background image

9/59

EN

For example: Serial number 20151001521 indicates the valve manufactured in 2015, in October, 

with sequence number 1521.

Product life time and waste management

Maximum operating life time of this product is 15 years from date of manufacture.
At the end of the product’s life time, the product must be withdrawn from service. The provider 

of the device shall prevent the reuse of the product and handle the product in compliance with 

“Directive of European Parliament and Council 2008/98/EC on waste“.
In accordance to Article 33 of REACH GCE, s.r.o. as responsible manufacturer shall inform all 

customers if materials containing 0.1% or more of substances included in the list of Substance 

of Very High Concern (SVHC). The most commonly used brass alloys used for bodies and other 

brass components contain 2-3% of lead (Pb), EC no. 231-468-6, CAS no. 7439-92-1. The lead 

will not be released to the gas or surrounding environment during normal use. After end of 

life the product shall be scrapped by an authorized metal recycler to ensure efficient material 

handling with minimal impact to environment and health. To date we have no information that 

indicates that other materials containing SVHC of concentrations exceeding 0.1% are included 

in any GCE product.

9.2. REPAIR AND SERVICE OPERATIONS 

Repairs and service can be only done by a GCE certified person who also holds all necessary
certificates in compliance with national standards for mounting and repair of dedicated gas
devices.
For information about a service in your area please contact GCE or distributor of GCE product.
Usually the combination valves can be repaired while fitted on the cylinder.
Repair that do not need to be done by certified personnel include exchange of the below
mentioned components:

• 

guard,

• 

labels,

• 

protective covers and separable hose adaptors.

All labels on the equipment must be kept in good, legible condition by the provider and the 

user during the entire product life time.
Use only genuine GCE components.

Any product sent back to GCE (or GCE authorised centre) for repair or maintenance shall be 

properly packaged to prevent contamination or damage during storage, transportation and 

handling.
For product to be repaired, the fault short description or some reference to a claim nr. should 

be indicated.

10. GLOSSARY

Consult instruction for use 

Suitable for Hospital care use

Caution! 

Suitable for Home care use

Keep away from heat and 

flammable materials.

Suitable for Emergency care 

use

Keep away from oil and 

grease! 

Fragile, handle with care

Keep dry!

Weight of product

Summary of Contents for MediVitop

Page 1: ...ES PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVE DRUCKREGLER MIT FLASCHENVENTILEN EN DE MediVitop DETENDEURS INTEGRES REGULADORES DE PRESI N INTEGRADOS CON V LVULAS DE BOTELLA FR ES RIDUTTORE DI...

Page 2: ...ix No 1 of instruction for use Flow rate is listed in the Appendix No 1 of instruction of use in the table on the position C and this Appendix is supplied to every product The saturation of gas must b...

Page 3: ...tion valve storage at temperature below 20 C do not use the combination valve until its temperature reaches at least 20 C For the combination valves designed to be used with mixture of gases O2 N2 O t...

Page 4: ...h the pressure regulator and finally delivered to the patient through the flow outlet or the pressure outlet Outlet positive pressure is fixed by the manufacturer and each combination valve is provide...

Page 5: ...closed D COMBINATION CONTROL KNOB SHUT OFF VALVE FLOW SELECTOR The valve is fitted with combination control knob for valve turning on off and setting of particu lar flows The valve is turned on by ant...

Page 6: ...p tube does not have such function Ex cess flow device and dip tube are to avoid contamination from cylinder entering the combina tion valve K BED HANGER OR HUMIDIFIER HOLDER OPTION Bed hanger enables...

Page 7: ...flow control head each valve is provided with so called end stop located downstream the maximum flow position Do not try to apply excessive force on the combination control knob shut off valve flow s...

Page 8: ...soft cloth damped in oil free soap water rinsed with clean water Clean ing of external surface can be carried out with an alcohol based solution with damped wipes If other cleaning solutions are used...

Page 9: ...ontaining SVHC of concentrations exceeding 0 1 are included in any GCE product 9 2 REPAIR AND SERVICE OPERATIONS Repairs and service can be only done by a GCE certified person who also holds all neces...

Page 10: ...arranty period is 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 p...

Page 11: ...N2O Atemluft Air Helium He Kohlendioxid CO2 Xenon Gemische der aufgef hrten Gase 2 1 PATIENTENPROFIL Der Druchfluss ist einstellbar von 0 bis 25 Liter pro Minute Informationen bez glich der Durch flus...

Page 12: ...ei einer Temperatur unter 20 C gelagert darf es nicht verwendet werden bevor wieder ein Wert von mindestens 20 C erreicht F r Kombiventile die zur Verwendung mit einem Mischgas aus O2 N2 O vorgesehen...

Page 13: ...glern f r medizinische Gase Das aus der Flasche austretende Gas str mt zun chst durch das Haupt Absperrventil anschlie end durch den Druckregler und wird schlie lich ber einen Flow oder Druckanschluss...

Page 14: ...hlossenem Absperrventil anzeigt D STEUERGER TKOMBINATION ABSPERRVENTIL UND DURCHFLUSSW HLER Das Ventil ist mit der Steuerger tkombination zum ffnen Schlie en des Ventils und zur Ein stellung von beson...

Page 15: ...sflasche im Falle eines Bruchs des Kombiventils ber oberhalb des Anschlussstutzens z B wenn die Flasche umf llt und besch digt wird Das Steigrohr bietet keine derartige Funktion Die ber str mvorrichtu...

Page 16: ...langsam gegen den Uhrzeigersinn in die Stellung ON drehen Stellen Sie die gew nschte Durchflussmenge ein Bevor Sie Zubeh r am Flowausgang anschlie en stellen Sie sicher dass keine Verbindung zum Pati...

Page 17: ...chl ssen entfernen 7 ZUBEH R ZUBEH R DAS AN DEN FLOW ANSCHLUSS ANGESCHLOSSEN WERDEN KANN Schl uche von Atemmasken Nasenbrillen oder Befeuchter ZUBEH R DAS AN DEN DRUCKANSCHLUSS ANGESCHLOSSEN WERDEN KA...

Page 18: ...gierungen enthalten 2 3 Blei Pb EG Nr 231 468 6 CAS Nr 7439 92 1 Bei normalem Ge brauch wird Blei nicht in das Gas oder in die Umwelt freigesetzt Am Ende seiner Lebensdauer muss das Erzeugnis von eine...

Page 19: ...des Produktes Obere und untere Luftfeuch tigkeitsgrenze Umgebungsdruck Limit Obere und untere Tempera turgrenze Verwendungsdatum Eingangsparameter SN Seriennummer Ausgangsparameter REF Artikelnummer...

Page 20: ...nktionen der Sch nellkupplung und Verfahren zum Anschlie en Abziehen Nr 3 Post Filling Checks berpr fung nach dem F llen Nr 4 Valve assembly and filling instruction Ventilmontage und F llanleitung HER...

Page 21: ...n 1 de la notice d utilisation Le d bit est r pertori dans l annexe n 1 de la notice d utilisation dans le tableau position C et cette annexe est fournie avec chaque produit La saturation du gaz doit...

Page 22: ...ur une bouteille la limite de temp rature minimale valide est de 40 C En cas de stockage de la vanne combin e des temp ratures inf rieures 20 C ne l utilisez pas avant que sa temp rature n atteigne au...

Page 23: ...de gaz m dicaux Le gaz sortant de la bouteille est d abord command par le robinet de fermeture principal puis il passe par le r gu lateur de pression pour enfin tre administr au patient par la sortie...

Page 24: ...ille Il est de type actif autre ment dit il indique la quantit de gaz dans la bouteille que le robinet de fermeture soit ouvert ou ferm D BOUTON DE COMMANDE COMBIN ROBINET DE FERMETURE ET S LECTEUR DE...

Page 25: ...n cas de rupture de la vanne combin e au dessus du raccord d entr e p ex en cas de chute de la bouteille Le tube plongeur n a pas cette m me fonction Le limiteur de d bit et le tube plongeur permetten...

Page 26: ...est connect la sortie de d bit Ouvrir lentement le bouton de commande combin robinet de fermeture et s lecteur de d bit dans le sens antihoraire en position ON R gler le bouton de commande combin robi...

Page 27: ...eur Replacez les capuchons de protection de sortie le cas ch ant Assurez vous que les bou chons sont propres avant de remplacer les bouchons 7 ACCESSOIRES ACCESSOIRES RACCORDABLES LA SORTIE DE D BIT f...

Page 28: ...iages de laiton les plus souvent utilis s pour les corps et autres composants en laiton contiennent 2 3 de plomb Pb N CE 231 468 6 N CAS 7439 92 1 En cas d utilisa tion courante le plomb ne peut pas s...

Page 29: ...s du produit Limite haute et basse du degr d humidit Pression ambiante limite Limite haute et basse du niveau de temp rature Date limite d utilisation Param tre d entr e SN Num ro de s rie Param tre d...

Page 30: ...disconnecting procedure Sp cifications du rac cord rapide et proc dure de raccordement d branchement N 3 Contr les apr s remplissage N 4 Instruction de montage et de remplissage de la valve FABRICANT...

Page 31: ...El rango de caudal suministrado es de 0 hasta 25 l min Puede encontrar m s informaci n re lativa al caudal en el ap ndice N 1 de las instrucciones de uso La informaci n sobre el caudal se encuentra en...

Page 32: ...20 C no se deber usar la v lvula antes de que la temperatura haya ascendido a 20 C como m nimo En el caso de las v lvulas compactas aptas para mezclas de O2 y N2O la temperatura m nima de funcionamie...

Page 33: ...as de la botella se controla en primera instancia con la v lvula de corte principal a continuaci n pasa a trav s del regulador de presi n y se suministra finalmente al paciente a trav s de del caudal...

Page 34: ...a botella tanto si la v lvula de corte est abierta como si est cerrada D V LVULA DE CORTE Y CAUDAL METRO La v lvula est provista de un mando combinado para apertura cierre y regulaci n de caudal La v...

Page 35: ...mbinada por encima del racor de entrada es decir por ca da de la botella La sonda no tiene esta funci n Tanto la protecci n por exceso de caudal como la sonda sirven para evitar la contaminaci n proce...

Page 36: ...de las agujas del reloj hasta la posici n ON Ajuste el caudal solicitado girando el mando Asegurese antes de conectar cualquier accesorio que el paciente no este conectado al mis mo Una apertura r pi...

Page 37: ...n de funcionamiento 10 bar medidores de caudal eyec tores Venturi respiradores artificiales OTROS ACCESORIOS DE USUARIO Trapecio para cama soporte de humidificador ACCESORIOS DE LAS ESTACIONES DE LLEN...

Page 38: ...r desechado por un centro de reciclaje de metales autori zado para garantizar un manejo efi ciente del material con un impacto m nimo para el medio ambiente y la salud Hasta la fecha no tenemos inform...

Page 39: ...ero de referencia P1 M xima presi n de salida LOT N mero de lote P2 M xima presi n de salida REF 1 N mero de referencia Fabricante Devuelva el equipo para el reciclaje No bote el equipo en la basura c...

Page 40: ...sconnecting procedure Caracter sticas del acoplamiento r pido y procedimiento de conexi n desconexi n N 3 Comprobaciones posteriores al llenado N 4 Instrucciones de montaje y llenado de la v lvula MAN...

Page 41: ...i circa le specifiche del flusso I valori del flusso sono elencati nell appendice 1 delle istruzioni per l uso alla posizione C della tabella l appendice viene fornita con ogni prodotto La saturazione...

Page 42: ...montata su una bombola di 40 C In caso di immagazzinamento della valvola riduttrice al di sotto di 20 C non utilizzare la valvola prima che la sua temperatura raggiunga almeno i 20 C Per le valvole r...

Page 43: ...e con quella di riduttore di pressione per l uso con gas medicali Il gas in uscita dalla bombola viene dapprima controllato dalla valvola principale di intercettazione quindi passa attraverso al ridut...

Page 44: ...ntit di gas nella bombola a valvola di intercettazione aperta o chiusa D MANOPOLA DI REGOLAZIONE COMBINATA VALVOLA DI INTERCETTAZIONE E SELETTORE DI FLUSSO La valvola dotata di una manopola di regolaz...

Page 45: ...gas dalla bombola nel caso in cui la valvola riduttrice sia rotta sopra allo stelo per es per caduta della bombola Il pescante non ha questa funzione Limitatore di flusso in eccesso e pescante permet...

Page 46: ...o la manopola di regolazione combinata valvola di intercettazione e selettore di erogazione fino alla posizione ON Posizionare la manopola di regolazione combinata valvola di intercettazione e seletto...

Page 47: ...icare una forza eccessiva la coppia massima consigliata 3 Nm Sfiatare la pressione dai dispositivi connessi Disconnettere tutti i dispositivi connessi Riposizionare i cappucci di protezione dell uscit...

Page 48: ...delle Sostanze estremamente problematiche SVHC Le leghe di ottone pi comunemente utilizzate per la produzione dei riduttori e degli altri componenti in ottone contengono il 2 3 di piombo Pb in riferi...

Page 49: ...le Conservare in luogo asciutto Peso del prodotto Limite superiore ed inferiore di umidit Limite di pressione ambiente Limite superiore ed inferiore di temperature Utilizzare fino Parametri di ingress...

Page 50: ...necting procedure Caratteristiche dell innesto rapido e procedura di collegamento scollegamento N 3 Controlli post riempimento N 4 Instruzioni per il montaggio e il riempimento della valvola FABBRICAN...

Page 51: ...hu pr toku jsou k nalezen v p loze 1 n vodu k pou it kde tato informace je uvedena v tabulce pod p smenem C pro ka dou vari antu v robku Saturace medicin ln ho plynu mus b t stanovena l ka em nebo ane...

Page 52: ...u p i transportu a skladov n sestavy ventilu s lahv plat spodn teplotn mez 40 C V p pad skladov n ventilu p i teplot pod 20 C nepou vejte ventil do t doby ne jeho teplota dos hne alespo 20 C Pro venti...

Page 53: ...entilu pro pou it s medicin ln mi plyny Plyn z lahve je nejprve zen hlavn m uzav rac m ventilem pak proch z regula n m ventilem a nakonec je dod v n pacientovi p es pr tokov nebo tlakov v stup V stupn...

Page 54: ...taven po adovan ho pr toku Ventil je zapnut proti sm ru hodinov ch ru i ek z pozice OFF do ON Po adovan pr toky se nastavuj ot en m proti sm ru hodinov ch ru i ek Uzav rac ventil se zav e oto en m po...

Page 55: ...v s zvlh ova e umo uje p ipojit zvlh ova do kombinovan ho ventilu POJISTKA VYSOKOTLAK STI PR TR N DISK VOLITELN V BAVA Pojistka vysokotlak sti slou jako ochrana l hve a vysokotlak sti ventilu proti p...

Page 56: ...c ho ventilu pr to n hlavy oto it nadm rou silou kdy se zastav na pozici maxim ln ho pr toku p i ot en proti sm ru hodinov ru i ek Hodnota pr toku medicin ln ho plynu mus b t p edeps na l ka em 6 1 2...

Page 57: ...inovan mu ventilu v dy zkontrolujte vz jemnou kompatibilitu s napojen m a proveden m v robku 8 I T N Ne istoty odstra te jemn m had kem namo en m v bezolejnat m dlov vod a n sledn vypran m v ist vod i...

Page 58: ...m pro mont e a opravy vyhrazen ch plyno v ch za zen Pro informace o servisu ve va em okol pros m kontaktujte GCE nebo distributora GCE v robk Opravy kombinovan ch ventil GCE kter nemus b t prov d ny c...

Page 59: ...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 platn pouze na v robky kter jsou po...

Page 60: ...esk republika http www gcegroup com Doc Nr IFU0079 DOI 2021 01 08 Rev 07 TI A5 CB V1 UNITED STATES OF AMERICA CHINA INDIA RUSSIA MEXICO SWEDEN POLAND GERMANY FRANCE SPAIN ITALY IRELAND UNITED KINGDOM...

Reviews: