ResMed VPAP VPAP Adapt SV System manuale d’uso

VP AP ™ A dapt S V User Guide English Front Cover - User.qxp 05/04/2006 4:31 PM Page 1[...]

Global leaders in sleep and respiratory medicine www .m yr esmed.com 26869/2 06 04 VP AP Adapt S V User US A ENG Bleed this panel onto spine (if applicable) but NOT onto Front Cover Front Cover - User.qxp 05/04/2006 4:31 PM Page 2[...]

VP AP ™ Ad a p t SV User Guide English Reorder numb er: 26869/2 06 04[...]

ResMed Ltd (Manufacturer) 1 Elizabeth MacArthur Drive B ella Vista NSW 2153 A ustralia ResMed Corp (US Designated Agent) 1 4040 Danielson Street P ow ay CA 92064-6857 USA ResMed (UK) Ltd (EU Authorized R epresentative) 65 Milton Park Abingdon Oxfordshire O X1 4 4RX UK ResMed Offices Australia, A ustria, Finland, F rance, Germany , Hong Kong, Japan,[...]

i Cont ents Cont ents Introduct ion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 VP AP™ A dapt S V 1 User/owner responsibility 1 Definitions 1 Medical Inf ormation 1 Intended Use 1 Contraind ications 1 W a rnings 2 Cautions 2 Quic k S etup Guide . . . . . . . . . . . . . . . . . . . . . . . . . .[...]

ii Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Daily 31 W eek ly 31 P eriodically 32 Air Filter 33 Hypoall ergenic Ai r Filter 33 Ser vicing 33 T roub leshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Glossary . . . . . . . . . . . . . . . . . . . . . . [...]

1 Intr oduction Introduction VPAP ™ Adapt SV The VP AP ™ Ad ap t SV flow generator h as been des igned to b e reliable, comfortabl e and ea sy to use. You can ob serve yo ur treatment and mak e adju stments t o settin gs usin g a keypa d and LCD sc reen. ! CAUTION USA federal la w restricts this device to sale by or on the order of a physi cian[...]

2 • impaire d ability to c lear secr etions • pneumoth orax or pn eumomedi astinum • recen t cranial trauma or su rgery • c hronic h ypov entilation. Below ar e gener al w ar nings and cautions. F urt her specific w ar nings, cautions an d notes appear next to th e rel ev ant instr uctions in the manual. ! Warnings • The VP AP Adapt SV is[...]

3 Intr oduction The follow ing sid e effects m a y ar ise durin g a cours e of therap y with the VP AP Adapt SV: • drying o f the nose, mouth, or throat • bloatin g • ear or si nus dis comfort • ey e irritation • skin r ashes • c hest discom fort.[...]

4[...]

5 Quick S etup Guide Quick Setup Guide 1 Attach the a ir tubing a nd pressu re sensor tu be to the VP AP Adapt SV and mask (page 9). 2 Attach a humi difier if req uired (pa ge 11). 3 Switch on the VP AP Ada pt SV. Make s ure the ma sk is unblo cked. 4 Select the mask setting (p age 22). 5 Perform the Ai r Circuit Learn function (pa ge 22) at first-[...]

6[...]

7 VP AP Adapt SV System VPAP Adapt SV Syste m VPAP Adapt SV Componen ts The VP AP Adapt SV flo w genera tor is supplied w ith air tubing an d a power co rd. Masks ar e supplied separately , as you and your c linician ha ve to decide whi ch mas k is best for you. Masks that ca n be used w it h VP AP Adapt SV are lis ted on page 8. Some peo ple exp e[...]

8 Figu re 3 : Ai r tu bing fu lly a sse mbled All neces sary ai r tubing co mponents are packed with th e VP A P Adapt SV: • a 6’6" (2 m) length of air tu bing • a pressure sensor t ube (to meas ure pressure at the mas k) with Luer connec tors • tube clip s (to ho ld the p ressu re senso r tube ont o the a ir tubing) • a pro ximal cu[...]

9 VP AP Adapt SV System Assembling the VPAP Ada pt SV System Complete th e following s teps to a ssemble the VP AP Adapt SV syste m. Mak e sure the area around the uni t is clean (dus t free) and clear of be dding, clo thes and any other pote ntial blockag es. To add a humidifie r see pag e 11. ! WARNI NG Use only the air tubing s ystem su pplied w[...]

10 2 Connect air t ubing Connect the air tube fir mly ont o the air outl et at the fr ont of the unit . Figu re 4: Front vi ew of VP AP Ada pt SV T o attach t he press ure se nsor tube to the unit , screw the Luer connector on to the sock et on the side of the unit . Figure 5: Twis ting the Luer lock conne ctors together ! WARNI NG Use care wh en h[...]

11 VP AP Adapt SV System Humidifiers A humidifie r may be required if you are e xperienci ng dryness of the nose , throat , or mouth. Th e followi ng ResMed humidifiers are comp atible wi th the VP AP Adapt SV: Figu re 7: H umi difiers comp atib le wit h the VP AP Ad apt SV When using a humidifier, stop the VP AP Adap t SV by using the Start/Stop k[...]

12 HumidAire 2i™ The Hum idAire 2i pr ovides hea ted humidi fication for the VPAP Ad apt SV. To attach the HumidAire 2 i , remove the VP AP Adapt SV front cover and a ttach the humidi fier docking station a nd water chamber. No other ac cessories a re required for use . Plea se refer to the HumidAire 2i User’s Ma nual for details . Once you hav[...]

13 VP AP Adapt SV System HumidAire™ You will ne ed a medium si z e 21" (5 2 cm) air tube to connect th e VP AP Adapt SV unit to the HumidAire™ (see Fi gure 7). 1 Make sure bo th the HumidAire and th e VP AP Adapt SV a re turned o ff. Fill the HumidAire with w ater as descri bed in the humidifie r manual. Pl ace the filled water c hamber i [...]

14 5 Connect the mask sys tem to the fre e end of the lo ng air tubing. Th e final assembl y should look like this : 6 Switch on the HumidAire and the VP AP Adapt SV . ! WARNI NG Make sure that the powe r cords and p lugs are in g ood condition and the equipment is not damaged . 7 Perform the Ai r Circuit Learn function (se e page 22). For informa [...]

15 VP AP Adapt SV System ResLink™ The Res Lin k is a devi ce that records data onto a SmartMe d ia™ car d during yo ur therapy. T he card can be re turned to yo ur clinician so that they can observe you r progress and adjust flow ge nerator par ameters if nec essary. Th e Res Li n k connects to the bac k of VP AP Ada pt SV as shown. F or full d[...]

16 Using DC Power to Run t he VPAP Adapt SV The VPAP Adapt SV ca n be run on DC in case of power failure. ResM ed supplie s separately a co nverter that al lows a 12 V or 24 V b attery to be con nected to the DC inpu t of the VP AP Adapt S V. When u s ing DC, power is turned on and off via the switch o n the connec tor that connects the DC-DC conve[...]

17 Using th e VP AP Adapt SV Using the VPAP Adapt SV ! WARNI NG Before starting therapy with a new ma sk select the correct mas k type in the Settings menu (page 22 ). When adding or removing a ne w component su ch as a mask, h umidifier, or anti -bacterial filter, pe rform the Air Circuit Lea rn function (page 22). Starting Treatment When the sy s[...]

18 Control Panel Functions The contro l panel o f the VP AP Adapt SV has a keyp ad tha t allows you to: • start or stop treatment • adjust set tings on the flow generato r • mute o r stop al arms • view treatm ent dat a. Figure 13: The VPAP Adapt SV control panel LCD s creen Displays informati on about fl ow generat or setting s, alarms a n[...]

19 Using th e VP AP Adapt SV Left k ey (green) • Enters a men u . • Confirms and appl ies set tings. • P erforms the function indicated by the tex t abov e it in the LCD (eg, ’enter ’ , ’c hange’). Right k ey (red) • P erforms the function indicated b y the text a bov e it in the LCD (eg, ’e xit’). • Cancels operatio ns. • E[...]

20 To chang e a settin g, press t he Up /Down key un til you a rrive at the men u you require. • Pr ess the Left k ey to enter the menu, then use the Up/Down k ey again to scroll throu gh the options. • Once y ou find the option y ou require press the Left k ey to select the func tion that is d isplay ed in the bot tom lef t of the screen (eg, [...]

21 Using th e VP AP Adapt SV Menus The option s avail able in the Settings menu wi ll depend on the the rapy you are receivin g (either ASV or CPAP mode ), as set by your clinic ian. Figure 15: Navigating the Pa tient menu A VG PRESS: 10.4 SW: SX432-0100 VP AP Adapt SV ASV MODE SOUND LEVEL:LOW SOUND LEVEL:LOW These menus appe ar only if at least on[...]

22 Setting s Menu You will only see the option s releva nt to your th erapy. In CPAP ( Continuous Positive Airw ay Pressure) mo de, the clini cian sets a p ressure that w ill be constant throughout t reatment. In ASV mode, the VP A P Adapt SV continua lly meas ures you r breat hing and regu lates t he air pre ssure accord ingly. Mask Select the ty [...]

23 Using th e VP AP Adapt SV 7 . When the functio n is comple te, a screen w ill appear s ay ing that the circui t has bee n learned successfu lly . The ne xt menu item is then dis play ed. Commenc e treatment as describe d in “Starting T reatment” on page 1 7. If there is a problem with the circuit a screen saying ’Inv alid ci rcuit’ wi ll[...]

24 Mask-fit Gives a rating of how well th e mask wa s fitting du ring your la st session on the VP AP Adapt SV. T he star s indicate ho w good the fit was ( more stars = better fit). Averag e Pressure Provides informatio n on the avera ge air pr essure du ring your mos t recent session on the VP AP Adapt SV . Usage Tells yo u how lon g the VP AP Ad[...]

25 Using th e VP AP Adapt SV Servicing Menu This men u displa ys the fol lowing i nformation : • SN—the flo w generator’ s serial num ber • PCB—the flo w gen erator’ s PCB numbe r (PCB—printed circuit bo ard) • SW—the version of sof tware cur rently installed on t he flo w generator . Treatment Screens There are th ree Treatm ent [...]

26[...]

27 Ala rms Alarms The VP AP Adapt S V unit is fitted with alarms to alert y ou to changes that will affec t your t reatmen t. The mos t commo n reason for an al arm to sou nd is because the system has not been pro perly assem bled. Check tha t the air tubin g and pres sure sen sor tube have been properly attac hed to the fl ow generator and mas k ([...]

28 Will clea r when: • the lo w press ure cond ition is fix ed • treatment is stoppe d by pressing the Start/Stop key . Power Fa il Alarm Triggered by: • pow er failure • mac hine is di sconnec ted or sw itc hed of f while deli vering treat ment. If a po wer fail al arm sounds: • the flo w generato r stops deliv ering air pres sure. Will [...]

29 Ala rms • c hec k that the air t ube and sens or tu be are connecte d properly . Will stop when: • the mask leak ha s been rectifi ed. Note : The High Lea k alarm can be turned off in the Leak A lert option in the Settings m enu. Insufficient Pressure Support Alarm Triggered by: • air pres sure at the mask has fail ed to reac h an exp ecte[...]

30[...]

31 Cleani ng and Maint enance Cleaning and Maintenance You shoul d regularl y carry out th e cleaning and mai ntenance des cribed in th is manual. ! CAUTION Do not wash the pressure sensor tube. If fluid e nters the pressure s ensor tube allow i t to dry comple tely by han ging it in a c lean place out of direct sunlight . If the pressure s ensor t[...]

32 Figure 19: Air tubing asse mbly removed for cleaning ! CAUTION • Do not use b leac h, c hlorine-, alcohol-, or a romatic-based s olutions (including all sc ented oils), moisturising or antibact erial soaps to clean the cushion, mask, air tubing, or the VP AP Adapt SV . These solutions may cause hardening and reduce t he life of the product. ?[...]

33 Cleani ng and Maint enance Air Filter Inspect th e air filter ev ery month and check if it is blocked by dirt or co ntains holes. The filter s hould be replaced ev ery six months, or more often i f the flow generator i s operati ng in a du sty environ ment. ! WARNI NG Do not wash the air filter onc e it has be come soiled. The air filter is not [...]

34 apparent, you should exe rcise ca ution an d have th e device inspecte d by an authorize d ResMed service cen ter. If you feel the u nit is not perfo rming proper ly, see “Troubl eshootin g” on page 35 . ! CAUTION Inspection and repair sho uld only be p erformed by an authorized serv ice agent. Unde r no circumstan ces shoul d you attempt to[...]

35 T roubles hootin g Troubleshooting If there is a problem , try the foll owing sugg estions. If the probl em cannot be solved, c ontact your equipment suppl ier or ResMe d. Do not atte mpt to open the flow gene rator. Prob lem Possible cause Solu tio n Insuf ficient air deliv ered from flow generator Air filter is dirty . Replace air filter . Air[...]

36[...]

37 Glossary Glossary Alarms When more th an one a larm is acti vate d at the one ti me, the highest p riority alarm w ill be disp lay ed. Backlight The ba c kl ight turns of f if no but to n has be en pre ssed for t wo minu tes. It can also be k ept permanently on b y sel ecting A uto in the B ac klight screen o f the Option s men u. bpm breaths pe[...]

38[...]

39 T echnical Sp ecifica tions Technical Specifications Dime nsions (H x W x D) 5.6" x 9.8" x 11.5" (142 mm x 248 mm x 293 mm) Weight Flow genera tor with cover: 8. 14 lb (3.7 kg) Flow gen erator with Humi daire 2i (empty): 9.24 l b (4.2 kg ) Environmental condition s Ope ratin g temper ature : 41 o F to 104 o F (+5 o C to +40 o C) S[...]

40 • Insuf ficient p ressure s upport alar m Is trigger ed if f or 3 breath s in a ro w the maximum m ask pressu re ac hiev ed at inspira tor y to expirato r y transition is either <87 .5% of the absolute m a sk pressure target ted at that poi nt, or < ab solute mask press ure targeted min us 1 cm H 2 O , whic heve r is the lo wer . • Hig[...]

41 T echnical Sp ecifica tions T able 4: M aximum low impedance flo w at stated pres sures Pressure (c m H 2 O) Flow (L/min) 4.2 21 7 8.6 218 13 . 0 2 19[...]

42 Mask sett ing: flow/pre ssure ch aracteri stics Glossary of symbols Read the op erating ma nual be fore using Type CF eq uipment AC switch Class II equi pment 0 10 20 30 40 50 60 0 5 10 15 20 25 Fu ll Face Act iv a Ultra Vi sta Press ure (c m H 2 O) Flow ( L/min)[...]

43 T echnical Sp ecifica tions Guidance and Manufact urer’s Declaration — Electromagnetic Emissions and Immunity Guidance and manufactur er ’ s declaration – electr om agnetic emissions The VP A P Adapt SV is inten ded for use in the ele ctromagnet ic environment specified below . The customer or the user of t he VP AP Adapt SV should assur[...]

44 (Continued nex t page) Guidance and manufactur er ’ s declaration – electr om agnetic immunity The VP A P Adapt SV is inten ded for use in the electr omagnet ic environment specified be low . The customer or the user o f the VP AP Adapt SV should assure that it is used in such an environment. Immunity t est I E C 6 0 6 01- 1- 2 tes t l eve l[...]

45 T echnical Sp ecifica tions Guidan ce and manuf actur er ’ s declar ation – ele ctro magnetic immuni ty (continued) The VP AP Adapt SV is inten ded for use in the electromagnet ic environment sp ecified below . The cu stomer or the us er of the VPAP A dapt SV should assu re that it is us ed in such an environment. Immunit y tes t I E C 6 0 6[...]

46 Reco mmended se parat ion dis tances betw een por table and mob ile RF communi cations equipment and the VP AP Adapt S V The VP AP Adapt SV is inte nded for use in an environment in which radiated R F disturbance s are contr olled. The custome r or the us er of the V P AP Adapt SV can h elp prevent electr omagnetic interference by maint aining a[...]

47 Limited W arranty Limi ted Warrant y ResMed wa rrants that yo ur ResMed product sh all be fre e from defect s in material and workmansh ip for the perio d specified below fro m the date of purchase by the initi al consu mer. This warranty is not transferab le. Not e: Some m odels are no t available in all regi ons. If the produc t fails under c [...]

48[...]

49 Index Index A Ai r Circui t L earn fu nction 22 air filter 33 hy po-all ergeni c 33 air pre ssure monitorin g 24 air tubi ng at t aching to mask 10 cleaning 31 connect ing 10 air tubi ng sy stem 7 , 8 , 10 alarm flow bloc ked 29 high lea k 28 high p ressure 28 low mask pres sure 27 power fail 28 alarm LED 19 anti- bacteri al filt er 15 B bac k l[...]

50 S yst em Erro r 7 mess age 35 T trea tmen t scr eens 25 U user/owner responsibi lity 1 V VP AP Adapt SV 7 usage 24[...]