VPAP™ Auto - Sleep Restfully, Inc.
Contents
1. transient burst supply lines be that of a typical IEC 61000 4 4 commercial or hospital 1 kV for input Not Applicable environment output lines Surge 1 kV differential 1 kV differential Mains power quality should IEC 61000 4 5 mode mode be that of a typical commercial or hospital 2 kV common 2 kV common environment mode mode Voltage dips short lt 5 U lt 12V Mains power quality should interruptions and gt 95 dip in Ut gt 95 dip in 240V be that of a typical voltage variations on or 0 5 cycle for 0 5 cycle commercial or hospital power supply input environment lines 40 U 96 V If the user of the VPAP IEC 61000 4 11 60 dip in Ut 60 dip in 240V Auto device requires or 5 cycles for 5 cycles continued operation during power mains interruptions 70 U 168 V it is recommended that the 30 dip in Ut 30 dip in 240V VPAP Auto device be or 25 cycles for 25 cycles powered from an uninterruptible power lt 5 U lt 12V source gt 95 dip in Ut gt 95 dip in 240V or 5 sec for 5 sec Power frequency 3 A m 3 A m Power freguency magnetic 50 60 Hz magnetic field IEC 61000 4 8 fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ut is the AC mains voltage prior to application of the test level Continued next page Technical Specifications 35 36 Guidance and manufacturer s declaration electromagnetic immunity Th2. a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and and mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted heoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which he VPAP Auto device is used exceeds the applicable RF compliance level above the VPAP Auto device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the VPAP Auto device Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Recommended separation distances between portable and mobile RF communications equipment and the VPAP Auto series of devices The VPAP Auto device is intended for use in an environment in which radiated RF disturbances are controlled The customer or the user of the VPAP Auto device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the VPAP Auto device as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output 150 KHz to 80 MHz 80 M
3. G 1 Removing the Module To remove the Data Card module pull it off the back of the VPAP Auto G 2 Note To protect the data communications port always ensure there is a module attached to the back of the device Using the Data Card to Collect Data Please refer to the illustrations in section H of the illustration sheet If your clinician needs to review your treatment they will ask you to use the Data Card to copy data from your VPAP Auto and to return the card to them The Data Card will be provided in a convenient mailback envelope Data is copied onto the Data Card when it is inserted into the device The original data will remain stored on the device It takes up to 30 seconds to copy data onto the Data Card 1 Insert the Data Card e Switch on the VPAP Auto and wait until you see the standby RAMP or SETTLING screen e Hold the Data Card with the arrow facing up and insert it into the slot in the Data Card module H 1 e Push the card in smoothly until it stops moving H 2 and messages start appearing on the LCD 2 Copy data onto the Data Card Data copying starts automatically when the Data Card is inserted into the Data Card module The Card Inserted Please Wait message is displayed on the VPAP Auto LCD while data is being copied Copying takes up to 30 seconds The Copy Complete Remove Card message is displayed on the LCD when copying has finished e Remove the Data Card from the Data Card
4. Inspect the air filter every month to check if it is blocked by dirt or contains holes With normal use of an VPAP Auto the air filter needs to be replaced every six months or more often if your device is in a dusty environment WARNING gt Do not wash the air filter The air filter is not washable or reusable The air filter cover protects the device in the event of accidental liquid spillage onto the device Ensure the air filter and air filter cover are fitted at all times Servicing CAUTION Do not attempt to open the VPAP Auto case There are no user serviceable parts inside e Inspection and repair should only be performed by an authorized agent Under no circumstances should you attempt to service or repair the flow generator yourself This product VPAP Auto should be inspected by an authorized ResMed service center 5 years from the date of manufacture Prior to this the device is intended to provide safe and reliable operation provided that it is operated and maintained in accordance with the instructions provided by ResMed Applicable ResMed warranty details are provided with the device at the time of original supply Of course as with all electrical devices if any irregularity becomes apparent you should exercise caution and have the device inspected by an authorized ResMed service center If you feel that your flow generator is not performing properly see Troubleshooting on page 27 Troubleshooting If
5. at its option the defective product or any of its components This Limited Warranty does not cover a any damage caused as a result of improper use abuse modification or alteration of the product b repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs c any damage or contamination due to cigarette pipe cigar or other smoke d any damage caused by water being spilled on or into a flow generator Warranty is void on product sold or resold outside the region of original purchase Warranty claims on defective product must be made by the initial consumer at the point of purchase This warranty is in lieu of all other express or implied warranties including any implied warranty of merchantability or fitness for a particular purpose Some regions or states do not allow limitations on how long an implied warranty lasts so the above limitation may not apply to you ResMed shall not be responsible for any incidental or consequential damages claimed to have occurred as a result of the sale installation or use of any ResMed product Some regions or states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation may not apply to you This warranty gives you specific legal rights and you may also have other rights which vary from region to region For further information on your warranty rights contact your local ResMed dealer o
6. Starting Treatment SmartStart Stopping Treatment Using the Mask Fitting Feature Messages on the VPAP Auto LCD Modules Helpful Hints Cleaning and Maintenance Daily Cleaning Weekly Cleaning Periodic Cleaning Replacing the Air Filter Servicing Troubleshooting Technical Specifications Accessories Symbols which Appear on the Device Limited Warranty awww o N Contents Contents iV Introduction Definitions This guide contains special terms and icons that appear in the margins to draw your attention to specific and important information e Warning alerts you to possible injury e Caution explains special measures for the safe and effective use of the device Note is an informative or helpful note User Owner Responsibility The user or owner of this system shall have sole responsibility and liability for any injury to persons or damage to property resulting from operation which is not in accordance with the operating instructions supplied e maintenance or modifications carried out unless in accordance with authorized instructions and by authorized persons Please read this guide carefully before use Introduction 1 Medical Information What the VPAP Auto Device is Intended for The VPAP Auto is indicated for the treatment of obstructive sleep apnea OSA in patients weig
7. and the location of the air filter and power sockets Power cord A 3 Power cord to attach the VPAP Auto to the AC mains power Travel bag A 4 Air tubing A 5 The 6 6 2 m air tubing connects the VPAP Auto to your mask Mask You will also need a ResMed mask system supplied separately The following ResMed mask systems are recommended for use with the VPAP Auto Nasal Masks e Mirage Vista Nasal Mask Ultra Mirage Nasal Mask Ultra Mirage II Nasal Mask e Mirage Activa Nasal Mask Nasal Pillows Systems Mirage Swift Nasal Pillows System e Mirage Swift I Nasal Pillows System I Full Face Masks e Mirage Liberty Full Face Mask e Mirage Quattro Full Face Mask e Ultra Mirage Full Face Mask Notes Not all masks are available in all regions ResMed devices have been designed and manufactured to provide optimum performance using ResMed vented mask systems Other mask systems may be used however performance and data outputs may be affected In VAuto mode only ResMed masks are compatible for use with the VPAP Auto Your clinician needs to set up your VPAP Auto for use with your particular mask Humidifier Please refer to the illustration in section B of the illustration sheet The VPAP Auto System 7 A humidifier may be required if you are experiencing dryness of the nose throat or mouth The VPAP Auto is compatible for use with the HumidAire 3i heated hum
8. filter 20 replace mask 19 service due 20 Responsibility user owner 1 Right key 12 Runny or blocked nose 23 S Setting up 9 Settling screen 12 Settling time 12 18 27 Start stop key 11 Starting treatment 17 Supplemental oxygen 8 T Technical specifications 31 32 Traveling 23 Troubleshooting 27 U Up key 11 Use on aircraft 23 Used time screen 12 User owner responsibility 1 Using the menus 12 V VPAP Auto dimensions 32 servicing 26 W Warnings related to treatment 4 Warranty 39 Weekly cleaning 25 268108 2 oos VPAP Auto User 2 6 8 1 0 8 Global leaders in sleep and respiratory medicine www myresmed com
9. once the settling time has elapsed Set pressure s In CPAP mode this displays the set treatment pressure centimeters of water In S mode it displays exhalation and inhalation pressures centimeters of water In VAuto mode it displays the EPAP and IPAP pressures centimeters of water Apnea indicator CPAP mode VAuto mode Visual indicator that displays an A to indicate an apnea is occurring Operating Instructions 17 Pressure bar graph Graphical display of the changing pressure Leak Current mask leak liters per minute Respiratory rate Number of breaths per minute Minute ventilation Volume of air inhaled per minute liters per minute Tidal volume Volume of air inhaled per breath milliliters per breath Breath phase expiration This screen item displays in the format breath type phase display expiration type as shown below eg S TiMn Breath type S spontaneous Phase display inspiration blank expiration Expiration type TiMn expiration triggered at completion of minimum inspiration hold time TiMx expiration triggered at completion of maximum inspiration hold time C expiration triggered spontaneously within Ti Min and Ti Max Ramp Time S mode CPAP mode Ramp time is a feature which can be enabled by your clinician If you have difficulty falling asleep with full pressure select a ramp time The airflow will start very gently while you fall asleep The pressure will slowly increase to full operating
10. other than domestic and those directly connected to a low voltage power supply network which supplies buildings used for domestic purposes Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document Warnings The VPAP Auto device should not be used adjacent to or stacked with other eguipment If adjacent or stacked use is necessary the VPAP Auto device should be observed to verify normal operation in the configuration in which it will be used The use of accessories eg humidifiers other than those specified in this manual is not recommended They may result in increased emissions or decreased immunity of the VPAP Auto device Guidance and manufacturer s declaration electromagnetic immunity The VPAP Auto device is intended for use in t customer or the user of the VPAP Auto devic environment he electromagnetic environment specified below The e should assure that the device is used in such an Electromagnetic z IEC60601 1 2 Compliance Immunity test environment test level level guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD concrete or ceramic tile If IEC 61000 4 2 8 kV air 8 kV air floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV Mains power quality should
11. ports of your mask may not clear all exhaled gas from the tubing Some rebreathing may occur The airflow for breathing produced by this device can be as much as 11 F 6 C higher than the temperature of the room Caution should be exercised if the room temperature is warmer than 90 F 32 C When AC mains power 100 240V AC is not available always use a ResMed DC 12 converter The DC 12 converter is available as an optional accessory If supplied the ResScan Data Card module is designed for use with specific ResMed devices Only use the ResSan Data Card module if supplied as specified in this manual Note The above are general warnings and cautions Specific warnings cautions and notes appear with the relevant instructions in the manual Adverse Effects Patients should report unusual chest pain severe headache or increased breathlessness to their prescribing physician An acute upper respiratory tract infection may require temporary discontinuation of treatment The following side effects may arise during the course of therapy with the device drying of the nose mouth or throat nosebleed bloating ear or sinus discomfort eye irritation skin rashes chest discomfort Medical Information 5 The VPAP Auto System Please refer to the illustrations in section A of the illustration sheet Front view A 1 Shows the keypad and LCD screen and the air outlet Rear view A 2 Shows where the module attaches
12. 79 AU 724589 AU 764761 EP 0651971 EP 0661071 EP 0858352 EP 0920845 EP 0927538 EP 0934723 JP 3638613 US 4944310 US 5199424 US 5245995 US 5522382 US 5704345 US 6029665 US 6138675 US 6213119 US 6363933 US 6398739 US 6591834 US 6635021 US 6675797 US 6705315 US 6745768 US 6770037 US 6935337 US 7004908 US 7040317 Other patents pending Protected by design registrations AU 302180 AU 302181 AU 302182 AU 302183 AU 302184 AU 302185 AU 302186 CN 200430121212 2 CN 200430121211 8 CN 200430121214 1 CN 200430121215 6 CN 200430121216 0 CN 2004301212175 EP 269436 HK 0412901 9 JP 1257662 JP 1257663 JP 1266956 JP 1266957 JP 1267270 JP 1267271 NZ 405614 NZ 406923 NZ 406924 Others pending HumidAire HumidAire 3i SmartStart AutoSet ResScan Ti Control Ultra Mirage VPAP Vista and VPAP Auto are rademarks of ResMed Ltd HumidAire SmartStart Vista AutoSet and VPAP are registered in U S Patent and Trademark Office 2007 ResMed Ltd 268108 2 07 08 Contents Introduction Definitions User Owner Responsibility Medical Information What the VPAPTM Auto Device is Intended for Contraindications Warnings Cautions The VPAP Auto System Mask Supplemental Oxygen Preparing for Use Setting Up the VPAP Auto Assemble the Mask Operating Instructions
13. Hz to 800 MHz 800 MHz to 2 5 GHz power of transmitter Ww d 1 17 VP d 0 35 VP d 0 7 VP 0 01 0 17 0 04 0 07 0 1 0 37 0 11 0 22 1 1 17 0 35 0 7 10 3 69 1 11 2 21 100 11 70 3 50 7 0 For transmitters rated ata din metres m can be de maximum output power no ermined using the equation P is the maximum output power rating of the transmi manufacturer NOTE 1 At 80 MHz and 800 MHZ the separation dis t listed above the recommended separation distance applicable to the frequency of the transmitter where tter in watts W according to the transmitter ance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Technical Specifications 37 38 Limited Warranty ResMed warrants that your ResMed product shall be free from defects in material and workmanship for the period specified below from the date of purchase by the initial consumer This warranty is not transferable Product Warranty Period ResMed humidifiers ResControl ResLink ResTraxx 1 Year ResMed flow generators 2 Years Accessories mask systems including mask frame cushion 90 Days headgear and tubing Excludes single use devices Note Some models are not available in all regions If the product fails under conditions of normal use ResMed will repair or replace
14. RESMED VPAP Auto POSITIVE AIRWAY PRESSURE DEVICE User Guide English RESMED B INTEGRATED HUMIDIFIER D SETTING UP THE VPAP AUTO VPAP Auto Component of 268108 2 ILLUSTRATIONS A SYSTEM COMPONENTS 2007 ResMed Ltd Carry handle LCD screen Air outlet TONS 4 ResScan DATA CARD Air filter cover Module Air inlet SS 5 2007 ResMed Ltd 2007 ResMed Ltd 2007 ResMed Ltd Note Some products not available in all regions HUMIDAIRE 3i AND VPAP AUTO H USING THE DATA CARD HumidAire 3i 2007 ResMed Ltd BLANK MODULE Data communications port Fur TD DO ip DO cc N o o N 2007 ResMed Ltd 2007 ResMed Ltd Note Some products not available in all regions RESMED VPAP Auto POSITIVE AIRWAY PRESSURE DEVICE User Guide English ResMed Ltd Manufacturer 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed Corp US Designated Agent 14040 Danielson Street Poway CA 92064 6857 USA ResMed UK Ltd EU Authorized Representative 65 Milton Park Abingdon Oxfordshire OX14 4RX UK ResMed Offices Australia Austria Brazil China Finland France Germany Hong Kong India Japan Malaysia Netherlands New Zealand Norway Singapore Spain Sweden Switzerland UK USA see www resmed com for contact details Protected by patents AU 691200 AU 697652 AU 699726 AU 702820 AU 709279 AU 7136
15. SpO oxygen saturation and HR heart rate takes priority If treatment has not commenced the VPAP Auto will display one of the following screens whether a humidifier is connected or not Prior to starting treatment SpO2 98 RAMP 20min 98 SETTLE 20min 98 menu HR 60 menu t HR 60 menu HR 60 Max Ramp off Max Ramp set Max Settle set or to non zero value to non zero value Max Settle off Figure 4 Menu display with ResLink and oximeter Accessing the Menus To navigate and make selections within the Patient Menu use the Up Down key to scroll through items within a level the Left key to enter a submenu and to apply an option choice the Right key to navigate out of a menu or submenu and to exit without changing options Oxygen saturation SpO2 The saturation of blood hemoglobin 90 Heart rate HR The number of heartbeats in a 60 second time frame beats per minute Operating Instructions Starting Treatment The VPAP Auto unit should be assembled beside your bed with the air tubing and mask system connected See Setting Up the VPAP Auto on page 9 1 Plug the power cord into the power source A welcome message is displayed on the LCD screen The Ramp or Settling screen then appears Note If you have the HumidAire 3i attached please refer to the relevant user manual for operating instructions 2 Fit your mask as described in the mask user instructions 3 Lie down and arrange the air tubing so tha
16. When you have checked the air tubing press the Start Stop key to restart the device If this does not clear the message disconnect the power cord and then reconnect it to restart the device Display error message SYSTEM ERRnnnn Call Service Component failure Record error number and contact your ResMed service center Display error message HIGH LEAK Adjust Mask You have experienced excessively high leak levels for more than 20 seconds Check that your air tubing is connected properly and that your mask does not leak excessively Use the mask fitting feature to help you to fit your mask properly If this message appears again contact your clinician Display error message Exxxx where xxxx defines an error Component failure Return your VPAP Auto for servicing The following message is displayed on the LCD after you try to update settings using the Data Card Card Error Remove Card The Data Card is not inserted correctly The Data Card is only partly inserted You may have removed the Data Card before settings were copied to the VPAP Auto Ensure that the Data Card is inserted with the arrow facing up and pointing towards the device Ensure that the device is switched on and in standby mode before you insert the Data Card Ensure that the Data Card is inserted into the slot on the Data Card module as far as it will go Reinsert the Data Card and wait for t
17. air from the device flushes the exhaled air out through the mask vent holes However when the device is not operating insufficient fresh air will be provided Ports may be incorporated into the mask or in connectors that are near the mask Medical Information 3 through the mask and the exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation This applies to most models of PAP devices In the event of power failure or machine malfunction remove the mask The VPAP Auto can be set to deliver pressures up to 20 cm H 0 In the unlikely event of certain fault conditions pressures up to 30 cm H20 are possible If oxygen is used with this device the oxygen flow must be turned off when the device is not operating If oxygen has been left on while the device is not operating disconnect the oxygen and wait 60 minutes before turning on the device again Explanation When the PAP device is not in operation and the oxygen flow is left on oxygen delivered into the ventilator tubing may accumulate within the PAP machine enclosure and create a risk of fire This applies to most types of PAP machines Oxygen supports combustion Oxygen should not be used while you are smoking or in the presence of an open flame Always ensure airflow is being generated by the device before the oxygen supply is turned on Always turn the oxygen supply off before stoppi
18. ask Clean the mask according to the instructions supplied with the mask Air tubing Disconnect the air tubing from the VPAP Auto and humidifier if used and hang the tubing and mask in a clean dry place until next use Humidifier If you are using a humidifier clean it according to the instructions in the humidifier user s manual Weekly Cleaning 1 Remove the air tubing from the VPAP Auto andthe mask 2 Wash the air tubing in warm water using mild detergent Rinse thoroughly hang and allow to dry 3 Before next use assemble the mask and headgear according to the user instructions 4 Reconnect the air tubing to the air outlet and mask Periodic Cleaning 1 Clean the exterior of the VPAP Auto with a damp cloth and mild liquid soap 2 Check the air filter for blockage or holes see Replacing the Air Filter on page 26 WARNING J Beware of electric shock Do not immerse the unit or power cord in water Always unplug the unit before cleaning and be sure it is dry before plugging back in e The mask system and air tubing are subject to normal wear and tear Inspect them regularly for damage Cleaning and Maintenance 25 Replacing the Air Filter To replace the air filter 1 Remove the air filter cover at the back of the VPAP Auto Air filter cover 2 Remove and discard the old air filter 3 Insert a new filter with the blue tinted side facing out from the device 4 Replace the air filter cover
19. e The SW screen displays the current software version that is installed in your VPAP Auto Figure 2 summarizes the VPAP Auto standard menu series e To access the VPAP Auto menus Press the Left key menu while the VPAP Auto or Ramp or Settling screen is displayed To scroll through items within the menu Press the Up Down key To exit out of the menu Press the Right key exit VAuto mode S mode amp CPAP mode SETTLE 20min menu RAMP 20min menu f EXHALATION MED change exit USED 00000hrs 00000 00000days MASK MIR FULL change exit SW SX3650201 il exit Figure 2 VPAP Auto Menu Series Note The Exhalation screen is only available if enabled by a clinician Menus with a Humidifier If the HumidAire 3i is connected to the VPAP Auto and treatment has not commenced the VPAP Auto will display one of the following screens RAMP 20min menu f warmup SETTLE 20min menu warmup CPAP and S modes VAuto mode shows RAMP setting shows SETTLING setting Figure 3 Patient Menu display with humidifier prior to starting treatment After treatment starts the treatment screen displays see Figure 5 Treatment screens all modes on page 17 Preparing for Use 13 14 Menus with a ResLink and Oximeter If your clinician has recommended that you use a ResLink module and the ResLink and an oximeter are connected to the VPAP Auto then display of
20. e VPAP Auto device is intended for use in the electromagnetic environment specified below The customer or the user of the VPAP Auto device should assure that the device is used in such an environment Immunity IEC60601 1 2 Complianc Electromagnetic environment test test level e level guidance Portable and mobile RF communications equipment should be used no closer to any part of the VPAP Auto device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 17 VP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 10 V m 10 V m d 0 35 VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 0 70 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol G OTE 1 At 80 MHz and 800 MHz the higher freguency range applies OTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people
21. e set pressure and treatment will begin If you do not wish to wait three minutes hold down the Start Stop key for at least three seconds to start treatment immediately lf you press the Start Stop key for less than three seconds the device will return to standby mode the RAMP or SETTLING screen is displayed CPAP mode S mode VAuto mode First screens only display if Ramp or Settling are selected Mode Ramping Indicator Mode Ramping Indicator Mode Settling Indicator Set EPAP pressure Set IPAP pressure CPAP pressure S RAMP 8 0 11 0 VA SETL gt gt gt gt t PS 3 0 Pressure Support VAUTO 8 0 11 0 A gt gt gt gt PS 3 0 Pressure Apnea Indicator Leak ln Ha Respiratory rate bpm Minute ventilation L min Tidal volume mL Top row VAuto and S mode only Ti Max setting sec Breath phase expiration Average l E ratio last 5 breaths Average inspiration time last 5 breaths S TiMn TiMx 4 0 meie T 1 16 Note Set values are those selected by the clinician Figure 5 Treatment screens all modes The treatment screens contain the following information Treatment mode Mode of treatment set by your clinician Options are CPAP Sand VAuto Ramping indicator CPAP mode S mode Appears if the VPAP Auto is in ramp mode This disappears once the ramp time has elapsed Settling indicator VAuto mode Appears if the VPAP Auto is in settling mode This disappears
22. eturn equipment or to call a particular person or number Modules Note Do not remove modules while power is connected to the VPAP Auto Your VPAP Auto will have one of two modules fitted to the back a blank module or a ResScan Data Card module Using a Blank Module Please refer to the illustrations in section F of the illustration sheet The blank module is a protective cover on your VPAP Auto At times you may wish to remove or attach the module for example to use another module To remove the blank module pull it off the back of the VPAP Auto to show the data communications port F 1 To attach the blank module push the blank module onto the data communications port until the module clicks into place F 2 Note To protect the data communications port always ensure there is a module attached to the back of the device Using a ResScan Data Card Module Please refer to the illustrations in section G of the illustration sheet The ResScan Data Card module is an accessory to the VPAP Auto Use a ResScan Data Card with the Data Card module to collect data and update settings in the VPAP Auto The module and card give your clinician convenient access to data about your treatment and can provide you with new device settings from your clinician without your having to leave home Attaching the Module To attach the Data Card module push it onto the data communications port at the back of your VPAP Auto until it clicks into place
23. he Settings Success Remove Card message to appear on the LCD Troubleshooting 29 Problem Possible Cause The card is not a ResScan Data Card Solution Only use a ResScan Data Card The following message is displayed on the LCD after you try to copy datatoa Data Card Card Error Remove Card The Data Card is not inserted correctly The card is not a ResScan Data Card You may have removed the Data Card before data was copied to it Ensure that the Data Card is inserted with the arrow facing up and pointing toward the device Use a ResScan Data Card as specified in this manual Reinsert the Data Card and wait forthe Copy Complete Remove Card message to appear on the LCD The following message is displayed on the LCD after you try to update the settings using the Data Card Settings Invalid Remove Card The identification details on the Data Card do not match the details on your device Contact your clinician immediately The following message is displayed on the LCD after you try to update the settings using the Data Card Settings Error Remove Card There is a data error on the Data Card Contact your clinician immediately The following message is NOT displayed on the LCD after you try to update the settings using the Data Card Settings Success Remove Card The settings were not updated Contact your clinician immediately 30 Technical Specificat
24. hing more than 66 Ib 30 kg It is intended for use in the hospital and home CAUTION USA ONLY Federal law restricts this device to sale by or on the order of a physician Contraindications Positive airway pressure therapy may be contraindicated in some patients with the following pre existing conditions severe bullous lung disease pneumothorax pathologically low blood pressure dehydration cerebrospinal fluid leak recent cranial surgery or trauma Warnings The entire manual should be read before using the VPAP Auto Advice contained in this manual should not supersede instructions given by the prescribing physician A patient should not connect a device to the data communication port unless instructed to do so by their health care provider or physician Only ResMed products are designed to be connected to the data communication port Connecting other devices could result in injury or damage to the VPAP Auto device The VPAP Auto should only be used with masks and connectors recommended by ResMed or by a physician or respiratory therapist A mask should not be used unless the VPAP Auto device is turned on and operating properly The vent hole or holes associated with the mask should never be blocked Explanation The VPAP Auto is intended to be used with special masks or connectors which have vent holes to allow continuous flow of air out of the mask When the device is turned on and functioning properly new
25. ible with external humidifiers HumidAire 3i humidifier The HumidAire 3i attaches to the front of the VPAP Auto to provide heated humidification No other accessories are required for its use The VPAP Auto automatically detects the presence of the HumidAire 3i No menu changes are required Please refer to the relevant user manual for details WARNING Make sure that the water chamber is empty and thoroughly dried before transporting the HumidAire 3i When using the travel bag always separate the VPAP Auto unit and the Humidaire 3i and place the HumidAire 3i in its pouch The VPAP Auto is now ready for use To start treatment see Operating Instructions on page 15 Features of the VPAP Auto The control panel of the VPAP Auto unit includes a keypad for navigating through the menus and delivering treatment LCD screen Up key Left key Right key START STOP ym nt Down key Start Stop Key Figure 1 VPAP Auto Keypad and LCD The LCD is used to display the menus and other data The arrows and lowercase text on the bottom line of the LCD prompt the use of the keys within the menus The keypad is used to navigate through the menus access the mask fit feature and start stop treatment The functions of the keys and quick key combinations are listed in Table 1 The LCD backlight turns off after two minutes of inactivity It turns back on when you press a key Table 1 Keys on the front panel and the
26. idifier B WARNING Only the HumidAire 3i is compatible for use with the VPAP Auto Please refer to Warnings on page 3 Accessories Please refer to the illustrations in section C of the illustration sheet The following accessories are available for use with the VPAP Auto ResScan Data Card C 1 e ResScan Data Card module C 2 Blank module C 3 DC 12 converter C 4 e Air tubing 9 10 3 m C 5 Note ResMed recommends the following tubing products for use with the VPAP Auto 9 9 3 m air tubing gray PN 14980 6 6 2 m air tubing gray PN 14948 disposable air tubing clear PN 14912 Supplemental Oxygen The VPAP Auto is designed to be compatible with the use of low flow oxygen therapy provided from an external source At a fixed flow rate of supplemental oxygen flow the inhaled oxygen concentration will vary depending on the pressure settings patient breathing pattern mask selection and the leak rate This warning applies to most types of PAP machines Preparing for Use Setting Up the VPAP Auto 1 Place the VPAP Auto on a table near the head of your bed CAUTION Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord Note You can also place your VPAP Auto on the floor beside or underneath your bed Ensure that the area is free from dust and clear of bedding clothes or any other objects that could block the air inlet Co
27. ill see either the Ramp screen S mode and CPAP mode or the Settling screen VAuto mode Ramp Screen S mode CPAP mode If your clinician has set a maximum ramp time the Ramp screen is displayed after the Welcome screen On the Ramp screen you can immediately set a ramp time Ramp time is the period during which the pressure increases from a low pressure to the prescribed treatment pressure See Ramp Time on page 18 Ramp time can be altered in five minute increments from OFF to a maximum ramp time set by your clinician by the using the Up Down key Settling Screen VAuto mode If your clinician has set a maximum settling time the Settling screen is displayed after the Welcome screen On the Settling screen you can immediately set a settling time Settling time is the period for which the device remains at Min EPAP with an inspiratory pressure determined by Pressure Support on top of Min EPAP See Settling Time on page 18 Settling time can be altered in five minute increments from OFF to a maximum settling time set by your clinician by the using the Up Down key Menus The menu allows you to view details about the time used and the current software version of your VPAP Auto The Used time screen displays the total number of hours for which you have used the device since it was last reset by the clinician It also displays the number of days the VPAP Auto was used out of the total number of days available for us
28. ions Performance Operating pressure range 3 to 20 cm H20 Maximum single fault pressure 30 cm H 0 Pressure measurement tolerance 0 5 cm H20 4 of the measured reading Flow measurement tolerance 0 1 or 20 of reading whichever is greater Dynamic pressure characteristics VAuto mode 4 to 20 cm H20 measured at the mask Min EPAP pressure 4 cm H20 Max IPAP pressure 20 cm H20 Pressure Support 0 to 10 cm H20 S mode PAP 5 to 20 cm H20 measured at the mask EPAP 3 to 20 cm H20 measured at the mask CPAP mode 4 to 20 cm H20 measured at the mask Sound pressure level Radiated sound pressure is measured at lt 30 dBA at 10 cm H20 and 3 3 37 1 m according to ISO17510 Dimensions L x W x H 4 4 x 6 5 x 5 7 112 mm x 164 mm x 145 mm Weight 2 9 Ib 1 3 kg Power supply Input range 100 240V 50 60Hz 40VA typical power consumption lt 100VA maximum power consumption Housing construction Flame retardant engineering thermoplastic Environmental conditions Operating temperature 41 F to 95 F 5 C to 35 C Operating humidity 10 95 non condensing Storage and transport temperature 4 F to 140 F 20 C to 60 C Storage and transport humidity 10 95 non condensing Operating Altitude Sea level to 8500 Electromagnetic Compatibility Product complies with all applicable electromagnetic compatibility requirements EMC according to IEC60601 1 2 for residential commercial and light industry en
29. ir functions Key Function LCD screen e Displays VPAP Auto information including the menus and m treatment screens Start Stop e Starts or stops treatment CT e Extended hold for at least three seconds starts the mask fit feature Up e Allows you to scroll through the VPAP Auto menus and submenus and increase the settings options Down e Allows you to scroll through the VPAP Auto menus and submenus and increase the settings options Preparing for Use 11 Key Function Left e Performs the function indicated by the guiding text displayed above it on the LCD screen Guiding text S includes menu change and apply Right e Performs the function indicated by the guiding text displayed above it on the LCD screen Guiding text includes exit and cancel To assist you in adjusting the VPAP Auto the keypad and LCD are equipped with a backlight The LCD backlight comes on when the unit is turned on or when you press a key and turns off after two minutes The keypad backlight is on at all times when the VPAP Auto is powered Using the Menus The VPAP Auto unit provides a set of functions which are arranged in menus and submenus Via the LCD screen the menus and submenus allow you to view and change the settings for a particular function You can access the menus regardless of whether the VPAP Auto is in standby mode or delivering therapy After the Welcome screen appears and device self checks are complete you w
30. layed on the LCD and is visible if the device is not delivering therapy The backlight on the LCD flashes when a message is displayed Your clinician can set any of the following reminders on your LCD Message Description Action INSERT CARD May appear if your Insert your Data Card see Section H of the device is Data Card illustrations sheet and follow any instructions enabled that your clinician has given you When you have done this the message will disappear from the LCD Pressing the Left Ok key will also remove the message REPLACE ay appear when Press the Left Ok key to remove the MASK your mask is due message from your LCD and replace your for replacement mask with a new one CALL ay appear as a Press the Left Ok key to remove the PROVIDER reminder to message from your LCD and contact your contact your clinician clinician for example to discuss how your therapy is going Operating Instructions 19 Message Description Action REPLACE May appear as a Press the Left Ok key to remove the FILTER reminder to message from your LCD and replace the air replace the air filter filter on your device SERVICE DUE May appear as a Press the Left Ok key to remove the reminder to return message from your LCD your device for service Customized Your clinician may Press the Left Ok key to remove the messages also set reminders message from your LCD for other reasons for example to r
31. ly Connect firmly at both ends Air tubing kinked or punctured Straighten or replace VPAP Auto unit does not stop when you remove your mask SmartStop is disabled Note SmartStop is not available if you are using a full face mask or if Leak Alert is enabled Enable SmartStop if possible SmartStop is enabled but the flow generator does not stop automatically when you remove your mask Incompatible humidifier or mask system being used Use only equipment as recommended and supplied by ResMed Pressure rises inappropriately Talking coughing voluntarily breath holding eg while rolling over in bed or intentionally breathing in an unusual manner Mask cushion is buzzing against the skin Cushion seated incorrectly Cushion seated incorrectly causing excessive leak Air tubing is kinked or punctured Humidifier control dial set too high resulting in accumulation of water in the air tubing Avoid talking with a nasal mask on and breathe as normally as possible Adjust the headgear Adjust headgear or re fit cushion Straighten or replace air tubing Turn humidifier control dial down and empty the water from the air tubing Problem Display error message Check tube Key if done Possible Cause The air tubing is loose or blocked Solution Check that the air tubing is connected securely to your mask and the air outlet on the front of the VPAP Auto
32. module No additional data is copied onto the card once the Copy Complete Remove Card message is displayed even if the card is left in the device To add additional data to the Data Card reinsert the card and repeat these steps 3 Remove the Data Card Grip the end of the Data Card and pull it out of the Data Card module H 3 4 Store the Data Card Your Data Card should be stored in its mailback envelope when not in use 5 Mail the Data Card to your clinician When mailing the Data Card to your clinician 1 Insert the Data Card into the pocket provided on the mailback envelope Fold up the mailback envelope Operating Instructions 21 2 Place the mailback envelope containing the Data Card in a postal envelope and seal it 3 Make sure that your clinician s name and address details are on the postal envelope and mail it back immediately Using the Data Card to Update Settings If your clinician has provided a Data Card with new device settings e With the device in standby RAMP or SETTLING mode insert the Data Card into the slot on the Data Card module Updating will start automatically The Card Inserted Please Wait message is displayed on the LCD while updating is in progress Updating takes up to 30 seconds The Settings Success Remove Card message is displayed on the LCD if the settings were updated successfully Note This message only appears once If you re insert the Data Card after you have updated y
33. ng the airflow from the device Note At a fixed rate of supplemental oxygen flow the inhaled oxygen concentration will vary depending on where the oxygen is introduced the pressure settings patient breathing pattern mask selection and leak rate Do not use the VPAP Auto if there are obvious external defects or unexplained changes in performance Do not open the VPAP Auto case There are no user serviceable parts inside Repairs and internal servicing should only be performed by an authorized service agent Explosion hazard do not use in the vicinity of flammable anesthetics Warnings Related to Treatment If you stop your PAP or bilevel treatment your sleep apnea will return immediately Always consult your clinician if you expect to be in a situation where you cannot use your VPAP Auto unit If you are admitted to a hospital or prescribed any other form of medical treatment always inform the medical staff that you are being treated with PAP or bilevel It is also important to contact the clinician who is treating you for sleep apnea If you experience an infection of the upper respiratory tract middle ear or sinuses contact your clinician before continuing your PAP or bilevel treatment You may be advised to stop treatment until the infection has cleared If you continue with treatment during an infection be sure to clean your mask and tubing after every use Cautions At low pressures the flow through the exhalation
34. nnect the power cord to the socket at the rear of the flow generator D 1 Plug the other end of the power cord into the power outlet WARNING Make sure the power cord and plug are in good condition and the equipment is not damaged Connect one end of the air tubing firmly onto the air outlet D 2 WARNING Only ResMed air tubing should be used with your flow generator A different type of air tubing may alter the pressure you actually receive reducing the effectiveness of your treatment e Blocking the air inlet or tubing while in operation could lead to overheating of the device e Inthe clinical environment any personal computer that is used with your CPAP system must be at least 5 1 5 m away from or at least 8 2 5 m above the patient It must also comply with the relevant test standard For personal computers the international standard is IEC 60950 or equivalent Assemble the Mask 1 Assemble your mask system according to the mask user instructions 2 Connect your mask system to the free end of the air tubing D 3 3 Check that the mask setting on the MASK screen is the one recommended for the mask you are using see the table in How to Select the Mask Type on page 18 The VPAP Auto is now ready for use D 4 Preparing for Use 9 10 Humidifier Use Please refer to the illustration in section E of the illustration sheet and your HumidAire 3i manual WARNING The VPAP Auto is not compat
35. nt Drip proof IPX 4 Dangerous voltage C Start Stop and Mask fit Technical Specifications 33 34 Guidance and Manufacturer s Declaration Electromagnetic Emissions and Immunity Guidance and manufacturer s declaration electromagnetic emissions The VPAP Auto device is intended for use in the electromagnetic environment specified below The customer or the user of the VPAP Auto device should assure that the device is used in such an environment Emissions test Compliance Electromagnetic 2 environment guidance RF emissions CISPR11 Group 1 The VPAP Auto device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic eguipment RF emissions CISPR 11 with Class B The VPAP Auto device is suitable for serial adapter use in all establishments including domestic establishments and those RF emissions CISPR 11 with Class B directly connected to the public low USB adapter voltage network that supplies buildings used for domestic purposes Harmonic Emissions Class A IEC 61000 3 2 Voltage Fluctuations Flicker Complies Emissions IEC 61000 3 3 Class B for all system configurations except when a ResLink with oximeter is attached to a VPAP Auto device powered from a DC 12 adapter in which case the system is Class A compliant Class A is suitable for use in all establishments
36. our settings this message is not displayed Remove the Data Card from the Data Card module Store the Data Card in its mailback envelope when not in use WARNING If your clinician has told you to use this Data Card to update the settings on your device and the Settings Success message does not appear contact your clinician immediately Helpful Hints Starting Out Mouth Leaks When using a nasal mask try to keep your mouth closed during treatment Air leaks from your mouth can decrease the effectiveness of your treatment If mouth leaks are a problem a full face mask or chin strap may help Contact your clinician or eguipment supplier for further details Mask Fitting The flow generator delivers the most effective treatment when the mask is well fitted and comfortable Treatment can be affected by leaks so it is important to eliminate any leaks that may arise If you have problems trying to get a comfortable mask fit contact your sleep clinic or equipment supplier You may benefit from a different mask size You can also use the Mask Fitting feature to help you fit your mask properly See Using the Mask Fitting Feature on page 15 Before wearing your mask wash your face to remove excess facial oils This will allow a better fit and prolong the life of the mask cushion Nasal Irritation Dryness You may experience dryness of the nose mouth and or throat during the course of treatment especially during winte
37. pressure over the selected ramp time The clinician has set a maximum ramp time you may select any value up to the maximum Settling Time VAuto mode Settling time is a feature which can be enabled by your clinician If you have difficulty falling asleep with the VPAP Auto operating select a settling time The airflow will remain at Minimum Pressure for the period of time that you set giving you time to fall asleep After this time the VPAP Auto will be able to increase pressure in response to events The clinician will set a maximum settling time you may select any value up to the maximum How to Select the Mask Type Scroll to MASK and select Change Left key Press the Up or Down keys until you see the mask type that you reguire The following table shows the setting that should be selected for each mask type Table 3 Settings for mask types Settings Mask ULTRA Ultra Mirage Nasal Mask Ultra Mirage II Nasal Mask MIR FULL Mirage Liberty Full Face Mask Mirage Quattro Full Face Mask Ultra Mirage Full Face Mask ACTIVA Mirage Activa Nasal Mask SWIFT irage Swift Nasal Pillows System Mirage Swift Il Nasal Pillows System STANDARD Mirage Vista Nasal Mask Messages on the VPAP Auto LCD Your clinician may have set your VPAP Auto to remind you about important events such as when to replace your mask when to insert your Data Card if your device is Data Card enabled and so on The reminder message is disp
38. r In many cases a humidifier may resolve this discomfort Contact your clinician for advice Runny or Blocked Nose You may experience sneezing and or a runny or blocked nose during the first few weeks of treatment In many cases nasal irritation can be resolved with a humidifier Consult your clinican for advice Use with DC Power You must use a ResMed DC 12 converter to connect the VPAP Auto to a 12 V or 24 V DC power source Contact your equipment supplier or ResMed for details WARNING The device should not be connected to both AC and DC power sources simultaneously Traveling with the VPAP Auto International Use Your VPAP Auto flow generator has an internal power adapter that enables it to operate in other countries It will operate on power supplies of 100 240V and 50 60Hz No special adjustment is necessary but you may need a plug adapter for the region for which you are using the device Use on an Aircraft Please consult the medical services department of your carrier if you intend to use your VPAP Auto on an aircraft The VPAP Auto complies with US FCC Part 15 Class B requirements if no external data cables are used Note You should not use your VPAP Auto while the aircraft is taking off or landing Operating Instructions 23 24 Cleaning and Maintenance You should regularly carry out the cleaning and maintenance described in this section Refer to your mask manual for detailed instructions Daily Cleaning M
39. r ResMed office R001 307 2 05 06 Limited Warranty 39 40 Index A Accessories 8 Air filter 7 27 replacing 26 Air pressure 27 Air tubing 7 cleaning 25 connect to air outlet 9 kinked 27 Aircraft 23 B Backlight LCD and keypad 12 C Cleaning daily 25 periodic 25 weekly 25 Cleaning mask 25 Components 7 D Daily cleaning 25 Data Card 29 DC 12 converter 23 Definitions 1 Down key 11 Dryness 23 Dynamic pressure characteristics 31 E Electromagnetic Compatibility 32 Error messages 29 F Features of the VPAP Auto 11 H Headgear position 27 Helpful hints 22 HumidAire 3i 10 Humidifier 7 10 cleaning 25 Humidifier use 10 l International use 23 English K Keypad 7 L LCD 7 error messages 30 messages 19 Left key 12 Limited Warranty 39 M Mask 7 attaching 9 mask fit 16 mask type 18 port 27 position 27 Mask fit 15 star rating 16 Mask fitting 22 Mask screen 16 Mask settings 18 Mask types 18 Medical information 3 Menus 12 14 using 12 with humidifier 13 Modules attaching 7 Mouth leaks 22 N Nasal irritation 23 Noise level 32 O Operating instructions 15 Oxygen supplemental 8 P Periodic cleaning 25 Power cord 7 27 connecting 9 Index 41 42 Power sockets 7 Power sources 23 Preparing for use 9 Pressure mask fit 16 R Ramp screen 12 Ramp time 12 18 27 Reminders 19 call provider 19 customized messages 20 insert card 19 replace air
40. r pressure delivery starts The following display will appear on the LCD screen indicating that the mask fitting feature is operating Your device willramp to the mask fit pressure and will remain at this pressure for three minutes The LCD also displays a mask fit star rating See Table 2 MASK FIT KKK excelnt mask fit star rating Notes The mask fit star rating display disappears after three minutes The mask fitting feature can only be started from the RAMP or SETTLING screen When the device is in VAuto mode the mask fit pressure is 10 cm H30 When the device is in CPAP mode the mask fit pressure is the set treatment pressure or 10 cm H20 whichever is greater When the device is in S mode the mask fit pressure is EPAP or 10 cm H 0 whichever is greater Leak Alert and SmartStop functions are disabled while using Mask Fit Adjust your mask mask cushion and headgear until you have a secure and comfortable fit Once you have a secure and comfortable fit check your mask fit star rating on the LCD screen Table 2 explains the mask fit star ratings Note If there is another person nearby to check your mask fit star rating you can adjust your mask mask cushion and headgear while lying down Table 2 Definitions of Mask Fit Star Rating Star rating Definition EM Excellent HEER Very good FE Good A Adjust mask Adjust mask Adjust mask 4 After three minutes the pressure reverts to th
41. t it is free to move if you turn in your sleep 4 To start treatment simply breathe into the mask see SmartStart M Air will begin flowing slowly and will build up to full operating pressure in about 10 to 15 seconds Note If the VPAP Auto does not start automatically you can also press the Start Stop key SmartStart The VPAP Auto has a function called SmartStart SmartStart enables your device to start automatically when you breathe into your mask If your clinican has enabled SmartStop your device will stop automatically when you take your mask off Stopping Treatment To stop treatment at any time remove your mask and press the Start Stop key or if your clinician has enabled SmartStop simply remove your mask and treatment will end Note SmartStop will not work if You have selected MIR FULL for your mask type e Your clinician has enabled Leak Alert Using the Mask Fitting Feature You can use the VPAP Auto mask fitting feature to help you fit your mask properly This feature delivers air pressure for a three minute period prior to starting treatment during which you can check and adjust your mask fit to minimize leaks Operating Instructions 15 16 Note Make sure that the mask setting on the MASK screen is the same as the mask you are using To use the mask fitting feature Fit your mask as described in the mask user instructions Hold down the Start Stop key for at least three seconds until ai
42. there is a problem try the following suggestions If the problem cannot be solved contact your equipment supplier or ResMed Do not attempt to open the device Problem No display Possible Cause Power not connected Solution Ensure the appropriate power cord is connected to your VPAP Auto and the power switch if available is on Insufficient air delivered from VPAP Auto Ramp or settling time is in use Air filter is dirty Air tubing is kinked or punctured Air tubing not connected properly ask and headgear not positioned correctly Cap s missing from access port s on mask Pressure required for treatment may have changed Wait for air pressure to build up or change ramp or settling time Replace air filter Straighten or replace tubing Check air tubing Adjust position of mask and headgear Replace cap s See your clinician to adjust the pressure VPAP Auto does not start when you breathe into the mask Power cord not connected properly Power outlet may be faulty Breath is not deep enough to trigger SmartStart Connect power cord firmly at both ends Try another power outlet Take a deep breath in and out through the mask Troubleshooting 27 28 Problem Possible Cause There is excessive leak Solution Adjust position of mask and headgear Caps may be missing from ports on mask Replace them Air tubing not connected proper
43. vironments For further details see Guidance and Manufacturer s Declaration Electromagnetic Emissions and Immunity on page 34 Technical Specifications 31 32 Noise Level VPAP Auto CPAP mode 10 cm H O set pressure Measured total A weighted sound pressure level 24 dBA dB re 20 uPa Uncertainty dB re 20 Pa 2 dBA Measured values are determined according to the noise test procedure given in ISO 17510 1 Note The sum of a measured noise emission value and its associated uncertainty represents an upper boundary of the range of values that is likely to occur in measurements a Declared dual number noise emission values in accordance with ISO 4871 Air filter Two layered powder bonded polyester non woven fiber Air tubing Flexible plastic 1 x 6 6 2 m length Air outlet The 22 mm conical air outlet complies with EN 1281 1 IEC 60601 1 classification Class double insulation Type CF Note The manufacturer reserves the right to change these specifications without notice Accessories Data Card Dimensions L x W x D 2 56 x 0 87 x 0 03 65 04 mm x 22 15 mm x 0 85 mm Data Card Module Dimensions H x W x D 1 95 x 1 66 x 0 47 49 7 mm x 42 2 mm x 12 mm Note The manufacturer reserves the right to change these specifications without notice Symbols which Appear on the Device N Attention consult accompanying documents wv Type CF eguipment Class Il equipme
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