Eclipse™ 850 & Plus Operating Instructions Rev A

DISCLAIMER SPACELABS BURDICK, INC. MAKES NO REPRESENTATIONS OR WARRANTIES WITH RESPECT TO THE CONTENTS OR USE OF THIS MANUAL, OR WITH RESPECT TO ANY SPACELABS BURDICK, INC. HARDWARE OR SOFTWARE, AND EXPRESSLY DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Copyright © 2001 Spacelabs Burdick, Inc. All rights reserved. Printed in the United States of America. No part of this publication may be reproduced, photocopied or transmitted without the express written consent of the publisher.

Authorized EC Representative Spacelabs Medical SARL 6, allée des Saules 94042 Créteil FRANCE

Spacelabs Burdick, Inc. 500 Burdick Parkway Deerfield, Wisconsin 53531 U.S.A.

Telephone: 33 (0) 1 45.13.22.44 Fax: 33 (0) 1 45.13.22.00

(800) 777-1777

(608) 764-1919

Quick Reference Instructions CONNECT PATIENT

PRECORDIAL LEAD PLACEMENT

Refer to lead placement chart

V3

POWER ON… Press

V1

V4

V2

V5 V6

on/stby

Wait for ECG screen and confirm "SENSORS OK" message. If no response or "LOW BATTERY" appears, plug power cord into AC outlet.

FOR A STAT ECG… Press

ECG

ECG W/PATIENT INFORMATION… Press

Ñ I

intercostal space at right V1 Fourth margin of sternum

Type patient’s ID# Press

intercostal space at left V2 Fourth margin of sternum

enter

Type patient’s LAST NAME Press

intercostal space at V4 Fifth junction of left midclavicular line

enter

Type patient’s FIRST NAME

Midway between position V2 and V3 position V

Press

V

4

At horizontal level of position V4 5 at left anterior axillary line

enter

Type patient’s DATE OF BIRTH example: 04 Press Press

14

1952

enter

F

horizontal level of position V4 V6 atAt left midaxillary line

LIMB LEAD PLACEMENT or

-M

Enter remaining patient information Press RA

LA

Verify waveforms on screen Press

ECG

FOR A CONTINUOUS RHYTHM PRINTOUT Press

MAN

Press

STOP

to stop rhythm printing.

RL

LL

070-1046-00 PHOTOCOPY THIS PAGE AS NEEDED

A

Table of Contents Table of Contents... i Intended Use... iii Warnings, Cautions & Notices... iv Definitions of Symbols Used... vi

Chapter 1

General Information... 1-1 Inspection Upon Delivery... 1-1 General Description... 1-2 Interpretive Analysis Program... 1-3 Safety Features... 1-4 Using Multiple Electrical Apparatus... 1-4

Chapter 2

Equipment Setup... 2-1 Equipment Connections... 2-1 Equipment Setup... 2-4 Turning the Unit On... 2-7

Chapter 3

Keyboard and Displays... 3-1 The Keyboard... 3-1 The PREVIEW Screen... 3-4 A sample menuÑthe EDIT ID menu... 3-6 Using Menus... 3-8 Lists and System Notes... 3-9

Chapter 4

System Setup and User Setup... 4-1 Configuring SYSTEM SETUP Menu... 4-1 Configuring the USER SETUP Menus... 4-5 Acquiring a Printout of Eclipse Program Settings... 4-16

Chapter 5

Patient Preparation... 5-1 Choosing the environment... 5-1 Preparing Patients for Resting ECGs... 5-1 Resting ECG Lead Placement & Coding Chart... 5-3 Alternative Lead Placements... 5-7 Preparing Patients for Exercise Stress Testing... 5-10

Chapter 6

Acquiring ECG Reports... 6-1 Acquiring a Stat ECG... 6-1 Acquiring an Auto ECG... 6-2 Printing Reports... 6-4 Temporarily Changing Current Settings... 6-5 Acquiring an Auto Rhythm or a Manual Rhythm... 6-6 Acquiring an ECG Using Alternative Lead Placements... 6-7 Entering Patient Demographics... 6-9

Eclipse Operating Instructions

i

Chapter 7

Managing Patient Records...7-1 Using the DIRECTORY Menu...7-1 Accessing Saved Files...7-3 Additional Functions...7-6

Chapter 8

Sending and Receiving Records...8-1 How record status affects the sending operations...8-1 Changing Record Status...8-1 Setting up the Unit to Send and Receive...8-2 Receiving requisitions from PYRAMIS...8-4 Sending records to PYRAMIS...8-5 Sending and Receiving records from an Eclipse...8-6 Receiving records from PYRAMIS...8-6

Chapter 9

Sample Printouts...9-1 Print Directory Report...9-1 Print Setup Report...9-2 Standard 12-Lead, 4-Channel Auto ECG (Eclipse 850)...9-5 Standard 12-Lead, 6-Channel Auto ECG (Eclipse 850)...9-6 Standard 3-Channel Rhythm & Manual ECG (Eclipse 850)...9-8 Standard 12 Channel Rhythm & Manual ECG (Eclipse Plus)...9-9

Chapter 10

Troubleshooting...10-1 Troubleshooting Basic Unit Problems...10-1 Troubleshooting Trace Problems...10-2 Troubleshooting Printer Problems...10-3 Recognizing and Reducing ECG Artifacts...10-4

Chapter 11

Maintenance and Service...11-1 Calibrating the Battery Status Gauge...11-1 Inspecting for Damage...11-2 Cleaning and Disinfecting the Eclipse...11-2 Testing Equipment...11-3 Notice to responsible service personnel...11-5 Performance Disclosures...11-5 Technical Specifications (Eclipse 850)...11-7 Technical Specifications (Eclipse Plus)...11-9

Chapter 12

Measurement Matrix...12-1 Index... IN-1

ii Eclipse Operating Instructions

Intended Use WARNING: The Eclipse should not be connected to nonmedical equipment unless the non-medical equipment complies with IEC 601-1. In addition, the enclosure leakage current of non-medical equipment connected to the Eclipse should not be allowed to exceed 500µA in fault condition. To maintain a proper enclosure leakage current, provide additional protective earth grounding, use an additional isolating transformer or use a ßoating power supply. WARNING: The Eclipse and any non-medical equipment that it is connected to should not be allowed within the patientÕs vicinity, which extends 6 feet (1.83 m) beyond the perimeter of the bed, table or chair, and 7 1/2 feet (2.29 m) above the ßoor. WARNING: NEVER create a direct connection between an Eclipse and a PYRAMIS computer if the Eclipse is already connected to a patient. Under the supervision of a qualiÞed physician trained in the subject of ECG interpretation, the Eclipse 850 and Eclipse Plus can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures. This equipment produces a 12 lead (view) electrocardiogram which can be used as a Þrst step for assessment of patients with cardiac arrythmias, intraventricular conduction block, pre-excitation syndrome and ischemic heart disease. Records stored and used during the life of the patient can assist physicians in the diagnosis and natural history of heart related illnesses (such as coronary artery disease). With appropriate support equipment, the Eclipse 850 can also be used in the evaluation of exercise induced ischemia of the heart typically referred to as an exercise stress test. The resultant electrical activity of the heart can be recorded as a 12 lead and further analyzed for ischemic episodes. This equipment is not designed to produce a deÞnitive interpretation nor an exhaustive evaluation of the patientÕs heart but rather provide an effective beginning for evaluation of patients with heart abnormalities.

Eclipse Operating Instructions

iii

Warnings, Cautions & Notices

Warnings WARNING: The Eclipse should not be connected to non-medical equipment unless the non-medical equipment complies with IEC 6011. In addition, the enclosure leakage current of non-medical equipment connected to the Eclipse should not be allowed to exceed 500µA in fault condition. To maintain a proper enclosure leakage current, provide additional protective earth grounding, use an additional isolating transformer or use a ßoating power supply. WARNING: The Eclipse and any non-medical equipment that it is connected to should not be allowed within the patientÕs vicinity, which extends 6 feet (1.83 m) beyond the perimeter of the bed, table or chair, and 7 1/2 feet (2.29 m) above the ßoor. WARNING: NEVER create a direct connection between an Eclipse and a PYRAMIS computer if the Eclipse is already connected to a patient. WARNING: This device is NOT intended for unattended or continuous patient monitoring. It is intended for short-term ECG waveform acquisition. There are no audible or visible alarms. WARNING: Never remove the battery pack and attempt to recharge it using an external battery charger. Fire or explosion may result. WARNING: Explosion hazard. Do NOT use in the presence of ßammable anesthetics. WARNING: Electrical shock hazard. Do NOT contact unit or patient during deÞbrillation. Otherwise, serious injury or death could result. WARNING: NEVER position deÞbrillator paddles very close to or over ECG sensors. Remove all chest sensors (V-Leads/C-Leads) from a patient before deÞbrillation to allow proper paddle placement. Severe burns may result from improper placement of deÞbrillator paddles. Before using any deÞbrillator, consult the operating instructions for that equipment. WARNING: Electrical shock hazard. Operate the unit from its battery supply if the integrity of the protective earth conductor is in doubt. Otherwise, serious injury or death could result. iv Eclipse Operating Instructions

WARNING: If safety procedures not performed, increased risk to patient and device can occur. WARNING: Hazardous voltage. To reduce the risk of electrical shock, do not attempt to remove the cover under any circumstances. Refer servicing to a qualiÞed technician.

Cautions CAUTION:

Federal law restricts this device to sale by or on the order

of a physician CAUTION: The unit must be operated only at the line voltage and frequency speciÞed on the rating plate. CAUTION: Although the Eclipse is designed to meet IEC 601-1-2 EMC immunity requirements, the presence of strong EMI Þelds generated by electronic, surgical or diathermy instruments in close proximity to the unit may cause trace noise or input overload conditions. CAUTION: Fire hazard. Use only approved battery packs. Replace Eclipse 850 battery pack with the battery speciÞed on the label inside the battery compartment.

Notices NOTICE: Do not place used battery pack in your regular trash. The incineration, landÞlling, or mixing of NiCad batteries with municipal waste is PROHIBITED BY LAW in most areas. Return this battery pack to a government-approved battery recycler. Contact your local waste management ofÞcials for more information. NOTICE: Computer assisted interpretation is a valuable tool when used properly. However, no automated interpretation is completely reliable and interpretations should be reviewed by a qualiÞed physician before treatment, or non-treatment, of any patient. NOTICE: Because the Eclipse offers different lead conÞgurations, always ensure that the appropriate lead placement is employed for the lead conÞguration selected. NOTICE: Waveforms displayed on the Eclipse screen are not intended to be used for diagnostic purposes. Use displayed waveforms to assess signal quality only. NOTICE: Damage caused by using unapproved recording paper may void your warranty.Your Eclipse Electrocardiograph is intended for use with approved ECG supplies; its reliability and performance are directly affected by the supplies you use. Eclipse Operating Instructions

v

DeÞnitions of Symbols Used Safety Symbols Attention. Consult accompanying documents. Danger! High voltage. Hazardous voltage. DeÞbrillation-Protected Type CF Equipment. Equipotentiality (used to label the grounding lug). Complies with the EMC/Radiocommunications requirements set out by the Australian Communication Authority under Radiocommunications Act, 1992. Meets or exceeds Council Directive 93/42/EEC, MDD, Class IIa.

vi Eclipse Operating Instructions

Labeling Symbols Alternating Current (AC) Automatic Operation Custom Lead Triplet Frequency Response Heart Rate Input/Output Connection LCD Screen Contrast Manual Operation On/Standby Stop Function

I0I0

Serial port Battery Compartment

+

Battery Charge Status Modem

RJ11

Modem

Eclipse Operating Instructions

vii

viii Eclipse Operating Instructions

Chapter

1

General Information Congratulations on your purchase of a top quality Eclipse ECG machine. By listening to our customers, we have designed the Eclipse to suit your speciÞc needs, incorporating features that people like yourself have requested. Your business is important to us. If you would like more information or if you have any questions, contact your local representative or Spacelabs Burdick Technical Support Department at (800) 522-7025, (425) 882-3700 or (608)7641919. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Inspection Upon Delivery Your new Eclipse was carefully inspected before shipment. Please inspect your unit upon delivery for any damage which may have occurred in transit. If you notice any damage, please contact your shipping agent. If items are missing, contact your local representative or Spacelabs Burdick Technical Support Department at (800) 522-7025, (425) 882-3700 or (608)7641919. NOTE: Your Eclipse Electrocardiograph is intended for use with approved ECG supplies; its reliability and performance are directly affected by the supplies you use.

Eclipse Operating Instructions

1-1

Chapter 1 General Information

General Description Figure 1-1 Eclipse 850 and Eclipse Plus

l l l l l l l l l l l l

1-2 Eclipse Operating Instructions

Portable; may be operated from battery or AC line power. Eclipse Plus features an active-matrix color LCD. Eclipse 850 features a backlit, grayscale LCD. Prints using a thermal printer and thermosensitive, Z-fold paper. Operates in manual and automatic modes. Records in either standard or Cabrera lead formats. Alternative lead selections include Pediatric (V4R), Alternate Chest Lead, Nehb, and Frank. Stores and, with interpretive models, analyzes waveforms acquired in automatic mode. Prints at least 200 pages at 25 mm/s recording speed when the internal battery is fully charged. Continuously recharges the battery whenever the unit is connected to AC line power. Enhanceable. Software enhancements are quickly and easily introduced. Allows you to preview waveforms before you print, saving time and supplies. Features selectable patient demographic Þelds that you may use to suit your needs.

Interpretive Analysis Program

Interpretive Analysis Program About the program The Eclipse is available with an interpretive analysis program. This program is widely respected as one of the most accurate available today. It was developed by Prof. Peter MacFarlane of the Glasgow Royal InÞrmary who has been involved in computerized ECG interpretation since its inception in the 1960s. The ECG Interpretation Criteria PhysicianÕs Guide is included with the Operating Instructions. This guide outlines the criteria used by the analysis program.

Features of the interpretive analysis program l

DEVELOPED IN A HOSPITAL ENVIRONMENT The interpretive program was developed in the University Department of Medical Cardiology in the Glasgow Royal InÞrmary. Unlike many products which are developed with the aid of outside consultants, this program was developed in the environment for which it is intended.

l

USES AGE, SEX AND RACE DATA EXTENSIVELY More than 500 measurements, plus the patientÕs age, sex, race, clinical classiÞcation and medications are factored into each analysis. Several criteria for abnormalities are age, race and sex dependent. Race, for example is key in identifying hypertrophy and T-wave abnormalities.

l

USES CLINICAL HISTORY The program is the Þrst to use clinical class as an integral part of analysis just as a physician would consider clinical class in his or her evaluation.

l

UNDER CONTINUOUS DEVELOPMENT & ENHANCEMENT The program has been clinically tested against more than 80,000 ECGs and is continuously under development.

l

ACCURATELY DETECTS NORMAL ECGs Normal ECGs are easily identiÞed and sorted so the physician may quickly verify results.

Eclipse Operating Instructions

1-3

Chapter 1 General Information

Safety Features WARNING: Electrical shock hazard. Do NOT contact unit or patient during deÞbrillation. Otherwise, serious injury or death could result. WARNING: NEVER position deÞbrillator paddles very close to or over ECG sensors. Remove all chest sensors (V-Leads/ C-Leads) from a patient before deÞbrillation to allow proper paddle placement. Severe burns may result from improper placement of deÞbrillator paddles. Before using any deÞbrillator, consult the operating instructions for that equipment. Includes a 3-conductor, hospital-grade power cable. Includes an electrically isolated, DB-15 style patient cable. This conforms to IEC safety, pinout and mechanical requirements. This symbol which appears on the rear panel, indicates this equipment meets the requirements of Council Directive 93/42/EEC, MDD, Class IIa. This symbol next to the patient cable connector indicates this equipment is classiÞed as deÞbrillation-protected, Type CF equipment. The patient cable and input circuits are designed to prevent damage to the recorder if the unit is connected to a patient during deÞbrillation.

Using Multiple Electrical Apparatus Use caution when monitoring patients who must be protected from very small electrical currents. Susceptible patients include patients with cardiac catheters or pacemakers. Consult a qualiÞed technician before using multiple electrical apparatus in this patient environment. The Eclipse patient leads are electrically isolated from ground and the device meets the most stringent IEC and ANSI/AAMI medical standards for leakage currents. However, a potential hazard may occur if the enclosure leakage currents from multiple pieces of equipment combine and are inadvertently routed directly to a patientÕs heart via a catheter or pacemaker lead. Only equipment which is certiÞed to IEC and ANSI/AAMI medical standards should be used in this environment. Use of certiÞed equipment does not, however, completely eliminate this possible hazard. Another potential hazard may occur if two devices near a patient are powered from different circuits. If the grounds of the two circuits are at different potentials, which can occur under certain fault conditions, then a ground loop can exist between the enclosures of the two devices. If devices must be powered from separate circuits in the vicinity of a susceptible patient, then the grounding lugs on the devices should be electrically connected via an equipotential cable. Please also consult Chapter 2, ÒEquipment Setup.Ó

1-4 Eclipse Operating Instructions

Chapter

2

Equipment Setup

Equipment Connections WARNING: The Eclipse should not be connected to nonmedical equipment unless the non-medical equipment complies with IEC 601-1. In addition, the enclosure leakage current of non-medical equipment connected to the Eclipse should not be allowed to exceed 500µA in fault condition. To maintain a proper enclosure leakage current, provide additional protective earth grounding, use an additional isolating transformer or use a ßoating power supply. WARNING: The Eclipse and any non-medical equipment that it is connected to should not be allowed within the patientÕs vicinity, which extends 6 feet (1.83 m) beyond the perimeter of the bed, table or chair, and 7 1/2 feet (2.29 m) above the ßoor. WARNING: NEVER create a direct connection between an Eclipse and a PYRAMIS computer if the Eclipse is already connected to a patient.

Connecting power cord and peripheral equipment CAUTION: The unit must be operated only at the line voltage and frequency speciÞed on the rating plate. Connect AC line power and external equipment via the connectors on the back panel (see Figure 2-1). For patient safety, all equipment in patient environment should be IEC 601-1 approved. All connected equipment should be IEC 950 approved or equivalent. Consult a qualiÞed technician to verify equipment compatibility.

Eclipse Operating Instructions

2-1

Chapter 2 Equipment Setup

Figure 2-1 Eclipse Back Panel

A

B

Eclipse Plus Back Panel

C

G

D

F E

D

A

Eclipse 850 Back Panel IOIO

G

F E

(A) SERIAL PORT (ECLIPSE PLUS & 850 WITH COMMUNICATIONS) Connect compatible fax/modems to this serial connector using an approved modem cable. You must have the fax or SCP-ECG software installed to use this function. Most Hayes-compatible modems supporting Fax Service Class 2 commands will work with the Eclipse. This connector is also used for direct connection of the unit to a compatible management system using an approved Direct Connect cable. (B)

EXPANSION (ECLIPSE PLUS)

This connector is reserved for future expansion. (OR)

RJ11

(C) INTERNAL MODEM (ECLIPSE PLUS & 850 WITH COMMUNICATIONS) Connect the phone line you will be using for faxing or sending records into this RJ11 connector if your unit is equipped with an internal fax/modem. (On the Eclipse 850, this connector is located on the left side of the unit, if you are facing the unit. See Figure 2-2 on pg. 2-3.)

2-2 Eclipse Operating Instructions

Equipment Connections

(D)

AC POWER

Use the supplied power cord to connect the unit to AC line power here. There is no switch to disconnect AC line power. To do this you must unplug the unit. The battery is automatically charged whenever the unit is connected to AC line power. (E)

POWER INDICATOR

Verify that the unit is receiving AC line power when this green light is on. (F)

EQUIPOTENTIAL GROUNDING

Connect peripheral equipment directly to the Eclipse protective earth ground via this post. This is necessary only if peripheral equipment requires equipotential grounding. (G) ANALOG OUTPUT /STRESS INTERFACE (ECLIPSE PLUS & 850 WITH COMMUNICATIONS) On the Eclipse 850, this analog output provides the same 3 channels of waveforms which are currently displayed on the PREVIEW screen. Frank and Nehb are not supported. Alternatively, connect the stress interface using an approved monitor cable via this connector. On the Eclipse Plus, this analog output provides one channel waveform which is the Þrst channel which is currently displayed on the PREVIEW screen, unless the PREVIEW screen is displaying all 12 leads. In this case, channel II is output.

Connecting the Patient Cable Connect the Patient Cable via the connector on the front of the unit. In the Þgure below, the Eclipse 850 is shown; however, the connector for the Patient Cable on the Eclipse Plus is in the same approximate location. Figure 2-2 Patient Cable Connector (Eclipse 850 shown)

(Internal Modem)

Patient Cable

Make sure the connector on the cable is arrow-side-up then Þrmly push the connector until the arrow point is aligned with the edge of the Eclipse.

Eclipse Operating Instructions

2-3

Chapter 2 Equipment Setup

Equipment Setup Grounding WARNING: Electrical shock hazard. Operate the unit from its battery supply if the integrity of the protective earth conductor is in doubt. Otherwise, serious injury or death could result. Maximum patient and operator safety is ensured only when the Eclipse is properly grounded. To do this, connect the power cable to the AC Power connector (see Figure 2-1 on pg. 2-2) and connect the other end to a properly grounded, AC line outlet.

Using the Battery (Eclipse 850) The battery that is shipped with the Eclipse 850 has been charged at the factory. When battery power is being used, the message ÒBATTERYÓ is displayed. When the unit is connected to AC line power, the message ÒAC ONÓ is displayed. When fewer than 15 minutes of operating time remain, the message ÒLOW BATTERYÓ ßashes and the unit beeps every 30 seconds. If the battery charge level drops too low, the unit displays the message, ÒPOWERING DOWN.Ó Then, after 5 seconds, the unit shuts off. Connect the unit to AC line power at this point to operate the unit and recharge the battery (the battery fully recharges in about 5 hours). NOTE: Under extreme conditions, the unit may not have enough battery power to power up. If the unit beeps 3 times or displays the message, ÒBattery Low-Please ChargeÓ when powering up, then plug the unit into AC line power and recharge the battery for 5 hours.

2-4 Eclipse Operating Instructions

Equipment Setup

Using the Battery (Eclipse Plus) CALIBRATION AND CHARGING THE BATTERY NOTE: The battery that is shipped with the Eclipse Plus is not fully charged. To prepare the Eclipse Plus for normal use, follow the procedure below to calibrate the Battery Status gauge and charge the battery. 1. Unplug the Eclipse from AC line power. 2. Press ON/STBY to turn the Eclipse on. Press M to go to the Main menu. Press B, then press Enter to turn on the Battery Exercise Mode. 3. Fully discharge the battery by operating the unplugged unit until the unit powers down from lack of power. 4. Ensure that the battery is discharged by pressing the On/Standby key. If the unit does not turn on or if it powers down within a few seconds, the battery is discharged. 5. Reconnect AC power to fully recharge the battery in about 5 hours. NOTE: You may operate the Eclipse from AC line power while the battery is charging. However, this will increase charging time. WHEN TO CHARGE THE BATTERY +

During operation of the Eclipse Plus, the Battery Status gauge in the PREVIEW screen tracks battery charge status (see Figure 3-2 on pg. 3-4). When all 8 bars are lit, the battery is fully charged. When battery power is being used, the message ÒBATTERYÓ is displayed and the minus sign ( - ) is highlighted indicating that charge is being drained. When the unit is connected to AC line power, the message ÒAC ONÓ is displayed and the plus sign ( + ) is highlighted indicating the battery is charging. When fewer than 15 minutes of operating time remain, the message ÒLOW BATTERYÓ ßashes and the unit beeps every 30 seconds. If the battery charge level drops too low, the unit displays the message, ÒPOWERING DOWN.Ó Then, after 5 seconds, the unit shuts off. Connect the unit to AC line power at this point to operate the unit and recharge the battery (the battery fully recharges in about 5 hours). NOTE: Under extreme conditions, the unit may not have enough battery power to power up. If the unit beeps 3 times or displays the message, ÒBattery Low-Please ChargeÓ when powering up, then plug the unit into AC line power and recharge the battery for 5 hours.

Eclipse Operating Instructions

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