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    © All Rights Reserved
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    7 views36 pages

    Specificatii Gorj

    Uploaded by

    Zákány Zoltán

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    of 36
    Seae solute celitate pentru sandtete Gey masse) Seda: RO30111 Ba Mare, fon Slaviei E3/; Pune de ere Baia Maes, Vitor 5971-2: CLF: RO 2192263 Te -+40262-27614, fi: 440-262.176733, 0722-2432; ema: info@elneddno, office @elmedom.0 Nr. 2166 / 29.09.2020 Citre, Consitiul Judetean Gorj Str. Victoriei nr. 4; Localitate: Térgu Jiu; Jud.: Gorjs Cod Postal: 210165; Tara: Romania Tel, +40 253214006, Fax. +40 253212025; e-mail: liliana@ejgorj.ro; Adresa internet: www.cjgor).r0 Amexa 1 PROPUNERE TEHNICA LOT 1 Spirometru -1 hue. S.C. Elmed $.R.L Baia Mare este “Unitate tehnico-medicala” autorizati de Ministerul Sindtiii, conform Titlul 19 din Legea 95/2006, define Avizul de functionare nr. $822/11.01.2019, a se vedea Documentele de calificare pentru activitati de tip B si C - import, depozitare, comercializare si reparare, verificare, punere in funcfiune .ispozitive medicale”, pentru toata grupa si tipurile de aparate (exploréri functionale, fizioterapie, chirurgie, anestezie, terapic intensiva, de laborator, de stomatologie, inclusiv radiologie, imagisticd medicala), din dotarea unitailor sanitare: spitale, laboratoare, cabinete medicale si de stomatologie. 1, Deseriere produsului ofertat ‘Aparatul ofertat este un spirometru model Spirolab, produs de firma italiana MIR S.r.. ~ Medical International Research. Acesta este destinat utifizrii de cétre personal medical calificat sau de citre pacienfi sub supravegherea unui doctor i a fost conceput pentru a testa functile plaménului, Poate efectua teste de spirometie la pacienti de orice varsté, exclusiv nou-nascuti si bebelusi 2. Specificatii tehnice Spirometru— 1 bue. ‘Specificalttehnice impuse ‘Modul in eare réspunde oferta Producttor prin caietal de sarcini solicitrié autortatii contractante (denumire, (cetinte minime obligatorit) | (Aceastt coloana va fi completati de cite ofertant adresa) i va confine caracteristicile tehnice ofertate) 7 2 cran tactil (Touchscreen) LCD color de minim 7 inch, cu rezolutie de minim Conform Brosurl pag. 4: Ecran: Afisaj LCD color touch screen de 7 inch, rezolutie 800 x 480 pixeli ena Meni simplu bazat pe | Conform Brogura pag. 2: icoane afigate pe tastele _| Fiecare functie poate fi activaté print-o simpld atingere pe | MIR S.r.l.— virtuale de pe ecran bara de meniu intuitivd aflaté tot timpul pe ecran Medical ‘Conform Manual de utlizare pag. 26: International Afigarea si citiea rezultatelor de spirometrie—Deindata | Research ce testul FVC s-a terminat, vor fi afisate rezultatele de spirometrie, Pe ecran se vad graficele Debit/Volum si. | Via del Voluny Timp, parametrii selectai in setari privind cel mai | Maggiolino, ‘Afigarca testari in timp real | bun test dinte toate cele efectuate in sesiunea respectiva si | 125, 00155, srafic si valorie raportul in procente al comparitii cu valorile teoretice, si | Roma, Italia conform Manual de utilizare pag 23: Modul online | (Conectat la un PC) — Pe linga parametri obignuiti de spiromete si curbele tn timp real FIV, sistemul poate de asemenea aduna informa mult mai sofisticate cum arf L date de profil ventilator side volum extrapolat (Vex!). ato FER Pin. Pagina 1 din S EN Rot 2 ¢ etme Meo © ) Cinsiea2e @ Nia y Wane: Conectare la PC prin Soft WinspiroPro (update-uri gratuite) Conform Brogura pag. 3: Accesorii incluse: Winspiro PRO Software PC performant pentru spirometrie ¢i oximetrie — Upgradare gratuita Imprimanta termicd ‘incorporata: utilizeazi hartie termica cu latimea de ‘minim 100 mm - maxin 112mm Conform Manual de utilizare pag. 31: Dac in meniul de service a fost activaté tiparirea direct USB, atunei pe ecran va aparea un banner care permite alegerea tipului imprimantei care se va utiliza: imprimanta | ‘ermicd sau imprimanta cu conexiune direct’ USB. LLatimea hartci termice este de 112 mm dupa cum se vede in imaginea atasata. ‘Turbina digitale bidirectional (reutilizabila sau de unic& utilizare) ‘Conform Brosuri pag. 4: Senzor Mux: turbind digital) bidirectionala si conform Manual de utilizare pag. 5: Dispozitivul poate fi utiliza cu doua feluri de turbine: reutilizabile, sau de unicd folosints Senzor intem de ‘temperatura semiconductor (0-45°C) pentru convertire automata BTPS ‘Conform Manual de utlizare pag. 20: Corectia volumelor si debitelor inspiratoii se face automat cu ajutorul senzorului temperaturii ambiante care rmisoard temperatura din interiorul dispozitivului si permite calcularea factorului BTPS siconform Brosura pag. 4 Senzor de temperatura: semiconductor (-45°C) Datele pacientului se Conform Manual de utilizare pag. 21 Introducerea datelor pacientului — Acest eeran pen accesul la datele tuturor pacientilor. Codul ID nu este obligatoriu. Atingefi csufele gti pentru a accesa diferitele MIRS, inrad e iows | csi nods dace tn ttre virwalt de | Medica ‘dupa nume sau cod ID vrcontoan Manual de utilzare pag. 2: Research Putefi cduta dupa urmatoarelecriterii; ID, Nume, Data er nasterii, Data efectuarii testului, Toate | siaestonsa, | ‘Conform Manual de utilizare pag. 2: ‘ me Gass Cele mai bune 3 masuritori | La sfarsitl sesiunii,cénd introduceti un nou subiect sau | Roma. Italia ‘se memoreazi automat | comutati pe faza POST, cele mai bune tre teste efectuate 7 | anterior se salveazA automat in athiv Capacitaie memorie de | Conform Brosura pag. 2: teste intre 9000-10000 inregistrare 10.000 de teste de spirometrie ; ‘Conform Manual de uilizare pag. 11-12: =e Din tabelul eu parametri msuraj se vede c& sunt in total at 52.de parametri | Conform Manual de utlizare pag. 11 Interpretare automata a _| Spirolab poate efectua teste FVC, VCHVC si MVV si peste 30 de parametri profilul ventilator, de asemenea indexul de acceptabilitate (Comtrolul calif) side reproductibilitate al Conform Broyura pag. 2: Compare PRE-POST | Comperarebronhsitatoure FV, FEV, IVC, MVV, PRE/POST ox o serie de parametri selectabili Conform Manual utilizare pag. 3: Configurati dispozitivul (data, ora, valorile asignate, Setare pentru limbaj gi limba, et.) dupa cum serie fa secfiunea 2.5 | valori de refering siconform Manual de utilizare pag. 19: \Valori de referinta — Aceasti sectiune v8 permite si setai valoarea teoretied doritt: ERS, Knudson... Conform Brosurd pag. 2: Poirvit pentru copii ~ Stimulator pediatric brevetat ~ ‘gama largl de imagini si | Direct pe ecran pentru a imbundtafi conformarea snimati i in timpul testelor de spirometrie GER Coa Pagina 2 din § ai Sono (f AAMED 1475/9) UI R92283 Na, ang 0 ‘Masurare flux: £16 L/s ‘Conform Brogura pag. 4: Masurare flux: 216 Lis Precizie flux: #5 % sau 200 ml/s ‘Conform Brogura pag, 4 Precizie flux: £5 % sau 200 mV/s ‘Volum maxim masurat 10 L. Conform Manual de utilizare pag. 12: Volum maxim masurat: 10 L Precizie volum: £3 % sau 50 ml Conform Brosuri pag, Precizie volum: +3 % sau 50 ml Rezistenja dinamica: <1,5 emH2O/Lis ‘Conform Brosurd pag. 4: Rezistenja dinamied: <1,5 cmH2O/Lis Parametrii prineipali masurati: FVC, FEV1, FEV1/ FVC, FEVI/VC,.PEF, FEF25, FEF50, FEF75, FEF25-75, FEF75-85, Varst8 pliman, Volum extrapolat, FET,Time to PEF, FEV0.5, FEV0.S5/FVC,FEV0.75,FEV0,75/FVC, PEV2, FEV2/ FVC, FEV3, FEV3/ FVC, FEV6, FEV l/FEV6, FEV1/PEF, FEV1/FEV0.5, FIVC, FIV1, FIVI/ FIVC, PIF, FIF25, FIFSO, FIF75, FEFS0/FIFSO, VC, IVC, IC, ERV, IRV, Rf, VE, VT, tl, tE, VTAL, tEATOT, MVV (mésurat), MVV (ateulat) Conform Brogura! pag. 4: Parametrii de spirometrie: FVC, FEVI, FEVI/FVC, FEVI/VC, PEF, FEF25, FEPSO, FEF7S, FEF25-75, FEF7S-85, Varst® plaméni, Volum extrapotat, FET, Timp péna la PER, FEVO.5, FEVO.5/FVC, FEV0.75, FEV0.7S/FVC, FEV2, FEV2/FVC, FEV3, FEV3/ FVC, FEV6, FEVI/ FEV6, FEVLPEF, FEVI/FEVO.5, FIVC, FIV1, FIVI/FIVC, PIF, FIF25, FIFSO, FIF7S, FEFSO/FIFSO, VC, IVC, IC, ERY, IRV, Rf, VE, VT, th, 2, VTA, tEATOT, MVV (maisurat), MVV (calculat). Calibrarea: nu este necesard, dar se poate realiza Conform Manual de utilizare pag. 19-20: ‘Turbina nu necesita calibrare, doar o curétare periodicd. Dacd totusi doriti st efectuati o calibrare, refinefi urmatoarele: calibrarea poate fi efectuaté atat pe turbinele reutilizabile, cit si pe cele de unica folosingd. Conditii de utilizare: funetionare ccontinus Conform Manual de wtilizare pag. 13: Condit de utilizare: Dispozitiv pentru uilizare continua ‘Conexiune: USB sau Bluetooth 2.1 ‘Conform Brogura pag, 4: Conectivitate: USB 2.0, Bluetooth 2.1 ‘Alimentare: De la acumulator reincircabil NIMH 7,2 V (6 elemente de 1,2 V) 4000 mAh sau de Ia refeaua electrica prin adaptor de refea Model calles, 12W-NIEFM Conform Manual de utilizare pag. 13: Alimentare: Baterie reincarcabila NiMH 7,2V (6 baterii, 1,2 fiecare), 4000 mAh gi incdreator baterie: Model c.ae.c. 12W-NIEFM jmensiuni: minim 210 x 200 x 50 ‘Conform Brogura pag, 4: Dimensiuni: 220 x 210 x 51 mm Greutale: maxim 1500 g (inclusiv baterile) ‘Conform Brosuri pag. Greutate: 1450 g (cu baterile incluse) Condit de pastrare: ~ Temperatura: min -40°C, max +70°C - Umiditate relativas min 10% RH; max 95% RH ‘Conform Manual de utlizare pag. 13: Condit de depozit ‘Temperaturdz MIN 40°C, MAX +70°C Umiditate: MIN 10% RH: MAX 95% RH Conditit de transport = Temperaturi: min -40°C, max +70°C ~ Umiditate relativa: min 10% RH; max 95% RH ‘Conform Manual de uilizare pag. 13: Conditii de transport ‘Temperatura: MIN -40°C, MAX 470°C Uniditate: MIN 10% RH: MAX 95% RH Conditii de funcfionare: ~ Temperatura: min +10°C, max +40°C. - Umiditate relati max 95% RH min 10% RH; Conform Manual de utilizare pag. 13: Conditi de funcrionare: ‘Temperatura: MIN +10°C, MAX 440°C ‘Unmiditate: MIN 10% RH; MAX 95% RH. MIR Sw. Medical Intemational Research Via det Maggiolino, 125, 00155, Roma, Italia Rel 22 Pagina 3 din 5 ipal protectiel electrice: Conform Manual de utilizare pag. 13 = Dispozitiv Clasa Il Protectic electric’: Clasa Tl Gradul proteciei electrice: Conform Manuel de uilizare pag. 13: | BF Grad de protectie electrica: BF _ — protec ls patrons Conform Manvel de wilizre pag. 13: ; protectie impotriva pitrunderifapet: IPX 1 Sera oaie PS | aispcitiv proteatimpotrva patrunderit apei ‘Accesoriiincluse in setul de livrare: ~ Soft WinspiroPro pentru Conform solicitarii Autorititii Contractante setul de conectare la PC livrare va include urmatoarele: = Cablu USB - Soft WinspiroPro pentru conectare la PC - Cablu ~ Geant de transport USB =Clem& nazala 1 buc. ~ Turbind de unicd folosing 1 ue. ~ Baterie reincarcabila NiMH 72V (6 elemente de 1,2 V) ea 4000 mAh 1 buc. =Batencrencae - Geanté de transport = Clem nazalé— 1 buc. - Turbina reutilizabila — 1 buc. = Pies bucala de unica folosinta — | buc. iMH 7,2V (6 elemente de International ; 1,2¥) 4000 mAh ~ 1 buc. Research + Incareator retea model c.a/e.e. | . fnearcator retea model c.a./c.c. 12W-NIEFM — 1 12W-NIEFM I buc. a Ic. Via del (Condifii_service in garantie Maggiolino, ~ Minim 36 luni de la data TTermenul de garanfie va fi de 36 de luni sitneepe la data) 125, 00155, _punerii in funcfiune semnarii procesului verbal de receptie. Roma, Italia ~ Timp de intervene: maxim 24 ore de la solicitare, la sediul beneficiarului Condit eu caracter tehnie ~ Transport asigurat de ofertant a pina ee ah a vest de ‘Transportul va fi asigurat de ofertant péind la sediul indicat Perehcier de beneficiar. ‘Timp de interventie va fi de maxim 24 ore de la solicitare, la sediul beneficiarului. ~ Ofertantul si alba personal pentru efectuarea instalarii si | Conform documentelor atasate: - Scrisoare de Autorizare de la producitor - Certificat de instruie tehnica de la producator service-ului dispovitivului ~ Instruirea personalului medical sitehnic la sediul indicat de | beneficiar dupa punerea in func{iune a aparaturii Dupii punerea in funefiune a aparatului, ofertantul va efectua o instruire a personalului medical si tehnic ta sediul indicat de beneficiar. 3. Metodologia de livrare, ambalare, etichetare, transport si asigurare pe durata transportului, Livrarea echipamentului medical se va face la locetia Spitalului de Pneumoftiziologie "Tudor Viadimirescu”, comuna Runcu, judeful Gorj, in prezena reprezentanfilor autoritétii contractante si ai furnizorului. Ambalajul va fi prevazut astfel incdt s& reziste manipularii accidentale, expunerii la ‘temperaturi extreme, precipitajilor din timpul transportului si depozitrii in locuri deschise. Transportul si toate costurile asociate vor fi in sarcina exclusiva a Contractantului. Produsul va fi asigurat impotriva pierderii sau deteriorérii intervenite pe parcursul transportului si cauzate de orice factor exter. Contractantul este responsabil pentru livrarea in termen a produsului, 4. Metodologia privind instalarea, punerea in functiune, testare. Instalarea, punerea in funciune si testarea se va face la locul de livrare indicat de Autoritatea Contractanté. Dupa instalare si punere in functiune, Contractantul va efectua teste functionale ale produsului fara niciun fel de costuri din partea Autoritatii Contractante. ft, Pagina 4 din § x net 22 S te ano : 5. Instruirea personalului Dupa punerea in functiune a aparatului ofertantul va efectua o instruire a personalului medical gi tehnic la sediul indicat de beneficiar, Vor fi instruite minim 5 — maxim 10 persoane. Instruirea se va cefectua in limba roman. Pe durata sesiunii de instruire contractantul va asigura materiale suport in Himba romana, cum ar fi Manualul de utilizare al produsului. 6. Termen de livrare. Termenul de livrare va fi de maxim 20 de zile de la data semna contractului de citre ambele art Garantie. ‘Termenul de garantie al produsului va fi de 36 de luni si incepe la data semnérii procesului verbal de receptie. Garantia va acoperi toate costurile rezultate din remedierea defectelor in perioada garantie, inclusiv, dar ira ase limita la: ~ diagnoza defectelor, inclusiv costurile de personal; ~ Tepararea tuturor componentelor defecte sau furnizarea unor noi componente; inlocuitea partilor defecte; + instalarea in starea initial, ~ testarea, pentru asigurarea unei functionsri corecte; = repunerea in functiune, 8. Asigurarea mentenanfel pe perioada de garantie. Jin perioada de garanjie ofertantul va asigura mentenanta aparatului in conformitate cu cerintele/procedurile stabilite de producttorul echipamentului, cu personalul siu propriu, autorizat de producator. Operatiunile care vor fi efectuate sunt: inspectic, testare, operatiuni de intretinere periodic’, reglaje, revizi, reparatii curente. Mentenanfa preventiva va acoperi toate costurile aferente interventiei, inclusiy forja de munca, piescle de schimb si altele. Dupa fiecare interventie preventiva se vor efctua teste de functionare ale produsului si se va prezenta un raport care va include act i 9. Receptia produsului Recepjia produsului se va efectua pe bazai de proces verbal semnat de Contractant si de Autoritatea Contractanté. Recepfia produsului, aét cantitativa cat si calitativa, se va realiza in termen de maxim 5 zile lucrétoare de la livrarea produsului. Recepfia se va realiza in prezenta unui reprezentant al futnizorului Pentru @ clarifica la fafa locului pentru a clarifica diferentele cantitative si calitative. La receptia rodusului, furnizorul va prezenta: = aviz de insofire a mar = manuaV/nstructiuni de utiizare in limba romana = cataloage, pliante si late documente necesare in vederea asiguriirii corespondenjei intre specificafile tehnice ale produsului livrat si cerinfele minimale din caietul de sarcini; + proces-verbal de insruire a personaluluis ~ certificat de garamte si calitate; ~ cettficat de conformitate. Valabilitatea ofertei: 29.01.2021 {n speranfa cf oferta noastrsatisface necesitifile autoriitii contractante, cu deosebita consideratie, Data completarii Operator economic 29.09.2020 S.C. ELMED S.R.L, Director General Pagina $ din 5 pew atio Spirolab’ IS Mi R ie 5 eae Spirometer 1EDI" AL. INTERNATION. with Oximetry option. Orn www.spirometry.com fey www.oximetry.com E b S| ee Senkon cu oeremaini®, eA Wane af- Spirolab’ Spirometru portabil awe M i R cu optiune de oximetrie HEAL WIERWATIONAL Afisaj touchscreen de 7 inchi www.spirometry.com www.oximetry.com ConFOR CU oRreINALEL \°, -4- Spirolab® Fast, simple, durable diagnostic spirometer * FYC, FEVI, IVC, MW, PRE/POST . Bronchodilator comparison with a wide or 900 hours of Oximetry recording range of selectable parameters * Wireless Real Time test * Long life Rechargeable Battery on PC via Bluetooth” * Color Touchscreen 7 inches display * Fast and silent built-in printer with customizable printout format * Direct connection to external USB Printer Fast and intuitive for modernprofessionals @ a i Oximetry option Available with adult ! pediatric finger probe Spirolab® Spirometru de diagnostic rapid, simplu si durabil * Baterie reincdrcabilé durabild Afisaj touchscreen color 7 inchi Conectare directa la o imprimantd externa via USB Intuitiv $i rapid pentru profesionistii moderni Optiunea de oximetrie Disponibilé cu senzor de deget adult / pediatric sau 900 de ore de oximetrie * Teste wireless in timp real pe calculator via Bluetooth * Imprimanté incorporaté rapide sisilentioasd cu formate de tparire personalizabile Qeu ~ FlowMIR® ad MIR Disposable Flowmeter (complies with ATS/ERS standards) Spirometry testing requires maximum accuracy andhygiene, Each turbine is factory calibrated with « computerized system and itis packaged individually in a clean room. * No Cross-Contamination 100% hygiene guaranteed! * No calibration required Option available: reusable turbine. to — | cain cae * Network Version available Summary Printout of al tests Spirometry carried out report FlowMIR® een Turbind MIR de unica folosintaé (corespunde standardelor ATS/ERS) Testele de spirometrie necesité. precizie $iigiend maxind. Fiecare turbind este calibratd din fabricé de un sistem computerizat si este impachetata individual intr-o incéipere curaté, * Ford risc de contaminare Igiena 100% gorantatd ! * Nu necesité calibrare Optiunidisponibile: turbina reutilizabila, Geanta de transport ° Disponibité versiune de retea Sumarul Report de tuturor spirometrie testelor . Pa spd * Ralersie vo, CuIRa9z263 ComrOR cu oRrG -3- Spirolab® - Spirometry - Technical. ‘Specifications Power supply: Rechargeable battery and mains power . . . . it} * Mouthpieces: 30 mm (1.18 inch) . (8,66 x 8,26 x 2in) Bite) | Spirolab® ~ Oximetry (optional) - Technical specifications * Sp02 ronge: 0.99% * p02 accuracy: * 2% between 70-99% Spoz * Pulse Rate ronge: 18-300 BPM * Pulse Rate accuracy: 2BPM or 2% whichever is greate © Memory capacity: up 10 900 hours oximetry ¢ eases: same setae baum eg ee ere soearaan ANMIR S255... bess Eaemee LISS rig-stuation sierapera Smamen pages Sess LneLabe ar Spirolab® - Spirometrie - Specificatii tehnice © Alimentare: Baterie reincércabild si retea cece eee 2 g 8 = s = & 3 8 2 ee s (8,66 x 8,26 x Zin) (3, 1b) Spirolab® - Oximetrie (optional) - Specificatii tehnice © Gama SpO2 :0-99% © Precizia SpO2 : + 2% intre 70-99% SpO2 Gomé puls: 18-300 BPM Precizie puls : 2BPM sau 2% care este mai more Capacitate memorie: pénd la 900 de ore de oximetrie . Stalin 25 Eomocaa rere feiss orn ‘ose cm Us ame pete) ss-0081 kePemtenond Se £4108) 30-200, ‘nase ose Pes iron | ance tamuscrome ——psacowesar20%@ | irdnsset re, Rasstoweezeiese Bavsmaiacown —‘kmerspomeyom Spirometru Spirolab Lajime hartie: 112 mm mamERM meat eecme ORPEMMALEL et conrOR CU it ANMIR cotter sptomety tet calls for a patients complete collaboration, ‘The reals o ‘xh as quiekly ae possible. f these key condi unacceptable” ‘The aeceprabibity of «test Lifcrently-able persons Spirola rained depend on the patient's ability to intake and Se canon e met the wzometry esl wl a be tlable on as doctors ha * the decors responsibilty, Hs cre mut be ken when desing with ede pans chien or ‘The product must ot be sed if malfunctions orf age detected or sapere a thee ‘pay compromise reas, When the spirolab device is used as an oximeter, shown on the display need to be checked Sbitolah devices are subject to continuous checks daring production and these ‘comply with the safety and quality standard aid down ia Council Directive 93/42/1 ass dove hasbeen removed from its packaging, examine it careful to make ‘sure thee are no sigas of damage. In che event of isk ono se the device but rerun it immed the manatee for pcan replacement som wc of the device, we strongly advte the user inform his or her doctor, 90 Decree No. 46/1997 implem Risk of cross contamination decease eee mt be cleaned before being sed on. ew patent Theo of ener acter viral filters eft to the doctor's dlseretion, {he eisposable turbine sensor must be replaced fo each pation. 122 Turbine ~si ‘erbns are nad of lst dispove ofthe turbines please "he following information i valid for both types of turbine fp ites "Never pone ube vero of wate ra low contac vith hot i és Ks (3 | Rew, ) ( sex |e Zierse outa Page \ Mae ®, s “4, wv ane COWFOR cu oRveINALD: AN MIR Shia n varstd,eopillor sau Persoanelor eu dizabiliti, ‘Apsral me va tli dat observa veo fineionae anormal au un defect ear ar tea influenta corectitudinen ezaltaelor ‘tent ca svi ssigurai ef nu prezina vreun semn de iciorare. In azul in cre consti vreo problem, mu lla el eas chee produedtorului pentru o eventual Siguranta pacientului gi perform sunt respectate. Produciterul ‘erespectarea instractiunilor de w Pralaal trebuiewtiat conform Manualulai de ailizare, tn special duph cam este ddescris in paragraful Scopul utiliza Si s¢ vor folosi doar accesori originale specifiate de production Uulnen turbinelor, senzorilor de oximetrie sau a altor Denence cenit Sut origaale poate provoca ctricronate sau poate comprone ctionarea corecti a dispezitivul De acces, utlizarea acestora nu este permisa, Niealaattprodusul dacs. depasit durata de viaf, care fn condi de ulizare ‘normal, este de eca. 10 ani. jiveltl de inchrcare al baterci este monitorteat constant de disposal insusi. Dispozitival va afisa an mesaj de avertizare n cazal in care bateria este nefunctionali. « garantate doar daca atentionarile gi cerin{cle standardclor tate pentru producerea oriciror pagube cauzate de 41.2.1 Riscul de contaminare incrueigats Pent a evita or 8 folosinta pentra fiecare Pacient fn parte. Turbinele reutlizabile tnlzate pe un pou pacient. Uilizarea unui fir antbacterian este la aitatines dara losin trebuic inlocuita dupa fiecare pacient. Urmitoaree informati se referi la ambele tipuri de wurbine, "Nu expunetiniciodat senzori bine! ajc de ap su de er sn permite contact lor cu lichide ierbint Rete | | Pag ain a0 CONFOR CU oR reINA AN MIR Spiralab — =I pita cen he connected to PG or another computed sytem. The sponte data from ever ee, is stored in the device and Fa caatamfered to aPC and displayed (Hnw/volume eurven spiumetc panmctear nine Parameters optional), The device can be connected to aPC via a micro USB porn E fast re-reading ‘The normality values (theoretic) can sencrally use the values recommended by the RS. Oximetey function met sensor Featutex wo ight emitng dds (1D); one emi vse red light and the other infra-red. Both bands of light OF meaty the Ringer to cach aight detector. During che parse through the fnges ae or light is absorbed by the blood an Fete depending on dhe concentaon of hemoglobin ‘The amount each hake frequency absorbed depends on how oxjgenated the Blood is inside the tissue. Ths operating principle ensures accutate and reproducible eadinge without the nce to ‘constantly calibrate the device ‘The oximetry sensor can be disinfected with Isopropyl alcohol, 15 Technical specifications slow ica compere desertion ofthe specications for te dsc, the bine wate nl ow msn and the oximetry sengor. 154 Spirometer specifications AN MIR lab Sepa ay Post 8 conetat fun PC sau lau al stem compterizat. Dace de spirmetric ela ects tet sunt stocte in aparat Be kmsterat pe un PC si afste (cubes debivolum, parame de sponte sf optional paeoes tae et). Dispozitivul poate fi conectat la PC via port miero-USE (be isponibili pentru o recite rapids. Valorite de normaltae (coretice) pot fi selects dis eclo fi Unlunié Europene doctor folsesin general valor recomandate de ERS (European Respaton Seccey Funetia de oximetrie Humpoasa este absorbiti de singe si de tsutl male in funetie de concentain de hemoglesins ark ie freeventi Htminoasd absorbité din ambele fescicule depinde de cit de oxigenat este singe in tsut seer aati fimctonareasigurt et precise reproducible fra nevoie de albreirepclte ale apart, Senzorul de oximetie poate fi dezinfectat cu alcool izopropilc. 1S Speciticati tebnice Ince ce urmeezt se pein descrcre complet spefclilorehnee ale apraali le turin se senvoal de debit siale senzoruluj de oximetrie 154 Specitiatiispirometrie AN MIR Flow/volume sensor Bi-directional wabine “Temperature sensor semiconductor (045°C) Method of detection Ini meson Flow rate EIST ye Volume accuracy 23% or 50m. Flow accuracy 5% oF 200 mbJa Dynamic resisiance at BLJa_| <05 eal 0/1 J 152, Definitions Oximeter specifications Drop in Sp02 peril of 150 see. Desaturation event Pulke variation event panes ‘Onimetry tt pameteae Rise in Pulse >= 10 BPM in a8 40 sec inated period and vubsequeat deop ina 8 40 sce period limited and subsequent rise >=2% inside an ovecall BPN iad an rebel eth Deen eam aut AR mR A % SPO? max Maximum SPO2 daring the tet % BPN rain ‘linisum BPX doing the test aM BPM max Maximare BPM daring the est BPA Median YSPO2 Medan SPO2 % Median BPM Neckar BPM BAT Tol Duration of Beta em Ana Total measuring ime (union of te excading rere) ‘hmm T<90%o Tine with S02 Tes than 9% Ye bim Taio ie with $02 less than 87% Yeblimmss is Time with SpO2 less than 5% of the mean Ve “F=A0BPM “Time passed with Pulse rate <40 BPM “TS 120BPM “Fie pass with Pale ate S130 BPM ikem [Method of dzicetion Ted and ints Ig absopaion curing rage of "SPO: (0— 99% (with 1% increments) Bar 1 Recuracy of 480, 2 2% berwcen TOS SPO Tumber of beats for calculating the median SpO% | beats ule rate measuring range 15 500 BPN | [Resolution of pulse rate TPM se rate accuracy £2 BPM or Ph of highest alee interval for ealculatng median pulse Fale Bseconds Signal quality 0 8 daplay mens signaling: Beeps with frequeney depending on pulse rate Revs Page 120637 COUERR GU OR rGMALEL ns) LMER >| “ w Manen® AN MIR Spit a ee — — ——— =: ye ___ , =——— +e bn wed Saar haa Tatiana tote Seniconducer aC] Magia de tesege oe [Watrastaatioess —t foe Misurare fx S160 Pret volar EF au aL Precise fax £3 san 500 ‘Rezistenfa dinamick Ia 12 Lis | = $% io pron Hina de 40sec, so cree subenvet de >-296 Eveniment desarurare intr-o perioada total de 150 sec. venient val pus Cis de pul >= 10 DM in peal Tn BU Se Wa SHIGC SISGNCRTS 2=8 BPM intr-o perioadd total de 150 see. Paramitttestului de oximetrie: n impul test SPO? maxim fh tempultestlul ‘BPM minim in timpultestulu 'BPM maxim in timpul testulut SPO2 mediu BPM medi Durata tstulal ‘Timp total de misurare (durata tetulul fir aeroury Timp eu SpO2 mat mic de 90% ‘Timp eu SpO2 mai mic de 89% “Timp cu SpO2 mai mic de 5% din valoarea mode “Timp scurs cu puls <40 BPM T=120BPM_ Timp sours cu puls <120 BPM oda de detecie ‘Absorpis Taniai osu gnaogn interval miserare %SPOZ 09986 (eu increment de 1% |[Rezolufie SpO2 T caraiefe S02 = 26 ee TO SOD Runir de bret pare arculaea S07 meas a [interval naisurare puls T8— 300 BPM ie le TSPM curate pus +2 BPM sau 2% dn alorea tea al mae aterval pentru calealarea pala media Teenie Kistesemat a et =e ———| Semnalizare acusticl: + Bip-urieu freeventa dependent de rata pulsului oe Pag iain 3? FOUTAR CU AN MIR Sounds in the event of exceeding pre-set threshold values ofthe %aSpO2or pulserte Sounds during oxiescty if batety low Sounds in the event of no signal present (finger not inserted propcly, connector no propery atch) Sound the next time the device i tured on following an interrupted test due to low battery Spirolab ‘The specifications tha apply to oximetry and pulse raw are the same regardless ofthe sensor used a8 longasitis one of those mentioned beforehand. 153 Other fearuees ii “The memory ean store the data rom over 1000 spiromncirc wats The at mamnbor femony has not been established as it depends on the configuration set by the doctor = “inches colour toneh sereen LCD Diaplay with 800480 resolution a Touch sezeen lterface USB, Blustooth Frequency range 2402-280 Miz (Output power: 1001 Iatuetooth interface ‘Frequency tolerance: 20 ppm ‘Type of snrenna: permanently attached Antenna gun: 0 max dBi = Tifespan ‘About 10 ee ‘of use onomy 10 hours Dimensions ‘ain body 2205210357 mm ei ‘Central unit 1450 including arse pack Appliance not suitable “Fletrical Safety THC 6060T-1 prricablesstatetaite Hlectro Magnetic Compatibility IC 60601-1-2 HKey performance (in accordance with | Accuracy in measuring spirometuy parameters in accowdance with the ATS wamlard [EN 6o601-1- 2007) ‘Measurement of oximetry parameters with accuracy as defined inthe able on page 13. Page 0637 AN MIR ‘Sunete in cazul depasiri limite valritor presctate pentru SpOz sau puls ‘Sunete in timpul efectuaritestelor de oximetrie dacd bateria este aproape descdreaté Sunete in caz de lips semnal (degetul neinserat corespunzitor.conectorul nealagat corespunzitor) ‘Sunete la urmatoarea pornire dup un test tnirerupt din cauza bateriei care sna descdreat ab Spesifcaile care se aplicd oximetrci si pulsului sunt aceleas indiferent de senzorul uilizat, ade timp edt sunt dintre cele mentionate 153 Alte caracteristict Viatncs Memoria poate soca datele a paste 10.000 de teste do spirometrie, Numfral exact au a fost stabilit, depinzand de configuratiasotata de doctor. ra ‘Aligaj LCD color touch sereen de 7 inch, eu rezoluie d= BOOI8D rasta “Touch sereen interfete USB, Bluetooth Tntervalfreevenfie 2402-2480 Miz putere de igie: 0,001 Interfata Bluetooth Toleranfa in frecvent:20 ppm Tip antend: atagata permanent Amplifcare antené: 0 max dBi ata de viaté a bateriel ‘ca 10 ani de ulizare NodicalecMWNIMSCSCSY [Autonomie =10 ore Unitatea prinejpala 220321031 man Unitatcacentrabi 1450 g inchs baler) ‘Casall "i Siguran electricd IEC 6060] [banderdeaplicabite ‘Compatbilitate eleetromagneticd IEC 60601-1-2 ‘Acuratejea misuritorilor parametrlor de spirometie conform aandardclor ATS ‘Misuritorile paremetrilor de oximetrie cu acuratejea definitt in tabelul de la pag. 12 [Performante eheie conforme cu {standardul EN 60601-1: 2007) Revs ( ANMIR In the "Incentive" section, you can configure the pacdiatrc incentive to improve spizometic performance. “The incentive may be enabled or disabled; should tbe enabled, by sclecting "ON" on the left, you must enter the age theeshold up to ‘which the incentive is displayed; use the numeric keypad on the Dottom to set this valu, Calibration For ealibration, see parageaph 25.1 below, Oximenry In this section, you can configure all alarms seated to an oximetry test. By setting the dested alarms to “ON”, you will activate a box where you can set the relevant theeshold value sing the numeric keypad. _—- + -9 - If you choose the last predicted value NHANES III, the imitations provided for i the past by the standard NITANES TI will be appli Delete archive Using the numeric keyboard, enter the PIN set to permanently delete all the tests stored in the device 25.1 Calibrating turbines "The disposable turbine is inspected befor itis sealed i the package, and hence doct not nce calibration. Rete Page 190637 COMFOR cy ‘In seetiunea “Incentive” puteti configura stimulentul pentru copii pentru inbundttireatestulul de spirometre. Accasté funcjie poate 11 activaté sau deaactivata. La activare, selectind "ON" in stings, trebuie si introduoati limita de varstt pind la care stimulentul este afigat; utiliza tasta numeric’ din partea de jos pentru a seta aceasta valoare. Calibrare Pentru calibrare, consulta paragraful 2.5.1 de mai jos. Oximetrie in aceasté secjiune puteti configura toate alarmele legate de testele de oximetrie, Seténd alarma dorté pe "ON", veti activa © efsutl in care putefi seta valoarea de prag uilizind tasiatura Uliana tasttura numeric, introduceti codul PIN pentru a seta stergerea definitiva a tuturortestelorsalvate in dispovitiv. 25.1 Calibrarea turbinelor ‘Tarbina de unici folosinté se inspecteazs inaintea sigifril in ambalai, prin urmare nu necesith calibrare. fs Res | (—ngiaen —) (2 COMFOR CU ORDGINALHL | ASN MIR Spirolab Calibration tkex place based on the IVC (expimtory) and HVC Gaspiratos) values messured during atest performed with a calibrated syringe Te neces the calibration setting, select the sevice menu item "Calibration; the Fit sercen, "Last values" allows you to cheek eutrent percentages applied by the device. By choosing "New calibration”, you can cleulae new conversion factors. Make atest using the syringe calibration - a [Make the following act in the same sequence: ‘+ Make an inspiration manoeuvre © Make an expiration manoeuvre © Make an inspiration manacuvee once again (On the display its shown the graphic ofthe test ‘then HL [calibration comection i < 1096 then the values are shows as in the following screen, “Tap “OK” to set the new correction vals Ir the values are > 10 % then the following message appears on the he FC and FIVE vals are not accepted. Tis means thatthe system it unable to correct sch a lange calibration ero. In this ease check thatthe epirola is working propesy by fiting a new turbine and/or clean the tusbine in qusstion. ‘Yo cance! ths calibration in use and restore the factory settings, sclect “Pactony values” feom the calibration menu. Then tp ‘According to the "Standardised Lung Function Testing” publication of the Buropean Respiratory Society (Vol 6, Supplement 16, March 1993), sir expelled from the mouth has a temperature of about 35/54. [To convert the volumes and se flow ates to BTPS (37°C) condition, they must be increased by a factor of 2.6%. The BTPS factor fora termperatare of 35°C ie 1.026, which ein facta correetion of 26%. Im practice, the BTPS factor for expiratory volumes and flow eatee ie content and equal 1425, |The BTPS factor for inspmory volumes and flow rates depends on ambient temperature, ae ar dats inhaled isa hat temperature, |For instance, with an ambient temperature of 20°C with Relative Humidity of 50%, the BTPS factor is 1.102, which represents [fa Slite ayringe is used for the test and ifthe epirolah device is perfectly calibeated, the PVC (eytinge) value measueed will be: 3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BIPS). |f the ambient air temperature is 20°C, the FIVC (syringe) value measured will be: 3.00 (FIVC) x 1102 (BIPS) = 3.31 L IVC at BIPS). ‘The user must be aware thatthe volume of the syringe shown was converted to BTPS and the "alterations" of the results suhen compared with expected values do not therefore represent an error. For example, ifyou perform calibration withthe data measures: FVC = 3.08 Land FIVC= 3.31 Lat an ambient temperature of 20°C, the correction coefficient wil Reels (pageant COMFOR CU ORVeIMALEL AN MIR Capra bazar pe vaorile suas ale FV (expiratory st FIVC (inspira) ntmpul anu tet feet cu seringd de calibrate. Pentru a accesa setarea de calibrate, select in meniul de service ‘rocentajul curentaplicat de aparat, Selectind "New calibration", putei calcula noi factori de conversie, Efectuati un test utilizand seringa de ealibrar, Efectuati urmitorilpasi in acceasiordine: “Calibration”; primul eeran, "Last values", vl permite s8 verificati * Facetio manevré de inspirare + Facctio manevré de expirare * Facet din now o manevra de inspirare Pe ceran se va alia grafcultestulu ‘poi apa Dack coretia de calibrare este < 10%, atuncivalorile sunt agate «dupa cum se vede in ecranul urmitor. ‘Apiisati “OK” pentru a seta noile valori de eoretie. Daca valorlesunt> 109% pe ecran va area urmacorul mesaj: ‘Vabse FV FIV mi su acspat. Asta iseann sistema spat coretao cou declare at de mare In cst ae Vettes’ dac’ spirolab functioneazi corect prin atagarea unc alte turbine, si sau - curdjatiturbinarespectiva, Pentrua ago si arevent Ia setiile de fabred, selectati “Factory values’ ‘Apoi apisati eral acer mtarlzatls fence palimonare”publiate de European Respiratory Sociey (VoL 6 Suplinnatl 16, martie 1993), acral expirat pe gurd are otemperaturl de cea. 53/3400 DIPS pera ar valorile de volum si debit pera conijile BERS (37°C) le vor trebui marie ea wn factor de 2,6%. Factorul] rolmne i aeniemheraterd de 3°C ete 1026, cera cereprenas de fap caret de 26% le eset eg 'BIPS pentru} tele expiratori 026, +i daci dispositival Spirolab este perfect calibra, valoarea FVC (serings) va 026 (BIPS) = 3.08 L.(FVC a BTPS), acd temperatura ambiants este de 20°C, valoarea FIVC (seringa) va fde: 3.00 (FIVC) x 1.102 (BTPS)=3.31 L (FIVC a BTPS). Usilcatorultrebuie sf fe atent alibrare cu datele masurate: 331.L lao temperatura ambianté de 20°C, coefcientul de coreetic va fi: ANMIR si EXPIRATORY 00% 26 Patient data Vo theme, ou can see he pt ae mengenet a +" enter a pic or che repute evs a change current patent data Tapping the "Ethnic group" field brings up a drop down menu where you can choo ded va ‘The icon’ “slows you to delete the last character entered Te icon allows you to enter uppercase characters. ‘he icon IBM allows you to enter information in the next fk. : ‘The icon Mill atows you ro setura to the main sexeen without ‘oe saving dat a a Theo on Allows you to save youretre and rem wo the in 1 the "Hthnie rowp” field, the following options will appeat: “Nosaupsclecied "10084 “Caucasian Fae Se of NTS/ERS standards: depending on the ethnic groupe, the corection percentage aes onthe predicted values ofthe following parameters: AEA COR, ice eaten 2] a ww IVC, PREVI, FIEV3, FEV6, FIVE, FIV, BVG, IC, Ve ERY, TV, V/A ra nen COMPAR CU oRE) ns AN MIR Spirola EXPIRARE 0% INSPIRARE, 00% Pentra a NU este o ervare, ci consecinta logic a ceca ce s-a explicat mai sus Calibrarea se tal poate elctan Tolosind sofware-al winapiPRO cave ete lvrat eu aparatal, Pentru deal Tezate de Procedura de calibrare cu acest software, consultati manualal online wiespiroPRO. 26 Datele pacieatalui On san il pete aes stn dtr pce pani onuepelliodepecoatsanaticamnpemtoacaaive ‘© Puteti modifies datele pacientuluicurent tingid ea * cimpul “Ethnic group”, veti accesa a list din care veti putea face seletia doi Pictograma | permite stergerea ultimului caracter inttodus. Pictograma permite ntoduserea eu majuscule Pictoprama permite introducerea informatior in ‘ céimpul urna. Pictograma [BA permite revenir salvarea datelor cecranul principal Rat be permite salvarea datelor introduse Caueazian ~Affosameriean —Mexican-ameriean Altle —Pakistancz Cusstrimosiafficani 87% Aborigin 3% {In cazul standardelor ATS/ERS ietie de grupul etnic seta, procentul de corectie actioneaz asupra valorlor prezise ale ‘urmitorilor parametri: FYC, FEVI, FEV3, FEV6, FIVC, FIVI, EVC, IC, VC, ERV, TV, TVA Res Pag 21 din 37 FOR cu ORIEN AN MIR eae - . - Spirolab —— = . - x aa an tn the exe of NITANES IT standards: depending onthe etre group st diferent predict formulae ae take into account (in accordance withthe reference standart). ‘Once the desired ethnic group has been selected, the device completes defining the pationt parameters and retuins automatically tothe ln the case of GLI for every lthnic group the device applies a diferent rable to calculate the preted values and nota correction percentage 262 Editing patient data Select the icon andl use the scrcen a described in section 26.1, Inthe main sezeen, youean acces the deta preseatinthe deviceacchive SSS VT Or ect se peat et a a Wwe rst ve anv oxy Fach option selected wl bring up a box in which you can enter the search data 2.72 Viewing archived data "he achive display the list of paions, stasting wth the most recent Select the patent roquzed by eapping th line (which becomes SS ST SST orange) and choote one of the enabled functions listed at the Fm bottom ofthe seen "The enabled icons are coloured, while the grey omes are disabled “To quit the stehve, wse the on * AN MIR Spit Dac cazil standardlor NHANES Ill in funetie de grup etnic seat, se aun considera difrite Formule teorsice (in conformilate cu standardul de referin{3). Odaté ce grupul etnie dori a fost selecta, principal, ispozitivul termina de defini parametei pacientuli gi se teintoaree automat in ecranul {in cazul GLI pentru fiecare grup etnic dispozitivul apc un tabel difert ‘Pentru a calcula valorile teoretice si nu un procent de corectic, 2.62 Editarea datelor pacientului Selecta pictograma i utiliza ceranul dup cum este descris in sectiunea 2.6. ra crea un nou pacient ca mai inainte, 2.7 Vizualizarea datelor salvate 214 Cum se cauti tn arhiv Sy inecranul pri i ace le in arhiva ay A ea FR Ineraat principal put accesa datele presente in rv apart — li rs Sau scletati dup tipul testulus a a FVC Post ve Mvy oxy, |Laselectareaoricdrei optiuni va apie o casuf in care pute introduce datele edutate, 2.7.2 Vinualizarea datelor arhivate ‘Arhiva afigeaza o list de pacienti, incepand cu cel mai recent. Sclectatipacientul dort prin atingerea liniei respective (care se a in portocaliu) si alegeti una dintre functile activate listte in prtea de jos 2 ecranulul Pictogramele active sunt colorate, jar cele inactive sunt ori Pentru a ics din arhiv8, utiliza pictograma Revs Pg.2.in 37 708 CU ORreIMAL AN MIR ‘Vo view the spirometry tests perfoumed by the selected patent, use the icon ‘The information is displayed as in the image on the right. On the left you have the test trend in graph form (Fow/Volume and Volume/ Tim), while on the ight you have various quality related ‘messages and the values of the parameters selected in the service ‘menu. By swiping your finger in the patameter aces, you ean view bother parameters selected in the service menu. You can delete one of the tests performed as follows: tap the column relating to the test data eo be deleted; the data will be Selected by two bands on the left and rights now tap the icon fon the lower right. And tap “OK" in the popup window whieh appears om the seren. -Ateach screen you can go back othe prvion step by pig io view the selected pation’ oximetry tet, we the icon ‘he data csplaed as inthe image othe right, with the paphie tren ofthe % SpO2 and BPM alwayson the lef and the numerical ‘ales of the vaso parameters om the ight, You may cance the test by using the icon OH on the lower right. {fou want to perform a new rest onthe slected patent for this fete, yo can use the con forthe est tobe performed 4 message 4 displayed to confi whether of not you wish to psforms new teston the selected paint Tap "YES" to coniem oF "NO to po tek, Ui fhe patent has performed several spirometry or oxic tests, the inl list indicates Gn beackets next to the typeof tes) the mmber of tort saved, To view tests other than the first, ap the icons (for spirometry) ot foroxymety) 273 Displaying the last te Daring test sessions, the spirometer automatically saves upto 8 E'VC tests som the main green, using the icon: inthe ease of spicometty tests + © inthe ease of oximetry tests atchive and printed, cithec together or indvidealy. Numbers may appear on the mai seteen, next othe spirometry test icons, for example: ‘The sumber inside the red circle represents inthis case, the F'VC tests performed in the cusrent session. 28 Online made (connected to a PC) "This function acts like an actual laboratory-based seal me spirometer connected to PC. Connection to the PC an be performed by USB or by a witless Bluetooth connection, Spirolab becomes an intligent sensor for ‘measuring volume and fow rate while the PC controls the functions, including turning on and off ‘he computer softwate allows the ust of move up-dated bronchial provocation protocols and can display FISV1 dose and time- sponses ‘it canmot be remotely operated. The settings om the PC ate transferred to the device tse the device remotely. For example, ifyou use epirolab connected to the PC anc Res | © 1 rage 250687 AN MIR Spies Ponta vizalizatedele cfectuate de pecienul sect angi CAC Pictograma : oe Infomatia va fi afgata ea tn figura din dreapta, fn sings avelt testl in forma grafic (Flux Volum 3i Volum/Timp) in timp ‘in dreapia ave diferte messje legate de caltatea si valorle Parametilor selecta in menial de service. Lovind eu degetul zona parametilor, pei vizulia salt parameti select in menial de service. ——— Puts sterge un test dup cum urmeaza:atingeticoloana cre se refer la datele care urmeaz af sere; datele vor fi mareats de feo bent sign Indep: acum alge pgm din partea din dreapta jos. Atingeti OK tn fereasta care va prea pe eran, Din fecare eran pute reveni la pasul anterior tastind a Pentru a vizualiza testul de oximetrie al pacientului selectat, Datele sunt afigate dupa cum se vede fn figura din dreapts, cu = _maficul % SpO2 si BPM totdeauna in stinga, ir valorile a soe ‘numerive ale difertilor parametri in dreapta. ind pictograma © din partea dreapta jos mou test pe pacientl selectat di acest ceran, pute flosiiconul testului dort se va aga un ‘mesaj care vi inreaba dac& dort sau nus efectuafi un nou test ‘pe pacientlselectat. Atingeti "VES" (DA) pentru a confirm, sau." NO" (NU) pentru a v8 intoarce inapo. DOUBDES | Daci pacientul a efeetuat mai multe test de spirometie side oximetre, lista inital indict inre paranteze lingA tpl testului) rnumarul testelorsalvate. Pentru a vizuaiza alte teste deed primul, (pentru spirometrie) sau” (penteuoximetre), 2.73 Afigarea ultimel sesiuni de teste Jn impul scsiunitor de teste, spivometrlsalveaa automat pn la 8 teste FVC. Din ecranl principal uiliznd pictogramele: cazul tester de spitometric © imeazul testelor de oximettic Acestea vor putea fi regisite in ual Peecranul principal vor putea aparea numere chiar léngi iconuriletestelor de spirometrie efectuate, ca de exemplu: Numiul din intriorul cerculuirosu repeezina, in acest caz, test FVC efectuat in sesiunea curenth, 28 Modul online (conectat tun PC) Aceastifuncti se comporté ca un spirometru de laborstor tn timp real coneetat la un PC. ‘Conexiunea cu PC-ul poate firealizaté via USB sau wireless via Bluetooth, Spirolab devine estfel un senzor intel ‘msurarea volumului sia huxulu, in timp ce PC-ul fi controleazfimeti Softwareul calculatorului permite folosirea mai multor protocoale updatate de provocare bronhialé si poate afiga doza FEV! si ‘spunsul tn timp. [Cand dispozitivl este conectat Ia un PC, nm poate fi operat de la distanfi. SetSrile de pe calculator suat transferate p disporitv si rimiin active de fiecare dati vetifolosi aparatul la distant, De exemplu, Gaci utiliza’ spirolab conectat peas) Pag 23 ia 39 Zany |e apariers \e Sit eeto CouFaR CU ORDGIMALUL \%, Nu *Y4ne.g0™ AN MIR a peyforma POST test, proceed as follows tray Ed on the main sereen “The sercen on the sight shows the ist ofall dhe patients who have Performed a PRI test om the same dy. Sclect the patient required and choose one ofthe features enabled below. The user is prompred to confirm the move ro POST mode: tap "YES fe carryout the test in POST mode, or ap "NO" 1 go back. , t | By "POS" cst, we mean a spirometry test performed after administering the paticnt a bronchodilator. ‘The tests subsequently performed om the selecred patient show the Following parametct: ow Pie © ‘The values for the test performed © The values ofthe best PRE teet performed by the same patient on the same dy (in the same session} © ‘The percentage change berween PRE and POST values (nthe column labelled CHG) ‘You cannot perform a POST vest on patient if the archive only contin PRE tests caried out on previous days (sessions other than the current one). 1f,dusinga POST session, you create anew patient or retrieve another patient fom the sichive, the device automaticly exits the current POST session, 2.10 Displaying and reading spirometry rewules Seroll through the parameters aca to iow any other parameters et 2404 Interpreting spicometry results “The interpretation of spizomeny refers to Vorced Vital Capacity (FV) and is seen by means of indicator lighting. “The messages can include the following: 4 Notmal spizometry 4 Sight obstuction/sesteeton | (Moderate obstruction restriction 4 Moderately severe obstruction/ striction 4 Severe obstruction restriction 1} (Very severe obstrution/restriction “The final inteepectation level i "estrietion + obstruction", where the indicator light indicates the worst parameter between restriction and obstruction. “Thanks toa mathematical analysis known 2s quality contol that ie applied to some indices and parameters calculated in F'VC tests, the spirolab device can produce diferent comments that help to understand the reliability of tests caried out “The quay contol system ues letters as described below: Ist case: PRE tat 1“ acthe end of two acceptable texts, the vation of the two highest IE value an the two higher FEN‘ vale are les than or ‘salt 100. atthe end of two acceptable tents he variation of the two highest VI vals is between 101 and 150 ml st the nd of two aecepable testy, the vation ofthe two highest FEV1 vals between 151 and 200ml fry 1D= only one tet ws acceptable or thee more than one cepa test bu the vaianon of heh highest EV vals Cs aime Sane te Pd e | conpen cu cere AN MIR Pot foun POST proces nl ior : et ee oe ae: TiAl Eran din dreapt alga lisa tulrorpaienjlor care au efectant tntest PRE in aceai Selecta pacienal drt i leet una din faite activate ma jos. Utilizator exe rat st contre dca tea st weal ia modal POST: alge "YES" (da pnt a efectua un teat in modul POST. ‘sau "NO" (nu) pentru a va intoarce inapoi. Spirolab Prin testal “POST” noi injelegem un test de spirometrc efectuat dupa ce pacientul bronhodilatatr, Testl efectuat ulterior pe pacientul selectat aati urmitori parameti © Valorile pentru testulefeetuat; * Valorie celui mai bun test PRE efeectuat pe acelasi pacient in aceeagt zi (de ex. in aceeag sesiune); '* Modificarea de procentaj dintre valorile PRE si POST (in eoloans mareati CHG). ‘Nu pute efectua un test POST pe un pacient daca arhiva contine doar testele PRE efectuate in zlele precedente (altésesiune decd ‘eva curent. Daca, in timpulsesiunii POST, creaii un nou pacient sau aceesafi un alt pacient din arhiva, apaatuliese in mod automat din sesiunea POST eurenti 2.10 Afigarea si citirea rezultatelor de spirometric. SS Defilati in zona = aren pon vaio let de paramet. Vex = 2.10.1 Interpretarea rezultatelor de spirometrie Interpretarearezultatclor de spirometrc so refera la Capacitatea ajutoru indicatoarelor luminoase. Mesajele pot include urmétoarcle: 4 Spitomette normalé 4 Obstructefestrictie neinsemnata 4 Obstrucjefestricie moderatd sever “ Obstructerestictie grav 4 Obstrucjietestictie foarte grav, Ultimal nivel de imterpretare est “restrctie+ obstructie” unde indicatorul luminos indicd cel mai prost parametru dnire resritie slobstructic. Multumité anatize! matematice numite control al calif care se aplic’ unor indict si parametii calcula la testele FVC, sparatul spirolab poate produce diferte comentari ear ajut la ingelegerea gradului de incrodere a testelor efeetuate ‘Sistemul de control al cali floseste litre, dupa cum urmeaz8: ‘Copal 1: testul PRE ‘A= Ia finalul a doui teste acceptable, varitia celor dou cele mai mari valori ale FEVI i FEV6 este mai mic8 sau egal ev 100 mL. celor doul cele mai mari valori ale Bella Joaet seep, aia color du cl salma val le FEV1 te ate 11150 Il C= na dns spc hr ove ma a lo ale PEt 5 9200 aL 4 Doar un atest cepa sete all Sun et esa dar vtiaa elo out a alae FEV ‘jin 200m, is = reitdoss ANAE® >| = Mit FORTUR GU cere, 2" / N% ey 45.597 AN MIR Spit sprint dh lst test perfinmed, retrieve the test using the ion “Tepe th performed, retrieve d ing for spirometry or © for oximetry. When you haveviewed the test, press the jean “Choose one funetion in 5 seconds (when all the balls become orange) no function is elected, then after 5 seconds the thermal printed ‘wll stare sotomatial 1 the dicet USB printing is disabled then towching the icon “* wil start automatically the thermal priate “prin test ct tn the past and store in the archive, perform a search as debe in sceon 27-1; once payed, tp “Als in thease wll appear the banner to select she printing type: thermal printer or via USB connection “The system print the information selected inthe "Spirometry” = "Results" settings 34 Up-dating internal software {When the device is connected toa PC via the USB port, the eptolab internal sofeware can be up-dated. Up-dates can be downloaded vor retsion fms wwr'spitometry com. For further information about downloading up-ates, refer tothe “winspizoPro” manu 4, MAINTENANCE Spirolab devices need litle maintenance. You should periodically: 1+ Clean and chock rewable turbines Replacement disposable tusbines at each test ‘© Clean the oximetry sensor (for reusable vento) Replace the adhesive tape om the wrap type oximetry sensor Recharge the incenal battery pack All the maintenance operations deserbed in the User Manual must be carted ou with great care, Faure to follow these instructions ‘nay lead to incorteet readings or the ineorec interpretation of readings that have een taken ‘Mltmodifcatone, adjustment, pats and reconigurstions must be performed by the manufacrarer or by personne] authorised by the srannfactce In the event of problems, do not attempt to make repairs. ‘The ting of configurable parameiers must be performed by qualified staff. In no ease does the incozrct setting ofthe devi place» patient at sk 41 Cleaning and checking reusable turbines “he volume aod flow turbine sensors usable with spirolab are of two types: disposable and reusable. ‘These guarantee peat accuracy snalawe the added benefit of aot nedig to be petiodcally calibrated. \ simple clean before every use wll ensure thet the turbine keeps ‘working ast should (only foe reusable turbines) Trot dckocabe turbines cleaning s not necessary a they are supplied clean and packaged in sealed envelope. When you hare finished using them, they should be dscatded, fone every us, perform the test described in section 41.1 below that allows you ro tet the efficiency ofthe rorbine If the esis negative, act as follows. Faacee ae dbable turbine, remove it feom ts housing n the MiniFlowmeter by tuming it anti-clockwise and polling gently. Yo Feit ‘emoval, you can pash the bottom of the turbine gently with a inges Beak the forbine in a col liguid detergent and shake itso as to emove any impurities that have deposited inside; leave to souk for the period of time recommended by the detergent mannfactuer that is shown in the instvetions for ue. conbOR cu oRrerMALEL \\ MIR Spica Penu_a tpt ulm test efectust, cual test utlizind fasta pentru spirometrie sau 7 pentru oximetric. Cand Alzeto functie in 5 secunde (cdnd toate bilele devin portocali); dac nici o funetie mu este selectat8, dupa 5 secunde imprimanta termied va porn automat. acd tiparirea direeti USB este devactivati, apisind pictograma “* , imprimanta termied va pori automat, Pentra a tipi un test efectuat in trecut gi salvat in arhiv,efectuaio edutare dupa cum este descris in sectiunce 2.7.1; odatdafigt, apis. De asemenea in acest caz va apie bannerul de selectare a tipulul tipi: imprimanta termied sau via USB. Sistemltipiresteinformatia selects la settle "Spirometry" - "Results. 34 Updatarea software-ulul Intern ‘Ciné dispozitivul este conecta fa un PC via port USB, software-ul internal Spirolab poate fi updata. Update-urle pot f

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