Respironics REMstar Auto M Series Manuel d'utilisateur

1032975 JH 2/28/06PROVIDER MANUAL

1-5PROVIDER MANUAL1.4 SYSTEM OVERVIEWe device, shown in Figure 1–2, is a sleep apnea system that delivers Continuous Positive Airway Pressure (CPAP)

1-6 PROVIDER MANUAL1.4.2 RAMPe device is equipped with a linear ramp feature that allows patients to reduce the pressure and then gradually increa

1-7PROVIDER MANUAL1.4.3 EVENT DEFINITIONSe REMstar Auto M Series monitors breathing and detects apneas and hypopneas.EVENT DEFINITIONApnea Detection

1-8 PROVIDER MANUAL1.5 ACCESS LEVELSere are two levels of access for the device, provider mode and user mode.1.5.1 ACCESSING PROVIDER MODEPrescrib

1-9PROVIDER MANUAL1.5.1.2 REMSTAR AUTO M SERIES PROVIDER MODE SETTINGSFor the REMstar Auto M Series device, you can modify the following settings in

1-10 PROVIDER MANUAL1.5.2 ACCESSING USER MODEe device defaults to user mode when you apply power. If you are in provider mode and want to access th

1-11PROVIDER MANUAL1.6 GLOSSARYe following terms and acronyms appear throughout this manual:TERM/ACRONYM DEFINITIONActive State The state of the dev

1-12 PROVIDER MANUAL1.7 SYMBOL KEY e following symbols appear on the device and power supply:SYMBOL DEFINITIONConsult accompanying instructions for

2-1PROVIDER MANUALCHAPTER 2: DEVICE CONTROLS AND DISPLAYSis chapter describes the device’s control buttons and displays, patient circuit connections

2-2 PROVIDER MANUALe display buttons are described below:BUTTON DESCRIPTIONAllows you to access the Data screens. Also allows you to navigate to the

e REMstar® Pro M Series with C-Flex™ system is covered by one or more of the following patents: 5,148,802; 5,313,937; 5,433,193; 5,632,269; 5,803,065

2-3PROVIDER MANUAL2.1.2 CONTROL PAD INACTIVITYSome screens have timeout periods. e screens timer starts when the screen is initially displayed and i

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3-1PROVIDER MANUALCHAPTER 3: SETUPis chapter contains information on how to:• Install the air filters• Assemble the patient circuit• Supply power

3-2 PROVIDER MANUALFilter AreaDisposable Ultra-FineFilter (optional)Reusable GrayFoam Filter(required)FIGURE 3–1 INSTALLING THE AIR FILTERNote: Se

3-3PROVIDER MANUALFollow the steps below to show the patient how to connect the breathing circuit to the device:1. Connect the flexible tubing to the

3-4 PROVIDER MANUAL2. Connect the tubing to the mask:a. If the patient is using a mask with a built-in exhalation port, connect the mask’s connec-

3-5PROVIDER MANUAL3.3 SUPPLYING POWER TO THE DEVICEYou can power the device using AC or DC power.Caution: If this device has been exposed to either

3-6 PROVIDER MANUALFIGURE 3–7 CONNECTING THE POWER SUPPLY CORD TO THE DEVICE4. Ensure that all connections are secure.Important! To remove AC pow

3-7PROVIDER MANUAL3.4 COMPLETE ASSEMBLY EXAMPLEFigure 3–8 shows an example of how a complete assembly will look, with breathing circuit con-nected an

3-8 PROVIDER MANUAL3.5 VERIFYING THE PRESSUREWARNING: If the device fails to perform within the stated specifications, have the system serviced by

3-9PROVIDER MANUAL3. Turn the manometer on. If it does not display a reading of zero, adjust the manometer to calibrate it. If the manometer has vari

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4-1PROVIDER MANUALCHAPTER 4: OPERATING THE DEVICEis chapter explains how to start the device and change the settings.4.1 STARTING THE DEVICE1. Plu

4-2 PROVIDER MANUAL3. Finally, from user mode, once you press the button to turn on the airflow, the Active Display screen displays, shown in Figu

4-3PROVIDER MANUAL4.2 CHANGING AND VIEWING SETTINGS IN PROVIDER MODEAccessing provider mode unlocks additional settings that cannot be modified while

4-4 PROVIDER MANUAL4.2.1 REMSTAR PRO M SERIES PROVIDER SETUP SCREENSFigure 4–5 shows how to navigate the REMstar Pro M Series Provider Setup screen

4-5PROVIDER MANUALe REMstar Pro M Series Provider Setup screens are described below.+Data Setup1. Provider Mode Standby Screen The Standby screen a

4-6 PROVIDER MANUAL0:25 MinRamp Time5. Ramp Time Screen When you set the ramp time, the device increases the CPAP pressure from the value set on th

4-7PROVIDER MANUALShow AHI/LeakFeature: ON9. Show AHI/System Leak Screen You can select whether or not the Apnea/Hypopnea index and System Leak avera

4-8 PROVIDER MANUAL4.2.2 REMSTAR PRO M SERIES PROVIDER DATA SCREENSFigure 4–6 shows how to navigate the REMstar Pro M Series Provider Data screens.

iPROVIDER MANUALTABLE OF CONTENTSChapter 1: Introduction ...

4-9PROVIDER MANUALe REMstar Pro M Series Provider Data screens are described below.+Data Setup1. Provider Mode Standby Screen From the Standby scre

4-10 PROVIDER MANUAL 7 Day Avg: 0.0 30 Day Avg: 0.0 System Leak L/min4. System Leak Screen Th

4-11PROVIDER MANUAL4.2.3 REMSTAR AUTO M SERIES PROVIDER SCREENSFigure 4–7 shows how to navigate the REMstar Auto M Series Provider Setup screens usin

4-12 PROVIDER MANUALe REMstar Auto M Series Provider Setup screens are described below.+Data Setup1. Provider Mode Standby Screen The Standby scr

4-13PROVIDER MANUAL5.0 cmH2OAuto: Min5. Auto Minimum Pressure Screen This screen allows you to modify the Auto Minimum pres-sure setting. The setting

4-14 PROVIDER MANUAL4.0 cmH2ORamp Start Pres4.0 cmH2OAutoramp8. Ramp Starting Pressure Screen You can increase or decrease the ramp starting pressu

4-15PROVIDER MANUAL Off 120 180 240Split Night Time11. Split Night Time Screen You can modify the Split Night Time setting on this screen

4-16 PROVIDER MANUAL4.2.4 REMSTAR AUTO M SERIES PROVIDER DATA SCREENSFigure 4–8 shows how to navigate the REMstar Auto M Series Provider Data scree

4-17PROVIDER MANUALe REMstar Auto M Series Provider Data screens are described below.+Data Setup1. Provider Mode Standby Screen From the Standby sc

4-18 PROVIDER MANUAL 7 Day Avg: 10.030 Day Avg: 12.090% PressurecmH2O4. 90% Therapy Pressure Screen This screen di

ii PROVIDER MANUALChapter 4: Operating the Device ...4

4-19PROVIDER MANUALTotal Hours: 98:36Blower Hours7. Blower Hours Screen This screen displays the total number of hours that the blower has been act

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5-1PROVIDER MANUALCHAPTER 5: DEVICE ALERTS AND TROUBLESHOOTINGis chapter describes the device alerts and provides troubleshooting information.5.1 D

5-2 PROVIDER MANUAL5.1.1 ALERT SUMMARY TABLEe following table summarizes the high and medium priority alerts.ALERT AUDIBLE INDICATORVISUAL INDICA

5-3PROVIDER MANUALALERT AUDIBLE INDICATORVISUAL INDICATORDEVICE ACTIONPOSSIBLE CAUSEPATIENT ACTIONPROVIDER ACTIONSmartCard Error • • Bac

5-4 PROVIDER MANUALALERT AUDIBLE INDICATORVISUAL INDICATORDEVICE ACTIONPOSSIBLE CAUSEPATIENT ACTIONPROVIDER ACTIONAuto Off None The words Auto Off

5-5PROVIDER MANUAL5.2 TROUBLESHOOTINGe table below lists common problems you or the patient may experience with the device or mask and possible solu

5-6 PROVIDER MANUALPROBLEM WHY IT HAPPENED WHAT TO DOThe device does not op-erate when you press the button. The airflow does not turn on.There may b

5-7PROVIDER MANUALPROBLEM WHY IT HAPPENED WHAT TO DOThe Ramp feature does not work when you press the Ramp button ( ).The Ramp Time is set to 0. Or,

5-8 PROVIDER MANUALPROBLEM WHY IT HAPPENED WHAT TO DOThe device has fallen off the table or nightstand.The device may not have been properly seated on

1-1PROVIDER MANUALCHAPTER 1: INTRODUCTIONis chapter provides information on:• System contents• Intended Use• Warnings, cautions, and contraindica

5-9PROVIDER MANUALPROBLEM WHY IT HAPPENED WHAT TO DOThe patient is having problems connecting the tubing to the device.They have lost the air outlet p

5-10 PROVIDER MANUALPROBLEM WHY IT HAPPENED WHAT TO DOThe air out of the mask is much warmer than usual. The air filters may be dirty.The device may b

6-1PROVIDER MANUALCHAPTER 6: CIRCUITS AND ACCESSORIESis chapter describes the Respironics-approved breathing circuit and accessories available for t

6-2 PROVIDER MANUAL6.3 SMARTCARDe device is delivered with an Encore Pro SmartCard. e SmartCard is a plastic card similar in size and shape to a

6-3PROVIDER MANUAL6.6 ADDING SUPPLEMENTAL OXYGENOxygen may be added at the mask connection. Please note the warnings listed below when using oxygen w

6-4 PROVIDER MANUAL6.6.2 ADDING SUPPLEMENTAL OXYGENe delivered oxygen concentration varies with changes in flow in the circuit. e following may ha

7-1PROVIDER MANUALCHAPTER 7: CLEANING AND MAINTENANCEis chapter describes how to clean the device and its filters.7.1 CLEANING THE DEVICEWarning: T

7-2 PROVIDER MANUAL7.2 CLEANING OR REPLACING THE FILTERSCaution: Operating the device with a dirty filter may keep the system from working properly

7-3PROVIDER MANUAL6. Reinstall the filters, inserting the white ultra-fine filter first if applicable, as shown in Figure 7–2. Filter AreaDisposable Ultr

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1-2 PROVIDER MANUAL1.2 INTENDED USEe Respironics REMstar Pro M Series and REMstar Auto M Series systems are CPAP (Continu-ous Positive Airway Press

8-1PROVIDER MANUALCHAPTER 8: SPECIFICATIONSENVIRONMENTALOPERATING STORAGETEMPERATURE 41° F (5° C) to 95° F (35° C) -4° F (-20° C) to 140° F (60° C)RE

8-2 PROVIDER MANUALPRESSUREPressure Increments: 4.0 to 20.0 cm H2O (in 0.5 cm H2O increments)Pressure Stability: <10.0 cm H2O (±0.5 cm H2O) ≥10.

A-1PROVIDER MANUALAPPENDIX A: EMC INFORMATIONGUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONSis device is intended for use in the

A-2 PROVIDER MANUALGUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITYis device is intended for use in the electromagnetic environmen

A-3PROVIDER MANUALGUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITYis device is intended for use in the electromagnetic environment

A-4 PROVIDER MANUALRECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THIS DEVICEe device is intended for

LIMITED WARRANTYRespironics, Inc. warrants that the system shall be free from defects of workmanship and materials and will perform in accordance with

1-3PROVIDER MANUAL• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame.• When using oxygen with

1-4 PROVIDER MANUAL• Pins of connectors identified with the ESD warning symbol ( )should not be touched. Connections should not be made to these conn