Philips DreamStation BiPAP autoSV, User Manual

Page 1: ... HM 06 13 2017 EN INTL Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 USA Respironics Deutschland GmbH Co KG Gewerbestrasse 17 82211 Herrsching Germany User manual DreamStation BiPAP autoSV REF 1128728 ...

Page 2: ... Koninklijke Philips N V 2017 All rights reserved ...

Page 3: ... 3 You are now in Provider mode You can choose between the following Provider mode screens Therapy Alarms Comfort Device Info Patient Mode Navigating the Provider mode screens The User Interface UI on this device allows you to adjust the device settings and view information about therapy The UI is composed of the display screen and the control dial Rotate the control dial in either direction to sc...

Page 4: ...Maximum EPAP setting This setting will be the maximum level of pressure applied during the expiratory breath phase You may adjust the setting from the minimum EPAP setting up to the lesser value of either maximum pressure or 20 cmH2 O PS Min This screen allows you to modify the Minimum Pressure Support setting This setting is the minimum difference that is permitted between IPAP and EPAP You may a...

Page 5: ...inute ventilation is less than or equal to the specified setting The default is 0 Comfort settings Choosing this screen will take you to a sub menu where you can adjust the humidification and pressure comfort settings These settings are described here Note Not all settings shown here will display on the device The displaywill vary based on therapy device model and device settings Icon Text Descrip...

Page 6: ...erapy for that mode If SmartRamp mode is not enabled then the standard linear pressure ramp mode is active Ramp Time This enables you to modify the Ramp time setting in 5 minute increments The range for this setting is 0 off to 45 minutes Ramp Start You can increase or decrease the ramp starting pressure in 0 5 cmH2 O increments You may adjust the setting from 4 cmH2 O to the EPAP min setting Flex...

Page 7: ...ou to select the appropriate Mask Type resistance setting also known as System One Resistance Control for your Philips Respironics mask This feature allows the device to adjust the level of pressure compensation to match your mask Refer to the packaging of your mask to identify the resistance setting for your mask Note It is important to use the appropriate Mask Type resistance setting to ensure p...

Page 8: ...ault patient reminders that are enabled in the therapy device from the factory Note This does not turn off additional reminders that you may have activated in Encore Encore messages must be cleared or modified in Encore Reset Data Use the Reset Data function to clear patient data from the therapy device as well as an SD card and modem if installed After you pres the control dial to execute Reset D...

Page 9: ...e these codes in EncoreAnywhere EncorePro or Encore Basic to populate the troubleshooting dashboard Updating software using the SD card You can update the device software using the SD card The software update must be done when the therapy is off 1 Insert an SD card with the new software version into the device A pop up screen appears asking Would you like to upgrade software 2 Turn the control dia...

Page 10: ...er guide DreamStation BiPAP autoSV 1128728 R10 HM 06 13 2017 EN INTL Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 USA Respironics Deutschland GmbH Co KG Gewerbestrasse 17 82211 Herrsching Germany ...

Page 11: ... features and optional humidification settings 19 2 8 Patient menu navigation 21 2 9 Connecting to Wi Fi if available 26 2 10 Bluetooth wireless technology 27 2 11 Check mask fit 29 2 12 Sleep progress 29 2 13 Altitude compensation 30 3 Alarms alerts and troubleshooting 31 3 1 Device alarms 31 3 2 Device alerts 31 3 3 Alarm and alert LED indicators 31 3 4 Alarm and alert audible indicators 32 3 5 ...

Page 12: ...ne travel 48 5 Care cleaning and disinfection 49 5 1 Caring for the filters 49 5 2 Home cleaning device and humidifier 50 5 3 Home cleaning tubing 50 5 4 Hospital and institution cleaning device and humidifier exterior 50 5 5 Hospital and institution disinfection device and humidifier exterior 51 5 6 Service 52 6 Specifications disposal and EMC 53 6 1 Specifications 53 6 2 Disposal 56 6 3 EMC info...

Page 13: ...mponents are optional accessories that may not be packaged with the device Device SD card User manual Flexible tubing Carrying case Reusable blue pollen filter Power cord Disposable light blue ultra fine filter optional Power supply Humidifier optional 1 2 Intended use The device is intended to provide mask applied non invasive ventilatory support to adult patients 30 kg for the primary treatment ...

Page 14: ...rescription changes before using the device The health care professional is responsible to ensure that the prescription settings are correct and compatible with the patient after using this feature Installing the wrong prescription for a particular patient may result in improper therapy lack of appropriate safety monitoring and injury to the patient Operating and storage temperatures Do not use th...

Page 15: ...e 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 Verify operation of the Patient Disconnect alarm with any changes in the patient circuit Improperly functioning ventilator If you notice any unexplained changes in the performance of the device if it is making unusual sounds if water is spilled into ...

Page 16: ...air in the presence of nitrous oxide or in an oxygen enriched environment Do not use the device near a source of toxic or harmful vapors 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 Explanation of the Warning When the device is not in operation and the oxygen ...

Page 17: ...he possibility of damage to the device Electrostatic Discharge ESD Do not use antistatic or conductive hoses or conductive patient tubing with the device Pins of connectors marked with the ESD warning symbol shall not be touched and connections shall not be made without special precautions Precautionary procedures include methods to prevent build up of electrostatic charge e g air conditioning hum...

Page 18: ... occur Only use a Philips Respironcis DC power cord and battery adapter cable Use of any other system may cause damage to 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 Tobacco use Tobacco smoke...

Page 19: ... Control Accuracy table in chapter 6 In the event of certain fault conditions a maximum pressure of 60 cmH2 O is possible Warning Physicians should assess individual patient risks before prescribing autoSV therapy for patients with chronic symptomatic heart failure NYHA II IV with left ventricular ejection fraction below 45 and moderate to severe predominant central sleep apnea The physician shoul...

Page 20: ...with RTCA DO 160G section 21 category M AC power Separate collection for electrical and electronic equipment per EC Directive 2012 19 EU DC power Bluetooth symbol IP22 Drip proof equipment This device contains an RF transmitter Caution consult accompanying documents Oximeter connection ESD warning symbol Serial connection Class II Double Insulated Avoid ultraviolet radiation Type BF applied part D...

Page 21: ...e comfortable The ramp function allows you to lower the pressure when trying to fall asleep The air pressure will gradually increase until the prescription pressure is reached Additionally the Flex comfort feature provides increased pressure relief during the expiratory phase of breathing Several accessories are also available for use with the device Contact your home care service provider to purc...

Page 22: ...stest rise time while a setting of 6 is the slowest Providers should adjust the rise time to find the most comfortable setting for the patient Rise time cannot be adjusted when Bi Flex is enabled 1 5 2 4 PRESSURE IPAP EPAP TIME Rise Time Digital Auto Trak Digital Auto Trak is an important ventilation feature due to its ability to recognize and compensate for unintentional leaks in the patient circ...

Page 23: ...rapy 4 Door SD card filter access This door lifts open for access to the SD card and filter area 5 LCD display screen This is the User Interface for the therapy device 6 Control dial Turn the dial to scroll between options on the screen Press the dial to choose an option and silence and acknowledge alarms 7 Door accessory access This door lifts open for access to the optional accessories 8 Humidif...

Page 24: ... or require assistance setting up using or maintaining the device or accessories please contact your home care service provider To contact Philips Respironics directly use the following contact details Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 1 724 387 4000 Deutschland Gewerbestrasse 17 82211 Herrsching Germany 49 8152 93060 ...

Page 25: ...fine particles The reusable blue 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 reusable blue filter is supplied with the device A disposable light blue ultra fine filter may also be included If your filter is not already installed when you receive your device you must...

Page 26: ...el 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 Note When positioning the device make sure that the power cable is accessible because removing power is the only way to turn off the device Cautions Make sure the filter area on the side of the device is not blocked by bedding curtains or other ite...

Page 27: ... into the power inlet on the side of the device 4 Verify that the plug at the side 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 Note If the Incorrect Power Supply icon appears on the screen please repeat step 4 Important To remove AC power disconnect the power supply cord from t...

Page 28: ... device such as the Whisper Swivel II Philips Respironics flexible tubing 1 83 m 6 ft Philips Respironics headgear for the mask To connect your breathing circuit to the device complete the following steps 1 Connect the flexible tubing to the air outlet on the back of the therapy device Line up the connector 1 at the top of the heated tube to the top of the air outlet port on the back of the device...

Page 29: ...ng a full face mask a mask covering both your mouth and your nose the mask must be equipped with a safety entrainment valve An exhalation port is required Do no block the exhalation port This can reduce airflow and result in rebreathing of exhaled air 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 ...

Page 30: ...ed You may resume therapy as needed 2 6 Navigating the device screens The User Interface UI on this device allows you to adjust the device settings and view information about your therapy The UI is composed of the display screen and the control dial Rotate the control dial in either direction to scroll through the menus on the display screen Press the control dial to open a menu To adjust a settin...

Page 31: ...re setting You can change this setting from 0 to 5 Only displays when optional heated tube is connected 3 Adjustable humidifier setting You can change this setting from 0 to 5 Only displays when humidifier is attached 4 Enabled features If enabled the following therapy features will display here Opti Start Humidifier I or E indicates IPAP or EPAP state Patient breath indication Note The Patient me...

Page 32: ...e humidifier setting 2 7 2 Ramp feature The device is equipped with an optional ramp feature that your home care service provider can enable or disable This feature reduces the air pressure when you are trying to fall asleep and then gradually increases ramps the pressure until your prescription setting is reached allowing you to fall asleep more comfortably If ramp is enabled on your device after...

Page 33: ...ter assist you over the phone My Setup This menu contains comfort settings that you can adjust as needed 2 8 1 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 home care provider may periodically ask you for this information Note Additional icons may appear if optional accessories...

Page 34: ...e for the most recent 1 day time frame as well as values for the last 7 days and 30 days If you observe a large increase in the percent of time in periodic breathing indicated her contact your home care provider for assistance This screen only displays if your home care provider has enabled it 90 Pressure 90 Pressure This screen displays the nightly value of 90 Pressure for the most recent 1 day t...

Page 35: ...sed when the sessions were greater than 4 hours and a check code number used by your home care service provider Upload Allows user to initiate a modem call when an optional cellular modem or Wi Fi accessory is installed Signal strength is indicated at the top right of this screen After the modem upload has finished the screen will either display a green check mark with the text Completed to indica...

Page 36: ... or disable this feature When your provider enables Flex a level will already be set for you on the device You can increase or decrease the setting from 1 to 3 The setting of 1 provides a small amount of pressure relief with higher numbers providing additional relief Note If a lock icon is displayed on this screen it indicates that your provider has locked this setting and you cannot change it Hum...

Page 37: ...eature allows you to check the fit of your mask prior to starting therapy This is done by measuring the amount of leak Wi Fi Wi Fi This feature allows you to setup or edit your Wi Fi connection It only displays when a Wi Fi modem is installed and turned on Modem This feature alows you to turn the modem off temporarily or turn it back on When the modem is turned off it will automatically turn on ag...

Page 38: ... within range of your device Press the control dial to select your network 3 If your network is secure a Passkey pop up screen appears Enter your network password and then select the green check mark Once your password is entered the Wi Fi accessory will connect to your network When the completed screen appears press the control dial to close the screen Note If a red X appears over the signal stre...

Page 39: ...h your therapy device powered up and the blower off initiate Bluetooth Setup from the DreamMapper mobile app 2 If you need to select from a list of available Bluetooth devices the therapy device will appear as PR BT XXXX XXXX will be the last four digits of the serial number listed on your therapy device 3 Your mobile device will require you to confirm pairing via one of these two methods Enter a ...

Page 40: ...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 This equipment generates uses and can radiate radio f...

Page 41: ...e green check mark indicates that the leak found allows for optimal performance of the device 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 fit you can stop therapy adjust the fit of your mask and rerun the Check Mask Fit Refer to the instructions that came with your mask ...

Page 42: ...30 Device setup DreamStation BiPAP autoSV User Manual 2 13 Altitude compensation This device automatically compensates for altitude up to 7 500 feet No manual adjustment is necessary ...

Page 43: ...alarm conditions Most alerts do not appear while therapy is being delivered The different types of alerts are Status Message appears on the screen Notification Message appears on the screen and Therapy button LED flashes Alert Message appears on the screen Therapy button LED flashes and audible sound beeps once while alert is displayed 3 3 Alarm and alert LED indicators 10 1 2 Red flashing alarm L...

Page 44: ...s repeated twice 3 beeps a pause and then 2 more beeps This indicator continues until the cause of the alarm is corrected or the audible alarm is silenced Medium priority When a medium priority alarm is active a series of beeps sounds in a 3 beep pattern This pattern repeats until the cause of the alarm is corrected or the audible alarm is silenced Alerts When an alert appears on screen a brief 1 ...

Page 45: ...ce over lower priority alarms 3 7 What to do when an alarm occurs Complete the following steps when an alarm occurs 1 Observe the patient and ensure that adequate ventilation and oxygenation if appropriate are available 2 Listen to the audible alarm and look at the alarm indicators and whether the LED is solid or flashing 3 Look at the display to check the alarm message that appears on screen and ...

Page 46: ...ontinue using your device High Operates This alarm occurs when the patient has not triggered a breath within the time specified in the apnea alarm setting The device continues to operate The alarm will automatically terminate when two consecutive patient breaths are detected that meet the apnea alarm time setting Press the control dial to silence the alarm Press the control dial again to acknowled...

Page 47: ...or service Device inoperative Shuts down Check tube is not crushed or folded such that air flow is restricted Check mask is attached properly and without any obstruction If the alarm continues contact your home care service provider for service Device inoperative Shuts down Remove your mask and remove power from the device Rinse or replace the reusable air filter or replace the disposable ultra fi...

Page 48: ...l to silence the alarm Press the control dial again to acknowledge and remove the alarm from the screen Remove your mask and remove power from the device Restore power If the alarm continues contact your home care service provider for service High Operates This may be caused by a malfunctioning device Press the control dial to silence the alarm Press the control dial again to acknowledge and remov...

Page 49: ...ead write underway No action needed Change Accepted Status Confirms acceptance of prescription change or device upgrade No action needed Oximetry Good Connection icon only Status Displays on the therapy screen when the blower is on and 3 seconds of good connection is detected Appears at the beginning of therapy This screen will not display again if the oximetry sensor is removed and reapplied unle...

Page 50: ...ed Notification or Alert Indicates SD card has been removed from therapy device and not reinserted before the start of the current therapy session Reinsert SD card or press the control dial to clear alert Oximetry Good Study icon only Notification After exiting therapy the therapy device will display the Good Oximetry pop up screen if the oximetry sensor maintained a good connection for at least 4...

Page 51: ...herapy device Turn off device and disconnect from power Detach the humidifier visually check that electrical contacts are clear then reconnect humidifier and power cord If alert continues contact your home care service provider Heated Tube Error Contact support if the problem persists Status Heated tube error only when heated tube is present Heated tube may be overheated or damaged Turn off device...

Page 52: ...ble power supply if needed Busy Status Displayed when the device is temporarily inaccessible due to data communication No action needed Three Night Summary n a Status Displays last 3 nights of hourly use Press control dial to acknowledge and clear the screen Otherwise message times out after 30 seconds Check Mask Fit n a Status Displayed when Check Mask Fit function is enabled from Patient Menu Th...

Page 53: ... they can determine if the problem is with the device or power supply If you are using DC power make sure your DC power cord and battery adaptor cable connections are secure Check your battery It may need 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 y...

Page 54: ...e 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 Make sure the device is away from direct sunlight and heating equipment If using the humidifier with the device check the humidifier settings and lower the setting if possible Make sure there ...

Page 55: ...owever many factors impact water consumption including the ambient temperature and humidity in your bedroom your humidifier or heated tube settings the level of mask leak and the duration of your sleep session First make sure that the water chamber is filled to the maximum fill line at the start of your sleep session Check that your mask is fitted properly and adjust as needed to reduce mask leak ...

Page 56: ...water in the humidifier basin could spill over the humidifier lid hinge and might damage your furniture Disconnect power from the device Remove the water chamber pour out any excess water until the water level is at or below the maximum fill line and set the chamber aside Separate the humidifier from the therapy device and pour out the spilled water Once the heater plate has cooled wipe the inside...

Page 57: ...DreamStation BiPAP autoSV device comes with an SD card inserted in the SD card slot on the side of the device The SD card records information for the home care provider Your home care provider may ask you to periodically remove the SD card and send it to them for evaluation 4 3 Cellular modem The DreamStation Cellular Modem is designed for use with select Philips Respironics therapy devices Once i...

Page 58: ...by Philips Respironics authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly damage Do not use any accessories detachable parts and materials not recommended by Philips Respironics Incompatible parts or accessories can result in degraded performance 4 6 Oximeter The DreamStation oximetry system when part of the DreamStation BiPAP auto...

Page 59: ...to be operated from a 12 VDC free standing battery Cautions Always ensure that the DC power cord securely fits into your therapy device prior to use Contact your home care provider or Philips Respironics to determine if you have the appropriate DC cord for your specific therapy device When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is runni...

Page 60: ... along with you to help security personnel understand the device 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 If traveling with the optional humidifier do not travel with water in the water tank If you are traveling to a country with a line voltage different than the one you are currently using a di...

Page 61: ...usable filter 1 If the device is operating stop the airflow Disconnect the device from the power source 2 Remove the filter s from the device Refer to the Installing and replacing the air filters section of this manual 3 Take the reusable filter to a sink turn it upside down and run warm tap water through the white middle portion of the filter to rinse away any debris 4 Shake the filter to remove ...

Page 62: ...inse thoroughly Air dry Inspect the tubing for damage or wear Discard and replace if necessary Note Refer to the DreamStation humidifier manual for the instructions on how to clean the heated tube 5 4 Hospital and institution cleaning device and humidifier exterior Warning To avoid electrical shock always unplug the power cord from the wall outlet before cleaning the device DO NOT immerse the devi...

Page 63: ...he product Review all applicable instructions for additional warnings and cautions If using the device and humidifier on multiple users the device and humidifier exterior should be disinfected between patient use as follows 1 Clean the device and humidifier as indicated in Hospital and institution cleaning device and humidifier exterior 2 Use one of the following to disinfect all exterior surfaces...

Page 64: ...than inspection for normal wear or damage and device cleaning Warning If you notice any unexplained changes in the performance of this device if it is making unusual or harsh sounds if it has been dropped or mishandled if water is spilled into the enclosure or if the enclosure is broken disconnect the power cord and discontinue use Contact your home care provider ...

Page 65: ...llateral standard General Requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601 1 11 Medical Electrical Equipment Part 1 11 General Requirements for Basic Safety and Essential Performance Collateral standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ISO 10...

Page 66: ...s 6 1 6 Electrical AC Power Consumption with 80W power supply Note Power supply is part of the medical electrical equipment 100 240 VAC 50 60 Hz 2 0 1 0 A DC Power Consumption 12 VDC 6 67 A Fuses There are no user replaceable fuses 6 1 7 Radio specifications Operating Frequency Range 2402 2480 MHz Maximum Output Power 10 dBm Modulation GFSK P 4 DQPSK 8DQPSK 6 1 8 Intake port filters Pollen Filter ...

Page 67: ...trol accuracy Parameter Range Accuracy IPAP 4 30 cmH2 O 2 5 cmH2 O EPAP 4 20 cmH2 O 2 5 cmH2 O CPAP 4 20 cmH2 O 2 5 cmH2 O Breath rate 4 to 30 BPM greater of 1 BPM or 10 of setting Inspiration time 0 5 to 3 seconds 10 of setting 0 1 second Pressure measured at the patient connection port with or without the integrated heated humidifer no patient flow 6 1 12 Pressure accuracy Pressure increments 4 ...

Page 68: ...is affected by locating it closer to another device simply separate the devices to remove the condition Pressure and Flow Accuracy If you suspect that the pressure and or flow rate accuracy is affected by EMC interference remove power and relocate the device to another area If performance continues to be affected discontinue use and contact your home care provider SpO2 and Pulse Rate Accuracy The ...

Page 69: ...Electrostatic Discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast Transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for supply mains 1 kV for input output lines Mains power quality sho...

Page 70: ...onducted 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 a...

Page 71: ...2 years from the date of purchase from an authorised Respironics dealer 3 If the Product is found to contain a defect of workmanship or materials or fails to perform in accordance with the Product specifications during the applicable warranty period Respironics will repair or replace at its option the defective material or part 4 The customer is responsible for returning the product to an authoris...

Page 72: ...60 Limited warranty DreamStation BiPAP autoSV User Manual ...