autoSV TM with Encore SmartCard® User Manual
This BiPAP system is covered by one or more of the following patents: U.S. Patent Nos. 5,148,802; 5,239,995; 5,313,937; 5,433,193; 5,632,269; 5,803,065; 6,029,664; 6,305,374 and 6,539,940; Australian Patent Nos. 638054; 661575; 698519; 723681; 734319 and 733655; Canadian Patent Nos. 2,024,477; 2,162,981 and 2,259,795; European Patent No. EP0425092; German Patent No. 69021681.5-08; and Japanese Patent Nos. 2832812; 2137336; and 2926392. Other U.S. and foreign patents pending. © 2007 Respironics, Inc.
Table of Contents Chapter 1: Package Contents.................................................................................................................1 Chapter 2: Warnings and Cautions.......................................................................................................2 2.1 Warnings.....................................................................................................................................2 2.2 Cautions........................................................
Chapter 7: Alarms..................................................................................................................................25 7.1 Introduction to Alarms.........................................................................................................25 7.2 What to Do When an Alarm Occurs.....................................................................................26 7.3 Alarm Tables.........................................................................................
Chapter 1: Package Contents Your BiPAP autoSV device should include the following items. If any of these items are missing, contact your health care professional. BiPAP autoSV with Encore SmartCard Reusable Gray Foam Filters Carrying Case Disposable Ultra-fine Filter User Manual Filter Cap Power Cord Flexible Tubing 1.83 m (6 ft.) x 22 mm i.d.
Chapter 2: Warnings and Cautions WARNING: Indicates the possibility of injury to the user or operator. CAUTION: Indicates the possibility of damage to the device. NOTE: Places emphasis on an operating characteristic. Caution: U.S. federal law restricts this device to sale by or on the order of a physician. 2.1 Warnings • • • • • • • • • • This manual serves as a reference. The instructions in this manual are not intended to supersede the instructions of your health care professional.
• • • • • • • • • • • • Explanation of the Warning: The device is intended to be used with special masks or connectors that have exhalation ports to allow continuous flow of air out of the mask. When the device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask exhalation port. However, when the device is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed.
2.2 Cautions • • • • • • NOTE: The device may only be operated at temperatures between 41° F (5° C) and 95° F (35° C). A properly installed, undamaged reusable foam inlet filter is required for proper operation. Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter. Do not place the device in or on any container that can collect or hold water. Condensation may damage the device. Always allow the device to reach room temperature before use.
Chapter 3: Introduction to the Device 3.1 Definitions The following terms appear throughout this manual: Apnea A condition marked by the cessation of spontaneous breathing. BPM Breaths Per Minute CPAP Continuous Positive Airway Pressure EPAP Expiratory Positive Airway Pressure Exhaled Tidal Volume (VTE ) The exhaled volume of each breath High Priority Alarm An alarm signal indicating a condition that requires immediate attention.
IPAP Pressure EPAP Pressure Rise Time Time Figure 3–1 IPAP and EPAP Breathing Levels You can adjust the Rise Time to make the pressure change more comfortable. 3.3 What is the BiPAP autoSV Device? The device, shown in Figure 3–2, supplies air pressure through a breathing circuit. Figure 3–2 The BiPAP autoSV Device A breathing circuit, shown in Figure 3–3, consists of: • Circuit tubing to deliver air from the device to your interface (e.g.
NOTE: The exhalation port may be part of the mask or may be part of a separate exhalation device, but is required to minimize the potential for CO2 rebreathing. The system senses your breathing effort and changes pressure levels when you inhale and exhale depending on the mode of operation. WARNING: The device can operate on AC or DC power. The DC power option is not intended as a battery backup.
Chapter 4: Device Controls and Display Features Figure 4–1 shows the location of the device’s alarm power indicators, control panel, Pressure On/Off button, and the breathing circuit connection. Alarm and Power Indicators Control Panel Breathing Circuit Connection Pressure On/Off Button Figure 4–1 Device Front and Top 4.1 Pressure On/Off Button The device’s Pressure On/Off airflow.
4.2 Control Panel The control panel contains the following control buttons and indicators. 4.2.1 Control Buttons The control buttons on the control panel are shown in Figure 4–3. Display Screen Scroll Button Pressure On/Off Button Alarm Reset Button RESET HEAT RAMP Heated Humidifier Button User Buttons SILENCE Ramp Button Alarm Silence Button Figure 4–3 Control Panel HEAT When the optional REMstar Heated Humidifier has been prescribed, this button controls the humidifier’s output.
10 4.2.2 Alarm and Power Indicators Figure 4–4 shows the device’s alarm and power indicators. AC Power Indicator (Green) High Priority Alarm LED (Red) AC Power Alarms DC DC Power Indicator (Green) Low/Medium Priority Alarm LED (Yellow) Figure 4–4 Alarm and Power Indicators AC Power Indicator The green AC Power LED lights up when the device is connected to AC Power. DC Power Indicator The green DC Power LED lights up when the device is connected to DC power.
11 The information shown on the display screen is defined as follows: ALARM Indicates that the device requires user attention as indicated on the screen. APNEA Indicates that an apnea alarm has occurred. BPM CARD cm H2O Indicates that a breath rate setting is being displayed. This symbol flashes when the device is providing timed backup breaths. Indicates that a SmartCard is inserted and detected. Indicates that the alphanumeric digits are displaying a pressure value.
12 4.2.4 Breathing Circuit Connection Figure 4–6 shows where the circuit tubing connects to the device. Patient Interface Exhalation Port Circuit Tubing Bacteria Filter (Optional) Breathing Circuit Connection Figure 4–6 Typical Breathing Circuit Connection 4.2.5 Rear Panel Figure 4–7 shows the device’s rear panel.
13 Chapter 5: Setting up the BiPAP autoSV Device 5.1 Installing the Air Filters The device uses one or two removable filters at the air inlet. The disposable white ultra-fine filter is optional. You must install the gray foam filter before operating the device. The foam filter is washable and reusable. CAUTION: A properly installed, undamaged foam filter is required for proper operation.
14 5.2 Where to Place the Device Place the device on its base somewhere within easy reach of where you will use it. Make sure that the air inlet on the rear of the device is not blocked. Place the device on a hard, flat surface. If you block the air flow around the device, the device may not work properly. WARNING: Position the humidifier so the water level is lower than you, and the humidifier is on the same level or lower than the device. See the humidifier instructions for complete setup information.
15 B. If you are using a mask with a separate exhalation device, connect the open end of the circuit tubing to the exhalation device as shown in Figure 5–4. Position the exhalation device so that the vented air is blowing away from your face. Circuit Tubing Exhalation Port Figure 5–4 Connecting a Exhalation Device Connect the mask’s connector to the exhalation device, as shown in Figure 5–5. See the mask instructions for complete setup information.
16 5.4 Complete Setup Figure 5–6 shows the completed breathing circuit setup. Patient Interface Exhalation Port Circuit Tubing Bacteria Filter (Optional) Breathing Circuit Connection Figure 5–6 Complete Breathing Circuit 5.5 Plugging the Device In You can use AC or DC power to operate the BiPAP autoSV device. WARNING: The DC power option is not intended as a battery backup when using AC power.
17 3. Leaving a small amount of slack in the cord, connect the cord on the other side of the power supply to one of the power inlets on the device, as shown in Figure 5–7. The power cord has a locking connector. To properly plug the cord in: a. Pull the locking mechanism back. b. Push the connector into place. c. Release the lock. Figure 5–7 Plugging in the AC Power Supply NOTE: You can plug the cord into either of the power inlets on the back of the device. 4.
18 Chapter 6: Operating the Device 6.1 Starting the Device 1. Plug in the device to an AC or DC power source to power up the device. A confirmation alarm sounds, and the control pad buttons light up. NOTE: If the alarm does not sound or the buttons do not light up, the device requires servicing. Call your health care professional. Several screens appear initially during this step: a. The first screen that appears is the Self Test screen, shown in Figure 6–1.
19 NOTE: d. With the exception of the button, the control pad is inactive during these first three screens. Each of these screens appears for approximately 1-3 seconds. The next screen that appears is the Standby screen, shown in Figure 6–4. This indicates that the device is in the Standby state (the blower is off). PATIENT HEAT APNEA LIGHT CARD HOURS Figure 6–4 Standby Screen 2. Press the button to put the device into the Operate state (and turn on the airflow).
20 6.
21 3. You can exit this screen by pressing the Left or Right User buttons or the SILENCE button. For additional information on using a humidifier with the device, see Chapter 10. 4. To turn the humidifier ON/OFF, press the HEAT button until the device beeps twice and the text HEAT appears/disappears. 6.2.2 Navigating the User Display Screens You can navigate the rest of the user display screens by pressing the Left and Right User keys.
22 1. From either the Monitoring or Standby screens, press the Right User button until you reach this screen. The Rise Time Setting screen is shown in Figure 6–8. RISE TIME Figure 6–8 Rise Time Setting Screen 2. Increase or decrease the rise time setting from 1 to 6 by pressing the HEAT or RAMP button until you find the right setting. A setting of 1 is the fastest rise time, while 6 is the slowest. 6.2.2.2 Changing the Ramp Starting Pressure The device is equipped with an optional ramp feature.
23 1. From either the Monitoring or Standby screens, press the Right User button until the LED Backlight Setting screen appears, as shown in Figure 6–10. LIGHT Figure 6–10 LED Backlight Setting Screen 2. Press the HEAT or RAMP button to select a new setting. A setting of 1 means the light is on, while 0 means the light is off. 6.3 Monitoring Measured Parameters You can view four measured parameters—leak, respiratory rate, minute ventilation, and exhaled tidal volume.
24 1. Leak Screen This screen, shown in Figure 6–12, shows the average of the leak values for the previous six breaths. LEAK Figure 6–12 Leak Screen 2. Respiratory Rate Screen This screen, shown in Figure 6–13, shows the average rate of respiration for the previous six breaths. Figure 6–13 Respiratory Rate Screen 3.
25 Chapter 7: Alarms 7.1 Introduction to Alarms The device provides three alarm levels: high, medium, and low priority. High Priority These alarms require immediate response. The alarm signal consists of a red LED indicator and a sound that is either a periodic pattern consisting of a two-second beep followed by two seconds of silence or a pattern of three beeps, a pause, and then two more beeps. The display has ALARM at the top of the screen. The tables in Section 7.
26 7.2 What to Do When an Alarm Occurs The following example applies to most alarm conditions. Follow these steps unless otherwise directed by the alarm tables that follow. 1. Look at the alarm indicators and listen to the alarm sound. Alarm LED Lights Up AC Alarms Power DC Figure 7–3 Alarm LED Lights Up Note the color of the LED and whether the LED is solid or flashing. 2. Look at the display for text.
27 7.3 Alarm Tables The following tables summarize the high priority, medium priority, and low priority alarms. 7.3.1 High Priority Alarms Alarm LED Red Flash Alarm Sound Display Message Device Action Possible Cause ••• •• ALARM and PATIENT flash Operates Breathing circuit is disconnected or has a large leak. Press the RESET button to reset the alarm. Reconnect the circuit or fix the leak. ALARM and APNEA flash Operates An apnea event occurred during therapy.
28 7.3.2 Medium Priority Alarms Alarm LED Yellow Flash Alarm Sound Display Message ••• Device Action Possible Cause Operates Battery is nearly discharged. DC Power LED Flashes Your Action Press the RESET button to reset the alarm. Replace the battery. If the alarm continues, contact your health care professional. 7.3.
29 Chapter 8: Troubleshooting This chapter describes problems that you may experience with your BiPAP autoSV device or mask and provides possible solutions. Problem Why It Happened What To Do The device does not operate when you press the button. If the power LED is off, there’s Check the outlet power and verify that no power at the outlet or the the device is plugged in. If the problem device is unplugged. If the continues, call your health care professional.
30 Problem Why It Happened What To Do Redness occurs when the mask cushion comes in contact with the skin. This could be due to improper mask fitting or improper mask cleaning. Be sure to rinse the mask thoroughly after cleaning to remove residue. See the mask cleaning instructions for detailed information. If the problem continues, contact your health care professional for a refitting or a different size mask. Redness occurs when the mask cushion accessory comes in contact with the skin.
31 Problem Why It Happened What To Do The device’s display is erratic. The device or power supply has been dropped or mishandled, or the device or power supply is in an area with high EMI emissions. Unplug the device and the power supply. A SmartCard error occurs. The SmartCard is not inserted properly. It may be inserted upside down or backwards. Remove the SmartCard and reinsert it so that the printed side of the card is facing up and the end with the arrow goes into the device first.
32 Chapter 9: Cleaning and Maintenance 9.1 Cleaning the Device Before cleaning or performing any routine maintenance, always make sure the device is not operating and disconnect the device from the power source. NOTE: The following cleaning instructions are for the BiPAP autoSV device only. To clean the accessories, refer to each accessory’s instruction sheet. CAUTION: Do not immerse the device or allow any liquid to enter the enclosure, inlet filter, or any openings.
33 3. Remove the filters from the enclosure by gently pulling around the edges of the filters. The top filter is the reusable gray foam filter. The bottom filter is the optional disposable white ultra-fine filter, as shown in Figure 9–2. Reusable Gray Foam Filter Disposable Ultra-fine Filter Figure 9–2 Removing the Filters 4. Examine the filters regularly for cleanliness and integrity. 5. If needed, wash the gray foam filter in warm water with a mild detergent.
34 Chapter 10: Accessories 10.1 Adding a Humidifier The REMstar Heated Humidifier, REMstar Passover Humidifier, and H2 Heated Humidifier are available from your health care professional. The humidifiers may reduce nasal dryness and irritation by adding moisture (and heat, if applicable) to the airflow. CAUTION: For safe operation, the humidifier must always be positioned below the circuit connection at the mask and the air outlet on the device. The humidifier must be level for proper operation.
35 Chapter 11: 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 (5600 feet to sea level) 83 to 102kPa Physical Dimensions: 9.75 in. L x 6.625 in. W x 4.4 in. H (24.8 cm L x 16.8 cm W x 11.2 cm H) Weight: 4 lbs (1.
36 Pressure 4 to 30 cm H2O Output: Control Accuracy Parameter Range Accuracy IPAP Min 4 to 30 cm H2O ± 5 cm H2O* IPAP Max 4 to 30 cm H2O ± 5 cm H2O* EPAP 4 to 25 cm H2O ± 5 cm H2O* Breath Rate 4 to 30 BPM Greater of ± 1 BPM or ± 10% of the setting (when measured over a 4 minute period) Timed Inspiration 0.5 to 3.0 seconds ± (0.
37 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.
38 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 BiPAP autoSV 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.
1001 Murry Ridge Lane Murrysville, PA 15668 USA Respironics Deutschland Gewerbestrasse 17 82211 Herrsching, Germany 1040200 JR 3/1/07
