REF 1064858 1070569-01 NS 08/23/10 BiPAP S/T USER MANUAL
© 2010 Koninklijke Philips Electronics N.V. All rights reserved.
i BiPAP S/T user manual Table of Contents Chapter 1. Introduction....................................................................................................................................... 1 Package Contents............................................................................................................................................ 1 Intended Use.......................................................................................................................................
ii Starting and Stopping the Device..................................................................................................20 Monitor Pressure Screen....................................................................................................................21 Changing the Comfort Settings......................................................................................................22 Changing and Viewing the Setup Options..............................................................
1 BiPAP S/T user manual 1. Introduction This chapter provides an overview of the device. Package Contents The BiPAP S/T system may include the following components. Some components (e.g., humidifier) are optional accessories that may not be packaged with the device. AC Power Adapter (REF 1058190) Package Contents Reusable Gray Foam Filter Carrying Case Power Cord Humidifier Ventilator Secure Digital (SD) Card User and Provider Manuals Flexible Tubing (1.
2 Intended Use The BiPAP S/T device is intended to provide non-invasive ventilatory support to treat adult patients weighing over 30 kg (66 lbs) and pediatric patients 7 years or older and weighing over 18 kg (40 lbs) with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. This device may be used in the hospital or home. WARNING The effectiveness of Bi-Flex has not been established for pediatric patients.
3 Patient Circuits The device should be used only with masks and connectors recommended by Philips Respironics or with those recommended by the health care professional or respiratory therapist. A mask should not be used unless the device is turned on and operating properly. The exhalation port(s) associated with the mask should never be blocked.
4 Oxygen When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen. When using oxygen with this system, turn the device on before turning on the oxygen. Turn the oxygen off before turning the device off. This will prevent oxygen accumulation in the device. 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.
5 Improperly Functioning Ventilator If you notice any unexplained changes in the performance of the device, if it is making unusual sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is cracked or broken, disconnect the power cord and discontinue use. Contact your home care provider.
6 Cautions A caution indicates the possibility of damage to the device. Electrostatic Discharge (ESD) Pins of connectors should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used. Precautionary procedures include methods to prevent build-up of electrostatic charge (e.g.
7 Notes •• Additional warnings, cautions and notes are located throughout this manual. •• Please see the “Limited Warranty” section of this manual for information on warranty coverage. Contraindications The device is contraindicated on patients without a spontaneous respiratory drive.
8 Patient Precautions •• Immediately report any unusual chest discomfort, shortness of breath, or severe headache. •• If skin irritation or breakdown develops from the use of the mask, refer to the mask instructions for appropriate action.
9 Several accessories are also available for use with the device. Contact your home care provider to purchase any accessories not included with your system. The figure below illustrates some of the device features, described in the table below. SD Card (Accessory) Slot Air Outlet Port SD Card Cover Power Inlet Tab Side Cover Filter Area Device Features Feature Description Air Outlet Port Connect the flexible tubing here. SD Card (Accessory) Slot If applicable, insert the optional SD card here.
10 Control Buttons The figure below shows the display screen and primary control buttons on the device. LCD Display Screen Humidifier Icon and Number Settings Control Wheel/ Push Button Control Buttons Alarm Silence/ Indicator Button Ramp Button Feature Display Screen Description Shows therapy settings, patient data, and other messages. The startup screen is shown temporarily when the device is first powered. Humidifier This symbol lights up when the optional humidifier is attached.
11 Available Therapy Modes The table below describes the therapy modes available on the device: Therapy Modes CPAP S S/T Description Continuous Positive Airway Pressure; CPAP maintains a constant level of pressure throughout the breathing cycle. Spontaneous Pressure Support; A Bi-level therapy mode where breaths are patient-triggered and patient-cycled.
12 Ramp If enabled, the device is equipped with a linear ramp function. The Ramp feature will reduce the pressure and then gradually increase (ramp) the pressure to the prescription pressure setting so patients can fall asleep more comfortably. Rise Time If enabled, the device provides a feature called Rise Time in S and S/T modes. Rise time is the amount of time it takes the device to change from the expiratory pressure setting to the inspiratory pressure setting.
13 Symbols The following symbols appear on the device and power supply. Symbol Description For Airline Use. Complies with RTCA DO-160F section 21, category M. DC Power Connector Consult accompanying instructions for use. Type BF Applied Part Class II (Double Insulated) Drip Proof Equipment Caution! U.S. federal law restricts this device to sale by or on the order of a physician.
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15 BiPAP S/T user manual 2. Device Setup Installing the Air Filter The device uses a gray foam filter that is washable and reusable. CAUTION The reusable filter screens out normal household dust and pollen. A properly installed, undamaged It must be in place at all times when the device is operating. One gray foam filter is required for reusable gray foam filter is supplied with your device. If your filter is proper operation.
16 Connecting the Breathing Circuit To use the system, you will need the following accessories in order to assemble the recommended circuit: •• Philips Respironics interface (nasal mask or full face mask) with integrated exhalation port, or Philips Respironics interface with a separate exhalation device (such as the Whisper Swivel II) •• Philips Respironics 1.83 m (6 ft.
17 Supplying AC Power to the Device Complete the following steps to supply AC power to the device: 1. Plug the socket end of the power cord (included) into the power supply (also included). 2. Plug the pronged end of the power cord into an electrical outlet that is not controlled by a wall switch. 3. Plug the power supply cord’s connector into the power inlet on the back of the ventilator. 4. Ensure that all connections are secure.
18 Symbol Description Flex Control hPa/cmH2O Humidifier Information Language Leak Machine Hours Min Vent Minute Ventilation Mode No No Settings Available Off (disabled) On (enabled) Patient Disconnect Provider Mode Ramp Time Ramp Start Pressure Reinsert SD Card Reset Blower Hours Reset Therapy Hours RR BiPAP S/T user manual Respiratory Rate
19 Symbol Description Rise Time Rise Time Control SD Card Corrupted SD Card Full SD Card Inserted SD Card Inserted: Prescription Accepted SD Card Inserted: Prescription Rejected SD Card is Write-Protected SD Card Removed Setup Setup Parameter Display Therapy (Blower Off ) Therapy (Blower On) Therapy Hours TI Timed Inspiration Ventilator Inoperative VTE Exhaled Tidal Volume Tubing Type Tubing Type Control Yes (Selection Confirmed) Chapter 2 Device Setup
20 Navigating the Device Screens Turn the Wheel to toggle between options and settings on the screen. Press the Wheel to choose an option or setting that is highlighted. If you choose “Back” or the icon on any screen, it will take you back to the previous screen. Starting and Stopping the Device Note: Your device will either display in icon mode or text mode. Examples will be shown in both modes. 1. Supply power to the device. 2. The Main Menu screen appears, shown below.
21 9. Verify that the device beeps when therapy is stopped. If the device does not operate accordingly, contact your home care provider, as the alarm system may not be fully functional. Monitor Pressure Screen From the Main Menu, if you select Therapy and then press the Wheel, the following Monitor Pressure screen appears. S/T 20.
22 The bottom section of the display shows additional measured parameters which may include: •• •• •• •• Note: The measured parameters display one at a time on-screen. Respiratory Rate (RR) Tidal Volume in milliliters (ml) Minute Ventilation (Min Vent) in liters per minute (lpm) Leak in lpm Changing the Comfort Settings FLEX 2 4 3 Icon View Comfort Your device is equipped with optional Flex, Ramp, and Rise Time features that your health care professional may prescribe for you.
23 Ramp Start Setting The device is equipped with an optional ramp feature that your home care provider can enable or disable. This feature reduces the air pressure when you are trying to fall asleep and then gradually increases (ramps) the pressure until your prescription setting is reached, allowing you to fall asleep more comfortably. Note: If the ramp feature is disabled, nothing will happen when you press the Ramp button.
24 Changing and Viewing the Setup Options Note: The screen will only show From the Main Menu, when you highlight the Setup option and press 4 selections at a time. As you rotate the Wheel to toggle over the Wheel, the Setup screen below appears. different options, the screen will slide up and down accordingly.
25 The following items appear on the Information screen: •• Monitor Parameters - Displays the available parameters. •• Therapy Hours - Displays the average amount of time therapy is received over a 7 day and 30 day period. •• Blower Hours - Displays the total number of hours that the blower has been on. It can be reset by your home care provider. This setting allows the provider to track device usage between patients. •• Machine Hours - Displays the total number of hours that the blower has been on.
26 Viewing Measured Parameters Several measured parameters can be viewed on-screen. The following table describes each measured parameter. The measured parameters that display on the Monitor Pressure screen only appear one at a time. The Setup Parameter Display setting on the Setup screen allows you to choose which measured parameters you want displayed. The parameters below appear on both the Monitor Pressure and Monitor Parameters screens.
27 BiPAP S/T user manual 3. Device Alarms This chapter describes the ventilator alarms and what you should do if an alarm occurs. There are three types of alarms: •• High Priority – Require immediate response by the operator •• Medium Priority – Require prompt response by the operator •• Low Priority – Require operator awareness. These alarms alert you to a change in the ventilator status.
28 Alarm LED Indicators The Alarm Silence/Indicator button lights up as follows whenever an alarm is detected: •• Red Flashing Indicator – High priority alarm is detected. •• Yellow Flashing Indicator – Medium priority alarm is detected. •• Yellow Solid Indicator – Low priority alarm is detected. The Alarm Silence/Indicator button does not light up when informational messages display.
29 •• Medium Priority – When a medium priority alarm is active, a series of beeps sounds in a 3-beep pattern. This pattern repeats until the cause of the alarm is corrected or the audible alarm is silenced. The alarm descriptions later in this chapter display this indicator as: • • • •• Low Priority – When a low priority alarm is active, a series of beeps sounds in a 2-beep pattern. This pattern repeats until the cause of the alarm is corrected or the audible alarm is silenced.
30 Alarm Message Screens When an alarm message is activated, an alarm screen is displayed, showing the text or icon specific to the most recent, highest priority alarm. Pressing the Control Wheel will reset the alarm and remove the alarm screen from the display. Resetting the alarm allows you to return to the previous screen. If multiple alarms occur during the same period of time, the alarm screen will display the higher priority alarm (higher priority alarms take precedence over lower priority alarms).
31 Alarm Low Pressure Alarm Priority High Audible Indicator ••• •• Visual Indicators Red flashing button; Device Action User Action Operates This could be caused by an excessive leak or blockage or a device malfunction. Press the Alarm Silence/Indicator button to silence the alarm. Remove your mask. Check for the following: dirty inlet filters, blocked air intake, excessive leak in the patient circuit. If the alarm continues, contact your home care provider.
32 Alarm Patient Disconnect Priority High Audible Indicator ••• •• Visual Indicators Red flashing button Device Action Operates This alarm occurs when the patient circuit is disconnected or has a large leak. Press the Alarm Silence/Indicator button to silence the alarm. Reconnect the patient circuit or fix the leak. If the alarm continues, contact your home care provider for service.
33 Alarm SD Card Full Priority Low Audible Indicator •• Visual Indicators Solid yellow button Device Action User Action Operates This alarm occurs when the SD card is full. Press the Alarm Silence/Indicator button to silence the alarm. Remove the SD card and replace it. Operates This alarm occurs when the device cannot read the SD card. The card may be inserted incorrectly. Remove the SD card and reinsert. If the alert continues to occur, replace the SD card or contact your home care provider.
34 Alarm SD Card Removed Priority Info Audible Indicator • Visual Indicators SD card removed Device Action Operates This message occurs when the SD card is removed from the device. It is present for 30 seconds or until the user acknowledges it. No action is needed. Device operate; Humidifier shuts down Alert is present for 12 minutes or until the condition is fixed. Turn off airflow and reconnect the humidifier to the device according to the humidifier instructions.
35 Troubleshooting The table below lists some of the problems you may experience with your device and possible solutions to those problems. Problem Nothing happens when you apply power to the device. The backlight on the buttons does not light. Why It Happened There is no power at the outlet or the device is unplugged. What To Do If you are using AC power, check the outlet and verify that the device is properly plugged in. Make sure there is power available at the outlet.
36 Problem Why It Happened What To Do The device display is erratic. The device has been dropped or mishandled, or the device is in an area with high Electromagnetic Interference (EMI) emissions. Unplug the device. Reapply power to the device. If the problem continues, relocate the device to an area with lower EMI emissions (away from electonic equipment such as cellular phones, cordless phones, computers, TVs, electronic games, hair dryers, etc.).
37 Problem Why It Happened What To Do The mask feels uncomfortable to wear, there is significant air leakage around the mask, or you experiences other mask-related issues. This could be due to improper headgear adjustment or improper mask fitting. Make sure you are properly fitted with the correct size mask. If the problem continues, contact your home care provider to be fitted with a different mask. You have a runny nose. This may be caused by a nasal reaction to the airflow.
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39 BiPAP S/T user manual 4. Accessories There are several accessories available for your BiPAP S/T system such as a humidifier. Contact your home care provider for additional information on the available accessories. When using the optional accessories, always follow the instructions enclosed with the accessories. CAUTION Humidifier You can use the System One Heated humidifier or the Pass-over humidifier with your device. They are available from your home care provider.
40 Supplemental Oxygen Oxygen may be added anywhere in the patient circuit provided that a pressure valve is used. Please note the warnings listed below when using oxygen with the device. WARNINGS •• When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen. •• When using oxygen with this system, turn the device on before turning on the oxygen. Turn the oxygen off before turning the device off. This will prevent oxygen accumulation in the device.
41 DC Power Cord The Philips Respironics DC power cord can be used to operate this device in a stationary recreational vehicle, boat, or motor home. The Philips Respironics DC Battery Adapter Cable, when used with the DC Power Cord, enables the device to be operated from a 12 VDC free-standing battery. Refer to the instructions supplied with the DC Power Cord and adapter cable for information on how to operate the device using DC power.
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43 BiPAP S/T user manual 5. Cleaning the Device Follow the instructions below to clean the device: 1. Unplug the device, and wipe the outside of the device with a cloth slightly dampened with water and a mild detergent. Let the device dry completely before plugging in the power cord. 2. Inspect the device and all circuit parts for damage after cleaning. Replace any damaged parts.
44 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. WARNING Service The device does not require routine servicing. BiPAP S/T user manual If you notice unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if the enclosure is broken, or if water has entered the device, discontinue use, and contact your home care provider.
45 BiPAP S/T user manual 6. Specifications Environmental Operating Storage Temperature 5° C to 35° C (41° F to 95° F) -20° C to 60° C (-4° F to 140° F) Relative Humidity 15 to 95% (non-condensing) 15 to 95% (non-condensing) Atmospheric Pressure 101 kPa to 77 kPa (0-2286 m / 0-7500 ft) N/A Physical Dimensions: 18 cm x 14 cm x 10 cm (7” L x 5.5” W x 4” H) Weight: Approximately 1.
46 Fuses: There are no user-replaceable fuses. Type of Protection Against Electric Shock: Class II/Internally Powered Equipment Degree of Protection Against Electric Shock: Type BF Applied Part Degree of Protection against Ingress of Water (Device and AC power supply): Drip Proof, IPX1 Mode of Operation: Continuous Pressure Pressure Increments: 4.0 to 25.0 cm H2O (in 1.
47 Noise Minimum Alarm Sound Level: 45 dB(A) Disposal Dispose of the device in accordance with local regulations.
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49 BiPAP S/T user manual 7. 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 RF emissions Compliance Group 1 CISPR 11 Electromagnetic Environment - Guidance The device uses RF energy only for its internal function.
50 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 IEC 60601 Test Compliance Level Level Electrostatic ±6 kV contact Guidance ±6 kV contact Discharge (ESD) Floors should be wood, concrete or ceramic tile.
51 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.
52 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.
53 BiPAP S/T user manual 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.
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