Eclipse Premier Electrocardiograph Operating Instructions Rev A

Copyright © 2004 Quinton Cardiology, Inc. All rights reserved. Quinton Cardiology, Inc. 3303 Monte Villa Parkway Bothell, Washington 98021-8969 (800) 426-0337

(425) 402-2485

Authorized Representative per MDD 93/42/EEC MDSS Burckhardtstrasse 1 D-30163 Hannover, Germany

PHOTOCOPY THIS PAGE AS NEEDED

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

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 Patient Cable... 2-2 Grounding... 2-2 Loading Recording Paper... 2-3 Turning the Unit On... 2-4 Using the Battery... 2-4

Chapter 3

Keyboard and Displays... 3-1 The Keyboard... 3-1 The PREVIEW Screen... 3-4 A sample menu-the EDIT ID menu... 3-6 Using Menus... 3-7 Lists and System Notes... 3-8

Chapter 4

System Setup and User Setup... 4-1 Configuring SYSTEM SETUP Menu... 4-1 Configuring the USER SETUP Menus... 4-5 Acquire Printout of Eclipse Premier 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

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

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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 Equipment Connections...8-1 How record status affects the sending operations...8-3 Changing Record Status...8-3 Setting Up the Unit to Send and Receive...8-4 Receiving requisitions from PYRAMIS...8-6 Sending records to PYRAMIS...8-7 Sending and Receiving records from an Eclipse...8-8 Receiving records from PYRAMIS...8-8

Chapter 9

Sample Printouts...9-1 Print Directory Report...9-1 Print Setup Report...9-2 Standard 12-Lead, 4-Channel Auto ECG...9-3 Standard 12-Lead, 6-Channel Auto ECG...9-4 Standard 3-Channel Rhythm & Manual ECG...9-5 Measurement Matrix...9-6 Median Complex...9-7

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...11-1 Inspecting for Damage...11-1 Cleaning and Disinfecting...11-1 Testing Equipment...11-2 Notice to responsible service personnel...11-3 Performance Disclosures...11-3 EMC Declaration Tables...11-6 Technical Specifications...11-10

Chapter 12

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

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Intended Use WARNING: The Eclipse Premier should not be connected to non-medical 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 Premier 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 floating power supply. WARNING: The Eclipse Premier and any non-medical equipment that it is connected to should not be allowed within the patient’s 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 floor. WARNING: NEVER create a direct connection between an Eclipse Premier and a PYRAMIS computer if the Eclipse Premier is already connected to a patient. Under the supervision of a qualified physician trained in the subject of ECG interpretation, the Eclipse Premier 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 first 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). This equipment is not designed to produce a definitive interpretation nor an exhaustive evaluation of the patient’s heart but rather provide an effective beginning for evaluation of patients with heart abnormalities.

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Warnings, Cautions & Notices

Warnings WARNING: The Eclipse Premier 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 Premier 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 floating power supply. WARNING: The Eclipse Premier and any non-medical equipment that it is connected to should not be allowed within the patient’s 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 floor. WARNING: NEVER create a direct connection between an Eclipse Premier and a PYRAMIS computer if the Eclipse Premier 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 flammable anesthetics. WARNING: Electrical shock hazard. Do NOT contact unit or patient during defibrillation. Otherwise, serious injury or death could result. WARNING: NEVER position defibrillator paddles very close to or over ECG sensors. Remove all chest sensors (V-Leads/C-Leads) from a patient before defibrillation to allow proper paddle placement. Severe burns may result from improper placement of defibrillator paddles. Before using any defibrillator, 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 qualified technician. WARNING: Position the Eclipse Premier away from other equipment. If it is necessary to use the Eclipse Premier adjacent to or stacked with other equipment, then observe the Eclipse Premier to verify normal operations. WARNING: Use of accessories or cables other than those specified, with the exception of accessories and cables sold by Quinton Cardiology, inc. as replacement parts for internal components, may result in increased emissions or decreased immunity of the Eclipse Premier.

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 specified on the rating plate. CAUTION: Although the Eclipse Premier is designed to meet IEC 601-1-2 EMC immunity requirements, the presence of strong EMI fields 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.

CAUTION: The Eclipse Premier requires special precautions regarding EMC. Install and use the Eclipse Premier according to the guidelines of the EMC declaration tables. CAUTION: Portable and RF communications equipment may affect the Eclipse Premier. Always observe the recommended separation distances as defined in the EMC declaration tables.

Notices NOTICE: Do not place used battery pack in your regular trash. The incineration, landfilling, 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 officials for more information. Eclipse Operating Instructions

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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 qualified physician before treatment, or non-treatment, of any patient. NOTICE: Because the Eclipse Premier offers different lead configurations, always ensure that the appropriate lead placement is employed for the lead configuration selected. NOTICE: Waveforms displayed on the Eclipse Premier 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 Premier electrocardiograph is intended for use with approved ECG supplies; its reliability and performance are directly affected by the supplies you use.

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Definitions of Symbols Used Safety Symbols Attention. Consult accompanying documents. Danger! High voltage. Hazardous voltage. Defibrillation-Protected Type CF Equipment. Equipotentiality (used to label the grounding lug). Meets or exceeds Council Directive 93/42/EEC, MDD, Class IIa.

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 Eclipse Operating Instructions

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Serial port

I0I0 Battery Compartment +

Battery Charge Status Modem

RJ11

Modem

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Chapter

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General Information Congratulations on your purchase of a top quality Eclipse Premier electrocardiograph. By listening to our customers, we have designed the Eclipse Premier to suit your specific 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 Eclipse Technical Support at (800) 426-0337 or (425)402-2485. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Inspection Upon Delivery Your new Eclipse Premier 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 Eclipse Technical Support at (800) 426-0337 or (425)402-2485. NOTE: Your Eclipse Premier electrocardiograph is intended for use with approved ECG supplies; its reliability and performance are directly affected by the supplies you use.

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Chapter 1 General Information

General Description Figure 1-1 Eclipse Premier

● ● ● ● ● ● ● ● ● ● ●

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Portable; may be operated from battery or AC line power. Features an active-matrix color 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 800 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 fields that you may use to suit your needs.

Interpretive Analysis Program

Interpretive Analysis Program About the program The Eclipse Premier includes an interpretive analysis program. This analysis program is widely regarded as one of the most accurate available today. It was developed in the 1980s by Prof. Peter MacFarlane, of the University of Glasgow, who has been involved in computerized ECG interpretation since its inception in the 1960s. The algorithm has been continuously enhanced to improve results. The ECG Interpretation Criteria Physician’s Guide outlines the criteria used by the analysis program.

Features of the interpretive analysis program ●

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

●

USES AGE, GENDER AND RACE DATA EXTENSIVELY More than 500 measurements, plus the patient’s age, gender, race, clinical classification and medications are factored into each analysis. Several criteria for abnormalities are age, race and gender dependent. Race, for example is key in identifying hypertrophy and T-wave abnormalities.

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

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PRODUCES CLEAR REASON STATEMENTS Reasons appending abnormalities are given in conversational language. For example, wording like, “High voltages in limb leads,” is used rather than, “R amp > age, sex dependent limit in limb leads.”

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

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

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PROVIDES USER-SELECTABLE QTc FORMULAS Provides four clinically proven methods of calculating QTc, for use in diagnosis and pharmaceutical studies: Hodges, Bazett, Fridericia, and Framingham. Eclipse Operating Instructions

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Chapter 1 General Information

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PROVIDES INTERPRETATIONS IN TWO FORMATS Select BRIEF format for short, concise analysis statements with minimal explanations, presented in mixed case nomenclature (for example, “Normal ECG”). Select FULL format for lengthier analysis statements-presented in upper case nomenclature (for example, “NORMAL ECG”)- and reason statements, which precede the analysis statements.

Safety Features WARNING: Electrical shock hazard. Do NOT contact unit or patient during defibrillation. Otherwise, serious injury or death could result. WARNING: NEVER position defibrillator paddles very close to or over ECG sensors. Remove all chest sensors (V-Leads/ C-Leads) from a patient before defibrillation to allow proper paddle placement. Severe burns may result from improper placement of defibrillator paddles. Before using any defibrillator, 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 classified as defibrillation-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 defibrillation.

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 qualified technician before using multiple electrical apparatus in this patient environment. The Eclipse Premier patient leads are electrically isolated from ground and the device meets the most stringent IEC and ANSI/AAMI medical standards for leakage currents.

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Using Multiple Electrical Apparatus

However, a potential hazard may occur if the enclosure leakage currents from multiple pieces of equipment combine and are inadvertently routed directly to a patient’s heart via a catheter or pacemaker lead. Only equipment which is certified to IEC and ANSI/AAMI medical standards should be used in this environment. Use of certified 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, “Equipment Setup.”

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Chapter 1 General Information

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Chapter

2

Equipment Setup WARNING: Trip hazard. Route all cables away from main work areas to minimize risk of tripping and injury. NOTE: For patient safety, all equipment in patient environment should be EN 60601-1 approved.

Figure 2-1 Back Panel

C

B

A

Key A

AC power connector

Connect the supplied power cord here. There is no switch to disconnect AC line power. To do this you must unplug the unit from the AC outlet. The battery is automatically charged whenever the unit is connected to AC line power.

B

Power indicator

When the green light is on the unit is receiving AC line power.

C

Equipotential grounding

Connect equipotential ground cable here. NOTE: Equipotential grounding is only required if peripheral equipment is attached to the Eclipse.

CAUTION: The unit must be operated only at the line voltage and frequency specified on the rating plate. NOTE: The diagram above shows standard connections. Additional connections may be available if your unit includes communication options. Refer to “Setting Up the Unit to Send and Receive” on pg. 8-4 for information and instructions on configuring the unit for communication options.

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Chapter 2 Equipment Setup

WARNING: Position the Eclipse Premier away from other equipment. If it is necessary to use the Eclipse Premier adjacent to or stacked with other equipment, then observe the Eclipse Premier to verify normal operations. 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 qualified technician to verify equipment compatibility.

Patient Cable Connect the patient cable via the connector on the front of the unit. Figure 2-2 Patient Cable Connector

Patient Cable

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

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. NOTICE: For proper grounding, Quinton Cardiology, Inc. recommends the use of medical grade AC outlets. Maximum patient and operator safety is ensured only when the Eclipse Premier is properly grounded. To do this, connect the power cable to the AC Power connector (see Figure 2-1 on pg. 2-1) and connect the other end to a properly grounded, AC line outlet. 2-2 Eclipse Operating Instructions

Loading Recording Paper

Loading Recording Paper NOTE: Damage caused by using unapproved recording paper may void your warranty. 1. Turn the Eclipse Premier on. 2. Open the paper compartment door by lifting and sliding it out to the left. 3. Remove any remaining paper from the paperwell. 4. Lift the top sheet of the new stack of paper and pull it to the right. 5. Place the paper into the compartment. 6. Slide the compartment cover back into place until you notice a definite click as it snaps into the feed rollers. 7. Press the “P” key to advance the paper to the next sheet. 8. Tear off paper by pulling up and to the right. Do not pull additional paper out of the printer. 9. Select the paper type in the System Setup menu (see “Paper Type” on pg. 4-4).

Use only approved, thermally responsive ECG paper. The following ECG papers are recommended: 1. Assurance ®, permanent trace, Z-fold. Thermal image integrity guaranteed for 25 years when stored in accordance with manufacturer’s specifications. 2. Standard trace, Z-fold. Thermal image integrity guaranteed for 5 years when stored in accordance with manufacturer’s specifications. The printer is pre-adjusted at the factory. Do not try to make adjustments.

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