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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.

mmuniTy

EsT

iEC 60601 T

EsT

EvEl

omplianCE

EvEl

lECTromagnETiC

nvironmEnT

uidanCE

Electrostatic Discharge

(ESD)

IEC 61000-4-2

±8 kV contact

±2 kV, ±4 kV, ±8 kV, &

±15 kV air discharges

±8 kV contact

±2 kV, ±4 kV, ±8 kV, &

±15 kV air discharges

Floors should be wood,

concrete or ceramic

tile. If floors are

covered with synthetic

material, the relative

humidity should be at

least 35%.

Electrical fast Transient/

burst

IEC 61000-4-4

±2 kV for power supply

lines, 100 kHz repetition

rate

±2 kV for power supply

lines, 100 kHz repetition

rate

Mains power quality

should be that of

a typical home or

hospital environment.

±1 kV for input-output

lines; 100 kHz repetition

rate

N/A- Device does not

have user I/O lines that

are longer than 3m in

length.

Surge

IEC 61000-4-5

±1 kV differential mode

±2 kV common mode

±1 kV differential 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.

Содержание DreamStation 2

Страница 1: ...DreamStation 2 CPAP Advanced Auto CPAP Advanced User manual ...

Страница 3: ...lacing the air filters 20 Connecting the breathing circuit 22 Starting the device 24 Performance check 25 Bluetooth wireless technology 25 Pairing your therapy device to your Bluetooth enabled mobile device 25 Therapy On display 26 Therapy Off display 30 Navigating the settings screens 32 Settings screens 33 Modem call 35 4 Pop up messages and troubleshooting 37 Pop up messages 37 Status pop up me...

Страница 4: ...1 Environmental 51 Physical 51 Service life 51 Standards compliance 52 IEC 60601 1 classification 52 Electrical 52 Water capacity 52 Heater plate 53 Humidity 53 Declared dual number noise emissions values in accordance with ISO 4871 53 Pressure accuracy 53 Maximum flow rate typical 54 ISO 80601 2 70 Pneumatic Diagram 54 Wireless notices 55 Radio Specifications 56 Intake Port Filters 57 Heated Tubi...

Страница 5: ...ive risks and benefits of using this equipment the clinician should understand that this device can deliver pressures up to 20 cmH2 O In the event of certain fault conditions a maximum pressure of 40 cmH2 O is possible Studies have shown that the following pre existing conditions may contraindicate the use of CPAP therapy for some patients Bullous Lung Disease Pathologically Low Blood Pressure Byp...

Страница 6: ...ow bacteria filter should be installed in line between the device and the circuit tubing to prevent contamination Humidification can increase the resistance of the bacteria filter and the operator must monitor the bacteria filter frequently for increased resistance and blockage to ensure the delivery of the therapeutic pressure Improperly functioning device If you notice any unexplained changes in...

Страница 7: ...afety entrainment valve An exhalation port is required Do not block the exhalation port This can reduce airflow and result in rebreathing of exhaled air At low expiratory pressures the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing some rebreathing may occur Do not pull or stretch the tubing This could result in circuit leaks Do not cover the tubing wit...

Страница 8: ... 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 Failure to use the pressure valve could result in a fire haz...

Страница 9: ... between a wireless phone and a pacemaker to avoid potential interference with the pacemaker The DreamStation 2 on board Bluetooth communication should be considered a wireless phone in this regard Maintenance Never operate the device if any parts are damaged or if it is not working properly Replace damaged parts before continuing use Periodically inspect electrical cords cables tubing and accesso...

Страница 10: ...specifications section later in this manual Filters A properly installed undamaged Philips Respironics reusable pollen filter is required for proper operation Dirty inlet filters may cause high operating temperatures that may affect device performance Regularly examine the inlet filters as needed for integrity and cleanliness Never install a wet filter into the device You must ensure sufficient dr...

Страница 11: ...device humidifier or onto your furniture Damage to the humidifier or therapy device may occur Use only room temperature distilled water in the humidifier water tank Do not put any chemicals or additives into the water Possible airway irritation or damage to the humidifier water tank may result If using the integrated humidifier do not start therapy without the humidifier water tank installed Do no...

Страница 12: ...tion device Caution U S federal law restricts this device to sale by or on the order of a physician DC power Direct current For indoor use only Equipment is designed primarily for indoor use IP22 Drip proof equipment MR unsafe Do not use device in a Magnetic Resonance MR environment Approved for airline use Bluetooth symbol Indicates the device has Bluetooth capabilities Maximum fill line Unique D...

Страница 13: ...ents Your system may include the following items Device Carrying case Flexible Tubing Humidifier water tank SD Card 6 ft 1 83 m power cord User manual Reusable filter Power supply Quick start guide Disposable ultra fine filter optional How to contact Philips Respironics Should you experience trouble with this equipment or require assistance setting up using or maintaining the device or accessories...

Страница 14: ...ort during therapy This humidification level is controlled through the output of the heated humidifier as well as the temperature of the optional heated tubing Use of the integrated humidifier with the heated tubing allows for a comfortable level of humidity to be maintained at the mask Several accessories are also available for use with your device Contact your home care provider to purchase any ...

Страница 15: ...ops 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 10 Humidifier air inlet outlet seal Provides a seal between the device and the humidifier water tank 5 Humidifier water tank Removable water tank that holds the water for humidification shown installed 11 Heater plate Warms the water in...

Страница 16: ... 12 Humidifier water tank 4 7 4 5 6 6 3 1 2 8 ...

Страница 17: ...s 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 The fill lines also appear on the sides of the water tank base 8 Water tank seal Provides a seal between the water tank lid and base Removable for ease of cleaning 9 Grip indent not shown Grip indent located on...

Страница 18: ... not place the device directly onto carpet fabric or other flammable materials Do not place the device in or on any container that can collect or hold water Supplying AC power to the device Warning Periodically inspect electrical cords and cables for damage or signs of wear Discontinue use and replace if damaged Caution Do not use extension cords with this device Complete the following steps to op...

Страница 19: ... 15 1 OR 2 3 ...

Страница 20: ...pproximately 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 pan Cautions Do not attempt to fill the humidifier water tank while it is still attached to the device Use only room temperature distilled water in the tank Do not put any chemicals or additives into the water Possible airway irritatio...

Страница 21: ...fier 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 ...

Страница 22: ...our 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 ...

Страница 23: ...Reattach the lid Place the hooks on the lid 1 over the small tabs on the water tank base 2 1 1 2 2 3 Press down 3 until the lid snaps securely over the lid front tab 4 on the front of the water tank base 3 4 ...

Страница 24: ...r 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 The ultra fine filter is recommended for people who are sensitive to tobacco smoke or other small particles The grey reusable filter is supplied with the device A disposable blue ultra fin...

Страница 25: ... the filter out of the device 3 If applicable place a dry grey reusable pollen filter on top of a new optional blue disposable ultra fine filter align the arrows on both filters and firmly snap them together 4 Place the filter into the therapy device 5 Reinstall the humidifier water tank ...

Страница 26: ...it leaks Inspect the tubing for damage or wear Discard and replace the tubing as necessary If you are using a full face mask a mask covering both your mouth and your nose the mask must be equipped with a safety entrainment valve If the device is used by multiple persons such as rental devices a low resistance main flow bacteria filter should be installed in line between the device and the circuit ...

Страница 27: ...ou are using the optional 12 mm heated tubing or 12 mm performance tubing connect the provided mask adapter to the mask connection end of the tubing The 12mm performance tubing also requires a device adapter When connecting the adapter to the CPAP the clips should be aligned to the sides with the slight bump facing straight down 3 Connect the tubing to the mask For proper placement and positioning...

Страница 28: ...rmal and acceptable Correct large amount of mask leaks or eye irritation by adjusting your mask headgear Note If you are using the device in a bed with a headboard try placing the tubing over the headboard This may reduce tension on the mask 3 Press the Therapy button on top of the device to turn on airflow and begin therapy The Therapy button ring will illuminate blue Note If your home care provi...

Страница 29: ...uide you through these instructions Note After initiating pairing in DreamMapper you will have 30 seconds to complete the setup After this time it will be cancelled automatically Follow the steps below to manually pair to your mobile phone or tablet 1 With your therapy device powered up initiate Bluetooth Setup from the DreamMapper mobile app Note From DreamMapper you may need to select from a lis...

Страница 30: ...n with touch capability 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 1 2 3 5 6 4 7 Symbol Feature Description 1 cmH2O Therapy pressure Displays the prescription pressure setting If RAMP PLUS is running the current delivered pressure is displayed ...

Страница 31: ...icon A settings screen displays your current setting Continue to tap the humidification icon until the desired setting is displayed The available settings are Off or 1 5 with 1 as the lowest humidity and 5 as the highest humidity Once humidification is set the device will return to the therapy screen after a few seconds and automatically activate the new setting for current and future therapy sett...

Страница 32: ...urn to the therapy screen after a few seconds and automatically activate the new setting for current and future therapy settings 4 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...

Страница 33: ... a change to the RAMP PLUS pressure or restart RAMP PLUS Note RAMP PLUS pressure and time can also be adjusted in the Settings Menu on your main screen if enabled by your home care provider Note The device goes dark after 60 seconds of inactivity To wake up the device tap anywhere on the display This will simultaneously reactivate your RAMP PLUS pressure if set or it will take you to your prescrib...

Страница 34: ... modem available except when in Airplane Mode Not shown Bluetooth Displays when the device has Bluetooth available When the symbol is grey it indicates that Bluetooth is available If the device is connected to a Bluetooth client phone tablet etc it will appear white This symbol does not appear when Airplane Mode is enabled Not shown Airplane mode Displays when Airplane Mode is enabled It will repl...

Страница 35: ...reaching your goal will be displayed through a pop up screen congratulating you Additionally a display of Complete will appear on the Last Session screen AHI If enabled by your provider this feature displays the nightly Apnea Hypopnea index AHI value for the most recent one day time frame Mask fit This screen displays how your mask fit during the most recent one day time frame A display of Good fi...

Страница 36: ...ed appear in blue Note If you see a series of dots on a setting it indicates that there is more than one screen for that setting 3 Tap the setting you want to view or change 4 Tap the screen to change or select the setting The display returns to the previous menu screen and the setting is saved Note If you do not change a setting tap Back on the top left of the screen to exit back to the Last Sess...

Страница 37: ...ice detects an event and identifies the need to increase your pressure When RAMP PLUS has concluded your prescribed therapy pressure will resume Note RAMP PLUS pressure can also be adjusted on the display screen during therapy Humidity You can change the humidification level setting from 0 to 5 This symbol only displays when humidification is enabled Heated tube temperature You can change this set...

Страница 38: ...nd a status code See the Modem Call section later in this manual for a description of the codes View reports If enabled by your provider tapping View Reports will allow you to view the past 1 7 30 90 180 or 365 days of therapy data The remaining items in this table are accessed through View Reports Report range Select the desired time period for the report 1 7 30 90 180 or 365 days Days used The n...

Страница 39: ...cessful or fails a message will be displayed on the device settings Modem call screen indicating the status number The status numbers are explained in the following table If an error code is displayed contact your home care provider They should check the Philips Respironics proprietary compliance software for additional information Number Description 0 0 0 1 0 2 Connection is in progress 0 3 Conne...

Страница 40: ... 3 0 3 1 3 2 Software configuration error If problem persists contact your home care provider The provider should check the Philips Respironics proprietary compliance software for additional information 4 0 4 1 4 2 4 3 Invalid Device Configuration Error Modem Service Required ...

Страница 41: ...n or replace filter as needed Blockage at device inlet Alert Low leak Ensure mask and tube are connected properly without any obstruction Blockage at tube or mask Check tube is not crushed or folded such that air flow is restricted Alert Contact support There may be a problem with your heated tube Therapy will run without heating the tube Heated tube may be overheated or damaged Turn off device De...

Страница 42: ...r If the alert continues to occur contact your home care provider Notification Notification The attached power supply is operating from a battery and does not support humidification Disconnect the battery pack and use a compatible power supply or use the device without humidification Check Power light blinks continuously Indicates an incompatible power supply is attached Switch to a Philips provid...

Страница 43: ...r the next session Status pop up messages Following the pop up message required actions or tap Dismiss to clear the message Screen Text Description Bluetooth See the Connectivity section later in this manual for Bluetooth information SD Card Activity Do not remove SD card SD card read write underway Update Your prescription has been updated A prescription update was successful Update A prescriptio...

Страница 44: ...herapy hours not met Your pulse oximetry recording was unsuccessful Minimum therapy hours not met Your pulse oximetry recording was unsuccessful Reminder pop up messages Reminder messages are messages from your home care provider reminding you of routine actions such as changing the device filters mask replacement or upcoming appointments The pop up will automatically time out or you can click Dis...

Страница 45: ...recharged or replaced If the problem persists check the DC cord s fuse following the instructions supplied with your DC cord The fuse may need to be replaced If the problem still occurs contact your home care provider The airflow does not turn on There may be a problem with the blower Make sure the device is powered correctly Press the Therapy button on top of the device to start airflow If the ai...

Страница 46: ...a full humidifier water tank should last for a typical sleep session if the humidifier tank is filled to the maximum fill line at the beginning of the sleep session However many factors impact water consumption including your humidifier or heated tube settings the level of mask leak and the duration of your sleep session Make sure that the humidifier water tank is filled to the maximum fill line a...

Страница 47: ... and stores that data along with the time stamp The data from the pulse oximeter is checked for validity and thrown away if not valid This data is not displayed locally but is logged and after a minimum of 4 hours of data is collected it is sent to the remote server If the CPAP is not able to get 4 hours of good data it alerts the patient and the patient will need to use it again the next night Th...

Страница 48: ...ard 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 Your home care provider may ask you to periodically remove the SD card and send it to them for evaluation Updating software using an SD card You can update the device software using an SD card The software update must be done when the therapy is off 1...

Страница 49: ...Follow the setup instructions provided with your pulse oximeter and finger sensor 2 Attach the finger sensor to your forefinger 3 Press the Therapy button on your device to begin therapy 4 Once the device detects a good connection with the pulse oximeter both the Bluetooth symbol and SpO2 will display on the top of the display screen Note It may take up to 30 seconds for the device to recognize th...

Страница 50: ...e presence of nitrous oxide If supplemental oxygen is added at the exit of the flow generator or humidifier 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 prevent the backflow of oxygen from the patient circuit into the device when the unit is off Failure to use the pressure valve could result i...

Страница 51: ...r system may cause damage to the device Refer to the instructions supplied with the DC power cord and adapter cable for information on how to operate the device using DC power Carrying case and airline travel 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...

Страница 52: ...e cloth into the areas around the therapy button humidifier air inlet outlet seal and any other areas where soil may be difficult to remove Ensure that you remove all visible soil 5 Use a lint free cloth dampened not dripping with clean water to remove all detergent residue 6 Inspect the device for cleanliness If necessary repeat the cleaning steps until all surfaces are visibly clean 7 Allow the ...

Страница 53: ... 4 Fully immerse and rinse each item separately with potable water for one minute and agitate vigorously 5 Allow all parts to air dry 6 Inspect the humidifier water tank for damage If any parts show signs of wear or damage contact your home care provider for a replacement 7 Re install the water tank seal To install insert the seal into the back of the tank base and then press the seal down until i...

Страница 54: ...f necessary Caring for the filters Notes Only Philips supplied filters should be used as replacement filters Replace the blue disposable ultra fine filter if it is damaged or has accumulated debris Under normal usage you should rinse the grey reusable filter at least once every two weeks and replace it with a new one every six months The disposable ultra fine filter should be replaced after 30 nig...

Страница 55: ... 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 29 lbs Service life The expected service life of the DreamSta...

Страница 56: ... 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 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 ...

Страница 57: ... Sound Power Level Uncertainty 15 and 22 mm tubing type 27 dB A 2 dB A 35 dB A 2 dB A 12 mm tubing type 27 dB A 2 dB A 35 dB A 2 dB A Pressure accuracy Pressure Increments 4 20 cmH2 O in 0 5 cmH2 O increments Maximum static and dynamic pressure accuracy according to ISO 80601 2 70 2015 Tube Type Static Dynamic 4 to 20 cmH2 O 15 and 22 mm tubing type 0 5 cmH2 O 1 0 cmH2 O 12 mm tubing type 1 0 cmH2...

Страница 58: ...ction port l min 120 117 108 101 92 15 mm tubing type heated or non heated Average flow at the patient connection port l min 121 135 125 116 107 22 mm tubing type Average flow at the patient connection port l min 122 141 131 122 112 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 ...

Страница 59: ...ation 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 These limits are designed to provide reasonable protect...

Страница 60: ...10 2155 MHz Receive Band 5 824 849 MHz Transmit 869 894 MHz Receive Band 12 699 716 MHz Transmit 729 746 MHz Receive Band 13 746 756 MHz Receive 777 787 MHz Transmit 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 Bandwidth 1 MHz ...

Страница 61: ... out 41 C 106 F Material Flexible plastic and electrical components 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...

Страница 62: ...ted discontinue use and contact your home care provider Guidance and Manufacturer s Declaration Electromagnetic Emissions This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The device uses RF energy o...

Страница 63: ...ncrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 35 Electrical fast Transient burst IEC 61000 4 4 2 kV for power supply lines 100 kHz repetition rate 2 kV for power supply lines 100 kHz repetition rate Mains power quality should be that of a typical home or hospital environment 1 kV for input output lines 100 kHz repetition rate N A Devi...

Страница 64: ...in UT for 1 cycle 70 UT 30 dip in UT for 0 5 seconds 5 UT 95 dip in UT for 5 seconds Mains power quality should be that of a typical home or hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3...

Страница 65: ...Bands between 150 kHz and 80 MHz 10 V m 80 MHz to 2 7 GHz Telecommunication frequencies as specified in clause 8 10 of IEC 60601 1 2 2014 450 810 870 930 1720 1845 1970 and 2450 MHz at 28 V m 385 MHz at 27 V m 710 745 780 5240 5500 and 5785 MHz at 9 V m 3 Vrms 150 kHz to 80 MHz 6 Vrms Amateur Radio ISM Bands between 150 kHz and 80 MHz 10 V m 28 V m 27 V m 9 V m Portable and mobile RF communication...

Страница 66: ...ersons caused by accident misuse abuse Acts of God water ingress repair or alteration by anyone other than Philips Respironics or its authorized service center failure to operate in accordance with the terms of the operating manual and instructions lack of reasonable care the discontinuance of a network e g 2G 3G etc by a carrier e g ATT Verizon etc or other defects not related to material or work...

Страница 67: ...BE LIABLE FOR ANY ECONOMIC LOSS LOSS OF PROFITS OVERHEAD OR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES Repair replacement or return of purchase price by Philips Respironics is the original purchaser s sole and exclusive remedy under this warranty This warranty gives you specific legal rights and you may also have other rights that vary from state to state Some states do not allow the exclusion or...

Страница 68: ...1143581 R02 ZL 01 27 2021 EN DOM 1143581 ...

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