Panda iRes and Giraffe Warmers Bag and Mask Option Operation and Maintenance Supplement Rev 05

© 2007 General Electric Company All rights reserved. General Electric Company reserves the right to make changes in specifications and features shown herein, or discontinue the product described at any time without notice or obligation. Contact your GE Representative for the most current information. Panda is a trademark owned by Datex-Ohmeda, Inc. GE and GE Monogram are trademarks of General Electric Company. All other company and product names mentioned may be trademarks of the companies with which they are associated.

Table of Contents __________________________________________ Important Safety Information...v About this Supplement...ix Scope and intended users...ix Organization of this supplement...ix References...x Chapter 1 - Introduction... 1-1 System Description and Indications for Use... 1-1 Controls and Connections... 1-2 System Components... 1-4 Chapter 2 - System Setup and Checkout Procedures... 2-1 Gas supply connection... 2-1 Suction checkout... 2-5 Oxygen delivery checkout... 2-8 Chapter 3 - Operating the Resuscitation System... 3-1 Chapter 4 - Maintenance and Cleaning... 4-1 Repair Policy... 4-1 Maintenance schedule... 4-1 Cleaning Instructions... 4-2 Dovetail Rail Suction Tubing Disassembly... 4-2 Appendix A - Specifications and Standards...A-1 Specifications...A-1 Standards...A-2 Appendix B - Conforming with Standards and Directives...B-1 GE Service Centers... back cover

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

This page intentionally blank.

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

Important Safety Information __________________________________________ Before using the Bag and Mask resuscitation system on the Panda iRes and Giraffe Warmers, read through this entire supplement. As with all medical equipment, attempting to use this device without a thorough understanding of its operation may result in patient or user injury. This device should only be operated by personnel trained in its operation under the direction of qualified medical personnel familiar with the risks and benefits of this type of device. Additional precautions specific to certain procedures are found in the text of this manual. Complete the checkout procedures in this manual before putting the unit into operation. If the unit fails any portion of the checkout procedure it must be removed from use and repaired. Do not use the warmer in the presence of flammable anesthetics; an explosion hazard exists under these conditions. Always disconnect the power before performing service or maintenance procedures detailed in this manual. Apply power only if you are specifically instructed to do so as part of the procedure. Thoroughly air dry the warmer after cleaning it with flammable agents. Small amounts of flammable agents, such as ether, alcohol or similar cleaning solvents left on the warmer can cause a fire. Only competent individuals trained in the repair of this equipment should attempt to service it as detailed in the Service Manual. Detailed information for more extensive repairs is included in the service manual solely for the convenience of users having proper knowledge, tools and test equipment, and for service representatives trained by GE Healthcare.

WARNINGS, CAUTIONS, NOTES, and SYMBOLS in this manual: This section

introduces the various types of warnings, cautions information notes and symbols used in this guide to alert you to possible safety hazards and to provide you with additional information. warning: A Warning statement is used when the possibility of injury to the patient or the operator exists. Caution: A Caution statement is used when the possibility of damage to the equipment exists. NOTE: A Note provides additional information to clarify a point in the text.

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

v

Warnings, Cautions and Notes This section identifies the general warnings, cautions and notes associated with the use of the Bag and mask resuscitation optional equipment on the Panda iRes and Giraffe Warmers. warning: As with all medical equipment, carefully route patient cabling and tubing to reduce the possibility of patient entanglement or strangulation. warning: The presence of oxygen can increase the flammability of materials. Eliminate all sources of ignition when using the resuscitation system warning: U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner.

For professional use only

NOTE: Ranges listed in this supplement manual represent the operational ranges of the equipment. The gauge ranges may exceed operational ranges. NOTE: Air always means medical grade air. NOTE: Additional copies of this supplement are available on request from the GE Healthcare Service Office listed on the back cover

vi

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

Symbols This section identifies the symbols displayed on the resuscitation system.

Symbol

Description Suction Peak Inspiratory Pressure

PEEP

Positive End Expiratory Pressure Airway pressure manometer

Manufacturer Vacuum Oxygen tank

Use no oil Catalog number Bag and mask Air tank

Serial number Do not reuse Consult instructions for use EC representative For professional use only

Resuscitation - Bag & Mask

Professional use only. This equipment may only be used by persons who have received adequate training in resuscitation techniques.

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

vii

This page intentionally blank

viii

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

About this Supplement __________________________________________ Scope and intended users This supplement describes the features and operation of the optional Bag and Mask resuscitation system on the Panda iRes and Giraffe Warmers. The Bag and Mask resuscitation is integral to the Panda iRes and Giraffe Warmers used in hospital delivery rooms and neonatal intensive care units (NICU). The intended users for this manual consists of end users of the equipment, primarily care providers in infant delivery rooms and NICUs, and hospital biomedical engineering services.

Organization of this supplement This supplement is organized into the following chapters and appendices: Important Safety Information provides important safety information for the safety of both the patient and the care giver. Chapter 1 - Introduction describes the overall Bag and Mask resuscictation system and its individual components. Chapter 2 - System Setup and Checkout Procedures describes the procedures to set up the resuscitation system prior to use. Chapter 3 - Operating the Resuscitation System describes the procedures to administer air and oxygen to the baby using the bag and mask resuscitation system. Chapter 4 - Maintenance and Cleaning provides information on maintenance and cleaning of the equipment. Appendix A - Specifications provides information on standards, specifications and operating environment. Appendix B - Conforming with Standards and Directives provides information on the European Council Directive and the disposal of electrical/electronic equipment. Inside back cover provides a geographically organized list of Datex-Ohmeda service centers.

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

ix

References References to other manuals pertaining to the Giraffe and Panda Warmers are: • Giraffe Warmer Operation and Maintenance Manual, M1110734 • Panda Warmer Operation and Maintenance Manual, M1110737 • SpO2 Option, Operation and Maintenance Supplement M1110918 • T-piece Option, Operation and Maintenance Supplement M1109204 • Service Manual - Resuscitation Giraffe and Panda Warmers, M1128929 • Service Manual - Giraffe and Panda Warmers, M1128921

x

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

Chapter 1

Introduction __________________________________________ System Description and Indications for Use The Panda iRes and Giraffe Warmers integrated resuscitation system provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.1 Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide. The Bag and Mask resuscitation system includes: • Venturi suction device • Two medical gas flowmeters • Airway pressure manometer Optional features include:

• Air/Oxygen blender with high-pressure yokes

1 As stated in The International Liaison Committee on Resuscitation (ILCOR) Consensus on Science With Treatment Recommendations for Pediatric and Neonatal Patients: Neonatal Resuscitation, The International Liaison Committee on Resuscitation Pediatrics 2006;117;978-988; originally published online Apr 17, 2006; DOI: 10.1542/peds.2006-0350

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

1-1

System Controls and Connections: Bag and Mask system with Air/Oxygen blender and high pressure yokes

Suction On/Off switch

Vacuum regulator gauge

Suction control knob

Airway pressure manometer

Medical gas On/Off switch

Flow meter control knobs

Manometer connector

Blender control knob Medical gas outlets

Oxygen tank gauge

Air tank gauge Figure 1: System controls and connections; Bag and Mask resuscitation system with Air/Oxygen blender and high pressure yokes

1-2

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

System Controls and Connections: Bag and Mask (without Air/Oxygen blender and high pressure yokes)

Suction On/Off switch

Vacuum regulator gauge

Suction control knob

Airway pressure manometer

Medical gas On/Off switch

Flow meter control knobs

Manometer connector Medical gas outlets

Figure 2: System controls and connections; Bag and Mask resuscitation system without Air/Oxygen blender and high pressure yokes

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

1-3

System Components

1. Suction Component

2. Air/Oxygen Delivery Component

3. Tank Pressure Gauges

Figure 3: Resuscitation System Components

1-4

Component

Component Number

Description

Suction

1

A venturi vacuum supplies continuous suction range from 0 to 150 mm Hg (0 to 20 kPa) for clearance of the oral, tracheal and nasal passages. A switch turns the suction component on, and a knob controls the suction. A vacuum gauge indicates the suction. Tubing attached to the suction outlet connects to a collection canister below the bed level.

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

System Components Component

Component Number

Oxygen Delivery

2

Description F lowmeters: Two flowmeters control the flow of medical gases from outlets below their control knobs. A manual resuscitator may be attached to either outlet, but must be used with an airway pressure manometer. Warning: The medical gas outlets are not designed for use with a nasal cannula or an oxygen hood. B  lender (on models equipped with a blender): The optional blender regulates O2 from both medical gas outlets from 21 to 100% oxygen. Inlet ports on the back of the unit allow attachment to gas supplies. A  irway Pressure Manometer: The airway pressure manometer allows a trained clinician to see pressure throughout the respiratory cycle. The airway pressure manometer displays both PIP (Peak Inspiratory Pressure) and PEEP (Positive End Expiratory Pressure).

Tank Pressure Gauges

3

T he integral airway pressure manometer may be attached to a manual resuscitator (not included). The resuscitation system manometer will not display delivery pressures above 80 cm H2O. However, the attainable delivery pressure of some manual resuscitators may exceed 80 cm H2O Two regulator gauges show pressure in air and O2 tanks mounted to the back of the warmer.

Warning: The Bag and Mask resuscitation system is not intended for oxygen delivery other than resuscitation.

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

1-5

Supply Pressure Alarm (air/oxygen blender option only) An alarm whistle sounds from the air oxygen blender when the following conditions exist: • At least one gas supply (air or oxygen) is supplying gas to the system, and • There is inadequate pressure from either the air or oxygen source, and • The medical gas switch is “On”. If the alarm whistle sounds while using medical gas tanks, check the tank pressure gauges, silence the alarm by turning both the suction and medical gas switches “Off” and replace the tank that is empty. If the alarm whistle sounds while using the wall gas supply, silence the alarm by turning both the suction and medical gas switches “Off” and use an auxiliary gas tank supply. Warning: Do not operate the resuscitation system during a Supply Pressure alarm. The resuscitation system may not supply accurate FiO2 and adequate pressures when this alarm condition occurs, and the blender will not operate properly.

1-6

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.

Chapter 2

System Setup and Checkout Procedures __________________________________________ warning: Complete the preoperational checkout procedures in this supplement before putting the resuscitation system into operation. If the resuscitation system fails any portion of the checkout procedure it must be removed from use and repaired. Prior to each use, always check the resuscitation system for visible damage, such as broken knobs and fittings or gauges with needles that do not rest at zero.

Gas supply connection Tank Installation (Blender option only) Illustration

Step

Description

1

Ready the tank by removing any manufacturer’s packaging, but do not remove the gasket supplied with the tank. Insert the tank into the tank holder.

2

Resuscitation - Bag & Mask

M1110023

Rev. 05

Lift the tank and seat it in the yoke on the back of the resuscitation system.

© 2007 General Electric Company, all rights reserved.

2-1

Illustration

Step

Description

3

Ensure sure the gasket is properly placed and tighten the yoke. The tank is now firmly connected at the yoke.

4

Using the tank wrench, slowly turn the valve counter-clockwise and verify that the tank contains an adequate supply of gas by examining pressure on the gauge on the front panel of the resuscitation system. warning: Open tank valve SLOWLY to avoid damaging the regulators.

5

2-2

Resuscitation - Bag & Mask

M1110023

Rev. 05

Repeat the process for the second tank.

© 2007 General Electric Company, all rights reserved.

Tank Removal (Blender option only) Illustration

Step

Description

1

Using the tank wrench, turn the tank valve clockwise until it is fully closed. Warning Close the tank valve before disconnecting the tank from the regulator.

Resuscitation - Bag & Mask

M1110023

Rev. 05

2

To disconnect the tank from the regulator, unscrew the yoke handle by turning it counter-clockwise.

3

Lift the tank and unseat it from the yoke on the back of the resuscitation system.

© 2007 General Electric Company, all rights reserved.

2-3

Illustration

Step

4

Description Remove the tank from the tank holder.

Wall Installation Illustration

Step

Description

1

Attach the wall source hose connectors to the indexed inlet ports on the back of the unit. Turn the medical gas On/Off switch to “On” and adjust the flow meter knobs to verify wall pressure.

Caution: When using wall gas sources, close the tank valves to avoid draining the tanks to low or empty.

2-4

Resuscitation - Bag & Mask

M1110023

Rev. 05

© 2007 General Electric Company, all rights reserved.