250 Series Service Manual Rev E

GE Healthcare

Corometrics™ 250 Series Monitor Service Manual

Corometrics 250 Series Monitor English 2020551-001 ( (paper) © 200 General Electric Company. All Rights Reserved.

GUARANTEE All equipment sold by GE Medical Systems Information Technologies, is fully guaranteed as to materials and workmanship for a period of 1 year. GE Medical Systems Information Technologies reserves the right to perform guarantee service operations in its own factory, at an authorized repair station, or in the customer’s installation. Our obligation under this guarantee is limited to repairing, or, at our option, replacing any defective parts of our equipment, except fuses or batteries, without charge, if such defects occur in normal service. Claims for damage in shipment should be filed promptly with the transportation company. All correspondence covering the instrument should specify the model and serial numbers. GE MEDICAL SYSTEMS Information Technologies A GE Healthcare Company

GE Medical Systems Information Technologies will make available on request such circuit diagrams, component diagrams, component parts lists, descriptions, calibration instructions, or other information which will assist the users or appropriately qualified technical personnel to repair those parts of the equipment which are classified by GE Medical Systems Information Technologies as repairable. Refer to the 250 Series Service Manual for further information. NOTE: In addition to software version 4.50, the information in this manual also applies to previous software revisions of Corometrics 250 Series Monitor. There are no user-apparent differences among these software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. NOTE: For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies

Ohmeda Oximetry and other trademarks (OxyTip+®, PIr™, TruSat™, TruSignal™, TruTrak+®, SuperSTAT™) are the property of GE Medical Systems Information Technologies, a division of General Electric Corporation. All other product and company names are the property of their respective owners. MASIMO SET® is a trademark of Masimo Corporation. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to the device. NELLCOR®, OxiMax®, C-LOCK® and SatSeconds™ are trademarks of Nellcor Puritan Bennett. CAUTION: In the United States of America, Federal Law restricts this device to sale by or on the order of a physician.

Corometrics and Marquette are registered trademarks of GE Medical Systems Information Technologies. GE is a registered trademark of General Electric Company. All other product and brand names are trademarks or registered trademarks of their respective companies. ©2005, 2006 GE Medical Systems Information Technologies. All rights reserved. No part of this manual may be reproduced without the permission of GE Medical Systems Information Technologies.

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CE

0459

Compliance

A GE brand Corometrics 250 Series Monitor bears CE mark CE-0459 indicating its conformity with the provisions of the Council Directive 93/42/ EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. The device is manufactured in India; the CE mark is applied under the authority of Notified Body GMED (0459). The country of manufacture and appropriate Notified Body can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility-Medical Electrical Equipment” and standard EN 60601-1 “General Requirements for Safety.”

Components of the Certified Systems

The IEC electromagnetic compatibility (EN) standards require individual equipment (components and accessories) to be configured as a system for evaluation. For systems that include a number of different equipment that perform a number of functions, one of each type of equipment shall be included in the evaluation. The equipment listed below is representative of all possible combinations. For individual equipment certification, refer to the appropriate declarations of conformity.

Component Description

• • • • • • • • • • • • • •

Exceptions

None

Monitor System EMC: Immunity Performance

Be aware that adding accessories or components, or modifying the medical device or system may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration.

250 Series Maternal/Fetal Monitor Model 146 Fetal Acoustic Stimulator Intrauterine Pressure Transducer FECG Cable/Legplate Ultrasound Transducers (x2) Blood Pressure Hose and Cuff MSpO2 Interconnect Cable and Sensor MECG Cable FECG/MECG Adapter Cable Remote Event Marker RS-232C Interconnect Cables (x3) Central Nurses Station Interconnect Cable Model 2116B Keyboard and Interconnect Cable Model 1563AAO Telemetry Cable

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Contents

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Introduction... 1-1 Revision History... 1-1 Safety Information... 1-3 Responsibility of the Manufacturer... 1-3 Responsibility of the User... 1-3 References to Persons, Places, and Institutions... 1-3 Hazard Definitions... 1-4 Product Specific Hazards... 1-5 Cautions... 1-8 Electromagnetic Interference... 1-9 Equipment Symbols... 1-10 Service Requirements... 1-11 Equipment ID... 1-11 Intended Audience... 1-11 Intended Use... 1-12 Related Manuals... 1-13

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Equipment Overview... 2-1 Equipment Description... 2-3 Front Panel Description... 2-4 Front Panel Displays... 2-7 Display Example... 2-8 Setup Screens... 2-8 Softkeys... 2-8 Mode Title Softkeys... 2-8 Waveform Softkeys... 2-9 Dedicated Softkey Area... 2-9 Rear Panel Description... 2-12 Optional Components... 2-14 Software Upgrades... 2-14 Adding Spectra Alerts... 2-14 Adding Fetal Movement Detection... 2-14

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Peripheral Components... 2-14 Nellcor® Puritan Bennett Model N-200 Maternal Pulse Oximeter... 2-14 Nellcor Puritan Bennett Model N-400 Fetal Pulse Oximeter... 2-15 DINAMAP® Models PRO Series 100-400 and ProCare... 2-15 ILC-1926... 2-16 Quantitative Sentinel/Perinatal System... 2-16 Theory of Operation... 2-18 Systems Overview... 2-18

3

Installation... 3-1 Tools Required... 3-3 Connections... 3-3 Fetal Acoustic Stimulator... 3-3 Remote Marks Connector... 3-3 ECG Out Connector... 3-3 J101 Connector (Model 340 Telemetry System Interface)... 3-4 J109, J110, and J111 Connectors (RS-232C)... 3-5 Power... 3-6 Self-Test Routine... 3-7 Battery-Backed RAM Status... 3-8 Setup... 3-9 Loading Strip Chart Recorder Paper... 3-9 Mounting a Strain Gauge... 3-12 Setup Screens... 3-12 Service Mode Screens... 3-12 Service Lock Screen... 3-13 Install Options Screens... 3-14 Printing System Setup Information... 3-20 Communications Setup Screen... 3-21 Baudrate... 3-21 Mode... 3-21 Configuration Switches... 3-22 Factory Defaults... 3-23

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Maintenance... 4-1 Maintenance Schedule... 4-3 Visual Inspection... 4-4 Cleaning... 4-5 Monitor Exterior... 4-5 Display... 4-6 Tocotransducer and Ultrasound Transducer... 4-6 Leg Plates and MECG Cables... 4-6 Maternal NIBP Cuffs and Hoses... 4-7 SpO2 Sensors... 4-8 Periodic Thermal Printhead Cleaning... 4-8 Cleaning the UA Strain Gauge... 4-8 Disposal of Product Waste... 4-9 Patient Applied Parts... 4-9 Packaging Material... 4-10 Monitor... 4-10 Electrical Safety Tests... 4-10 Initial Conditions... 4-10 AC Line... 4-10 Ground Impedance... 4-10 Unit to Primary Leakage... 4-10 Patient-to-Ground Leakage for ECG... 4-11 Patient-to-Line Leakage for ECG... 4-12 Patient-to-Ground Leakage for IUP... 4-12 Patient-to-Line Leakage for IUP... 4-13 Patient-to-Ground Leakage for MSpO2... 4-13 Patient-to-Line Leakage for MSpO2... 4-14 Patient-to-Ground Leakage for US... 4-14 Patient-to-Line Leakage for US... 4-15 Patient-to-Ground Leakage for US2... 4-15 Patient-to-Line Leakage for US2... 4-16 Ground Continuity... 4-16 Dielectric (Hi-Pot) Tests... 4-16 Checkout... 4-19 General... 4-19 Equipment Required... 4-20 Self-Test Routine... 4-20 Front Panel Button Test... 4-22 Connecting the Simulator... 4-22 MECG Test... 4-23

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FECG Test... 4-26 Ultrasound Test... 4-29 Fetal Movement Detection Test... 4-31 Ultrasound Transducer Test... 4-32 Uterine Activity Test... 4-33 Testing the Tocotransducers... 4-35 Strain Gauge Transducer Test... 4-36 Pattern Memory Test... 4-37 Dual Heart Rate Test (Non-Pattern)... 4-38 FECG/US Modes... 4-38 Dual Ultrasound Modes... 4-39 Alarm Test... 4-40 MSpO2 Test... 4-42 NIBP Calibration and Testing... 4-43 Purpose... 4-43 Required Hardware... 4-43 General Calibration Sequence... 4-43 Calibration Verification... 4-44 Calibrate Transducers... 4-44 Overpressure Detection... 4-45 System Leakage... 4-45 Display Check... 4-45 Checking a Display... 4-46 Verifying the DSP Board Operation... 4-46 Maternal SpO2 Calibration... 4-47 Hardware Switches... 4-47 Main Board SW1 Switch Settings... 4-48 J102 Analog Output Connector DAC Static Test... 4-48 Verification... 4-49 RS-232C Connector Loopback Test... 4-51 Making a Loopback Test Connector... 4-51 Testing the Port(s)... 4-51 Calibration... 4-52

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Before You Begin Electronic Calibration... 4-53 General... 4-53 Handling Precautions... 4-53 Power Supply Voltages-Verification... 4-53 Main Board Power Supply Voltages... 4-53 Isolated Power Supply Board Voltages... 4-54 Isolated FECG/UA Board Voltages... 4-54 Recorder Photosensor Calibration... 4-55 Adjusting the Paper-Low Photosensor... 4-55 Adjusting the Paper-Out Photosensor... 4-55 Adjusting the Paper-Loading Sensor... 4-56 Repair Log... 4-57 Preventative Maintenance Inspection Report... 4-58 Configuration... 4-58 Tools Required... 4-58 Visual Inspection... 4-58 Comments:... 4-61

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Troubleshooting... 5-1 Diagnostic Tests... 5-3 Main Motherboard and DSP Board Self-Test... 5-3 Monitor Self-Test... 5-3 Error Log Screen... 5-3 Diagnostic Control Screen... 5-5 Recorder Calibration Test... 5-6 CPU Version... 5-6 DSP Version... 5-6 Run Time... 5-7 Recorder Time... 5-7 Recorder Servicing... 5-7 FAQs... 5-16 System Troubleshooting... 5-37 General Troubleshooting... 5-46 Ultrasound Troubleshooting... 5-47 FECG Troubleshooting... 5-47 External Uterine Activity Troubleshooting... 5-48 Internal UA Troubleshooting... 5-49 MECG Troubleshooting... 5-49

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Blood Pressure Troubleshooting... 5-50 Maternal Pulse Oximetry Troubleshooting... 5-51

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Parts List, Drawings, and Replacement... 6-1 Ordering Parts... 6-3 Service Parts... 6-3 Field-Replaceable Units (FRUs)... 6-4 FRU List... 6-4 FRU Main Reference Guide Drawing... 6-6 Assembly/Disassembly of FRUs... 6-8 2025177-003 Speaker... 6-8 2025177-004 Main Board... 6-8 2025177-005 DSP Board... 6-9 2025177-006 Main Power Supply... 6-9 2025177-007 Dual Ultrasound Board... 6-10 2025177-008 FECG/UA Board... 6-11 2025177-009 Isolated Power Supply Board... 6-11 2025177-010 SpO2 Carrier Board with Nellcor MSpO2 Module... 6-12 2025177-011 SpO2 Carrier Board with Masimo MSpO2 Module... 6-12 2025177-012 SpO2 Carrier Board with TruSignal MSpO2 Module... 6-13 2025177-013 Front-end Motherboard... 6-14 2025177-014 Chassis... 6-15 2025177-016 COMM Board... 6-18 2025177-017 Recorder Assembly... 6-18 2025177-018 Recorder Board... 6-19 2025177-019 Cables... 6-21 2025177-020 Pneumatics Assembly... 6-22 2025177-021 Display Assembly... 6-23 2025177-022 Front Bezel... 6-23 2025177-023 Keypads... 6-26 2025177-026 Trim Knob and Encoder... 6-27 2025177-027 Power Switch Assembly... 6-28 2025177-028 Main Power Supply... 6-28 2025177-029 MECG Board... 6-30 2025177-031 Top Cover Gasket... 6-30

A

Technical Specifications...A-1 General Monitor... A-3 Operating Modes... A-4 Strip Chart Recorder... A-11

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Alarms Summary...B-1

Electromagnetic Compatibility...C-1 Electromagnetic Compatibility (EMC)... C-3 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions...C-3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity...C-4 Recommended Separation Distances...C-6 Compliant Cables and Accessories...C-7

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Introduction

Revision History Each page of this manual has a revision letter located at the bottom of the page. This letter identifies the revision level of the entire manual. This may be important if you have different manuals and you do not know which is the most current. For the initial release, all pages have the revision letter A. For the second update, all pages receive the revision letter B. The latest letter of the alphabet added to the table below corresponds to the most current revision.

Revision

Revision E

Date

Comment

A

29-June-2005

Initial Release

B

16-September-2005

Add Gasket Top Cover FRU

C

21-March-2006

Update Nellcor changes

D

30-November-2006

Update front cover, T-2 page, add kPa mode, delete old accessory part numbers

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Introduction: Safety Information

Safety Information The information presented in this section is important for the safety of both the patient and operator. This chapter describes how the terms Danger, Warning, Caution, Important, and Note are used throughout the manual. In addition, standard equipment symbols are defined.

Responsibility of the Manufacturer GE is responsible for the effects on safety, reliability, and performance if: „

assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE;

„

the electrical installation of the relevant room complies with the requirements of appropriate regulations; and

„

the monitor is used in accordance with the instructions of use.

Responsibility of the User This device is intended for use by clinical professionals who are expected to know the medical procedures, practices, and terminology required to monitor obstetrical patients. This manual documents all possible parameters available in the 250 Series of monitors. It is the responsibility of each hospital to ensure that the Labor and Delivery staff is trained in all aspects of the selected model. The 250 Series Monitor is designed to assist the perinatal staff by providing information regarding the clinical status of the mother and fetus during labor. The monitor does not replace observation and evaluation of the mother and fetus at regular intervals, by a qualified care provider, who will make diagnoses and decide on treatments or interventions. Visual assessment of the monitor display and strip chart must be combined with knowledge of patient history and risk factors to properly care for the mother and fetus.

References to Persons, Places, and Institutions References to persons, places, and institutions used within this manual are solely intended to facilitate user comprehension of the 250 Series Monitor’s use and functions. Extreme care has been taken to use fictitious names and related information in the examples and illustrations provided herein. Any similarity of this data to persons either living or dead and to either current or previously existing medical institutions should be regarded as coincidental.

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Introduction: Safety Information

Hazard Definitions Six types of special notices are used throughout this manual. They are: Danger, Warning, Caution, Contraindication, Important, and Note. The warnings and cautions in this Safety section relate to the equipment in general and apply to all aspects of the monitor. Be sure to read the other chapters because there are additional warnings and cautions which relate to specific features of the monitor. When grouped, warnings and cautions are listed alphabetically and do not imply any order of importance.

Definitions of Terminology

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Danger

A DANGER notice indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

Warning

A WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Caution

A CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Cautions are also used to avoid damage to equipment.

Contraindication

A CONTRAINDICATION describes any special symptom or circumstance that renders the use of a remedy or the carrying out of a procedure inadvisable, usually because of a risk.

Important

An IMPORTANT notice indicates an emphasized note. It is something you should be particularly aware of; something not readily apparent.

Note

A NOTE indicates a particular point of information; something on which to focus your attention.

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Introduction: Safety Information

Product Specific Hazards WARNINGS ACCIDENTAL SPILLS-In the event that fluids are accidentally spilled on the monitor, take the monitor out of operation and inspect for damage. APPLICATION-This monitor is not designed for direct cardiac connection. CONDUCTIVE CONNECTIONS-Avoid making any conductive connections to applied parts (patient connection) which are likely to degrade safety. CONDUCTIVE PARTS-Ensure that the conductive parts of the lead electrodes and associated connectors do not contact other conductive parts including earth. CONNECTIONS-The correct way to connect a patient to the monitor is to plug the electrode leads into the patient cable which in turn connects to the monitor. The monitor is connected to the wall socket by the power cord. Do not plug the electrode leads into the power cord, a wall socket, or an extension cord. DEFIBRILLATION-During defibrillation, all personnel must avoid contact with the patient and monitor to avoid a dangerous shock hazard. In addition, proper placement of the paddles in relation to the electrodes is required to minimize harm to the patient. DEFIBRILLATION PROTECTION-When used with the GE Medical Systems Information Technologies-recommended accessories, the monitor is protected against the effects of defibrillator discharge. If monitoring is disrupted by the defibrillation, the monitor will recover. ELECTRICAL SHOCK-To reduce the risk of electrical shock, do not remove monitor cover. Refer servicing to qualified personnel. ELECTROMAGNETIC INTERFERENCE-Be aware that strong electromagnetic fields may interfere with monitor operation. Interference prevents the clear reception of signals by the monitor. If the hospital is close to a strong transmitter such as TV, AM or FM radio, police or fire stations, a HAM radio operator, an airport, or cellular phone, their signals could be picked up as monitor signals. If you feel interference is affecting the monitor, contact your Service Representative to check the monitor in your environment. Refer to Electromagnetic Interference on p. 1-7 for additional information.

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Introduction: Safety Information

WARNINGS ELECTROSURGERY-The monitor is not designed for use with high-frequency surgical devices. In addition, measurements may be affected in the presence of strong electromagnetic sources such as electrosurgery equipment. EXPLOSION HAZARD-Do not use this equipment in the presence of flammable anesthetics or inside an oxygen tent. GROUNDING-Do not defeat the three-wire grounding feature of the power cord by means of adaptors, plug modifications, or other methods. A dangerous shock hazard to both patient and operator may result. INOPERABLE MECG-The MECG trace is not visible during a LEADS OFF condition or an overload (saturation) of the frontend amplifier during differential input voltage of more than ±300mV. INSTRUCTIONS-For continued and safe use of this equipment, it is necessary to follow all listed instructions. However, the instructions provided in this manual in no way supersede established medical procedures concerning patient care. The monitor does not replace observation and evaluation of the patient, at regular intervals, by a qualified care provider who will make diagnoses and decide on treatments and interventions. INTERFACING OTHER EQUIPMENT-Monitoring equipment must be interfaced with other types of medical equipment by qualified biomedical engineering personnel. Be certain to consult manufacturers’ specifications to maintain safe operation. LEAKAGE CURRENT TEST-The interconnection of auxiliary equipment with this device may increase the total leakage current. When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients. Serious injury or death could result if the leakage current exceeds applicable standards. The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: use of the accessory in the patient vicinity; and evidence that the safety certification of the accessory has been performed in accordance with the appropriate EN60601.1 and/or EN60601.1.1 harmonized national standard.

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Introduction: Safety Information

WARNINGS LINE ISOLATION MONITOR TRANSIENTS-Line isolation monitor transients may resemble actual cardiac waveforms, and thus cause incorrect heart rate determinations and alarm activation (or inhibition). MRI USE-Do not use the electrodes during MRI scanning; conducted current could potentially cause burns. PATIENT CABLES AND LEADWIRES-Do not use patient cables and electrode leads that permit direct connection to electrical sources. Use only “safety” cables and leadwires. Use of non-safety patient cables and leadwires creates risk of inappropriate electrical connection which may cause patient shock or death. PACEMAKER PATIENTS-Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. Refer to “Appendix A, Technical Specifications” for disclosure of the pacemaker pulse rejection capability of the 250 Series Monitor. RF INTERFACE-Known RF sources, such as cell phones, radio or TV stations, and two-way radios, may cause unexpected or adverse operation of this device. SIMULTANEOUS DEVICES-Do not simultaneously connect more than one device that uses electrodes to detect ECG and/or respiration to the same patient. Use of more than one device in this manner may cause improper operation of one or more of the devices. STRANGULATION-Make sure all patient cables, leadwires, and tubing are positioned away from the patient’s head to minimize the risk of accidental strangulation. WATER BIRTHS-Do not use the monitor to directly monitor patients during water births, in whirlpool or submersion water baths, during showers, or in any other situation where the mother is immersed in water. Doing so may result in electrical shock hazard.

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