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Instructions
1.
Remove GO
VENT from package and connect oxygen tubing to a pressurized gas source.
2
2.
Select 100% or 50% FiO
delivery:
2
[a]
If 100% FiO
is to be
[b]
2
delivered to the patient,
delivered to the patient,
connect tubing to the white
connect tubing to the white
gas connector with the DISS
gas connector with the DISS
thread connection on the
thread connection on the
patient tee. Ensure that
patient tee. Ensure that
the green knob is turned
the green knob is turned
clockwise until it comes to
counterclockwise until it
comes to a stop.
a
stop.
100%
3.
Set desired inspiratory flow rate - a good starting flow is between 10 to 25 L/min. Adjust
as needed. See ENTRAINED FLOW CHART for "Total delivered flow" requirements.
Note: Perform a FUNCTIONAL CHECK by occluding patient port with supply gas
flowing and verify that pressure DOES NOT EXCEED 60 cm-H
4.
Verify PIP pressure at approximately 25 cm-H
pre-set). Adjust PRESSURE DIAL to achieve desired peak
pressure.
Note: Indicated pressures are approximate and may vary
depending on conditions and settings. Verify with a
manometer.
Note: For use with a mask, clear mouth and airway of
visible foreign bodies and use accepted techniques
to ensure correct position of airway. Hold mask firmly
against face ensuring a tight seal while positioning the
head to maintain an open airway. When using an endotracheal tube, connect patient
adaptor directly to endotracheal tube.
Note: It is very important to be trained in the correct application of the face mask before any
attempt is made to use the GO
cause loss of pressure and cause the device to not cycle.
Note: PEEP is about 1/5
of PIP. Indicated pressures are
th
approximate and depend on conditions and settings.
Verify with a manometer by connecting between modulator and patient connector.
I-time is counted off manually (1-1000, 2-1000, ...) or with a watch.
©2020 - The protocol design and recommendations contained in this document are subject to change without notice.
GO
VENT
TM
is a trademark of VORTRAN Medical Technology 1, Inc.
2
ENTRAINED FLOW CHART
If 50% FiO
is to be
50% connector
2
Supply
Entrained
flow
flow
(L/min)
(L/min)
6
14
8
17
10
20
12
23
50%
15
25
O.
2
O (factory
2
PRESSURE DIAL
VENT during a sealed mask ventilation. Leaks can
2
LBL PN 6039 REV F
5. Adjust EXHALATION RATE DIAL to achieve desired respiratory rate.
Additionally, you may increase or decrease supply flow rate to achieve a
faster or slower respiratory inspiratory rate. PRECAUTION: The GO
may enter into a spontaneous "pressure assisted" mode (mandatory
rate stops), when adjusting rate dial clockwise or with changing
conditions. To return to automatic cycling, rotate rate dial counter-
Total
clockwise until desired mandatory respiratory rate is achieved.
delivered
flow
Note: Observe rise and fall of chest corresponding to patient's inhalation
(L/min)
and exhalation. Listen for expiratory flow from modulator. Listen to chest sounds.
20
Note: If patient vomits, disconnect patient adaptor from modulator and remove rate dial if
necessary. Tap out vomitus on hard surface to dislodge and reassemble.
25
Clear patient's airway and reconnect. Clearing procedure should take less than 20
30
seconds. Check that inhalation and exhalation occur without obstruction.
35
Note: The GO
VENT is pressure limited and is equipped with a redundant pressure
2
40
pop-off valve which will activate at a maximum of 60 cm-H
Note: Changes in patient's lung compliance will result in respiratory rate changes.
In such an event, make appropriate clinical changes.
Note: If patient draws air through entrainment port or device is set to FiO
concentration delivered to patient may differ from concentration at gas inlet of patient
connector.
Note: Gas supply source must be capable of delivering up to 40 L/min. Typical required
supply pressure is 50 ± 5 PSIG.
Note: The GO
VENT will deliver 40 L/min against a patient pressure of 20 to 40 cm-H
2
when the green knob is turned all the way clockwise and is connected directly to a 50
PSIG source. Lower flows are obtainable with flowmeter adjustment.
Note: The GO
VENT will deliver FiO
2
way counterclockwise and is supplied with oxygen flow from 6 to 15 L/min with
resulting output flow of 20 to 40 L/min respectively (see "ENTRAINED FLOW
CHART").
The GO
VENT provides constant flow, pressure cycled ventilatory support in either pressure control
2
or pressure support modes on patients weighing 10kg and above. The device includes the pulmonary
modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee
to supply gas flow, entrain additional air, and provides a redundant pop-off valve for safety. The
working mechanism of the GO
spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of
spring force will affect the PIP setting by 1~3 cm-H
long as the final adjustments are made in a secured position (strapped or taped to the patient).
Non-clinical testing has demonstrated the GO
a patient in the MR enviroment under the following conditions.
- Static magnetic field of 3.0 -Tesla or less
- Maximum spatial field gradient of 5,000 gauss/cm (50 T/m)
VENT
2
O.
2
of 50% (±10%) when the green knob is turned all the
2
Brief Device Description
VENT consists of a moving diaphragm which adds or subtracts
2
O. The GO
VENT will function in any position as
2
2
MRI Safety Information
VENT is MR Conditional . It can be safely used with
2
EXHALATION
RATE
of 50%, oxygen
2
O
2

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Inhaltsverzeichnis
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Inhaltszusammenfassung für Vortran GO2VENT

  • Seite 1 ©2020 - The protocol design and recommendations contained in this document are subject to change without notice. - Static magnetic field of 3.0 -Tesla or less VENT is a trademark of VORTRAN Medical Technology 1, Inc. - Maximum spatial field gradient of 5,000 gauss/cm (50 T/m) LBL PN 6039 REV F...
  • Seite 2 VENT. If the use or operation of the GO VENT is unclear, contact your distributor or Automatic Gas Powered Resuscitator dealer for clarification or visit www.vortran.com. Warnings 6. For a minute ventilation of 10 L/min and an I:E ratio of 1:1, [a] at 100% FiO...
  • Seite 3 Nota: Para utilizar con una máscara, la boca y las vías aéreas deben estar sin obstrucciones de cuerpos extraños visibles Breve descripción del dispositivo y se debe utilizar las técnicas aceptadas para asegurar la posición correcta de la vía aérea. Sostenga la máscara firmemente en el rostro para asegurar un sellado hermético El dispositivo GO2VENT proporciona soporte de ventilación sometida a ciclos de presión (modos de control mientras posiciona la cabeza para mantener una vía aérea de presión o soporte de presión) con flujo constante en pacientes que pesen 10 kg o más. El dispositivo abierta. Al utilizar un tubo endotraqueal, conecte el adaptador del paciente directamente al tubo incluye un modulador pulmonar (una válvula de exhalación que se abre a una presión PIP y se cierra a endotraqueal. una presión PEEP) y un conector en T del paciente para el suministro del flujo de gas y el arrastre de aire Nota: Es muy importante estar capacitado en la aplicación correcta de la máscara facial antes de adicional; y dispone de una válvula de salida redundante de seguridad. El mecanismo de funcionamiento intentar utilizar el dispositivo GO VENT durante la ventilación con máscara sellada. Las fugas...
  • Seite 4 - Ninguna Reacción adversa • Ajuste la exhalación con el medidor de - Ninguna velocidad. Consulte las instrucciones de uso - Precaución - No reutilizar - Compatible con RM en condiciones específicas - Número de catálogo - No estéril - Utilizar antes de - Código de lote Indicaciones de uso • Vuelva a ajustar (flujo, PIP, velocidad) según Fabricado y distribuido por: El uso de este dispositivo debe estar a cargo de 0123 sea necesario. VORTRAN Medical Technology 1, Inc. PACIENTE personal capacitado para dar soporte de emergecia, MT Promedt Consulting GmbH 21 Goldenland Court #100 - Sacramento, CA 95834 EE. UU. a corto plazo, de flujo constante y con ventilación Altenhofstrasse 80 Tel.: +1 (916) 648-8460 Fax: +1 (916) 243-1338 sometida a ciclos en pacientes que pesen 10 kg o 66386 St. Ingbert, Germany www.vortran.com más. Ph: +49 6894 581020 Fax: +49 6894 581021 www.mt-procons.com Hecho en los EE. UU.
  • Seite 5 Nicht-klinische Prüfungen haben gezeigt, dass das GO VENT bedingt MRT-sicher ist. Es kann sicher mit VENT ist eine eingetragene Handelsmarke von VORTRAN Medical Technology 1, Inc. einem Patienten in der MRT-Umgebung unter den folgenden Bedingungen verwendet werden: - Statisches Magnetfeld von maximal 3 Tesla - Maximaler räumlicher Feldgradient von 5000 Gauss/cm (50 T/m)
  • Seite 6: Vorsichtsmaßnahmen

    Wenn es Unklarheiten zur Verwendung oder Bedienung des GO VENT gibt, bitten Sie Ihren Automatisches Gas-betriebenes Vertriebshändler oder Händler um eine Erklärung oder gehen Sie im Internet auf www.vortran.com. Beatmungsgerät Für ein Atemminutenvolumen von 10 l/min und einem I:E-Verhältnis von 1:1 [a] bei einer 100 % FiO Warnhinweise Einstellung - läuft das GO...
  • Seite 7 VENT funziona un tutte le posizioni purché le regolazioni finali vengano riduzione della pressione e impedire al dispositivo di funzionare. effettuate in una posizione sicura (con il dispositivo allacciato o fissato mediante nastro al paziente). Nota: la PEEP è circa 1/5 della PIP. I valori di pressione indicati sono approssimativi e dipendono dalle condizioni e dalle impostazioni. Verificare la pressione con il manometro, collegandolo tra il modulatore e il connettore del paziente. Il tempo di inspirazione è Informazioni sulla risonanza magnetica contato manualmente (1-1000, 2-1000, ...) o con un orologio. Test non clinici hanno dimostrato che il GO VENT è compatibile con la risonanza magnetica. Può essere utilizzato in sicurezza con un paziente in un ambiente RM che soddisfi le condizioni seguenti: ©2020 - Il disegno del protocollo e le raccomandazioni presenti in questo documento sono soggetti a modifiche senza preavviso. - Campo magnetico statico pari o inferiore a 3,0 Tesla VENT è un marchio di VORTRAN Medical Technology 1, Inc. - Campo magnetico a gradiente spaziale massimo di 5000 gauss/cm (50 T/m) LBL PN 6039 REV F...
  • Seite 8 Controindicazioni • Regolare l’espira- Prodotto senza lattice di gomma naturale - Nessuna zione con l’apposita Reazioni avverse manopola - Nessuna Consultare le istruzioni per l’uso - Attenzione - Non riutilizzare - A compatibilità RM condizionata - Numero di catalogo - • Regolare i valori Non sterile - Usare entro - N. lotto necessari (flusso, Indicazione per l’uso Prodotto e distribuito da: PIP, frequenza) 0123 VORTRAN Medical Technology 1, Inc. Questo dispositivo deve essere utilizzato in casi PAZIENTE MT Promedt Consulting GmbH 21 Goldenland Court #100 - Sacramento, CA 95834 USA di emergenza e per brevi periodi, da personale Altenhofstrasse 80 Tel: +1 (916) 648-8460 Fax: +1 (916) 243-1338 adeguatamente formato, per somministrare supporto www.vortran.com 66386 St. Ingbert, Germany ventilatorio a flusso costante e con cicli di pressione Ph: +49 6894 581020 su pazienti del peso di almeno 10 kg. Fax: +49 6894 581021 www.mt-procons.com Prodotto negli Stati Uniti...
  • Seite 9: Brève Description De L'appareil

    (fixation sur le patient par une sangle ou par une bande adhésive). Des fuites peuvent provoquer une perte de pression et empêcher l’appareil de s’actionner. Remarque : la PEP est environ 1/5 de la PIP. Les pressions indiquées sont approximatives et dépendent des conditions et des paramètres. Vérifier la pression à l’aide d’un manomètre en Informations relatives à l’IRM réalisant le branchement entre le modulateur et le raccord patient. Le temps d’inspiration est mesuré manuellement (1-1 000, 2-1 000, etc.) ou à l’aide d’une montre. Des tests non cliniques ont démontré que le GO VENT présente une compatibilité avec la RM sous conditions. Il peut être utilisé en toute sécurité sur un patient dans l’environnement RM dans les conditions suivantes: ©2020 - La conception du protocole et les recommandations contenues dans le présent document peuvent faire l’objet de - Champ magnétique statique de 3,0 teslas ou moins modifications sans préavis. - Gradient de champ spatial maximum de 5 000 gauss/cm (50 T/m) VENT est une marque commerciale de VORTRAN Medical Technology 1, Inc. ÉTIQUETTE RÉF. 6039 RÉV. F...
  • Seite 10: Avertissements

    ± 5 cm H O pour 40 ~ 60 cm H Contre-indications Non fabriqué en latex de caoutchouc naturel - Aucune • Régler l’expiration avec le régulateur de Réaction indésirable Consulter le mode d’emploi - Mise en garde - Ne pas réutiliser - Compatibilité IRM conditionnelle - Numéro de catalogue - débit Non stérile - Date limite d’utilisation - Code de lot - Aucune • Ajuster à nouveau Indications Fabriqué et distribué par : (débit, PIP, etc.) au 0123 VORTRAN Medical Technology 1, Inc. besoin PATIENT Cet appareil est conçu pour être utilisé par du MT Promedt Consulting GmbH 21 Goldenland Court #100 - Sacramento, CA 95834 États-Unis personnel dûment formé pour administrer une assis- Altenhofstrasse 80 Tél. : +1 (916) 648-8460 Fax : +1 (916) 243-1338 tance respiratoire d’urgence à court terme, à volume 66386 St. Ingbert, Germany www.vortran.com constant et à pression contrôlée sur des patients Ph: +49 6894 581020 Fax: +49 6894 581021 pesant 10 kg et plus. www.mt-procons.com Fabriqué aux États-Unis.
  • Seite 11 Nota: é muito importante ter formação sobre a aplicação correcta da máscara facial antes de tentar A alteração da força elástica afecta a definição PIP em 1~3 cm-H O. O GO VENT funcionará em qualquer utilizar o GO VENT durante uma ventilação com máscara ajustada. As fugas podem originar perda de pressão e fazer com que o dispositivo não funcione. posição, desde que os ajustes finais sejam efectuados numa posição segura (preso ou colado no paciente). Nota: a PEEP (Pressão Expiratória Final Positiva) é aproximadamente 1/5 da PIP. As pressões indicadas são aproximadas e dependem das condições e Informação relativa a RM definições. Introduza um manómetro entre o modulador e o conector do paciente, para verificar a respectiva pressão. Testes não clínicos demonstraram que o GO VENT é Condicional para RM. Pode ser utilizado com O tempo inspiratório é contado manualmente (1-1000, 2-1000, ...) ou com um relógio. segurança com um doente no ambiente RM nas condições seguintes: - Campo magnético estático de 3,0 – Tesla ou menos - Gradiente de campo espacial máximo de 5000 gauss/cm (50 T/m) ©2020 - A concepção do protocolo e as recomendações contidas neste documento estão sujeitas a alterações sem aviso prévio. VENT é uma marca registada da VORTRAN Medical Technology 1, Inc. LBL PN 6039 REV F...
  • Seite 12: Especificações

    Contraindicações Não fabricado com látex de borracha natural - Nenhuma • Ajustar a expiração Reação Adversa com o regulador da frequência Consultar instruções de utilização - Atenção - Não reutilizar - Condicional para RM - Número de catálogo - Não esterilizado - - Nenhuma Utilizar até - Código do lote • Reajustar (fluxo, PIP, Indicação para utilização Fabricado e distribuído por: frequência) conforme 0123 necessário VORTRAN Medical Technology 1, Inc. Este dispositivo só deve ser usado por pessoal PATIENT 21 Goldenland Court #100 - Sacramento, CA 95834 USA MT Promedt Consulting GmbH devidamente qualificado e formado na prestação de Altenhofstrasse 80 Tel.: +1 (916) 648-8460 Fax: +1 (916) 243-1338 um suporte de ventilação de ciclo de pressão, de 66386 St. Ingbert, Germany www.vortran.com fluxo constante, de curto prazo e de emergência em Ph: +49 6894 581020 doentes que pesem 10 ou mais quilos. Fax: +49 6894 581021 www.mt-procons.com Fabricado nos EUA...
  • Seite 13 (1-1.000, 2-1.000, ...) eller med et ur. - Maksimalt spatialt gradientfelt på 5.000 gauss/cm (50 T/m) ©2020 - Protokollens design og anbefalingerne i dette dokument kan ændres uden varsel. VENT er et varemærke tilhørende VORTRAN Medical Technology 1, Inc. LBL PN 6039 REV F...
  • Seite 14: Specifikationer

    Fremstillet og distribueret af: 0123 Dette apparat skal anvendes af korrekt uddannet VORTRAN Medical Technology 1, Inc. PATIENT personale til at levere kortvarig ventilationsstøtte som MT Promedt Consulting GmbH 21 Goldenland Court #100 - Sacramento, CA 95834 USA nødhjælp med konstant flow under tryk på patienter,...
  • Seite 15 De I-tijd wordt handmatig (1-1000, 2-1000, ...) of met een stopwatch afgeteld. Niet-klinische tests hebben aangetoond dat de GO2VENT MRI-veilig is. Het instrument kan onder de volgende voorwaarden veilig bij patiënten in een MRI-omgeving worden gebruikt: - Statisch magnetisch veld van 3,0 –...
  • Seite 16: Voorzorgsmaatregelen

    Indien het gebruik of de bediening van de GO VENT onduidelijk is, neemt u voor meer informatie contact op met uw leverancier of dealer of gaat u naar www.vortran.com. Automatisch door gas aangedreven reanimatietoestel Voor een ademminuutvolume van 10 l/min en een I:E-verhouding van 1:1, [a] bij een instelling van 100%...

Inhaltsverzeichnis