ResMed 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 S V User Guide English Reorder numb er: 26869/2 06 04[...]

ResMed Ltd (Manufacturer) 1 Elizabeth MacArthur Drive B ella Vista NSW 21 53 Australia ResMed Corp (US Designated Agent) 1 4040 Danielson Street Po way CA 92064-6857 USA ResMed (UK) Ltd (EU Authorized R epre sentative) 65 Milton P ark Abingdon Oxfordshire OX1 4 4RX UK ResMed Offices Australia, A ustria, Finland, France, Germany , Hong Kong, Japan, [...]

i Cont ents Cont ents Introduct ion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 VP AP™ A dap t 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 roublesho oting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Glossary . . . . . . . . . . . . . . . . . . . . . . [...]

1 Intr oducti on Introduction VPAP ™ Adapt SV The VP AP ™ Ada pt SV flow generator h as been des igned to be re liable, 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 phy sicia[...]

2 • impaire d ability to c lear secr etions • pneumoth orax or pn eumomedi astinum • recen t cran ial trauma or su rgery • c hronic h ypov entilation . Below ar e gener al w ar nings and caution s. Fur ther 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 [...]

3 Intr oducti on The follow ing sid e effects m a y ar ise during a co urse of the rapy with the VP AP A dapt SV: • dryin g of the no se, mouth, or throat • bloatin g • ear or si nus dis comfort • ey e irritation • skin r ashes • c hest disc omfor t.[...]

4[...]

5 Quick S etup Guid e Quick Setup Guide 1 Attach the a ir tubing a nd pressu re sensor tu be to the VP AP Adapt SV an d mask (page 9). 2 Attach a h umidifier if req uired (pa ge 11). 3 Switch on the VP AP Adapt S V. Make sure the mask is un blocked. 4 Select the mask settin g (page 2 2). 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 generator is supp lied w ith air tubi ng and a pow er cord. Masks a re suppli ed separate ly , as you and your c linicia n hav e to decide w hic h 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 e[...]

8 Figu re 3 : Ai r tu bing fu lly a ssembl ed All neces sary ai r tubing co mponents are packed with the VP AP Adapt SV: • a 6’6" (2 m) length of air t ubing • a press ure sensor t ube (to me asure press ure at the m ask) w ith Luer connec tors • tube clip s (to ho ld the p ressu re sens or tube ont o the a ir tubing) • a pro ximal c[...]

9 VP AP Adapt SV System Assembling the VPAP Ada pt SV System Complete th e followi ng steps to a ssemble the VP AP A d apt 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 tub ing system su pplied[...]

10 2 Connect air t ubing Connect the air tube fir mly ont o the air ou tlet at the fr ont of the unit . Figu re 4: Fron t vi ew of VPAP Adapt SV T o attach the pres sure se nsor tube to the unit , screw the Luer connector on to the sock et on the side of the unit . Figure 5: Tw isting the Luer lock conne ctors together ! WARNI NG Use care wh en han[...]

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 humidifi ers are comp atible wi th the VP AP A dapt SV: Figu re 7: H umi difiers compat ible with the VP AP Ad apt SV When using a humidifier, stop the VP AP A dapt SV by using the Start/Stop k[...]

12 HumidAire 2i™ The Hum idAire 2i p rovides 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 hum idifier do cking st ation and water ch amber. N o other acces sories ar e required for use . Plea se refer to the HumidAire 2i User’s Ma nual for details . Once you [...]

13 VP AP Adapt SV System HumidAire™ You will ne ed a medium size 21" (52 cm ) air tube to co nnect the VP AP Adap t SV unit to the HumidAire™ (see Fi gure 7). 1 Make sure bo th the HumidAire and th e VP AP A dapt SV a re turned off. Fill the HumidAire with w ater as des cribed in the humidifie r manual. Pl ace the filled water c hamb er in[...]

14 5 Connect the mask sys tem to the fre e end of th e long air tub ing. The fi nal assembl y should look like t his: 6 Switch on the HumidAire and the VP AP A dapt 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 Link is a de vice that records data onto a Sma rtMedia™ car d during your therapy. T he card can be re turned to yo ur clinician so that they c an observe you r progress a nd adjust fl ow genera tor param eters if nec essary. Th e Re sL i nk 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 fail ure. ResMed su pplies separately a co nverter that al lows a 12 V or 2 4 V battery to be con nected to the DC inpu t of the VP AP Adapt S V. When using D C, power is turned on and off via the switch o n the connec tor that connec ts the DC-DC conve[...]

17 Using th e VP AP Adap t 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 Treatm ent When the sy[...]

18 Control Panel Functions The contro l panel o f the VP AP Adapt SV has a ke ypad tha t allo ws you to : • start or stop treatm ent • adjust set tings on the flow generato r • mute o r stop alarms • 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, alarm s [...]

19 Using th e VP AP Adap t SV Left k ey (green) • Enters a menu. • 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 by the te xt abov e it in the LCD (eg, ’exit’). • Cancels operatio ns. • Exte[...]

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

21 Using th e VP AP Adap t SV Menus The option s available in the Setti ngs menu will dep end on the therapy y ou are receivin g (either ASV or CPAP mode ), as set by your clinic ian. Figur e 15: Navigating the Patient 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 o[...]

22 Setti ngs 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 yo ur brea thing and regu lates t he air pr essure accord ingly. Mask Select the typ[...]

23 Using th e VP AP Adap t SV 7 . When the functio n is comple te, a screen w ill appe ar say ing that the circ uit 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 i s a probl em with th e circuit a s creen sa ying ’Inva lid circu it’[...]

24 Mask-fit Gives a rating of how well th e mask wa s fitting du ring your last sessi on on the VP AP Adapt SV. T he stars in dicate ho w good the fi t was (more stars = be tter fit). Aver age Pressure Provides informatio n on the a verage 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 A[...]

25 Using th e VP AP Adap t SV Servicing Men u This men u displays the followin g informat ion: • 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 cu rrently installed on the fl ow genera tor . Treatment Screens There are th ree Treatm ent [...]

26[...]

27 Ala rms Alarms The VP AP Adapt S V unit is fitted with alarm s to alert you to c hanges tha t will aff ect your t reatmen t. The m ost comm on 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 pr essure sen sor tube have be en properl y attached to the fl ow gene rator and mas[...]

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 sconnected or s wit c h ed of f while deliv ering treatment . If a po wer fail al arm sounds: • the flo w gene rator stops deliv ering air pr essure. Will[...]

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

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 i n this manual. ! CAUTION Do not wash the pressure sensor tube. If fl uid enters 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 as sembly removed for cleaning ! CAUTION • Do not use b leac h, c hlorine-, alcohol- , or aromatic-base d solutions (including all sc ented oils), moisturising or antibac terial soaps to clean the cushion, mask, air tubing, or the VP AP Adapt SV . These solutions may caus e hardening and reduce the life of the product. ?[...]

33 Cleani ng and Maint enance Air Filter Inspect th e air filter every month and check if it is blocked by dirt or co ntains holes. The filter s hould be replaced every 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 soil ed. The air fil ter is not [...]

34 apparent, you should exe rcise caution an d have the devi ce inspe cted by a n 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 y our equipmen t supplier or ResMed. Do not atte mpt to open the flow gene rator. Prob lem Possible ca use Sol utio n Insuf ficient air deliv ered from flow generator Air filter is dirty . Replace air filter . Ai[...]

36[...]

37 Glossary Glossary Alarms When more th an one a larm is a ctivate d at the on e time, the highest pr iority alarm will be display ed. Backlight The ba c kl ight turns of f if no but to n has be en pres sed for t wo minu tes. It can also be k ept permanently on b y selecting A uto in the B ac klight scre en of the Option s menu. bpm breaths pe r m[...]

38[...]

39 T ech nical 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 gen erator 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) [...]

40 • Insuf ficie nt pressu re support ala rm Is trigger ed if for 3 br eaths in a row th e maximum m ask pressu re ac hiev ed at inspira tor y to expirato r y transition is either <87 .5% of the absolu te mask pressure target ted at that poi nt, or < absolute mask pre ssure targeted min us 1 cm H 2 O , whic heve r is the lo wer . • High l[...]

41 T ech nical Sp ecifica tions T able 4: Maximum lo w impedance f low at stated pressures 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 aracter istics Glossary of symbols Read the op erating ma nual be fore using Type CF eq uipment AC switch Class II e quipment 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 ech nical Sp ecifica tions Guidance and Manufact urer’s Declaration — Electromagnetic Emissions and Immunit y Guidance and manufactur er ’ s declaration – electromagnetic 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 o f the VP AP Adapt SV should assur[...]

44 (Continued nex t page) Guidance and manufactur er ’ s declaration – electromagnetic 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 suc h an environment. Immunity t est I E C 6 0 6 01- 1- 2 tes t l eve l [...]

45 T ech nical Sp ecifica tions Guidan ce and manuf actur er ’ s declar ation – ele ctro magnetic im munity (c ontinued) The VP AP Adapt S V is inten ded for use in the electromagnet ic environment sp ecified below . The cu stomer or the us er of the VP AP Adapt SV should assu re that it is us ed in such an environment. Immunit y tes t I E C 6 [...]

46 Reco mmended s eparat ion dis tances betw een por table and mobile RF communi cation s 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 u ser 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 shall b e free from d efects 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 l e. Not e: Some m odels are not availa ble in a ll regions . If the produc t fails under c[...]

48[...]

49 Index Index A Ai r Circu it L earn fu nction 22 air filt er 33 hy po-all erge nic 33 air pre ssure monitorin g 24 air tubi ng at t aching to mask 10 cleaning 31 conne cting 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 [...]

50 S yst em Er ror 7 mess age 35 T trea tmen t scr eens 25 U user/owner responsi bility 1 V VP AP Adapt SV 7 usage 24[...]