USER Manual 1038585 JR 10/02/06
Important! Fill in the information below when you receive the BiPAP Auto M Series system. Serial No.
Complete the following steps to set up your M Series device. Plug the AC power cord connector into the power supply, then plug the power cord into an electrical outlet. Plug the power supply cord connector into the device. Press the therapy. button to begin Attach the tubing to the optional swivel and attach the swivel to the device’s air outlet. Or, attach the tubing directly to the air outlet.
Complete the following steps to set up your M Series device and humidifier. Connect the humidifier power supply connector to the device power supply. Plug the AC power cord connector into the power supply, then plug the power cord into an electrical outlet. Lift the humidifier door to access the water tank. Plug the power supply cord connector into the device. Fill the tank with water until it reaches the fill line.
Final system setup for the device. Final system setup for the device and humidifier.
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...............................................
4.4 Changing the Device Settings............................................................................... 4-4 4.4.1 Navigating the Display Screens................................................................ 4-5 4.4.1.1 Viewing Data on the Patient Data Screens................................ 4-5 4.4.1.2 Viewing and Modifying Patient Setup Screens....................... 4-7 4.5 Completing the FOSQ Questionnaire................................................................. 4-9 4.
Chapter 1: Introduction This chapter provides information on: • 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 BiPAP® Auto with Bi-Flex® M Series system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea (OSA) only in spontaneously breathing patients weighing >66 lbs (30 kg). The device is to be used only on the instruction of a licensed physician. The system can deliver Bi-level therapy or Auto Bi-level therapy, both with and without Bi-Flex.
• If oxygen is used with the device, the oxygen flow must be turned off when the device is not in use. Explanation of the Warning: When the device is not in operation and the oxygen flow is left on, oxygen delivered into the tubing may accumulate within the device’s enclosure. Oxygen accumulated in the device enclosure will create a risk of fire. • Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame.
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 BiPAP Auto M Series system offers several options in how therapy is delivered, so treatment can be personalized to meet your needs. The system delivers two different positive pressure levels: IPAP (Inspiratory Positive Airway Pressure) and EPAP (Expiratory Positive Airway Pressure). Your home care provider will make the correct pressure settings. When prescribed for you, the device provides several special features to help make your therapy more comfortable.
Device Feature Accessory Module Description If applicable, insert the optional accessory card here. Air Outlet Connect the flexible tubing here. Bi-Flex Button This button allows you to change the Bi-Flex comfort setting, if Bi-Flex is prescribed for you. See Chapter 4 for more information about Bi-Flex. Display Screen Shows therapy settings, patient data, instructions, and error messages.
1.5 Glossary The following terms and acronyms appear throughout this manual: Term/Acronym 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 Bi-level Adjusts the pressure automatically to improve patient comfort based on monitoring of apnea, hypopnea, and snoring events.
1.6 Symbol Key The following symbols appear on the device and power supply: Symbol Definition 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 No User Serviceable Parts 1.
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 BiPAP Auto M Series device. Bi-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 device’s display screen shows the set pressure, patient data, instructions, and error messages. See Chapter 4 for instructions on navigating the display screens. Figure 2–3 provides a view of the entire device control panel, with the cover door open. Placement Area for Optional Quick Reference Label Cover Door Previous Screen Button Next Screen Button Decrease Button Increase Button Bi-Flex Ramp Button Start/Stop Button Bi-Flex Button Figure 2–3 Device Control Panel 2.1.
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.
3.2 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. Air must flow freely around the device for the system to work properly. Make sure the device is away from any heating or cooling equipment (e.g., forced air vents, radiators, air conditioners). 3.
2. Connect the tubing to the mask: a. If you are using a mask with a built-in exhalation port, connect the mask’s connector to the flexible tubing, as shown in Figure 3–3. Exhalation Port Mask's Connector Flexible Tubing Connector Figure 3–3 Connecting a Mask with Built-in Exhalation Port 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.
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 or Portable Battery Pack 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 nightstand or table.
Chapter 4: Device Operation This chapter explains the therapies available with the BiPAP Auto M Series device, how to start the device, and how to change the settings. 4.1 Available Therapies The device delivers the following therapies: • Bi-level – Provides one level of output pressure during EPAP (Expiratory Positive Airway Pressure) and a second higher level during IPAP (Inspiratory Positive Airway Pressure).
3. Press the button to turn on the airflow. The Active Display screen appears, shown in Figure 4–3. 9.0 E 20.0 I cmH2O Active Screen During Exhalation (EPAP) cmH2O Active Screen During Inhalation (IPAP) Figure 4–3 Active Display (with SmartCard) 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.
4.3 Using the Ramp and Bi-Flex Features You can press the (Ramp) button to activate the Ramp feature, or the Bi-Flex button to change the Bi-Flex setting, if your provider has enabled these features. 4.3.1 Ramp Feature The device is equipped with an optional ramp feature that your home care provider can enable or disable.
4.3.2.2 Bi-Flex Locked Your provider may enable Bi-Flex, but lock the setting so you cannot adjust the level. If Bi-Flex is locked, a screen similiar to the one shown in Figure 4-5 appears. Bi-Flex Setting 1 2 3 Figure 4–5 Bi-Flex Locked Screen The arrow appears above the setting the provider has prescribed for you, and a lock symbol displays to indicate that you cannot adjust the setting. 4.3.2.
4.4.1 Navigating the Display Screens 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. 4.4.1.1 Viewing Data on the Patient Data Screens Figure 4–7 shows how to navigate the Patient Data screens.
Therapy Usage 7 Day Avg: 30 Day Avg: 2. Hrs/Night 5:00 8:00 Therapy Usage Screen This screen displays the number of hours that the device provided therapy, as 7-day and 30-day averages. The maximum value that can be displayed for both averages is 24 hours. Note: Sessions > 4 7 Days: 30 Days: 3. 5 Sessions 8 Sessions Sessions Greater than 4 Hours Screen This screen displays the number of device therapy sessions that exceeded 4 hours in 7-day and 30-day periods.
6. Apn-Hyp Index 7 Day Avg: 30 Day Avg: Apnea/Hypopnea Index Screen This screen displays your Apnea/Hypopnea index (AHI) for the last 7 and 30 days. AHI = 0.0 AHI = 0.0 Note: Compliance Check 7. This screen only displays if your home care provider has enabled it. It is only for reference. Your home care provider may periodically ask you for this information.
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. Bi-Flex Setting Screen This screen displays the Bi-Flex level set by your home care provider.
Ramp Start Pres 4. Ramp Starting Pressure Screen You can increase or decrease the ramp starting pressure in 0.5 cm H2O increments by pressing the + or – buttons. The default setting is 4 cm H2O. You can adjust the setting from 4 cm H2O to the prescription pressure setting. Note: This screen will not display if your provider has not enabled Ramp on your device. 5. Mask Alert Screen You can enable or disable the mask alert setting by pressing the + or – buttons to select OFF or ON.
To answer the FOSQ questionnaire, complete the following steps: 1. Make sure that the SmartCard or modem is properly installed. Answers to the questionnaire are saved onto the SmartCard or sent to the health care professional via a wired or wireless modem (when available). If you are using a SmartCard, a SmartCard symbol ( ) appears in the upper right corner of the Active Display screen.
Chapter 5: Device 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 SmartCard Error Audible Indicator • • Visual Indicator Backlights: ◊ ◊ ◊ Screen displays the following flashing error symbol: Device Action The device continues to operate and provide therapy, but data logging is unavailable and FOSQ is deactivated. Possible Cause A problem exists with the SmartCard inserted in the accessory slot. The card may be improperly inserted or the data may be corrupt. Patient Action Remove the SmartCard to clear the alert.
Alert Patient Reminder Audible Indicator None Visual Indicator Backlights: ◊ ◊ ◊ Device Action Possible Cause Patient Action The device continues to operate. Your home care provider may set a patient reminder scheduled to pop up at a particular time to remind you to replace your mask, change your filters, etc. Press any of the display buttons to acknowledge the message and clear it.
Problem The device does not operate when you press the button. The airflow does not turn on. Why It Happened There may be a problem with the blower. What to Do Make sure the device is powered correctly, following the instructions on the previous page. If the audible indicator sounds and the button backlights turn on when you apply power, but the airflow does not turn on, there may be a problem with your device. Contact your home care provider for assistance. Note: The device’s display is erratic.
Problem The device has fallen off your table or nightstand. Why It Happened The device may not have been properly seated on the nightstand, or the placement of the tubing may have caused the device to fall. What to Do Always make sure your device is placed on a hard, flat surface so the 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 The air out of the mask is much warmer than usual. Why It Happened The air filters may 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 BiPAP Auto 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 Pass-over humidifier with your device. They are available from your home care provider.
6.2 Using the SmartCard Some BiPAP Auto 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 BiPAP Auto 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.
2. Remove the filter(s) from the enclosure by gently squeezing the filter in the center and pulling it away from the device, as shown in Figure 7–1. 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.
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 BiPAP Auto M Series device does not require routine servicing. Warning: 7.
7.5.1 International Travel If you are traveling to a country with a line voltage different than the one you are currently using, a different power cord or an international plug adaptor may be required to make your power cord compatible with the power outlets of the country to which you are traveling. Contact your home care provider for additional information.
Chapter 8: Specifications Environmental Operating Storage Temperature 41 to 95°F (5 to 35°C) -4 to 140°F (-20 to 60°C) Relative Humidity 15 to 95% (non-condensing) 15 to 95% (non-condensing) Atmospheric Pressure 77 to 101kPa (0 to 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.
Pressure Pressure Increments: 4.0 to 25.0 cm H2O (in 0.5 cm H2O increments) Pressure Stability: <10.0 cm H2O (±0.5 cm H2O) ≥10.0 cm H2O (±1.0 cm H2O) Dynamic pressure accuracy is measured at the patient end of the circuit with a Whisper Swivel II and varying flow conditions. 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%), and an atmospheric pressure of 101.54 kPascals.
Appendix A: EMC Information Guidance and Manufacturer’s Declaration - Electromagnetic Emissions: This device is intended for use in the electrmagnetic 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.
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.
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NO P OS T AG E NECESSARY IF MAILED IN THE UNITED STATES BUSINESS REPLY MAIL F I RS T - C L A S S M A I L PERMIT NO 231 GR A N D R AP ID S M N POST AGE WI LL BE PAID BY ADDRESSEE PO BOX 7014 GRAND RAPIDS MN 55744-8029 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.
