Teleflex HUDSON RCI aquatherm III Operating Manual

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Teleflex Medical

3015 Carrington Mill Blvd., Morrisville, NC 27560

Non-sterile Heated Humidifiers – RTP-HD-T5008

This document contains proprietary information. It may not be reproduced without prior written approval.

>>THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT<<

Document #: FRM-000756

Page 1 of 1

REPRESENTATIVE LABELS/

INSTRUCTIONS FOR USE

For Use by Affiliates of Teleflex

Revision#: 00

Document #:

Revision #:

Issue Date:

Issue Date: See Agile

Parent Document: WI-003907

FRM-000756

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Table of Contents

Summary of Contents for Teleflex HUDSON RCI aquatherm III

Page 1 REPRESENTATIVE LABELS/ INSTRUCTIONS FOR USE For Use by Affiliates of Teleflex This document contains proprietary information. It may not be reproduced without prior written approval. >>THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE BEFORE USING THIS DOCUMENT<<...
Page 2 Nebulizer Heater International Operating Manual...
Page 3: Table Of Contents
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Aquatherm, Aquapak and Hudson RCI are registered trademarks of Teleflex Incorporated or its affiliates.
Page 4: Features
Features Illuminated power switch Temperature control knob Adjustable temperature range Corrosion-resistant metal components Figure 1: Aquatherm III Heater...
Page 5: Introduction
. Heater Operation The Hudson RCI Aquatherm III Heater is placed between a nebulizer adaptor and a reservoir of sterile solution. When gas flow is initiated to the nebulizer, sterile solution is drawn up from the reservoir and through the stainless steel puncture pin in the center of the Hudson RCI Aquatherm III Heater.
Page 6: Warnings And Cautions
Warnings and Cautions This manual uses special indicators to convey information of a specific nature. A warning is a condition that can endanger an operator, patient or a service person . A caution is a condition that can damage equipment . These are the warnings and cautions for the Aquatherm III Nebulizer Heater: Warning: Fire Hazard.
Page 7 Caution: Do not autoclave, gas sterilize, pasteurize or immerse this device in liquid . Severe equipment damage will result . Caution: Do not operate the heater with a dry reservoir bottle . Caution: Do not leave the power ON while changing a reservoir bottle . Caution: Do not overtighten the reservoir bottle .
Page 8: Symbols
Symbols The following symbols are used in this manual and on the heater labels: Symbol Definition Symbol Definition Power ON Consult Instructions for Use Power OFF Follow Instructions for Use Ampere Rx Only Alternating Current Caution Volt Product is not sterile Hertz Warning: Hot Surface Protective Earth (ground)
Page 9: Operating Environment
Operating Environment Ignition Sources All sources of ignition must be kept away from the Aquatherm III Nebulizer Heater, and preferably out of the room in which the heater is being used . In a hospital environment, an incubator is an example of an ignition source.
Page 10 Guidance and manufacturer’s declaration - electromagnetic emissions The Aquatherm III Heater is intended for use in the electromagnetic environment specified below. The customer or the user of the Aquatherm III Heater should assure that it is used in such an environment . Emissions test Compliance Electromagnetic environment –...
Page 11 Guidance and manufacturer’s declaration - electromagnetic immunity The Aquatherm III Heater is intended for use in the electromagnetic environment specified below. The customer or the user of the Aquatherm III Heater should assure that it is used in such an environment . Immunity test IEC 60601 Compliance...
Page 12 Guidance and manufacturer’s declaration - electromagnetic immunity The Aquatherm III Heater is intended for use in the electromagnetic environment specified below. The customer or the user of the Aquatherm III Heater should assure that it is used in such an environment . IEC 60601 Compliance Immunity test...
Page 13 Recommended separation distances between portable and mobile RF communications equipment and the Aquatherm III Heater. The Aquatherm III Heater is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled . The customer or the user of the Aquatherm III Heater can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Aquatherm III Heater as recommended below, according to the maximum output of the communications equipment.
Page 14: Specifications
Specifications Electrical Characteristics Voltage and Power: 220–240 AC at 50 Hz, 0 .8 A Warning: This unit requires 220–240 AC, 50 Hz sine wave input . When used in ambulances, helicopters and other mobile life support vehicles requiring an invertor, do not use square wave or pulse-width modulated sine wave output .
Page 15: Controls And Indicators
Controls and Indicators Main Power Switch This switch is illuminated when the heater is turned ON . Temperature Control Knob Adjusts the temperature of the heater, within a range of 1 to 7 (Approximately 25°C to 37°C). Flow Chart Label A chart for Total Oxygen Flow is printed on the side of each heater.
Page 16 Figure 2: The Aquatherm system using a nebulizer and Aquapak reservoir.
Page 17: Directions For Use
Directions for Use Installing the Heater Performance of this procedure requires a compressed gas source, a clean, unused nebulizer adaptor and a Hudson RCI Aquapak reservoir bottle . The Aquatherm is intended to be installed and monitored by trained medical professionals . Thoroughly clean and test the heater before installing and placing it in service .
Page 18 9 . Inspect all connections and ensure they are secure . Placing the Heater in Service Warning: Always measure and verify aerosol temperature before connecting the heater to the patient . Warning: Always measure and verify oxygen concentration before connecting the heater to the patient .
Page 19 Changing the Reservoir This procedure is performed to replenish the supply of water in the nebulizer system after a reservoir bottle has been emptied . 1 . Turn the heater OFF and shut off the oxygen or air supply. It is not necessary to alter the setting on the temperature adjustment knob.
Page 20 Removing the Heater from Service This procedure is performed to remove the heater from service and properly store it after each use . Warning: Burn Hazard . Internal components are hot, up to 135 °C, and may contain liquid at temperatures up to 100 °C .
Page 21: Service
You may authorize replacing your heater with a remanufactured or replacement heater . This authorization permits Teleflex Medical to ship you a replacement heater promptly after receiving your old heater. If you choose to have your serial-numbered heater serviced and returned, repairs and turnaround time may be longer than with the replacement program .
Page 22 6 . Set heater temperature adjustment knob in a fully clockwise position (setting 7). 7 . Plug heater into an outlet meeting the voltage requirements on the unit label . 8 . Turn the heater main power switch ON . The power indicator must illuminate . 9 .
Page 23: Troubleshooting Guide
Possible Cause(s) Recommended Action Problem: Power switch does not illuminate. 1 . Unit is not connected to Power . 1 . Plug the power cord into the grounded electrical to power outlet . Ensure there is power at the outlet . 2 .
Page 24: Warranty
. IN NO EVENT SHALL TELEFLEX MEDICAL BE LIABLE FOR CONSEQUENTIAL DAMAGES . Some states, provinces or countries do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you .
Page 25 Teleflex Medical Incorporated Morrisville, NC 27560 USA Dublin Rd . 11245 North Distribution Cove USA: (866) 246 6990 Athlone, Co . Westmeath International: +1 919 544 8000 Ireland Olive Branch, MS 38654 © Copyright 2009, 2010, 2011, 2013, 2019 Teleflex L02916 R01...
Page 26 Nebulizer Heater en: International Operating Manual it: Manuale d’uso internazionale L02916 R01 L02922 R01 nl: Internationale gebruikershandleiding es: Manual operativo internacional L02919 R01 L02923 R01 sv: Internationell Användarmanual fr: Manuel de l’opérateur L02924 R01 L02920 R01 de: Internationale Betriebsanleitung L02921 R01 AQUATHERM III NEBULIZER HEATER OPERATING MANUAL TFX-004318 R01 CD Kit...