GE Healthcare
Corometrics 250cx Series Service Manual Rev P
Service Manual
204 Pages
Preview
Page 1
GE Healthcare
Corometrics™ 250cx Series Monitor Service Manual
Corometrics 250cx Series Monitor English 2036947-001 Revision P © 2023 General Electric Company. All Rights Reserved
GE Healthcare
Corometrics™ 250cx Series Monitor Service Manual
Corometrics 250cx Series Monitor English 2036947-001 Revision P © 2023 General Electric Company. All Rights Reserved
© 2005 - 2023 by 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. SuperSTAT™ is the property of GE MEDICAL SYSTEMS Information Technologies, a GE Healthcare Company which is a division of General Electric Corporation. 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. Warranty This product is sold by GE Healthcare with a GE repair warranty period of 12-month to cover labor and parts* (except for the expendable parts like fuses or batteries which have a 30-day warranty) under the terms and conditions set forth in the GE Healthcare Warranty Statement presented to the customer at the point of sale. * The warranty time may vary in some regions. Refer to the warranty information provided at the point of sale.
Table of Contents
Compliance...xviii Components of the Certified Systems...xviii Component Description...xviii Exceptions...xviii Monitor System EMC: Immunity Performance...xviii
About this Manual... 1 Scope and Intended Users ...1 Conventions... 1 User Responsibility...1 References... 2 Definitions of Terms...2 Symbols... 3
Important Safety Information... 5 Warnings, Cautions and Notes...6 Electromagnetic Interference...9
Chapter 1: System Description... 11 1.1 System Overview... 11 1.2 Front Panel Controls, Indicators, and Connectors... 13 1.3 Display Description... 15 1.3.1 Primary Labor Parameters... 16 1.3.2 Additional Parameters ... 16 1.3.3 Waveform... 16 1.3.4 Time... 16 1.3.5 Softkeys... 16 1.4 Rear Panel Descriptions... 19 1.5 Peripherals Description... 21 1.5.1 CorometricsTM 340 Telemetry and Mini Telemetry ... 21 1.5.2 Quantitative Sentinel/Perinatal System... 21 1.5.3 Exergen® TAT-5000TM...22 1.5.4 DINAMAP® Models PRO Series 100-400 and ProCare... 22 1.6 Theory of Operation ... 22 © 2023 by General Electric Company. All rights reserved.
2036947-001
xiii
Table of Contents 1.6.1 Digital System Processor (DSP) / Display Board... 23 1.6.2 Main Board... 25 1.6.3 User-Interface Keypad & Volume/Alarm Keypad Boards... 26 1.6.4 Video Decoder Board... 26 1.6.5 Recorder Board... 26 1.6.6 Communications Board... 26 1.6.7 MSpO2 Connector Board... 26 1.6.8 MSpO2 Carrier Board... 27 1.6.9 FECG/UA Board... 27 1.6.10 MECG Board... 27 1.6.11 Dual Ultrasound Board... 27 1.6.12 Isolated Power Supply Board... 28 1.6.13 Front-End Motherboard... 28 1.6.14 Memory Battery... 28
Chapter 2: Installation... 29 2.1 Time Required for Installation... 29 2.2 Environmental Requirements... 29 2.3 Tool Requirements... 29 2.4 Installation Procedure... 29 2.4.1 Strip Chart Recorder Paper Load... 29 2.4.2 Peripheral Connections... 31 2.4.3 Power Cord Attachment... 31 2.4.4 System Configuration... 31
Chapter 3: Maintenance and Checkout... 35 3.1 Procedures Schedule... 35 3.1.1 Environmental Requirements... 36 3.2 Tool Requirements... 36 3.3 Maintenance and Checkout Procedures... 37 3.3.1 Visual Inspection... 37 3.3.2 Cleaning (Thermal Print Head)... 37 3.3.3 Transducer Checks... 38 3.3.3.1 Ultrasound Transducer Checks... 38 3.3.3.2 TOCO Transducer Checks... 38 3.3.4 Functional Checks... 39 3.3.4.1 System Checks... 39 3.3.4.2 RS-232C Loopback Check... 40 3.3.4.3 Alarms Check... 41 3.3.4.4 MSpO2 Check... 43 3.3.4.5 MECG Input Check... 44 xiv
2036947-001
© 2023 by General Electric Company. All rights reserved.
Table of Contents 3.3.4.6 FECG Input Check... 45 3.3.4.7 Ultrasound Input Check... 45 3.3.4.8 Uterine Activity Input Check... 46 3.3.4.9 Dual Heart Rate Check (FECG/US Modes)... 48 3.3.4.10 Dual Heart Rate Check (Dual Ultrasound Modes)... 49 3.3.5 NIBP Calibration Check... 50 3.3.6 Electrical Safety Tests... 50 3.3.6.1 Ground Resistance Check... 51 3.3.6.2 Ground (Earth) Leakage Current and Enclosure Leakage Current Checks... 51 3.3.6.3 Patient-to-Ground (Patient Source) Leakage Current Checks... 52
Chapter 4: Calibration... 55 4.1 Calibration Schedule... 55 4.2 Environmental Requirements... 56 4.3 Tool Requirements... 56 4.4 Calibration Procedures... 56 4.4.1 NIBP Calibration Check... 56 4.4.1.1 Calibration Verification... 57 4.4.1.2 Transducer Calibration... 58 4.4.1.3 Overpressure Detection... 58 4.4.1.4 System Leakage... 58 4.4.2 Recorder Photosensors Check... 59 4.4.2.1 Paper-Low Photosensor Adjustment... 59 4.4.2.2 Paper-Out Photosensor Adjustment... 60 4.4.2.3 Paper-Load Photosensor Adjustment... 60 4.4.3 Recorder Calibration (offsets) Check... 61
Chapter 5: Diagnostics and Troubleshooting... 63 5.1 General Troubleshooting Table... 63 5.2 Ultrasound Troubleshooting Table... 67 5.3 FECG Troubleshooting Table... 69 5.4 External Uterine Activity Troubleshooting Table... 70 5.5 Internal Uterine Activity Troubleshooting Table... 72 5.6 MECG Troubleshooting Table... 73 5.7 Blood Pressure Troubleshooting Table... 73 5.8 Maternal Pulse Oximetry Troubleshooting Table... 75 5.9 Main Board Troubleshooting – Voltage Checks... 76 5.10 FECG/UA Board Troubleshooting – Voltage Adjustments... 77 5.11 Recorder Troubleshooting... 77 5.11.1 Vertical Offset Adjustment... 77 5.11.2 Horizontal Offset Adjustment... 79 © 2023 by General Electric Company. All rights reserved.
2036947-001
xv
Table of Contents 5.11.3 Light Printing... 80
Chapter 6: Repair and Replacement Procedures... 85 6.1 Top Cover, Top Cover Gasket, and Timekeeping RAM Chip Replacement... 86 6.2 Speaker Replacement... 87 6.3 DSP/Display Board Replacement... 88 6.4 Communication Board Replacement... 89 6.5 Pneumatics Assembly Replacement... 90 6.6 Main Board Replacement... 92 6.7 Display Assembly Replacement... 93 6.8 Power Switch Assembly Replacement... 95 6.9 Trim Knob Control Assembly Replacement... 96 6.10 Keypads Replacement... 97 6.11 Main Power Supply / Fan Replacement... 99 6.12 Dual Ultrasound Board Replacement...101 6.13 FECG/UA Board and MECG Board Replacement...102 6.14 SpO Carrier Board (with Nellcor/Masimo SpO Module) Replacement...103 2 2 6.15 Isolated Power Supply Board Replacement...104 6.16 Front-end Motherboard Replacement...105 6.17 Recorder Assembly and Recorder Door Button Replacement...107 6.18 Recorder Board Replacement...109 6.19 Recorder Stepper Motor Replacement...110 6.20 Recorder Paper-Out/Paper-Low Photosensor Replacement...111 6.21 Recorder Paper-Loading Photosensor Replacement...113 6.22 Recorder Thermal Print Head Replacement...114 6.23 Front Bezel Replacement...115
Chapter 7: Service Parts... 119 7.1 Illustrated Parts...120 7.2 Labels...125 7.3 Power Cords...126 7.4 FRU List...127
Appendix A: Technical Specifications... 133 A.1 General Product Specifications...134 A.2 Strip Chart Recorder Specifications...135 A.3 Operating Modes Specifications...136
Appendix B: Alarm Summary ... 143
xvi
2036947-001
© 2023 by General Electric Company. All rights reserved.
Table of Contents
Appendix C: Electromagnetic Compatibility... 145 C.1 Manufacturer’s Guidance and Declaration – Electromagnetic Emissions...145 C.2 Manufacturer’s Guidance and Declaration – Electromagnetic Immunity...146 C.3 Recommended Separation Distances...148 C.4 Compliant Cables and Accessories...148
Appendix D: PS320 Fetal Simulator Setup... 151 D.1 Parts Required...151 D.2 PS320 Fetal Simulator Setup...152
Appendix E: Service Mode Screens... 155 E.1 Service Lock Screen...156 E.2 Install Options Screens...157 E.3 Printing Setup Information...161 E.4 Communications Setup Screen...161 E.5 Diagnostic Control Screen...162 E.6 J102 Screen...163 E.7 NIBP Calibration Screen...164 E.8 Setup Screen Defaults...164 E.8.1 Operator Setup Screens...165 E.8.2 Service Mode Screens...168
Appendix F: CPU Software Upgrade... 171 F.1 Tool Requirement...171 F.2 Upgrade Procedure...171
Appendix G: CorometricsTM 325 Simulator Setup and Use... 173 G.1 Simulator Setup...173 G.2 Alarms Check...173 G.3 MECG Input Check...176 G.4 FECG Input Check...177 G.5 Ultrasound Input Check...179 G.6 Uterine Activity Check...180 G.7 Pattern Memory Check...181 G.8 Dual Heart Rate Check (Non-Pattern, FECG/US Modes)...182 G.9 Dual Heart Rate Check (Non-Pattern, Dual US Modes)...183 G.10 Fetal Movement Detection Check...184
© 2023 by General Electric Company. All rights reserved.
2036947-001
xvii
Compliance A GE brand Corometrics™ 250cx 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 • • • • • • • • • • • • •
250cx 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 1563AAO Telemetry Cable
• •
Exergen® TAT-5000™ External 15” display
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. xviii
2036947-001
© 2023 by General Electric Company. All rights reserved.
About this Manual
Scope and Intended Users This service manual describes the installation, maintenance, checkout, calibration and repair of the CorometricsTM 250cx Series monitor. The intended users for this service manual are biomedical engineering service providers of the hospitals and GE service personnel.
Conventions 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. SENSITIVE TO ELECTROSTATIC DISCHARGE CAUTION An electrostatic discharge (ESD) Susceptibility symbol is displayed to alert service personnel that the part(s) are sensitive to electrostatic discharge and that static control procedures must be used to prevent damage to the equipment.
User Responsibility This Product will perform in conformity with the description thereof contained in this 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. This Product 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 CorometricsTM 250cx Series monitor. 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 CorometricsTM 250cx 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
© 2023 by General Electric Company. All rights reserved.
2036947-001
1
About this Manual 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. WARNING: This device shall not be repaired other than in accordance with written instructions provided by GE Healthcare and by GE Healthcare trained personnel. CAUTION: Untied States federal law restricts this device to sale by or on the order of a licensed medical practitioner.
References The following table lists other manuals pertaining to the CorometricsTM 250cx Series monitor service manual: References CorometricsTM 250cx Series Monitor Operator’s Manual (English) CorometricsTM Model 340 Service Manual Mini Telemetry System Service Manual
Orderable Part Number 2036946-001 2006920-001 2049821-001
Visit www.flukebiomedical.com Fluke® PS320 Fetal Simulator User’s Manual Maternal/Fetal Monitoring Clinical Application Operator’s Manual 15457AA CorometricsTM Fetal Acoustic Stimulator Operator’s Manual 1168AA
Definitions of Terms Term BPM ECG ESD FECG FHR FAST FMD HBC INOP IUPC LCD MECG NIBP REM SpO2 TOCO
2
Definition Beat Per Minute Electrocardiogram Electro Static Discharge Fetal Electrocardiogram Fetal Heart Rate Fetal Acoustic Stimulation Test Fetal Movement Detection Heart Beat Coincidence Inoperable Intra-Uterine Pressure Catheter Liquid Crystal Display Maternal Electrocardiogram Non-Invasive Blood Pressure Remote Event Marker Pulse Oximeter Oxygen Saturation Non-invasive method of measuring uterine activity
2036947-001
© 2023 by General Electric Company. All rights reserved.
About this Manual Term UA US
Definition Uterine Activity Ultrasound
Symbols This section identifies the symbols that are displayed on the CorometricsTM 250cx Series monitor: Equipment Symbols TYPE BF EQUIPMENT: Type BF equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment has an F-type applied part. DEFIBRILLATOR-PROOF TYPE BF EQUIPMENT: Type BF equipment is suitable for intentional external and internal application to the patient, excluding direct cardiac application. Type BF equipment is type B equipment with an F-type isolated (floating) part. The paddles indicate the equipment is defibrillator proof. TYPE CF EQUIPMENT: Type CF equipment is suitable for intentional external and internal application to the patient, including direct cardiac application. Type CF equipment has an F-type applied part. DEFIBRILLATOR-PROOF TYPE CF EQUIPMENT: Type CF equipment is suitable for intentional external and internal application to the patient including direct cardiac application. Type CF equipment is F-type applied part that provides a higher degree of protection against electric shock than that provided by Type BF applied parts. Consult accompanying documents. Alternating Current (AC) Ground Equalization Potential Post POWER OFF: disconnection from the mains POWER ON: connection to the mains European Union Representative Catalog Number Serial Number Manufacturer
© 2023 by General Electric Company. All rights reserved.
2036947-001
3
About this Manual Equipment Symbols Date of Manufacture (in YYYY-MM format) Untied States federal law restricts this device to sale by or on the order of a licensed medical practitioner. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment. The UDI (Unique Device Idendtification) is a unique marking for identification of the medical device.
4
2036947-001
© 2023 by General Electric Company. All rights reserved.
Important Safety Information
The service information is important for the safety of both the patient and operator and also serves to enhance equipment reliability. WARNING: Before servicing the CorometricsTM 250cx Series monitor, 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 be serviced only by authorized service personnel. Additional precautions specific to certain procedures are found in the text of this manual. 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 any way 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. WARNING: The user or service staff should dispose of all the waste properly as per federal, state, and local waste disposal regulations. Improper disposal could result in personal injury and environmental impact Do not use malfunctioning equipment. If the system is under warranty, contact GE technical support at the number on the back of the manual PRIOR to performing any repairs on the system.
© 2023 by General Electric Company. All rights reserved.
2036947-001
5
Important Saftey Information
Warnings, Cautions and Notes WARNING: ACCIDENTAL SPILLS: In the event that fluids are accidentally spilled on the monitor, take the monitor out of operation and inspect for damage. WARNING: APPLICATION: This monitor is not designed for direct cardiac connection. WARNING: CONDUCTIVE CONNECTIONS: Avoid making any conductive connections to applied parts (patient connection) which are likely to degrade safety. WARNING: CONDUCTIVE PARTS: Ensure that the conductive parts of the lead electrodes and associated connectors do not contact other conductive parts including earth. WARNING: 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. WARNING: 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. WARNING: DEFIBRILLATION PROTECTION: When used with the GE-recommended accessories, the monitor is protected against the effects of defibrillator discharge. If monitoring is disrupted by the defibrillation, the monitor will recover. WARNING: ELECTRICAL SHOCK: To avoid electrical shock hazard, do not operate the monitor with the top cover removed. WARNING: ELECTROMAGNETIC INTERFERENCE: 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 section for additional information. WARNING: 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.
6
2036947-001
© 2023 by General Electric Company. All rights reserved.
Important Saftey Information
WARNING: EXPLOSION HAZARD: Do not use this equipment in the presence of flammable anesthetics or inside an oxygen tent. WARNING: GROUNDING: To avoid electrical shock hazard to the patient or the operator, do not defeat the three-wire grounding feature of the power cord by means of adaptors, plug modifications, or other methods. WARNING: 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. WARNING: 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 WARNING: INTERFACING OTHER EQUIPMENT: Monitoring equipment must be interfaced with other types of medical equipment by qualified biomedical engineering personnel. Consult manufacturers’ specifications to maintain safe operation. WARNING: 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 harmonized national standard. WARNING: 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). WARNING: MRI USE: Do not use the electrodes during MRI scanning. Conducted current could potentially cause burns. WARNING: 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.
© 2023 by General Electric Company. All rights reserved.
2036947-001
7
Important Saftey Information WARNING: 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. For disclosure of the pacemaker pulse rejection capability of the monitor, refer to Appendix A. WARNING: 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. WARNING: 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. WARNING: STRANGULATION: Make sure all patient cables, leadwires, and tubing are positioned away from the patient’s head to minimize the risk of accidental strangulation. WARNING: 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. WARNING: EXTERNAL VGA CONNECTIONS: Connect only to GE-recommended display. ONLY remove cover plate if external display is used. WARNING: TELEMETRY CONNECTIONS: Connect only to GE-recommended telemetry system. Contact your GE service representative for more information. WARNING: COLOR DISPLAY: Certain colors may have limited visibility at a distance. Color-blind individuals may experience this more often. WARNING: EXERGEN® TAT-5000™: Cable assembly 2036641-001, 2036641-002, 2036641-003, and 2036641004 cannot be field serviced. Do NOT attempt any repairs to this assembly. This assembly must be returned to the factory for any repairs. This assembly, as shipped, is important to patient safety. WARNING: DISPOSAL: This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor contain mercury). CAUTION: ANNUAL SERVICING: For continued safety and performance of the monitor, verify the calibration, accuracy, and electrical safety of the monitor annually. Contact your GE service representative.
8
2036947-001
© 2023 by General Electric Company. All rights reserved.
Important Saftey Information CAUTION: DAILY TESTING: It is essential that the monitor and accessories be inspected every day. It is recommended practice to initiate the monitor’s selftest feature at the beginning of each monitoring session. CAUTION: ENVIRONMENT: The performance of the monitor has not been tested in certain areas, such as x-ray and imaging suites. The monitor is not recommended for use in these environments. CAUTION: EQUIPMENT CONFIGURATION: The equipment or system should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, the equipment or system should be tested to verify normal operation in the configuration in which it is being used. CAUTION: PERFORMANCE: Report all problems experienced with the monitor. If the monitor is not working properly, contact your service representative for service. The monitor should not be used if it is not working properly. CAUTION: PINCHING: Keep fingers clear of the paper roller because the roller could pinch your fingers. CAUTION: STATIC ELECTRICITY: This assembly is extremely static sensitive and should be handled using electrostatic discharge precautions. CAUTION: TRAPPING: Keep hands, hair, jewelry, and loose clothing away from the paper roller because the roller could trap these items. CAUTION: TRIPPING: Arrange monitoring equipment so that cords and cables do not present a tripping hazard.
Electromagnetic Interference This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2: 2007, EN60601-1-2:2007, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in the health-care and home environments (for example, cellular phones, mobile two-way radios, electrical appliances), it is possible that high levels of such interference due to close proximity or strength of a source, may result in disruption of performance of this device. Refer to the Electromagnetic Immunity information in this product’s service manual for EN 60601-1-2 (2007) Edition 3 compliance information and safety information for this product. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with these instructions, may cause harmful interference with other devices in the vicinity. Disruption or interference may be evidenced in the form of erratic readings, cessation of operation, or incorrect
© 2023 by General Electric Company. All rights reserved.
2036947-001
9
Important Saftey Information functioning. If this occurs, the site of use should be surveyed to determine the source of this disruption, and actions taken to eliminate the source. The user is encouraged to try to correct the interference by one or more of the following measures: • • • •
Turn equipment in the vicinity off and on to isolate the offending equipment. Reorient or relocate the other receiving device. Increase the separation between the interfering equipment and this equipment. If assistance is required, contact your GE service representative.
10
2036947-001
© 2023 by General Electric Company. All rights reserved.
Chapter 1: System Description
1.1 System Overview The CorometricsTM 250cx Series monitor is a medical device for monitoring maternal/fetal parameters (Fetal Heart Rate, Uterine Activity, Maternal Non-Invasive Blood Pressure, Maternal Pulse Oximetry, and Maternal/ Fetal ECG) in labor and delivery (antepartum, intrapartum, and postpartum care). The monitor is equipped with an LCD display, which provides simultaneous display of fetal and maternal parameters plus the maternal waveforms, and a recorder, which prints continuous trends and alphanumeric data on one strip chart. The system is compatible with Centricity® Perinatal Clinical Information Systems and other information systems to streamline capture and archiving of patient data. The CorometricsTM 250cx Series monitors are offered in two models: 1. Maternal/Fetal monitor (CorometricsTM 259cx): This model supports two Fetal Heart Rate (FHR) channels, Uterine Activity (TOCO or IUP), Maternal Non-Invasive Blood Pressure (NIBP), Maternal Pulse Oximetry (MSpO2), Fetal ECG (FECG), and Maternal ECG (MECG). 2. Fetal monitor (CorometricsTM 256cx): This model supports two Fetal Heart Rate (FHR) channels, Uterine Activity (TOCO or IUP), and Fetal ECG (FECG). Table 1-1: Monitor Models and Features
Monitor Model
Features
Maternal/Fetal monitor (Corometrics 259cx) TM
Fetal Only monitor (Corometrics 256cx) TM
US, US2, TOCO, IUP, FECG, MECG, NIBP, MSpO2 US, US2, TOCO, IUP, FECG
Below optional components are also available to order: A. Software Upgrade CD: The CD can be purchased to upgrade the monitor software to the latest version using the RS-232 serial port of the monitor. B. Spectra Alerts option: Each monitor unit can be upgraded to include Spectra Alerts option. This feature analyzes heart rate and uterine activity data to detect certain abnormal trends and alert the clinician. C. Fetal Movement Detection option: Each monitor unit can be software upgraded to include the Fetal Movement Detection (FMD) software option. This feature is designed to detect gross fetal body movements and body movements with associated limb movement.
© 2023 by General Electric Company. All rights reserved.
2036947-001
11