Philips 861304 manual

HEARTSTART FRx DEFIBRILLATOR OWNER’S MAN UAL 86130 4 Editio n 8[...]

Phil ips Medi cal Syste ms[...]

Phil ips Medi cal Syste ms       Hear tStar t FRx Def i br illator QUICK REFERENC E[...]

Phil ips Medi cal Syste ms Inte ntio nally blank .[...]

Phil ips Medi cal Syste ms Hear tStar t FRx 861304 Automated Exter nal Defibr illator Ed ition 8 IMPOR T ANT NO TE: I t i s i m p o r t a n t t o u n d e r s t a n d t h a t s u r v i v a l r a t e s f o r s u d d e n c a r d i a c a r r e s t a r e directly related to how so on victim s are defibrill ated . For e very mi nute of dela y , the chanc[...]

Phil ips Medi cal Syste ms HEARTSTA RT FRx 861304 O WNER’S MA NU AL Ab ou t Th is E dit io n The inform ation in this guid e applies to the HeartStar t FRx Defibr illator 86130 4. This inform ation is sub ject to chang e. Please conta ct P hilip s at www .medic al.phi lips.co m/ heartsta rt or yo ur local distri butor for informatio n on re visio[...]

Phil ips Medica l Systems i CONTENT S 1 Introduction to th e Hear tStart F Rx Desc ript ion ... ... ..... ... ..... ... ..... ...... ... ..... ... ..... ... ..... ... ..... ... ...... .. ...... ... ..... ... ..... ...... .. . 1 Sud den Ca rdiac A rrest .. ... ..... ... ..... ...... .. ...... ... ..... ... ..... ...... .. ...... ... ..... ... ..... [...]

Ph il ips M e dic al Sys te m s ii HEARTSTA RT FRx 861304 O WNER’S MANU AL APPENDICES A Accessories . .............. ............... .............. ............... .............. ............... ............... ........... ... 21 B Glossary of terms ....... ............... .............. ............... .............. ............... ............[...]

Phil ips Medi cal Syste ms 1 1 Introduction to the Hear tStar t FRx Description The Phi lips Hear tStar t FRx Def ibrillato r 86130 4 (“F Rx”) is an auto mate d ext ernal de fibrill ator ( A ED) . Smal l, ligh twei ght, rugged, and batt ery pow ered, it is designed f or simple an d r eliab le operat ion by minima lly tr ained user s. T he F Rx [...]

2 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL Ind ica tio ns for Use The FRx should be used to treat someon e you t hink ma y b e a victim of S C A . A person i n SCA : • does n ot re spond when sh ak en, an d • is not breath in g no rma lly . If in doubt, apply the pa ds. Follow the voice instructio ns for each step in u[...]

3 Phil ips Medi cal Syste ms F or mor e information Contac t y our loc al Philip s dis t ribu tor f or ad dit ional i nforma tion abou t the FRx. W e wi ll be happ y to answer any qu estio ns you ma y ha ve an d to pr ovide y ou with c o pie s of t he cl inical summ aries of sever al key st u die s u si ng Ph il ip s au t om at ed ext er na l de fi[...]

4 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL IMPOR T ANT NO TE: The FRx is de signed to be used w ith a carr y case . A number of carr y cases are o f fer ed to meet the needs of your in d ivid ua l de fibr il la tion p r o g ram . The se inc lud e a st and ard carr y ca se an d a hard-shell c arr y case . See App endix A fo[...]

5 Phil ips Medi cal Syste ms instru cted. When the self-test i s ov er , the FRx wi ll rep or t the r esults, then turn off and go to standby mode. The b linkin g gr een Ready light sh ows the defibrill ator is ready for use . * 4. Place the Quick Refer ence Guide, a brief illustra t ed guide for using the FRx to treat a victim of s udden c ardiac [...]

6 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL Recommended accessories It i s alw a ys a goo d id ea to hav e a sp are ba tter y an d a sp are pa ds s et. Other things tha t ar e usefu l to k eep with t h e FRx include: • scissors — for cuttin g the v ictim’ s clothes i f needed • disposa b le glo ves — to pr otect t[...]

7 Phil ips Medi cal Syste ms 3 Using the Hear tStar t FRx IMPOR T ANT NO TE : B e su re t o rea d t h e R e mi nd e r s s e ct i o n a t t h e end of th is c hapte r as wel l as t he warn ings and pr ecau tio ns in Appe ndix D . Ov er view If y ou thin k someone is in SC A, act quickly and calml y . If someone else is avail able , ask h i m or her [...]

8 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL STEP 1: Press the g r een on/off button Press the On/Off butto n to turn on the FRx. Th e FRx tell s y ou t o re mo ve al l clothe s from the pers on’ s che st. If necessa r y , rip or cut off the clo thi ng to ba re the per son’ s chest. STEP 2: Follow the FRx’ s voice ins [...]

9 Phil ips Medi cal Syste ms STEP 3 : Pr ess the f lashing orange Shock button if instructed As so on a s th e He ar tSt ar t FRx dete cts t hat th e pa ds are attach ed to the p atient, the pads i cons turn off. T he F Rx begins analyzin g the patient' s hear t rh ythm . It tell s y ou that n o one sh ould be to uching th e pa tient, and the [...]

10 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL If a s hoc k is no t need ed: The bl ue i-bu tton comes on solid, to sh ow that it is saf e to touch the pati ent. The FRx also tells y ou to perf orm C PR if needed. (I f CPR is not needed – for ex ample, if t he patient is mo ving or regainin g co ns ciou sn es s – fol low [...]

11 Phil ips Medi cal Syste ms If the vi ctim is under 5 5 po unds or 8 year s ol d, and you have an Infant/Child K ey: • Inser t the Infant/C hild K ey into the slot at the top ce nter of the fr ont panel of the FR x ( see illustra tion at l eft). The pink por tion of the K ey pivots (1) and fits into the slot (2), with the front of the K ey lyin[...]

12 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL If the vi ctim is under 5 5 pounds or 8 years old, but you do NO T h ave an Infant/Child K ey: • DO NO T DE LA Y T REA TMEN T . • T urn on the FRx and follow inst ructions to remov e al l clothi ng fr o m the tors o, to bare bo th the chest and the back. • Place the one pad[...]

13 Phil ips Medi cal Syste ms Remi nder s • Remove any me dici ne p atche s an d res idual ad hesive from t he patien t’ s che st before applying the pads. • Do not place the pad s dir ect ly over an implanted pace mak er or de fibr il lat or . A no ti ceab le lum p wi th a su rgic al s ca r sh oul d indicate the po sition of a n imp lanted d[...]

14 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL 4 After using the Hear tStar t FRx After e ach use 1. Check the outsi de of the FR x for sig n s of damage, dirt, or conta minat ion. If you see signs of dam age , conta ct Phi lips for tech n ic al support. If the defi b ril lator is dirty or contam inated, cle an it accor ding [...]

15 Phil ips Medi cal Syste ms FRx data storage The FRx aut omaticall y stor es data ab out its last clin ical use in its intern al memo r y . The stored data can b e conveniently tran sferr e d to a p erso nal comp uter or a hand held com puter runn ing the appropriate applicat ion in th e Phi lips Hear t Star t Even t Review data mana gement sof t[...]

16 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL • t he FR x’ s st atus (e ntir e in cide nt ) • the FRx ’ s rhythm analysi s decision s (en tir e inci dent) • the elapsed tim e ass ociate d wi th s tored events (enti re incident ) 5 Maintaining the Hear tStar t FRx Routine maintenance The F Rx is very simpl e to main[...]

17 Phil ips Medi cal Syste ms P e riodic checks Other t han the ch ecks r ec ommended aft er each use of th e FRx, mainten ance is li mited to period icall y chec king the foll owing: • Check the green Rea dy light. If the gr een Ready light is not blinking , see T roublesh ooting Tips, below . • Replace any used, damaged or expire d supplies a[...]

18 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL T roublesho oting tips The F Rx’ s g re en R eady l ight is you r g uide to knowing if the de fibr il la to r is read y for use . • If the Read y light is blinki ng: The FRx ha s passe d the batter y inse r tion self -test and the last periodi c self- test and is ther efor e [...]

19 Phil ips Medi cal Syste ms APPEND ICES A Access o ries B Glo ssary of term s C Glossa ry of sy mbols/ cont rols D Warning s an d precauti on s E Technic al infor ma tion F Config ura tion G Testin g and tr oubl esho oti ng H Addi ti onal tec hnical data req ui red for Eur opean co nform ity[...]

Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANU AL Notes[...]

21 Phil ips Medi cal Syste ms APPENDICES A Acce ssor ie s Accesso ries* for the Hear tStart F Rx Defibril lator 861304 available separately from y o ur local Philips r epresenta tiv e or online at www .medica l.phi lips.co m/heartstart in clu de . • Bat teri es (spar e i s r ecommend ed) • Batte r y [REF: M5070A] • A viation a pplic atio ns b[...]

22 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES • Infrare d adapter for use with Hear tStart Even t Review softwar e [RE F: ACT -I R] • Hear tStar t FRx Defibrillator Quic k Refe renc e Guide [REF: 9898031386 01] • T rainin g • HeartStart T raining Pad s II (kit contai ning on e set of T raining Pads II in t[...]

23 Phil ips Medi cal Syste ms APPENDICES BG l o s s a r y o f t e r m s The terms liste d in this Gloss ar y are define d in the contex t of the Ph ilips HeartStart FRx Defibr illator 8613 04 and its use. AED Autom ated e xternal de fibrilla tor (a s emi-a utomat ic de fibril lator). AE D mode T he standa rd tr eatm ent mode fo r the He ar tSt ar t[...]

24 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES HeartSta rt Even t R ev ie w A s uit e of data manageme nt softwar e applic ations f or use by traine d perso nnel to re v ie w and ana lyze FRx Def ibrill ator pati ent use and by autho rized per sonnel to alter FR x co nfigur ation . Inform ation is available from Ph[...]

25 Phil ips Medi cal Syste ms APPENDICES On/Of f bu tton A gr een but ton loca ted on the fr ont of th e HeartS tart FRx Def i br illator . Pr essing the On /Off butt on wh en the defi brilla tor is in s tan dby mode turn s the de fibr illator on; pres sing and holdi ng the On/ Off button for on e seco nd when the defibr illat or is on turn s the d[...]

26 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES SMAR T NSA p ause See “NSA pa use. ” SM AR T Pads II The ad hesiv e pads used with th e HeartSta r t FRx Def ibri llator to defib rill ate patie nts of any age or we ight. T he pads are app lied t o the p atie nt’ s ba re skin and used to det ect th e patient ’[...]

27 Phil ips Medi cal Syste ms APPENDICES C Glossar y of symbols/controls symb ol de script ion On/Of f bu tto n. Green . Pressin g t he On/Of f bu tton wh en th e de fibri llato r is in standb y mode turn s the d efibrilla tor on; press ing a nd h olding the On /Off b utton for one seco nd wh en th e de fibrilla tor i s on turns the defibril lato r[...]

28 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES Do not expose t he batte r y to high he at or open flames. Do not inci nerate the bat te r y . Do no t mutil ate th e ba tter y or op en th e ba tter y ca se . Do n ot exp o se to mo is ture. Handle wit h ca re . This side u p . Defi brilla tion prote cti on. Defi bril[...]

29 Phil ips Medi cal Syste ms APPENDICES Envir on ment al (tempe rature and r e lative hum idity) requ irements. Insta ll the batte r y in th e defib rillato r before the date (MM-Y YYY) sh own on the associa ted la bel. Ref erenc e order nu mber . Ser ial nu mb er . Lot numbe r . Date of man ufactur e (989 803139301 o nly) Clas s 9 miscel laneou s[...]

30 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES Repla ce pads after 24 h ours. Expi ration ( r efer to ass ociated date co de). Expi ration date. Federal law (US A) restri cts this d evice t o sa le by or o n t he order of a physician. Not for use wit h Laerdal defibrillat o r models 911, 1000, 2000, or 3000. Not fo[...]

31 Phil ips Medi cal Syste ms APPENDICES D W ar nings and Prec autions It is i mpor tant to un derstand ho w to use you r HeartStart FRx Defib rillator s afely . Pleas e read these war nings and pr ecauti ons car efull y . A war ning descri bes somethi ng that coul d cause se rious perso nal injury or dea t h. A pr ecaut ion des cribe s somethi ng [...]

32 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES pad s Do not allo w the pads to contac t other elect rode s or metal parts tha t are in con tact wit h th e p atie nt. Precautions de vic e handli ng The FRx was d esigned to be stur dy and r eliable f or many diff erent use con d itio ns. Howev e r , h andling the FRx[...]

33 Phil ips Medi cal Syste ms APPENDICES E T ec h ni cal infor m at ion Hear t Star t FRx 861 304 De fibrill ator s pecificat ions The s pecif icat ions p rovided in th e followi ng ta ble s are no mina l va lues. Additio nal in for ma ti o n can b e fo un d in th e T echni cal Reference Manual for HeartStart Defib rillat ors, lo cate d onli ne a t[...]

34 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES Controls and indic ators sea ling Meets IEC 529 c lass IPx5 f or jett ing water an d clas s IP5x f or soli d objec ts (dus t prote ct ed ). ESD /E MI (r ad iat ed and imm un ity ) See Ap pen dix F . air craft: method Mee ts R T CA/DO-160D :1997 Section 21 (Cat egory M [...]

35 Phil ips Medi cal Syste ms APPENDICES Defib rillat ion w a veform cate gor y no minal sp ecifica tion s wa veform parameters Biphasic truncated exponential. Wa veform parameters ar e autom atically adjust ed as a fu nction of patie nt defi brillat ion imp edance . In the diagra m a t left , D is the d uration of ph ase 1 and E is the dura tion o[...]

36 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES ener g y Using Hea r tSta rt SM AR T Pads II for adult de fibr illation : 15 0 J nominal (±15%) into a 50 ohm load. Usin g He ar tSta r t SM AR T Pad s II with Inf ant/ Child K ey ins er ted : 50 J nomin al (±15%) into a 50 o hm load. S ample ped i atri c e nergy dos[...]

37 Phil ips Medi cal Syste ms APPENDICES ECG analysis system ECG analysis performance cate gor y spec ific atio ns funct ion Evaluates i mped ance of adhesi ve pads f or pr oper co ntact with pati ent skin, and ev aluates the ECG rh ythm and sign al quali ty to d etermine if a s hock i s appr opriat e . shocka ble rhythms V entric ular fibri llatio[...]

38 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES Acc e sso ri es sp ec ifi cati o ns Heart Start SMAR T Pad s II 9898 031392 61 non-shockable rhythm — all other non-s hockabl e rh ythms c 450 speci ficity >95% (88%) a. From Philips M edical Sy stems Hear tstream ECG rhythm datab ases. b. American He art Associat[...]

39 Phil ips Medi cal Syste ms APPENDICES M50 70A bat ter y and 98 98 0313 93 01 T SO C- 142* bat ter y Infant/C hild K ey 989803 139311 * The condition s and tests re quir ed for TSO appr oval of this article ar e minimum performa nce standar d s. It is the r esponsib ility of t hose instal ling this article either on or withi n a specific type or [...]

40 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES Environm ent al co ns ide rati ons By com plying with your nati ona l or local regulatio ns rega rding dis pos al of e lectric , ele ctr onic, and ba ttery waste, y ou can mak e a posi tive c ontri bution to our shar ed envi ronm ent. produ ct in formation defibril lat[...]

41 Phil ips Medi cal Syste ms APPENDICES FC o n f i g u r a t i o n Ov er view The Ph ilips H ear tSt ar t FRx D efib rillato r com es with a fac tor y default con figura tion desi gned to me et the needs of most user s. T his conf igurati on can onl y be chang ed by using H e artStart C onfig ure vers ion 1.0 or higher , Ev ent R ev iew v ersi on [...]

42 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES Patient treatment pr otoco l options par amete r se tting s default default descri ption “call EMS” v oice re minder ti ming • At po wer on (w hen the user tur ns on the FRx) • At po wer on and at the sta r t of th e first patie nt care p ause • At th e start[...]

43 Phil ips Medi cal Syste ms APPENDICES pr otocol pause time r (minute s) 0.5, 1 .0, 1.5, 2.0, 2 .5, 3.0 2.0 A 2-min ute pro tocol pause for C PR aut om atic a lly star ts aft er voice inst ruction is gi ven when a s hoc k ser ies is co m plet ed. After t he pr otocol pause, the defibrilla tor returns to rh yth m anal ysis . If th e use r pres ses[...]

44 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES NSA pau se ti mer (minute s) 0.5, 1 .0, 1.5, 2.0, 2 .5, 3.0 2.0 A 2-minu te NSA pause for C PR aut om atic a lly star ts aft er voice inst ruction is gi ven when no shock i s advis ed (NSA). * If th e use r pres ses th e i-but ton for opti onal CPR coachi ng, the FRx p[...]

45 Phil ips Medi cal Syste ms APPENDICES CPR Coaching adult vent ilati on instru ctio n y es, n o y es Optional CPR Coa c hin g inclu des res cue br eaths at the rate dete rmined by the CPR Coachi ng compr ession: ventilation ratio for adults wh e n an ad ul t pa ds set is ins talled. N ote: if thi s param ete r is configured t o NO, C PR Coac hing[...]

46 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES G T esting and troubleshooting Te s t i n g The Hea r tSta r t F Rx D efi bril lato r a utom ati cally te st s its b atter y , conn ect ed SMA R T Pads II, and interna l circuitr y ever y day . It aler ts you if it find s a problem. See th e T e chni cal R eference G u[...]

47 Phil ips Medi cal Syste ms APPENDICES If the FRx d oes not turn on when y ou pr ess the On/ Off button, r emo v e the batt er y and repl ace it with a new batt er y if av ailable and pr ess the On/O ff button to t urn on th e de fib rillato r . If n o spa re bat ter y is availab le , rem ove the in sta lled batt er y for fiv e second s, then r e[...]

48 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES ... to sto p a ll motio n • The p atie nt is bein g m oved or jostled. • The envi ronme nt is dr y and mo vemen t ar ound t he pati ent is causin g static el ectrici ty to int erfere with EC G analys i s. • Rad io or el ectrical sourc es are in terf erin g wit h [...]

49 Phil ips Medi cal Syste ms APPENDICES T roubles hoot in g whil e the F Rx is not b ein g used (g reen Ready ligh t is not on) Press th e blue i-butto n to chec k defib rillat or sta tus, a nd follow a ny instruc tion s the device gives. beha vior pos sible ca use r ecommend ed a c ti on chirp s or i-bu tton flashes • The bat t ery pow er is lo[...]

50 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES H Additional tech nical dat a required for Europ e an confor mity Electromagne tic c onformity Guidanc e and manufact urer’ s declar ation: T he Hea r tStart FRx is inte nd ed f or use in t he electr omag netic en viro nment sp ecif ied in th e tables belo w . The cu[...]

51 Phil ips Medi cal Syste ms APPENDICES Elec tro magnet ic immun ity imm unit y test I EC 60601 test l evel compli ance level ele ctro magnetic envir onment - guidan ce elect rosta tic di scha rg e (ESD) IEC 61000-4 -2 ± 6 kV contac t ± 8 kV ai r ± 6 kV con tact ± 8 kV air Ther e ar e no specia l requi re ments with respec t t o e lec trosta t[...]

52 Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANUAL APPENDICES Reco mmend ed s epar ation d istance s betw een portabl e and mo bil e RF com munica tions equip m en t an d th e He artSt art FR x Def ibr ill ato r The H ear t Star t FR x D efibr illat or is inte nded for us e in a n e lectromag net ic en v ir onment in which ra dia[...]

53 Phil ips Medi cal Syste ms APPENDICES Shoc k cy cle t imin g The F Rx’ s Quick S hock feat ure all ows it to de l iv er a shoc k within 8 se conds, typ ical, fol lowing a CPR paus e. From shock to shock , the FRx ta kes <20 second s, typi cal, inc ludin g analysi s. Afte r 15 shock s, the FRx ta kes <30 seco nds from anal yzing to re ady[...]

Phil ips Medi cal Syste ms HEARTSTART FRx 861304 O WNER’S MANU AL Notes[...]

Phil ips Medi cal Syste ms Intent ionall y blank.[...]

PO WE R T O SA VE A LIFE Phil ips Medical S ystems is pa r t of Ro ya l Philips Electro nics REF: 989 803138 731 Philips Me dic al Sy st ems United St a tes Philips Medi cal Systems 2301 Fifth A venue, Suite 200 Seattle, W A, USA 98121 (800) 263-3342 Canad a Philips Medi cal Systems 281 Hillmount Road Markham, On tario L6C 2S3 (800) 291-6743 Eur o [...]