Resuscitaire Models WBR82, RW82 and WMRW82 Technical Service Manual Rev 2 Aug 2005

Proprietary and Confidential Draft 8 Sep 05

Resuscitaire® Radiant Warmer Products Service Manual Revisions Revision Letter

Pages Affected

Original Issue Revision 2

Date December, 2004 August, 2005

82 990 45 (MU16506)

Resuscitaire® Radiant Warmer Products Service Manual (82 990 45)

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© 2005 by Draeger Infant Medical Care, Inc. ALL RIGHTS RESERVED. No part of this text shall be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information or retrieval system without written permission from Draeger Infant Medical Care, Inc. Second Edition First Printing 2004 Printed in the USA Air-Shields® is a registered trademark of Draeger Infant Medical Care, Inc. AMP® is a registered trademark of The Whitaker Corporation. AutoBreath™ is a trademark of Draeger Infant Medical Care, Inc. Bio-Tek® is a registered trademark of Bio-Tek Instruments, Inc. Canoe™ is a trademark of Illinois Tool Works, Inc. Care-For-Me™ Cover is a trademark of Draeger Infant Medical Care, Inc. Critter Covers® is a registered trademark of Draeger Infant Medical Care, Inc. CSA® is a registered trademark of Canadian Standards Association. Fluke® is a registered trademark of Fluke Corporation. Linde® is a registered trademark of Union Carbide Corporation. Loctite® is a registered trademark of Loctite Corporation. Nylatch® is a registered trademark of Hartwell Corporation. Nylok® is a registered trademark of Nylok Fastener Corporation. Resuscitaire® is a registered trademark of Draeger Infant Medical Care, Inc. RM2001™ is a trademark of Draeger Infant Medical Care, Inc. Teflon® is a registered trademark of E. I. du Pont de Nemours and Company.

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Resuscitaire® Radiant Warmer Products Service Manual (82 990 45)

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The information contained in this manual is subject to change without notice. Dräger Medical makes no commitment to update or keep current, the information contained in this manual. The only product warranty intended by Dräger Medical is the express, written warranty accompanying the bill of sale to the original purchaser. Dräger Medical makes no other warranty, express or implied, and in particular, makes no warranty of merchantability or fitness for a particular purpose. The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Dräger Medical. To order additional copies of this manual, call Technical Support, and place a parts order for part number 82 990 45 (MU16506).

Resuscitaire® Radiant Warmer Products Service Manual (82 990 45)

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NOTES:

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Table of Contents Chapter 1: Introduction Purpose... 1 - 1 Audience... 1 - 1 Organization... 1 - 1 Chapter 1: Introduction... 1 - 1 Chapter 2: Troubleshooting Procedures... 1 - 1 Chapter 3: Theory of Operation... 1 - 1 Chapter 4: Removal and Replacement Procedures... 1 - 2 Chapter 5: Parts List... 1 - 2 Chapter 6: Calibration and Maintenance Procedures... 1 - 2 Chapter 7: Accessories... 1 - 2 Document Symbol Definition... 1 - 3 Introduction... 1 - 4 Overview... 1 - 4 Abbreviations... 1 - 7 Features... 1 - 7 Warmer Module... 1 - 7 Cart/Bassinet (Resuscitaire® Birthing Room Warmer (WBR82) and Cart Only)... 1 - 8 Bassinet (Resuscitaire® Radiant Warmer (RW82) Only)... 1 - 8 Controller Module... 1 - 9 Blender Module (Factory-Installed Option)... 1 - 10 Resuscitation Module (Factory-Installed Option)... 1 - 10 RM2001™ Gas Delivery Module without AutoBreath™ Infant Resuscitator... 1 - 10 Resuscitation Module without AutoBreath™ Infant Resuscitator... 1 - 13 Resuscitation Module with AutoBreath™ Infant Resuscitator (not available in the U.S.)... 1 - 17

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Suction... 1 - 20 Gas Supply Module (Optional)... 1 - 23 Apgar Timer... 1 - 24 Weigh Scale (Optional)... 1 - 24 Alarms... 1 - 25 High Temperature... 1 - 25 Check Patient... 1 - 25 Probe... 1 - 25 Baby Skin Temperature... 1 - 26 Power Fail... 1 - 26 System Fail... 1 - 26 Blender Module Differential Bypass Alarm (Optional)... 1 - 26 Specifications... 1 - 27 Physical Specifications... 1 - 27 Electrical Specification... 1 - 29 Alarm Specifications... 1 - 30 Resuscitation Modules Specifications (Resuscitaire® Birthing Room Warmer (WBR82) and Resuscitaire® Radiant Warmer (RW82) Only)... 1 - 31 AutoBreath™ Infant Resuscitator Specifications... 1 - 33 Suction Specifications... 1 - 34 Regulations, Standards, and Codes... 1 - 35 Device Classification (EN 60601 Medical Electrical Equipment Part I: General Requirements for Safety)... 1 - 36 Model Identification... 1 - 36 Safety Tips... 1 - 38 Warning and Caution Labels... 1 - 39 Chapter 2: Troubleshooting Procedures Getting Started... 2 - 1 Initial Actions... 2 - 2 Function Checks... 2 - 2 Controller Module... 2 - 3

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Mechanical... 2 - 8 Resuscitation Equipment (Optional)... 2 - 14 Supply Pressure... 2 - 14 Blended Gas Supply (Optional)... 2 - 15 Suction... 2 - 16 Final Actions... 2 - 21 Troubleshooting... 2 - 22 Off-Line Diagnostic Tests... 2 - 27 Diagnostic Test #1-Software Level Display... 2 - 29 Diagnostic Test #2-ROM Device Checksum Display... 2 - 31 Diagnostic Test #3-Power Fail Test... 2 - 33 Diagnostic Test #4-Key Check... 2 - 35 Diagnostic Test #5-Heater Duty Cycle Test... 2 - 38 Diagnostic Test #6-Heater/Relays AC Line Voltage Display... 2 - 41 Diagnostic Test #7-EEPROM Status Test... 2 - 46 Diagnostic Test #8-Unit Configuration Display... 2 - 48 Diagnostic Test #9-ADC Offset/Gain Display... 2 - 50 Diagnostic Test #10-Ambient Temperature Probe Display... 2 - 52 Diagnostic Test #11-Skin Probe Temperature Display... 2 - 54 Diagnostic Test #12-Skin Probe Display Temperature Accuracy... 2 - 56 Diagnostic Test #13-Logic Voltage Display... 2 - 58 Diagnostic Test #14-Supercap Voltage Display... 2 - 60 Diagnostic Test #15-Watchdog Timer Test... 2 - 62 Diagnostic Test #16-Speaker Test... 2 - 64 Diagnostic Test #17-Back-Up Audio Annunciation Test... 2 - 68 Diagnostic Test #18-Error Log Display and Clear (Units with Firmware Version 1.05 and Higher Only)... 2 - 70 System Error Codes... 2 - 71 Heater Does Not Turn On... 2 - 76 Pre-Warm Mode Is Not Activated Upon a Reset of the System... 2 - 78 Heater Is On, but Indicators Are Off... 2 - 79

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Suction Does Not Obtain Desired Pressure... 2 - 80 Blender Module Oxygen Concentration Reading Does Not Match Blender Module Setting... 2 - 82 Blender Module Sets Off Alarms... 2 - 83 Blender Module Output Mixture Is Out of Specified Range of 20.8% to 100% . 2 - 83 Patient Gas Supply Measured Flow Is Out of Specified Range... 2 - 83 Patient Gas Supply Pressure Relief Gauge Exceeds 60 cm H2O ± 20 cm H2O . . 2 - 85 AutoBreath™ Infant Resuscitator Inhalation/Exhalation (I/E) Ratio Is Out of Specification... 2 - 85 AutoBreath™ Infant Resuscitator Measured Breaths-Per-Minute (BPM) Is Out of Specified Range... 2 - 85 Chapter 3: Theory of Operation Introduction... 3 - 1 Electrical System... 3 - 1 Display P.C. Board (PCB1)... 3 - 1 Power and Control P.C. Board (PCB2)... 3 - 2 Power Supply Circuit... 3 - 3 Control Circuitry... 3 - 4 System Interfaces... 3 - 5 System Fail Logic... 3 - 5 Power Fail Logic... 3 - 5 Probe Fail... 3 - 6 Pneumatic System... 3 - 6 Gas Supply Module... 3 - 8 Resuscitation Module... 3 - 10 Blender Module (Optional)... 3 - 12 Hardware... 3 - 12 Heating Element... 3 - 13 Examination Light... 3 - 13 Software... 3 - 13 Electrical System... 3 - 13

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Pneumatic System... 3 - 13 Chapter 4: Removal and Replacement Tool and Supply Requirements... 4 - 1 Upper Post Covers... 4 - 4 Removal... 4 - 4 Replacement... 4 - 5 Controller Module... 4 - 6 Removal... 4 - 6 Replacement... 4 - 7 Blender Module... 4 - 8 Removal... 4 - 8 Replacement... 4 - 10 Resuscitation Module... 4 - 12 Removal... 4 - 12 Replacement... 4 - 14 Gas Supply Module... 4 - 16 Removal... 4 - 16 Replacement... 4 - 18 Oxygen or Air Yoke... 4 - 20 Removal... 4 - 20 Unit Equipped with Oxygen and Air Yokes... 4 - 24 Unit Equipped with Two Oxygen Yokes... 4 - 24 Replacement... 4 - 25 Quartz Heater Assembly... 4 - 26 Removal... 4 - 26 Replacement... 4 - 28 Heater Grill... 4 - 31 Removal... 4 - 31 Replacement... 4 - 33 Warmer Head Top Cover... 4 - 35 Removal... 4 - 35

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Replacement... 4 - 36 Controller Module Front Panel... 4 - 37 Removal... 4 - 37 Replacement... 4 - 39 Chapter 5: Parts List Service Parts Ordering... 5 - 1 Recommended Spare Parts... 5 - 4 Resuscitaire® Radiant Warmer without Resuscitation... 5 - 6 Upper Post Assembly for the Resuscitaire® Radiant Warmer (Models without Resuscitation Only)... 5 - 10 Resuscitaire® Radiant Warmer with Resuscitation... 5 - 12 Upper Post Assembly (Units with Resuscitation Only) for the Resuscitaire® Radiant Warmer... 5 - 18 Resuscitaire® Birthing Room Warmer-82 3E2 70... 5 - 22 Resuscitaire® Birthing Room Warmer-82 1A1 70 and 82 1B1 70... 5 - 26 Wall Mounted Resuscitaire® Radiant Warmer Assembly-82 000 70/80... 5 - 30 Cart Assembly (Bassinet) for the Resuscitaire® Radiant Warmer... 5 - 34 Cart Assembly for the Resuscitaire® Birthing Room Warmer-82 005 50, 82 005 50NOK, and 82 005 50TLC... 5 - 38 Cart Base Assembly for the Resuscitaire® Birthing Room Warmer-81 005 75... 5 - 40 Bassinet Assembly for the Resuscitaire® Birthing Room Warmer... 5 - 42 Front, Side, and Rear Panel Assemblies for the Resuscitaire® Birthing Room Warmer Bassinet Assembly... 5 - 46 Variable Height Adjustable Cart Base and Column Assembly for the Resuscitaire® Radiant Warmer... 5 - 48 Resuscitation Variable Height Adjustable Cart, 240V Base and Column Assembly for the Resuscitaire® Radiant Warmer (for the U.K.)... 5 - 52 Variable Height Adjustable Cart Assembly, without Resuscitation, for the Resuscitaire® Radiant Warmer... 5 - 56 Resuscitation Variable Height Adjustable Cart Assembly, 120V/220V/240V for the Resuscitaire® Radiant Warmer... 5 - 60 Variable Height Adjustable Cart, 120V/240V Base and Column Assembly (Models with Variable Tilt Bassinet) for the Resuscitaire® Radiant Warmer . . . 5 - 64

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Resuscitation Variable Height Adjustable Cart Assembly, 120V/240V for the Resuscitaire® Radiant Warmer (Models with Variable Tilt Bassinet)... 5 - 68 Variable Height Adjustable Cart Assembly, 120V/240V with Variable Tilt Bassinet for the Resuscitaire® Radiant Warmer... 5 - 72 Bassinet Subassembly for the Resuscitaire® Radiant Warmer... 5 - 76 Warmer Head Assembly... 5 - 78 Heater Subassembly... 5 - 82 Controller Assembly... 5 - 84 Blender-81 600 80 and Blender Blank-81 600 70... 5 - 88 RM2001™ Gas Delivery Module Assembly... 5 - 90 Resuscitation Module Assembly (Models without AutoBreath™ Infant Resuscitator)... 5 - 91 Resuscitation Module Assembly (Models with AutoBreath™ Infant Resuscitator)... 5 - 92 Oxygen Pipeline with Oxygen Cylinder (Pin-Index) Gas Supply Module- Diameter Index Safety System (DISS), Non-Interchangeable Screw Thread (NIST), and Low-Pressure... 5 - 94 Gas Supply Module with Oxygen Reserve, Deutsche Industrie Norm (DIN) Cylinder Fittings-White Hose or Green Hose... 5 - 98 Oxygen/Air Pipeline with Pin-Indexed Oxygen/Air Cylinder Gas Supply Module-Diameter Index Safety System (DISS), Non-Interchangeable Screw thread (NIST), and Low-Pressure... 5 - 102 Gas Supply Module with Oxygen/Air Reserves and Deutsche Industrie Norm (DIN) Cylinder Fittings-Blue/Green and Yellow Hoses or Blue/White and Black Hoses... 5 - 106 Gas Supply Module with Ente Nationale Italiano di Unificazione (UNI) Cylinder Fittings, Oxygen Reserve, and White Hoses... 5 - 110 Gas Supply Module with Oxygen/Air Reserve, Ente Nationale Italiano di Unificazione (UNI) Cylinder Fittings, and White/Black Hoses... 5 - 114 Display P.C. Board (PCB 1) Assembly... 5 - 118 Power and Control P.C. Board (PCB 2) Assembly... 5 - 119 Chapter 6: Calibration and Maintenance Procedures Calibrating the Resuscitation Module... 6 - 1 Calibrating the Oxygen and Air Regulators... 6 - 2

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Calibrating the Auxiliary Flow... 6 - 2 Adjusting the Pressure Regulator... 6 - 2 Adjusting the Auxiliary Flow and Flow Valve to Zero... 6 - 3 Adjusting the Auxiliary Flow Relief Valve... 6 - 4 Calibrating the Suction... 6 - 4 Adjusting the Suction Valve to Zero Flow... 6 - 4 Adjusting the Maximum Suction Relief Gauge for Accuracy and to Zero 6 - 5 Calibrating the Patient Gas Supply... 6 - 6 Adjusting the Pressure Regulator... 6 - 6 Assessing the Accuracy of the Airway Pressure Gauge and Adjusting Airway Pressure... 6 - 7 Adjusting the Airway Pressure Valve to Zero... 6 - 8 Checking Zero on the Airway Pressure Gauge... 6 - 9 Adjusting the Patient Flow and Airway Flow Valve to Zero (Model with Blender Module Only)... 6 - 9 Adjusting the Patient Airway Relief Valve... 6 - 11 Calibrating the AutoBreath™ Infant Resuscitator... 6 - 12 Adjusting the Pressure of the Regulator... 6 - 12 Adjusting the Switch Point... 6 - 12 Adjusting the Pilot Pressure... 6 - 13 Adjusting the Positive End Expiratory Pressure (PEEP) Valve to Zero. . 6 - 14 Adjusting the PEEP Pressure... 6 - 15 Adjusting the Breath Rate... 6 - 15 Calibrating the Controller Assembly... 6 - 18 Adjusting the Precision 5V Reference... 6 - 18 Adjusting the Skin Probe 1 Temperature Sensor... 6 - 19 Adjusting the Skin Probe 2 Temperature Sensor... 6 - 19 Adjusting the Heater Voltage Sensor... 6 - 19 Cleaning... 6 - 21 Steam Cleaning... 6 - 22 Cleaning Difficult to Access Areas... 6 - 22

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Disinfecting... 6 - 22 Cleaning Painted Surfaces... 6 - 22 Cleaning Clear Plastic and Acrylic Surfaces... 6 - 22 Cleaning Metal Surfaces... 6 - 23 Cleaning the Reusable Baby Skin Temperature Probe... 6 - 23 Sterilizing Equipment... 6 - 23 Cleaning Method... 6 - 24 Disassembling the Warmer... 6 - 24 Assembling the Warmer... 6 - 25 Cleaning the Reusable Breathing Circuit... 6 - 27 General Maintenance... 6 - 31 P.C. Board Handling... 6 - 31 Verifying the DC Power Requirements... 6 - 32 Testing the Leakage Current... 6 - 33 Setup... 6 - 33 Procedure... 6 - 33 Verifying the Heater Head Electrical Requirements... 6 - 34 Checking the Pneumatic System... 6 - 35 Testing for Leakage... 6 - 35 Checking for Pneumatic Leaks... 6 - 36 Checking the Gas Supply Module and Tank Yokes (Models Equipped with Reserve Gas Supply Only)... 6 - 36 Checking the Pipeline Supply to the Blender Module (Models Equipped with Blender Module Only)... 6 - 36 Checking the Performance of the Resuscitation Module... 6 - 38 Checking the Oxygen Concentration (Models Equipped with the Blender Module Only)... 6 - 38 Checking the Airway Pressure Gauge (Models without AutoBreath™ Infant Resuscitator Only)... 6 - 39 Checking the Suction... 6 - 39 Checking the Supply Switch... 6 - 39 Preventive Maintenance... 6 - 40

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Preventive Maintenance Schedule... 6 - 41 Preventive Maintenance Checklist... 6 - 42 Disposal... 6 - 43 Chapter 7: Accessories Resuscitaire® Radiant Warmer Products Accessories... 7 - 1

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Chapter 1 Introduction Purpose This manual provides requirements for the normal operation and maintenance of the Resuscitaire® Birthing Room Warmer (WBR82), the Resuscitaire® Radiant Warmer (RW82), and the Resuscitaire® Wall Mounted Radiant Warmer (WMRW82). It also includes parts lists (in chapter 5) for ordering replacement components.

Audience This manual is intended for use by only facility-authorized personnel. Failure to observe this restriction can result in severe injury to people and serious damage to equipment.

Organization This manual contains seven chapters.

Chapter 1: Introduction In addition to a brief description of this service manual, chapter 1 also provides a product overview.

Chapter 2: Troubleshooting Procedures Repair analysis procedures are contained in this chapter. Use these procedures to gather information, identify the maintenance need, and verify the effectiveness of the repair.

Chapter 3: Theory of Operation This chapter describes the application of the mechanical, electrical, and hydraulic systems employed in this product.

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Proprietary and Confidential Draft 8 Sep 05 Organization Chapter 1: Introduction

Chapter 4: Removal and Replacement Procedures Chapter 4 contains the detailed maintenance procedures determined necessary in chapter 2.

Chapter 5: Parts List This chapter contains the part-ordering procedure and illustrated parts lists.

Chapter 6: Calibration and Maintenance Procedures Calibration, cleaning, preventive maintenance, and other general procedures are described in this chapter.

Chapter 7: Accessories A list of additional products that can be used in conjunction with the Resuscitaire® Radiant Warmer Products is available in chapter 7.

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Resuscitaire® Radiant Warmer Products Service Manual (82 990 45)

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Document Symbol Definition This manual contains different typefaces and icons designed to improve readability and increase understanding of its content. Note the following examples: • Standard text-used for regular information. • Boldface text-emphasizes a word or phrase. • NOTE:-sets apart special information or important instruction clarification. • The symbol below highlights a WARNING or CAUTION: Figure 1-1. Warning and Caution

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A WARNING identifies situations or actions that may affect patient or user safety. Disregarding a warning may result in patient or user injury.

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A CAUTION points out special procedures or precautions that personnel must follow to avoid equipment damage.

• The symbol below highlights an ELECTRICAL SHOCK HAZARD WARNING: Figure 1-2. Electrical Shock Hazard Warning

• The symbol below highlights an EMC hazard: Figure 1-3. EMC Hazard

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Introduction Overview The Resuscitaire® Birthing Room Warmer (WBR82) is designed especially for labor and delivery use (see figure 1-4 on page 1-5). It consists of a detachable cart and bassinet and a freestanding warmer that provides heat control and monitors skin temperature and includes an Apgar timer. The Resuscitaire® Birthing Room Warmer also includes an optional resuscitation package with suction and oxygen delivery or AutoBreath™ Infant Resuscitator which is a gas-powered, time-cycled, continuous flow, pressure-limited resuscitator (not available in the U.S.). Other options include a reserve gas supply and Blender Module. The Resuscitaire® Radiant Warmer (RW82) is designed for use during labor and delivery (see figure 1-5 on page 1-6). The Resuscitaire® Radiant Warmer consists of a bassinet, warmer, and a Controller Module that provides heat control, monitoring of the skin temperature, and Apgar timing. The Variable Height Adjustable (VHA) Resuscitaire® Radiant Warmer provides an adjustable mattress height from 89.9 cm (35.4") to 109.9 cm (43.3"). The Resuscitaire® Radiant Warmer also includes the same optional resuscitation package with suction and oxygen delivery or AutoBreath™ Infant Resuscitator which is a gas-powered, time-cycled, continuous flow, pressure-limited resuscitator (not available in the U.S.)that are available with the Resuscitaire® Birthing Room Warmer. The Resuscitaire® Wall Mounted Radiant Warmer (WMRW82) is designed specifically for labor, delivery, and birthing room use (see figure 1-6 on page 1-7). The Resuscitaire® Wall Mounted Radiant Warmer consists of a warmer and a Controller Module that provide heat control, monitoring of the skin temperature, and an Apgar timer. The Resuscitaire® Wall Mounted Radiant Warmer is installed permanently and, therefore, is not portable. There are no resuscitation options available with this product. For operating precautions for the Resuscitaire® Radiant Warmer Products and their accessories, refer to the Resuscitaire® Radiant Warmer Products User Manual (82 990 40) (MU12149).

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Figure 1-4. Resuscitaire® Radiant Warmer (RW82)

Controller Module

Warmer Module

Blended Gas Supply Module Examination Light

Resuscitation Module Gas Supply Module

Bassinet

X-ray Tray Cassette

Handle

Pass-through Drawer

Resuscitation Equipment Storage Compartment

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