Corometrics 250 Operators Manual Rev E

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 Marking Information

CE Marking Information 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 equipments 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: „ „ „ „ „ „ „ „ „ „ „ „ „ „ „

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250 Series Maternal/Fetal Monitor Model 146 Fetal Acoustic Stimulator Intrauterine Pressure Transducer TOCO 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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CE Marking Information

Exceptions The Monitor System EMC: Immunity Performance None 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.

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Contents

1

Safety... 1-1 General Information... 1-3 General Use... 1-3 Responsibility of the Manufacturer... 1-3 Responsibility of the User... 1-3 Definitions of Terminology... 1-4 Monitor Contraindications, Warnings, and Precautions... 1-5 Warnings... 1-5 Cautions... 1-7 Electromagnetic Interference... 1-9 Equipment Symbols... 1-10

2

Introduction... 2-1 About the Manual... 2-3 Purpose... 2-3 Intended Audience... 2-3 Illustrations... 2-3 Fetal Monitoring Indications for Use... 2-3 Surveillance... 2-3 Maternal Monitoring Indications for Use... 2-3 Blood Pressure... 2-3 Pulse Oximetry... 2-4 Heart/Pulse Rate... 2-4 Series Overview... 2-4 The 250 Series Monitor Features (256 and 259)... 2-4 System Parameters (256 and 259)... 2-4 Fetal Parameters... 2-5 Maternal Parameters (259 only)... 2-6 Adding Fetal Movement Detection and/or Spectra Alerts... 2-6

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Controls, Indicators, and Connectors... 3-1 Front Panel Description... 3-3 Front Panel Displays... 3-6 Display Example... 3-7 Primary Labor Parameters... 3-8 FHR Display... 3-8 UA Display... 3-9 Additional Parameters... 3-10 Maternal NIBP... 3-10 MHR/P Area... 3-11 MSpO2 Area... 3-12 Waveform Area... 3-12 Time and Waveform Message Area... 3-12 Battery-Backed RAM Status... 3-13 Softkeys... 3-13 Mode Title Softkeys... 3-13 Waveform Softkeys... 3-13 Dedicated Softkey Area... 3-14 Rear Panel Description... 3-16

4

Setup Procedures... 4-1 Loading Strip Chart Recorder Paper... 4-3 Power... 4-6 Interruption of Power... 4-6 Self-Test Routine... 4-7 Setup Screens... 4-7 Using the Trim Knob Control... 4-8 General Setup Screen... 4-9 Play Song... 4-9 Song Volume... 4-9 Brightness... 4-9 Paper Speed... 4-9 Date... 4-10 Time... 4-10 MSpO2 Print Interval... 4-10 FSpO2 Print Interval... 4-10 FSpO2 Trace... 4-10 Service... 4-10 Preparing the Monitor for Patient Use... 4-11

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Fetal Heart Rate Monitoring... 5-1 Ultrasound (External Method)... 5-3 Methodology... 5-3 US/US2 Setup Screen... 5-3 Volume... 5-3 Alert... 5-4 Alarm Volume... 5-4 FECG (Internal Method)... 5-4 Methodology... 5-4 Artifact Elimination... 5-4 FECG Setup Screen... 5-5 Volume... 5-5 Alarms... 5-5 Audio Alarms... 5-5 Alarm Volume... 5-5 Fetal Heart Rate Alarms... 5-6 FHR Threshold Alarms... 5-6 FHR High Alarm... 5-7 Sample Clinical Exceptions... 5-8 Active Signal Quality Alarm... 5-8 Resolved Signal Quality Alarm... 5-8 100% Signal Loss... 5-9 Silencing an Audio Alarm... 5-9 Summary... 5-10 Single Fetal Heart Rate Monitoring... 5-10 Dual Fetal Heart Rate Monitoring... 5-10 Heartbeat Coincidence... 5-11 Fetal Heart Rate Offset... 5-11 Activating the Fetal Heart Rate Offset Feature... 5-11 De-Activating the Fetal Heart Rate Offset Feature... 5-12

6

Uterine Activity Monitoring... 6-1 Tocotransducer (External Method)... 6-3 Methodology... 6-3 Establishing a Baseline... 6-3 Initial Referencing... 6-3 For Trimline Tocotransducers only... 6-3 For other transducers (e.g., Nautilus)... 6-3 Accounting for Belt Tension... 6-4 More About Referencing... 6-4 Out of Range Condition... 6-4 Manually Setting the Baseline at the Default Value... 6-4 Manually Overriding the Baseline Default Value... 6-4 Automatic Baseline “Zeroing”... 6-4

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Internal Method - Intrauterine Pressure (IUP)... 6-5 Methodology... 6-5 Why You Must Zero the System... 6-5

7

Maternal Heart/Pulse Rate Monitoring... 7-1 MHR/P Source... 7-3 MHR/P Setup Screen... 7-4 Source... 7-4 HR/PR Trace... 7-5 Volume... 7-5 Alarms... 7-5 Alarm Volume... 7-5 MECG Lead... 7-5 MECG Pacer... 7-6 Maternal ECG Monitoring... 7-7 Theory and Methodology... 7-7 Pacemaker Safety Information... 7-7 MECG Waveform... 7-8

8

Maternal Non-Invasive Blood Pressure Monitoring... 8-1 Blood Pressure Safety Precautions... 8-3 Warnings... 8-4 NIBP Determination... 8-5 SuperSTAT NIBP Determination... 8-5 Accelerated Determination... 8-6 Systolic Search... 8-6 NIBP Setup Screen... 8-7 Mode... 8-7 Target... 8-7 NIBP Done Volume... 8-8 Alarms... 8-8 Alarm Volume... 8-8 NIBP Monitoring... 8-8 Checklist... 8-8 Patient Preparation... 8-8 Blood Pressure Methodology... 8-9 Hydrostatic Effect... 8-10 Manual Mode... 8-10 Automatic Mode... 8-10 Taking a Manual Reading Between Auto Determinations... 8-11 Venous Return in Auto Mode... 8-11 Adjusting the Interval Time Between Automatic Determinations... 8-11

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NIBP Interval Button Shortcut... 8-12 Terminating a Determination in Progress... 8-13 Smart BP Feature... 8-13 Enabling/Disabling Smart BP... 8-13 Methodology... 8-13

9

Maternal Pulse Oximetry Monitoring... 9-1 MSpO2 Technology... 9-3 Which Module is Installed?... 9-3 Theory of Operation... 9-4 Ohmeda TruSignal™ Oximetry... 9-4 TruSignal™ Enhanced SpO2... 9-4 Signal processing... 9-4 Masimo SET®... 9-4 Signal Processing... 9-4 Nellcor OxiMax®... 9-5 Automatic Calibration... 9-6 SatSeconds™... 9-6 SatSeconds “Safety Net”... 9-8 Using SatSeconds... 9-8 MSpO2 Setup Screen... 9-9 Response Time (Nellcor 506 Technology Only)... 9-9 Response Time (Nellcor NELL-3 Technology Only)... 9-9 Sensitivity (Masimo Technology Only)... 9-9 Averaging Time (Masimo Technology Only)... 9-10 Print Interval... 9-10 %O2 Trace... 9-10 Alarms... 9-10 Alarm Volume... 9-10 MSpO2 Methodology... 9-10 MSpO2 Pulse Beat Audio... 9-11 The MSpO2 Waveform... 9-11 Module and Probe Compatibility... 9-11 Modules and Sensors... 9-12 No Implied License... 9-12 Sensors... 9-12

10

Alarms... 10-1 Introduction... 10-3 Alarm Setup... 10-3 Master Alarm Setup Screen... 10-3 Alarms... 10-3 Alarm Volume... 10-4

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Alarm Silence... 10-4 Alarm Setting Indicators... 10-5 Maternal Alarm Occurring During Setup... 10-5 Alarm Behavior... 10-5 Fetal Heart Rate Alarms... 10-6 FHR Patient Alarms... 10-6 Active Patient Alarm... 10-6 Resolved Patient Alarm... 10-6 FHR Signal Quality Alarms... 10-6 Active Signal Quality Alarm... 10-6 Resolved Signal Quality Alarm... 10-7 Silencing an FHR Audio Alarm... 10-7 Maternal Alarms... 10-7 Maternal Patient Alarms... 10-7 Active Patient Alarm... 10-7 Resolved Patient Alarm... 10-7 Signal Quality Alarms... 10-7 Active Signal Quality Alarm... 10-8 Resolved Signal Quality Alarm... 10-8 Silencing a Maternal Audio Alarm... 10-8 Alarms Summary... 10-9

11

Recorder Modes... 11-1 Modes... 11-3 Off Mode... 11-3 On Mode... 11-3 Maternal-Only Mode... 11-3 What is the Maternal-Only Mode?... 11-3 Printing Style... 11-3 Changing Recorder Modes... 11-4 Functionality with a QS System... 11-5 Paper Versus Electronic Strip Charts... 11-5 Fetal Heart Rate Alarms... 11-6 Trends... 11-6 Multiple Trends... 11-6 SpO2 Scale... 11-7 Annotations... 11-7 Standard Annotations... 11-8 Blood Pressure Annotations... 11-8 Maternal Pulse Oximetry Annotations... 11-9 Annotations from a Central Information System... 11-9 Multiple Annotations... 11-9

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Summary of Annotations... 11-10 Adjustable Recorder Font Size... 11-13 Chart Style Vital Signs Printing... 11-14 Enabling/Disabling Chart-Style Printing... 11-14 Examples of Printing Styles... 11-15 Chart-Style Printing Examples... 11-15 Real-Time Printing Example... 11-15 Chart-Style 7-Minute Exception for NIBP... 11-15 Strip Chart Paper... 11-16 Paper-Low, Paper-Out, and Paper-LoadING Error Conditions... 11-18

12

Maternal Vital Signs History... 12-1 What is the Maternal Vital Signs History Screen?... 12-3 Using the Maternal Vital Signs History Screen... 12-4 Displaying the Screen... 12-4 Selecting the HX Interval... 12-4 Printing the Maternal Vital Signs History Screen... 12-5 Printing the Entire Vital Signs History... 12-5 Printing a Page of the Vital Signs History... 12-5 Stopping the Printing of Maternal Vital Signs History... 12-5

13

Heartbeat Coincidence... 13-1 Heartbeat Coincidence Theory... 13-3 Using the Heartbeat Coincidence Feature... 13-3 Enabling/Disabling Heartbeat Coincidence Detection... 13-3 Display Indicator... 13-3 Strip Chart Annotation... 13-5

14

Waveforms... 14-1 Waveform Area... 14-3 Selecting the Waveform... 14-3 Waveform Speed... 14-3 ECG Size... 14-3 MECG Lead Select... 14-3 MECG Pacer Label... 14-3 Moving Gap... 14-4 Freezing Waveforms... 14-4 Printing a Waveform Snapshot... 14-5 Recorder On... 14-5

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Recorder in Maternal-Only Mode... 14-6 Recorder Off... 14-6 Stopping a Print Command... 14-6

15

Maintenance... 15-1 Cleaning... 15-3 Monitor Exterior... 15-3 Display... 15-4 Tocotransducer and Ultrasound Transducer... 15-4 Leg Plates and MECG Cables... 15-4 Maternal NIBP Cuffs and Hoses... 15-5 General... 15-5 Materials... 15-5 Procedure... 15-5 SpO2 Sensors... 15-6 Maternal SpO2 Calibration... 15-6 NIBP Maintenance... 15-6 Disposal of Product Waste... 15-7 Patient Applied Parts... 15-7 Packaging Material... 15-7 Monitor... 15-7

16

Troubleshooting... 16-1 General Troubleshooting... 16-3 Ultrasound Troubleshooting... 16-4 FECG Troubleshooting... 16-4 External Uterine Activity Troubleshooting... 16-5 Internal UA Troubleshooting... 16-6 MECG Troubleshooting... 16-6 Blood Pressure Troubleshooting... 16-7 Maternal Pulse Oximetry Troubleshooting... 16-8

17

Technical Specifications... 17-1 General Monitor... 17-3 Operating Modes... 17-4 Strip Chart Recorder... 17-11

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18

Supplies & Accessories... 18-1 General Add-Ons Ordering Information... 18-3 Paper Supplies Ordering Information... 18-3 Ultrasound Ordering Information... 18-3 FECG Ordering Information... 18-4 Tocotransducer Ordering Information... 18-4 IUPC Ordering Information... 18-4 MECG Ordering Information... 18-5 NIBP Ordering Information... 18-5 MSpO2 Ordering Information... 18-6 Peripheral Device Ordering Information... 18-6

A

Factory Defaults...A-1 Table of Defaults... A-3

B

Fetal Movement Detection...B-1 Introduction... B-3 Availability...B-3 Methodology...B-3 Using Fetal Movement Detection While Monitoring... B-3 Enabling/Disabling Fetal Movement Detection...B-3 Display Indicator...B-4 Strip Chart Annotation...B-4 Using the FM Remote Marker to Complement the Patient Record...B-4

C

Spectra Alerts...C-1 Important Safety Information... C-3 Using the Spectra Alert Option... C-4

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Enabling/Disabling Spectra Alerts...C-4 Methodology...C-4 Alert Indications... C-6 Active Alerts...C-6 Silencing Alerts...C-6 Resolved Alerts...C-7 Alert Suspension Feature...C-7 Enabling/Disabling the Alert Suspension Feature...C-7 Suspending Audio Alerts (and the Nurse Call Interface)...C-7 Restoring Audio Alerts (and the Nurse Call Interface)...C-7 Alert Parameters Summary... C-9 Resetting Alerts... C-12 False Pattern Recognition...C-12 Mode Switching...C-12 Trend Screen... C-13 Uterine Contraction Frequency... C-13 Enabling/Disabling UC Frequency Display...C-14 UC Frequency in UA Display Area...C-14 UC Frequency Histogram...C-15 Enabling/Disabling UC Chime...C-15 Nurse Call Interface... C-16 Alert Parameters... C-17

D

Frequently Asked Questions...D-1 FAQs...D-3

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Safety

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Safety:

For your notes



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Safety: General Information

General Information General Use If the monitor is cold to the touch or below ambient temperature, allow it to stabilize before use. To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies. Parts and accessories used shall meet the requirements of EN60601-1-1. Disposable devices are intended for single use only. They should not be reused. Periodically, and whenever the integrity of the monitor is in doubt, test all functions. Refer to the “Maternal/Fetal Monitoring, Clinical Applications Manual” for information concerning the limitations of internal and external fetal heart rate monitoring techniques.

Responsibility of the Manufacturer GE Medical Systems Information Technologies 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 Medical Systems Information Technologies;

„

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 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 250 Series monitor is only one clinical indicator of fetal status during labor. The monitor is designed to assist the perinatal staff in assessing the status of a patient. 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

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Safety: Definitions of Terminology

must be combined with knowledge of patient history and risk factors to properly care for the mother and fetus.

Definitions of Terminology 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



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.

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Safety: Monitor Contraindications, Warnings, and Precautions

Definitions of Terminology Danger

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

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.

Monitor Contraindications, Warnings, and Precautions Warnings 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 Technologiesrecommended accessories, the monitor is protected against the effects of defibrillator discharge. If monitoring is disrupted by the defibrillation, the monitor will recover. 5HYLVLRQ(

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Safety: Monitor Contraindications, Warnings, and Precautions

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 page 1-9 for additional 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. EQUIPMENT USE-The use of this equipment is restricted to one patient at a time. 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 MECG LEADS OFF condition or an overload (saturation) of the front-end 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’



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