Respironics REMstar Pro M Series User Manual
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Respironics REMstar Pro M Series User Manual

Cpap with c-flex, humidifier, and smartcard
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USER MANUAL
1016444
JH 2/14/06

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  • Page 1 USER MANUAL 1016444 JH 2/14/06...
  • Page 2 5,794,615; 6,105,575; 6,609,517; 6,629,527; 6,622,724; 6,564,797; 6,427,689, and 6,932,084. Other patents pending. REMstar, Whisper Swivel, Encore Pro, and Encore Pro SmartCard are trademarks of Respironics, Inc. NOTE: The C-Flex mark is used under license. © 2006 Respironics, Inc. All rights reserved.
  • Page 3 E-mail Where did you first hear about your M Series device? Homecare Provider Sleep Lab Internet/Website Tradeshow Friend/Colleague Other (please specify) Would you like to receive information regarding new products from Respironics? If Yes, Preferred Method? Phone Direct Mail Email...
  • Page 4 reply_card1.pdf reply_card1.pdf 9/19/05 9/19/05 10:52:10 AM 10:52:10 AM FIRST-CLASS MAIL PERMIT NO. 231 GRAND RAPIDS MN PO BOX 7014 GRAND RAPIDS MN 55744-8029...
  • 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 ........................1-9 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 4.3 Changing the Device Settings ................4-5 4.3.1 Navigating the Display Screens ............... 4-6 4.3.1.1 Viewing Data on the Patient Data Screens ....... 4-6 4.3.1.2 Viewing and Modifying Patient Setup Screens ...... 4-8 4.4 Completing the FOSQ Questionnaire ..............4-11 4.5 Patient Reminder Screen ..................4-12 Chapter 5: Device Alerts and Troubleshooting ..............

  • Page 9: Chapter 1: Introduction

    • System overview • Glossary and symbol key • How to contact Respironics YSTEM ONTENTS Your REMstar Pro 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

    Several accessories are available to make your OSA treatment with the REMstar Pro M Series system as convenient and comfortable as possible. To ensure that you receive the safe, effective therapy prescribed for you, use only Respironics accessories.
  • Page 11 Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of 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 result in a fire hazard.

  • 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: System Overview

    YSTEM VERVIEW The REMstar Pro M Series device, shown in Figure 1–2, is a sleep apnea 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 several special features to help make your therapy more comfortable.
  • Page 14 Figure 1–3 illustrates many of the device features, described in the table below. Start/Stop Ramp Button Button C-Flex Button Power Inlet Display Screen Air Outlet (under door) Medical Filter Area Equipment Note (on bottom) Accessory Module 1–3 REM IGURE STAR ERIES YSTEM VERVIEW...

  • Page 15: Breathing Circuit Overview

    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 providing therapy. Apnea A condition marked by the cessation of spontaneous breathing. Auto-Off...

  • 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 Notified Body Approval for Standards Compliance TUV Safety Standard Compliance UL Recognized for Canada and the United States...

  • Page 18: How To Contact Respironics

    OW TO ONTACT 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 or 1-724-387- 4000. You can also use the following address: Visit Respironics web site at: www.respironics.com...

  • Page 19: Chapter 2: Device Controls And Displays

    ISPLAYS 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 three primary control buttons on the REMstar Pro M Series device. C-Flex 2–1 P IGURE RIMARY...
  • 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 menu. Allows you to access the Data screens. Also allows you to navigate to the next screen when in the Data or Setup menu.

  • 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 Pro M Series device’s rear panel (without a humidifier). DC Power Inlet Air Outlet Port...
  • 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 opera- tion.
  • 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.

  • Page 28: Using Dc Power

    SING OWER 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: Complete Assembly Example

    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 HOWN WITH PTIONAL CCESSORY ODULE Figure 3–8 shows an example of how you should route your tubing and situate your device on your nightstand for the best setup possible.
  • Page 30 STAR ERIES ANUAL...

  • Page 31: Chapter 4: Device Operation

    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 three primary buttons light up and the Software Version screen momentarily appears, shown in Figure 4–1. V 1.0 4–1 S IGURE...
  • Page 32 3. Press the button to turn on the airflow. The Active Display screen appears, shown in Figure 4–3. 15.0 cmH 2 O 4–3 A IGURE CTIVE ISPLAY MART The Active Display screen shows the set pressure. Some symbols indicating when certain conditions are turned on or detected will also appear on the Active Display screen or on the Standby screen.

  • Page 33: Using The Ramp And C-Flex Features

    Put on your mask assembly when the air starts to flow. Make sure that no air is leaking from your mask into your eyes. If it is, adjust the mask and headgear until the air leak stops. See the instructions provided with your mask for more information.

  • Page 34: C-Flex Enabled

    4.2.2 C-F OMFORT EATURE The C-Flex comfort feature allows you to adjust the level of air pressure relief that you feel when you exhale during therapy. Your home care provider can enable or disable this feature. 4.2.2.1 NABLED When your provider enables C-Flex, a C-Flex level will already be set for you on the device. If this is not comfortable for you, you can increase or decrease the setting.

  • Page 35: Changing The Device Settings

    HANGING THE EVICE ETTINGS You can view the set pressure on the Active Display screen, as well as the following information on the Patient Data screens: • Therapy usage hours • Number of sessions greater than 4 hours • System leak (if enabled by your home care provider) •...

  • Page 36: Navigating The Display Screens

    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 and — buttons to adjust the settings on the Patient Setup screens. 4.3.1.1 IEWING ATA ON THE ATIENT CREENS...
  • Page 37 The Patient Data screens are described below. Standby Screen The Standby screen appears when you first apply power to the device. You can access the Patient Data menu from this screen by – FOSQ Setup pressing the buttons. Note: You can access the Patient Setup screens by pressing the + button, and the FOSQ questionnaire by pressing the —...
  • Page 38 4.3.1.2 IEWING AND ODIFYING ATIENT ETUP CREENS Figure 4–7 shows how to navigate the Patient Setup screens. – FOSQ Setup Press Press C-Flex Setting Press 1 2 3 Auto Off Ramp Start Pres Feature: ON 4.0 cmH 2 O Mask Alert Feature: ON 4–7 N IGURE...
  • Page 39 The Patient Setup screens are described below. Standby Screen The Standby screen appears when you first apply power to the device. You can access the Patient Setup menu from this screen by – FOSQ Setup pressing the + button. Once inside the Setup menu, press the buttons to cycle through the screens.
  • Page 40 Auto Off Screen Auto Off You can enable this feature if you want the device to automati- cally turn the airflow off whenever you remove the interface (e.g., Feature: ON mask) from your airway. Press the + or – buttons to select OFF or ON. If this feature is en- abled, then the words Auto Off...

  • Page 41: Completing The Fosq Questionnaire

    FOSQ Q OMPLETING THE UESTIONNAIRE Note: The FOSQ option only appears on the Standby screen if you have a SmartCard inserted or a modem connected to the device. From the Standby screen, you can access the FOSQ questionnaire by pressing the – button. The FOSQ test is a ‘quality of life’...

  • Page 42: Patient Reminder Screen

    After you answer the first question, press the button to access the next FOSQ screen and continue answering each question. If you need to go back to a previous screen, press the button. There are 30 FOSQ questions. Once you have reached the last question, press the button to save your answers and exit the questionnaire.

  • Page 43: Chapter 5: Device Alerts And Troubleshooting

    5: D HAPTER EVICE 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 two alert levels, high and medium priority. •...
  • Page 44 LERT UMMARY ABLE The following table summarizes the high and medium priority alerts. LERT UDIBLE ISUAL EVICE CTION OSSIBLE AUSE ATIENT CTION NDICATOR NDICATOR System Error • • • • Backlights: The device enters the Device failure Press any of the display ◊◊...
  • Page 45 LERT UDIBLE ISUAL EVICE CTION OSSIBLE AUSE ATIENT CTION NDICATOR NDICATOR Mask Leak • • The device continues The breathing Check your breathing Backlights: to operate. circuit is discon- circuit connections and re- ◊ ◊ ◊ nected or there is connect the tubing if it has a large air leak.

  • Page 46: Troubleshooting

    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 when There’s no power If you are using AC power, check the outlet you apply power to the at the outlet or power and verify that the device is properly...
  • Page 47 ROBLEM APPENED HAT TO The device’s display is The device or Unplug the device and the power supply. erratic. power supply has Reapply power to the device. If the problem been dropped continues, relocate the device to an area with or mishandled, lower EMI emissions (e.g., away from electronic or the device or...
  • Page 48 ROBLEM APPENED HAT TO The device has fallen off The device may Always make sure your device is placed on a your table or nightstand. not have been hard, flat surface so the feet on the bottom of properly seated the device can adhere to the surface (make sure on the nightstand, there is no fabric under the device).
  • Page 49 ROBLEM APPENED HAT TO You are having problems You have lost the If you are not using a humidifier, you cannot connecting the tubing air outlet port or connect your tubing to the device without the to the device. are traveling and detachable air outlet port, shown below.
  • Page 50 ROBLEM APPENED HAT TO The air out of the mask The air filters may Clean or replace the air filters as described in is much warmer than be dirty. Chapter 7. usual. The device may be The temperature of the air may vary somewhat operating in direct based on your room temperature.

  • Page 51: Chapter 6: Accessories

    6: A HAPTER CCESSORIES Contact your home care provider for additional information on the accessories available for your REMstar Pro M Series system. When using optional accessories, always follow the instructions enclosed with the accessories. DDING A UMIDIFIER You can use the M Series Heated humidifier or the M Series Pass-over humidifier with your device.

  • Page 52: Using The Smartcard

    SING THE MART Some REMstar Pro M Series systems come with a SmartCard accessory module installed in the accessory slot on the back of the device to record information for the home care provider. Your home care provider may ask you to periodically remove the SmartCard and send it to him/her for evaluation.

  • Page 53: Chapter 7: Cleaning And Maintenance

    HAPTER LEANING AND AINTENANCE This chapter describes how to clean the device and its filters and provides tips on traveling with your REMstar Pro 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.
  • Page 54 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 55: 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 Pro M Series device does not require routine servicing. Warning: If you notice unexplained changes in the performance of this device,...

  • Page 56: Traveling With The System

    It may be helpful to bring this manual along with you to help security personnel understand the REMstar Pro 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 M Series device when you remove the humidi- fier from the device.

  • Page 57: Chapter 8: Specifications

    8: S HAPTER PECIFICATIONS NVIRONMENTAL PERATING TORAGE 5° C (41° F) to 35° C (95° F) -20° C (-4° F) to 60° C (140° F) EMPERATURE 15 to 95% (non-condensing) 15 to 95% (non-condensing) ELATIVE UMIDITY 77 to 101kPa (0 - 7500 ft) TMOSPHERIC RESSURE HYSICAL...
  • Page 58 RESSURE Pressure Increments: 4.0 to 20.0 cm H O (in 0.5 cm H O increments) Pressure Stability: <10.0 cm H O (±0.5 cm H ≥10.0 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 @ 20°...
  • Page 59 A: 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...
  • Page 60 ’ 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 61 ’ 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 62 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 63 (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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