VPAP® III & III ST - Air Liquide Australia
Contents
1. Adjust position of mask and headgear Plugs may be missing from ports on mask Replace them Air tubing not connected properly Connect firmly at both ends Air tubing kinked or punctured Straighten or replace VPAP unit does not stop when you remove your mask SmartStart Stop is disabled Enable SmartStart Stop SmartStart is enabled but the flow generator does not stop automatically when you remove your mask Display error message Check tube Key if done Incompatible humidifier or mask system being used The air tubing is loose Use only equipment as recommended and supplied by ResMed Check that the air tubing is connected securely to your mask and the air outlet on the front of the To clear the error message press any key on the VPAP keypad Displays error message SYSTEM ERROR Call service Component failure Return your VPAP for servicing Excessive motor noise Component failure Return your unit for servicing Display error message High leak in last session You have experienced excessively high leak levels during the night 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 SYSTEM SPECIFICATIONS Dynamic pressure characteristics IPAP 4 cm to 25 H2. TROUBLESHOOTING Solution Ensure the power cable is connected and that the switch at the back of the unit is in the ON position Insufficient air delivered from the VPAP Ramp Time is in use Air filter is dirty Air tubing is kinked or punctured Air tubing not connected properly Mask and headgear not positioned correctly Plug s missing from access port s on mask Pressure required for treatment may have changed Wait for air pressure to build up Replace air filter Straighten or replace tubing Check air tubing Adjust position of mask and headgear Replace plug s See your clinician to adjust the pressure The VPAP does not start when you breathe into the mask Power cord not connected properly Power outlet may be faulty The VPAP unit not switched on SmartStart not on Mask Alarm has been enabled SmartStart has automatically been disabled Use of a Mirage Full Face Mask Connect power cord firmly at both ends Try another power outlet Switch power switch at rear of the VPAP to ON Enable SmartStart Disable Mask Alarm to enable SmartStart SmartStart does not work with a full face mask as the anti asphyxia valve will not allow sufficiently high pressure on exhalation 29 Problem Possible Cause Breath is not deep enough to trigger SmartStart There is excessive leak Solution Take a deep breath in and out through the mask
3. Components 5 D Daily Cleaning 27 Definitions 1 Detailed Menu 15 16 17 Dimensions 31 Dryness 24 Dynamic flow characteristics 31 Dynamic pressure characteristics 31 E Electromagnetic Compatibility 31 Environmental Conditions 31 Error Messages 30 F Features of the VPAP 14 Front Key 14 G Glossary of Symbols 33 H Helpful Hints 24 High Leak Message 18 Housing Construction 31 HumidAire 2i 11 HumidAire 2iC 11 Humidifier 6 11 Humidifier Use 11 IEC 60601 1 Classifications 31 International Use 25 K Keys functions 14 INDEX L LCD Screen and Keypad 14 Left Key 14 M Mask Alarm 18 Mask Fitting 24 Mask Flow Pressure Characteristics 34 Mask Fit Star Rating definitions 24 Mask Fitting Feature 23 Masks 6 Medical Information 1 Menu Functions 18 Menu Type 15 Menus using the VPAP 15 Mouth Leaks 24 N Nasal Irritation 24 O Operating Instructions 21 Options Menu 19 P Power Supply 31 Preparing for Use 9 R Ramp Screen 15 Ramp time 15 Replacing the Air Filter 28 Responsibility user owner 1 Results Menu 19 Right Key 14 Run Hours Screen 15 Runny or Blocked Nose 24 5 Servicing 28 Servicing Menu 19 Setting Up 9 Settings Menu 18 Side Effects 4 SmartStart 22 41 42 Standard Menu 15 Starting Treatment 21 Stopping Treatment 23 System Specifications 31 T Travelling 25 Troubleshooting 29 U Up Down Key 14 User Owner Responsibility 1 Using the Mask Fitting feat
4. mask fitting feature delivers air pressure for a three minute period prior to starting treatment for checking and adjusting your mask fit to minimize leaks If a Ramp time is selected the mask can be adjusted at a pressure closer to the prescribed pressure To use the mask fitting feature Fit your mask as described in the user instructions Hold down the Front key for at least 3 seconds until air pressure delivery starts The following display will appear on the LCD screen indicating that the Mask Fitting feature is in operation The flow generator will ramp to the Mask Fit pressure and will remain at this pressure for 3 minutes A Mask Fit star rating Is also displayed See Definitions of Mask Fit Star Rating on page 24 Mask Fit Mask Fit Star rating excelnt RESMED Notes The Mask Fit star rating display disappears after minutes The Mask Fitting feature can only be started from the or Ramp screen e he Mask Fit pressure is the set treatment pressure or 10 cm H30 whichever is greater 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 Definitions of the Mask Fit star ratings are presented Table 4 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
5. 7 US D467335 US D468011 Other designs pending VPAP HumidAire HumidAire 2i IPAP Max IPAP Min Mirage SmartStart Smart Data Ultra Mirage and Vista are trademarks of ResMed Ltd 2003 ResMed Ltd CONTENTS INTRODUCTION anna DEFINITIONS USER OWNER RESPONSIBILITY MEDICAL INFORMATION WHAT THE VPAP AND III ST ARE FOR TELL YOUR DOCTOR IF WARNINGS CAUTIONS THE V PAP SYSTEM a a aci dois Ro oe C a dcr rbi eds VPAP COMPONENTS MASKS HUMIDIFIER ACCESSORIES PREPARING FOR USE SETTING UP THE VPAP FEATURES OF THE VPAP OPERATING INSTRUCTIONS STARTING TREATMENT STOPPING TREATMENT USING THE MASK FITTING FEATURE HELPFUL HINTS CLEANING AND MAINTENANCE DAILY WEEKLY PERIODICALLY REPLACING THE AIR FILTER SERVICING w a NOOU CONTENTS INTRODUCTION DEFINITIONS This manual contains special terms and icons that appear in the margins to draw your attention to specific and important information INTRODUCTION WARNING Alerts you to possible injury 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 proper
6. ART DATA enter exit auroaPPEAR oorr l change exit ENGLISH GERMAN FRENCH LANGUAGE ENGLISH i Eme ITALIAN SPANISH PORTUGUESE SWEDISH DUTCH SERVICING enter exit RUN HRS 8888 SN 123456789123 v D a menu item 456789 1 exit View only 123456789123 submenu item 4567 t exit View only function setting option SW View only Ax View only bold text indicates 2m 3m default setting Figure 2 VPAP Detailed Menu Series PREPARING FOR USE 17 18 MENU FUNCTIONS DETAILED MENU ONLY The VPAP menu functions are summarized in Tables 1 4 below with a brief description of what each function does and the available setting options To access these functions see Detailed Menu on page 16 SETTINGS MENU The Settings Menu allows you to view and change certain operating features of the Table 1 Settings Menu Functions Function Mask Function Description Selects your mask type Setting Options MIRAGE MIR FULL Full Face STANDARD Vista Modular ULTRA Ultra Mirage Tube Length Selects the length of air tubing connecting your mask to the VPAP 2m 3m 6ft6in 9ft10in Humidifier Selects the type of humidifier to be used with NONE PASSOVER the HUMIDAIRE If the HumidAire 2i is used the above setting options do not appear and H2i i
7. After 3 minutes treatment will begin Definitions of the Mask Fit star ratings are presented in Table 4 e If you do not wish to wait 3 minutes hold down the Front key for at least 3 seconds and treatment will begin immediately OPERATING INSTRUCTIONS 23 f you press the Front key for less than 3 seconds the unit will return to standby mode the or Ramp screen 15 displayed Table 5 Definitions of Mask Fit Star Rating Star rating Definition EERE Excellent dide Very good Good dde Adjust mask Adjust mask HIGH LEAK Adjust mask HELPFUL HINTS STARTING OUT MOUTH LEAKS If 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 equipment 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 size or style of mask You can also use the Mask Fitting feature to help you fit your mask properly See Using the Mask Fitting Feature on page 23 Before wearing your mask wash your fac
8. Flicker Complies domestic purposes Emissions IEC 61000 3 3 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 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the VPAP 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 immunity of the SYSTEM SPECIFICATIONS 35 36 Guidance and manufacturer s declaration electromagnetic immunity The VPAP is intended for use in the electromagnetic environment specified below The customer or the user of the VPAP should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE Ut is the a c mains voltage prior to application of the test level Continued next page IEC60601 1 2 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mo
9. O measured at the end of standard 2m air tubing EPAP 4 cm H20 to 25 cm H O measured at the end of standard 2m air tubing Maximum single fault pressure 40 cmH O Dynamic flow characteristics 130 L min at 4 to 20 H O Sound pressure level lt 30 dB tested in accordance with the requirements of ISO 17510 1 2002 Dimensions x W x D 5 6in x 9 lin x 10 6in Weight 5 116 Air outlet 22mm taper compatible with EN 1281 1 1997 Anaesthetic amp Respiratory Equipment Conical Connectors Pressure measurement Internally mounted pressure transducer Flow measurement Internally mounted flow transducer Power Supply Input range 00 240V 50 60Hz 40VA typical power consumption lt OOVA maximum power consumption Housing Construction Flame retardant engineering thermoplastic Environmental Conditions Operating Temperature 41 to 104 F Operating Humidity 1076 9576 non condensing Storage and Transport Temperature 4 F to 140 F Storage and Transport Humidity 10 95 non condensing Electromagnetic Compatibility Product complies with all applicable electromagnetic compatibility requirements EMC according to IEC6060 1 1 2 for residential commercial and light industry environments For further details see Guidance and Manufacturer s Declaration Electromagnetic Emissions and Immunity on page 35 Air Filter Two layered powder bonded polyester non woven fiber Air Tubing Flexible plastic 6ft6in or 9f
10. P detailed menu series To access the VPAP menus Press the Left key menu while the VPAP or Ramp screen is displayed To scroll through ttems within a menu or submenu Press the Up Down key To enter a submenu Press the Left key enter To change a setting option for a function Press the Left key change 2 Press the Up Down key until the desired setting option appears 3 Press the Left key apply to select the setting option To exit without changing options Press the Right key cancel To exit out of a menu or submenu Press the Right key exit Note You can return to the VPAP or Ramp screen at any time by holding the Right key for at least 3 seconds VPAP screen Ramp screen RESMED VPAP III menu OFF 5 10 15 20 25 30 35 40 45 min RAMP 20min menu SETTINGS enter MASK ULTRA MIRAGE MIR FULL change exit STANDARD ULTRA TUBE LENGTH 2m change exit 2m 3m NONE PASSOVER HUMIDAIRE HUMID NONE If the HumidAire 2i is used the above change 1 exit options do not appear and H2i is displayed SMARTSTART OFF change exit ON OFF MASK ALARM OFF OFF change exit A a M LL a a 5 RESULTS enter exit amp MASK FIT These menus appear BM TOT good 1 exit only if at least one USAGE uns 7 Smart Data option has been enabled by the clinician OPTIONS enter t exit SM
11. VPAP amp III ST Reorder number 24807 1 03 06 USER S MANUAL English USA RESMED VPAP amp III ST Reorder number 24807 1 03 06 USER S MANUAL English USA Manufactured by ResMed Ltd 97 Waterloo Road North Ryde NSW 2113 Australia Tel 61 2 9886 5000 or 1 800 658 189 toll free Fax 61 2 9878 0120 Email reception 9 resmed com au Distributed by ResMed Corp 14040 Danielson Street Poway CA 92064 6857 USA Tel 1 858 746 2400 or 1 800 424 0737 toll free Fax 1 858 746 2900 Email reception 9 resmed com ResMed UK Limited 65 Milton Park Abingdon Oxfordshire OX14 4RX UK Tel 44 1235 862 997 Fax 44 1235 831 336 Email reception 9 resmed co uk ResMed Asia Pacific Ltd 97 Waterloo Road North Ryde NSW 2113 Australia Tel 61 2 9886 5000 or 1 800 991 900 toll free Fax 61 2 9889 1471 Email reception 9 resmed com au ResMed Finland Niittykatu 6 FIN 02200 ESPOO Suomi Puh 358 9 8676820 Faksi 358 9 86768222 S hk posti reception 9 resmed fi ResMed GmbH amp Co KG RudolfstraBe 10 D 41068 M nchengladbach Deutschland Tel 49 0 2161 3521 0 Reception 49 0 180 22 22 668 Service Telefon 0 06 Anruf 49 0 180 22 66 888 Wartungstelefon 0 06 Anruf Fax 49 0 2161 3521 1499 Email reception resmed de ResMed Japan Nihonbashi Hisamatsu Bldg 4F 2 28 1 Nihonbashi Hamacho Chuo Ku Tokyo 103 0007 Japan Tel 81 3 3662 5056 Fax 81 3 3662 5040 ResMed Malaysia Sd
12. a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance 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 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 Product Warranty Period AutoSet CS flow generator ResMed humidifiers ResControl 1 Year ResLink flow generator CPAP flow generator AutoSet T flow 2 Years generator AutoSet Spirit flow generator Accessories mask systems including mask frame cushion 90 Days headgear and tubing Excludes single use devices If the product fails under conditions of normal use ResMed will repair or replace 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 a
13. an 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 22 Ramp time can be altered in 5 minute increments from OFF to a maximum ramp time set by your clinician by the using the Up Down key MENU TYPE Depending on the type of menu that your clinician has set for your machine either a standard menu or a detailed menu appears STANDARD MENU The standard menu allows you to view details about the run hours and the current software version of your VPAP The Run Hours screen displays the total number of hours the VPAP has been used Figure summarizes the VPAP standard menu series o access the VPAP menus Press the Left key menu while the VPAP or Ramp screen is displayed To scroll through items within the menu Press the Up Down key o exit out of the menu Press the Right key exit VPAP screen Ramp screen RESMED VPAP III menu RUN HRS 8888 exit SW S11601009 5 exit Figure 1 VPAP Standard Menu Series OFF 5 10 15 20 25 30 35 40 45 min RAMP 20min menu View only View only PREPARING FOR USE 15 16 DETAILED MENU The detailed menu allows you to view and change settings such as mask type tube length and the humidifier used You can also view the run hours serial number and current software version of your VPAP Figure 2 summarizes the VPA
14. ates a patient triggered change and T Timed indicates a device triggered change Pressure bar graph Graphical display of the changing pressure Leak Current mask leak litres per minute Respiratory rate Number of breaths per minute Minute ventilation Volume of air inhaled per minute litres per minute It is the product of respiratory rate and tidal volume Tidal volume Volume of air inhaled per breath millilitres per breath RAMP TIME 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 pressure over the selected ramp time The clinician has set a maximum ramp time you may select any value up to the maximum SMARTSTART The VPAP has a function called SmartStart which can be enabled by your clinician If SmartStart is enabled VPAP will start automatically when you breathe into the mask and will stop automatically when you take your mask off This means you do not have to press the Front key to begin or end treatment STOPPING TREATMENT To stop treatment at any time remove your mask and press the Front key or if your clinician has enabled the SmartStart function simply remove your mask and treatment will end USING THE MASK FITTING FEATURE The VPAP Mask Fitting feature can be used to help you fit your mask properly The
15. d 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 CPAP or bilevel devices Ports may be incorporated in the mask or in connectors that are near the mask e he unit should only be connected to the components humidifiers or accessories specified in this manual Connection of other items may result in injury or damage to the VPAP unit e At low pressures the flow through the exhalation ports of your mask may not clear all exhaled gas from the tubing Some rebreathing may occur Explosion hazard do not use in the vicinity of flammable anesthetics e If oxygen is used with this device the oxygen flow must be turned off when the device is not operating Explanation of the warning VVhen the device is not in operation and the oxygen flow is left on oxygen delivered into the ventilator tubing may accumulate within the device enclosure Oxygen accumulated in the device enclosure will create a risk of fire This warning applies to most types of flow generators Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame Always ensure air flow is being generated by the device before the oxygen supply Is turned on Always turn the oxygen supply off before stopping the air flow from the device Note At a fixed rate of supplemental oxygen flow the inhaled oxygen concentrati
16. d in the morning if you reset the device If Auto Appear is set to OFF Smart Data is displayed in the Results menu only Language Selects the language the VPAP uses for all its display text English is the default language English German French Italian Spanish Portuguese Swedish Dutch SERVICING MENU Table 4 Servicing Menu Function Function Description Setting Options Run hours Displays the total number of machine hours View only Serial Number Displays the serial number for the View only SN Printed Circuit Displays the printed circuit board number View only Board PCB Software Displays the current software version installed View only in the These items also appear in the Standard Menu PREPARING FOR USE 19 20 OPERATING INSTRUCTIONS STARTING TREATMENT The VPAP unit should be assembled beside your bed with the air tubing and mask system connected See Setting Up The VPAP on page 9 1 Turn the main power switch at the back of the unit to on I Main power switch When the is turned on a welcome message is displayed on the LCD screen The VPAP or Ramp screen then appears Note If you have the HumidAire 2i attached please refer to the HumidAire 2i User s Manual for operating instructions 2 Fit your mask as described in the mask user instructions 3 Lie down and arrange the air tubing so that it is free to move if you turn
17. de 2 kV common mode lt 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles lt 5 Ut gt 95 dip in Ut for 5 sec 3 A m Compliance level 6 kV contact 8 kV air 2 kV Not Applicable 1 kV differential mode 2 kV common mode lt 12V gt 95 dip in 240V for 0 5 cycle 96V 6096 dip in 240V for 5 cycles 168V 3096 dip in 240V for 25 cycles 12V gt 95 dip in 240V for 5 sec 3 A m Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the VPAP requires continued operation during power mains interruptions it is recommended that the VPAP be powered from an uninterruptible power source Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Guidance and manufacturer s declaration electromagnetic immunity Continued The VPAP is intended for use in the electromagnetic environment specified below The customer or t
18. e performed by an authorized service agent REPLACING THE AIR FILTER Inspect the air filter every month to check if it is blocked by dirt or contains holes With normal use of a VPAP unit the air filter needs to be replaced every six months or more often if your unit is in a dusty environment To replace the air filter Remove the air filter cover at the back of the VPAP Air filter cover 2 Remove and discard the old air filter 3 Insert a new filter with the blue tinted side facing out 4 Replace the air filter cover WARNING Do not wash the air filter The air filter is not washable or reusable Note The air filter should be inspected once a month SERVICING Your VPAP flow generator is designed to give you years of trouble free operation The flow generator should not require regular servicing if it is maintained according to the instructions in this manual If you feel that your unit is not performing properly see Troubleshooting on page 29 CAUTION 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 TROUBLESHOOTING If 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 unit Problem No display Possible Cause Power not connected or switch at back is not on
19. e radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically 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 the VPAP is used exceeds the applicable RF compliance level above the VPAP should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the VPAP b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m 37 38 Recommended separation distances between portable and mobile RF communications equipment and the VPAP The VPAP is intended for use in an environment in which radiated RF disturbances are controlled The customer or the user of the VPAP can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the VPAP as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output 150kHz to 8OMHz 80 MHz to 800 MHz 800MHz to 2 5 GHz power of transmitter W d 1 17 d 0 35 VP d 0 35 NP 0 01 0 17 0 04 0 04 0 1 0 37 0 11 0 11 1 1 17 0 35 0 35 10 3 69 1 71 1 11 100 11 70 3 50 3 50 For transmitters rated at
20. e right to change these specifications without notice SYMBOLS WHICH APPEAR ON THE PRODUCT N Attention consult accompanying documents Class Il equipment Type CF equipment 4 Drip Proof IPX1 go Start Stop or Mask Fit SYSTEM SPECIFICATIONS 33 34 MASK FLOW PRESSURE CHARACTERISTICS Flow L min 70 60 50 40 30 20 10 5 10 15 Pressure cm H O Vista Mirage Modular Mirage Full Face Mask Series 2 Ultra Mirage 20 25 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS AND IMMUNITY Guidance and manufacturer s declaration electromagnetic emissions The VPAP is intended for use in the electromagnetic environment specified below The customer or the user of the VPAP should assure that it is used in such an environment Ec i Electromagnetic environment Emissions test Compliance guidance RF emissions CISPR11 Group 1 The VPAP 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 equipment RF emissions CISPR 11 The VPAP is suitable for use in all establishments including domestic Harmonic Emissions Class A establishments and those directly IEC 61000 3 2 connected to the public low voltage network that supplies buildings used for Voltage Fluctuations
21. e 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 winter 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 TRAVELLING WITH THE VPAP INTERNATIONAL USE Your flow generator has an internal power adapter that enables it to operate other countries It will operate on power supplies of 100 240 and 50 60Hz No special adjustment is necessary but you may need a plug adapter for the power outlet OPERATING INSTRUCTIONS 25 26 CLEANING AND MAINTENANCE You should regularly carry out the cleaning and maintenance described in this section DAILY Disconnect the air tubing and hang it in a clean dry place until next use Do not hang the air tubing in direct sunlight as it may harden and crack over time 2 Clean the mask according to the mask user instructions 3 If you are using a humidifier clean it according to the instructions in the manual WEEKLY Remove the air tubing from the VPAP unit and the mask 2 Wash the mask system according to the instruction
22. ercised if you are dehydrated or may become dehydrated for example as a result of fluid restriction or diuretic therapy including changes in therapy Discontinue therapy and seek medical advice if during therapy or when you start therapy each night you feel faint or light headed The following are general warnings that pertain to your use of a VPAP unit Specific warnings appear next to the relevant instructions in the manual WARNING e This is NOT a life support device It may stop operating with power failure or if a fault occurs in the unit The air flow for breathing produced by this device can be as much as 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 e The unit should only be used with masks and connectors recommended by ResMed or by your physician or respiratory therapist A mask should not be used unless the VPAP unit is turned on and operating properly The vent hole or holes associated with the mask should never be blocked Explanation The VPAP unit 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 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 through the mask and the exhale
23. he user of the VPAP should assure that it is used in such an environment IEC60601 1 2 test level Compliance Immunity test y level Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 10 V m IEC 61000 4 3 80 MHz to 2 5 GHz Electromagnetic environment guidance SYSTEM SPECIFICATIONS Portable and mobile RF communications equipment should be used no closer to any part of the VPAP including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17 d 0 35 NP 80 MHz to 800 MHz d 0 70 NP 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 NOTE 1 At 80 MHz and 800MHZz 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 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobil
24. ight key Up down key The VPAP keypad has the following keys Key Function Front Starts or stops treatment sw e Extended hold for at least seconds starts the Mask Fitting feature n Up Down Allows you to scroll through the VPAP menus submenus and setting options Left Performs the function indicated by the guiding text displayed above it on the LCD screen Guiding text includes menu enter change and IJ apply Right Performs the function indicated by the guiding text displayed above it 2 the LCD screen Guiding text includes exit and cancel To assist you in adjusting the VPAP 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 2 minutes The keypad backlight is on at all times when the VPAP is on 14 USING THE MENUS The VPAP 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 at any time regardless of whether the VPAP is in stand by mode delivering therapy or downloading data After the Welcome screen appears and device self checks are complete the VPAP or Ramp screen appears RAMP SCREEN If your clinician has set a maximum ramp time the Ramp screen is displayed after the Welcome screen On the Ramp screen you c
25. in your sleep CAUTION Do not leave long lengths of air tubing around the top of your bed It could twist around your head or neck while you are sleeping Make sure the area around the flow generator is dry and clean It should also be clear of bedding clothes and other potential blockages 4 To start treatment press the Front key or if your clinician has enabled the SmartStart function simply breathe into the mask and treatment will begin After starting treatment you can display one of the two treatment screens below Press the Up Down key to switch between views OPERATING INSTRUCTIONS 21 Ramping indicator Set pressure s U S RAMP 8 0 16 6 Trigger indicator S gt gt gt gt gt exit Pressure bar graph Respiratory rate Leak Minute ventilation LK 24L min RR 12 MV 12 0 VT 1000 Tidal volume Following are the descriptions of the treatment screens Treatment mode Mode of treatment set by your clinician Options include CPAP Spontaneous Spontaneous Timed VPAP III ST and Timed VPAP III ST Ramping indicator Appears ifthe VPAP is in ramp mode This disappears once the ramp time has elapsed Set pressure s In CPAP mode it is the set treatment pressure centimetres of water In other modes it is exhalation and inhalation pressures centimetres of water Trigger indicator How the changes the pressure when you are inhaling S Spontaneous indic
26. mmunications port is a modem that is locally approved Locally approved modems may also be connected in the clinical environment Inthe clinical environment any PC that is used with the VPAP system must be at least 5 5ft away from or at least 2 5m 8ft above the patient It must also comply with IEC 60950 or equivalent THE VPAP SYSTEM MASKS You will also need a ResMed mask system supplied separately The following ResMed mask systems are recommended for use with the VPAP D MIRAGE MASK MIRAGE VISTA MASK MASK k MIRAGE FULL FACE MODULAR MASK MASK SERIES 2 Note ResMed VPAP 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 To select an appropriate setting for another mask system find the closest match to ResMed mask in the Mask Flow Pressure Characteristics on page 34 HUMIDIFIER A humidifier may be required if you are experiencing dryness of the nose throat or mouth The is compatible for use with the following humidifiers HUMIDAIRE 2i heated humidifier HUMIDAIRE 21 passover humidifier 422 Ss 5 HUMIDAIRE heated humidifier ResMed PASSOVER humidifier WARNING Only the HumidAire 2i HumidAire 2iC HumidAire heated humidifier and the ResMed Passover are compatible for use with the VPAP Please refer to Warning
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28. nstructions Connect your mask system to the free end of the air tubing The VPAP is now ready for use To start treatment see Operating Instructions on page 21 HUMIDIFIER USE WARNING When using a humidifier position it lower than you and at the same level or lower than the VPAP HUMIDAIRE 2i The HUMIDAIRE 2i attaches to the front of the to provide heated humidification No other accessories are required for its use The VPAP automatically detects the presence ofthe HUMIDAIRE 2i No menu changes are required Please refer to the HumidAire 2i User s Manual for details HUMIDAIRE 2iC The HUMIDAIRE 2iC attaches to the front of a VPAP unit to provide passover humidification No other accessories are required for its use Please refer to the HumidAire 2iC User s Manual for details PREPARING FOR USE 11 HUMIDAIRE AND RESMED PASSOVER HUMIDIFIERS Medium size 2 in air tubing is a necessary accessory for connecting the VPAP unit to the HUMIDAIRE and ResMed PASSOVER humidifiers To set up the VPAP with the HUMIDAIRE or ResMed PASSOVER 1 Fill the HUMIDAIRE or PASSOVER with water as described in the humidifier manual 2 HumidAire Users Place the filled water chamber inside the HUMIDAIRE Connect the medium 2 in air tubing to the right connector port and the long air tubing 6ft6in or 9ft Oin to the left connector port on the humidifier Close the HUMIDAIRE lid ResMed Pass
29. on will vary depending on where the oxygen is introduced pressure settings patient breathing pattem mask selection and leak rate This applies to most types of flow generators WARNINGS RELATED TO TREATMENT WARNING e f you stop your CPAP 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 unit f 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 CPAP or bilevel It is also important to contact the clinician who is treating you for sleep apnea e If you experience an infection of the upper respiratory tract middle ear or sinuses contact your clinician before continuing your CPAP 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 The following are general cautions Specific cautions appear next to the relevant Instructions in the manual CAUTION Do not open the VPAP case There are no user serviceable parts inside Repairs and internal servicing should only be performed by an authorized service agent MEDICAL INFORMATION POSSIBLE SIDE EFFECTS The flow generator is designed to help you have a good night s sleep However you need to be aware of possible
30. over Users Connect the medium 2 in air tubing to the right connector port and the long air tubing 6ft6in or 9ft to the left connector port on the humidifier Medium 2 lin air tubing Medium 2 lin air tubing Long air tubing Long air tubing HumidAire ResMed Passover 3 Place the VPAP on top of the HUMIDAIRE or PASSOVER Do not place the VPAP unit underneath the humidifier This is to avoid water spilling into the unit HumidAire ResMed Passover 12 4 Connect the free end of the medium air tubing to the air outlet of the VPAP HumidAire ResMed Passover 5 Connect the mask system to the free end of the long air tubing The final assembly should look like this HumidAire ResMed Passover 6 HumidAire Users Plug the HUMIDAIRE power cord into a power outlet 7 Connect the power cord to the socket at the rear of the VPAP Plug the other end of the power cord into a power outlet WARNING Make sure that the power cord and plug are in good condition and the equipment is not damaged 8 Navigate to the humidifier setting if available in the VPAP menu See Detailed Menu on page l6 The VPAP is now ready for use with the HUMIDAIRE or the ResMed PASSOVER To start treatment see Operating Instructions on page 21 PREPARING FOR USE 13 FEATURES OF THE VPAP LCD SCREEN AND KEYPAD The control panel of the VPAP includes an LCD screen and keypad LCD screen Left key R
31. problems that may arise during CPAP or bilevel treatment WARNING Consult your clinician immediately if you experience any of the following symptoms during your CPAP or bilevel treatment headache e middle ear or sinus discomfort chest pain dryness of the nose mouth or throat e feeling bloated due to air swallowing air continually leaking out of the mouth while sleeping recurrence of any sleep apnea symptoms while on CPAP or bilevel Skin irritation may occur from sensitivity to the mask materials or from excessively tight headgear straps A correctly fitted mask and appropriately adjusted straps will often prevent skin irritation If problems persist contact your clinician for advice THE VPAP SYSTEM VPAP COMPONENTS Please identify and familiarize yourself with the following components of the VPAP unit VPAP III or VPAP ST Unit Front View Rear View LCD poe screen Filter cover Control panel Power switch Power Removable socket M front Auxiliary Serial Air outlet port communications port Power cord Carry bag Air tubing 6ft6in 2m WARNING Do not connect any device to the auxiliary port Although your health care provider may connect specially designed devices to the auxiliary port of the VPAP unit connection of other devices could result in injury or damage of the unit the home environment the only device that may be connected to the co
32. s on page 2 ACCESSORIES The following accessories are available for use with the VPAP ACCESSORY Air tubing 9ftlOin 3m HUMIDIFIER ACCESSORY HUMIDAIRE AND RESMED PASSOVER ONLY Medium air tubing 2 lin 52cm THE VPAP SYSTEM PREPARING FOR USE SETTING UP THE VPAP 1 Place the VPAP unit on a flat surface near the head of your bed If the unit is placed on the floor ensure that the area 15 free from dust and clear of bedding clothes or any other objects that could block the air inlet CAUTION Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord 2 Connect the power cord to the socket at the rear of the flow generator Plug the other end of the power cord into a power outlet Air filter _ power outlet WARNING Make sure the power cord and plug are in good condition and the equipment is not damaged The air filter cover protects the device in the event of accidental liquid spillage onto the device Ensure that the air filter and air filter cover are fitted at all times 3 Connect one end of the air tubing firmly onto the air outlet of the unit PREPARING FOR USE 10 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 Assemble your mask system according to the mask user I
33. s displayed SmartStart Turns the SmartStart function on or off ON OFF See SmartStart on page 22 Mask Alarm Turns the Mask Alarm signal on or off ON OFF If enabled the Mask Alarm feature will alert you when a high mask leak is detected An audible tone will sound and a high leak message will appear on the LCD screen Note If you select Mir Full as the mask option SmartStop is automatically disabled SmartStart may not work with a Mirage Full Face Mask due to safety features of the mask When Mask Alarm is set to ON SmartStart Stop automatically reverts to OFF SmartStop cannot be used with Mask Alarm because if a high leak occurs SmartStop will stop treatment before the Mask Alarm signal is activated RESULTS MENU Note These menus appear only if at least one Smart Data option has been enabled by the clinician See the VPAP Ill Smart Data Diary for further details Table 2 Results Menu Function Function Description Setting Options Mask Fit Displays a star rating corresponding to the View only Smart Data mask leak from the previous session Usage Displays usage hours from the previous View only Smart Data session OPTIONS MENU Table 3 Options Menu Function Function Description Setting Options Smart Data The Smart Data menu is displayed ON OFF Auto Appear or more of the options have been set to ON by the clinician If Auto Appear is set to ON the Smart Data screens are displaye
34. s supplied with it 3 Wash the air tubing in warm water using mild detergent Rinse thoroughly hang and allow to dry 4 Before next use assemble the mask and headgear according to the mask user instructions 5 Reconnect the air tubing to the air outlet and mask CAUTION Do not use bleach chlorine alcohol or aromatic based solutions including all scented oils moisturizing or antibacterial soaps to clean the cushion mask air tubing or the VPAP These solutions may cause hardening and reduce the life of the product Do not wash or dry the mask frame at a temperature above 176 F 80 C Exposure to higher temperatures may reduce the life of the product e Do not hang the air tubing in direct sunlight as the tubing may harden over time and eventually crack PERIODICALLY The mask and air tubing are subject to normal wear and tear Inspect them regularly for damage 2 Clean the exterior of the flow generator with a damp cloth and mild detergent 3 Inspect the air filter to check if it is blocked by dirt or contains holes See Replacing the Air Filter on page 28 WARNING Beware of electric shock Do not immerse the flow generator or power cord in water Always unplug the flow generator before cleaning and be sure that it is dry before reconnecting CLEANING AND MAINTENANCE 27 CAUTION Do not attempt to open the VPAP There are no user serviceable parts inside Repairs and internal servicing should only b
35. tlOin length IEC 60601 1 Classifications Class double insulation Type CF SYSTEM SPECIFICATIONS 31 Table 6 Displayed values Value Range Accuracy Display Resolution Pressure sensor at air outlet Pressure 5 to 30 cm H O 0 5 cm H2O 0 1 cm H O Flow sensor in flow generator Leak 0 120 L min 1 L min Tidal volume 100 3000 mL ui Tamil Respiratory rate 6 60 BPM 0 5 BPM 0 1 BPM Minute ventilation 0 6 60 L min TA 0 25 L min Results may be inaccurate in the presence of leaks The displayed values are estimates They are provided for trending purposes only Table 7 Maximum low impedance flow at stated pressures Pressure Flow cm H5O L min 6 6 177 13 2 202 20 0 202 PRESSURE VARIATION 25 00 Max Pressure 20 00 T 15 00 2 3 Pressure 2 10 00 amp 1 3 5 00 10 BPM 15 BPM 20 0 00 0 1 2 3 Breaths PRESSURE VOLUME CURVE 1 3 Max Pressure 2 3 Max Pressure 600 600 _ 500 _ 500 400 400 E 300 E 300 5 200 5 200 100 100 0 0 z 6 3 6 4 6 5 6 6 6 7 6 8 13 1 13 2 13 3 13 4 13 5 13 6 Pressure cm H O Pressure cm H O Max Pressure 600 _ 500 10 400 15 300 20 200 19 7 19 8 19 9 20 0 20 1 20 2 Pressure cm H O Note The manufacturer reserves th
36. ty 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 manual carefully before use MEDICAL INFORMATION WHAT THE VPAP 1 AND VPAP III ST ARE FOR The VPAP and VPAP III ST systems are intended for the treatment of adult patients with obstructive sleep apnea OSA CAUTION USA ONLY Federal law restricts this device to sale by or on the order of a physician TELL YOUR DOCTOR IF You must tell your doctor and CPAP continuous positive airway pressure or bilevel therapy must not be used if you have any of the following conditions e pneumothorax or pneumomediastinum e severe heart failure low blood pressure or dehydration surgery to the brain middle or inner ear pituitary gland or sinuses respiratory distress syndrome e middle ear infection or perforated ear drum severe nosebleed WARNINGS CPAP or bilevel therapy should be used with caution if you have any of the following conditions e respiratory failure cavities or cysts in the lung or previous history of pneumothorax e previous history of severe nosebleed e sinus infection Tell your doctor if you have any of these conditions Your doctor will advise you whether the likely benefits of CPAP or bilevel therapy outweigh the expected risks Special care should be ex
37. ure 23 Using the Menus 15 W Warnings Related to Treatment 3 Weekly Cleaning 27 Weight 31
38. uthorized 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 the flow generator Any product repaired or replaced under warranty will be returned freight prepaid to the dealer designated by the consumer The cost of transporting the product to an authorized service organization will be borne by the consumer 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 or ResMed office ROOO 303 4 02 11 LIMITED WARRANTY 39 40 INDEX A Accessories 7 Air Filter 31 Air filter 28 Air Tubing 31 B Back light LCD and Keypad 14 Cleaning and Maintenance 27 Cleaning Periodically 27
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