AQUATHERM III International Service Manual April 2004

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©2004 Hudson RCI. All rights reserved. This document contains proprietary information of Hudson RCI and its receipt or possession does not convey any rights to reproduce its contents, or to manufacture or sell any product described herein. Reproduction, disclosure to a third party, or use other than for the intended purpose without specific written authorization of Hudson RCI is strictly forbidden. AQUATHERM®, AQUAPAK®, the Hudson RCI logo, and Breathing, made easier are registered trademarks of Hudson Respiratory Care Inc. in the United States of America and in selected countries. This service manual is intended in support of the AQUATHERM III ® products as stated herein, both under Hudson RCI offered warranty, or out of warranty. Any servicing, repair, parts or component replacement, altering, modification, or misuses of the products relieves Hudson RCI or its authorized representatives of any obligation for any loss incurred by the customer, its representatives or third parties. This service manual is subject to change without notification at any time. There is no warranty as to the correctness of the content of this document expressed or implied by Hudson RCI. This service manual is part number 87324-01. For current technical information, please contact: Hudson Respiratory Care Inc. 27711 Diaz Road, P.O. Box 9020 Temecula, California 92589-9020 U.S.A. Tel 951-676-5611 Fax 951-676-1578

EU Respresentative Hudson RCI AB Centralvägen 1, SE-194 27 Upplands Väsby, Sweden Page i HUDSON RCI 87324-01 04/04

AQUATHERM III Nebulizer Heater

International Service Manual

Preface This service manual is developed in support of the Hudson RCI Quality Mission statement to ensure the highest quality, most cost effective products are available to our customers. This service manual is published for use by Hudson RCI trained service technicians and for biomedical technicians retained by the institution which owns the heater described in this manual.

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Revision Control Revision Letter NC

Revised By

Description of Revision

Date of Revision

Initial Release

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General Safety Precautions Safety is the foremost concern of Hudson RCI for its customers and service personnel. The general instructions below are intended to promote the safe and effective servicing of the AQUATHERM III Nebulizer Heater. Please read them carefully. •

Always adhere to applicable precautions stated on accompanying product literature or on product labels when using required tools, material, and equipment for servicing the AQUATHERM III Nebulizer Heater.

•

Always disconnect electrical power from the AQUATHERM III Nebulizer Heater prior to cleaning, servicing, disassembling and repairing.

•

When in use, always connect to a grounded electrical outlet supplying voltage appropriate for the AQUATHERM III Nebulizer Heater.

•

Do not connect the AQUATHERM III Nebulizer Heater to electrical outlets which are shared by heavy machinery or motors.

•

Always take precautions to prevent contact with potentially harmful blood bourne pathogens or contaminated saliva and mucus substances when handling and servicing humidifiers which have been returned from a hospital. Refer to AQUATHERM III Nebulizer Heater Operating Manual for proper cleaning procedures.

•

Never use the AQUATHERM III Nebulizer Heater with electrical power supplied in the presence of flammable and combustible solvents and materials.

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Table of Contents Title

Page

Page Copyright Information ...i Preface ...ii Revision Control ...iii General Safety Precautions ...iv Section 1 - Introduction 1.0 Intended Use of this Service Manual ...1 1.1 Features of this Service Manual ...1 Section 2 - Theory of Operation 2.0 Intended Use of Heater ...3 2.1 Principle of Operation ...3 2.2 Warnings and Cautions ...3 Section 3 - Specifications 3.0 General ...5 3.1 Heater Specification ...5 3.1.1 Electrical Characteristics ...5 3.1.2 Operating Environment...5 3.1.3 Mode of Operation ...6 3.1.4 Physical Characteristics ...6 3.1.5 Transportation and Storage Environment ...6 3.2 Accessories ...6 Section 4 - Controls and Indicators 4.0 Power Switch ...7 4.1 Temperature Control Knob ...7 Section 5 - Directions For Use 5.0 General ...9 5.1 Installing the Heater ...9 5.2 Attaching Heater System to Patient ...9 5.3 Changing the Nebulizer and Reservoir...10 Page v HUDSON RCI 87324-01 04/04

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5.4 5.5

Cleaning ...10 Maintenance ...11

Section 6 - Troubleshooting Guide 6.0 General ...13 6.1 User’s Troubleshooting Guide ...13 6.2 Technical Troubleshooting Guide ...16 Section 7 - Servicing the Heater, Replacement and Repair 7.0 General ...17 7.1 Field Repair ...17 7.2 Warnings, Cautions and General Notes ...17 7.3 Quick Reference Guide...18 7.3.1 Wire and Insulation...19 7.3.2 Fraction and Decimal Conversions to Metric...20 7.4 Tools for Dissassembly and Repair ...21 7.5 Disassembly Notes ...22 7.6 Separation of Upper and Lower Cases ...22 7.7 Part Replacements...22 7.7.1 Replacing Temperature Control Potentiometer ...23 7.7.2 Replacing Lower Case ...23 7.7.3 Replacing Power Cord ...23 7.7.4 Replacing Thermistor Sensor ...24 7.7.5 Replacing Thermal Cutoff Fuse ...25 7.7.6 Replacing Power Switch and Switch Cover ...25 7.7.7 Replacing Power Fuses...26 7.8 Replacing Controller Board Assembly ...26 7.8.1 Removing Assembly ...26 7.8.2 Reinstalling Assembly ...27 7.9 Replacing Upper Case Assembly ...27 7.9.1 Removing Assembly ...27 7.9.2 Reinstalling Assembly ...28 Section 8 - Temperature Control Check and Calibration 8.0 General ...29 8.1 Check and Calibration Equipment ...29 8.2 Temperature Check ...29 8.3 Temperature Calibration ...29 Page vi HUDSON RCI 87324-01 04/04

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Section 9 Reassembly of Cases 9.0 General ...31 9.1 Tools for Reassembly ...31 9.2 Reassembly of Upper and Lower Case Halves ...31 9.2.1 Preparation for Reassembly ...31 9.2.2 Lower to Upper Case ...32 9.3 Final Assembly ...32 9.3.1 Label Attachment ...32 9.3.2 Knob and Switch Cover Assembly ...33 Section 10 Performance Check 10.0 General ...35 10.1 Initial and Periodic Check ...35 10.2 Final Check ...35 10.3 Electrical Test Equipment ...36 10.4 Electrical Test ...37 10.5 Functional Water Test Equipment...37 10.6 Functional Water Test ...38 10.7 Conclusion ...38 Section 11 Illustrated Parts Breakdown 11.0 Intended Use of Illustrated Parts Breakdown ...41 11.1 Ordering Information ...41 11.2 Returning Heater or Replacement Parts to Hudson RCI ...41 11.3 Packaging Instructions ...42 11.4 Spare Parts and Bulk Quantities ...42 11.5 Abbreviations ...43 11.6 Replaceable Parts List...44 Section 12 Technical Service Bulletins 12.0 General ...49 12.1 Bulletin Record ...49

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Section 1 Introduction 1.0

Intended Use of this Service Manual This service manual describes field repair of the AQUATHERM III Nebulizer Heater, catalog numbers 050-12A, 050-12D, and 050-12E. This service manual is provided for use by owners of the AQUATHERM III Nebulizer Heater and Hudson RCI trained technicians. Instructions for field servicing are based on parts, tools, calibration instruments, and test equipment intended for field service and may differ from procedures, assembly fixtures, and production tooling used in the original manufacturer's high-volume manufacturing process. Familiarity with the AQUATHERM III Nebulizer Heater Operating Manual is a prerequisite for use of this service manual.

1.1

Features of this Service Manual •

Graphic drawings (Fig 2 and 3) are provided to help facilitate wiring, disassembly, and reassembly.

•

Illustrations accompany detailed disassembly and reassembly instructions.

•

Troubleshooting, testing, and calibration sections are provided.

•

Complete illustrated parts list.

•

Descriptions of required tools to perform heater service.

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Introduction

Section 1

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Section 2 Theory of Operation 2.0

Intended Use of Heater The AQUATHERM III Nebulizer Heater provides a continuously heated, moist air stream for patient respiratory applications.

2.1

Principle of Operation The Hudson RCI AQUATHERM III Nebulizer Heater, herein called the heater, is designed for use with Hudson RCI AQUAPAK Nebulizer Adaptors and Reservoir Bottles. The Hudson RCI AQUATHERM III Nebulizer Heater is placed between the nebulizer adaptor and the 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 AQUATHERM III heater. The solution passes through the pin and is heated. The heated solution is then drawn into the nebulizer adaptor where it is aerosolized into the gas stream. Rainout within the nebulizer adaptor returns to the reservoir and gradually warms the reservoir contents, contributing to the overall heat output of the device. An electronic temperature control circuit provides consistent heating across a wide range of adjustments. A nonreversing thermal fuse prevents overheating should the control circuit fail.

2.2

Warnings and Cautions WARNING: Fire Hazard. Do not use the heater in the presence of flammable anesthetic gases, solvents, or other combustible materials. WARNING: Burn Hazard. Internal components are hot (approximately 135°C) and may contain liquid of temperatures up to 100°C. Allow the heater to cool before handling. WARNING: Electrical Shock Hazard. Refer all servicing to qualified, trained personnel only. WARNING: Shock Hazard. While testing the heater, use caution not to touch the circuit board or any exposed connections. WARNING: Always measure and verify aerosol temperature before connecting to the patient. WARNING: Always measure and verify oxygen concentration before connecting to the patient.

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Theory of Operation

Section 2

WARNING: Do not leave the heater operative without oxygen flow. WARNING: Aerosol delivery tube length of less than 152 cm (5 feet) may result in aerosol delivery exceeding 41°C at the patient connection. WARNING: To prevent personal injury, only use tools and equipment that are properly maintained and in safe condition. WARNING: Do not return unit for use on patient unless heater passes electrical and functional tests. Follow equipment service and repair protocol for releasing unit for patient use. Caution: Do not autoclave, gas sterilize, pasteurize, or immerse this device in any liquid. Severe equipment damage will result. Caution: Do not clean heater surface with any alcohol products as this may cause deterioration of the plastic material. Caution: To avoid electrical shock damage to the unit during calibration, do not allow the potentiometer terminals or cartridge leads to come into contact with any part of the heater block or control board. Caution: Damage to the unit is possible if heater tube temperature exceeds 140°C. Cool heater, if temperature reaches 135°C, by turning potentiometer CCW or by turning power off. Restart calibration after unit has cooled. Caution: Do not operate the heater with a dry reservoir, or leave the heater operating when changing reservoir bottle. Caution: Always operate the heater in a vertical position for best performance. Caution: Not for use with any type of ventilator. Caution: Avoid overtightening AQUAPAK reservoir.

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Section 3 Specifications 3.0

General The AQUATHERM III Nebulizer Heater's voltage specifications are specific to the region in which the heater will be used. The heater catalog numbers 050-12A, 050-12D, and 05012E have been designed to meet the voltage and hertz requirements for Australia, Europe and the British Isle, respectively. The performance specifications are consistent for each catalog number. The operating, transportation, and storage requirements remain the same.

3.1

Heater Specifications NOTE: Unless otherwise specified, characteristics are the same for Ref./Catalog Numbers 050-12A, 050-12D, and 050-12E. WARNING: These heaters require sine wave input. To prevent over-heating, do not use square wave or pulse-width-modulated sine wave output. 3.1.1

Electrical Characteristics Input Voltage:

220-240 VAC

Frequency:

50 Hz

Power Consumption: 176 W (based on nominal 220 V) 184 W (based on nominal 230 V) 192 W (based on nominal 240 V) Power Fuses:

3.0 A, 250 V, quick-acting (2 required)

Thermal Fuse:

152 °C non-resetting

Leakage Current:

> 100 µA

Dielectric Withstand: 1,500 V minimum for one (1) minute Power Cord 3.1.2

10A @ 250VAC

Operating Environment Temperature:

10ºC to 40ºC

Relative Humidity:

30% to 75% (non-condensing)

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Specifications

3.1.3

Section 3

Mode of Operation Continuous

3.1.4

3.1.5

Physical Characteristics Weight:

860.0 Kg

Dimensions:

119 mm (H) x 81 mm (W) x 82 mm (D)

Power Cord:

Three-conductor cable

Length:

Approximately 3 meters

Nominal O.D.:

7.0 mm

Conductor Size:

3 x 1.00 mm2

Conductor Colors:

Brown (line), Blue (neutral), Green/yellow (ground)

Transportation and Storage Environment: Temperature:

-40.0ºC to 70.0ºC (-40ºF to 158ºF)

Relative Humidity:

10% to 100%

Barometric Pressure: 500 to 1060 hPa 3.2

Accessories: Water Solution:

Hudson RCI AQUAPAK Reservoir Bottle

Nebulizer Adaptor:

Hudson RCI AQUAPAK Nebulizer Adaptor

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Section 4 Controls and Indicators 4.0

Power Switch The AQUATHERM III Nebulizer Heater has two controls: a main power switch and a temperature control knob (see Figure 1). The power switch toggles ON and OFF. The ON position is identified by the symbol "-" and the OFF position is identified by the symbol "O". The switch illuminates when the heater is connected to power and the switch is in the "-" position.

4.1

Temperature Control Knob This rotary knob allows for adjustment of the heater temperature and is labeled TEMP CONTROL. The labeling utilizes colors and numbers to help denote relative temperature. Red represents warm and blue represents cool. The warmest position is “7” in the RED ZONE and the coolest position is “1” in the BLUE ZONE.

Figure 1 Front View of AQUATHERM III Nebulizer Heater

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Controls and Indicators

Section 4

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Section 5 Directions for Use 5.0

General This section includes instructions for: 1. Attaching the heater to a nebulizer adaptor and reservoir. 2. Attaching the heater system to a patient. 3. Changing the nebulizer and reservoir. 4. Cleaning and maintaining the heater.

5.1

Installing the Heater NOTE: Thoroughly clean and test the heater prior to use (See paragraph 5.4). 1. Check the heater to be sure that all surfaces are clean and intact. 2. Turn the power switch to the “OFF” position, "O". 3. Turn the temperature control knob fully counterclockwise to select the coolest temperature, at position “1”, in the label's BLUE ZONE. 4. Attach a clean, unused Hudson RCI 031-Series Nebulizer Adaptor to the threaded nebulizer connection on the top of the heater. 5. Attach an AQUAPAK Reservoir to the threaded connection in the bottom of the heater. Connect the nebulizer rainout-return tube to the return port on the reservoir. Caution: Avoid overtightening AQUAPAK Reservoir. Caution: Always operate the heater in a vertical position for best performance. 6. Connect the nebulizer to an oxygen source. Adjust the nebulizer to the desired oxygen concentration and adjust the oxygen flow to the recommended flow rate as stated in the instructions supplied with the nebulizer. 7. Plug the heater power cord into a grounded electrical outlet meeting the voltage requirements stated in this manual. Be sure there is power at the outlet. Turn the power switch to the “ON” position, "-". Verify that the power switch illuminates.

5.2

Attaching Heater System to Patient 1. Connect aerosol delivery tubing to the nebulizer outlet. The tubing must be at least 152cm in length and 22mm in diameter. 2. Turn the temperature control knob clockwise to the desired setting. For all flow entrainment settings, it is recommended that the operator start by selecting the midway point on the dial rotation (i.e., with the knob indicator straight up). Page 9

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Directions for Use

Section 5

3. Allow approximately 25 minutes for the outlet temperature to stabilize. Always adjust the temperature in small increments and allow approximately 20 minutes between adjustments for the outlet temperature to stabilize. WARNING: Always measure and verify aerosol temperature before connecting to the patient. WARNING: Always measure and verify oxygen concentration before connecting to the patient. WARNING: Do not leave the heater operative without oxygen flow. WARNING: Use of tubing that is shorter than 152cm in length may result in aerosol delivery exceeding 41°C at the patient connection. 4. Connect the open end of aerosol tubing to the patient delivery device, such as a mask. Comply with instructions supplied with the delivery device. 5.3

Changing the Nebulizer and Reservoir 1. Turn the heater power switch to the OFF position, "O" and extinguish the oxygen supply. Altering the temperature control knob is not required unless a setting change is desired. Caution: Do not operate the heater with a dry reservoir, or allow the heater to operate when changing the reservoir bottle. 2. Carefully remove the empty reservoir from the heater. WARNING: Burn Hazard. Internal components are hot (approximately 135°C) and may contain liquid at temperatures up to 100°C. Allow the heater to cool before handling. 3. Connect a full AQUAPAK reservoir to the threaded reservoir connection in the bottom of the heater. Caution: Avoid overtightening the reservoir. 4. Re-initiate oxygen flow and power to the heater. Adjust the oxygen flow to a desired setting and allow time for the temperature to stabilize.

5.4

Cleaning 1. Turn the heater OFF and unplug the power cord. Allow the system to cool for at least 10 minutes.

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