DreamStation 2 CPAP DreamStation 2 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....................................................................................................................................................................38 Home cleaning: device exterior, heater plate, and humidifier air inlet seal......................................................38 Home cleaning: humidifier water tank (lid, water tank base, and water tank seal) ........................................39 Home cleaning: tubing................................................
1. Safety Information Intended use The DreamStation 2 CPAP/DreamStation 2 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, accessories, and packaging. For a full list and description of the symbols used, 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 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. System contents Your system may include the following items: • Device • Carrying case • Flexible Tubing • Humidifier water tank • SD Card • 6 ft. (1.
2. System overview The DreamStation 2 CPAP/DreamStation 2 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 Heating 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 side 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 is the Philips logo, followed by the Respironics logo, and then the device model screen. Once fully powered on, the screen displays “To begin therapy click below”. Note: The device may prompt you to set the language and time. 2. Put on your mask assembly. Refer to the instructions supplied with the mask. A small amount of mask leak is normal and acceptable.
Therapy On display While the device is delivering therapy, the prescription pressure or RAMP PLUS pressure is displayed. You can also view and adjust your humidification 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 to the left or right of the display screen. 1 2 3 4 # Symbol Feature Description 1 cmH2O Therapy pressure Displays the prescribed pressure setting.
# Feature Description 3 Symbol 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.
Therapy Off display After Therapy is turned off a series of four screens that display a summary of your therapy may appear. A description of each screen is below. Each screen displays three times and then the screen displays: To begin therapy click below Note: Each screen must display one time and the therapy ring must illuminate white before therapy can be turned back on.
Device settings The device settings screens allow you to reset the device language and time and Bluetooth connections. You also can turn Airplane Mode on and off. Follow the steps below to navigate through the device settings screens. For each setting, press and hold the Therapy button to complete the action, or click the Therapy button to cancel the action. Note: To reset Bluetooth connections and change Airplane Mode you must follow the steps below to first pass through the language and time screens. 1.
4. Pop-up messages and troubleshooting Device pop-up messages Device pop-up messages may appear on your device to alert you of a device status update or required action. When the message appears, follow the action or note the code and then reference the following table for an explanation of the pop-up and any action that should be taken. Click the Therapy button to close the pop-up screen.
Code Condition/ Screen text Description Possible cause Action H-04 Humidification error - battery The attached battery does not support humidification. Use of battery pack for power. Disconnect the battery pack and use a compatible power supply or use the device without humidification. P-02 Incompatible power supply Indicates an incompatible power supply is attached. Incorrect power supply. Switch to a Philips-provided power supply that is capable of supporting humidification.
Code Condition/ Screen text Description Possible cause N/A Service Required Contact support (light blinks continuously} Indicates an error Device error. which enters device into “Safe State.” This allows power to remain on but airflow is disabled. Action Disconnect device from power. Reattach power cord to restore power. If the alert continues to occur, contact your home care provider. Status pop-up messages Status messages do not require action.
Screen Text Description SpO2 Successful You have achieved at least 4 hours of therapy and oximetry use. SpO2 Unsuccessful Minimum therapy hours not met. Your pulse oximetry recording was unsuccessful. 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.
Problem Why it happened What to do The device’s 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 electronic equipment such as cellular phones, cordless phones, computers, TVs, electronic games, hair dryers, etc.).
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 timecritical 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 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.
4. The device UI 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 device can pair to a pulse oximeter, using Bluetooth, for measuring %SpO2 and pulse rate. To use a pulse oximeter with your therapy device, follow these steps. 1. Follow the setup instructions provided with your pulse oximeter and finger sensor. 2. Attach the finger sensor to your forefinger. 3.
Supplemental oxygen Oxygen can be added to the patient circuit. 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. • Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame. • Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air, or in the presence of nitrous oxide..
Refer to the instructions supplied with the DC power cord and adapter cable for information on how to operate the device using DC power. Traveling with the system When traveling, the carrying case is for carry-on luggage only. The carrying case will not protect the system if it is put through checked baggage. Do not travel with water in the water tank. The device is suitable for use on airlines when the device is operating from an AC or DC power source.
6. Inspect the device for cleanliness. If necessary, repeat the cleaning steps until all surfaces are visibly clean. 7. Allow the device to dry completely before reconnecting it to a power source. 8. Inspect the device and all circuit parts (filter, tube, and mask) for damage, such as cracks, tears, or broken pieces. Replace any damaged parts. Home cleaning: humidifier water tank (lid, water tank base, and water tank seal) Clean the humidifier water tank before first use. Hand wash daily.
Home cleaning: tubing Hand wash the tubing, mask adapter (if included), and connectors (if included) before first use and weekly. Discard and replace the tubing every 6 months. 1. Disconnect the flexible tubing from the device. 2. Gently wash the tubing, including any adapters or connectors, in a solution of warm water and a mild liquid dish soap solution to adequately remove adhering substances from the tube, adapters, and connectors.
Service The device does not require routine servicing. 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. Contact your home care provider. 8.
• • • • • IEC 62366 Application of Usability Engineering in Medical Devices IEC 62304 Medical Device Software – Software Life-cycle Processes ISO 80601-2-70 Sleep Apnea Breathing Therapy Equipment ISO 80601-2-74 Respiratory Humidifying Equipment EN 60601-1-2 Electromagnetic Compatibility 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 Proo
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 • • • • • • • - 44 - 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.
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. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
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 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.
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1143533 R00 HM 04/06/2020 EN-DOM
