USER MANUAL 1016438 JH 9/12/05
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An application to join the American Sleep Apnea Association should be attached here. If it is not, you can contact the American Sleep Apnea Association at 1-202-293-3650. Name ______________________________________________ Phone No.
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. You are also invited to participate in the A.W.A.K.E.
TABLE OF CONTENTS Chapter 1: Introduction ..................................................................................................................1-1 1.1 System Contents ........................................................................................................1-1 1.2 Intended Use ...............................................................................................................1-2 1.3 Warnings, Cautions, and Contraindications ..............................................
4.3 Changing the Device Settings .............................................................................. 4-5 4.3.1 Navigating the Display Screens ............................................................... 4-5 4.3.1.1 Viewing Data on the Patient Data Screens............................... 4-5 4.3.1.2 Viewing and Modifying Patient Setup Screens ...................... 4-7 4.4 Completing the FOSQ Questionnaire ..............................................................4-10 4.
CHAPTER 1: INTRODUCTION This chapter provides information on: • REMstar Plus M Series system contents • Intended Use • Warnings, cautions, and contraindications • System overview • Glossary and symbol key • How to contact Respironics 1.
1.2 INTENDED USE The Respironics REMstar Plus 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 >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.
• 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. • Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air, or in the presence of nitrous oxide. • Do not use this device if the room temperature is warmer than 95° F (35° C).
1.3.2 CAUTIONS 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. Condensation may damage the device. • Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter.
1.4 SYSTEM OVERVIEW The REMstar Plus 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 pressure throughout the breathing cycle. When prescribed for you, the device provides several special features to help make your therapy more comfortable. The ramp function allows you to lower the pressure when you are trying to fall asleep.
Figure 1–3 illustrates many of the device features, described in the table below. Ramp Button Start/Stop Button C-Flex Button Power Inlet Display Screen (under door) Air Outlet le x Medical Equipment Note (on bottom) Accessory Module Filter Area FIGURE 1–3 SYSTEM OVERVIEW 1-6 DEVICE FEATURE Accessory Module DESCRIPTION If applicable, insert optional accessory module here. Air Outlet Connect the flexible tubing here.
1.4.1 BREATHING CIRCUIT OVERVIEW 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.
1.5 GLOSSARY The following terms and acronyms appear throughout this manual: TERM/ACRONYM 1-8 DEFINITION 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 When this feature is enabled, the device automatically discontinues therapy whenever the mask is removed.
1.6 SYMBOL KEY The following symbols appear on the device and power supply: SYMBOL DEFINITION Consult accompanying instructions for use.
1.7 HOW TO CONTACT RESPIRONICS 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.
CHAPTER 2: DEVICE CONTROLS AND DISPLAYS This chapter describes the device’s control buttons and displays, patient circuit connections, and rear panel connections. 2.1 CONTROLS AND DISPLAYS Figure 2–1 shows the three primary control buttons on the REMstar Plus M Series device. C-Flex FIGURE 2–1 PRIMARY CONTROL BUTTONS These buttons are described below. BUTTON DESCRIPTION Ramp – When the airflow is on, this button allows you to activate or restart the ramp function.
The display buttons are described below: BUTTON DESCRIPTION Allows you to access the Data screens. Also allows you to navigate to the previous screen when in the Data, FOSQ, or Setup menu. Allows you to access the Data screens. Also allows you to navigate to the next screen when in the Data, FOSQ, or Setup menu. Allows you to enter the FOSQ screens. Also allows you to decrease the settings on the patient setup screens. Allows you to enter the Setup screens.
2.2 REAR PANEL Figure 2–4 shows the REMstar Plus M Series device’s rear panel (without a humidifier). DC Power Inlet Air Outlet Port Accessory Slot Filter Area FIGURE 2–4 REAR PANEL The rear panel contains the following: • An accessory slot for optional accessories such as the SmartCard or modem (see Chapter 6, Accessories, for more information). • A filter area where the filter(s) supplied with your device should be inserted.
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CHAPTER 3: SETUP This chapter provides instructions on how to: • Install the air filters • Position the device • Connect the breathing circuit • Supply power to the device 3.1 INSTALLING THE AIR FILTERS 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.
Filter Area Disposable Ultra-Fine Filter (optional) Reusable Gray Foam Filter (required) FIGURE 3–1 INSTALLING THE AIR FILTER Note: 3.2 See Chapter 7, Cleaning and Maintenance, for information on how to clean or replace the air filters. WHERE TO PLACE THE DEVICE Place the device on a firm, flat surface somewhere within easy reach of where you will use it. Make sure the filter area on the back of the device is not blocked by bedding, curtains, or other items.
To connect your breathing circuit to the device, complete the following steps: 1. 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 connect the tubing directly to the air outlet. Detachable Swivel FIGURE 3–2 CONNECTING THE FLEXIBLE TUBING Note: 2.
b. 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 connector to the exhalation device. Exhalation Device Flexible Tubing Connector FIGURE 3–4 CONNECTING A MASK WITH A SEPARATE EXHALATION DEVICE Warning: The exhalation device (e.g.
3.4 SUPPLYING POWER TO THE DEVICE You can power the device using AC or DC power. Caution: If this device has been exposed to either very hot or very cold temperatures, 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.
FIGURE 3–6 CONNECTING THE POWER SUPPLY CORD TO THE DEVICE 4. Ensure that all connections are secure. Important! To remove AC power, disconnect the power supply cord from the electrical outlet. Warning: Inspect the power cord often for any signs of damage. Replace a damaged power cord immediately. 3.4.2 USING DC POWER The Respironics DC Power Cord (Reorder Number 1001956) can be used to operate this device in a stationary recreational vehicle, boat, or motor home.
3.5 COMPLETE ASSEMBLY EXAMPLE Figure 3–7 shows an example of how a complete assembly will look, with breathing circuit connected and power applied to the device. FIGURE 3–7 FINAL ASSEMBLY EXAMPLE (SHOWN WITH OPTIONAL ACCESSORY MODULE) 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. This will help prevent the device from falling off your nighstand or table.
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CHAPTER 4: DEVICE OPERATION This chapter explains how to start the device and change the settings. 4.1 1. STARTING THE DEVICE 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 FIGURE 4–1 SOFTWARE VERSION SCREEN Note: 2. Version 1.0 shown in Figure 4–1 is an example. Your device may have a different software version installed.
3. Press the button to turn on the airflow. The Active Display screen appears, shown in Figure 4–3. 15.0 cmH2O FIGURE 4–3 ACTIVE DISPLAY (WITH SMARTCARD) The Active Display screen shows the set pressure. Symbols also appear on the Active Display screen or Standby screen to indicate when certain conditions are turned on or detected. These symbols are described below: SYMBOL DESCRIPTION Ramp – You can initiate the ramp feature by pressing the Ramp button.
4.2 USING THE RAMP AND C-FLEX FEATURES You can press the (Ramp) button to activate the Ramp feature, or the C-Flex button to change the C-Flex setting, if your provider has enabled these features. 4.2.1 RAMP FEATURE The device is equipped with an optional ramp feature that your home care provider can enable or disable.
4.2.2 C-FLEX COMFORT FEATURE 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 C-FLEX ENABLED 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. To change the C-Flex setting, press the C-Flex button.
4.3 CHANGING THE DEVICE SETTINGS You can view the set pressure on the Active Display screen, and the following information on the Patient Data screens: • Therapy usage hours • Number of sessions greater than 4 hours Additionally, you can view and modify the following settings on the Patient Setup screens: • C-Flex (if enabled by your home care provider) • Altitude • Ramp starting pressure (if enabled by your home care provider) • Mask alert (enable/disable) • Auto off (enable/disable) 4.3.
Press the button to scroll forward through the data screens, or press the button to scroll through the screens in the reverse order. The Patient Data screens are described below. 1. – FOSQ Setup + Therapy Usage 7 Day Avg: 30 Day Avg: 2. Hrs/Night 5:00 8:00 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 pressing the or buttons.
4.3.1.2 VIEWING AND MODIFYING PATIENT SETUP SCREENS Figure 4–7 shows how to navigate the Patient Setup screens. – FOSQ Setup + Press + Press C-Flex Setting Press 1 2 3 Auto Off Altitude Feature: ON 1 2 3 Mask Alert Ramp Start Pres Feature: ON 4.
The Patient Setup screens are described below. – FOSQ 1. 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 pressing the + button. Once inside the Setup menu, press the or buttons to cycle through the screens. 2. C-Flex Setting Screen This screen displays the C-Flex level set by your home care provider. This setting allows you to adjust the level of air pressure relief that you feel when you exhale during therapy.
Mask Alert 5. Feature: ON Mask Alert Screen You can enable or disable the mask alert setting by pressing the + or – buttons to select OFF or ON. If this feature is enabled, then the words Mask Leak appear on the Active display screen if a significant mask leak is detected, and an audible alert sounds. Note: Auto Off 6. Feature: ON If your physician indicates that the Mask Alert is necessary for you, do not disable it.
4.4 Note: COMPLETING THE FOSQ QUESTIONNAIRE The FOSQ option only appears on the Standby screen if a SmartCard is inserted or a modem is 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’ questionnaire designed specifically for people with sleep disorders. The results allow health care professionals to see how therapy has improved the quality of your life.
3. 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. 4. There are 30 FOSQ questions. Once you have reached the last question, press the to save your answers and exit the questionnaire. 4.5 button PATIENT REMINDER SCREEN Your home care provider may set a patient reminder that will appear periodically to alert you to take certain actions, such as replacing your mask.
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CHAPTER 5: ALERTS AND TROUBLESHOOTING This chapter describes the device alerts and also provides troubleshooting information for issues you may run into when using the device. 5.1 DEVICE ALERTS The device provides two alert levels, high and medium priority. • High Priority – These alerts require immediate operator response. The alert signal consists of a high priority sound, which is a continuous two-beep pattern (indicated in the following table as: • • • •).
ALERT SUMMARY TABLE The following table summarizes the high and medium priority alerts. ALERT System Error AUDIBLE INDICATOR •• •• VISUAL INDICATOR Backlights: ◊◊ ◊◊ ◊◊ Screen displays the following message: DEVICE ACTION POSSIBLE CAUSE The device enters the “Safe state” in which the device power remains on, but the airflow is disabled. Device failure Press any of the display screen buttons to silence the alert. Remove the power supply cord from the device to remove power.
ALERT Mask Leak AUDIBLE INDICATOR • • VISUAL INDICATOR Backlights: ◊ ◊ ◊ DEVICE ACTION POSSIBLE CAUSE PATIENT ACTION The device continues to operate. The breathing circuit is disconnected or there is a large air leak. Check your breathing circuit connections and reconnect the tubing if it has come loose. Press any of the display buttons to clear the alarm. Make sure your mask is on properly before you press the button to restart the airflow. The words Mask Leak flash on the Active Display screen.
5.2 TROUBLESHOOTING The table below lists some of the problems you may experience with your device or mask and possible solutions to those problems. PROBLEM Nothing happens when you apply power to the device. The audible indicator does not sound and the backlights on the buttons do not light. WHY IT HAPPENED There’s no power at the outlet or the device is unplugged. WHAT TO DO If you are using AC power, check the outlet power and verify that the device is properly plugged in.
PROBLEM The device’s display is erratic. Device Resets/Reboots: The device shuts down and restarts automatically during therapy. (This is unlikely to occur.) The Ramp feature does not work when you press the Ramp button ( ). WHY IT HAPPENED WHAT TO DO The device or power supply has been dropped or mishandled, or the device or power supply is in an area with high Electromagnetic Interference (EMI) emissions. Unplug the device and the power supply. Reapply power to the device.
PROBLEM WHY IT HAPPENED WHAT TO DO The device has fallen off your table or nightstand. The device may not have been properly seated on the nightstand, or the placement of the tubing may have caused the device to fall. Always make sure your device is placed on a hard, flat surface so the rubber feet on the bottom of the device can adhere to the surface (make sure there is no fabric under the device). The device (and humidifier, if using) must be level for proper operation.
PROBLEM WHY IT HAPPENED WHAT TO DO You are having problems connecting the tubing to the device. You have lost the air outlet port or are traveling and forgot to bring the port with you. If you are not using a humidifier, you cannot connect your tubing to the device without the detachable air outlet port, shown below. You must have the port attached properly before connecting your tubing. You are experiencing excessive air leaks where the tubing connects to the device.
PROBLEM WHY IT HAPPENED The air out of the mask is The air filters may much warmer than usual. be dirty. The device may be operating in direct sunlight or near a heater. WHAT TO DO Clean or replace the air filters as described in Chapter 7. The temperature of the air may vary somewhat based on your room temperature. Make sure that the device is properly ventilated. Keep the device away from bedding or curtains that could block the flow of air around the device.
CHAPTER 6: ACCESSORIES Contact your home care provider for additional information on the accessories available for your REMstar Plus M Series system. When using optional accessories, always follow the instructions enclosed with the accessories. 6.1 ADDING A HUMIDIFIER You can use the M Series Heated humidifier or the M Series Passover humidifier with your device. They are available from your home care provider.
6.2 USING THE SMARTCARD Some REMstar Plus 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. Note: 6.3 The SmartCard does not need to be installed for the device to work properly. The SmartCard records device usage information for use by your home care provider.
CHAPTER 7: CLEANING AND MAINTENANCE This chapter describes how to clean the device and its filters and provides tips on traveling with your REMstar Plus M Series system. 7.1 CLEANING THE DEVICE 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. 1.
FIGURE 7–1 REMOVING THE FILTERS 3. Examine the filter(s) for cleanliness and integrity. 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. If the white ultra-fine filter is dirty or torn, replace it. 6.
7.3 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. 7.4 SERVICE The REMstar Plus M Series device does not require routine servicing.
7.5 TRAVELING WITH THE SYSTEM When traveling, the carrying case is for carry-on luggage only. The carrying case will not protect the system if it is put through checked baggage. For your convenience at security stations, there is a note on the bottom of the device stating that it is medical equipment. It may be helpful to bring this manual along with you to help security personnel understand the REMstar Plus M Series device.
CHAPTER 8: SPECIFICATIONS ENVIRONMENTAL OPERATING STORAGE TEMPERATURE 41° F (5° C) to 95° F (35° C) -4° F (-20° C) to 140° F (60° C) RELATIVE HUMIDITY 15 to 95% (non-condensing) 15 to 95% (non-condensing) ATMOSPHERIC PRESSURE 77 to 101kPa (0 - 7500 ft) N/A PHYSICAL Dimensions: 7.5” L x 5.0” W x 3.125” H (19 x 12.7 x 7.9 cm) Weight: Approximately 2.2 lbs.
PRESSURE Pressure Increments: 4.0 to 20.0 cm H2O (in 0.5 cm H2O increments) Pressure Stability: 4.0 to 20 cm H2O (±1.0 cm H2O) Measured in accordance with EN ISO 17510-1 @ 1/3, 2/3, and Pmax with BPM set to 10, 15, and 20 BPM @ 20° C (±5° C), 50% RH (±5%). Maximum Flow: 35 LPM Measured in accordance with EN ISO 17510-1 @ 1/3, 2/3, and Pmax with BPM set to 10, 15, and 20 BPM @ 23° C (±2° C), 50% RH (±5%). DISPOSAL Dispose of the device in accordance with local regulations.
APPENDIX A: EMC INFORMATION GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS 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. EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY 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.
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY 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. IMMUNITY TEST Power frequency (50/60 Hz) magnetic field IEC 60601 TEST LEVEL 3 A/m COMPLIANCE LEVEL 3 A/m ELECTROMAGNETIC ENVIRONMENT GUIDANCE Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital or home environment.
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THIS DEVICE The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
LIMITED WARRANTY Respironics, Inc. warrants that the system shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of two (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 defective material or part. Respironics, Inc. will pay customary freight charges from Respironics, Inc.
