Resuscitation Systems Service Manual Rev H

Revision History

Revision

Revision Date

Revision Description

H

April 2022

Added schematics of units purchased after July 2013 for T-Piece and BM blender, and added assembly drawing for assembly tubing

G

January 2022

Updated tolerance range and clarity on gas usage

F

May 2018

Added CE 0197 to back cover

E

November 2017

Updated legal manufacturer address and CE mark information.

D

July 2015

Implemented Product Controllership changes.

C

November 2013

Updated manual content because of redesign to fittings.

B

February 2013

Updated contents of Panda Warmer Manual CD for Freestanding and Wall Mount Warmer NPI and changes to resuscitation knobs.

A

March 2012

Corrected incorrect part numbers listed in illustrated parts section.

005

January 2012

Updated manual to support StAR.

004

March 2011

Implemented corrections and updates.

003

January 2010

Added language disclaimer.

002

November 2007

Updated formatting and text.

001

October 2007

Initial release.

iii

Revision History

iv

Table of Contents

About this Manual...ix Scope and Intended Users... ix Organization of this Manual... ix Conventions... x References... x Symbols... xi Abbreviations... xiii User Responsibility...xiv StAR Manual References...xv

Important Safety Information...xvii Chapter 1: Resuscitation Theory of Operation... 1 1.1 Gas Supply Sources...1 1.2 Suction... 1 1.3 Primary and Secondary Flow ...1 1.4 Airway Manometer...2 1.5 PIP (Positive Inspiratory Pressure)...2

Chapter 2: Resuscitation Checkout Procedures... 3 2.1 Resuscitation Maintenance Schedule...3 2.2 Priority Circuit Test Protocol...4 2.3 Supply Gas Check Valves...8 2.4 Blender Option Tank Circuit Leak Test... 10 2.5 Air/Oxygen Blender... 12 2.5.1 Multipoint Oxygen Concentration Check... 12 2.5.2 Blender Alarm Check... 13 2.6 Circuits and Manometer for PIP Relief Valves... 14 2.7 Primary Flow Valve... 17 2.8 Secondary Flow Valve... 18 2.9 Airway Manometer Zero... 19 2.10 Airway Manometer Accuracy... 20

v

Table of Contents 2.11 Suction Control Valve Zero... 22 2.12 Suction Maximum Flow... 23 2.13 Suction Gauge Zero... 23 2.14 Suction Gauge Accuracy... 24 2.15 Maximum Suction Relief... 25 2.16 Service Kit - Resuscitation Test Fixture... 26 2.17 Part Replacement Guide Table... 27

Chapter 3: Field Service Calibration Instructions... 31 3.1 Gas System Regulator... 33 3.2 Secondary Flow... 34 3.3 PIP Regulator... 36 3.4 Airway Manometer Accuracy... 38 3.5 PIP Valve Zero... 41 3.6 Primary Flow Valve... 43 3.7 Fixed Pressure Controlled Relief Valve - Red Circuit... 46 3.8 PIP Variable Relief Valve... 49 3.9 Suction Regulator... 53 3.10 Suction Valve Zero... 54 3.11 Suction Gauge Accuracy... 55 3.12 Suction Relief Valve... 56

Chapter 4: System Test Points... 57 4.1 T-piece units without blender... 58 4.2 T-piece units with blender... 60 4.3 Bag and mask units without blender... 62 4.4 Bag and mask units with blender... 64 4.5 StAR T-piece with blender... 66 4.6 StAR bag and mask with blender... 67

Chapter 5: Oxygen/Air Blender Service... 69 5.1 Blender Functional Description... 69 5.1.1 Blender Gas Outlet... 70 5.1.2 Blender Alarm Condition... 71 5.2 Blender Maintenance... 72 5.2.1 Recommended Maintenance Schedule... 72 5.2.2 Tools... 72 5.3 Blender Disassembly and Reassembly... 73 5.3.1 Blender Balancing Chambers... 73 vi

Table of Contents 5.3.2 Blender Lower Block... 75 5.3.3 Blender Proportioning Valve... 75 5.3.4 Blender Alarm Spool and Bypass Valve... 76 5.3.5 Blender Alarm... 78 5.3.6 Blender Oxygen Supply Fitting... 78 5.3.7 Blender Air Supply Fitting... 79 5.3.8 Blender Outlet Fitting... 79 5.3.9 Blender Side and Bottom Port Caps... 80 5.3.10 Blender Muffler... 80 5.3.11 Blender Final Assembly... 80 5.4 Blender Calibration and Test Procedure... 81 5.4.1 Blender Proportioning Valve... 82 5.4.2 Blender Calibration Verification... 84 5.4.3 Blender Alarm... 85 5.5 Blender Performance Check... 86 5.6 Blender Troubleshooting Guide... 86 5.7 Blender Parts... 87 5.8 Blender Specifications... 87

Chapter 6: System Schematics... 89 6.1 T-piece units with wall source... 90 6.2 T-piece units with blender... 91 6.3 Bag and mask units with wall source... 92 6.4 Bag and mask units with blender... 93 6.5 StAR T-piece with blender ... 94 6.6 StAR bag and mask with blender ... 95

Chapter 7: Service Parts... 97 7.1 Resuscitation units with T-piece... 98 7.1.1 Medical Gas Supply Fittings...104 7.2 Resuscitation units with bag and mask...106 7.2.1 Medical Gas Supply Fittings...110 7.3 Labels...111 7.3.1 T-Piece Warning labels set...111 7.3.2 Bag/mask Warning labels set...112 7.3.3 O2/Air label set...113 7.4 StAR assembly parts ...114 7.4.1 iRes Infant Resuscitation...116 7.4.2 Service assembly 1 ...118 7.4.3 Service assembly 2...119 7.4.4 Service assembly 3...120

vii

Table of Contents 7.4.5 Service assembly tubing 1...121 7.4.6 Service assembly tubing 2...122 7.4.7 Service assembly tubing 3 ...123 7.4.8 1510/1512 StAR assembly tubing 1...124 7.4.9 iRes service assembly 1...125 7.4.10 StAR service assembly 2 ...126 7.5 StAR Labels...127 7.5.1 T-Piece Warning labels set...127 7.5.2 Bag/mask Warning labels set...129 7.5.3 O2/Air label set...130

Chapter 8: Troubleshooting... 133 8.1 Troubleshooting High Pressure Relief Valves...133 8.2 Troubleshooting Low Pressure Relief Valves...134 8.3 Troubleshooting Tank Circuit Leaks...134 8.4 Troubleshooting Flow Charts...135

Appendix A: Specifications and Standards... 143 A.1 User Settings and Performance Specifications...143 A.1.1 Operating Environment...144 A.1.2 Storage Conditions...144 A.1.3 Physical Characteristics: Integrated (StAR)...144 A.2 Standards...144

viii

About this Manual

Scope and Intended Users This service manual describes the features and operation of the Resuscitation Systems - Panda iRes and Giraffe Warmers. The Resuscitation Systems - Panda iRes and Giraffe Warmers are used in hospital delivery rooms, hospital newborn nurseries, and neonatal intensive care units (NICU). The intended users for this service manual are identified in “Important Safety Information” on page xvii. NOTE: Images shown are for reference only. Appearance of actual product may vary.

Organization of this Manual The following table describes the organization of this manual: Chapter or Section “Important Safety Information” “Chapter 1: Resuscitation Theory of Operation” “Chapter 2: Resuscitation Checkout Procedures” “Chapter 3: Field Service Calibration Instructions” “Chapter 4: System Test Points” “Chapter 5: Oxygen/Air Blender Service” “Chapter 6: System Schematics” “Chapter 7: Service Parts” “Chapter 8: Troubleshooting”

Description Provides important safety information for the safety of the patients, care providers and biomedical engineering service personnel. Describes functions and identifies the sub-assemblies of the Resuscitation Systems - Panda iRes and Giraffe Warmers. Describes the procedures to set up and check out the Resuscitation Systems Panda iRes and Giraffe Warmers prior to use. Identifies the calibration test points and provides calibration procedures. Provides information on test points for all available resuscitation system configurations. Provides functional and service information on the oxygen/air blender assembly. Provides diagrams of available resuscitation unit configurations. Provides expanded diagrams of the unit’s sub-assemblies and associated part numbers. Provides information and decision trees to aid in tracing and correcting system malfunctions.

ix

About this Manual Chapter or Section “Appendix A: Specifications and Standards”

Description Provides information on standards, operating environment, storage conditions, user control settings, performance, and mechanical specifications.

Conventions This section introduces the various types of warnings, cautions, and information notes used in this service manual 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.

References To order manuals pertaining to the Panda iRes and Giraffe Warmers, order one of the following kits: Kit Giraffe Warmer Operation and Maintenance (OM) Manual Kit: • • • •

Giraffe Warmer, OM Manual SpO2 Option, OM Supplement Bag and Mask Option, OM Supplement T-piece Option, OM Supplement

Panda iRes Warmer OM Manual Kit: • • • •

x

Panda iRes Warmer, OM Manual SpO2 Option, OM Supplement Bag and Mask Option, OM Supplement T-piece Option, OM Supplement

Part Number Czech: M1160160 Danish: M1150873 Dutch: M1150871 English INTL: M1150867 English USA: M1150860 Finnish: M1161005 French: M1150862 German: M1150864 Greek: M1182379 Italian: M1150877 Czech: M1160161 Danish: M1150874 Dutch: M1150872 English INTL: M1150868 English USA: M1150861 Finnish: M1161004 French: M1150863 German: M1150866 Greek: M1182378 Italian: M1150878

Korean: M1170126 Lithuanian: M1204918 Norwegian: M1156625 Polish: M1160585 Portuguese: M1182377 Romanian: M1204120 Russian: M1161401 Spanish: M1150869 Swedish: M1150875 Turkish: M1168044 Korean: M1170125 Lithuanian: M1204919 Norwegian: M1156626 Polish: M1160586 Portuguese: M1182376 Romanian: M1203933 Russian: M1161402 Spanish: M1150870 Swedish: M1150876 Turkish: M1168043

About this Manual Kit Panda iRes and Giraffe Warmer Service Manual Kit:

Part Number M1150616

• Service Manual - Giraffe and Panda iRes Warmers Panda iRes and Giraffe Warmer Resuscitation Service Manual Kit: •

Service Manual - Resuscitation Giraffe and Panda iRes Warmers (this manual)

M1150617

Symbols This section identifies the symbols that are displayed on the device. Equipment configurations can differ. Labels or symbols may not appear on every device. Location of Symbols

Symbol

Description Use no oil. Professional use only. Equipment shall be used only by qualified, trained medical personnel. Consult accompanying documents. Manufacturer.

Back of resuscitation box

xxxx

Systems with this mark agree with the European Council Directive (93/42 EEC) for Medical Devices when they are used as specified in their Operation and Maintenance Manuals. The XXXX is the certification number of the Notified Body.

REF

Catalog Number.

SN

Serial Number. Date of manufacture.

Front of resuscitation box, suction component

Suction. Vacuum.

xi

About this Manual Location of Symbols

Symbol

Description T-piece.

Bag and mask.

Front of resuscitation box, air/oxygen delivery component

Peak Inspiratory Pressure.

Airway pressure manometer.

Oxygen. Medical grade air.

Front of resuscitation box, pressure gauges

Oxygen tank.

Medical grade air tank.

xii

About this Manual Location of Symbols

Symbol

Description Consult accompanying documents.

Catalog number. Lot number. Warning or Caution. Date of manufacture. T-piece manual resuscitator

Manufacturer. Clean, not sterile.

For single use only. Do not reuse.

xxxx PEEP

Systems with this mark agree with the European Council Directive (93/42 EEC) for Medical Devices when they are used as specified in their Operation and Maintenance Manuals. The XXXX is the certification number of the Notified Body. Positive End Expiratory Pressure.

NOTE: For information about the symbols on the bag and mask manual resuscitator, refer to the documentation provided with it. If the device is serviced by a GE Service Representative scan or enter the UDI label information into a service record.

Abbreviations This section identifies the abbreviations used in this manual, in alphabetical order. Abbreviation

Definition

CCW

Counter-clockwise.

Cm H20

A unit of pressure measured in centimeters of water.

xiii

About this Manual Abbreviation

Definition

CW

Clockwise.

In Lb

A unit of torque measured in inch-pounds-force.

KPa

A unit of pressure measured in kilopascals.

Mm Hg

A unit of pressure measured in millimeters of mercury.

NICU

Neonatal intensive care unit.

Nm

A unit of torque measured in newton metres.

PEEP

Positive end expiratory pressure.

PIP

Peak inspiratory pressure.

Psi

A unit of pressure measured in pounds of force per square inch.

SpO2

Saturation of Peripheral Oxygen, an estimation of the oxygen saturation level, usually measured with a pulse oximeter device.

StAR

Stand Alone Resuscitation

L/min

Liters per minute.

User Responsibility This Product will perform in conformity with the description thereof contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, GE Healthcare recommends that a telephone or written request for service advice be made to the nearest GE Healthcare Regional Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by GE Healthcare and by GE Healthcare trained personnel. The Product must not be altered without GE Healthcare’s prior written approval. The user of this Product shall have the sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than GE Healthcare.

xiv

About this Manual

StAR Manual References References to other manuals pertaining to StAR are: M1226876 M1239367 M1239369 M1239372 M1239374 M1239376 M1239378 M1239457 M1239459 M1239463 M1239466 M1239470 M1239472 M1239474 M1239476 M1239478 M1239480 M1239482 M1239485 M1239487 M1239489 M1239491 M1239493 M1239495 M1239497 M1239499 M1239501 M1239503

CARD, Quick Reference GuideT-Piece STAR English CARD, Quick Reference GuideT-Piece STAR Chinese CARD, Quick Reference GuideT-Piece STAR Czech CARD, Quick Reference GuideT-Piece STAR Danish CARD, Quick Reference GuideT-Piece STAR Dutch CARD, Quick Reference GuideT-Piece STAR Finnish CARD, Quick Reference GuideT-Piece STAR French CARD, Quick Reference GuideT-Piece STAR German CARD, Quick Reference GuideT-Piece STAR Greek CARD, Quick Reference GuideT-Piece STAR Hungarian CARD, Quick Reference GuideT-Piece STAR Italian CARD, Quick Reference GuideT-Piece STAR Korean CARD, Quick Reference GuideT-Piece STAR Norwegian CARD, Quick Reference GuideT-Piece STAR Polish CARD, Quick Reference GuideT-Piece STAR Portuguese CARD, Quick Reference GuideT-Piece STAR Russian CARD, Quick Reference GuideT-Piece STAR Spanish CARD, Quick Reference GuideT-Piece STAR Swedish CARD, Quick Reference GuideT-Piece STAR Turkish CARD, Quick Reference GuideT-Piece STAR Croatian CARD, Quick Reference GuideT-Piece STAR Estonian CARD, Quick Reference GuideT-Piece STAR Japanese CARD, Quick Reference GuideT-Piece STAR Lithuanian CARD, Quick Reference GuideT-Piece STAR Romanian CARD, Quick Reference GuideT-Piece STAR Slovak CARD, Quick Reference GuideT-Piece STAR Slovenian CARD, Quick Reference GuideT-Piece STAR Bulgarian CARD, Quick Reference GuideT-Piece STAR Indonesian

M1227098 M1239777 M1239779 M1239781 M1239784 M1239789 M1239791 M1239793 M1239795 M1239797 M1239800 M1239806 M1239815 M1239863

CARD, QUICK REFERENCE GUIDE BAG MASK STAR ENGLISH CARD, QUICK REFERENCE GUIDE BAG MASK STAR Chinese CARD, QUICK REFERENCE GUIDE BAG MASK STAR Czech CARD, QUICK REFERENCE GUIDE BAG MASK STAR Danish CARD, QUICK REFERENCE GUIDE BAG MASK STAR Dutch CARD, QUICK REFERENCE GUIDE BAG MASK STAR Finnish CARD, QUICK REFERENCE GUIDE BAG MASK STAR French CARD, QUICK REFERENCE GUIDE BAG MASK STAR German CARD, QUICK REFERENCE GUIDE BAG MASK STAR Greek CARD, QUICK REFERENCE GUIDE BAG MASK STAR Hungarian CARD, QUICK REFERENCE GUIDE BAG MASK STAR Italian CARD, QUICK REFERENCE GUIDE BAG MASK STAR Korean CARD, QUICK REFERENCE GUIDE BAG MASK STAR Norwegian CARD, QUICK REFERENCE GUIDE BAG MASK STAR Polish

xv

About this Manual M1240432 M1240434 M1240436 M1240438 M1240442 M1240444 M1240448 M1240450 M1240452 M1240454 M1240456 M1240460 M1240462 M1240464

CARD, QUICK REFERENCE GUIDE BAG MASK STAR Portuguese CARD, QUICK REFERENCE GUIDE BAG MASK STAR Russian CARD, QUICK REFERENCE GUIDE BAG MASK STAR Spanish CARD, QUICK REFERENCE GUIDE BAG MASK STAR Swedish CARD, QUICK REFERENCE GUIDE BAG MASK STAR Turkish CARD, QUICK REFERENCE GUIDE BAG MASK STAR Croatian CARD, QUICK REFERENCE GUIDE BAG MASK STAR Estonian CARD, QUICK REFERENCE GUIDE BAG MASK STAR Japanese CARD, QUICK REFERENCE GUIDE BAG MASK STAR Lithuanian CARD, QUICK REFERENCE GUIDE BAG MASK STAR Romanian CARD, QUICK REFERENCE GUIDE BAG MASK STAR Slovak CARD, QUICK REFERENCE GUIDE BAG MASK STAR Slovenian CARD, QUICK REFERENCE GUIDE BAG MASK STAR Bulgarian CARD, QUICK REFERENCE GUIDE BAG MASK STAR Indonesian

M1226780 M1239124 M1239127 M1239131 M1239135 M1239138 M1239195 M1239200 M1239204 M1239211 M1239217 M1239224 M1239227 M1239230 M1239233 M1239236 M1239242 M1239255 M1239258 M1239315 M1239319 M1239322 M1239326 M1239333 M1239336 M1239339 M1239343 M1239346 M1239358

MANUAL, User Reference Manual, iRes OM Manual, English USA MANUAL, User Reference Manual, iRes OM Manual, English - Intl MANUAL, User Reference Manual, iRes OM Manual, Chinese MANUAL, User Reference Manual, iRes OM Manual, Czech MANUAL, User Reference Manual, iRes OM Manual, Danish MANUAL, User Reference Manual, iRes OM Manual, Dutch MANUAL, User Reference Manual, iRes OM Manual, Finnish MANUAL, User Reference Manual, iRes OM Manual, French MANUAL, User Reference Manual, iRes OM Manual, German MANUAL, User Reference Manual, iRes OM Manual, Greek MANUAL, User Reference Manual, iRes OM Manual, Hungarian MANUAL, User Reference Manual, iRes OM Manual, Italian MANUAL, User Reference Manual, iRes OM Manual, Korean MANUAL, User Reference Manual, iRes OM Manual, Norwegian MANUAL, User Reference Manual, iRes OM Manual, Polish MANUAL, User Reference Manual, iRes OM Manual, Portuguese MANUAL, User Reference Manual, iRes OM Manual, Russian MANUAL, User Reference Manual, iRes OM Manual, Spanish MANUAL, User Reference Manual, iRes OM Manual, Swedish MANUAL, User Reference Manual, iRes OM Manual, Turkish MANUAL, User Reference Manual, iRes OM Manual, Croatian MANUAL, User Reference Manual, iRes OM Manual, Estonian MANUAL, User Reference Manual, iRes OM Manual, Japanese MANUAL, User Reference Manual, iRes OM Manual, Lithuanian MANUAL, User Reference Manual, iRes OM Manual, Romanian MANUAL, User Reference Manual, iRes OM Manual, Slovak MANUAL, User Reference Manual, iRes OM Manual, Slovenian MANUAL, User Reference Manual, iRes OM Manual, Bulgarian MANUAL, User Reference Manual, iRes OM Manual, Indonesian

xvi

Important Safety Information

Before using the Resuscitation Systems on the Panda iRes and Giraffe Warmers, read through this entire manual. 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 chapter in the Operation and Maintenance manual before putting the unit into operation. If the warmer fails any portion of the checkout procedure it must be removed from use and repaired. Only competent individuals trained in the repair of this equipment should attempt to service it as detailed in this 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. The information contained in this service manual pertains only to those models of products which are marketed by GE Healthcare as of the effective date of this manual or the latest revision thereof. This service manual was prepared for exclusive use by GE Healthcare service personnel in light of their training and experience as well as the availability to them of parts, proper tools and test equipment. Consequently, GE Healthcare provides this service manual to its customers purely as a business convenience and for the customer’s general information only without warranty of the results with respect to any application of such information. Furthermore, because of the wide variety of circumstances under which maintenance and repair activities may be performed and the unique nature of each individual’s own experience, capacity, and qualifications, the fact that a customer has received such information from GE Healthcare does not imply in anyway that GE Healthcare deems said individual to be qualified to perform any such maintenance or repair service. Moreover, it should not be assumed that every acceptable test and safety procedure or method, precaution, tool, equipment or device is referred to within, or that abnormal or unusual circumstances, may not warrant or suggest different or additional procedures or requirements. This manual is subject to periodic review, update and revision. Customers are cautioned to obtain and consult the latest revision before undertaking any service of the equipment. This section identifies general warnings, cautions, and notes associated with the use and servicing of the Resuscitation systems - Panda iRes and Giraffe Warmers. WARNING: Do not service, program or calibrate the resuscitation unit with the patient in the bed.

xvii

Important Safety Information

WARNING: 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. WARNING: The presence of oxygen can increase the flammability of materials. Eliminate all sources of ignition when using the resuscitation system. WARNING: The user or service staff should dispose all the waste properly as per federal, state, and local waste disposal regulations. Improper disposal could result in personal injury and environmental impact. CAUTION: Servicing of this product in accordance with this service manual should never be undertaken in the absence of proper tools, test equipment and the most recent revision to this service manual which is clearly and thoroughly understood. CAUTION: Technical competence is required to service the resuscitation unit; the procedures described in this service manual should be performed by trained and authorized personnel only. Maintenance should only be undertaken by competent individuals who have a general knowledge of and experience with devices of this nature. No repairs should ever be undertaken or attempted by anyone not having such qualifications. Genuine replacement parts manufactured or sold by GE Healthcare must be used for all repairs. Read completely through each step in every procedure before starting the procedure; any exceptions may result in a failure to properly and safely complete the attempted procedure. CAUTION: U.S. Federal law restricts this device to sale by, or on order of, a licensed medical practitioner. CAUTION: This device is for professional use only, by trained clinicians.

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 manual are available on request from the GE Healthcare office listed on the back cover of this manual.

xviii

Chapter 1: Resuscitation Theory of Operation

1.1 Gas Supply Sources Connecting to a wall source or, in some models, to cylinders, provides the gas source to the module. The module is fully pneumatic with no electronics used. When using cylinders with high pressure yokes, each cylinder pressure is monitored and displayed by a corresponding analog gauge. The cylinder pressure is regulated internally to a nominal 345 kPa (50 psi) before it is passed on to the various internal flow paths and is limited by a fixed pressure relief valve. Restrictors are employed in the cylinder side of the gas supply to limit flow in the event of a failure downstream, i.e. tube disconnection. Check valves are provided at each gas supply entry point to prevent cross-contamination and allow for use with a single supply connected. The Stand alone Giraffe Infant Resuscitation System (StAR) is equipped with a priority supply gas selection system. If both primary and optional gas sources are connected, the primary gas source will be used regardless of source pressure. In this case the primary source is diverted to a valve actuator that controls a normally open spool valve. When the primary source is turned on the spool valve closes, blocking flow from the optional gas supply. When the primary source is turned off or removed the spool valve opens, allowing flow from the optional gas supply.

1.2 Suction The gas source used to drive the suction circuit is provided by the oxygen supply source. The suction on/off switch controls whether this supply gas source is available to the Suction circuit or not. When the switch is on, source pressure passes through the switch to the suction system regulator where it is stepped down to approximately 138 kPa (20 psi). It then exits the regulator and passes through the suction control valve, the output of which is connected directly to a Venturi suction generator. By using the valve to control the flow through the suction generator, the amount of suction may be increased or decreased. As the flow through the Venturi is increased, the vacuum, or suction, also increases. The suction generated is limited by means of the suction relief valve. When the negative pressure generated reaches a predetermined point, this relief valve opens and limits it from going any higher. This pressure is monitored and displayed by the suction gauge that has an in-line restrictor as a dampener. A tube with filter, connected to the suction side of the suction generator, passes through the housing of the unit to a collection bottle, which, in turn, has a tube for patient use.

1.3 Primary and Secondary Flow Depending on the model used, the gas source to the Primary Flow section may be 100% oxygen or, in models with an air/oxygen blender, a blended concentration of air and oxygen. The gas on/off switch controls the passage of source gas to the primary and secondary flow circuits. When this switch is on, source gas passes to the gas system regulator where it is stepped down to 138 kPa (20 psi). From there, it passes through the primary and secondary flow valves that meter the flow to the patient connectors on the front of the module. In modules with an air/oxygen blender, before reaching the gas system regulator, the source gases pass through 1

Chapter 1: Resuscitation Theory of Operation the blender where they are mixed to an oxygen concentration determined by the blender knob setting on the front of the module. In T-piece models, the primary flow passes through two relief valves that control the airway pressure. This is explained later under PIP.

1.4 Airway Manometer Depending on the model, two different methods are used to connect the airway manometer that monitors airway pressure. In the bag and mask model, the airway pressure is monitored by connecting a separate tube from the end of the patient circuit to a fitting on the front of the module, which is connected to the airway manometer. In the T-piece model, the airway manometer is connected directly to the patient flow path within the module. In either case, there is a dampening restrictor in-line with the manometer. In the bag and mask unit, if the pressure goes above a predetermined value, there is a manometer relief valve in-line with the manometer that will open and prevent over pressurizing the gauge. The manometer relief valve is positioned after the manometer dampening restrictor. This relief valve is not necessary in the T-piece because the pressure is limited by the PIP circuit.

1.5 PIP (Positive Inspiratory Pressure) The PIP circuit provides control over airway pressure and is only available in T-piece units. It is integral to the Primary flow circuit. It begins with the PIP regulator that gets its source pressure from the gas system regulator. The PIP regulator reduces the pressure to 110 kPa (16 psi). The output of the PIP regulator branches off into two circuits; one circuit goes to the PIP variable relief valve that can be adjusted by the user via a knob on the front of the unit, and the other circuit goes to the PIP fixed relief valve. The PIP circuit that is adjustable by the user consists of the PIP valve, a series of restrictors and bleeds, and diaphragm-actuated relief valves (PIP fixed relief valve and PIP fixed relief valve). The primary flow path to the patient passes through the body of this relief valve, which has an orifice open to atmosphere that is obstructed by a diaphragm when the diaphragm is pressurized. Gas from the PIP regulator passes through the PIP valve, through the restrictors and bleeds and to the diaphragm. The more the PIP valve is opened, the more gas flows into this circuit and the ability of the bleeds to keep up with it is diminished. This increases the pressure placed on the diaphragm. Thus, the pressure may be varied by controlling the flow through the PIP valve from fully closed (no pressure) to fully open (maximum pressure). The restrictors and bleeds are used to set the maximum pressure applied to the diaphragm when the PIP control valve is fully open. There are two bleeds to atmosphere in this circuit, one is fixed (PIP fixed relief valve) and one is adjustable (PIP variable relief valve). The adjustable bleed is used to trim the maximum pressure with the PIP valve fully open. The pressure applied to the diaphragm opposes the airway pressure on the primary flow side of the diaphragm. As long as the effective diaphragm pressure is greater than the pressure on the primary flow side, the primary flow proceeds to the patient through the PIP variable relief valve with no loss to atmosphere. When the pressure in the primary flow circuit exceeds the effective pressure of the diaphragm at the orifice in the relief valve body, the diaphragm is overcome and allows the airway pressure to relieve to atmosphere through this orifice. The second PIP fixed relief valve in this circuit operates exactly as the first with the exception of the PIP valve. There is none. The pressure applied to its diaphragm is constant and is set internally with the adjustable bleed (variable resistor PIP fixed relief valve). It cannot be changed by the user. Its purpose is to provide a fixed maximum safety limit to the airway pressure in the primary flow circuit. 2

.

Chapter 2: Resuscitation Checkout Procedures

2.1 Resuscitation Maintenance Schedule Annually •

Perform the resuscitation system service checkout as described in this chapter.

Every Two Years •

Perform the complete blender maintenance as described in Chapter 5: Oxygen/Air Blender Service.

The following equipment and tools are required for checkout procedures: • • • • • • • • • • • • • • • •

Low flow measurement device (0-5 L/min)* High flow measurement device (3-17 L/min)* (when testing blender unit must also measure O2 %) High pressure measurement device 257-517 kPa (40-75 psi)* Low pressure measurement device (0-100 cm H2O)* Test Fixture Kit, M1132277 Region-specific gas fittings Vacuum measuring device (0-200 mm Hg)* O2 and air gas sources at 257-517 kPa (40-75 psi) Resuscitation checkout check list 5.5 mm Nut driver or Socket Test port Access Plugs Flat head screwdriver Needle nose pliers Hemostats (3) 3 mm hex wrench 2 mm hex wrench

* Make sure all test equipment is calibrated to manufacturer’s specification.

NOTE: Checkout procedures should be performed at the ambient condition 18-22 °C. All parameters stated in this service manual are valid for this temperature range. The resuscitator requires a clean, dry 100% oxygen gas source to the oxygen supply fitting on the back of the unit. It must be able to maintain 275 – 517 kPa (40-75 psi). If the unit has an air/oxygen blender installed, then also connect an air source able to maintain 275 – 517 kPa (40-75 psi) to the air fitting. The gas should always be connected unless instructed to do otherwise in the checkout procedure. The following describes how to perform a complete system check to the unit to verify it for patient use. Review all the steps prior to beginning to understand what is to be done. If any of these tests fail, remove the unit from patient use and submit it for service.

3