DreamStation 2 Advanced CPAP DreamStation 2 Advanced Auto CPAP User manual
© Koninklijke Philips N.V., 2020. All rights reserved.
Table of contents 1. Safety information..................................................................................................................................................................... 1 Intended use........................................................................................................................................................................... 1 Important.............................................................................................................
7. Cleaning and care.................................................................................................................................................................... 41 Home cleaning: device exterior, heater plate, and humidifier air inlet seal...................................................... 41 Home cleaning: humidifier water tank (lid, water tank base, and water tank seal) ........................................ 41 Home cleaning: tubing.............................................
1. Safety information Intended use The DreamStation 2 Advanced CPAP/DreamStation 2 Advanced Auto CPAP system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment. Important The device is to be used only on the instruction of a licensed physician.
Warnings A warning indicates the possibility of injury to the user or operator. Device usage This device is not intended for life support. Contact your health care professional if symptoms of sleep apnea recur. Personnel qualifications This manual serves as a reference. The instructions in this manual are not intended to supersede your health care professional’s instructions regarding the use of the device.
Patient circuits and tubing The device should only be used with compatible patient interfaces (e.g., masks, circuits and exhalation ports). Proper operation of the device 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. The exhalation port(s) associated with the mask should never be blocked.
Integrated humidifier For safe operation when using the integrated humidifier, the device must always be positioned below the breathing circuit connection at the mask. The device must be level for proper operation. Allow the heater plate and water to cool down for approximately 15 minutes before removing the humidifier water tank. A burn may result from: touching the heater plate, coming in contact with the heated water, or touching the humidifier water tank pan.
EMC Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment. See the EMC section of this manual for distances to observe between RF Generators and the ventilator to avoid interference.
Electrostatic Discharge (ESD) Do not use antistatic or conductive hoses or conductive patient tubing with the device. Condensation Condensation may damage the device. If the device has been exposed to either very hot or very cold temperatures, allow it to adjust to room temperature (operating temperature) before starting therapy. Do not operate the device outside of the environmental operating ranges listed in the “Technical specifications” section later in this manual.
Tobacco use Tobacco smoke may cause tar build up within the device. Device placement Do not place the device in or on any container that can collect or hold water. Do not place the device directly onto carpet, fabric, or other flammable materials. Do not plug the device into an outlet controlled by a wall switch. Do not place the device in or on any container that can collect or hold water. Take precautions to protect furniture from water damage.
Symbols glossary The following symbols may appear on the device, power supply, and accessories. For a full list and description of the symbols used on the device and its packaging, see www.symbols. philips.com. Symbol Title and Meaning Title and Meaning Type BF applied part To identify a type BF applied part complying with IEC 60601-1. Prescription device Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
Symbol Title and Meaning Symbol Title and Meaning AC power (Alternating current) Class II equipment (Double Insulated) To identify equipment meeting the safety requirements specified for Class II equipment. Caution, consult accompanying documents. Do not disassemble. Single patient use Indicates that the tubing is for single patient use only. Keep away from sunlight Indicates the medical device needs protection from light sources. Importer Indicates the entity importing the medical device.
2. System overview The DreamStation 2 Advanced CPAP/DreamStation 2 Advanced Auto CPAP is a Continuous Positive Airway Pressure therapy device designed for the treatment of Obstructive Sleep Apnea (OSA). The integrated humidifier and optional heated tubing is designed to deliver humidification to provide added comfort during therapy. This humidification level is controlled through the output of the heated humidifier as well as the temperature of the optional heated tubing.
# Feature Description # Feature Description 1 Air outlet port Connect the flexible tubing here 7 Filter access Access the filter here. 2 Heated tubing pin connector Line up and connect the heated tubing connector here 8 SD card access Access the SD card here. 3 Therapy on/off button Starts and stops the airflow for therapy. 9 Air inlet for the humidifier Connects to the humidifier water tank 4 Display screen This is the User Interface for the therapy device.
Humidifier water tank 1 3 2 5 4 4 8 6 6 7 - 12 -
# Feature Description 1 Lid Removable to fill the water tank. 2 Lid front tab Remove lid from here 3 Water tank release indent Unlatches water tank from the device when pressed 4 Lid hooks Connect over water tank base tabs 5 Water tank latch Latches the water tank to the device 6 Water tank base tabs Connect water tank lid hooks here to attach the water tank lid 7 Maximum fill lines Indicate the maximum water level for safe operation.
3. Device setup Installing/replacing the air filters Caution: A properly installed, undamaged Philips Respironics reusable pollen filter is required for proper operation. The device uses a reusable pollen filter that can be rinsed and a disposable ultra-fine filter. The reusable filter screens out normal household dust and pollens, while the ultra-fine filter provides more complete filtration of very fine particles. The reusable filter must be in place at all times when the device is operating.
4. Place the filter into the therapy device. 5. Reinstall the humidifier water tank. Where to place the device Place the device on a firm, flat surface somewhere within easy reach of where you will use it at a level lower than your sleeping position. Make sure the device is away from any heating or cooling equipment (e.g., forced air vents, radiators, air conditioners).
Complete the following steps to operate the device using AC power: 1. Plug the power supply cord’s connector into the power inlet on the bottom of the device 1 or 2 . For convenience, the power connection allows for the cord to connect and route in the direction that works best for your setup. An inset area on the bottom of the device allows the cord to be routed under the device 3 .
2. Plug the socket end of the AC power cord into the power supply 4 . 3. Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch 5 . 4. Verify that the plug on the bottom of the device, at the power supply, and at the electrical outlet are fully inserted. This will help to ensure that a secure, reliable electrical connection has been made. Important: To remove AC power, disconnect the power supply cord from the electrical outlet.
Removing the humidifier water tank 1. Gently press down on the indented area on the top of the humidifier water tank to unlatch the tank from the device. 2. Grip the top and bottom of the humidifier water tank and slide it out away from the device.
3. Remove the lid by pulling up on the lid tab while holding the water tank base. 4. Pour out any remaining water and rinse the water tank base. Filling and connecting the water tank 1. Place the water tank base on a firm, flat surface. Fill the water tank with distilled water no higher than the maximum fill lines , which are located on the back and sides of the water tank base.
2. Reattach the lid. Place the hooks on the lid 1 over the tabs on the water tank base 2 . 1 2 1 2 3. Press down 3 until the lid snaps securely over the tab 4 on the front of the water tank base.
4. Slide the humidifier water tank back into the device, using the tracks on the bottom of the water tank base for proper alignment and connection. Ensure that it is latched into place before proceeding.
To connect your breathing circuit to the device, complete the following steps. Note: If you are using the optional 12 mm (non-heated) performance tubing, an adapter is required to connect to the therapy device. Note: Tubing is identified on the cuff with the tubing identifier symbol: “12”, “15”, “HT12”, or “HT15”. 22 mm tubing contains no symbol. 1. Connect the flexible tubing to the air outlet on the therapy device.
Starting the device 1. Ensure power is supplied to the device. The first screen to display will be the Philips logo, Respironics logo, followed by the device model screen, and then a screen that contains a summary of your therapy. See the “Therapy off display” section later in this manual for a description of the User Interface (UI) screens. Note: The device may prompt you to set the language and time. These settings can always be adjusted from the device settings screen. 2. Put on your mask assembly.
Therapy Off display A summary of your therapy displays on the UI when therapy is turned off. From here you can tap “Settings” to view additional details about your therapy, perform a mask check fit, and adjust Comfort and Device settings. The following therapy results may appear on the Last Session screen. Text Description Duration This displays the amount of time you received therapy on the device for the most recent one day time frame.
Navigating the device screens The UI on this device allows you to adjust the device settings and view information about your therapy. The UI consists of the display screen and the touch panel. To adjust a setting: 1. Tap “Settings” from the Last Session screen. 2. Swipe up or down on the screen until you find the setting you want to adjust. The settings that can be changed appear in blue. 3. Tap the setting you want to view or change. 4. Tap the screen to change or select the setting.
Symbol Meaning Description Humidity You can change this setting from 0 to 5. Only displays when humidification is enabled. Heated tube temperature You can change this setting from 0 to 5. Only displays when optional heated tube is connected. FLEX This 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. When your provider enables Flex, a level will already be set for you on the device.
Therapy On display While the device is delivering therapy, the pressure setting is displayed. You can also view and adjust humidification, heated tube temperature, and RAMP PLUS settings. Note: The device goes into stand-by mode (display is black) after 60 seconds of inactivity. To wake up the device, tap anywhere on the display. 1 2 5 3 7 6 4 # Symbol Feature Description 1 cmH2O Therapy pressure Displays the prescription pressure setting.
# 4 Symbol Feature Description RAMP PLUS (Ramp+) The device is equipped with a RAMP PLUS feature that allows you to adjust your starting pressure for a set period of time (default of 30 minutes) for added comfort when you are trying to fall asleep. During that set time, the air pressure will remain at your set starting pressure unless the device detects an event and identifies the need to increase your pressure. When RAMP PLUS has concluded, your prescribed therapy pressure will resume.
# Symbol Feature Description 5 and 6 N/A Ramp indicator The therapy on display indicates when ramp is active. The circle around the therapy display is dotted blue (5) when ramp is active and solid blue (6) when ramp is not active or therapy pressure is achieved. 7 Oximetry connection This symbol displays during therapy when a pulse oximeter is connected to the therapy device. Not shown Therapy button ring The therapy button ring illuminates blue to indicate therapy is turned on.
4. Pop-up messages and troubleshooting Pop-up messages Device pop-up messages may appear on your screen to alert you of a required action, device status update, or reminder. When the pop-up message appears, follow any required actions. See table below or the “Troubleshooting” section later in this manual for additional solutions to problems you may be experiencing. Tap “Dismiss” to close the pop-up message. If you are unable to resolve the problem, contact your home care provider or Philips.
Message type Message Possible cause/additional action Alert Check Power Low Voltage. Please use a compatible power supply or fully charge the battery. Incompatible power supply is attached. Confirm a compatible Philips Respironics power supply is attached. Switch to compatible power supply if needed. If battery is being used, ensure battery is adequately charged. Alert Check Power Switch to a Philips-provided power supply that is Please use a compatible power capable of supporting humidification.
Message type Message Possible cause/additional action Notification SD Card Your SD card has been removed. Please reinsert to record therapy data. Indicates SD card has been removed from therapy device and not reinserted before the start of the current therapy session. Reinsert the SD card to record therapy data. Notification Notification Your Auto Trial period has concluded. Therapy pressure will return to original prescription setting. No additional action required.
Screen Text Description Update A prescription or setting update was unsuccessful. A prescription or setting update was unsuccessful. Contact your home care provider. SD Removed Reinsert Indicates SD card has been removed from therapy device and not reinserted before the start of the current therapy session. Reinsert the SD card to record therapy data. This message appears when therapy ends due to automatic off Auto Off Your device has automatically function. turned off due to inactivity.
Troubleshooting Problem Why it happened What to do Nothing happens when you apply power to the device. There’s no power at the outlet or the device is unplugged. 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. Make sure the AC power cord is connected correctly to the power supply and the power supply cord is securely connected to the device’s power inlet.
Problem Why it happened What to do The airflow is much warmer than usual. The air filters may be dirty. The device may be operating in direct sunlight or near a heater. Rinse or replace the reusable air filter or replace the disposable ultra-fine filter. 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.
5. Connectivity QoS: Wireless Quality of Service (QoS) refers to the necessary level of service and performance needed for the wireless functions of the device. It involves parameters such as reliability of data transmission, effective transfer rate, error rate, and mechanisms to define priority levels for time-critical signals.
Bluetooth wireless technology Bluetooth wireless technology 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 Obstructive Sleep Apnea (OSA) patients enhance their sleep therapy experience. Pairing your therapy device to your Bluetooth-enabled mobile device Note: You can only pair your therapy device to one mobile device at any given time.
6. Accessories There are several optional accessories available for your DreamStation 2 Advanced device. Contact your home care service provider for additional information on the available accessories. When using optional accessories, always follow the instructions enclosed with the accessories. SD card The device may come with an SD card inserted in the SD card slot behind the water tank. The SD card stores information for the home care provider.
3. When the update begins, the screen displays “Software Update Active” and the therapy button ring flashes. The screen will then appear black until the update is complete. 4. The device will restart when the upgrade is complete. Remove the SD card. 5. If an error occurs, contact Philips Respironics for a new SD card. Oximeter The DreamStation 2 Advanced device can pair to a pulse oximeter, using Bluetooth, for measuring %SpO2 and pulse rate.
• • 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. Do not connect the device to an unregulated or high pressure oxygen source. DC power A Philips Respironics DC power cord can be used to operate this device in a stationary recreational vehicle, boat, or motor home.
7. Cleaning and care Warning: Allow the humidifier heater plate and water to cool down for approximately 15 minutes before removing the water tank. A burn may result from: touching the heater plate, coming in contact with the heated water, or touching the tank base. Home cleaning: device exterior, heater plate, and humidifier air inlet seal Clean the device exterior surface weekly and between patients. Replace the humidifier air inlet seal between patients. 1.
3. Wash the humidifier water tank (lid, water tank base, and water tank seal) in the dishwasher (top shelf only) or the in a solution warm water and a mild liquid dishwashing detergent (1 teaspoon of liquid dish soap per gallon of warm water). 4. Allow all parts to air dry. 5. Inspect the humidifier water tank for damage. If any parts show signs of wear or damage, contact your home care provider for a replacement. 6. Re-install the water tank seal.
4. Visually inspect the tubing for cleanliness. Repeat the cleaning if not visually clean. 5. Inspect the tubing for damage or wear (cracking, tears, punctures, etc.). Discard and replace if necessary. Caring for the filters Notes • Only Philips supplied filters should be used as replacement filters. • Replace the disposable, ultra-fine filter if it is damaged or has accumulated debris.
8. Technical specifications Environmental Operating Temperature Device: 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) Atmospheric Pressure: Device: 101 to 77 kPa (0 - 2286 m / 0 - 7500 ft) Physical Dimensions 273.81 mm L x 158.5 mm W x 84.83 mm H (10.78 in L x 6.24 in W x 3.34 in H) Weight (empty water tank without power supply) 1040 g (2.
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 Water Device: Drip Proof, IP22 First characteristic numeral - 2 - Protection against ingress of solid foreign objects ≥ 12.5 mm diameter. Explanation: Protected against access to hazardous parts with a finger and protected against solid foreign objects of 12.5 mm diameter and greater.
Declared dual-number noise emissions values (in accordance with ISO 4871) Tube Size Sound Pressure Level (L) Uncertainty (K) Sound Power Level Uncertainty (K) 15 and 22 (mm) tubing type 30.5 dB(A) 2.0 db(A) 38.5 dB(A) 2.0 dB(A) 12 (mm) tubing type 30.5 dB(A) 2.0 db(A) 38.5 dB(A) 2.0 dB(A) Pressure accuracy Pressure Increments: 4-20cm H2O (in 0.
ISO 80601-2-70 Pneumatic Diagram 1 2 3 # 4 5 6 Feature 1 Air 2 Filter & air inlet 3 Blower 4 Air outlet 5 6 ft. tubing 6 Mask Wireless 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 2 device is capable of transmitting data between the therapy device and a mobile device.
• This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
Maximum Output Power 25 dBm Modulation OFDM/SC-FDMA Bandwidth: 1.4 MHz Bluetooth Operating Frequency Range 2.4-2.4835 GHz Maximum Output Power 0 dBm Modulation GFSK, P/4 DQPSK, 8DQPSK Bandwidth: 1 MHz Intake Port Filters Pollen Filter 100% Polyester 88% Efficient @ 7-10 micron size Ultra-fine Filter Blended Synthetic Fiber 95% Efficient @ 0.5-0.7 micron size Heated Tubing Specifications Maximum Recommended Pressure 20 cm H2O Inner Diameter 15 mm (HT15) 12 mm (HT12) Length 1.
Disposal Dispose of this device in accordance with local regulations. 9. EMC information Your unit has been designed to meet EMC standards throughout its Service Life without additional maintenance. There is always an opportunity to relocate your DreamStation 2 Advanced Therapy Device within an environment that contains other devices with their own unknown EMC behavior. If you believe your unit is affected by locating it closer to another device, simply separate the devices to remove the condition.
Emissions Test Compliance RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/Flicker emissions IEC 61000-3-3 Complies Emission of Radio Frequency Energy RTCA/DO-160G Section 21 Category M Electromagnetic Environment - Guidance The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Surge IEC 61000-4-5 ±1 kV differential mode ±1 kV differential mode ±2 kV common mode N/A: Device is Class 2 and does not have earth connection. Mains power quality should be that of a typical home or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in UT) for 0.
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.
1143581 R00 HM 04/05/2020 EN-DOM - 54 -
