Respironics REMstar M Series User Manual
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1016452
AM 2/09/06

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Summary of Contents for Respironics REMstar M Series

  • Page 1 1016452 AM 2/09/06...
  • Page 2 Customer Service Telephone Number: 1-800-345-6443 or 1-724-387-4000 The 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. © 2006 Respironics, Inc. and its affiliates. All rights reserved.
  • Page 5 1424 K Street NW, Suite 302, Washington D.C. 20005 Respironics, Inc. provided a grant to and is recognized as a founding sponsor of the American Sleep Apnea Association. As a non-profit organization, the American Sleep Apnea Association does not endorse or recommend any company or product.
  • Page 6 Join the American Sleep Apnea Association As a member of the American Sleep Apnea Association, you will receive a newsletter, WAKE-UP CALL, six times each year. This newsletter will inform you about the latest in medical advances, new technology, human interest stories of individual accomplishment, home care tips, and legislative affairs. Also, you will receive a medical alert identification bracelet.
  • Page 7: Table Of Contents

    1.4 System Overview .......................1-5 1.4.1 Breathing Circuit Overview ................1-7 1.5 Glossary .........................1-8 1.6 Symbol Key ........................1-8 1.7 How to Contact Respironics ................1-10 Chapter 2: Device Controls and Displays .................2-1 2.1 Controls and Displays ....................2-1 2.1.1 Control Panel Inactivity ................2-3 2.2 Rear Panel ........................2-3...
  • Page 8 Chapter 5: Alerts and Troubleshooting ..................5-1 5.1 Device Alerts ....................... 5-1 5.2 Troubleshooting ......................5-2 Chapter 6: Accessories ........................6-1 6.1 Adding a Humidifier ....................6-1 6.2 Adding Supplemental Oxygen ................6-2 Chapter 7: Cleaning and Maintenance..................7-1 7.1 Cleaning the Device ....................7-1 7.2 Cleaning or Replacing the Filters .................
  • Page 9: Chapter 1: Introduction

    • System overview • Glossary and symbol key • How to contact Respironics ystEM ontEnts Your REMstar M Series system includes the following items: Carrying Case User Manual Quickstart Guide Flexible Tubing Power Supply Reusable Gray Foam Filter Disposable Ultra-fine...
  • Page 10: Intended Use

    The Respironics REMstar M Series system is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing more than 66 lbs (30 kg). The device is to be used only on the instruction of a licensed physician. Your home care provider will make the correct pressure settings according to your health care professional’s prescription.
  • Page 11 • Repairs and adjustments must be performed by Respironics-authorized service personnel only. Unauthorized service could cause injury, invalidate the warranty, or result in costly damage.
  • Page 12: Cautions

    1.3.2 C aUtions A 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 adjust to room temperature before starting therapy.
  • Page 13 The REMstar M Series device, shown in Figure 1–2, is a sleep apnea therapy system that delivers Continuous Positive Airway Pressure (CPAP). CPAP maintains a constant level of pres- sure throughout the breathing cycle. When prescribed for you, the device provides a special feature to help make your therapy more comfortable.
  • Page 14: System Overview

    Figure 1–3 illustrates many of the device features, described in the table below. Start/Stop Ramp Button Button Power Inlet Display Screen Air Outlet (under door) Medical Filter Area Equipment Note (on bottom) 1–3 s igURE ystEM vERviEW EviCE EatURE EsCRiption Air Outlet Connect the flexible tubing here.
  • Page 15 1.4.1 b REathing iRCUit vERviEW The 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 or nose and mouth, depending on which interface has been prescribed for you •...
  • Page 16: Glossary

    lossaRy The following terms and acronyms appear throughout this manual: CRonyM Efinition Active State The state of the device when power is applied, the airflow is on, and the device is capable of providing therapy. Altitude Allows the user to modify the altitude setting. Can be set to 1, 2, or 3 cor- responding to low, medium, and high altitudes, respectively.
  • Page 17: Symbol Key

    yMbol The following symbols appear on the device and power supply: yMbol Efinition Consult accompanying instructions for use. DC Power Type BF Applied Part Class II (Double Insulated) IPX1 Drip Proof Equipment Electrostatic Discharge European Declaration of Conformity Canadian/US Certification TUV Safety Standard Compliance UL Recognized for Canada and the United States...
  • Page 18 EspiRoniCs To have your device serviced, contact your home care provider. If you need to contact Respironics directly, call the Respironics Customer Service department at 1-800-345-6443 (US and Canada only) or 1-724-387-4000. You can also use the following address: Visit Respironics web site at: www.respironics.com...
  • Page 19: Controls And Displays

    This chapter describes the device’s control buttons and displays, patient circuit connections, and rear panel connections. ontRols and isplays Figure 2–1 shows the two primary control buttons on the REMstar M Series device. 2–1 p igURE RiMaRy ontRol Uttons These buttons are described below.
  • Page 20 The display buttons are described below: Utton EsCRiption Allows you to access the Data screens. Also allows you to navigate to the previous screen when in the Data or Setup mode. Allows you to access the Setup screens. Also allows you to navigate to the next screen when in the Data or Setup mode.
  • Page 21: Rear Panel

    The screen times out after one minute if there is no activity and returns to the Standby screen. anEl Figure 2–4 shows the REMstar M Series device’s rear panel (without a humidifier). Power Inlet Air Outlet Filter Area 2–4 R...
  • Page 22 staR ERiEs anUal...
  • Page 23: Chapter 3: Setup

    3: s haptER EtUp This chapter provides instructions on how to: • Install the air filters • Position the device • Connect the breathing circuit • Supply power to the device nstalling thE iltERs Caution: A properly installed, undamaged foam filter is required for proper operation. The device uses a gray foam filter that is washable and reusable, and an optional white ultra-fine filter that is disposable.
  • Page 24 To use the system, you will need the following accessories in order to assemble the recommended circuit: • Respironics interface (e.g, nasal mask) with integrated exhalation port (or Respironics inter- face with a separate exhalation device such as the Whisper Swivel® II) •...
  • Page 25 To connect your breathing circuit to the device, complete the following steps: Connect the flexible tubing to the air outlet on the back of the device, as shown in Figure 3–2. You can use the optional, detachable swivel that is provided with your device and already attached to the tubing (shown in Figure 3–2), or you can remove the swivel and con- nect the tubing directly to the air outlet.
  • Page 26 If you are using a mask with a separate exhalation device, connect the open end of the flexible tubing to the exhalation device as shown in Figure 3–4. Position the exhalation device so that the vented air is blowing away from your face. Connect the mask’s connec- tor to the exhalation device.
  • Page 27: Using Ac Power

    Upplying oWER to thE EviCE You can power the device using AC or DC power. Caution: If this device has been exposed to either very hot or very cold tempera- tures, allow it to adjust to room temperature before beginning the following setup procedures. Warning: Route the wires to avoid tripping. Warning: This device is activated when the power cord is connected. Pressing the button turns the airflow on or off. Important! If you are using your device with a humidifier, refer to the Quick Start Guide included with your device or the instructions included with your humidifier for details on how to power the device and humidifier. 3.4.1 U aC p sing oWER Complete the following steps to operate the device using AC power. Plug the socket end of the AC power cord into the power supply, as shown in Figure 3–5.
  • Page 28 The Respironics DC Power Cord (Reorder Number 1001956) can be used to operate this device in a stationary recreational vehicle, boat, or motor home. The Respironics DC Battery Adapter Cable (Reorder Number 532209), when used with the DC Power Cord, enables the device to be operated from a 12 VDC free-standing battery.
  • Page 29 oMplEtE ssEMbly xaMplE Figure 3–7 shows an example of how a complete assembly will look, with breathing circuit con- nected and power applied to the device. 3–7 f igURE inal ssEMbly xaMplE Figure 3–8 shows an example of how you should route your tubing and situate your device on your night stand for the best setup possible.
  • Page 30 staR ERiEs anUal...
  • Page 31 4: d haptER EviCE pERation This chapter explains how to start the device and change the settings. taRting thE EviCE Plug the device in to an AC or DC power source. The Start/Stop and the Ramp buttons light up. The Software Version screen, shown below, momentarily appears. The num- ber that appears on your screen will be different from the number shown below.
  • Page 32: Using The Ramp Feature

    The Active Display screen shows the prescribed or ramping pressure. If the ramp feature is enabled by your health care provider, the Ramp symbol also appears as described below: yMbol EsCRiption If the Ramp feature is enabled, you can initiate it by pressing the Ramp button.
  • Page 33: Changing The Device Settings

    hanging thE EviCE Ettings You can view the prescribed or ramping pressure on the Active Display screen, as well as the fol- lowing information on the Patient Data screens: • Hours of Patient Use • Session Counter (number of sessions greater than 4 hours) •...
  • Page 34 4.3.1 n avigating thE isplay CREEns Use the button to navigate to the next screen and the button to navigate to the previous screen. Use the Plus ( and Minus (–) buttons to adjust the settings on the Patient screens. 4.3.1.1 iEWing thE atiEnt...
  • Page 35 Hours of Patent Use Vew Screen This screen shows you the total number of hours that the blower has been active. Your home care provider may peri- odically ask for this information. Sesson Counter Vew Screen >4 This screen shows you the number of sessions greater than four hours.
  • Page 36 4.3.1.2 iEWing and odifying thE atiEnt EtUp CREEns Press the button to enter the Setup screens. The figure below shows how to navigate the Patient Setup screens. Press To Enter These Screens Standby Screen (showing therapy hours) Altitude Adjustment Ramp Start Pressure Screen Adjustment Screen* 4–5 n...
  • Page 37 Alttude Adjustment Screen You can adjust the altitude setting by pressing the Plus (+) or Minus (-) buttons to increase or decrease the setting to 1, 2, or 3. Use these guidelines to find the setting best for you: • 1 = less than 2500 ft.
  • Page 38: Reporting Your Therapy By Phone

    EpoRting hERapy honE Your provider may ask you to report certain therapy values by telephone. To do so, follow the steps below in order: With the device in standby mode (the power is on but the blower is off), open the cover door. The Standby screen will display your total therapy hours (a sample is shown on the left).
  • Page 39: Device Alerts

    5: a haptER lERts and RoUblEshooting This chapter describes the device alerts and also provides troubleshooting information for issues you may run into when using the device. EviCE lERts The device provides high priority alerts. These alerts require immediate operator response. The alert signal consists of a high priority flashing pattern consisting of a continuous, bright-to-off, two-flash pattern (indicated in the following table as: ◊◊...
  • Page 40 RoUblEshooting The table below lists some of the problems you may experience with your device or mask and pos- sible solutions to those problems. RoblEM appEnEd hat to Nothing happens There’s no power at the If you are using AC power, check the outlet when you apply power outlet or the device is power and verify that the device is properly...
  • Page 41 RoblEM appEnEd hat to The device does not There may be a prob- Make sure the device is powered correctly, operate when you lem with the blower. following the instructions on the previous page. If the button backlights turn on when press the button.
  • Page 42 RoblEM appEnEd hat to The device has fallen The device may not Always make sure your device is placed on off your table or night have been properly a hard, flat surface so the rubber feet on the stand. seated on the night bottom of the device can adhere to the sur- stand, or the place- face (make sure there is no fabric under the...
  • Page 43 RoblEM appEnEd hat to The Ramp feature does Your home care pro- If Ramp has not been prescribed for you, not work when you vider did not prescribe discuss this feature with your home care press the Ramp button Ramp for you, or provider to see if they will change your your CPAP pressure prescription.
  • Page 44 RoblEM appEnEd hat to You are experiencing The air outlet port Remove the port and reattach it to make sure excessive air leaks is not installed cor- it’s properly installed. where the tubing con- rectly and doesn’t seal nects to the device. properly.
  • Page 45 Increase the room humidity. Consult with nose dryness. your health care professional about using a Respironics humidifier with the device. If you have a humidifier, refer to the instructions included with your humidifier to make sure it is working properly.
  • Page 46 staR ERiEs anUal...
  • Page 47 They are available from your home care provider. A humidifier may reduce nasal dryness and irritation by adding moisture (and heat, if applicable) to the airflow. Figure 6–1 shows the humidifier by itself and attached to the REMstar M Series device. Caution: For safe operation, the humidifier must always be positioned below the breathing circuit connection at the mask. The humidifier must be level for...
  • Page 48: Adding Supplemental Oxygen

    When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen. • 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 result in a fire hazard.
  • Page 49: Chapter 7: Cleaning And Maintenance

    7: C haptER lEaning and aintEnanCE This chapter describes how to clean the device and its filters and provides tips on traveling with your REMstar M Series system. lEaning thE EviCE Warning: To avoid electrical shock, always unplug the power cord from the wall outlet or DC power source before cleaning the device. Caution: Do not immerse the device in liquid or allow any liquid to enter the enclosure, inlet filter, or any opening. Unplug the device, and wipe the outside of the device with a cloth slightly dampened with water and a mild detergent.
  • Page 50 4. Wash the gray foam filter in warm water with a mild detergent. Rinse thoroughly to remove all detergent residue. Allow the filter to air dry completely before reinstalling it. If the foam filter is torn, replace it. (Only Respironics-supplied filters should be used as replacement filters.) 5.
  • Page 51: Cleaning The Tubing

    Clean the tubing daily. Disconnect the flexible tubing from the device. Gently wash the tubing in a solution of warm water and a mild detergent. Rinse thoroughly. Air dry. ERviCE The REMstar M Series device does not require routine servicing. Warning: If you notice unexplained changes in the performance of this device,...
  • Page 52 It may be helpful to bring this manual along with you to help security personnel understand the REMstar M Series device. If you typically use a humidifier with your device, but leave the humidifier home when traveling, make sure you attach the air outlet port to your device when you remove the humidifier from the device.
  • Page 53: Chapter 8: Specifications

    8: s haptER pECifiCations nviRonMEntal pERating toRagE 41° F to 95° F -4° F to 140° F EMpERatURE (5° C to 35° C) (-20° C to 60° C) 15 to 95% (non-condensing) 15 to 95% (non-condensing) ElativE UMidity 77 to 101 kPa (0 - 7500 ft.) tMosphERiC REssURE hysiCal...
  • Page 54: Pressure

    REssURE Pressure Increments: 4.0 to 20.0 cm H O (in 0.5 cm H O increments) Pressure Stability: 4.0 to 20.0 cm H O (±1.0 cm H Measured in accordance with EN ISO 17510-1 @ 1/3, 2/3, and Pmax with BPM set to 10, 15, and 20 BPM @ 68°...
  • Page 55 EMC i ppEndix nfoRMation ’ UidanCE and anUfaCtURER EClaRation lECtRoMagnEtiC Missions This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Missions oMplianCE lECtRoMagnEtiC nviRonMEnt anCE...
  • Page 56 ’ UidanCE and anUfaCtURER EClaRation lECtRoMagnEtiC MMUnity This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. iEC 60601 t MMUnity oMplianCE EvEl lECtRoMagnEtiC EvEl nviRonMEnt...
  • Page 57 ’ uidance and anufacturer eclaration lectroMaGnetic MMunity This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. iEC 60601 MMUnity oMplianCE lECtRoMagnEtiC nviRonMEnt EvEl EvEl UidanCE...
  • Page 58 ECoMMEndEd EpaRation istanCEs bEtWEEn oRtablE and obilE oMMUniCations qUipMEnt and EviCE The device is intended for use in an electromagnetic environment in which radiated RF distur- bances are controlled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communica- tions equipment (transmitters) and this device as recommended below, according to the maxi- mum output power of the communications equipment.
  • Page 59 (2) years from the date of sale by Respironics, Inc. to the dealer. If the product fails to perform in accordance with the product specifications, Respironics, Inc. will repair or replace – at its option – the defec- tive material or part.

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