GCE EASE II Instructions For Use Manual Download Page 72 | Manualshive

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Manufacturer:

GCE, s.r.o.

Žižkova 381, 583 01 Chotěboř, Česká republika

http://www.gcegroup.com

Doc. Nr.:

IFU0145

; DOI: 2020-11-02; Rev.:01; TI: A5, CB, V1

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Summary of Contents for EASE II

Page 1: ...II DEMAND VALVE INSTRUCTION FOR USE ODB ROV VENTIL N VOD K POU IT VALVE A LA DEMANDE MODE D EMPLOI DEMANDVENTIL BRUKSANVISNING VENTIL PO POTREBI UPUTE ZA KORI TENJE URE AJA GCE HEALTHCARE EN CS FR SV...

Page 2: ......

Page 3: ...ygen O2 Nitrous oxygen mixture O2 N2 O 50 50 3 OPERATIONAL TRANSPORT AND STORAGE SAFETY REQUIREMENTS Keep the product and its associated equipment away from heat sources fire cigarettes flammable mate...

Page 4: ...erating instructions performance data Do not use the product without properly familiarization of the product and its safe operation as defined in this Instruction for use Ensure user is aware of parti...

Page 5: ...ration of the demand valve Reassure and encourage him her to breathe normally NOTE Patients do not have to remove the mask or mouthpiece during exhalation 2 Place the mask on the patient and support t...

Page 6: ...nd disconnect from the gas supply prior to cleaning Refer to the exploded view of the demand valve parts below Fig 2 Demand valve parts U clip Patient port assembly Inhalation disc Demand Valve Fig 3...

Page 7: ...xhale valve flap are guaranteed to 20 sterilization cycles under the cleaning conditions mentioned below Example of cleaning with cold disinfectant Meliseptol Remove dirt with a soft cloth damped in w...

Page 8: ...ferred 7 6 CLEANING HOSE ASSEMBLY Hose assembly must be cleaned if contaminated or as part of regular cleaning It is not necessary to clean it after every use 1 De pressurize hose assembly and disconn...

Page 9: ...product life time replace as necessary All spare components must be kept in their original packaging to maintain batch suppliers iden tity All spare components must be stored in a dry dark and clean...

Page 10: ...or damaged metal probe connector may leak and should be replaced Send the demand valve to an approved GCE repairer for hose assembly replacement 7 Check the Demand Valve body and rear cap is not crac...

Page 11: ...e to a worn male hose probe or a fault in the gas supply connection To eliminate gas supply connection try a different supply point If leak continues hose assembly will require replacement Return the...

Page 12: ...hat other materials containing SVHC of concentrations exceeding 0 1 are included in any GCE product 8 4 2 SERIAL NUMBER AND DATE OF PRODUCTION Form of nine digit serial number stamped on the product i...

Page 13: ...lues quoted are nominal The manufacturer reserves the right to change specifications without notice Spare Parts and Accessories 10 1 ACCESSORIES PROVIDED WITH EASE II EASE II O2 N2O demand valve are t...

Page 14: ...two years from date of receipt by the GCE Customer or if this is not known 2 years from time of the product manufacture shown on the product The standard warranty is only valid for products cu accordi...

Page 15: ...p screws are in place Check patient port condition Check exhalation valve flap condition Check inhalation plate with pin condition Check inhalation valve flap condition LEAK CHECKS TICK Comments Actio...

Page 16: ...chrann slu ba prost ed Kysl k O2 Sm s oxidu dusn ho a kysl ku O2 N2O 50 50 3 BEZPE NOSTN PO ADAVKY NA PROVOZ P EPRAVU A SKLADOV N V robek v etn p slu enstv udr ujte mimo zdroje tepla ohe cigarety ho l...

Page 17: ...od k pou it technickou dokumentaci pro dan produkt Nepou vejte v robek bez dn ho sezn men se s v robkem a jeho bezpe n m provozem jak je pops no v tomto n vodu k pou it Zajist te aby m l u ivatel odpo...

Page 18: ...ln kontrolovat obsah l hve L hev by se m la v p pad pot eby vym nit 1 Poklidn vysv tlete pacientovi co se chyst te d lat Uklidn te ho a povzbu te ho aby d chal norm ln Pozn Pacienti b hem v dechu nemu...

Page 19: ...t n m syst m odtlakujte a odpojte od p vodu plynu Viz rozlo en pohled na sou sti odb rov ho ventilu n e Obr 2 C sti odb rov ho ventilu U klip V dechov ventil N d chov ventil Odb rn ventil Obr 3 Mont E...

Page 20: ...ov st Pokud je ventil kontaminovan krv nebo zvratky i t n je nezbytn Postupujte dle jedn z ist c ch metod popsan ch n e a Bu omyjte v echny sti v tepl vod o max teplot 60 C s pou it m vhodn ho dezinfe...

Page 21: ...SE II pro i t n m Membr na odb rov ho ventilu N dechov disk V dechov ventil Odb rov ventil Membr na v dechov ho ventiliu Fig A Fig B Fig C Fig D Fig E Rozmontov n p ed i t n m Smontov n po t n V decho...

Page 22: ...na sv m sto 7 5 I T N MASKY STENKY A IST C HO ADAPT RU 1 Masky pro v cen sobn pou it by m ly b t i t ny a sterilov ny dle isntrukc p ilo en ch k masce 2 stenky jsou ur eny pouze na jedno pou it Po pou...

Page 23: ...stavu po celou dobu ivotnosti V echny n hradn d ly mus b t skladov ny v origin ln m balen pro spr vnou identifikaci v robn d vky dodavatele V echny n hradn d ly mus b t skladov ny majitelem u ivatelem...

Page 24: ...n no Po lete A worn or damaged metal probe connector may leak and should be replaced Po lete odb rov ventil do pov en ho servisu GCE pro v m nu hadicov ho p slu enstv 7 Zkontrolujte t lo a zadn kryt o...

Page 25: ...4 Ot iv spoj mezi t lem odb rov ho ventilu a hadicov m uchycen m Pokud je detekov na net snost po lete odb rov ventil pov en mu servisu na opravu 5 Spoj mezi hadicov m p ipojen m a zdrojem plynu Poku...

Page 26: ...lovo neuvoln do plynu ani do okoln ho prost ed Po skon en ivotnosti mus b t v robek zlikvidov n autorizovanou firmou pro recyklaci kov aby byla zaji t na inn likvidace materi lu s minim ln m dopadem n...

Page 27: ...m d lka ROZM R VN J PR M R 12 7 mm POZN Uveden hodnoty jsou jmenovit V robce si vyhrazuje pr vo zm nit specifikaci bez ozn men 11 N HRADN D LY A P SLU ENSTV 11 1 P SLU ENSTV DOD VAN S EASE II EASE II...

Page 28: ...1 V stupn tlak P2 13 Z RUKA B n z ru n doba na v robek je dva roky od data doru en v robku z kazn k m GCE pokud nen datum doru en zn mo po t se z ru n doba od data uveden ho na v robku B n z ruka je p...

Page 29: ...tomnost t roubk na krytu Zkontrolujte stav v dechov ho ventilu Zkontrolujte stav v dechov membr ny Zkontrolujte stav n dechov ho disku v etn kol ku Zkontrolujte stav n dechov membr ny KONTROLA T SNOST...

Page 30: ...ents et elle convient l utilisation dans les milieux hospitaliers ainsi que dans les milieux pr hospitaliers soins d urgence Oxyg ne O2 M lange de protoxyde d azote et d oxyg ne O2 N2O 50 50 3 EXIGENC...

Page 31: ...S UTILISER d huile ou de graisse sauf indication contraire express ment mentionn e sur aucune partie du syst me EASE II Maintenir les mains propres sans huile et graisse Tenir toujours le syst me l ca...

Page 32: ...UCCAL ET DU FILTRE Choisissez un masque ou un embout buccal en un filtre adapt s au patient et raccordez les sur la valve la demande en les intro duisant sur le raccord conique de diam tre 22 mm sur l...

Page 33: ...il s av re souvent que l utilisation continue n est pas n cessaire Note Le personnel soignant peut aider maintenir la masque si le patient n en est pas capable 4 Pendant l administration surveillez l...

Page 34: ...re liquide Ne pas exposer aux temp ratures lev es par ex dans un autoclave sauf une indication contraire Pour appliquer un agent de nettoyage il est interdit de le pulv riser sinon la mati re pulv ri...

Page 35: ...sinfectant pendant 1 minute Une fois le d sinfectant appliqu rincer les composants l eau claire froide du robinet Les composants devraient tre soigneusement essuy s par un chiffon doux non abrasif b...

Page 36: ...doit tre nettoy si il est contamin ou bien selon les habitudes de mani re hebdomadaire Il n est pas n cessaire de le nettoyer apr s chaque utilisation 1 D pressurisez le sous ensemble flexible et d c...

Page 37: ...oduit pendant toute sa vie technique Tous les joints et bagues toriques doivent tre gard s dans un endroit sec obscur et propre par le propri taire et l utilisateur du produit pendant toute sa vie tec...

Page 38: ...vice 8 V rifier que les trois petites vis s curisant le corps de la valve sont en place Si l une des vis est manquante alors la valve doit tre renvoy e un r parateur agr e GCE 9 V rifier que l tiquett...

Page 39: ...a valve et le flexible Si une fuite est d tect e retourner la valve la demande un r parateur agr e GCE pour remplacement du flexible 5 Le raccord entre l embout du flexible et la source de gaz Si une...

Page 40: ...39 92 1 En cas d utilisation courante le plomb ne peut pas se lib rer dans le gaz ni dans le milieu environnant Une fois la dur e de vie du produit termin e ce dernier doit tre limin par une soci t sp...

Page 41: ...ION Pression de service 7 bar pression d clatement 56bar 23 C et 40bar 40 C MATERIAU PVC antistatique selon ISO 5359 POIDS 0 5kg longueur 3m DIAMETRE EXTERIEUR 12 7 mm NOTA Les valeurs indiqu es sont...

Page 42: ...re R f rence du produit Tenir au sec N de lot Date de fabrication Informations sur le fabricant Fragile Utiliser avant Pression d entr e P1 Pression de sortie P2 13 GARANTIE La garantie standard est d...

Page 43: ...vis du corps sont en place V rifier que le sous ensemble patient est intacte V rifier que la membrane d expiration est intacte V rifier que le sous ensemble valve d expiration avec tige est intacte V...

Page 44: ...f re ankomst till sjukhus ambulansv rd Syrgas O2 Blandning av lustgas och syrgas O2 N2O 50 50 3 S KERHETSKRAV VID DRIFT TRANSPORT OCH LAGRING Produkt och tillbeh r skall h llas utom p verkan fr n v rm...

Page 45: ...sanvisning och information om tekniska data Anv nd inte produkten utan att ordentligt k nna produkten och hur den anv nds p ett s kert s tt enligt Bruksanvisningen Se till att anv ndaren har k nnedom...

Page 46: ...ras regelbundet Flaskan skall bytas vid behov 1 F rklara lugnt och sakligt ndam let och anv ndningen av demandventilen f r patienten Lugna patienten och se till att hon han andas normalt ANM Patienten...

Page 47: ...delar nedan Bild 2 Demandventilens delar U Bygel Patientventilenhet Inandningsmembranenhet Demandventil Demontering innan reng ring Montering efter reng ring Bild E Bild A Bild B Inandnings membranenh...

Page 48: ...tilklaff Utandnings ventilklaff garanteras till 20 steriliseringscykler under nedanst ende reng ringsvillkor Exempel p reng ring med kallt desinfektionsmedel Meliseptol Ta bort smuts med en mjuk duk s...

Page 49: ...6 RENG RING AV SLANGPAKET Slangmontaget m ste reng ras om det r f rorenat eller som en del av regelbunden reng ring Det r inte n dv ndigt att reng ra den efter varje anv ndning 1 Sl pp ut trycket ur s...

Page 50: ...t GCE originaldelar 8 2 RLIGT UNDERH LL EASE II skall genomg en formell rlig inspektion Inga speciella verktyg eller testutrustning kr vs f r den rliga kontrollen Den rliga inspektionen kan utf ras av...

Page 51: ...ndventilens bakre lock till huvudenheten r p plats Om n gon av sp rskruvarna saknas returnera DV till en godk nd GCE reparat r 9 Kontrollera etiketten p det bakre locket r p plats och i gott skick Om...

Page 52: ...med utloppsh len mot rat och lyssna efter l ckage Inga l ckage b r h ras Om en l cka h rs det indikerar ett fel med antingen huvudventilen eller pilotventilen Returnera DV till en godk nd reparat r f...

Page 53: ...ppna flaskventilen Tom flaska Kontrollera indikatorn som visar kvarvarande m ngd Anslut ny flaska vid behov Snabbkopplingen r inte helt ansluten Ta ut anslutningsdonet och s tt i det i adaptern p nytt...

Page 54: ...ingsadaptor Demandventilen EASE II anv nds oftast med mask munstycke och fi lter Tillbeh r som r m rkta f r eng ngsanv ndning skall inte teranv ndas d det fi nns risk f r smitorisk till patienten Prod...

Page 55: ...n dagen f r kundens mottagande av produkten fr n GCE eller om detta inte r k nt 2 r fr n tidpunkten f r produktens tillverkning vilket visas p produkten Standarden Garantin g ller endast f r produkter...

Page 56: ...lskruvarna r p plats Kontrollera patientventilens skick Kontrollera utandningsventilklaffens skick Kontrollera inandningsdiskens skick inklusive pinne Kontrollera inandningsventilklaffens skick L CKA...

Page 57: ...nog oksida i kisika O2 N2O 50 50 3 SIGURNOSNI ZAHTJEVI ZA TRANSPORT RAD I SKLADI TENJE Ure aj pribor i priklju ke potrebno je dr ati daleko od Izvora topline vatre cigarete itd Zapaljivih materijala...

Page 58: ...datke o izvr enju Proizvod nemojte koristiti ukoliko niste dovoljno upoznat s proizvodom njegovim sigurnim upravljanjem opisanim u ovom naputku za uporabu Osigurajte da korisnik ima odre ene informaci...

Page 59: ...ravati sadr aj boce i po potrebi zamijeniti bocu 1 Mirno objasnite pacijentu to ete raditi Smirite ga i potaknite da normalno di e Napom Pacijenti ne moraju za vrijeme izdisaja masku ili usnik uklanja...

Page 60: ...p ventila za udisanje Sklop ventila za inhalaciju Ventil EASE II ventil po potrebi Rastavljanje ventila prije i enja Ponovno sastavljanje ventila na kon i enja Slika E Slika A Slika B Sklop diska za i...

Page 61: ...ili povra anjem i enje je nu no Postupajte u skladu sa jednom metodom za i enje koja je opisana u nastavku a Operite sve sastavne dijelove ventila tako er i klapne ventila toplom vodom na temperaturi...

Page 62: ...o etni polo aj 6 Ponovno montirajte sklop ventila za udisanje aspiraciju 7 5 I ENJE MASKE USNIKA I PRIKLJU KA ZA ODZRA IVANJE 1 Maske za vi ekratnu uporabu potrebno je istiti ili sterilizirati sukladn...

Page 63: ...gurnosne upute o kori tenju kisika navedene u poglavlju 4 Korisnik i vlasnik ure aja du ni su uvati sve etikete koje se nalaze na ure aju etikete moraju biti u dobrom stanju i itljive tijekom cijelog...

Page 64: ...no zamijeniti Ventil je potrebno dostaviti centru za tehni ku podr ku koji e obaviti zamjenu cijevi 7 Provjerite stanje tijela ventila EASE II ventila po potrebi i stra njeg poklopca jer ne smiju biti...

Page 65: ...a na krajevima cijevi U slu aju curenja dostavite ventil centru za tehni ku podr ku 4 Rotiraju i spoj izme u tijela ventila i cijevi U slu aju curenja dostavite ventil centru za tehni ku podr ku 5 Spo...

Page 66: ...eliku zabrinutost SVHC Naj e e kori tene mesingane legure koje se koriste za karoserije i druge mesingane komponente sadr e 2 3 olova Pb Br ES 231 468 6 Br CAS 7439 92 1 Prilikom normalne uporabe olov...

Page 67: ...sporuka Plina Plinovod Uvjet 2 8 7 0 bar pri protoku 200 L min Otpor Prilikom Udisanja Ako Je Tlak Na Dovodu 2 8 Bar Ve i od 0 15 0 2 kPa pri protoku od 10 l min 0 7 kPa pri protoku od 200 l min Otpor...

Page 68: ...ko postoji opasnost od zaraze bolesnika Linija proizvoda GCE Medical u stalnom je razvoju radi kontinuiranog postizanja pobolj anja Za sve informacije mo ete kontaktirati putem telefona na u Slu bu za...

Page 69: ...peraturna granica Oznaka proizvoda prema katalogu proizvo a a uvati u suhom prostoru Oznaka proizvodne partije Godina proizvodnje Informacije o proizvo a u Lomljivo Krajnji rok kori tenja ili uporabe...

Page 70: ...tijela ventila Provjerite stanje etikete Provjerite sva tri vijka na stra njem poklopcu tijela ventila Provjerite stanje ventila za udisanje aspiraciju Provjerite stanje klapne ventila za izdisaj Pro...

Page 71: ...r 2 Tehni ke karakteristike brze spojnice i postupak spajanja i odpajanja PROIZVO A GCE s r o Tel 420 569 661 111 Zizkova 381 Fax 420 569 661 602 583 01 Chotebor http www gcegroup com e ka Republika G...

Page 72: ...esk republika http www gcegroup com Doc Nr IFU0145 DOI 2020 11 02 Rev 01 TI A5 CB V1 UNITED STATES OF AMERICA CHINA INDIA RUSSIA MEXICO SWEDEN POLAND GERMANY FRANCE SPAIN ITALY IRELAND UNITED KINGDOM...

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