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10. Additional Notes

Immunity Test

IEC 60601 Test

Level

Compliance Level

Electromagnetic

Environment - Guidance

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to 80 MHz

6 Vrms
Amateur Radio
& ISM Bands
between 150 kHz
and 80 MHz

10 V/m
80 MHz to 2.7 GHz

Special
Telecommunication
Bands between
300 MHz and 5.6
GHz

3 Vrms
150 kHz to 80
MHz

6 Vrms
Amateur Radio
& ISM Bands
between 150 kHz
and 80 MHz

10 V/m

Up to 28 V/m

Portable and mobile RF
communications equipment
should be used no closer
to any part of the device,
including cables, than
the recommended 30 cm
separation distance.

Interference may occur in
the vicinity of equipment
marked with the following
symbol:

Содержание DreamStation Go

Страница 1: ...Auto CPAP CPAP User manual DreamStation Go ...

Страница 2: ...on Settings 15 Ramp Feature 15 Therapy Off Menu Navigation Settings 16 My Info 16 My Comfort 17 My Device 18 My Support 19 Check Mask Fit 20 Pairing Therapy Device to Bluetooth enabled Mobile Device 21 Device Pop Up Messages 22 4 Tubing 25 Tubing Types 25 Connecting the Tubing to Your Device 25 Changing Your Tube Type 26 Cleaning the Tubing 27 Tubing Device Pop Up Messages 27 5 Filter 28 Filter Ty...

Страница 3: ...e Battery Pack 37 8 Care and Maintenance 38 Caring for the Therapy Device or Battery Pack 38 Caring for the Reusable Filter 38 9 Troubleshooting 40 Tips and Tricks 40 Contacting Customer Service 42 10 Additional Notes 43 Traveling with the System 43 Airline Travel 43 Altitude Compensation 43 Adding Supplemental Oxygen 43 Service 43 Additional Notices 44 Specifications 45 Disposal 48 EMC Informatio...

Страница 4: ...al 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 The operator should read and understand this entire manual before using the device Operating and storage temperatures Do not use this device if the room temperature is warmer than 95 F 35 C because the temperature of the airflow may exc...

Страница 5: ...using a full face mask a mask covering both your mouth and your nose the mask must be equipped with a safety entrainment valve Do not pull or stretch the tubing This could result in circuit leaks Inspect the tubing for damage or wear Discard and replace the tubing as necessary Improperly functioning device If you notice any unexplained changes in the performance of the device if it is making unusu...

Страница 6: ... the device when the unit is off Failure to use the pressure valve could result in a fire hazard 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 anesthetic mixture in combination with oxygen or air in the presence of nitrous oxide or in an oxygen enriched environment Do not use the device ne...

Страница 7: ... monitor the breathing system filter frequently for increased resistance and blockage to ensure the delivery of the therapeutic pressure General Contact your health care professional if symptoms of sleep apnea recur Cautions A caution indicates the possibility of damage to the device US Federal Caution U S federal law restricts this device to sale by or on the order of a physician EMC Medical elec...

Страница 8: ...ired for proper operation Clogged inlet filters may cause high operating temperatures that may affect device performance Regularly examine the inlet filters as needed for integrity and to check for accumulated debris Never install a wet filter into the device You must ensure sufficient drying time for the rinsed filter Make sure the air inlet holes on the side of the device are not blocked by bedd...

Страница 9: ...of the cribriform plate prior history of head trauma and or pneumocephalus Chest 1989 96 1425 1426 The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear infection Not for use with patients whose upper airways are bypassed Contact your health care professional if you have any questions concerning your therapy Safety Symbols Glos...

Страница 10: ...ution U S federal law restricts this device to sale by or on the order of a physician Electrostatic sensitive devices ESD warning symbol Attention Observe precautions for handling electrostatic sensitive devices IEC 60878 IEC 60417 5134 Serial connection Identifies a connector for a serial data connection IEC 60878 IEC 60417 5850 Class II equipment Double Insulated To identify equipment meeting th...

Страница 11: ... ISO 15223 1 Serial number Identify the manufacturer s serial number for the medical device IEC 60878 ISO 7000 2498 Symbol 5 1 7 ISO 15223 1 Keep dry Indicates the medical device that needs to be protected from moisture IEC 60878 ISO 7000 0626 Symbol 5 3 4 ISO 15223 1 Fragile handle with care Indicates the medical device can be broken or damaged if not handled carefully IEC 60878 ISO 7000 0621 Sym...

Страница 12: ...afety signs Registered safety signs not currently FDA recognized EN 15986 2011 Symbols for medical devices containing phthalates not currently FDA recognized ISO 15223 1 2012 Medical devices Symbols to be used with medical devices labels General requirements IEC 60417 2002 DB Graphical symbols for use on equipment IEC TR 60878 2015 Graphical symbols for electrical equipment in medical practice ...

Страница 13: ...icroSD Card optional User Manual Disposable Fine Filter optional Reusable Filter Battery Pack optional 12 mm Micro flexible Tubing 12 Type 6 ft 1 83 m Power Cord Note If any of these items are missing contact your supplier Accessories The following accessories are available for your DreamStation Go system 6 ft 1 83 m Serial Communication Cable with ferrites 10 ft 3 04 m Power Cord Small Travel Kit...

Страница 14: ...ight Sensor Detects room light levels and adjusts brightness of the display screen 4 Air Outlet Port Connect the tubing here 5 Serial Connector Access the serial connector here 6 AC Power Inlet Connect the power cord here 7 Battery Pack Access This end cap slides off for access to the battery pack connection 8 microSD Card Access the microSD card here 9 Mobile Charging Port Access the USB charging...

Страница 15: ...sitioning the device make sure that the power cable is accessible because removing power is the only way to turn off the device Supplying AC Power to Your Device Complete the following steps to operate the device by plugging the AC power cord into an electrical outlet 1 Plug the power cord connector into the power inlet on the back of the device 2 Plug the pronged end of the AC power cord into an ...

Страница 16: ...leaks or eye irritation by adjusting your mask headgear See the instructions provided with your mask for more information or refer to the Check Mask Fit sec tion 5 Tap the therapy button again to turn off the therapy To turn off therapy when the display screen is off place and hold a finger on the display screen for three sec onds Alternatively tap anywhere on the display screen to wake up the dis...

Страница 17: ...wipe the touchscreen to change the setting 5 Tap the icon or tap the up arrow in the upper left corner of the display to save the setting and return to the previous menu option Notes The swipe icon on any screen indicates to swipe the display left or right to perform an action The tap icon on any screen indicates to press the display to perform an action Tapping the down arrow on the display when ...

Страница 18: ...scription setting is reached allowing you to fall asleep more comfortably If ramp is enabled on your device after you turn on the airflow tap the Ramp icon on the display You can use the ramp feature as often as you wish When you tap the Ramp icon the therapy screen will change to reflect the ramp in pressure and the numbers within the blue circle will reflect the gradual increase in pressure Your...

Страница 19: ...enu contains information that your supplier may direct you to read to them so they can better assist you over the phone My Info When you select My Info you will be able to view the following screens You cannot change settings in the My Info menu These screens are only for reference Your supplier may periodically ask you for this information If any of the below options are not visible your supplier...

Страница 20: ...the ramp starting pressure You can increase or decrease the ramp starting pressure in 0 5 cm H2 O increments Ramp time When you set the ramp time the device increases the pressure from the value set on the ramp screen to the therapy pressure setting over the length of time specified here Flex This allows you to adjust the level of air pressure relief that you feel when you exhale during therapy Yo...

Страница 21: ...will only display if they are available and enabled on your device If any of the below options are not visible your supplier did not enable those options Icon Type Description Therapy Ring This setting controls the therapy button LED light ring during therapy The LED light ring will remain on during therapy if you select Light On The LED light ring will fade with the display backlight if you selec...

Страница 22: ... version Performance Check 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 supplier Use Performance Check when directed to by your supplier At conclusion of the scan the screen displays a green checkmark if no issue is detected If device displays a red X plea...

Страница 23: ...eliver a test pressure while the screen counts down 40 seconds 4 After the test is complete the screen will either display a green checkmark or a red X The green checkmark indicates that there is an appropriate amount of leak The red X indicates that the leak may affect device performance however the device will remain functional and deliver therapy Note If you choose to try to improve your mask f...

Страница 24: ...ur mobile device 2 With your therapy device powered up and the blower off initiate Bluetooth Setup from the DreamMapper mobile app 3 The therapy device will appear as PR BT XXXX XXXX will be the last four digits of the serial number listed on the bottom of your therapy device or in My Support settings 4 Your mobile device will require you to confirm pairing via one of these two meth ods Enter a PI...

Страница 25: ...ree night summary of therapy n a Tap the display to acknowledge and clear the message Change Accepted Confirms acceptance of prescription change or device upgrade n a Tap the display to acknowledge and clear the message Pair 123456 Yes No Prompts to accept or decline pairing to a Bluetooth compatible device This device can be identified by the digits displayed n a Swipe the display to accept pairi...

Страница 26: ...y to acknowledge and clear the message Change Rejected A prescription or settings change was rejected Change missing or incorrect Contact your supplier Service Required Indicates an error which enters device into Safe State This allows power to remain on but airflow is disabled Device error Disconnect device from power Reattach power cord to restore power If the alert continues to occur contact yo...

Страница 27: ...orarily inaccessible due to data communication n a No action needed Software Upgrade Prompts to update the device for software changes n a Choose between Yes No when asked to upgrade the software If yes is selected the upgrade will be made Do not remove from power If you select no the message will be cleared ...

Страница 28: ...e a 15 identified on the tubing cuff as shown in the image above The 22 tubing type does not have any number or symbol on the tubing cuff as shown in the image above Connecting the Tubing to Your Device To connect the tubing to your device you will need the following Philips Respironics accessories Nasal or full face mask interface with built in exhalation or a nasal or full face mask interface wi...

Страница 29: ...filter If required connect a bacteria filter to the device air outlet and then connect the flexible tubing to the outlet of the bacteria filter When using the bacteria filter the device performance may be affected However the device will remain functional and deliver therapy Changing Your Tube Type Change your tube type by navigating to My Comfort Tube Type Swipe left or right to switch between tu...

Страница 30: ...ir dry Inspect the tubing for damage or wear Discard and replace as necessary Tubing Device Pop Up Messages Device pop ups are messages that show up on the user interface screen Condition Icon Description Possible Cause Action Low leak Check mask and tube Blocked airway Blockage at tube or mask Check tube is not crushed or folded such that airflow is restricted Check mask is attached properly and ...

Страница 31: ...re complete filtration of fine particles The disposable fine filter is recommended for people who are sensitive to tobacco smoke or other small particles The disposable fine filter is sold separately The disposable fine filter contains Philips Respironics branding in the media shown in the image above DO NOT rinse the disposable fine filter When using the disposable fine filter the device performa...

Страница 32: ...ice does not detect the performance of the filters nor does it recognize when a filter has been replaced Follow these steps to install replace a filter into your device 1 If replacing an existing filter pull out the old filter assembly 2 Insert a dry reusable filter or a new disposable fine filter into the filter access on the device Filter Device Pop Up Messages Device pop ups are messages that s...

Страница 33: ...t your supplier for additional information on the available accessories When using optional accessories always follow any instructions enclosed with the accessories Using the USB Port and the Micro USB Port The DreamStation Go device comes with a USB port and a micro USB port The USB port may be used to charge your mobile devices The micro USB port may be used by your supplier to extract therapy d...

Страница 34: ... to periodically remove the microSD card and send it to them for evaluation You will use the filter to remove the microSD card Turn off therapy and follow these steps to remove the microSD card 1 Remove the filter from the device Refer to the Installing or Replacing the Filter section in Chapter 5 of this manual 2 Use the end of the filter to push in on the microSD card This will push the microSD ...

Страница 35: ...vice and not reinserted before the start of the current therapy session microSD card was not reinserted into device Reinsert microSD card or click to clear alert microSD card error Remove and reinsert microSD card error detected Device cannot read the microSD card A problem may exist with the microSD card or it was ejected during a writing activity or it was inserted incorrectly Remove microSD car...

Страница 36: ...y pack LED Display The battery pack uses one green LED light to indicate the battery pack charge status when the battery pack is charging while not connected to the therapy device standalone charging The LED will be in one of the three modes Steady when the battery pack is fully charged Blinking when charging Off when connected to the therapy device 1 2 3 7 Battery Pack ...

Страница 37: ...settings mask leak and environmental conditions a fully charged battery pack typically lasts 8 hours For further information speak with your supplier Battery Pack Charge Indicator When Therapy Is Not Active The display touchscreen will show the battery charge percentage when the battery is connected to the therapy device but not in use shown below This screen will appear in your main menu selectio...

Страница 38: ...egularly Retain your packaging in case you ever need to return your battery pack to Philips Respironics Before using the battery pack for the first time you must plug it in until it is fully charged This may take up to 5 hours Attaching the Battery Pack to the Device After charging your battery pack is ready to use It can either be disconnected from the AC outlet and used as an external battery pa...

Страница 39: ...dalone mode follow these steps 1 Make sure the battery pack is fully charged Disconnect the power cord from the AC outlet and disconnect the power cord from the therapy device It can now be used with your therapy device as an external battery pack 2 Remove the battery pack end cap on the therapy device 3 Slide the battery pack onto the device where the end cap was Make sure the bat tery pack latch...

Страница 40: ...k is used in standalone mode and the therapy device enters standby mode the therapy device automatically shuts down the battery pack to preserve battery charge Disconnecting the Battery Pack 1 Disconnect the power cord 2 Hold the battery pack push button down for 5 seconds or the battery pack will shut off within 30 minutes when not in use 3 The power down pop up message will appear and the therap...

Страница 41: ...nse the reusable filter at least once every two weeks and replace it with a new one every six months The disposable fine filter should be replaced after 30 nights of use or sooner if it appears clogged DO NOT rinse the fine filter Follow these steps to rinse the reusable filter 1 If the device is operating stop the airflow Disconnect the device from the power source 2 Remove the filter from the de...

Страница 42: ...39 8 Care and Maintenance Notes Only Philips Respironics supplied filters should be used as replacement filters Replace the disposable fine filter if it is damaged or has accumulated debris ...

Страница 43: ...et or the device is unplugged If you are using AC power Check the outlet and verify that the device is properly plugged in and that there is power available at the outlet Make sure the AC power cord is connected correctly to the device s power inlet If you are using the battery pack Make sure your battery pack is securely connected to your device If the battery pack has been exposed to extreme tem...

Страница 44: ...k the current pressure setting on the therapy screen If the therapy pressure is set to the minimum setting 4 0 cm H2 O or the ramp starting pressure is the same as the therapy pressure the ramp feature will not work Make sure that the ramp time setting is 0 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 re...

Страница 45: ... is rapidly flashing Your battery pack may have been damaged If the battery pack has been exposed to extreme temperatures allow the battery pack to cool or warm to room temperature Unplug the battery pack from the power cord then plug the power cord back into the battery pack If the LED continues to rapidly flash replace your battery pack Service Required shown on display A device error has occurr...

Страница 46: ...ible with the power outlets of the country to which you are traveling Contact your supplier for additional information Airline Travel The device is suitable for use on airlines when the device is operating from an AC power source or battery pack Altitude Compensation This device automatically compensates for altitude up to 7 500 feet No manual adjustment is necessary Adding Supplemental Oxygen Oxy...

Страница 47: ...ent 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 This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interfe...

Страница 48: ...k 122 x 150 8 x 58 8 mm 4 803 L x 5 937 W x 2 315 H Weight Device Approximately 854 g 1 88 lb Battery Pack Approximately 696 g 1 53 lb Service life The expected service life of the DreamStation Go therapy device is 5 years The expected service life of the battery pack is 3 years Standards compliance This device is designed to conform to the following standards IEC 60601 1 General Requirements for ...

Страница 49: ...m diameter and greater Second characteristic numeral 2 Protection against ingress of water with harmful effects dripping 15 tilted Explanation Protected against vertically falling water drops when enclosure tilted up to 15 Mode of Operation Continuous Electrical AC Power Consumption 100 240 VAC 50 60 Hz 2 0 1 0 A Fuses There are no user replaceable fuses USB Charging Port Output 5 VDC 7 5 W 1 5 A ...

Страница 50: ...Uncertainty K 12 mm tubing type 30 7 dB A 2 dB A 38 7 dB A 2 dB A 15 mm tubing type 30 3 dB A 2 dB A 38 3 dB A 2 dB A 22 mm tubing type 30 3 dB A 2 dB A 38 3 dB A 2 dB A Note Values determined according to noise test code given in ISO 80601 2 70 2015 using the basic standards ISO 3744 and ISO 4871 Pressure Accuracy Pressure Increments 4 0 20 0 cmH2 O in 0 5 cmH2 O increments Maximum static pressur...

Страница 51: ...formation 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 Go 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 t...

Страница 52: ...dance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Flo...

Страница 53: ...ty 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 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location ...

Страница 54: ...80 MHz 10 V m 80 MHz to 2 7 GHz Special Telecommunication Bands between 300 MHz and 5 6 GHz 3 Vrms 150 kHz to 80 MHz 6 Vrms Amateur Radio ISM Bands between 150 kHz and 80 MHz 10 V m Up to 28 V m Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended 30 cm separation distance Interference may occur in the vicinity of ...

Страница 55: ...distributors of Respironics Inc products and Respironics Inc reserves the right to charge dealers for warranty service of failed product not purchased directly from Respironics Inc or authorized distributors Respironics Inc disclaims all liability for economic loss loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of this product Some states do no...

Страница 56: ...1128239 1128239 R02 AD 2 28 2017 EN DOM ...

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