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Respironics Inc.
Respironics Deutschland GmbH & Co. KG
1001 Murry Ridge Lane
Gewerbestrasse 17
Murrysville, PA 15668 USA
82211 Herrsching, Germany
DreamStation
BiPAP autoSV
1128728
REF
1128728 R10
User manual
HM 06/13/2017
EN-INTL

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Summary of Contents for Philips DreamStation BiPAP autoSV

  • Page 1 DreamStation BiPAP autoSV 1128728 Respironics Inc. Respironics Deutschland GmbH & Co. KG 1128728 R10 1001 Murry Ridge Lane Gewerbestrasse 17 User manual Murrysville, PA 15668 USA 82211 Herrsching, Germany HM 06/13/2017 EN-INTL...
  • Page 2 © Koninklijke Philips N.V., 2017. All rights reserved.
  • Page 3 This guide provides you with instructions on how to access and navigate the provider screens used to modify device settings. Refer to the user manual for more information on using the DreamStation BiPAP autoSV device. The device is to be used only on the instruction of a licensed physician. The clinician or home care service provider will make the correct pressure settings and device configurations including accessories, according to the health care professional’s prescription.
  • Page 4 DreamStation BiPAP autoSV Provider settings The following sections will describe the options available from the Provider screens. Therapy settings Choosing this screen will take you to a sub-menu where you can adjust the device therapy modes and pressure settings. These settings are described here.
  • Page 5 DreamStation BiPAP autoSV Alarm settings Choosing this screen will take you to a sub-menu where you can enable or disable the alarms described below. Icon Text Description Patient Disconnect You can enable or disable the Patient Disconnect alarm by Alarm choosing 0, 15, or 60 seconds.
  • Page 6 DreamStation BiPAP autoSV Icon Text Description Tube This setting allows you to choose the desired temperature for the Temperature heated tube: 0, 1, 2, 3, 4 or 5. SmartRamp When SmartRamp mode is enabled, the therapy device’s ramp function utilizes an auto-titrating algorithm during the ramp period. It allows patients the ability to stay at lower pressures during the ramp period, to improve their acclimation to therapy.
  • Page 7 This setting allows you to select the correct size diameter tubing that you are using with the device. You can choose either (22) for the Philips Respironics 22 mm tubing, or (15) for the Philips Respironics 15 mm tubing. When using Heated Tubing, the device will automatically change this setting to the appropriate tubing type (15H).
  • Page 8 DreamStation BiPAP autoSV Device settings Choosing this screen will take you to a sub-menu where you can adjust the way the device displays information. These settings are described here. Note Not all settings shown here will display on the device. The display will vary based on therapy device model and device settings.
  • Page 9 4. If an SD card error is detected, the Change Rejected icon appears . Remove the SD card and reinsert. If the alert continues to occur, contact Philips Respironics at 1-724-387-4000 or +49 8152 93060 for a new SD card.
  • Page 10 DreamStation BiPAP autoSV Respironics Inc. Respironics Deutschland GmbH & Co. KG 1128728 R10 1001 Murry Ridge Lane Gewerbestrasse 17 HM 06/13/2017 Murrysville, PA 15668 USA 82211 Herrsching, Germany EN-INTL 8 | Provider guide...
  • Page 11: Table Of Contents

    DreamStation BiPAP autoSV User Manual Table of contents 1. Introduction ................................. 1 Package contents .............................1 Intended use ..............................1 ............................2 Safety information Symbol key ................................8 System overview ..............................9 How to contact Philips Respironics ......................12 2. Device setup ...............................13 Installing and replacing the air filters .......................13 Positioning the device...........................14...
  • Page 12 DreamStation BiPAP autoSV User Manual Oximeter ................................46 Philips Respironics proprietary compliance software ................46 Roll stand .................................46 Supplemental oxygen ..........................47 4.10 DC power cord ..............................47 4.11 Carrying case and airline travel .........................48 Care, cleaning, and disinfection ........................49 Caring for the filters ............................49 Home cleaning: device and humidifier ....................50...
  • Page 13: Introduction

    DreamStation BiPAP autoSV User Manual 1. Introduction This chapter provides an overview of the DreamStation BiPAP autoSV device. Take time to read the entire manual before using your device for the first time. This chapter includes: • Package contents •...
  • Page 14: Safety Information

    Make sure the device is working properly at start-up. Always verify that the alarm LEDs light red then yellow momentarily. Contact Philips Respironics or an authorized service center for service if these indications do not occur at start-up. See Chapter 2 for more information about device start-up.
  • Page 15 Proper operation of the device, including alarms, with other circuits has not been verified by Philips Respironics and is the responsibility of the health care professional. A mask should not be used unless the device is turned on and operating properly.
  • Page 16 Do not connect the device to an unregulated or high pressure oxygen source. When using oxygen with this system, a Philips Respironics pressure valve must be placed in-line with the patient circuit between the device and the oxygen source. The pressure valve helps to prevent the back flow of oxygen from the patient circuit into the device when the unit is off.
  • Page 17 Periodically inspect electrical cords, cables, tubing, and accessories for damage or signs of wear. Discontinue use and replace if damaged. Repairs and adjustments must be performed by Philips Respironics-authorized service personnel only. Unauthorized service could cause injury, invalidate the warranty, or result in costly device damage. Contact your home care service provider for maintenance.
  • Page 18 When DC power is obtained from a vehicle battery, the device should not be used while the vehicle’s engine is running. Damage to the device may occur. Only use a Philips Respironcis DC power cord and battery adapter cable. Use of any other system may cause damage to the device.
  • Page 19 DreamStation BiPAP autoSV User Manual 1.3.4 Contraindications The device is contraindicated on patients without a spontaneous respiratory drive. If any of the following conditions apply to you, consult your physician before using the device: • Inability to maintain a patent airway or adequately clear secretions •...
  • Page 20: Symbol Key

    DreamStation BiPAP autoSV User Manual Symbol key The following symbols may appear on the device, power supply, and accessories: Symbol Definition Symbol Definition Consult accompanying For airline use. Complies with RTCA/ instructions for use. DO-160G section 21, category M. Separate collection for electrical...
  • Page 21: System Overview

    DreamStation BiPAP autoSV User Manual System overview 1.5.1 Device description The device is intended to augment patient breathing by supplying pressurized air through a patient circuit. It senses the patient’s breathing effort by monitoring airflow in the patient circuit and adjusts its output to assist in inhalation and exhalation.
  • Page 22 DreamStation BiPAP autoSV User Manual 1.5.2.2 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.
  • Page 23 DreamStation BiPAP autoSV User Manual 1.5.3 Device features The figure above illustrates some of the device features, described in the following table. Feature Description Therapy on/off button Starts and stops the airflow for therapy. Detects room light levels and adjusts brightness of LCD Ambient light sensor display screen.
  • Page 24: How To Contact Philips Respironics

    How to contact Philips Respironics Should you experience trouble with this equipment or require assistance setting up, using, or maintaining the device or accessories, please contact your home care service provider. To contact Philips Respironics directly, use the following contact details: Respironics, Inc.
  • Page 25: Device Setup

    DreamStation BiPAP autoSV User Manual 2. Device setup This chapter details how to set up the DreamStation BiPAP autoSV device. This chapter includes: • Installing the air filter • Positioning the device • Connecting the breathing circuit • Supplying AC power to the device •...
  • Page 26: Positioning The Device

    DreamStation BiPAP autoSV User Manual 2. If applicable, place a dry, reusable blue pollen filter (1) on top of a new, optional disposable light-blue ultra-fine filter (2) and firmly snap them together. 3. Place the new filter assembly back in the side of the therapy device. Swing the door closed.
  • Page 27: Supplying Ac Power To The Device

    DreamStation BiPAP autoSV User Manual Supplying AC power to the device Complete the following steps to operate the device using AC power: 1. Plug the socket end of the AC power cord (included) into the power supply (also included). 2. Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch.
  • Page 28: Connecting The Breathing Circuit

    To use the system, you will need the following accessories in order to assemble the recommended breathing 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) •...
  • Page 29: Starting The Device

    Starting the device 1. Ensure power is supplied to the device. The first screen to display will be the Philips Respironics logo, followed by the device model screen, and then the Home screen. The first time the device is powered on, a pop-up will prompt you to set the time on the device. The default setting is Greenwich Mean Time, but you may adjust the time in 30 minute increments to match your local time zone.
  • Page 30: Navigating The Device Screens

    DreamStation BiPAP autoSV User Manual 2. Put on your mask assembly. Refer to the instructions supplied with the mask. 3. Press the Therapy button ( ) on top of the device to turn on airflow and begin therapy. The current delivered pressure will display on the screen.
  • Page 31: Therapy Screen Features And Optional Humidification Settings

    DreamStation BiPAP autoSV User Manual Therapy screen features and optional humidification settings The following screen is displayed while therapy is turned on. The table below describes the different features that may appear on your screen. If an accessory is attached to the therapy device, additional symbols may appear.
  • Page 32: Ramp Feature

    DreamStation BiPAP autoSV User Manual 2.7.1 Adjusting the humidifier and heated tube settings If you have a humidifier, you can adjust tube temperature or humidifier settings while the device is delivering therapy by following these steps: 1. Turn the control dial counter-clockwise to activate the humidifier setting and clockwise to activate the heated tube setting.
  • Page 33: Patient Menu Navigation

    DreamStation BiPAP autoSV User Manual Patient menu navigation From the Home screen, you can scroll between the following four options: My Info Preheat My Provider My Setup My Info This menu provides summary statistics of your therapy use. Preheat This function lets you warm up your humidifier for 30 minutes before starting a therapy session.
  • Page 34 DreamStation BiPAP autoSV User Manual Icon Text Description This screen displays the nightly Apnea/Hypopnea Indices (AHI) value for the most recent 1 day time frame. It also displays the average of these individual nightly AHI values over a 7-day and a 30-day time frame. This screen only displays if your home care provider has enabled it.
  • Page 35 DreamStation BiPAP autoSV User Manual 2.8.3 My Provider When you select My Provider, you will be able to view the following screens. You cannot change settings in the Provider menu. These screens are only for reference. Your home care provider may periodically ask you for this information.
  • Page 36 Mask type This setting allows you to adjust the level of air pressure relief based on the specific Philips Respironics mask. Each Philips Respironics mask may have a System One resistance control setting. Contact your home care provider if you cannot find this resistance setting for your mask.
  • Page 37 This setting allows you to select the correct size diameter tubing that you are using with the device. You can choose either (22) for the Philips Respironics 22 mm tubing, or (15) for the Philips Respironics 15 mm tubing. When using Heated Tubing, the device will automatically change this setting to the appropriate tubing type (15H) and you will not be able to change it.
  • Page 38: Connecting To Wi-Fi (If Available)

    DreamStation BiPAP autoSV User Manual 2.9 Connecting to Wi-Fi (if available) If your device has a Wi-Fi accessory installed and enabled, follow the steps below to connect your device to Wi-Fi. For additional information, see the instructions included with your Wi-Fi accessory.
  • Page 39: Bluetooth® Wireless Technology

    DreamStation BiPAP autoSV User Manual 2.10 Bluetooth® wireless technology* Your device has Bluetooth wireless technology, which is one method by which you can transfer your therapy device’s data to DreamMapper*. DreamMapper is a mobile and web-based system designed to help sleep disordered breathing patients enhance their sleep therapy experience.
  • Page 40 2.10.2 Notices The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Philips Respironics is under license. Other trademarks and trade names are those of their respective owners. The DreamStation device is capable of transmitting data between the therapy device and a mobile device.
  • Page 41: Check Mask Fit

    DreamStation BiPAP autoSV User Manual 2.11 Check mask fit The optional Check Mask Fit feature can be enabled or disabled by your home care provider. This feature allows you to check the fit of your mask prior to starting therapy. This is done by measuring the amount of leak.
  • Page 42: Altitude Compensation

    DreamStation BiPAP autoSV User Manual 2.13 Altitude compensation This device automatically compensates for altitude up to 7,500 feet. No manual adjustment is necessary. Device setup...
  • Page 43: Alarms, Alerts, And Troubleshooting

    DreamStation BiPAP autoSV User Manual 3. Alarms, alerts, and troubleshooting This chapter describes the alarms and alerts and what you should do if an alarm or alert occurs. Reference the Troubleshooting section if you experience any problems while using the device.
  • Page 44: Alarm And Alert Audible Indicators

    DreamStation BiPAP autoSV User Manual Alarm and alert audible indicators An audible indicator sounds when any of the following occurs: • A device inoperative condition occurs • The blower is on and a power failure occurs • An alarm condition occurs •...
  • Page 45: Alarm Message Screens

    DreamStation BiPAP autoSV User Manual 3.6 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 dial once will silence the audible alarm. Press the control dial again to remove the alarm screen from the display.
  • Page 46: Alarm Summary Table

    DreamStation BiPAP autoSV User Manual Alarm summary table The following table summarizes the alarms. See Alarm and alert LED indicators and Alarm and alert audible indicators earlier in this chapter for LED and audible indicators for each alarm type. Alarm...
  • Page 47 DreamStation BiPAP autoSV User Manual Alarm Priority Device action User action Technical alarms Device Shuts down Press the control dial to silence the inoperative alarm. Disconnect the device from power. Immediately remove patient from ventilator and connect them to alternate source of ventilation.
  • Page 48 DreamStation BiPAP autoSV User Manual Alarm Priority Device action User action High Operates This could be caused by an excessive leak, blockage, or a device malfunction. Press the control dial to silence the alarm. Press the control dial again to acknowledge and remove the alarm from the screen.
  • Page 49: Alert Summary Table

    DreamStation BiPAP autoSV User Manual 3.9 Alert summary table The following table summarizes the alerts. See Alarm and alert LED indicators and Alarm and alert audible indicators earlier in this chapter for LED and audible indicators for each alert type. The screen below is an example of an alert screen.
  • Page 50 DreamStation BiPAP autoSV User Manual Alert Icon Priority Description User action Pair? Status Prompts to accept or Rotate the control dial to Yes/No decline pairing to a accept pairing (Yes), or Bluetooth compatible decline (No), then press device. the control dial to confirm selection.
  • Page 51 DreamStation BiPAP autoSV User Manual Alert Icon Priority Description User action SD Card Full. Notification SD card is full. Remove SD card and contact your home care service provider for a new SD card. Patient Message Notification Message from your Press the control dial to provider.
  • Page 52 DreamStation BiPAP autoSV User Manual Alert Icon Priority Description User action Check Power Notification Indicates an incompatible Confirm power cord is power supply is attached. fully inserted into device’s Incompatible power supply, power inlet. Confirm or power cord is not fully a compatible Philips inserted into device’s power...
  • Page 53: Troubleshooting

    DreamStation BiPAP autoSV User Manual 3.10 Troubleshooting Your device is equipped with a self-diagnostic tool called Performance Check. This tool can evaluate your device for certain errors. It also allows you to share key device settings with your Provider. Use Performance Check when directed by your provider.
  • Page 54 Make sure the Tubing type setting (22 or 15) matches feels too high or too low. may be incorrect. the tubing that you are using (Philips Respironics 22 or 15 mm tubing). If the Tubing type setting has been changed, contact your home care service provider.
  • Page 55 DreamStation BiPAP autoSV User Manual Problem Why it happened What to do I’m having difficulty The blower is not turned The humidifier setting and tube temperature adjusting the heated on, or the humidifier or settings can only be adjusted from the Therapy ON...
  • Page 56 DreamStation BiPAP autoSV User Manual Problem Why it happened What to do I accidentally spilled The water chamber has A small amount of water spilled in the basin of water into my humidifier been filled beyond the the humidifier will not harm your device. A small basin.
  • Page 57: Accessories

    SD card The DreamStation BiPAP autoSV device comes with an SD card inserted in the SD card slot on the side of the device. The SD card records information for the home care provider. Your home care provider may ask you to periodically remove the SD card and send it to them for evaluation.
  • Page 58: Link Module

    The Link Module is able to receive oximetry data and transfer it to the therapy device for home use or in a laboratory setting. For use in a laboratory setting, the Link Module also includes an RS-232 (or “DB9”) port to allow remote control of the DreamStation BiPAP autoSV device by a personal computer. Notes Please consult the instructions that accompany the Link Module for installation and removal.
  • Page 59: Supplemental Oxygen

    4.10 DC power cord A Philips Respironics DC power cord can be used to operate this device in a stationary recreational vehicle, boat, or motor home. In addition, a Philips Respironics DC battery adapter cable, when used with a DC power cord, allows the device to be operated from a 12 VDC free-standing battery.
  • Page 60: Carrying Case And Airline Travel

    DreamStation BiPAP autoSV User Manual 4.11 Carrying case and airline travel The device is suitable for use on airlines when it is operating from an AC or DC power source. Note The device is not suitable for airline use with any modems or humidifiers installed.
  • Page 61: Care, Cleaning, And Disinfection

    Never install a wet filter into the device. You must ensure sufficient drying time for the filter. Notes Only Philips Respironics-supplied filters should be used as replacement filters. Replace the disposable, ultra-fine filter if it is damaged or has accumulated debris.
  • Page 62: Home Cleaning: Device And Humidifier

    DreamStation BiPAP autoSV User Manual Home cleaning: device and humidifier Warning To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the device. DO NOT immerse the device in any fluids. 1. Unplug the device, and wipe the outside of the device with a cloth slightly dampened with water and a mild liquid dishwashing detergent.
  • Page 63: Hospital And Institution Disinfection: Device And Humidifier Exterior

    DreamStation BiPAP autoSV User Manual Hospital and institution disinfection: device and humidifier exterior Cautions Only the hospital and institution cleaning and disinfection procedure listed in this guide is recommended by Respironics. Use of other cleaning and disinfecting processes, not specified by Respironics, may affect the performance of the product.
  • Page 64: Service

    DreamStation BiPAP autoSV User Manual 5.6 Service The device does not require routine servicing or preventative maintenance other than inspection for normal wear or damage and device cleaning. Warning If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use.
  • Page 65: Specifications, Disposal, And Emc

    DreamStation BiPAP autoSV User Manual 6. Specifications, disposal, and EMC Specifications 6.1.1 Environmental Operating Temperature 5° to 35° C (41° to 95° F) Storage Temperature -20° to 60° C (-4° to 140° F) Relative Humidity (operating & storage) 15 to 95% (non-condensing)
  • Page 66 DreamStation BiPAP autoSV User Manual 6.1.5 IEC 60601-1 classification Type of Protection Against Electric Shock Class II Equipment Degree of Protection Against Electric Shock Type BF Applied Part Degree of Protection against Ingress of Device: Drip Proof, IP22 Water Link Module: Drip Proof, IP22...
  • Page 67 DreamStation BiPAP autoSV User Manual 6.1.10 Declared dual-number noise emissions values (in accordance with ISO 4871) The A-weighted sound pressure level Device: 25.8 dB(A) with and uncertainty of 2 dB(A). Device with Humidifier: 27.9 dB(A) with and uncertainty of 2 dB(A).
  • Page 68: Disposal

    DreamStation BiPAP autoSV User Manual 6.1.14 Spontaneous breathing during power failure conditions Patient flow Expiratory pressure (cmH Inspiratory pressure (cmH (lpm) Passive circuit Passive circuit <1.8 <2.1 <4.9 <5.5 Disposal Separate collection for electrical and electronic equipment per EC Directive 2012/19/EU. Dispose of this device in accordance with local regulations.
  • Page 69 DreamStation BiPAP autoSV User Manual 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.
  • Page 70 DreamStation BiPAP autoSV User Manual 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.
  • Page 71: Limited Warranty

    Note: For Australian and New Zealand customers this warranty replaces the warranty contained above. 1. Respironics, Inc., a Philips Healthcare company warrants that the Products shall be free from defects of workmanship and materials and will perform in accordance with the Product specifications. 2. This warranty is valid for a period of two (2) years from the date of purchase from an authorised Respironics dealer.
  • Page 72 DreamStation BiPAP autoSV User Manual Limited warranty...

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