Pulmodyne O2-MAX Bedienungsanleitung

O2-MAX
and
Pulmodyne's O2-MAX 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. O2-MAX System is intended for use on spontaneously breathing patients,
there is no assembly required. 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:
O2-MAX Generator is a fixed flow venturi device that uses an oxygen supply in conjunction with air to generate an output flow. O2-MAX Generator uses
a 50psi (~4 bar) oxygen supply, and can generate flows up to 140 lpm and fractional inspired oxygen (FiO
which are snapped onto the anti-asphyxia housing end of the circuit, are used to maintain positive pressure flow rates from 60 to 140 lpm.
OPERATING THE SYSTEM:
• Connect directly to a 50psi (~4 bar) gas source.
• Prior to use, be sure the device is free of obstructions and verify proper valve function.
• Place mask over patients face. Utilize the head strap to secure the mask firmly in place.
ATTACHING NEBULIZER CANISTER:
• Connect supply tubing with nebulizer canister to oxygen supply.
• Remove protective cap from nebulizer port and push nebulizer canister into port, turning ¼ of a turn to secure.
• Set gas flow. Check for aerosol mist. If necessary, tap the device until it begins to nebulize.
ATTACHING THE O2-MAX GUARD™ FILTER:
REF. A
WARNING:
• Do not connect any gas supply other than oxygen to the O2-MAX System.
• When not in use, disconnect O2-MAX oxygen line from 50psi (~4 bar) source.
• Watch the O2-CPAP valve to ensure that it remains open during inspiration.
• Monitor with any in-line pressure gauge or manometer with a range of 0-30cm H
during patient inspiration then the flow is too low, increase the flow rate to the patient.
• For use only by thoroughly trained personnel.
• Do not use O2-CPAP valve if it becomes occluded. An occluded O2-CPAP valve may obstruct patient's exhalation and result in potential injury. If this
occurs, discard entire system or remove the occluded O2-CPAP valve from the system and replace with another O2-CPAP valve.
• The circuit has an anti-asphyxia valve which prevents exhalation into the tubing in the event of no fresh gas flow. If the fresh gas flow fails, the anti-
asphyxia valve in the circuit will minimize the risk of asphyxia when there is no oxygen pressure. When there is not oxygen flow from the generator,
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 O2-CPAP valve during inspiration (which means that the generator is supplying adequate flow to meet patient
demand). Optionally, monitor the in-line pressure gauge or manometer during inspiration. If the pressure drops then the flow is inadequate.
• Monitor the patient's arterial blood oxygen saturation (SaO
• Monitor the patient for signs of dehydration and discomfort in the upper airways.
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 O2-MAX System or any of its components
in any solution. Dispose of O2-MAX System according to local established protocols when finished
with use.
Pulmodyne Inc.
M
2055 Executive Drive
Indianapolis, IN 46241 USA
www.pulmodyne.com
Made in the USA
P
Pulmodyne and ...bringing change to life are Registered Trademarks of Pulmodyne, Inc.
O2-MAX, O2-MAX Guard, and O2-CPAP are trademarks of Pulmodyne, Inc.
Fixed System-
™
Filter
1. Place the smooth side of the O2-MAX Guard Filter onto the anti-asphyxia housing of the circuit.
2. Snap into place (Ref. A)
3. Ensure the PEEP Valve is fully seated onto the filter before beginning therapy. (Ref. B)
4. Check for airflow and function as part of circuit checkout procedure, prior to use.
WARNING: Replace filter at least every 24 hours, or earlier if increased resistance is noted.
REF. B
).
2
Single Patient Use
Latex Free
With Nebulizer
O per local established protocol. If the pressure drops significantly
2
System includes:
1. Fixed Flow Generator with Filter
2. 72" Anti-Asphyxia Circuit
3. O2-CPAP™ Valve
4. Mask with Head Strap
5. Nebulizer (not pictured)
6. O2-MAX (Guard)™
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
) approximately 30%. The O2-CPAP valves,
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4.
3.
6.
2.
1.
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