord here.Display Screen . All System settings, total operating time, and therapy hours will bedisplayed here.Filter Cap & Filter . The pollen filter screens out normal household dust and pollens. Thefilter cap is designed to quiet the CPAP device.Humidifier Button . This button turns the REMstar Heated Humidifier on / off and allows theheater setting to be adjusted. This is an optional accessory that may bepurchased separatelyMedical Product Note . For convenience at airport security stations, a note on the bottom of thedevice states that it is medical equipment. Taking this manual with youwhen you travel also may help you at security checkpoints.Pressure On / OffButton . This button turns the airflow on or off.Ramp Button . This button starts the ramp cycle or accesses the device settings.SmartCard . The SmartCard records device usage information (e.g., times the systemwas used for therapy). Contact your home care provider for furtherinformation about the SmartCard.User Buttons . These buttons can be used to change some of the system settings and toanswer the FOSQ quality of life questionnaire.REMstar Pro User Manual 7
First Time SetupWARNING!DO NOT use the REMstar Pro system until an appropriateprofessional adjusts the settings!Note to home care provider: Before beginning setup, be sure that youhave available the REMstar Pro Home Care Provider SetupInstructions. It contains instructions for setting up the REMstar Pro.WARNING!DO NOT connect any equipment to the REMstar Pro unlessrecommended by Respironics or your doctor.WARNING!Respironics circuit accessories (i.e., nasal mask, exhalation port,tubing) are for single patient use only and are not intended to be usedon multiple patients.CAUTION!If the REMstar Pro has been exposed to either very hot or very coldtemperatures, allow it to adjust to room temperature (approximately 2hours) before beginning setup.ATTENTION!The SmartCard does not need to be installed for the REMstar Pro towork properly. The SmartCard records device usage information foruse by your home care provider. Contact your home care provider ifyou have any questions about the SmartCard.8 REMstar Pro User Manual
First Time SetupInstalling Filters1. Install the filter and filter cap. Foradditional filter options, refer to theAccessories section on page 17.CAUTION!The pollen filter must be in place at alltimes when the device is operating.a. Place one of the filters into thefilter area on the back of theREMstar Pro. An extra filter isincluded for your convenience.b. Attach the filter cap. Position the cap so that the smallopening on the cap is facing down. Insert the cap’s bottom tabsinto the openings below the filter area. Press down on the cap’stop tabs and insert them into the openings above the filter area.Power Cord2. Connect the power cord.Plug the socket end of the power cordinto the AC inlet on the back of theREMstar Pro. Plug the pronged end ofthe power cord into an electrical outlet.CAUTION!Inspect the power cord often for any signs of damage. Replace adamaged cord immediately.CAUTION!This device is activated when the power cord is connected. ThePressure On / Off button only turns the blower on/off.REMstar Pro User Manual 9
First Time Setup3. Place the REMstar Pro on a firm, flat surface.CAUTION!Device SettingsMake sure the REMstar Pro is awayfrom any heating or coolingequipment (e.g. forced air vents,radiators, air conditioners).Also, make sure that bedding,curtains, or other items are notblocking the filter or vents of theREMstar Pro. Air must flow freely aroundthe device for the system to work properly.Once the power cord is plugged in,the REMstar Pro will perform a briefself-diagnostic test. The followingmessage will then appear on thedisplay midifierButtonPressureUser ButtonsOn/Off ButtonRampButtonDisplay Screen: All device settings will appear here.Pressure On/Off Button: Use this button to turn the air flow on oroff. DO NOT turn the airflow on until the circuit tubing is connected.Humidifier Button: Use this button when the optional REMstarHeated Humidifier has been prescribed. This button will control theoptional heated humidifier’s output. Follow the instructions includedwith the humidifier.Ramp Button: Use this button to start the ramp cycle (which lowersthe airflow pressure) or to enter the settings menu. This will allow youto fall asleep more easily.User Buttons: These buttons can be used when entering variousmenus to change some of the device settings.10 REMstar Pro User Manual
First Time SetupDevice SettingsIMPORTANT!4. Follow the display screens to change the system settings. (Theairflow must be turned OFF.)DO NOT use the REMstar Pro if the display is erratic. Contact yourhome care provider for further instructions.a. The blower status will appear. Press the button below “Menu.”P OffUsageMenub. A message will display asking if you want to change the settings.Press the button below “Yes.”Change Settings?YesNoIf you press “No,” go to page 14 for instructions.NOTE: This menu can also be accessed (when the airflow is turnedoff) by pressing the ramp button. Pressing the ramp button (when theairflow is turned on) will lower the airflow pressure to the MinimumRamp Pressure setting.REMstar Pro User Manual 11
First Time SetupThe RampFeatureThe Ramp feature will reduce the pressure and then graduallyincrease (ramp) the pressure to the prescription pressure setting sothat you can fall asleep more comfortably. If your physicianprescribed ramp for you, the minimum ramp pressure setting willappear. If ramp has not been prescribed for you, go to Step d.Setting theMinimum RampPressurec. The minimum ramp pressure will appear. Your home careprovider will have already set a minimum ramp pressure. If youfeel the minimum ramp pressure is set too low or too high, youcan change the setting. (Range: 4 cm H2O - Prescription Pressure)If the minimum ramp pressure is correct, press the buttonbelow “Yes.”To change the pressure in 1 cm H2O increments, press thebutton below “ 1” until the desired pressure appears. Pressthe button below “Yes” to confirm the setting.Min Ramp P. 4Yes 1Air FlowTurned OnRamp ButtonPressedTherapyPressureMinimumRampPressure0 cm H2ORamp TimeMinutes12 REMstar Pro User Manual
First Time SetupTurning the AlertTone On or Offd. The audible mask alert is a beeping sound that the REMstar Promakes when a large, continuous air leak has been detected in thecircuit. You have the option of turning the alert tone On or Off.If the setting is correct, press the button below “Yes.”To change the setting, press the button below “No.”Press the button below “Yes” to confirm the setting.Mask Alert OnYesNoSetting ButtonLightse. The button lights setting will appear. This setting allows you tohave the lights behind the buttons turned on or off while the airflowis on. (The lights will always be on when the airflow is off.)If the setting is correct, press the button below “Yes.”To change the setting, press the button below “No.”Press the button below “Yes” to confirm the setting.Lights OnYesNoREMstar Pro User Manual 13
First Time SetupFOSQ TestWhen “Change Settings” appears, if youpress the button below “No,” a screen willappear that says “FOSQ Test?”Change Settings?YesNoThe FOSQ test is a “quality of life” questionnaire designedspecifically for people with sleep disorders. The results allow healthcare professionals to see how therapy has improved the quality of yourlife. By completing the questionnaire periodically, you can providevaluable information about the effectiveness of your treatment. Thisdevice has the ability to record your answers on the SmartCard for laterreview by the health care provider. Contact your home care provider forfurther instructions.IMPORTANT!If your doctor or home care provider instructs you to complete thequestionnaire, he will provide you with the instructions and thequestions and you will enter your answers into the REMstar Pro.Make sure the SmartCard is installed before answering the questions.A message will appear asking if you wantto take the FOSQ test. If you want to takethe test, Press the button below “Yes.”FOSQ Test?YesNoIf you do not want to take the test, pressthe button below “No” and the display willgo back to the main screen.A SmartCard is installed in the sideof the REMstar Pro to recordinformation for the home careprovider. Your home care providermay ask you to periodically removethe SmartCard and send it to him forevaluation.The arrow in the upper right corner of thedisplay screen signifies that the SmartCard isinstalled properly.14 REMstar Pro User ManualSmartCardªSmartCardP OffUsageMenu
First Time SetupAssemblingthe Circuit5. Assemble the circuit. You will need the following accessories in order toassemble the recommended circuit. Respironics Nasal Mask with integrated exhalation port(or Respironics mask with separate exhalation port such as the Whisper Swivel ) Respironics 6 ft. (1.83 m) Flexible Tubing Respironics Headgear (for the mask; not shown)WARNING!If the REMstar Pro is used for multiple persons (e.g., rental devices) a lowresistance, main flow bacteria filter should be installed in-line between thedevice and the circuit tubing. Pressures must be verified when alternate oroptional accessories are in place.a. Connect the flexible tubing to the airoutlet on the front of the REMstar Pro.b. If you are using a mask with a built-inexhalation port: Connect the mask’s connector tothe flexible tubing.Mask'sConnectorFlexibleTubingIf you are using a mask with a separate exhalationport: Connect the exhalation port to the flexibletubing.Position the exhalation port so that the vented air isblowing away from your face. Connect the mask’sconnector to the exhalation RNING!The exhalation port is designed to exhaust CO2 from the circuit. Continuousflow is required for safe operation. Do not block or otherwise try to seal theair openings on the exhalation port.WARNING!If you are using a full face mask (i.e., a mask covering both your mouth andyour nose), the mask must be equipped with a safety (entrainment) valve.REMstar Pro User Manual 15
AccessoriesContact your home care provider for additional information on theoptional accessories. When using optional accessories, always followthe instructions enclosed with the accessories.Adding aHumidifierCAUTION!Adding Oxygento the SystemThe REMstar Heated Humidifier andREMstar Pass-over Humidifiers are availablefrom your home care provider. Thehumidifiers may reduce nasal dryness andirritation by adding moisture (and heat ifapplicable) to the airflow.For safe operation, the humidifier must always be positioned below thecircuit connection at the mask and the a
10 REMstar Pro User Manual 3. Place the REMstar Pro on a firm, flat surface. Make sure the REMstar Pro is away from any heating or cooling equipment (e.g. forced air vents, radiators, air conditioners). Also, make sure that bedding, curtains, or other items are not blocking the filter or vents of the REMstar Pro. Air must flow freely around
Nov 12, 2018 · 2 The Sleep in America poll was run alongside the National Sleep Foundation’s validated sleep health assessment tool, the Sleep Health Index , which has been fielded quarterly since 2016.The Index is based on measures of sleep duration, sleep quality and disordered sleep. Am
uals experience disturbed sleep at least a few nights each week12 . Research presented at SLEEP 2013, the 27th Annual Meeting of the Associated Professional Sleep Societies, LLC, addressed sleep-related topics ranging from basic sleep science, such as cell and molecular genetics, to such clinical topics as sleep disorders and sleep and aging .
Academy of Sleep Medicine, the Department of Health and Human Services, the National Sleep Foundation, and the Sleep Research Society Contract no. N01-OD-4-2139 ISBN 0-309-10111-5 (hardback) 1. Sleep disordersÑSocial aspects. 2. Sleep deprivationÑSocial aspects. 3. SleepÑSocial aspects. 4. Public health. I.
The Pittsburgh Sleep Quality Index (PSQI) 21 is a 19-item ques-tionnaire used to measure sleep quality complaints. Seven com-ponent scores assess habitual duration of sleep, nocturnal sleep disturbances, sleep latency, sleep quality, daytime dysfunction, sleep medication usage
(WASO), total sleep time (TST), total time spent in bed (TIB), sleep efficiency (SE, i.e., the percent of the time asleep out of amount of time spent in bed), and sleep quality or satis-faction, which reflects a subjective global appraisal of each night's sleep. On the other hand, researchers have not agreed on the format of the sleep diary.
then compared with that of sleep deprived non-epileptic mice along with their non-sleep deprived peers. The mice, which have sleep cycles as short as 30 - 90 seconds, are deprived of sleep for 6 hours to up to 3 weeks at a time using a physical stimulus to awaken them. This research is being used to simulate sleep apnea and chronic sleep
Sleep apnea occurs when you stop breathing during the night. There are three types of sleep apnea: 1) Obstructive Sleep Apnea (OSA) – upper airway collapse causing obstruction. This is the most common form of sleep apnea. 2) Central Sleep Apnea
How to Use the National Sleep Foundation Sleep Diary Using this sleep diary takes just a few minutes each day. To get the most out of it: Use your sleep diary every day for two weeks (or for
