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Pulmodyne's GO-PAP™ System delivers continuous positive airway pressure (CPAP) throughout the breathing cycle. It provides
CPAP at preset levels throughout inspiration and exhalation, independent of the patient's flow rate. GO-PAP System is intended
for use on spontaneously breathing patients. SINGLE PATIENT USE ONLY.
INDICATIONS FOR USE:
To provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment.
CONTRAINDICATIONS:
May be contraindicated for patients with any of these conditions:
• Facial lacerations
• Laryngeal trauma
• Recent tracheal or esophageal anastomosis
• Gastrointestinal bleeding or ileus
• Recent gastric surgery
• Basilar skull fracture
• Patients at high risk of vomiting
• Emphysematous Bulla - when an area of the lung may be brittle and present a risk of bursting
• Hypovolaemia - low blood volume
HOW IT WORKS:
GO-PAP device is a fixed flow venturi device that uses an oxygen supply in conjunction with entrained air to generate an output
flow. GO-PAP is designed to connect to a metered flow oxygen supply set to 10 LPM. The PEEP valve is integrated into the
housing of the device and is designed to provide positive pressure.
OPERATING THE SYSTEM:
Connect O
tubing directly to gas source.
2
Prior to use, check to be sure the device is free of obstructions and verify proper valve function.
Set O
gas flow to 10 LPM. Do not exceed 10 LPM.
2
Place mask over patients face. Utilize the head strap to secure the mask in place.
WARNING:
• Do not connect any gas supply other than oxygen to the GO-PAP System.
• For use only by thoroughly trained personnel.
• Do not use the device if it becomes occluded. An occluded device may obstruct
patient's exhalation and result in potential injury. If this occurs, discard entire system.
• If the oxygen gas flow fails, the anti-asphyxia feature in the device will minimize
the risk of asphyxia when there is no oxygen pressure. When there is not oxygen
flow from the device, the mask should not be worn.
MONITORING THE PATIENT:
During operation, be sure to check the following on a regular basis:
Ensure that there are no leaks at the patient connection.
Ensure that there is flow from the GO-PAP device during inspiration
(which means that the device is supplying adequate flow to meet patient demand).
Monitor the patient's arterial blood oxygen saturation (SaO
Monitor the patient's end tidal CO
Monitor the patient for signs of dehydration and discomfort in the upper airways.
Monitor the patient's delivered FiO
CAUTIONS:
Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.
Single Patient Use Only. Do not sterilize or immerse the GO-PAP System or any of its components
in any solution. Dispose of GO-PAP System according to local established protocols when finished
with use.
System Includes:
1. Fixed Flow Device with integrated
PEEP and nebulizer port
2. Oxygen Supply Tube
3. Mask with Head Strap
Made in USA
Pulmodyne Inc.
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
2.
2.
EN-Medical Device
Operating Specifications: 5°C to 40°C
at humidity range of 15% to 95%
Storage Specifications: -20°C to 60°C
at relative humidity up to 95% non-con-
densing
).
2
Single Patient Use
GO-PAP™

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Resumen de contenidos para Pulmodyne GO-PAP

  • Página 1 GO-PAP device is a fixed flow venturi device that uses an oxygen supply in conjunction with entrained air to generate an output flow. GO-PAP is designed to connect to a metered flow oxygen supply set to 10 LPM. The PEEP valve is integrated into the housing of the device and is designed to provide positive pressure.
  • Página 2 GO-PAP-enheden er en venturienhed med fast flow, der bruger en ilttilførsel sammen med luftopblanding til at generere et outputflow. GO-PAP er designet til at blive tilsluttet til ilttilførsel med afmålt flow indstillet til 10 LPM. PEEP-ventilen er integreret i enhedens kabinet og er designet til at levere positivt tryk.
  • Página 3 • Vergewissern Sie sich, dass der Patientenanschluss nicht undicht ist. • Stellen Sie sicher, dass während der Einatmung ein Strom aus dem GO-PAP-Gerät austritt (dass also das Gerät einen Strom bereitstellt, der den Patientenbedarf deckt). • Überwachen Sie die Sauerstoffsättigung des arteriellen Blutes des Patienten (SaO 2 ).
  • Página 4 αναπνευστικού κύκλου. Παρέχει CPAP σε προκαθορισμένα επίπεδα καθ’ όλη τη διάρκεια της εισπνοής και της εκπνοής, ανεξάρτητα από τον ρυθμό ροής του ασθενούς. Το σύστημα GO-PAP προορίζεται για χρήση σε ασθενείς με αυθόρμητη αναπνοή. ΓΙΑ ΧΡΗΣΗ ΣΕ ΕΝΑΝ ΑΣΘΕΝΗ ΜΟΝΟ.
  • Página 5: Indicaciones De Uso

    CÓMO FUNCIONA: El dispositivo GO-PAP es un dispositivo de tipo venturi de flujo fijo que utiliza un suministro de oxígeno junto con aire arrastrado para generar un flujo de salida. GO-PAP está diseñado para conectarse a un suministro de oxígeno de flujo medido de 10 l/min.
  • Página 6 • Hypovolemia – alhainen veritilavuus TOIMINTATAPA: GO-PAP on kiinteän virtauksen venturilaite, joka muodostaa ulostulovirtauksen hapen ja ilman avulla. GO-PAP on tarkoitettu liitettäväksi 10 LPM:n nopeuteen asetettuun mitatun virtauksen happiliitäntään. Laitteeseen on integroitu PEEP-venttiili, ja se on suunniteltu tuottamaan positiivista painetta.
  • Página 7 COMMENT ÇA MARCHE : Le dispositif GO-PAP est un dispositif à venturi à débit fixe qui utilise une alimentation en oxygène conjointement avec de l’air entraîné pour générer un débit de sortie. GO-PAP est conçu pour se connecter à une alimentation en oxygène à débitmètre réglé...
  • Página 8 Il dispositivo GO-PAP è un dispositivo Venturi a portata fissa che utilizza una fonte di ossigeno in combinazione con l’aria intrappolata per generare un flusso in uscita. GO-PAP è progettato per essere collegato a un set per l’erogazione di ossigeno a flusso misurato impostato su 10 l/min.
  • Página 9: Contra-Indicaties

    Het GO-PAP-apparaat is een vast stromingsventuri-apparaat dat gebruik maakt van een zuurstoftoevoer in combinatie met ingeademde lucht om een uitgangsstroom te genereren. GO-PAP is ontworpen om te worden aangesloten op een gecontroleerde zuurstoftoevoer die is ingesteld op 10 LPM. De PEEP-klep is geïntegreerd in de behuizing van het apparaat en is ontworpen om positieve druk te leveren.
  • Página 10 GO-PAP-enheten er en venturienhet med fast flyt som bruker en oksygenforsyning sammen med innblandet luft for å generere en utgangsstrøm. GO-PAP er utformet for å kobles til en strømningsoksygenforsyning som måles, og som er innstilt til å være 10 LPM. PEEP-ventilen er integrert i enheten og er utformet for å gi et positivt trykk.
  • Página 11 GO-PAP™ System GO-PAP™ firmy Pulmodyne zapewnia stałe dodatnie ciśnienie w drogach oddechowych (CPAP) przez cały cykl oddechowy. Zapewnia on CPAP na wstępnie ustawionych poziomach podczas wdechu i wydechu niezależnie od natężenia przepływu pacjenta. System GO-PAP jest przeznaczony do stosowania u pacjentów oddychających samodzielnie. DO STOSOWANIA TYLKO U JEDNEGO PACJENTA.
  • Página 12: Indicações De Utilização

    COMO FUNCIONA: O dispositivo GO-PAP é um dispositivo com efeito de Venturi, de fluxo fixo, que utiliza uma fonte de oxigénio em conjunto com ar capturado para gerar um fluxo. GO-PAP foi concebido para ser ligado a uma fonte de oxigénio com medidor definido para 10 LPM.
  • Página 13: Indikationer För Användning

    GO-PAP-enheten är en venturienhet med fast flöde som använder syretillförsel tillsammans med luftinneslutning för att generera ett utflöde. GO-PAP är utformat för att anslutas till syretillförsel med ett uppmätt flöde inställt på 10 l/min. PEEP-ventilen är integrerad i höljet på enheten och är utformad för att ge ett positivt tryck.
  • Página 14 Hipovolemi - düşük kan hacmi ÇALIŞMA BİÇİMİ: GO-PAP cihazı, sürüklenen havayla birlikte oksijen kaynağı kullanarak çıkış akışı üreten sabit akışlı bir venturi cihazıdır. GO-PAP, 10 LPM seviyesine ayarlanmış sayaçlı bir oksijen kaynağı setine bağlanmak üzere tasarlanmıştır. Cihazın gövdesine PEEP valfi entegre edilmiş...

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