Electrocardiographs, Multichannel Interpretive: Scope of This Product Comparison

May 2003
Electrocardiographs, Multichannel; Interpretive

Scope of this Product Comparison
This Product Comparison covers multichannel and interpretive electrocardiographs that record the electrocardiogram (ECG) from two or more leads simultaneously and electrocardiographs that perform on-site data analysis and transmit ECG signals through a telephone modem. Both battery- and line-powered units are included. Units that automatically interpret the ECG signal, record the ECG waveform, and print out a complete analysis as a selectable or optional feature are also included. Units that only transmit and receive ECG signals and interpret results through a modem are excluded. For additional information on ECG recording and monitoring, see the following Product Comparisons: Defibrillators, External, Manual; Defibrillator/ Pacemakers, External Electrocardiographs, Single-Channel Physiologic Monitoring Systems, Acute Care; Neonatal; ECG Monitors Physiologic Monitoring Systems, Stress Exercise, Cardiac; Pulmonary Physiologic Monitoring Systems, Telemetric; ECG Monitors, Telemetric Recorders, Electrocardiography; Scanners, ECG These devices are also called: computer-assisted electrocardiographs, interpretive ECG machines.
UMDNS information
This Product Comparison covers the following device terms and product codes as listed in ECRIs Universal Medical Device Nomenclature System (UMDNS): Electrocardiographs, Multichannel, Interpretive [16-231] Electrocardiographs, Multichannel, Interpretive, Signal-Averaging [18-330] Electrocardiographs, Multichannel, Noninterpretive [18-329] Electrocardiographs, Multichannel, Noninterpretive, Signal-Averaging [17-687] measurements on a screen and warn of potentially life-threatening or precursor rhythms. In addition, ECG monitors usually display only one or two leads of the ECG and provide less signal fidelity than an electrocardiograph. Like single-channel electrocardiographs, multichannel units are used to diagnose cardiac abnormalities,
Purpose
Electrocardiographs detect the electrical signals associated with cardiac activity and produce an ECG, a graphic record of the voltage versus time. They are used to diagnose and assist in treating some types of heart disease and arrhythmias. Electrocardiographs differ from ECG monitors, which provide a continuous display of the ECG waveform and other physiologic
231943 424-008
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 G Fax +1 (610) 834-1275
E-mail hpcs@ecri.org
Healthcare Product Comparison System

electrodes are measured; these differences directly correspond to the hearts electrical activity. The standard 12 ECG leads are derived from various signals obtained through 9 electrodes placed on the skin surface 1 on each of 3 limbs and 6 on the chest. An additional electrode, which is typically placed on the right leg, is used as a reference to reduce external electrical interference. The standard 12-lead system includes three different types of leads: bipolar, augmented or unipolar, and precordial. Bipolar leads measure the ECG signal between two specific electrodes. The three standard bipolar limb leads are lead I (representing the difference between electrical potentials measured at the rightarm electrode and the left-arm electrode), lead II (between the right-arm electrode and the left-leg electrode), and lead III (between the left-arm electrode and the left-leg electrode). Each of these three leads forms one side of a configuration known as Einthovens triangle. The augmented or unipolar lead waveforms are obtained by measuring the voltage between one limb electrode and the average of the other two. Augmented leads require three electrodes and are designated according to limb right arm (aVR), left arm (aVL), and left leg (aVF). Precordial leads measure the voltage between one chest electrode (designated V1 through V6) and the average of all the limb electrode voltages (see Fig. 1). Each of the 12 standard leads presents a different perspective of the hearts electrical activity, producing ECG waveforms in which the P waves, QRS complex, and T waves vary in amplitude and polarity (see Fig. 2 on page 4). Many cardiac problems can be characterized by particular variations in the size, shape, duration, and polarity of these waves; a change in the length or amplitude of a segment between waves (e.g., ST segment); the appearance of additional waves; and/or variations in rhythm. The recordings can also provide the cardiologist with information regarding the size, shape, and orientation of the heart within the chest. Other lead configurations include those of the Frank system and Cabrera leads. The Frank configuration measures voltages from electrodes applied to seven locations the forehead or neck, the center spine, the midsternum, the left and right midaxillary lines, a position halfway between the midsternum and left midaxillary electrodes, and the left leg. This configuration can be used to produce the vectorcardiogram, a three-dimensional representation of the ECG. The Cabrera configuration uses the same limb electrode locations as the standard system but derives only the six frontal-plane leads and displays them in a different
determine a patients response to drug therapy, and reveal trends or changes in heart function. Multichannel electrocardiographs record signals from two or more leads simultaneously and are frequently used in place of single-channel units. Multichannel electrocardiographs offer several advantages over single-channel electrocardiographs. They simplify and facilitate interpretation of the record by enabling the comparison of multiple-lead recordings during the same heartbeat; as a result, diagnostic accuracy is often improved. For example, an abnormal beat identified in two or more leads simultaneously can be ruled out as an artifact without the need to switch leads. By recording an entire 12-lead ECG in about 10 seconds (in the automatic mode), multichannel units save time and require less work than singlechannel recordings, which usually must be cut and mounted before examination by the cardiologist. Some electrocardiographs can perform automatic measurement and interpretation of the ECG as a selectable or optional feature; other units can be modified to include these programs. Interpretive electrocardiographs detect the electrical signals associated with cardiac activity, compare these signals with an internal algorithm, and print out the patients ECG along with an interpretation. The computerized interpretation is often accompanied by measurements of the waveform components. The measurements and interpretation are based on analyses similar to those done by the cardiologist. Because computerized interpretation can be inaccurate, however, this feature should be viewed as a tool that can aid in interpreting the ECG, not as a replacement for a physicians careful analysis.
Principles of operation
Electrocardiographs record small voltages of about one millivolt (mV) that appear on the skin as a result of cardiac activity. The voltage differences between
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
I RA LA
II
III
LL
V1
V2
V3
V4
V5
V6
C337UN3A
Bipolar and Augmented Leads
Precordial Leads
Figure 1. The three standard groups of lead configurations

order (aVL, I, aVR, II, aVF, and III). Though not as commonly used, an esophageal lead (an electrode inserted down the esophagus) can detect signals from the posterior of the heart an area difficult to monitor using conventional lead placement. Multichannel electrocardiographs Multichannel electrocardiographs operate similarly to single-channel units. In both types, the user selects automatic or manual lead switching, signal sensitivity, frequency-response range, and chart speed. In the manual mode, the user selects the leads to be recorded, and the unit traces the ECG signal from these leads until others are selected. In the automatic mode, the user selects the same recording parameters and the analysis window (the recording time for each lead or group of leads), and the unit automatically completes the tracing as programmed; in some models, the analysis window is not selectable in the automatic mode. In some units, the operator can choose the lead groupings, their sequence, and the recording duration for each group. In standard 12-lead tracing, signals from each group of leads (i.e., bipolar, augmented, precordial) can be recorded for 2.5 seconds. For a rhythm strip, one lead (usually lead II) is recorded for the full 12 seconds. Most modern multichannel units can acquire all 12 leads simultaneously, but they usually print only 3 or 6 leads at a time; the user can choose from a number of different print formats. Some models also feature preview screens that display the signal from selected leads in real time on a limited number of channels, allowing the operator to verify signal quality before recording or printing. Compared to single-channel recorders, multichannel electrocardiographs improve diagnostic ability by providing a more complete view of the heart during the same beats; an atypical waveform present in simultaneous leads may indicate the existence of an abnormal beat as opposed to an artifact. In addition, some multichannel electrocardiographs identify various arrhythmias (e.g., sinus arrhythmias, premature ventricular contractions, bigeminy, atrial fibrillation, atrial flutter) and automatically extend the recording time. The signal sensitivity setting determines the size of the recorded ECG waveform. When an ECG signal becomes too large and produces a waveform that goes over scale (e.g., an arrhythmic beat), most multichannel units immediately switch to a lower sensitivity setting. Other units allow the user two options: record the affected channel or all channels at a lower sensitivity, or record the waveform as is, followed by a rerecording at a lower sensitivity. The user sets the frequency-response range to a diagnostic or filtered mode. All electrocardiographs have a factory-set frequency-response range; for most diagnostic purposes, the American Heart Association (AHA) currently recommends a frequency-response
QRS R-R Interval VAT T Wave P Wave R Amplitude ST P Amplitude T Amplitude
Q Amplitude
S Amplitude
S Wave P-R Interval P Wave, QRS Complex, and T Wave QT Interval Next P Wave, QRS Complex, and T Wave
C337UN3B
Figure 2. A typical ECG signal consists of the P wave, QRS complex, and T wave. The duration and strength (amplitude) of these pulses directly correspond to the condition of the conduction pathways within the heart.
band of 0.05 to 100 Hz. Electrical interference from muscle movement or line-power frequency can produce artifacts on the recording; therefore, most units are equipped with filters to reduce such interference. Some units use notch filters at 60 Hz to filter out linefrequency noise. Many units also have electromyogram (EMG) filters to prevent artifacts from patient movement, which corrupt the ECG recording. Because these filters limit the frequency response, however, they can adversely affect diagnoses that are based on certain details (e.g., amplitude) that may be filtered out. Filters should be used sparingly because they often change the characteristics of the recorded ECG; they usually do not affect the signal used for interpretation. Signal averaging is available on some models. It eliminates ambient noise in the ECG signal to reveal high-frequency, low-amplitude signals (late potentials) that may appear at the end of the QRS complex of patients who have suffered a myocardial infarction (MI), have unexplained syncope, or who have a ventricular arrhythmia. The presence of late potentials is believed to be associated with an increased risk of sustained ventricular tachycardia a prime factor in sudden cardiac death and a syndrome that accounts for approximately half the mortality that follows recovery from acute MI. The electrocardiograph uses high-pass filters to remove low-frequency signals, leaving only the QRS complex. Noise in the complex that can mask late potentials is removed by comparing heartbeats to a template a model beat made during the initial recording that most closely represents an artifact-free normal beat; beats are accepted only if they closely match the template. Approximately 200 to 300 beats are digitized and averaged; electrical activity that does not correspond to the averaged signal, such as noise from equipment or other sources, is canceled out. While ECG tracings from single-channel units typically require cutting and mounting so that the interpreter can quickly examine a single beat in more than one lead, multichannel electrocardiographs usually require little report preparation time. With most multichannel units, no cutting or mounting is necessary because the operator can choose the desired report format (e.g., the number and duration of the leads recorded simultaneously, regardless of whether a rhythm lead is printed) before recording. Most units obtain all 12 leads simultaneously and then allow the operator to print copies of the ECG in any number of formats on 81/2 11-inch paper, which can be placed directly into a patients chart. Some multichannel units have alphanumeric touchpanel keyboards for entering patient data to be printed at the top of the ECG recording. Other data that can appear on the recording includes the time, lead identifiers, heart rate, and recording parameters (e.g., sensitivity setting, chart speed, filtered mode). Some units display the heart rate and alarm during episodes of tachycardia. Other alarms indicate artifacts, loose electrodes, empty paper, and improper paper loading. In addition, some units have special circuits to detect pacemaker spikes. Stress-testing protocols, trending,

and rhythm monitoring can be programmed in some units with integral timers and selectable chart speeds. Other special features that are available in multichannel units include automatic recording and storing of rhythm strips for later retrieval, the ability to extend the recording time for several seconds if an abnormal rhythm is detected, and the ability to edit ECG reports stored in memory. Because the ECG waveform varies in polarity and amplitude with each lead location, most units automatically position the pen on the baseline before recording a new lead. Some units automatically print a calibration signal at the start of each lead or channel on the recorded strip. This helps the reader quickly identify the sensitivity and verify that it is the same between the leads; it also provides a quick point of reference against which the recorded waveform can be judged. Calibration can also usually be tested manually during recording to help determine if an abnormal tracing reflects the patients condition, reveals an artifact, or is a result of improper calibration. Some units are equipped with an analog output jack, allowing the ECG to be displayed on a separate monitor. Similarly, some units provide capabilities to control a treadmill, store exercise protocols, and print stress-test reports; others simply print the 12-lead ECG at fixed time intervals. Units also vary in their ability to electronically store ECG waveforms. Some electrocardiographs store the waveform for later retrieval, printing, and analysis. In addition, most of these systems can be interfaced (e.g., by RS232 or modem) to data management systems either within the hospital or at a remote location. ECG data management systems are computerbased systems that provide long-term storage of ECG waveforms. Some systems offer a variety of other capabilities such as pacemaker management, billing, vectorcardiography, and research and education programs. Some systems can also store information from other devices, such as stress-testing and Holter systems. ECG data management systems are proprietary and thus compatible only with electrocardiographs from the same manufacturer. Interpretive electrocardiographs The interpretive electrocardiographs computer uses predefined pattern-recognition techniques to identify normal and aberrant features of the ECG waveform. Each program identifies the complete waveform, locates each waveform component, and determines key measurements. Depending on the program, the average, most dominant, or median waveform from each lead configuration is selected for analysis. Incomplete waveforms, which are caused by switching to or from a lead group in the middle of a beat, are eliminated, and the remaining complete waveforms are processed according to the program. Waveform averaging can include all complete P, QRS complex, and T waveforms from each lead group or a certain number of successive waveforms. Irregularities in the morphology (shape) of any portion of the ECG waveform or in the rhythm (timing) of these waveforms indicate myocardial or conduction abnormalities, and both characteristics must be considered in the diagnosis of the hearts condition. Several interpretive units use diagnostic programs based on the Minnesota code, which classifies ECG waveforms by determining upper normal limits for selected ECG features. Other units have interpretive programs based on other sources of computerized ECG analysis. The unit prints the interpretation of a specific cardiac abnormality, a measurements list, and a plus or minus code, which reveals the severity of the patients condition (called a severity code or judgment). Statements explaining the diagnosis may also be printed. The measurements listing consists of numeric values calculated from the ECG waveform. The types of measurements calculated vary among units; the most common types include heart rate, waveform amplitude, waveform widths, intervals between the waveform components, and direction of the electrical activity (axis). Automatically generating this listing can eliminate the need to take these measurements manually with calipers. The trained ECG interpreter needs only to verify the computers interpretation with the ECG recording. Patient identification data can be entered and printed with the ECG report. Other information that may be printed includes sensitivity settings, filter mode, chart speed, program type, hospital name, room number, attending physician, patient diagnosis, attending technician, and patient name, age, sex, race, weight, height, blood pressure, and medication. Because the ECG is a complex and, under certain conditions, varying waveform, and because interpretation of the various waveform components often requires an experts inductive reasoning, interpretive electrocardiograph units can provide a suggested interpretation only. The physician must continue to formulate the final diagnosis based on the ECG tracing and a full history of the patient. For more information on electrocardiographs, see the Product Comparison titled ELECTROCARDIOGRAPHS, SINGLE-CHANNEL.

Reported problems
Because electrocardiographs have electrical safety standards that are well established and adhered to by all major manufacturers, few problems are associated with their use. Of these, the most common is artifact or noise. Causes of electrical noise include broken electrode wires, poor electrode cleaning or improper application (e.g., poor skin preparation), patient movement, nearby power lines or defective electrical equipment, baseline drift, and interference from pacemakers. Most electrocardiographs have features to reduce such interference, including optional filters that block the frequencies produced by patient movement and nearby power lines, circuitry that identifies pacemaker interference, visual indicators that signal poor electrode contact, and automatic baseline centering and pen correction to help control baseline drift. Incorrect placement of ECG leads can cause an abnormality to be overlooked. For example, left ventricular hypertrophy can be missed by the electrocardiograph if precordial leads are placed too high or too low in relation to the actual position of the right or left ventricle. Variations in electrode placement have greater significance in serial ECG analysis, during which ECGs of a single patient are recorded over time for later comparison. Differences in electrode positioning can result in varying interpretations that may not be due to changes in heart condition. Chest wall thickness can also affect diagnostic accuracy; precordial leads on a thin chest wall, even if properly positioned, may result in the appearance of an enhanced R wave on the ECG and an erroneous diagnosis of ventricular hypertrophy. Poor electrode preparation and attachment are commonly reported. Electrodes should not be removed from their packaging until ready for use, and each electrode should be checked for moistness before use. Electrodes should be attached to lead wires before they are applied to the patient. Additionally, adverse reactions to the adhesive used to attach electrodes have been reported. Adverse reactions include sensory irritation, urticaria (hives), irritant contact dermatitis, and allergic contact dermatitis. Because ECG waveforms vary from patient to patient and can be affected by medication and artifacts, the interpretation produced is only a suggestion based on the limited criteria of the diagnostic program. The physician is expected to make the final diagnosis by weighing all significant factors. ECRI has published an inspection procedure for electrocardiographs in its Health Devices Inspection and Preventive Maintenance System. This checklist provides information on how to perform tests and routine inspections and lists precautions that help identify factors that are most likely to degrade electrocardiograph function.
Purchase considerations
Electrocardiographs vary greatly in their degree of sophistication, and their capabilities should be consistent with the specific needs of the healthcare facility. Single-channel electrocardiographs, which record ECGs from one lead configuration at a time, are less expensive and generally smaller and lighter than their multichannel counterparts. However, single-channel systems generally require more technician time for recording, editing, and mounting the ECG for interpretation and filing. Multichannel electrocardiographs require less recording time, and many also eliminate the need for cutting and pasting because the ECG signals can frequently be printed in the desired format on 81/2 11-inch paper and placed directly in the patients chart. Many electrocardiographs perform some type of analysis on the ECG signal, such as waveform measurement or ventricular beat analysis, but not all units have complete interpretive software programs. The prospective buyer should be aware that only ECG units that specifically claim to have interpretive capability can generate diagnoses, reason statements, and recommendations for consultation or further testing (although, in some cases, the diagnostic software is available only as an option). Other factors to be considered when purchasing an electrocardiograph include ease of use, portability, type of paper required, clarity of recording, and cost of disposables such as electrodes and adhesives. Facilities should also keep in mind that some units can be interfaced to data management systems or to telephone modems for data transmission. To permit communication between the unit and other monitors or computers, models must have an RS232 port or other suitable digital interface. Optional carts make the units more transportable, provide a working surface for the user, and can hold spare lead wires, electrodes, and recording paper. Additional electrocardiograph features, such as automatic versus automatic/manual lead switching, availability (if desired) of stress-testing programs, and report format flexibility, should also be factored into the decision. Some bedside physiologic monitors have 12-lead ECG capability and can acquire diagnostic-quality ECG signals (with a frequency response of 0.05 to 100 Hz).

Twelve-lead ECGs from a bedside monitor can be transferred over a network to an ECG data management system for later analysis and report generation. vectorcardiography report of the Committee on Electrocardiography, American Heart Association. Circulation 1975 Aug;52(2):11-31. Pipberger HV, Cornfield J. What ECG computer program to choose for clinical application: the need for consumer protection. Circulation 1973 May;47:91820. Roth A, Bloch Y, Villa Y, et al. The CB-12L: a new device for transtelephonic transmission of a 12-lead electrocardiogram. PACE 1997 Sep;20(9 Pt 1):2243-7. Schijvenaars BJ, Kors JA, van Herpen G, et al. Effect of electrode positioning on ECG interpretation by computer. J Electrocardiol 1997 Jul;30(3):247-56. Timmis GG. Cardiovascular review. Orlando (FL): Academic Press; 1984. Uter W, Schwanitz HJ. Contact dermatitis from propylene glycol in ECG electrode gel. Contact Dermatitis 1996 Mar;34(3):230-1. Yakubo S, Ozawa Y, Tanigawa N, et al. Detection of late potentials: comparison of two commercial highresolution ECG systems. J Electrocardiol 1992;25(Suppl):151-5.
Stage of development
To aid in the consistent recording of ECGs, AHA has published guidelines on electrocardiograph instrumentation, and the International Electrotechnical Commission and the Association for the Advancement of Medical Instrumentation have defined standards for electrocardiograph performance (see Standards and Guidelines). Advances in electrocardiograph technology have centered on automating and simplifying data collection, reducing the time needed to obtain clinically acceptable ECG measurements, and using microprocessors to interpret the ECG signal or transmit it to a remote computer. Several multichannel electrocardiographs with single-channel recording capabilities can measure and analyze the ECG waveform components and, from this information, diagnose cardiac conditions. Analytic programs for these microprocessor-controlled units can be a standard part of the basic instrument package or supplied as an option. ECG technology development is directed toward including data from other clinical monitoring devices in the analysis and interpretation of ECG signals to provide a more comprehensive diagnosis of the patients medical condition. ECG machines that provide faster, more accurate, and more comprehensive diagnoses will assume a major role in guiding cardiac therapy in the future.
Standards and guidelines

Note: Although every effort is made to ensure that the following list is comprehensive, please note that other applicable standards may exist. American College of Cardiology. ACC revised recommendations for training in adult cardiovascular medicine core cardiology training II (COCATS 2) (revision of the 1995 COCATS training statement) [guideline]. 1995 (revised 2002). Signal-averaged electrocardiography [consensus statement]. J Am Coll Cardiol 1996 Jan 27(1):238-49. American College of Cardiology/American Heart Association. Guidelines for electrocardiography. Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Electrocardiography). J Am Coll Cardiol 1992 Mar; 19(3):473-81. American Heart Association. Recommendations for safe current limits for electrocardiographs [statement]. Committee on Electrocardiography. Circulation 1996 Feb;93(4):837-9. American National Standards Institute/Association for the Advancement of Medical Instrumentation. Diagnostic electrocardiographic devices [standard]. 2nd ed. ANSI/AAMI EC11R-1991. 1991 (reaffirmed 2001).
Bibliography
Aronson MH, Saluja HC, eds. ECG recorders. Med Electron 1990 Apr;21(2):122-30. Bailey JJ, Berson AS, Garson A Jr, et al. Recommendations for standardization and specifications in automated electrocardiography: bandwidth and digital signal processing. A report for health professionals by an ad hoc writing group of the Committee on Electrocardiography and Cardiac Electrophysiology of the Council on Clinical Cardiology, American Heart Association [special report]. Circulation 1990 Feb;81(2):730-9. Hsu K, Womble E, Tolan GD, et al. Simultaneous noise filtering and data compression of ECGs. Biomed Sci Instrum 1981;17:47-52. Pipberger HV, Arzbaecher RC, Berson AS, et al. Recommendations for standardization of leads and specifications for instruments in electrocardiography and

Disposable ECG electrodes [standard]. 3rd ed. ANSI/AAMI EC12-1991. 1991 (revised 2000). ECG cables and leadwires [standard]. ANSI/AAMI EC53-RC01. 1995 (reaffirmed 2001). International Electrotechnical Commission. Medical electrical equipment part 1: general requirements for safety [standard]. IEC 60601-1 (1988-12). 1988. Medical electrical equipment part 1: general requirements for safety. Amendment 1 [standard]. IEC 60601-1-am1 (1991-11). 1991. Medical electrical equipment part 1: general requirements for safety. Amendment 2 [standard]. IEC 60601-1-am2 (1995-03). 1995. Medical electrical equipment part 1: general requirements for safety. Section 1. Collateral standard: safety requirements for medical electrical systems. IEC 60601-1-1 (1992-06). 1992. Medical electrical equipment part 1: general requirements for safety. Section 1. Collateral standard: safety requirements for medical electrical systems. Amendment 1. IEC 60601-1-1-am1 (199511). 1995. Medical electrical equipment part 1: general requirements for safety. Section 2. Collateral standard: electromagnetic compatibility requirements and tests. IEC 60601-1-2 (2001-09). 2001. Medical electrical equipment part 2: particular requirements for the safety of electrocardiographs [standard]. IEC 60601-2-25 (1993-03). 1993. Medical electrical equipment part 2: particular requirements for the safety of electrocardiographs. Amendment 1 [standard]. IEC 60601-2-25-am1 (1999-05). 1999.
Supplier information
Burdick Burdick Inc A Quinton Co [105481] 500 Burdick Pkwy Deerfield WI 53531 Phone: (608) 764-7179, (800) 777-1777, Fax: (608) 764-7188 E-mail: info@burdick.com Internet: http://www.burdick.com Cardio Control Cardio Control GmbH [306308] Obere Dammstrasse 8-10 D-42653 Solingen Germany Phone: 49 (212) 5875290 Fax: 49 (212) 5875299 E-mail: info@cardiocontrol.com Internet: http://www.cardiocontrol.com Cardio Control Inc [392254] 1870 The Exchange Suite 250 Atlanta GA 30339 Phone: (770) 818-0074, (800) 277-8544 Fax: (770) 818-0075 E-mail: info@cardiocontrol-us.com Internet: http://www.cardiocontrol-us.com Cardio Control NV [151053] Mercuriusweg 1 NL-2624 BC Delft The Netherlands Phone: 31 (15) 7505000 Fax: 31 (15) 7505050 E-mail: info@cardiocontrol.com Internet: http://www.cardiocontrol.com Cardio Control Sarl [366532] Parc Eurasante 256 avenue Eugene Avinee F-59120 Loos France Phone: 33 (3) 28559079 Fax: 33 (3) 28559077 E-mail: info@cardiocontrol.com Internet: http://www.cardiocontrol.com Cardioline/Remco Cardioline Inc [163053] 3200 Dutton Ave Unit 312 Santa Rosa CA 95407 Phone: (707) 547-1740, (800) 942-0442 Fax: (707) 547-1742 E-mail: info@cardiolineusa.com Internet: http://www.cardioline.us
Citations from other ECRI publications

Health Devices
12-lead multichannel interpretive electrocardiographs [evaluation]. 1991 Oct;20(10):370-408. 12-lead multichannel interpretive electrocardiographs [evaluation update]. 1992 Dec;21(12):431-5. ST-segment distortion in manual report mode of electrocardiographs [User Experience Network]. 1995 Aug-Sep;24(8-9):362-3.
Health Devices Inspection and Preventive Maintenance System

Electrocardiographs. Procedure no. 410.

Remco Italia SpA-Cardioline [140226] strada Rivoltana Nuova 53 I-20060 Vignate MI Italy Phone: 39 (02) 9505181 Fax: 39 (02) 9566013 E-mail: a.dellasanta@cardioline.it Internet: http://www.cardioline.it Esaote Esaote China Ltd An Esaote Group Co [371773] Arion Community Centre Room 506 2-12 Queens Road West Hong Kong Hong Kong SAR Peoples Republic of China Phone: 852 225458386 Fax: 852 225433068 E-mail: esaote@esaotechina.com Internet: http://www.esaote.com Esaote Latinamerica SA An Esaote Group Co [393183] San Martin 551 Piso 8 Oficina 52 1004 Capital Federal Pcia de Buenos Aires Argentina Phone: 54 (11) 43281245 Fax: 54 (11) 43262407 E-mail: esaotela@infovia.com.ar Internet: http://www.esaote.com Esaote Sarl An Esaote Group Co [344891] 109 avenue Gabriel Peri F-94170 Le Perreux Sur Marne France Phone: 33 (1) 48712525 Fax: 33 (1) 48713630 E-mail: esaote.france@wanadoo.fr Internet: http://www.esaote.com Esaote SpA (Firenze) An Esaote Group Co [186838] via di Caciolle 15 I-50127 Firenze FL Italy Phone: 39 (055) 42291 Fax: 39 (055) 4229208 E-mail: international.sales@esaote.com Internet: http://www.esaote.com Fukuda Denshi Elmed Elmed Inc [101348] 60 W Fay Ave Addison IL 60101-5106 Phone: (630) 543-2792 Fax: (630) 543-2102 E-mail: medical@elmed.com Internet: http://www.elmed.com Fukuda Denshi Co Ltd [138380] 3-39-4 Hongo Bunkyo-ku Tokyo 113 Japan Phone: 81 (3) 56841251 Fax: 81 (3) 38141222 E-mail: info@fukuda.co.jp Internet: http://www.fukuda.co.jp
CompuMed CompuMed Inc [101172] 5777 W Century Blvd Suite 1285 PO Box 45003 Los Angeles CA 90045-0003 Phone: (310) 258-5000, (800) 421-3395 Fax: (310) 645-5880 E-mail: ecg@compumed.net Internet: http://www.compumed.net
Control-X Medical Control-X Medical Inc [108554] 2289 Westbrooke Dr Bldg C Columbus OH 43228-9644 Phone: (614) 777-9729, (800) 777-9729 Fax: (614) 777-0395 E-mail: lhurd@cxmed.com Internet: http://www.cxmed.com
Custo Med Custo Med GmbH [284600] Leibnizstrasse 7 D-85521 Muenchen/Ottobrunn Germany Phone: 49 (89) 7109800 Fax: 49 (89) 7109810 E-mail: info@customed.de Internet: http://www.customed.de

Fukuda Denshi UK [324748] 13 Westminster Court Hipley Street Old Woking, Surrey GU22 9LG England Phone: 44 (1483) 728065 Fax: 44 (1483) 728066 E-mail: service@fukuda.co.uk Internet: http://www.fukuda.co.uk Fukuda Denshi USA Inc [105044] 17725 NE 65th St Bldg C Redmond WA 98052 Phone: (425) 881-7737, (800) 365-6668 Fax: (425) 869-2018 E-mail: info@fukuda.co.jp Internet: http://www.fukuda.com Futuremed Futuremed America Inc [105786] 15700 Devonshire St Granada Hills CA 91344-7225 Phone: (818) 830-2500, (800) 222-6780 Fax: (818) 891-4755 E-mail: info@futuremedamerica.com Internet: http://www.futuremedamerica.com Galix Biomedical Instrumentation Galix Biomedical Instrumentation Inc [176265] 2555 Collins Ave Suite C-5 Miami Beach FL 33140 Phone: (305) 534-5905 Fax: (305) 534-8222 E-mail: galix@the-beach.net Internet: http://www.galix-gbi.com GE Medical Systems GE Medical Systems Asia (Japan) [300443] 4-7-127 Asahigaoka Hino-shi Tokyo 191-8503 Japan Phone: 81 (3) 425826820 Fax: 81 (3) 425826830 Internet: http://www.gemedical.co.jp GE Medical Systems Europe [171319] 283 rue de la Miniere boite postale 34 F-78533 Buc Cedex France Phone: 33 (1) 30704040 Fax: 33 (1) 30709855 E-mail: info@gemedicalsystems.com Internet: http://www.gemedicalsystems.com GE Medical Systems Information Technologies Cardiology Div [393585] 8200 W Tower Ave PO Box 414 Milwaukee WI 53223-3219 Phone: (414) 355-5000, (800) 643-6439 Fax: (414) 355-3790 Internet: http://www.gemedicalsystems.com getemed getemed Medizin und Informationtechnik AG [382201] Oderstrasse 59 D-14513 Teltow Germany Phone: 49 (3328) 39420 Fax: 49 (3328) 394299 E-mail: info@getemed.de Internet: http://www.getemed.de H & C Medical H & C Medical Devices SpA [232528] via Pisa 250 I-20099 Sesto San Giovanni MI Italy Phone: 39 (02) 22476861 Fax: 39 (02) 22476872 E-mail: info@hcmed.com Internet: http://www.hcmed.com MacQuarie MacQuarie Medical Systems Pty Ltd [305606] 301 Catherine Street PO Box 86 Leichhardt, NSW 2040 Australia Phone: 61 (2) 96927911 Fax: 61 (2) 96927965 E-mail: mms@machealth.com.au Internet: http://www.machealth.com.au Meditech Meditech Kft [277797] Ulloi utca 200 H-1191 Budapest Hungary Phone: 36 (1) 2808232 Fax: 36 (1) 2829388 E-mail: meditech@meditech.hu Internet: http://www.meditech.hu
10

Meditech USA [371342] 2287 Westbrooke Dr Columbus OH 43228 Phone: (614) 921-9488 Fax: (614) 777-0395 E-mail: sales@meditechusa.com Internet: http://www.meditechusa.com Midmark Diagnostics Group Midmark Diagnostics Group Div Midmark Corp [416480] 3300 Fujita St Torrance CA 90505-5016 Phone: (310) 530-5955, (800) 624-8950 Fax: (310) 530-1421 E-mail: info@midmarkdiagnostics.com Internet: http://www.midmarkdiagnostics.com Mortara Mortara Instrument GmbH [281445] Henricistrasse 124 D-45136 Essen Germany Phone: 49 (201) 268311 Fax: 49 (201) 268313 E-mail: mortara@t-online.de Internet: http://www.mortara.com Mortara Instrument Inc [104961] 7865 N 86th St Milwaukee WI 53224-3431 Phone: (414) 354-1600, (800) 231-7437 Fax: (414) 354-4760 E-mail: sales@mortara.com Internet: http://www.mortara.com Mortara Rangoni Europe srl [157063] via Oradour 7 I-40016 San Giorgio di Piano BO Italy Phone: 39 (051) 6650701 Fax: 39 (051) 6651012 E-mail: renna@mortara.com Internet: http://www.mortara.it Nasiff Nasiff Assoc Inc [328673] PO Box 88 Brewerton NY 13029 Phone: (315) 676-2346, (866) 627-4332 Fax: (315) 676-4711 E-mail: nasales@nasiff.com Internet: http://www.nasiff.com Philips Philips Medical Systems Cardiac & Monitoring Systems Div [397917] 3000 Minuteman Rd Mailstop 101 Andover MA 01810 Phone: (978) 687-1501, (800) 934-7372 Fax: (978) 794-7646 Internet: http://www.medical.philips.com Philips Medical Systems Asia [188101] 30/Fl Hopewell Centre 17 Kennedy Road Wanchai Hong Kong SAR Peoples Republic of China Phone: 852 28215888 Fax: 852 25276727 E-mail: medical@philips.com Internet: http://www.medical.philips.com Philips Medical Systems (Europe) Cardiac & Monitoring Systems Div [398047] Herrenberger Strasse 124 D-71034 Boeblingen Germany Phone: 49 (7031) 4641552 Fax: 49 (7031) 4644096 Internet: http://www.medical.philips.com Physio-Control Medtronic Physio-Control (Asia Pacific) [394222] Level 9 Forsyth Barr House Corner Armagh and Colombo Street Christchurch 1 New Zealand Phone: 64 (3) 3794429 Fax: 64 (3) 3792374 Internet: http://www.medtronicphysio-control.com Medtronic Physio-Control Corp [363222] 11811 Willows Rd NE PO Box 97006 Redmond WA 98073-9706 Phone: (425) 867-4000, (800) 442-1142 Fax: (425) 867-4121 Internet: http://www.medtronicphysio-control.com Nihon Kohden Nihon Kohden America Inc [103211] 90 Icon St Foothill Ranch CA 92610 Phone: (949) 580-1555, (800) 325-0283 Fax: (949) 580-1550 E-mail: info@nkusa.com Internet: http://www.nkusa.com
11

Medtronic Physio-Control GmbH [394223] Gutengergring 19 D-35463 Fernwald Germany Phone: 49 (640) 91410 Fax: 49 (640) 914120 E-mail: physioge@medtronic.com Internet: http://www.lifepak.de Medtronic Physio-Control Ltd (UK) [363833] Suite One Sherbourne House Croxley Business Park Watford, Hertfordshire WD18 8WW England Phone: 44 (1923) 212213 Fax: 44 (1923) 241004 Internet: http://www.medtronicphysio-control.com Progetti Progetti srl [272310] via Bruno Buozzi 28 I-10024 Moncaliere TO Italy Phone: 39 (011) 644738 Fax: 39 (011) 645822 E-mail: info@progettimedical.com Internet: http://www.progettimedical.com QRS Diagnostic QRS Diagnostic LLC [358809] 14755 27th Ave N Plymouth MN 55447 Phone: (763) 559-8492, (800) 465-8408 Fax: (763) 559-2961 E-mail: sales@qrsdiagnostic.com Internet: http://www.qrsdiagnostic.com Schiller Schiller AG [162079] Altgasse 68 CH-6341 Baar Switzerland Phone: 41 (41) 7664242 Fax: 41 (41) 7610880 E-mail: sales@schiller.ch Internet: http://www.schiller.ch Schiller America Inc [108674] 11300 NW 41st St Miami FL 33178 Phone: (786) 845-0620, (800) 247-8775 Fax: (786) 845-0602 E-mail: sales@schilleramerica.com Internet: http://www.schiller.ch Schiller Medizintechnik GmbH [160957] Rudolf-Diesel-Strasse 14 D-85521 Ottobrunn-Riemerling Germany Phone: 49 (89) 6299810 Fax: 49 (89) 6095090 E-mail: info@schillermed.de Internet: http://www.schillermed.de Schwarzer Schwarzer GmbH [284721] Barmannstrasse 38 D-81245 Muenchen Germany Phone: 49 (89) 839420 Fax: 49 (89) 83942186 E-mail: info@schwarzer.net Internet: http://www.schwarzer.net ST Electromedicina ST Electromedicina SA [226621] Calle Atenas 23-25 Nave 2 Poligono Industrial Cova Solera E-08191 Rubi (Barcelona) Spain Phone: 34 (93) 5862747 Fax: 34 (93) 5862749 E-mail: stelec@stelec.com Internet: http://www.stelec.com Suzuken Suzuken Co Ltd [158015] 8 Higashi Kataha-cho Higashi-ku Nagoya-shi, Aichi Pref 461-8701 Japan Phone: 81 (52) 9610854 Fax: 81 (52) 962-7440 E-mail: mo.takeuchi@suzuken.co.jp Internet: http://www.suzuken.co.jp Tepa Tepa Inc [399036] Gersan Sitesi 656 Sokak No 45 Ergazi TR-06370 Ankara Turkey Phone: 90 (312) 2570477 Fax: 90 (312) 2570478 E-mail: sales@tepa.com.tr Internet: http://www.tepa.com.tr
12

von Berg-Medizingeraete von Berg-Medizingeraete GmbH [417212] Bohnhofstrasse 62 D-08297 Zwoenitz Germany Phone: 49 (37754) 31300 Fax: 49 (37754) 31301 E-mail: info@ekg-direkt.de Internet: http://www.von-berg-medizingeraete.de Timing marker: A mark placed automatically on the ECG to indicate elapsed time (usually one mark each second). Channels acquired/printed simultaneously: In units that store 12 leads simultaneously, the recording format can be selected to simulate three- or six-channel printouts. However, all lead tracings represent the same heartbeat. Units that record rhythm strips simultaneously in a three-lead format are listed in the chart as having four-channel recording capabilities. Interpretation: Some units include or can be purchased with an option that allows computerized interpretation of the ECG. Measurements: Most interpretive programs calculate the intervals between the components of the ECG waveform (e.g., PR, QRS, QRSD, VAT), the amplitudes (e.g., P, Q, R, S, T), the widths of waves and complexes, the electrical axes (direction of electrical activity), and the heart rate. Because the QT interval can vary with patient age and gender, some interpretive programs correct the QT interval automatically (QTC). Arrhythmia ID: Whether the unit identifies arrhythmias. Analyzed waveform: The waveform within the analysis window that is interpreted by the diagnostic program. Analysis window, sec: The interval of time (in seconds) on which measurements and interpretation are based. Auxiliary output: An output jack may be available to transmit the ECG signals to a remote recorder or a digital transmission device. Auxiliary input: A DC input jack may be available to record non-ECG parameters. Defibrillator overload protection: A circuit that prevents damage to the electrocardiograph when sudden, large voltages are applied with a defibrillator. Some units may also have defibrillator protection circuitry in the patient cables. Abbreviations: AAMI Association for the Advancement of Medical Instrumentation AHA American Heart Association ANSI American National Standards Institute AS Australian Standard BP Blood pressure BSI British Standards Institution
13
About the chart specifications

The following terms are used in the chart: Configuration: Most tabletop electrocardiographs are cart mounted. The cart provides storage space for accessories (e.g., electrode gel, leads, tissues, magnet for pacemaker testing) and facilitates transport. Some units are portable and are easily carried from patient to patient, some are mobile but not portable, and others are small, handheld units that record and display the ECG on a liquid crystal display. These handheld units store several patients ECGs and interface with a tabletop or cart-mounted printer. Sensitivity, mm/mV: Sensitivity, or gain, can be manually selected to allow recording of large- or smallvoltage signals. Calibration signal: A manually or automatically activated 1 mV pulse used to verify sensitivity and performance. Frequency range, Hz: The range of frequencies that the device amplifies. For most diagnostic purposes, AHA recommends a frequency response band of 0.05 to 100 Hz. More limited or filtered responses may be switch selectable to minimize noise or artifacts. Some units use line-frequency (notch) and/or electromyogram (hum or muscle) filters. Input impedance, megohms: The impedance of the input stage of the amplifier. Low input impedance combined with poor electrode application can distort the ECG signal. CMRR @ 60 Hz, dB: The common mode rejection ratio (CMRR) is a measure of a devices ability to reject interfering signals common to all leads. Low rejection ratios (<80 dB) may result in a noisy signal or wide baseline. Leads-off indicator: Visual or audible alarm indicating that leads have become disconnected. Lead marker: The identifying code that accompanies the recording of each lead configuration. Units can use a dot-dash code or print alphanumerically.

B/W Black and white CE Communaute Europeen CE mark Conformite Europeene mark CMRR Common mode rejection ratio CRT Cathode ray tube CSA Canadian Standards Association DIN Deutsches Institut fuer Normung DOB Date of birth ECG Electrocardiogram EMG Electromyogram EN European Norm FDA U.S. Food and Drug Administration FTP File transfer protocol GB Gigabyte HL7 Health Level 7 Homologation Commission Nationale dHomologation HR Heart rate IC card Smart card IEC International Electrotechnical Commission ISO International Organization for Standardization IV Intravenous JIS Japanese Industrial Standards LAN Local area network LCD Liquid crystal display LED Light-emitting diode MB Megabyte MDD Medical Devices Directive NEMKO Norges Elektriske Materiellkontroll NIBP Noninvasive blood pressure Ni-Cd Nickel-cadmium Ni-MH Nickel metal hydride OSHA U.S. Occupational Safety and Health Administration PC Personal computer PCMCIA Personal Computer Memory Card International Association QTC QT-Interval Correction SAECG Signal-averaging ECG SCP Service Class Provider SQL Structured Query Language SVGA Super Video Graphics Array TUV Technischer Ueberwachungs Verein UL Underwriters Laboratories USB Universal Serial Bus VDE Verband Deutscher Electrotechniker VGA Video Graphics Array
Note: The data in the charts derive from suppliers specifications and have not been verified through independent testing by ECRI or any other agency. Because test methods vary, different products specifications are not always comparable. Moreover, products and specifications are subject to frequent changes. ECRI is not responsible for the quality or validity of the information presented or for any adverse consequences of acting on such information.
When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier discounts. And although we try to indicate which features and characteristics are standard and which are not, some may be optional, at additional cost. For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates change often.
Need to know more?

For further information about the contents of this Product Comparison, contact the HPCS Hotline at +1 (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or hpcs@ecri.org (e-mail).
14
Product Comparison Chart

MODEL BURDICK Atria 3000 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Adult/ped/neonate Mobile Optional BURDICK Eclipse 850 Worldwide Yes Yes Adult/ped/neonate Mobile Optional BURDICK Eclipse Plus Worldwide Yes Yes Adult/ped/neonate Mobile Yes BURDICK Elite II Worldwide Yes No Not specified Portable, mobile Optional
Automatic/manual 5, 10, 20, 5/10, 10/20 Yes
Automatic/manual 5, 10, 20 Yes
0.05-150 0.5-40
0.05-150 0.5-40
0.05-150 0.5-40
0.05-100 0.4-30
Input impedance, megohms CMRR @ 60 Hz, dB Leads-off indicator RECORDER Recording method
Meets or exceeds ANSI/AAMI Not specified Yes Digital thermal array Yes 8.5 x 11" Automatic Yes No 10, 25, 50
>50 Not specified No Digital thermal array Yes 50 mm roll No No No 25, 50
Integral printer Paper size Lead marker Timing marker Event marker Chart speed, mm/sec
Channels acquired simultaneously Channels printed simultaneously ECG TRANSMISSION Type
12
12
12
12
3, 4, 6, 12 Yes Modem, SCP-ECG, and/or fax
1 Yes SCP-ECG and fax
Colons separate data on similar models of a device.
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
15

MODEL BURDICK Atria 3000 MICROPROCESSOR Programs BURDICK Eclipse 850 BURDICK Eclipse Plus BURDICK Elite II
Pediatric and adult resting ECG
Adult/pediatric resting ECG
Keyboard Storage Normal, no. ECGs
Yes 4
Yes 40
Yes 120
Not specified 30
Expandable, no. ECGs PATIENT DATA
40 Same as 850 plus height and QTC formula
NA Name, ID no., sex, age, date, time, weight, BP, location, medication, race, DOB, comments, physician, clinical classification, technician, facility, 1 useridentified field HR, PR, QRS, QT/QTC, P, R, T axis, QT dispersion
NA Name, ID no., sex, age, date, time, weight, BP, location, medication, race, DOB, comments, physician, clinical classification, technician, facility, 1 useridentified field HR, PR, QRS, QT/QTC, P, R, T axis, QT dispersion
NA ID no., sex, age, race, medication, clinical classification, location
MEASUREMENTS
HR, PR, QRS, QT/QTC, P, R, T axis, QT dispersion, RR, long interpretation statements Yes Yes Optional diagnosis, measurements, and reason statements
HR, PR, QRS, QT/QTC, P, R, T axis
Arrhythmia ID Other printouts INTERPRETATION
Yes Yes Optional diagnosis, measurements, and reason statements; gender specific
Yes Yes Diagnosis, measurements, reason statements
Analyzed waveform
Average
Average
Average
Median complex
Analysis window, sec PREVIEW SCREEN DISPLAY No. of traces VISUAL INDICATORS
13 No LCD None Noise, drift, lead fail, low battery
13 LCD 3-lead LCD 3 Noise, drift, lead fail, low battery
13 Color LCD 12-lead LCD 3, 4, 6, 12 Noise, drift, lead fail, low battery
10 No LCD Not specified Fail
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
16

MODEL BURDICK Atria 3000 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS With communications No BURDICK Eclipse 850 With communications Yes BURDICK Eclipse Plus Yes Yes BURDICK Elite II No No
Yes 115/230 VAC
Yes 115/230 VAC
Yes 115/230 VAC
No 110/240 VAC
H x W x D, cm (in)
38.1 x 33.2 x 14 (15 x 13.1 x 5.5) 5 (11) Yes Ni-MH Not specified/14.4 1.5 Not specified
29.9 x 45.7 x 10.5 (11.8 x 18 x 4.1) 6.45 (14.2) Yes Ni-Cd Not specified/16.8 1.5 Not specified
125.7 x 43.4 x 65 (49.5 x 17.1 x 25.6) 39.5 (87) Yes Ni-Cd Not specified/16.8 1.5 Not specified
27.9 x 33 x 8.3 (11 x 13 x 3.3) 4.1 (9) Yes Ni-Cd Not specified/12.5 Not specified Not specified
WEIGHT, kg (lb) BATTERY OPERATION Battery type No./voltage Operating time, hr Charging time, hr PLANNING & PURCHASE List price Warranty Delivery time, ARO Service contract Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS
Not specified 3 years Not specified Yes 2003
$4,200 * 5 years Not specified Yes 1996
$8,950 * 13 months Not specified Yes 1997
$3,200 3 years Not specified Not specified Not specified
Not specified Not specified Selectable demographics; SCP-ECG compliant; upgradable via PC card; noninterpretive or interpretive.
Not specified Not specified Stress compatible; selectable demographics; SCP-ECG compliant; upgradable; interface to CardioVault EMR or ECG storage media on PC with Pyramis EMR system; long & brief interpretive statements; QTC calculations as selected by physician; reanalysis of ECG after stat ECG to QC data and classification.
Not specified Not specified Selectable demographics; SCP-ECG compliant; upgradable via PC card; standard interpretation that can be turned off; noninterpretive available; optional fax and communications modem; interface to Pyramis EMR system.
Not specified Not specified Selectable demographics; optional internal fax.
Colons separate data on similar models of a device. * $5,275 with interpretation (Eclipse 850); prices current as of October 2001.
17

MODEL CARDIO CONTROL Cardio Perfect MD WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Tabletop Optional CARDIO CONTROL Cardio Perfect Portable Worldwide Yes Yes Not specified Portable Optional CARDIOLINE/REMCO Delta 1 Plus Worldwide Submitted Yes Adult Portable Optional CARDIOLINE/REMCO Delta 3/6 Plus Worldwide Submitted Yes Adult Portable Optional
Automatic 5, 10, 20 Automatic
Automatic/manual 5, 10, 20 Automatic/manual
0.05-106 Notch filter; 40 Hz low pass optional
0.05-106 Notch filter; 40 Hz low pass optional
0.05-100 Digital, EMG-M1@40 Hz, M2@30 Hz, M3@25 Hz >100 >100 Yes Digital thermal head, 8 dots/mm Yes 60 mm (2.5") roll or z-fold paper Yes Yes No 6.25, 12.5, 25, 50
0.05-100 Digital, EMG-M1@40 Hz, M2@30 Hz, M3@25 Hz >100 >100 Yes Digital thermal head, 8 dots/mm Yes 112 mm (4.5"), z-fold paper Yes Yes No 6.25, 12.5, 25, 50
200 120 No Laser, matrix, or ink jet No 8.5 x 11", A4 Automatic Yes Yes 12.5, 25, 50
200 120 No Laser, matrix, or ink jet No 8.5 x 11", A4 Automatic Yes Yes 12.5, 25, 50
15
15
12
12
3, 4, 6, 12 Yes Modem, socket to socket, e-mail
3, 4, 6, 12 Yes Modem, socket to socket, e-mail
3 Optional Modem, serial, LAN
3, 6 Optional Modem, serial, LAN
18

MODEL CARDIO CONTROL Cardio Perfect MD MICROPROCESSOR Programs CARDIO CONTROL Cardio Perfect Portable Adult resting ECG CARDIOLINE/REMCO Delta 1 Plus CARDIOLINE/REMCO Delta 3/6 Plus
Adult resting ECG, optional stress testing Not specified Unlimited
Adult resting ECG
Adult resting ECG
Not specified Unlimited
Yes 1
Yes 1
Unlimited Name, ID, age, sex, address, weight, height, BP, indication, medication, comments
Unlimited Name, ID, age, sex, address, weight, height, BP, indication, medication, comments
100 Name, ID no., DOB, sex, age, height, weight, physician, location
MEASUREMENTS
HR, PR, QRS/QTC duration, PQRST duration and amplitude, ST level
HR, PR, QRS/QTC duration, PQRST duration and amplitude, ST level
PR, QRS, QT/QC, P, R, T axis, HR
P, QRS, QT/QC, P, R, T axis, HR
Yes Yes Diagnosis, measurements, average waveform, supporting statements
Analyzed waveform
Median complex, ECG strip
Median complex
Median complex
10 sec to 5 min Yes Not specified Not specified Real-time display on monitor, battery status, pretrigger recording
10 sec to 5 min Yes Not specified Not specified Real-time display on monitor, battery status, pretrigger recording
10 Optional Delta-Vis Not specified 3 Loose contact, noise, low battery, incorrect data
19

MODEL CARDIO CONTROL Cardio Perfect MD AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS No No CARDIO CONTROL Cardio Perfect Portable No No CARDIOLINE/REMCO Delta 1 Plus Optional Optional CARDIOLINE/REMCO Delta 3/6 Plus Optional Optional
Yes 9 V battery
Yes 9 V battery
Yes 110/220 VAC
Yes 110/220 VAC
H x W x D, cm (in)
28.5 x 18 x 5 (11.2 x 7.1 x 2) 0.95 (2.1) Yes Alkaline 1/9 >10 (600 ECGs) Not specified
17.5 x 10.5 x 3.5 (6.9 x 4.1 x 1.4) 0.4 (0.9) Yes Alkaline 1/9 >10 (600 ECGs) Not specified
31.3 x 23.9 x 11.4 (12.5 x 9.5 x 4.5) 2.8 (6.4) Yes Ni-Cd 1/12 1 8
31.3 x 23.9 x 11.4 (12.5 x 9.5 x 4.5) 2.8 (6.4) Yes Ni-Cd 1/12 1 8
$3,450-7,750 1 year, hardware 2 weeks 7.5% of list price * 1992
$999-2,750 1 year, hardware 2 weeks 7.5% of list price * 1992
$1,500 2 years Immediate Not specified Not specified
Not specified January to December Meets requirements of AHA, ANSI/AAMI, CE, IEC, NEMKO, and TUV.
Not specified January to December Meets requirements of AHA, ANSI/AAMI, CE, IEC, NEMKO, and TUV.
NA/not specified Not specified Auto 3-channel printout in auto 2 mode; LCD displays HR, lead status, speed, gain, filter, battery status, and warning messages; 3-channel rhythm in manual mode; auto standby to save battery; autotest at power on; manual autotest; alter parameters to improve copy quality; doctor/ facility name possible on all ECGs. Meets requirements of IEC 601-1.
NA/not specified Not specified Auto 3-channel printout in auto 2 mode; LCD displays HR, lead status, speed, gain, filter, battery status, and warning messages; auto standby to save battery; autotest at power on; manual autotest; recording parameters can be modified to improve copy quality; name of doctor or clinic can be preprogrammed to print on all ECGs.
Colons separate data on similar models of a device. * Per year.
20

MODEL CARDIOLINE/REMCO Delta 60 Plus WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Submitted Yes Adult Portable Optional CARDIOLINE/REMCO ELAN Worldwide Submitted Yes Adult/pediatric Portable Optional COMPUMED 507/507i Worldwide Yes Not specified Not specified Mobile Yes CONTROL-X MEDICAL EC 131 Worldwide No Yes Not specified Portable No
Automatic 5, 10, 20 Not specified
Automatic/manual 5, 10 Automatic
0.05-100 Digital, EMG-M1@40 Hz, M2@30 Hz, M3@25 Hz >100 >100 Yes Digital thermal head, 8 dots/mm Yes 210 x 270 mm (8.5 x 11") roll or z-fold paper Yes Yes No 6.25, 12.5, 25, 50
0.05-150 Notch, EMG 25, 30, 40 Hz, baseline
0-150 Notch filter
0.05-75 Notch filter
>100 >100 Yes Digital thermal head, 8 dots/mm Yes 210 mm z-fold paper Yes Yes No 6.25, 12.5, 25, 50
47 >100 Yes Thermal dot array
20 90 No Digital thermal array Not specified 58 mm Yes Yes No 25, 50
Yes 108 mm x 30 m roll Yes Yes No 5, 10, 25, 50
12
12
Not specified
3, 6 Optional Modem, serial, LAN
12, 6+6, 3 x 4 + 2 Yes Modem, serial, LAN, real-time LAN
3 Yes Not specified
3 Yes Serial cable
21

MODEL CARDIOLINE/REMCO Delta 60 Plus MICROPROCESSOR Programs CARDIOLINE/REMCO ELAN COMPUMED 507/507i CONTROL-X MEDICAL EC 131
Adult resting ECG
Yes 1
Rest ECG; opt interpretation/measurement, stress test, arrhythmia monitor Yes 100
Adult resting ECG
Resting
Not specified 1
Not specified 1 + PC option
Unlimited with optional PC card Name, ID no., DOB, sex, age, race, height, weight, BP, physician, medications, others
30 Patient name, ID no., sex, age, height, weight, race, 2 medication entries/patient (9 categories), date, time, optional location
Not specified NA
MEASUREMENTS
P, QRS, QT/QC, P, R, T axis, HR
PR, QRS, QT/QC, P, R, T axis, HR
All basic measurements
No
Yes Not specified Diagnosis, measurements, reason statements
NA NA No
Analyzed waveform
Median complex
Median complex
Not specified
NA
10 Yes Yes 6/12 Loose contact, battery level, printer errors, bad data
Not specified No Not specified 3 Yes
NA No Optional LCD Not specified Loose contact, noise, low battery
22

MODEL CARDIOLINE/REMCO Delta 60 Plus AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Optional Optional CARDIOLINE/REMCO ELAN Yes Yes COMPUMED 507/507i No No CONTROL-X MEDICAL EC 131 Yes Yes
Yes 110/220 VAC
Yes 110/220 VAC
Yes 100-240 VAC, 50/60 Hz 28.6 x 29.2 x 9.5 (11.3 x 11.5 x 3.8) 5 (11) Yes Rechargeable Not specified ~4 8
Yes 110/220 VAC
H x W x D, cm (in)
40.6 x 29.2 x 12.7 (16 x 11.5 x 5) 5.8 (13) Yes Ni-Cd 1/12 1 8
34 x 42 x 10 (13.6 x 16.8 x 4) 6 (13) Yes Ni-MH Not specified 4 1
26 x 12.5 x 5.5 (10.2 x 4.9 x 2.2) 1.5 (3.3) Yes Ni-Cd rechargeable 5/6 0.5 Not specified
$5,000 2 years Immediate 10% of price 2003
$3,200 1 year 30 days Not specified Not specified
Not specified 1 year Not specified No 1994
NA/not specified Not specified 3- and 6-channel printout w/interpretation; LCD displays HR, lead status, warning messages; standby to save battery; modifiable recording parameters; alphanumeric keypad; firmware for stress testing; Delta-Link for ECG management. Meets requirements of IEC 601-1.
0 Not specified User-defined recording modes, shortkey operations; saving and sending special keys; removable paper drawer; integrated cart and carrying bag available.
Not specified Not specified None specified.
NA/200 January to December Computer software for storing and retrieving ECG curves.
23

MODEL CONTROL-X MEDICAL EC 236-D WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide No Yes Not specified Tabletop No CUSTO MED Custo Card Worldwide, except USA No Yes Not specified Tabletop Not specified CUSTO MED Custo Card M Worldwide, except USA No Yes Not specified Tabletop Not specified CUSTO MED Custo Flash 200 Worldwide No Yes Not specified Tabletop No
Automatic 2.5, 5, 10, 20 Automatic
Automatic 5, 10, 20, 40 Not specified
Automatic 5, 10, 20, 40 Not specified
0.2-100 50/60 muscle
0.05-250 Yes
0.05-250 Yes
0.02-100 Yes
20+ 90 Yes Digital thermal array Yes 112 mm Yes Yes No 5, 25, 50, 100
Not specified Not specified Not specified Not specified
Not specified Not specified Not specified Not specified
100 Not specified Yes Solid-state memory
No Not specified Not specified Not specified Not specified Not specified
No Not specified Not specified Not specified Not specified Not specified
Not specified Any size required Yes Yes Yes 3, 10, 25
12
12
12
2-3
3 Yes Cable to PC
Not specified No NA
Not specified No NA
2-3 Yes Infrared
24

MODEL CONTROL-X MEDICAL EC 236-D MICROPROCESSOR Programs CUSTO MED Custo Card CUSTO MED Custo Card M CUSTO MED Custo Flash 200
Adult resting
Adult and pediatric resting ECG, optional stress testing Not specified Depends on PC capacity
Adult and pediatric resting ECG, optional stress testing Not specified Depends on PC capacity
Not specified
Not specified 30 + PC option
Not specified Not specified
Not specified Name, ID no., date
Depends on PC capacity Name, ID no., DOB, race, sex, age, height, weight, BP, medication
Depends on PC capacity Name, ID no., DOB, race, sex, age, height, weight, BP, medication
MEASUREMENTS
PR, QRS, P, R, T axis, HR
PR, QRS, QT/QTC, P, R, T axis, HR
Continual ECG, pathologic events
Not specified Not specified Yes
Analyzed waveform
Median complex
Median complex
Median complex
Not specified
6 Yes LCD Not specified Loose contact, noise, low battery
16 PC monitor Not specified Not specified Loose contact, pacemaker
16 PC monitor Not specified Not specified Loose contact, pacemaker
Not specified Yes Not specified Not specified None specified
25

MODEL CONTROL-X MEDICAL EC 236-D AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Yes Yes CUSTO MED Custo Card Not specified Not specified CUSTO MED Custo Card M Not specified Not specified CUSTO MED Custo Flash 200 Yes Yes
Yes 110/230 VAC or rechargeable batteries 31 x 24 x 7 (12.2 x 9.4 x 2.8) 2.8 (6.2) Yes Rechargeable Not specified Varies Not specified
Not specified 220 VAC
Not specified 220 VAC
Yes 220 VAC
H x W x D, cm (in)
40 x 63 x 46 (15.7 x 24.8 x 18.1) 14.5 (32) No NA NA NA NA
29 x 14 x 9.8 (11.4 x 5.5 x 3.9) 3 (6.6) No NA NA NA NA
9.8 x 6.5 x 2.2 (3.9 x 2.6 x 0.9) 0.11 (0.2) without batteries Yes See footnote * 2/1.5 24 Not specified
$3,700 1 year Not specified Not specified Not specified
Not specified 1 year Not specified Not specified Not specified
Not specified 1 year 6 weeks Yes 1997
Not specified January to December Meets requirements of IEC 601-1-25.
NA/not specified Not specified ISO 9001 certified.
NA/not specified Not specified ISO 9001 certified.
Not specified January to December Integrated parameter recognition; realtime ECG analysis; data transfer from computer to recorder via infrared technology.
Colons separate data on similar models of a device. * Mignon cells or rechargeable batteries.
26

MODEL ELMED ETA 3 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Not specified Not specified Adult/ped/neonate Mobile Yes ELMED ETA 3 AUTOMATIC Worldwide Not specified Not specified Adult/ped/neonate Mobile Yes ELMED ETA 125 Worldwide Not specified Not specified Adult/ped/neonate Portable Optional ELMED ETA 340 Worldwide Not specified Not specified Adult/ped/neonate Portable Optional
Manual 5, 10, 20 Manual
Manual 5, 10, 20 Manual
0.05-100 Notch and EMG filters
100 110 No Heated stylus
Not specified 125 mm No No No 1.25, 2.5, 5, 10, 12.5, 25, 50, 100
Not specified 150 mm No No No 1.25, 2.5, 5, 10, 12.5, 25, 50, 100
Not specified 125 mm No No No 25, 50
Not specified 125 mm Automatic No Yes 2.5, 25, 50
3 No NA
3 No NA
3 No NA
3 No NA
27

MODEL ELMED ETA 3 MICROPROCESSOR Programs ELMED ETA 3 AUTOMATIC ELMED ETA 125 ELMED ETA 340
Stress testing
Stress testing
Not specified
Not specified
No Not specified
No Not specified
No Not specified
No Not specified
MEASUREMENTS
Not specified
Not specified
Not specified
Not specified
Not specified Not specified No
Analyzed waveform
NA
NA
NA
NA
NA Yes No NA None specified
NA Yes No NA None specified
NA No No NA None specified
NA Optional No NA None specified
28

MODEL ELMED ETA 3 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Yes Yes ELMED ETA 3 AUTOMATIC Yes Yes ELMED ETA 125 Yes No ELMED ETA 340 Yes Yes
Yes 110/220 VAC
Yes 110/220 VAC
Yes 110/220 VAC
Yes 110/220 VAC
H x W x D, cm (in)
Not specified
Not specified
15 x 47.5 x 30.5 (6 x 19 x 12) 11.4 (25) Yes D cell 12/1.5 6 NA
12.7 x 31.8 x 27.9 (5 x 12.5 x 11) 5.9 (13) Yes Ni-Cd 1/12 3 NA
29.5 (65) Yes Gel cell 1/12 6 NA
29.5 (65) Yes Gel cell 1/12 6 NA
$2,745 1 year From stock Yes Not specified
Not specified Not specified Add-on module capability; auto baseline correction and pen centering; pacemaker pulse protection circuit; self-check; HR and tachycardia alarm optional. Meets requirements of CSA, IEC, OSHA, and UL 544.
Not specified Not specified Add-on module capability; auto baseline correction and pen centering; pacemaker pulse protection circuit; self-check; HR and tachycardia alarm optional. Meets requirements of CSA, IEC, OSHA, and UL 544.
Not specified Not specified Alphanumeric printer. Meets requirements of CSA, IEC, OSHA, and UL 544.
Not specified Not specified Alphanumeric printer. Meets requirements of CSA, IEC, OSHA, and UL 544.
29

MODEL ESAOTE ArchiWin WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Laptop Optional ESAOTE ArchiWin Colour Worldwide Yes Yes Not specified Laptop Optional ESAOTE Formul@ Worldwide Yes Yes Not specified Cart Optional ESAOTE P80 Worldwide Yes Yes Not specified Desktop, portable Optional
Automatic/manual 2.5, 5, 10, 20 1 mV
Automatic/manual 5, 10, 20 1 mV
270 0-150
270 0-150
270 0-150
0-150 0-150
>50 100 Yes Separate optional thermal printer, laser printer No A4/letter Yes Yes Yes 5, 12.5, 25, 50
>50 100 Yes Separate optional thermal printer, laser printer Not specified A4/letter Yes Yes Yes 5, 12.5, 25, 50
>50 100 Yes Separate optional thermal printer, laser printer Optional A4/letter Yes Yes Yes 5, 12.5, 25, 50
>15 100 Yes Thermal printer
Yes Z-fold 90 x 70 mm, 90 mm roll Yes Yes Yes 5, 25, 50
12
12
12
12
3, 6, 12 Yes Modem, serial, floppy, network, PCMCIA
3, 6, 12 Yes Modem, serial, floppy, network, PCMCIA
3, 6, 12 Yes Modem, serial, floppy, network
3 No NA
30

MODEL ESAOTE ArchiWin MICROPROCESSOR Programs ESAOTE ArchiWin Colour ESAOTE Formul@ ESAOTE P80
Optional interpretative SW, LPA, RRV, and stress package Not specified 140 floppy (rest ECG), 50,000 hard drive, 200 stress
Optional interpretative SW, LPA, RRV, and stress package Not specified 140 floppy (rest ECG), 50,000 hard drive, 200 stress
Interpretative SW and stress package, optional LPA and RRV Not specified 140 floppy (rest ECG), 50,000 hard drive, 200 stress
Adult resting interpretation
Not specified 1 for copy
Not specified Name, ID no., DOB, race, sex, age, height, weight, BP, medications, physician notes
NA Name, ID no., DOB, race, sex, age, height, weight, BP, medications, physician notes
MEASUREMENTS
ECG sync and 1 lead
ECG sync and 1 lead
32 ECG parameters
15 ECG parameters
Not specified Not specified Diagnosis, measurements, reason statements
Analyzed waveform
Median complex
Median complex
Median complex
Median complex
Not specified 9" LCD B/W Not specified Electrode contact, battery/main status, chart speed, filter status
Not specified 9" LCD Color Not specified None specified
10 SVGA monitor Not specified Not specified Electrode contact, battery/main status, chart speed, filter status
10 No Not specified Not specified Electrode contact, battery/main status, chart speed, filter status
31

MODEL ESAOTE ArchiWin AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Analog No ESAOTE ArchiWin Colour Analog No ESAOTE Formul@ Analog No ESAOTE P80 No No
Yes 100/240 VAC
Yes 100/240 VAC
Yes 115/230 VAC
Yes 115/230 VAC
H x W x D, cm (in)
32.8 x 25.4 x 7.5 (13 x 10 x 3) 3.8 (8.4) Yes Ni-Cd 1/12 1 Not specified
32.8 x 25.4 x 7.5 (13 x 10 x 3) 4.8 (1.8) Yes Ni-Cd 1/12 1 Not specified
78 x 66 x 144 (30 x 26 x 57) 80 (176.4) Yes Ni-Cd 1/12 Only for backup Not specified
29.6 x 56 x 72.5 (12 x 22 x 29) 2.9 (6.4) Yes Lead acid 1/12 2 Not specified
Not specified 1-3 years 1 month Yes 2002
Not specified Not specified Fully automatic; large configurability; trolley for rest; connects to SVGA color monitor; direct connection to PC for Windows printouts.
Not specified Not specified Fully automatic; large configurability; trolley for stress and rest; connects to SVGA color monitor; direct connection to laser printer.
Not specified Not specified Fully automatic; configurable; direct connection to laser printer; LPA and RRV options.
Not specified Not specified 1-key operation; 2 automatic pre-set formats.
32

MODEL ESAOTE P80Power WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Desktop Optional ESAOTE P80Six Worldwide Yes Yes Not specified Desktop Optional ESAOTE P80White Worldwide Yes Yes Not specified Flexible, desktop, portable Optional ESAOTE P8000Power Worldwide Yes Yes Not specified Desktop Optional
0-150 0-150
0-150 0-150
0-150 0-150
0-150 0-150
>15 100 Yes Thermal printer, external PC printer Yes Z-fold 90 x 70 mm, 90 mm roll, A4 Yes Yes Yes 5, 25, 50
>15 100 Yes Thermal printer, external PC printer Optional 210 x 280 mm Yes Yes Yes 5, 25, 50
Yes 210 x 280 mm Yes Yes Yes 5, 25, 50
12
12
12
12
3, 6, 12 Yes Serial
3, 6, 12 No NA
3, 12 No NA
3, 6, 12 Yes Serial
33

MODEL ESAOTE P80Power MICROPROCESSOR Programs ESAOTE P80Six ESAOTE P80White ESAOTE P8000Power
Optional adult and pediatric interpretation, rest spirometry Not specified 45, internal memory
Optional adult and pediatric interpretation, stress test, rest spirometry Not specified 45, internal memory
NA Name, ID no., DOB, race, sex, age, height, weight, BP, medications, physician notes
MEASUREMENTS
15 ECG parameters
15 ECG parameters
Yes
32 ECG parameters
Analyzed waveform
Median complex
Median complex
Not specified
Median complex
10 LCD 120 x 90 mm Not specified Not specified Electrode contact, battery/main status, chart speed, filter status
10 No Not specified Not specified Electrode contact, battery/main status, chart speed, filter status
Not specified No Not specified Not specified None specified
10 9" LCD Not specified Not specified Electrode contact, battery/main status, chart speed, filter status
34

MODEL ESAOTE P80Power AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS No No ESAOTE P80Six No No ESAOTE P80White Yes No ESAOTE P8000Power No No
Yes 115/230 VAC
Yes 115/230 VAC
Yes 115/230 VAC
Yes 115/230 VAC
H x W x D, cm (in)
39.9 x 33.8 x 10.5 (16 x 13 x 4) 5 (11) Yes Lead acid 1/12 4 Not specified
39.9 x 33.8 x 10.5 (45.7 x 13.3 x 4.1) 4.2 (9.4) Yes Lead acid 1/12 6 Not specified
29.6 x 22 x 72.5 (11.7 x 8.7 x 28.5) 2.9 (6.4) Yes Lead acid 1/12 2 Not specified
39.9 x 33.8 x 10.5 (15.7 x 13.3 x 4.1) 5 (11) Yes Lead acid 1/12 4 Not specified
Not specified Not specified 1-key operation; 2 automatic pre-set formats; time and date; automatic recognition of external printer; intelligent filtering applicable on recorded signal; 2 units in 1 desk.
Not specified Not specified 1-key operation; 2 automatic pre-set formats softkey; automatic paper drawer.
35

MODEL FUKUDA DENSHI FCP-2155 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Mobile and portable Optional FUKUDA DENSHI FX-3010 Worldwide Yes Yes Not specified Mobile and portable Optional FUKUDA DENSHI FX-4010 Worldwide Yes Yes Not specified Tabletop and portable Optional FUKUDA DENSHI FX-7202 Worldwide Yes Yes Not specified Mobile and portable Optional
Automatic/manual 2.5, 5, 10, 20, auto Automatic/manual
Automatic/manual 2.5, 5, 10, 20, auto, 1+auto Automatic/manual
0.05-150 50/60 Hz AC, 40 Hz muscle, 0.5 Hz drift
0.05-150 50/60 Hz AC, 25/35 Hz muscle, 0.25/0.5 Hz drift 50 >103 Yes Thermal array
50 >100 Yes Thermal
Yes 63 mm x 30 m roll Yes Yes No 25, 50
Yes 145 mm x 30 m roll Yes Yes No 10, 25, 50
Yes 210 mm x 30 m roll Yes Yes No 10, 25, 50
Yes 110 mm x 20 m z-fold Yes Yes Yes 10, 12.5, 25, 50
1, 3
12
12
12
12 Yes RS232C
3, 6, 3+rhythm Yes RS232C
3, 6, 12, 3+rhythm Yes RS232C option
3, 6, 3+rhythm Yes LAN
36

MODEL FUKUDA DENSHI FCP-2155 MICROPROCESSOR Programs FUKUDA DENSHI FX-3010 FUKUDA DENSHI FX-4010 FUKUDA DENSHI FX-7202
Adult and pediatric resting ECG
Adult and pediatric resting ECG, stress testing Not specified 1,000 with IC card (20 MB)
Not specified NA
Adult and pediatric resting ECG, optional stress testing Not specified 1,000 with IC card (20 MB)
Not specified 128 (built-in memory)
NA ID no., age, sex, height, weight
NA ID no., age, sex, height, weight, ward, department, meds, symptoms, BP
NA ID no., age, sex, height, weight, ward, department, meds, symptoms, BP
NA ID no., age, sex, height, weight, ward, department, meds, symptoms, BP, race, comments
MEASUREMENTS
HR, PR, QRS, QT time, QTC, RR, axis
HR, PR, QRS, QT time, QTC, RR, axis
HR, PR, QRS, QT time, QTC, axis, RV5/SV1
Yes No Diagnosis, measurements, reason statements, RR interval
Yes Yes Diagnosis, measurements, reason statements, RR interval, arrhythmia
Analyzed waveform
Not specified
Not specified
Not specified
Not specified
10 No LCD Not specified Loose contact, ID no., sex, age, HR, sensitivity, filter, battery
10, 20 Yes LCD w/back light Not specified Loose contact, ID no., sex, age, HR, sensitivity, paper speed, filter, battery, message
10, 20 Yes LCD w/back light Not specified Loose contact, ID no., sex, age, HR, sensitivity, paper speed, filter, battery, message, IC card
10, 20 Yes LCD w/back light Not specified Loose contact, ID no., sex, age, HR, sensitivity, paper speed, filter, battery, IC card, function keys
37

MODEL FUKUDA DENSHI FCP-2155 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS No Yes FUKUDA DENSHI FX-3010 Yes Yes FUKUDA DENSHI FX-4010 Optional Optional FUKUDA DENSHI FX-7202 No No
Yes 115/230 VAC
Yes 115/230 VAC
Yes 115/230 VAC
Yes 100-230 VAC
H x W x D, cm (in)
6.3 x 26 x 18.2 (2.5 x 10.2 x 7.2) 2.4 (4.4) Yes Not specified 1/9.6 1 Not specified
6.5 x 29.7 x 21 (2.6 x 11.7 x 8.3) 4.5 (9.9) Yes Not specified 1/9.6 1 Not specified
10.1 x 37.8 x 33.8 (4 x 14.9 x 13.3) 8 (17.6) Optional Not specified 1/9.6 1 Not specified
6 x 26 x 19.5 (2.4 x 10.2 x 7.7) 2.6 (5.7) Optional Ni-MH 1/9.6 0.5 Not specified
Not specified Not specified Quick-charge battery; arrhythmia detection.
NA/not specified Not specified Built-in handle for portability; quickcharge battery; touchscreen operation.
NA/not specified Not specified 2 modular inputs for optional features; data storage on IC card; arrhythmia analysis; 12-lead cubic expression display.
NA/not specified Not specified Arrhythmia analysis; 12-lead cubic expression display; full key and touchscreen operation.
38

MODEL FUKUDA DENSHI FX-7402 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Tabletop and portable Optional FUTUREMED ARCHIMED DATA ACQUISITION SYSTEM Worldwide Not specified Yes Not specified Mobile Optional FUTUREMED EZ-3 Worldwide Yes Yes Adult/ped/neonate Mobile Optional FUTUREMED P80 Power Worldwide Yes Yes Adult/ped/neonate Mobile Yes
Automatic/manual 2.5, 5, 10, 20 Automatic/manual
0.05-200 30, 45, 50, 60
0.05-150 0.05-35, 0.05-25, 0.3-25, 0.3-35, 0.15-25, 0.15-35 100 100 Yes Digital thermal array Not specified 3.5" wide roll or 3.5 x 2.7" z-fold Yes Yes No 5, 25, 50
0.05-150 25, 30, 70, 150, 250
100 100 Yes Thermal printer, laser printer Not specified 8.5 x 11" Yes Yes Yes 5, 12.5, 25, 50
>50 100 Yes Not specified
Yes 210 mm x 30 m roll Yes Yes Yes 5, 10, 12.5, 25, 50
Not specified 8.5 x 11" Yes Yes Not specified 5, 10, 25, 50
12
12
12
12
3, 12, 3+rhythm, 6+rhythm Yes RS232C
3, 4, 6 Optional Memory card
3 No NA
12 Yes External modem
39

MODEL FUKUDA DENSHI FX-7402 MICROPROCESSOR Programs FUTUREMED ARCHIMED DATA ACQUISITION SYSTEM Not specified FUTUREMED EZ-3 FUTUREMED P80 Power
Adult and pediatric resting ECG, optional stress testing Not specified 300 (built-in memory), 1,000 with IC card (20 MB)
Not specified
Not specified
Not specified 12
No 12
Yes 45
NA ID no., age, sex, height, weight, ward, department, meds, symptoms, BP, race, comments, name
Not specified Handwritten
Not specified Via keyboard
MEASUREMENTS
Yes
Optional
Not specified Not specified Optional
Analyzed waveform
Not specified
Not specified
Not specified
Not specified
10, 20 Yes LCD, ext backlit Not specified Loose contact, ID no., sex, age, HR, sensitivity, paper speed, filter, battery, IC card, function keys, message
Not specified No Not specified Not specified Not specified
10 No No NA Lead off, battery, 12-lead ECG tracing, demographics, paper speed, loose leads
NA Yes LCD Not specified Not specified
40

MODEL FUKUDA DENSHI FX-7402 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS No No FUTUREMED ARCHIMED DATA ACQUISITION SYSTEM Network, transmission Not specified FUTUREMED EZ-3 No No FUTUREMED P80 Power Yes No
Yes 100-230 VAC
Yes 110/220 VAC
Yes 110/220 VAC
Yes 110/120 VAC
H x W x D, cm (in)
10 x 33.5 x 34.6 (3.9 x 13.2 x 13.6) 6 (13.2) Optional Ni-MH 1/9.6 1 Not specified
32.8 x 25.4 x 7.5 (12.9 x 10 x 3) 3.8 (8.4) basic ECG; 4.8 (10.6) stress Yes Ni-Cd 1/12 3 Not specified
6.9 x 29 x 21 (2.7 x 11.4 x 8.3) 2.9 (6.4) Yes Lead acid 1/12 3 Not specified
33.9 x 33.8 x 10.4 (13.4 x 13.3 x 4.1) 4.3 (9.5) Yes Lead acid 1/12 2 Not specified
Not specified 2 years, parts and labor Not specified Not specified Not specified
$1,850 2 years From stock Not specified Not specified
$3,600 * 2 years From stock Not specified Not specified
NA/not specified Not specified Arrhythmia analysis; 12-lead cubic expression display; full key and touchscreen operation; data storage on IC card and built-in memory; external display.
Not specified June to June Page-formatted long-term rhythm recording; monitor output; upgradable to interpretive ECG. Meets requirements of AHA and IEC 601-1.
Not specified June to June 1-touch operation; automatic baseline centering; optional measurement module; customizable setup; 1,000 Hz sampling rate. Meets requirements of AHA and IEC 601-1.
Not specified June to June None specified.
Colons separate data on similar models of a device. * $4,600 with interpretation.
41

MODEL FUTUREMED P80 Six WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Adult/ped/neonate Mobile Yes GALIX BIOMEDICAL INSTRUMENTATION ECG-PS Asia, Latin America No No Adult/pediatric PC/laptop-based Optional GE MEDICAL SYSTEMS CARDIOSOFT Asia, Europe, Latin America Yes Yes Not specified Portable Not specified GE MEDICAL SYSTEMS CARDIOSYS Asia, Europe, Latin America Yes Yes Not specified Mobile Yes
Automatic/manual 5, 10, 20 Yes
Automatic/manual/ stress test 5, 10, 20, 40 Automatic/manual/ stress test 0.05-150 0.05-20/35 muscle, 0.05-50/60 main
Automatic/manual/ stress test 5, 10, 20, 40 Automatic/manual/ stress test 0.05-150 0.05-20/35 muscle, 0.05-50/60 main
0.05-150 25, 30, 70, 150, 250
0.05-150 AC, drift, muscle
>50 100 Yes Not specified
100 >100 Yes PC Windows-supported printers No 8.5 x 11", A4 Yes Yes Yes 25, 50, 100
100 >50 Yes Laser
100 >50 Yes Thermal array, laser
Not specified 8.5 x 11" Yes Yes Not specified 5, 25, 50
Not specified 210 x 300 mm or 216 x 280 mm Yes Yes Yes 25, 50
Not specified 210 x 300 mm or 216 x 280 mm Yes Yes Yes 5, 10, 25, 50, 100
12
12
12
12
12 No NA
3, 6, 6+6, 12, 12+ rhythm Yes Fax, e-mail
12 Yes Modem, hardwired
12 Yes Modem, hardwired
42

MODEL FUTUREMED P80 Six MICROPROCESSOR Programs GALIX BIOMEDICAL INSTRUMENTATION ECG-PS GE MEDICAL SYSTEMS CARDIOSOFT GE MEDICAL SYSTEMS CARDIOSYS
Not specified
Adult resting ECG, stress testing, signal-averaged ECG PC keyboard 50,000 reports with waveforms
Not specified
Not specified
No 12
Not specified Handwritten
Unlimited Name, ID, age, sex, weight, height, address, physician, date, time, indication, medication, comments
MEASUREMENTS
Optional
PR, QRS, QT/QTC, P axis, QRS axis, T axis, ST level, HR
Optional ST level, slope, and resting ECG
Optional ST level, slope, and resting ECG
Analyzed waveform
Not specified
Not specified
Not specified
NA No No NA Not specified
10 Print preview PC monitor, laptop 1-12 Real-time display on monitor, filters, speed, gain, HR, date, time, patient name, ID, lead identification, printing format
43

MODEL FUTUREMED P80 Six AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS No No GALIX BIOMEDICAL INSTRUMENTATION ECG-PS No No GE MEDICAL SYSTEMS CARDIOSOFT Optional No GE MEDICAL SYSTEMS CARDIOSYS Optional No
Yes 110/120 VAC
Yes 5 V, provided by the PC/laptop through USB 3 x 6.3 x 14 (1.2 x 2.5 x 5.5) not including PC 0.23 (0.5), not including PC No NA NA NA NA
Yes 115/230 VAC
Yes 115/230 VAC
H x W x D, cm (in)
33.9 x 33.8 x 10.4 (13.4 x 13.3 x 4.1) 5 (11) Yes Lead acid 1/12 2 (full charge) Not specified
4.5 x 24 x 12 (1.8 x 9.4 x 4.7) 0.7 (1.5) No NA NA NA Not specified
115 x 68 x 82.5 (42.3 x 26.8 x 32.5) 60 (132.3) No NA NA NA Not specified
$3,100 * 2 years From stock Not specified Not specified
$2,350 18 months 1 week Optional 2002
Not specified Not specified Not specified Not specified Not specified
Not specified Not specified Not specified Not specified Not specified
Not specified June to June None specified.
NA/not specified March to February Link to PC using USB port; Windows 98/00/ NT; cardiac stress test SW; optional VLP analysis.
Not specified May to April List price set according to country; PC-based software with CORINA; spirometry; holder BP; late potentials.
Not specified May to April List price set according to country; PC-integrated; right-heart catheterization; spirometry; holder BP; late potentials.
Colons separate data on similar models of a device. * $3,600 with interpretation.
44

MODEL GE MEDICAL SYSTEMS MAC 1200 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Adult/pediatric Portable, mobile Yes GE MEDICAL SYSTEMS MAC 5000 Worldwide Yes Yes Adult/pediatric Mobile Optional GETEMED CardioLink * Worldwide Submitted Yes Not specified Mobile, portable, tabletop Optional H & C MEDICAL CARDIETTE daedalus view * Worldwide Not specified Yes Not specified Mobile Optional
Automatic/manual/ arrhythmia 5, 10, 20, 40 Automatic
Automatic/manual, stress test 2.5, 5, 10, 10/5, 20 Automatic, -3 dB @ 0.01-150 Hz 0.01-150 Notch, EMG
Automatic/manual 2.5, 5, 10, 20 No
Automatic/manual 1.25, 2.5, 5, 10, 20, 40, automatic Automatic
0.08-150 Sinc 3 order
0.05-100 50/60 Hz AC, 25-35 Hz muscle, baseline drift >10 100 Yes PC hard drive
0.05-150 See footnote **
>100 >140 Yes Thermal array
>10 @ 10 Hz >140 Yes Thermal array
>100 100 Yes Digital thermal printer Yes A4 z-fold or roll Yes Yes No 1.25, 2.5, 5, 10, 12.5, 25, 50
Yes 8.5 x 11" or A4 z-fold Automatic Yes Annotation 5, 25, 50
Yes 8.5 x 11" or A4 z-fold Automatic Yes Yes 5, 12.5, 25, 50
No Depends on printer Yes Yes Yes 12.5, 25, 50, 100
12
15
12
12
3, 6, 12 Yes Modem
3, 6, 12, 15 Yes Modem, RS232, 802.11b wireless LAN
12 Yes Internet
3, 4, 5, 12 Yes RS232
Colons separate data on similar models of a device. * Model(s) listed are currently marketed; specifications current as of October 2001. ** 35 Hz at 6 dB/octave, modified 50 Hz notch, antidrift-phase high-pass filter without trace distortion.
45

MODEL GE MEDICAL SYSTEMS MAC 1200 MICROPROCESSOR Programs GE MEDICAL SYSTEMS MAC 5000 GETEMED CardioLink * H & C MEDICAL CARDIETTE daedalus view * Resting ECG, ERGO program
Adult, pediatric
Adult, pediatric
Not specified 45
Not specified 150
Adult and pediatric resting ECG, optional stress testing Not specified Unlimited
Not specified 1
NA Name, age, ID, sex, weight, height, race, date, location, time, medication
NA Name, age, ID, sex, weight, height, date, location, time, medication, chart speed, sensitivity filter
Unlimited Name, ID no., DOB, sex, age, height, weight, BP, medications, address, 2 telephone numbers, gatekeeper/physician
Optional Name, age, sex, date, time, comments, location
MEASUREMENTS
Yes
Yes
PR, QRS, QT/QTC, P, R, axis, HR
QRS, PQ, QTC, (QT corrected seconds), ST-segment take-off, QRS axis, Q/R, R/S, P, HR Yes Yes Diagnosis, measurements, reason statements
Yes Yes Yes
Yes Yes Yes
Yes Yes Optional
Analyzed waveform
Median average from each lead group
Median complex
Representative cycles from each lead
10 Yes LCD 3 Lead off, low battery
10 Yes LCD 2, 6, 12, 15 Lead off, low battery
10 PC screen PC screen Not specified Loose contact, noise, low battery, bad data
10 Yes Not specified Not specified Antidrift, power supply, low battery, clamp, overload, loose contact, end paper, door open, automatic centering, chart speeds, sensitivity, filter, operating mode
Colons separate data on similar models of a device. * Model(s) listed are currently marketed; specifications current as of October 2001.
46

MODEL GE MEDICAL SYSTEMS MAC 1200 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS No No GE MEDICAL SYSTEMS MAC 5000 1 channel 10 V (ECG-out) ** 2 channels, 0-10 V ** GETEMED CardioLink * No Yes H & C MEDICAL CARDIETTE daedalus view * Yes Yes
Yes 95-240 VAC
Yes 100-240 VAC
Yes 110/220 VAC
Yes 110-120/220-240 VAC, 50/60 Hz 6.2 x 34.7 x 32.8 (2.4 x 13.7 x 12.9) ~4.5 (9.9) Yes Rechargeable Not specified 40 min Not specified
H x W x D, cm (in)
14.5 x 3.7 x 12.6 (5.7 x 1.5 x 5) 5.6 (12.3) Yes Ni-Cd 1/18 @ 1.3 AHr 50 pages ~4
9.4 x 38.1 x 35.1 (3.7 x 15 x 13.8) 6.8 (15) Yes Ni-MH 1/18 @ 3.5 A-hr 15% 6 cont display or 100 single-page rpt ~4.5 from total discharge-no display Not specified 1 year Immediate Not specified Not specified
3.5 x 15.9 x 9.5 (1.4 x 6.3 x 3.7) 0.34 (0.75) Optional 9 V or rechargeable 1/9 2 Not specified
Not specified 3 years Immediate Yes Not specified
Not specified 2 years Immediate Optional 1998
Not specified January to December Graphics display; software cartridges for field upgradability; optional carrying case.
Not specified January to December Multiple recording formats; transmits/ receives data to/ from ECG cart and MUSE data management system.
Not specified January to December Data transfer via BDT, GDT, HL7; pacemaker pulse detection and protection; defibrillator protection, marker.
Not specified Not specified Alphanumeric keyboard; LCD display; upgrade at any time; optional stress-test protocol, remote tx (SCP protocol), 70tracing memory, and PC connections. Meets requirements of EN 60601-1/-1-2/ -2-25 and IEC 62D-WG1(263)WD.
Colons separate data on similar models of a device. * Model(s) listed are currently marketed; specifications current as of October 2001. ** 2 channels 0-10 V (analog); 1 TTL output channel with programmable polarity delay and width; VGA.
47

MODEL H & C MEDICAL CARDIETTE excel 106scp * WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Not specified Yes Not specified Portable Optional H & C MEDICAL CARDIETTE start 200 * Worldwide Not specified Yes Not specified Mobile Optional H & C MEDICAL CARDIETTE start 200HV * Worldwide Not specified Yes Not specified Mobile Optional MACQUARIE CT100 See footnote ** Yes Yes Adult/pediatric Mobile, portable No
Automatic/manual 5, 10, 20, automatic Not specified
Automatic/manual 5, 10, 20, automatic Automatic
Automatic/manual 5, 10, 20, automatic Automatic
0.05-150 See footnote ***
0.05-100 Notch/EMG
Not specified Not specified Not specified Digital thermal printer Yes 104 mm Yes Yes Not specified 5, 25, 50
>100 100 Yes Digital thermal printer Not specified A4 z-fold or roll Yes No No 5, 25, 50
>100 100 Yes Digital thermal printer Yes A4 z-fold or roll Yes No No 5, 25, 50
>10 >100 Yes Thermal
Not specified 58 mm x 12 m Yes No No 12.5/25/50
12
12
12
12
3, 6 Yes Modem
3, 6 No NA
3, 6 Yes RS232
1 or 3 No NA
Colons separate data on similar models of a device. * Model(s) listed are currently marketed; specifications current as of October 2001. ** Africa, Asia, Asia Pacific, Europe, Middle East, South America. *** 35 Hz at 6 dB/octave, modified 50 Hz notch, antidrift-phase high-pass filter without trace distortion.
48

MODEL H & C MEDICAL CARDIETTE excel 106scp * MICROPROCESSOR Programs Resting ECG H & C MEDICAL CARDIETTE start 200 * Not specified H & C MEDICAL CARDIETTE start 200HV * Resting ECG MACQUARIE CT100
Not specified
Not specified 80
Not specified 1
No Not specified
Not specified Name, ID no., age, sex, BP, height, weight, date, comments, location
NA ID no., age, sex, date, time
MEASUREMENTS
QRS, PQ, QTC, (QT corrected seconds), ST-segment take-off, QRS axis, Q/R, R/S, P, HR Not specified Not specified Diagnosis, measurements, reason statements
QRS, PQ, QTC, ST, QRS axis, Q/R, R/S, P, HR
QRS, PQ, QTC, (QT corrected seconds), ST-segment take-off, QRS axis, Q/R, R/S, P, HR Yes Yes Diagnosis, measurements, reason statements
No
NA NA No
Analyzed waveform
Not specified
NA
10 Optional Not specified Not specified Antidrift, power supply, low battery, clamp, overload, loose contact, end paper, door open, automatic centering, chart speeds, sensitivity, filter, operating mode
Not specified No Not specified Not specified None specified
10 Yes Not specified Not specified Antidrift, power supply, low battery, clamp, overload, loose contact, end paper, door open, automatic centering, chart speeds, sensitivity, filter, operating mode
NA No LCD Not specified Battery level, memory, time, status
49

MODEL H & C MEDICAL CARDIETTE excel 106scp * AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Not specified Not specified H & C MEDICAL CARDIETTE start 200 * No No H & C MEDICAL CARDIETTE start 200HV * Yes Yes MACQUARIE CT100 No No
Not specified 110-120/220-240 VAC, 50/60 Hz 6.5 x 30 x 21.8 (2.6 x 11.8 x 8.6) 3 (6.6) Yes Rechargeable Not specified Not specified Not specified
Yes 110-120/220-240 VAC; 50/60 Hz 6.2 x 34.7 x 32.8 (2.4 x 13.7 x 12.9) ~4 (8.8) Yes Rechargeable Not specified 40 min Not specified
Yes 110-120/220-240 VAC; 50/60 Hz 6.2 x 34.7 x 32.8 (2.4 x 13.7 x 12.9) ~4 (8.8) Yes Rechargeable Not specified 40 min Not specified
Yes 2 main and rechargeable batteries 21 x 16.5 x 4.5 (8.3 x 6.5 x 1.8) 1.5 (3.3) Yes Lead acid Not specified/6.3 Not specified 3
H x W x D, cm (in)
$1,100 1 year 2-4 weeks $70/year 1991
Not specified Not specified Remote tx (SCP protocol); PC connection with optional software. Meets requirements of EN 60601-1/-2-25 and NEMKO.
Not specified Not specified User name; mask for patient data; different report formats; copy of the stored tracing. Meets requirements of EN 60601-1/-1-2/ -2-25 and IEC 62D-WG1(263)WD.
Not specified Not specified Real-time PC connection with optional software. Meets requirements of EN 60601-1/2-25 and IEC 62D-WG1(263)WD.
Not specified June to July Meets specifications of AS3200 and IEC 601-2-25.
50

MODEL MACQUARIE CT200 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered See footnote * Yes Yes Not specified Mobile, portable No MEDITECH E-Lite Worldwide Submitted Yes Adult Portable No MIDMARK DIAGNOSTICS GROUP IQmark Digital ECG Worldwide Yes Yes Adult/ped/neonate MS Windows PC based Optional MIDMARK DIAGNOSTICS GROUP IQmark Digital ECG PDA Worldwide Yes Yes Adult/ped/neonate MS Pocket PC based Not required
Automatic/manual 5, 10, 20, 40 Automatic
User selectable 5, 10, 20 Yes
User selectable 5, 10, 20 Yes
0.05-100 Notch/EMG
0.05-150 Baseline, inside noise 50/60 Hz
>10 >100 Yes Thermal or PC
100 120 Yes PC-connected printer
>100 100 Yes Microsoft Windowssupported printers No 8.5 x 11", A4 Yes Yes Not specified 10, 25, 50, 100 display; 25 print
>100 100 Yes Microsoft Windowssupported printers No 8.5 x 11", A4 Yes Yes Not specified 25
Yes 58 mm x 12 m or A4 Yes Yes No 12.5/25/50
Not specified A4 Yes Yes No 10, 25, 50, 100, 200
12
12
12
12
1/3/6/12 Yes Modem/hard
12 Yes Modem
3x4+1 rhythm, 3x4+3 rhythm, 6x2, 12 Yes Fax, e-mail, FTP, reports, network
3x4+1 rhythm, 3x4+3 rhythm, 6x2, 12 Yes Fax, e-mail, FTP, reports, network
Colons separate data on similar models of a device. * Africa, Asia, Asia Pacific, Europe, Middle East, South America.
51

MODEL MACQUARIE CT200 MICROPROCESSOR Programs MEDITECH E-Lite MIDMARK DIAGNOSTICS GROUP IQmark Digital ECG MIDMARK DIAGNOSTICS GROUP IQmark Digital ECG PDA Pediatric and adult resting ECG; touchscreen or handwriting recognition See Programs above ~300 ECGs in 64 MB Pocket PC device, 10 sec on all 12 leads Unlimited Name, ID, age, sex, medication, BP, history, location, physician, race, date, comments, technician, vitals
Adult resting ECG, +12 lead life on PC
Not specified
Not specified 1 full 12-lead ECG inside unit
Alphanumeric 55,000 in 1 GB storage, 10 sec on all 12 leads
200 max floppy disk; more on PC hard disk Name, ID, DOB, sex, age, height, weight, medications, doctor and cardiologist comment, ECG referral status
Not specified In proprietary database on PC, SW included with recorder
Unlimited Name, ID, age, sex, medication, BP, history, location, physician, race, date, comments, technician, vitals
MEASUREMENTS
HR, QRS axis, P axis, QRS, PR, and QT duration automatic; all/any of the above manual Database Not specified Rhythm analysis, measurements, interpretation
Continuous
PR, QRS, QT/QTC, P axis, QRS axis, T axis, ST, VAT, HR
PR, QRS, QT/QTC, P axis, QRS axis, T axis, ST, VAT, HR
No Yes * Telemed diagnostic algorithm, measurements, online editing
No Yes * Telemed diagnostic algorithm, measurements, online editing
Analyzed waveform
12 leads, 10 sec each
Not specified
Representative beat from each lead
Representative beat from each lead
9/lead PC screen LCD Not specified Loose contact, noise, low battery, bad data
Not specified Yes PC screen Not specified None specified
10 Yes Yes 3x4+1 rhythm, 4, 12 Noise, loose contact, report status, filters, speed, gain, HR, BP, date, time, patient name, ID, lead identification, lead off, online editing
10 Yes Yes 3 Noise, loose contact, report status, filters, speed, gain, HR, BP, date, time, patient name, ID, lead identification, lead off, online editing
Colons separate data on similar models of a device. * Name, patient ID, race, sex, BP, weight, height, age, physician, technician, date of report, reviewed by, review date, history, medication, comments.
52

MODEL MACQUARIE CT200 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Yes No MEDITECH E-Lite Not specified Not specified MIDMARK DIAGNOSTICS GROUP IQmark Digital ECG No No MIDMARK DIAGNOSTICS GROUP IQmark Digital ECG PDA No No
Yes 2 main and rechargeable batteries 21 x 16.5 x 4.5 (8.3 x 6.5 x 1.8) 1.5 (3.3) Yes Lead acid Not specified/6.3 Not specified Not specified
Yes AA battery (2)
Yes 3 VDC
Yes 3 VDC
H x W x D, cm (in)
10 x 8.7 x 2.4 (4 x 3.4 x 0.9) 0.2 (0.4) Yes AA/Ni-Cd; Ni-MH 2/3 >25 Not specified
2.3 x 7.1 x 12.7 (0.9 x 2.8 x 5) without PC 0.3 (0.7) without PC Yes Alkaline 2/1.5 60 Not specified
2.3 x 7.1 x 12.7 (0.9 x 2.8 x 5) w/o handheld device 0.3 (0.7) without handheld device Yes Alkaline 2/1.5 60 Not specified
$1,300 1 year 2-4 weeks $70/year 1991
1,400 (US$2,208) 2 years, extended avail on recorder Not specified Not specified Not specified
Not specified 1 year Immediate Yes Not specified
Not specified 1 year Immediate Yes Not specified
Not specified June to July Meets specifications of AS3200 and IEC 601-2-25.
Not specified Not specified List price is for UK only; price varies by country.
Not specified Not specified Link to PC using standard serial or USB port connections; fax/modem transmission; Windows 95/98/ME/2000/ NT/XP; SQL server database; peer-topeer network database; auto save of patient data/test; full online review and editing features, including zooms, electronic calipers, customizable list of diagnostic statements, indications, others.
Not specified Not specified Supports MS Pocket PC 2002 handheld devices; also links to PC using standard serial or USB port connections; supports Windows 95/98/ ME/2000/NT/XP; SQL server database; peer-to-peer network database; autosave of patient data/ test; fax/modem transmission; full online review and editing features, including zooms, electronic calipers, customizable list of diagnostic statements, indications, others.
53

MODEL MORTARA ELI 100 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Portable Optional MORTARA ELI 200 Worldwide Yes Yes Not specified Portable Optional MORTARA ELI 250 Worldwide Yes Yes Not specified Portable Optional MORTARA Landscape Worldwide Yes Yes Not specified Portable Optional
Automatic/manual 5, 10, 20 Automatic
0.05-300 0.05-40
0.05-160 Source-consistency filter
47 130-210 Yes Digital thermal array Yes 108 mm x 30 m Yes Yes No 5, 10, 25, 50
49 130-210 Yes Digital thermal array Yes 8.5 x 11" Automatic Yes No 5, 10, 25, 50
See footnote * See footnote * Yes Digital thermal array Yes A4, 8.5 x 11" Yes Yes No 5, 10, 25, 50
See footnote * See footnote * Yes Digital thermal array writer or laser printer Detachable 8.5 x 11" Automatic Yes No 5, 10, 25, 50
12
12
12
12
3, 4, 6 (2-page) Yes Modem, direct
3, 4, 6, 3 + 3, 12 Yes Modem, direct
3+1, 6, 3+3, 12, or 6+6 (2 pages) Yes Modem, direct, LAN
3, 4, 6, 3 + 3 Yes RS232, optional modem
Colons separate data on similar models of a device. * Meets requirements of AAMI/ANSI standard EC-11a (1985, revised 1992) and IEC 601 for diagnostic ECG.
54

MODEL MORTARA ELI 100 MICROPROCESSOR Programs MORTARA ELI 200 MORTARA ELI 250 MORTARA Landscape
Adult resting ECG
Adult resting ECG, serial comparison
Adult resting ECG
Adult resting, serial comparison
Not specified Up to 40, expandable to 150
Not specified Up to 40, expandable to 150
Alphanum/functions Up to 60 (internal)
Not specified Up to 150
NA Name, ID no., age, sex, height, weight, race, medications, date, time, room, location, comment; custom ID available with data management system
Up to 300 Name, ID no., age, sex, height, weight, race, medications, date, time, room, location, comment; custom ID available with data management system
NA Name, ID no., age, sex, DOB, custom ID available with data management system
MEASUREMENTS
HR, PR, QRS, QT/QT, P, QRS and T axis, full measurement matrix
HR, PR, QRS, QT/QTc, P, QRS and T axis, full measurement matrix
Yes Yes Diagnosis, measurements, reason statements; optional serial comparison
Yes Config/pt directory Diagnosis, measurements, reason statements
Yes Yes Diagnosis, measurements, reason statements; optional serial comparison
Analyzed waveform
Median complex for contour analysis, rhythm-for-rhythm analysis 10 No Not specified Not specified System status, battery status, lead fail, noisy data, loose contact, reverse leads, writer door status, out of paper
Median complex for contour analysis, rhythm-for-rhythm analysis 10 No Not specified Not specified System status, battery status, lead fail, noisy data, loose contact, reverse leads, writer door status, out of paper
Median complex for contour analysis, rhythm-for-rhythm analysis 10 Yes Not specified Up to 8 System status, battery status, lead fail, noisy data, reversed leads, writer door status, out of paper
Median complex for contour analysis, rhythm-for-rhythm analysis 10 10.4" color LCD Not specified Not specified System status, battery status, lead fail, noisy data, loose contact, reverse leads, out of paper
55

MODEL MORTARA ELI 100 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Yes Yes MORTARA ELI 200 Yes Yes MORTARA ELI 250 Yes Yes MORTARA Landscape Yes Yes
Yes 100/240 VAC
Yes 100/240 VAC
Yes 100-240 VAC
Yes 100/240 VAC
H x W x D, cm (in)
9.5 x 28.6 x 29.2 (3.8 x 11.3 x 11.5) 4.9 (11) Yes Gel cell Not specified 4 (>1,000 ECG), rechargeable battery Not specified
12.1 x 43.8 x 35.6 (4.8 x 17.3 x 14) 11.3 (25) Yes Gel cell Not specified 4 (>1,000 ECG), rechargeable battery Not specified
8.9 x 38.1 x 43.2 (3.5 x 15 x 17) 4.5 (10) with battery Yes Gel cell Not specified Not specified Not specified
See footnote *
See footnote ** Yes Gel cell Not specified/12 4 Not specified
Not specified 3 years mail-in Immediate Not specified Not specified
Not specified 3 years mail-in Immediate Not specified Not specified
Not specified 1 year, parts and labor Not specified Yes 2003
Not specified 3 years mail-in or 1 year on-site Immediate Not specified Not specified
Not specified Not specified Simultaneous 12-lead acquisition; artifact filter; multiple print formats; >1,000 ECGs/ battery charge; X-12 wireless patient cable, internal modem.
Not specified Not specified Simultaneous 12-lead acquisition; artifact filter; multiple print formats; >1,000 ECGs/ battery charge; X-12 wireless patient cable, internal modem, serial comparison, and expanded ECG storage optional.
Not specified Not specified Simultaneous 12-lead acquisition; multiple print formats; waveform preview; large paper tray; short form instruction card on writer cover; patient directory sorted by user preference; internal modem; pre-populate ID entry via patient directory; internal storage.
Not specified Not specified Simultaneous 12-lead acquisition; highresolution color LCD for display of all 12 leads; sourceconsistency filter; multiple print formats; X-12 wireless patient cable; serial comparison; internal modem optional.
Colons separate data on similar models of a device. * 5.3 x 33 x 27.9 cm (2.1 x 13 x 11 in), monitor and writer; 3.6 x 26.7 x 27.9 cm (1.4 x 10.5 x 11 in), monitor only. ** 4.5 kg (10 lb), monitor and writer; 1.8 kg (4 lb), monitor alone.
56

MODEL MORTARA Portrait WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Mobile Yes NASIFF CARDIO Diagnostic System Worldwide, except Western Europe Yes No Adult/ped/neonate PC/Windows Optional NIHON KOHDEN ECG (-9130K : -9320A-2 : -9320A-3) USA Yes Yes Adult/ped/neonate Mobile Optional PHILIPS PageWriter 10/10i Worldwide Yes Yes Not specified Handheld No
Customizable 2.5, 5, 10, 10/5, 20 Automatic
Automatic/manual 5, 10, 20 Selectable
0.05-160 Source-consistency filter
0.05-120 or higher 50/60 Hz line filters, 40 Hz muscle tremor, baseline >100 >120 Real time, reversal Laser, ink jet, dot matrix, any PC printer PC printer Depends on printer Automatic Yes Yes 25, 50
0.05-100, 0.05-150 AC, baseline, EMG
0.05-150 Baseline wander, noise, artifact
Exceeds standards Exceeds standards Yes Digital thermal array Yes 8.5 x 11" Automatic Yes No 5, 10, 25, 50
10 110 Yes Digital thermal
100 110 Yes Optional infrared connect No NA Automatic Yes No NA
Not specified 216 mm Yes Yes Yes 5, 10, 12.5, 25, 50
12
12
12 : 12 : 12, 15
12
6, 12, 3 + 3, 6 + 60 sec Yes Modem, direct
1, 2, 3, 6, 12 Yes Fax, modem, e-mail attachment, LAN, satellite
3, 4, 6, 12 Analog, digital Not specified
NA Optional Fax, programmable modem, RS232
57

MODEL MORTARA Portrait MICROPROCESSOR Programs NASIFF CARDIO Diagnostic System Resting, full disclosure stress, Holter, NIBP, SpO2, temperature Yes Unlimited NIHON KOHDEN ECG (-9130K : -9320A-2 : -9320A-3) Measurements, analysis PHILIPS PageWriter 10/10i
Adult resting ECG, serial comparison, signal-line averaging, 12-lead Holter Not specified Up to 300
Not specified 3,200
Not specified 30 (flash)
Unlimited Name, SSN, age, sex, medications, physicians, height, weight, address, full chart, more available
9,600 (ECG-9320A) ID, name, age/birthdate, sex, height, weight, race, BP (systolic and diastolic)
NA ID
MEASUREMENTS
Yes Yes Diagnosis, measurements, reason statements; serial comparison
HR, R-R, P duration, PR interval, QRS duration, P/R/T axes, QT/QTC, electronic caliper for manual measurement * Via Holter module Yes ** Diagnostic, global and full measurements, electronic caliper, reason statements, serial comparisons Medical complex
QRS rate, PR interval, QRS duration, QT/QTC, P/QRT/T axes, RV5/SV1
HR, PR, QT, QTC, PQRST axis
Yes Detail measurements Yes
No No Optional
Analyzed waveform
Median complex for contour analysis, rhythm-for-rhythm analysis 8 Yes Not specified Not specified System status, battery status, lead fail, noisy data, loose contact, reverse leads, writer door status, out of paper
Yes
Each individual waveform from leads
12 Yes PC monitor (CRT/LCD) Not specified Loose contact, failed lead, noise, bad data
10 Yes 12-lead Not specified Low battery, leads off, paper empty
2.5 LCD Not specified Not specified Lead off, low battery
Colons separate data on similar models of a device. * Also ST slope/elevation. ** Resting, historical/serial comparisons, stress summary and complex reports, Holter summary reports, ECG reports, etc.
58

MODEL MORTARA Portrait AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Yes Yes NASIFF CARDIO Diagnostic System R wave, respiration Not specified NIHON KOHDEN ECG (-9130K : -9320A-2 : -9320A-3) Analog, digital Analog, digital PHILIPS PageWriter 10/10i Yes No
Yes 100/240 VAC
Yes Any PC power source
Yes 110 VAC, 60 Hz
Yes 110/220 VAC
H x W x D, cm (in)
53.3 x 36.8 x 11.4 (21 x 14.5 x 4.5) 13.6 (30) Yes Gel cell Not specified 4 Not specified
5.1 x 10.2 x 11 (2 x 4 x 5) 0.7 (1.5) No Uses PC power Uses PC power Uses PC power Uses PC power
17.3 x 42.5 x 15.7 (6.8 x 16.7 x 6.2) 13.8 (30.4) Yes Lead acid 1/12 0.5 1 : 0.5 : 0.5
6.1 x 17 x 20.3 (2.4 x 6.7 x 8.2) 1 (2.2) Yes Ni-MH Not specified 1 Not specified
Not specified 1 year on-site Immediate Not specified Not specified
$2,195 2 years plus free software upgrades Stock Available 1990
Not specified 3 years Purchaser definable Optional 2000 : 1999 : 2000
$2,350 1 year 1 week Not specified 2000
Not specified Not specified Simultaneous 12-lead acquisition; high-resolution LCD for display of all 12 leads; sourceconsistency filter; multiple print formats; optional X-12 wireless patient cable, internal modem, stress testing, 12-lead Holter monitoring, and signal averaging.
Not specified Not specified Integrated patient record database; clinical ECG management system; telecommunication utility; remote monitoring software; EMR chart, stress option, Holter opttion; NIBP, SpO2, temperature.
Not specified April to April RS232C ports; optional modem connections, flashcard storage, and stress-test recording.
Not specified Not specified Meets requirements of CSA, TUV, and UL.
59

MODEL PHILIPS PageWriter 100 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Tabletop/cart mount Optional PHILIPS PageWriter 200 Worldwide Yes Yes Not specified Tabletop/cart mount Optional PHILIPS PageWriter 300 PI Worldwide Yes Yes Not specified Tabletop/cart mount Optional PHILIPS PageWriter XLi Worldwide Yes Yes Not specified Tabletop/cart mount Optional
100 110 Yes Digital thermal array Yes 8.5 x 11", A4 Automatic Yes No 5, 10, 25, 50
100 Not specified Yes Digital thermal array Yes 8.5 x 11", A4 Automatic Yes No 5, 10, 25, 50
12
12
12
16
3, 6, 12 No NA
3, 6, 12 Optional Fax, programmable modem, RS232
60

MODEL PHILIPS PageWriter 100 MICROPROCESSOR Programs PHILIPS PageWriter 200 PHILIPS PageWriter 300 PI PHILIPS PageWriter XLi
Not specified None
Not specified Optional 30 (flash)
Not specified Optional 30 (flash)
Not specified 50-150 (diskette)
NA None
NA Name, ID no., room, age, sex, height, weight, operator, department, BP, requested by, user-defined 1, user-defined 2
NA Name, ID no., room, age, sex, height, weight, operator, department, BP, requested by, user-defined 1, user-defined 2
See Other Specifications Name, ID no., age, sex, height, weight, BP, race, Rx, Dx, operator, room, department, requested by, user-defined 1, user-defined 2
MEASUREMENTS
No No No
No No No
No No Diagnosis, measurements, reason statements
No Yes Diagnosis, measurements, reason statements, graphical axis
Analyzed waveform
NA
NA
NA No Not specified Not specified Lead off, low battery
NA LCD Not specified Not specified Lead off, low battery
2.5 LCD Not specified Not specified Lead off, low battery
2.5 LCD Not specified Not specified Loose contact, artifact, low battery
61

MODEL PHILIPS PageWriter 100 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS No No PHILIPS PageWriter 200 Optional No PHILIPS PageWriter 300 PI Optional No PHILIPS PageWriter XLi Yes No
Yes 110/220 VAC
Yes 110/220 VAC
Yes 110/220 VAC
Yes 110/220 VAC
H x W x D, cm (in)
10.2 x 43.2 x 38.1 (4 x 17 x 15) 8.6 (19) Yes Lead acid Not specified 40 min Not specified
14 x 56.5 x 39.4 (5.5 x 22.3 x 15.5) 21.8 (48) Yes Lead acid Not specified 40 min Not specified
$2,750 3 years in USA 1 week Not specified 1994
$9,350 3 years 1 week Not specified 1990
Not specified Not specified Meets requirements of CSA, TUV, and UL; standard ACI and TPI.
Not specified Not specified Simultaneous 16-lead acquisition; remote start button; 3.5" disk drive storage; data can be stored at 500 Hz sample rate; acute cardiac ischemia predictive instrument; optional late potential SAECG and vectorcardiography Meets requirements of CSA, TUV, and UL.
62

MODEL PHILIPS PageWriterTouch WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Cart mount Integrated cardiograph/cart system Automatic 5, 10, 20 Automatic PHYSIO-CONTROL LIFEPAK 12 Worldwide Yes Yes Not specified Portable Not specified PROGETTI EPG 6 View Worldwide No Yes Adult/ped/neonate Portable Optional PROGETTI EPG 612 Worldwide No Yes Adult/ped/neonate Portable Optional
Automatic/manual See footnote * Internal autocal
Automatic/manual 5, 10, 20 Not specified
0.05-40 or 0.05-150 50/60 Hz notch
0.05-145 Notch, EMG
0.05-100 Notch, EMG
100 110 Location onscreen Digital thermal array Yes 8.5 x 11", A4 Automatic Yes No 5, 10, 25, 50
Not specified 90 Yes Digital thermal array Yes 50 mm x 75 ft roll or 100 mm x 55 ft Yes Yes Yes 25, 50 (12-lead, time based)
>100 >110 Yes Dot matrix
100 100 Yes Dot matrix
Yes 110 mm x 25 m Yes Yes Yes 5, 10, 25, 50
12
12
12
12
3, 6, 12 Optional LAN, optional wireless LAN and modem
3, 4 Yes Modem and cell phone or direct connect to a PC
6 Yes RS232
6 Yes RS232
Colons separate data on similar models of a device. * 10 automatic; 2.5, 5, 10, 15, 20, 25, 30, 40 manual.
63

MODEL PHILIPS PageWriterTouch MICROPROCESSOR Programs PHYSIO-CONTROL LIFEPAK 12 PROGETTI EPG 6 View PROGETTI EPG 612
Adult and pediatric resting ECG and 12lead ECG Not specified 2 full-capacity records, up to 100 single waveforms events & annotations Cascading ECG, trend summary report Name, ID no., age, sex, date
RIC
Not specified
Not specified Several hundred in flash memory, 10 on floppy diskette
Yes 12
Yes 12
Several thousand on PC card Name, ID no., age, sex, race, Sx, Hx, Dx, DRG, BP, Rx, reason for order, MD name, UPIN, order number, encounter ID, stat ECG, department, operator ID, room, weight, height, user defined HR, PR, QT, QTC, PQRST axis
No Yes
No No
MEASUREMENTS
HR, PQRST axis, PR interval, QRS, QT/QTC
Yes
Yes
No See Other Specs Diagnosis, measurements, reason statements, graphical axis
Yes Yes Diagnostic statements, measurements
Yes Yes Yes
No No Yes
Analyzed waveform
Average beat and each individual waveform from leads
Yes
Yes
10 Complete printed ECG See footnote * Not specified Loose contact, artifact, low battery
10 No EL or LCD Not specified 12-lead too noisy, leads off, pacer on interpretation suppressed, progress messages, system status messages, data-transmission messages
10 Yes Graphic 3, 6 ECG channels
10 No Info NA Data of recordings
Colons separate data on similar models of a device. * 15" diagonal color liquid crystal touchscreen.
64

MODEL PHILIPS PageWriterTouch AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Yes No PHYSIO-CONTROL LIFEPAK 12 Yes No PROGETTI EPG 6 View Yes Yes PROGETTI EPG 612 Yes No Yes Yes 110/220 VAC Yes 5 removable/replaceable battery type options 31.8 x 38.9 x 21.6 (12.5 x 15.3 x 8.5) 6 (13.2) without batteries Yes See footnote * Not specified Depends on type of display Not specified Yes 110/220 VAC 110/220 VAC
H x W x D, cm (in)
45 x 45.8 x 16 (17.7 x 18 x 6.3) 14 (30.9) Yes Lithium-ion SMART 2/10.8 40 min Not specified
24 x 16 x 6 (9.4 x 6.3 x 2.4) 2 (4.4) Yes Ni-Cd Not specified/12 5 3
22 x 19 x 6 (8.7 x 7.5 x 2.4) 1.9 (4.2) Yes Ni-Cd Not specified/12 5 3
$14,900 1 year 1 week Not specified 2003
$7,995-17,995 1 year; 5 years in hospital Not specified Not specified Not specified
Not specified 1 year Immediate 10% of list price 2002
Not specified 1 year 3 weeks 10% of list price 1999
Not specified Not specified Optional magneticcard reader; optional bar-code reader; ECG snapshots can be shown as thumbnails in INDEX or full size in PREVIEW; 1 min full-size FD for 1 lead printout or 5 min half-size FD for 3 lead printouts.
Not specified Not specified Uses Marquette 12SL analysis program for pediatric and adult analysis; configurable to include AED and manual defibrillation; upgradable; data storage and retrieval; fax transmission; MUSE CV and LIFENET compatible; enhanced battery system; external pacing and SpO2 optional; ADAPTIV biphasic waveform technology; NIBP; EtCO2; 2 IBP lines; vital signs trending; ST-segment monitoring.
NA/not specified Not specified Parameter calculation; connects to SA2; 240 x 320 LCD, 3/6 channels.
NA/not specified Not specified Connects to spirometer; multiple languages.
Colons separate data on similar models of a device. * 5 removable and replaceable battery-type options: FASTPAK (Ni-Cd), FASTPAK 2 (Ni-Cd), LIFEPAK SLA (sealed lead acid), LIFEPAK 1.7 A-hr (Ni-Cd), or LIFEPAK 2.4 A-hr (Ni-Cd).
65

MODEL PROGETTI EPG Plus WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide No Yes Adult/ped/neonate Portable Optional PROGETTI EPG View Worldwide No Yes Adult/ped/neonate Portable Optional QRS DIAGNOSTIC Biolog 12 Channel ECG Worldwide Yes Yes Adult/pediatric Portable, PC based NA QRS DIAGNOSTIC EKGCard Worldwide Yes Yes Adult/pediatric Portable, PC based NA
Automatic 0.5, 1, 5, 10, 20 Automatic
0.05-100 Notch, EMG
0.05-145 Notch, EMG
0.05-175 Power filter (50 or 60 Hz), EMG
100 100 Yes Dot matrix
>100 >110 Yes Dot matrix
12.4 103 Yes Laser, dot matrix, ink jet No 8.5 x 11", A4 Yes No Yes 12.5, 25, 50
12.4 103 Yes Laser, dot matrix, ink jet No 8.5 x 11", A4 Yes No No 12.5, 25, 50
Yes 60 mm x 25 m Yes Yes Yes 5, 10, 25, 50
12
12
12
12
3 Yes RS232
3 Yes RS232
12 Yes Modem
12 Yes Network
66

MODEL PROGETTI EPG Plus MICROPROCESSOR Programs PROGETTI EPG View QRS DIAGNOSTIC Biolog 12 Channel ECG Resting ECG QRS DIAGNOSTIC EKGCard
Not specified
RIC
Resting ECG
Yes 12
Yes 12
No Unlimited
No Unlimited
None No
No Yes
NA ID no., DOB, sex, height, weight, race
NA Name, ID no., DOB, sex, height, weight, race
MEASUREMENTS
Yes
Yes
HR, P, PR, QRS, QT, QTC, P axis, QRS axis, T axis
No No Yes
Yes Yes HES algorithm
No Not specified Narrative interpretation, measurements
Analyzed waveform
Yes
Yes
Not specified
Not specified
10 No Info NA Data of recordings
10 Yes Graphic 3 ECG channels
10 Yes Yes 12 Lead off
67

MODEL PROGETTI EPG Plus AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Yes No Yes Yes 110/220 VAC 110/220 VAC Yes 110/220 VAC, battery Yes 110/220 VAC, battery PROGETTI EPG View Yes Yes QRS DIAGNOSTIC Biolog 12 Channel ECG Yes Yes QRS DIAGNOSTIC EKGCard No No
H x W x D, cm (in)
13.3 x 8.3 x 1 (5.2 x 1.2 x 0.4) 0.27 (0.6) Yes AA 2/not specified 6 Not specified
9.1 x 8.5 x 2 (3.4 x 3.3 x 0.8) 0.28 (0.6) Optional Not specified Not specified Not specified Not specified
Not specified 1 year 3 weeks 10% of list price 1998
Not specified 1 year Immediate 10% of list price 2001
$2,495 w/interp 3 years Immediate $200/year 1993
Not specified Not specified Connects to spirometer; multiple languages.
NA/not specified Not specified Parameter calculation; 240 x 320 LCD; 3 channels.
Not specified January to December None specified.
68

MODEL QRS DIAGNOSTIC Universal ECG WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Adult/pediatric Portable, PC based NA SCHILLER AT-104 PC Worldwide Yes Yes Not specified Portable, self-sufficient PC-ECG Optional SCHILLER CardioLaptop AT-110 Worldwide Yes Yes Not specified Mobile Optional SCHILLER CardioLaptop PT-160 Worldwide Yes Yes Not specified Mobile Optional
Automatic/manual 2.5, 5, 10, 20 Automatic, manual
0-150 Notch, EMG, digital smoothing filters
0.05-150 Notch, EMG, digital smoothing, baseline, myogram line >100 >100 Yes Digital thermal array Yes 8.3 x 5" Automatic Yes Yes 10, 25, 50
0.05-150 Notch, EMG, digital smoothing, baseline, myogram line >100 >100 Yes Digital thermal array Yes 8.3 x 8.3" Automatic Yes Yes 10, 25, 50
12.4 103 Yes Laser, dot matrix, ink jet No 8.5 x 11", A4 Yes No No 12.5, 25, 50
>100 100 Yes Digital thermal array External via PC 3.5", 8.5 x 11" via PC Automatic Yes Yes 10, 25, 50
12
12
12
12
12 Yes Network
3, in stand alone, no real time via PC Yes RS232
6, 12 Yes RS232, Ethernet
6, 12 Yes RS232, Ethernet
69

MODEL QRS DIAGNOSTIC Universal ECG MICROPROCESSOR Programs SCHILLER AT-104 PC SCHILLER CardioLaptop AT-110 SCHILLER CardioLaptop PT-160
Resting ECG
Adult and pediatric resting ECG, stress testing, BP No Unlimited, via PC
Adult and pediatric ECG, stress testing, BP Direct function keys Unlimited
Adult and pediatric ECG, stress testing, BP Direct function keys Unlimited
No Unlimited
NA Name, ID no., DOB, sex, height, weight, race
Unlimited, via PC Name, ID no., age, sex, height, weight, BP, medication, comments, DOB, room no., referring physician
Unlimited Name, ID no., DOB, sex, race, height, weight, BP, date, time, medications, physician, location, comments
Unlimited Name, ID no., DOB, sex, race, height, weight, BP, date, time, medications, physician, location, comments
MEASUREMENTS
PR, QRS, QT, QTC, HR, P, Q, R, S, T, QT dispersion
PR, QRS, QT, QTC, HR, P, Q, R, S, T
Yes See footnote * Diagnosis, measurements, reason statements
Analyzed waveform
Not specified
10 PC monitor, CRT Not specified 12, on PC monitor Reversed leads, muscle tremor, loose contact, baseline wander, system status, low battery, hookup test
10 Color TFT Not specified 12 Reversed leads, muscle tremor, loose contact, baseline wander, system status, low battery, hookup test
10 Color TFT Not specified 12 Reversed leads, muscle tremor, loose contact, baseline wander, system status, low battery, hookup test
Colons separate data on similar models of a device. * Summary graphs of BP, speed/elevation, HR, tabular final report, ST-trend graphs, average complex graphs, full-disclosure rhythm of entire stress test, user-customizable, CS-200 model also with VES and arrhythmias.
70

MODEL QRS DIAGNOSTIC Universal ECG AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS No No SCHILLER AT-104 PC Yes Yes SCHILLER CardioLaptop AT-110 Yes Yes SCHILLER CardioLaptop PT-160 Yes Yes
Yes 110/220 VAC, battery
Yes 110/130/220/240 VAC, 50/60 Hz 5 x 15 x 23 (2 x 6 x 9) 1.9 (4.2) Yes Ni-Cd 1/7.2 2.5 4
Yes 90-240 VAC
Yes 115/230 VAC
H x W x D, cm (in)
9.1 x 8.5 x 2 (3.4 x 3.3 x 0.8) 0.28 (0.6) Optional Not specified Not specified Not specified Not specified
100 x 350 x 285 (39.4 x 137.8 x 112) 6.8 (15) Yes Lithium 1/12 30 min 2
130 x 432 x 332 (51.2 x 170 x 130.7) 12.7 (28) Yes Lead acid 1/12 50 min 2
Not specified 1-3 years 2-4 weeks On request 1996
Not specified/>2,150 January to December PC-ECG; can also be conventional 3channel ECG recorder; standard resting ECG with interpretation for adults and peds; QT dispersion; data management exercise ECG; signal averaging; HR variability; pacemaker analysis; integrated data management program SEMA. Meets requirements of BSI, CSA, Homologation, IEC 601-1, ISO 9001, MET, UL 544, and VDE.
Not specified January to December PC-based system with Windows NT; 128 MB RAM; 5 RS232 interfaces; parallel interface; Ethernet; integrated to HIS over exp/imp. Meets requirements of BSI, CSA, Homologation, IEC 601-1, ISO 9001, MET, UL 544, and VDE.
Not specified January to December PC-based system with Windows NT; 128 MB RAM; 5 RS232 interfaces; parallel interface; Ethernet; integrated to HIS over exp/imp. Meets requirements of BSI, CSA, Homologation, IEC 601-1, ISO 9001, MET, UL 544, and VDE.
71

MODEL SCHILLER CARDIOVIT AT-1 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Tabletop, portable Optional SCHILLER CARDIOVIT AT-2 Worldwide Yes Yes Not specified Tabletop, portable Optional SCHILLER CARDIOVIT AT-2plus Worldwide Yes Yes Not specified Tabletop, portable Optional SCHILLER CARDIOVIT AT-4 Worldwide Yes Yes Not specified Tabletop, portable Optional
Automatic/manual 2.5, 5, 10, 20 Automatic
0-150 Notch, EMG filters
0-150 Notch, EMG, baseline and smoothing filters >100 100 Yes Digital thermal array Yes A4, 8.5" x 11" Automatic Yes No 5, 25, 50
0-150 Notch, EMG filters, baseline
0.05-150 Notch, EMG, digital smoothing filters
>100 90 Yes Digital thermal array Yes 90 mm, 3.5" wide Automatic Yes No 5, 25, 50
>100 100 Yes Digital thermal array Yes A4, 8.5" x 11" Automatic Yes No 5, 10, 25, 50
100 >100 Yes Digital thermal array Yes 90 x 90 mm, 3.5" width Automatic Yes No 5, 10, 25, 50
12
12
12
12
3 No NA
6 real time, 12 auto point No NA
6, 12 Yes RS232
3 Yes RS232
72

MODEL SCHILLER CARDIOVIT AT-1 MICROPROCESSOR Programs SCHILLER CARDIOVIT AT-2 SCHILLER CARDIOVIT AT-2plus SCHILLER CARDIOVIT AT-4
Adult resting ECG
Adult resting ECG
No None
No None
Yes Optional, up to 40
No 40
None Name, ID, age, sex, height, weight, BP, medication
None Name, ID, age, sex, height, weight, BP
NA Name, age, sex, user ID, height, weight, BP, medication, comments, recording conditions (date, time, filter)
NA Name, ID no., age, sex, height, weight, BP, medication, comments, date, time
MEASUREMENTS
HR, RR, P, PR, QRS, QT, ATC, axis, T Sokolow
HR, RR, P, PR, QRS, QT, QTC, axis, T Sokolow
HR, RR, P, PR, QRS, QT, QTC, axis, T Sokolow
HR, RR, P, PR, QRS, QT, QTC, axis T
Yes No Diagnosis, measurements, reason statements
Analyzed waveform
10 No No NA Lead group, loose electrodes, battery operation, low battery, power, paper, filter status
10 No No NA Lead group, loose electrodes, battery operation, low battery, power, paper, filter status
10 LCD,14x12",120x90 mm Not specified 3 Lead group, loose electrodes, battery status, date, time, power, paper, filter status, source
10 LCD, 125 x 90 mm Not specified 12 via PC Muscle tremor, loose contact, baseline wander, system status, low battery, hookup test
73

MODEL SCHILLER CARDIOVIT AT-1 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS No No SCHILLER CARDIOVIT AT-2 No No SCHILLER CARDIOVIT AT-2plus Yes Yes SCHILLER CARDIOVIT AT-4 Yes DC input 0.5 V/cm
Yes 110-115/220-240 VAC, 50/60 Hz 6.9 x 29 x 21 (2.7 x 11.4 x 8.3) 2.9 (6.5) Built-in charger Lead acid 1/12 2 4
Yes 110-115/220-240 VAC, 50/60 Hz 10.1 x 40 x 33 (4 x 15.7 x 13) 4.8 (10.6) Built-in charger Lead acid 1/12 5 6
Yes 100-115/220-240 VAC, 50/60 Hz 10.2 x 40 x 33 (4 x 15.7 x 13) 5 (11) Built-in charger Lead acid 2/12 4 6
Yes 90-250 VAC, 50/60 Hz
H x W x D, cm (in)
5 x 23 x 15 (2.0 x 9.1 x 5.9) 1.9 (4.3) Built-in charger Lead acid 1/9.6 1.5 2.5
Not specified 1-3 years Not specified On request 1995
Not spec/>40,000 January to December Meets requirements of BSI, CSA, Homologation, IEC 601-1, ISO 9001, MET, UL 544, and VDE.
Not specified/>6,000 January to December Meets requirements of BSI, CSA, Homologation, IEC 601-1, ISO 9001, MET, UL 544, and VDE.
Not specified/>9,700 January to December Spirometry; automatic ECG measurements and interpretation; data transmission and archiving on a PC. Meets requirements of BSI, CSA, Homologation, IEC 601-1, ISO 9001, MET, UL 544, and VDE.
Not specified/>4,200 January to December Telemedicine optional. Meets requirements of AAMI, AHA, CSA, Homologation, IEC 601-1, ISO 9001, UL, and VDE.
74

MODEL SCHILLER CARDIOVIT AT-10 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Yes Yes Not specified Tabletop, portable Optional SCHILLER CARDIOVIT AT-102 Worldwide Yes Yes Not specified Tabletop, portable Optional SCHILLER CS-200 Worldwide Yes Yes Not specified Mobile Cart mounted SCHWARZER Cardos 12 Worldwide No Yes Not specified Portable, cart Not specified
Automatic/manual 2.5, 5, 10, 20 Automatic
Automatic/manual 5, 10, 20, 40 Automatic, manual
Not specified 5, 10, 20 Not specified
0-150 Notch, EMG, filters, baseline
Not specified 35, 50 Hz
>100 100 Yes Digital thermal array Yes, & laser via PC 210 mm width (8.5" x 5.5") Automatic No No 2.5, 5, 10, 12.5, 25, 50, 100
>100 100 Yes Digital thermal array Parallel port A4, 8.5 x 11" with parallel port Automatic Yes No 5, 25, 51
>100 100 Yes Digital thermal array Yes 8.5 x 11" Automatic Yes Yes 5, 10, 12.5, 25, 50
Not specified Not specified Not specified Thermal printer, laser jet Yes 210 x 150 mm thermal Not specified Not specified Not specified 1, 2, 5, 20, 25, 50, 100
12
12
12
12
3, 6, or 8 Yes RS232
6 real time, 12 auto point, 6 or 12 No RS232
12 Yes RS232
Not specified Yes Fiberoptic
75

MODEL SCHILLER CARDIOVIT AT-10 MICROPROCESSOR Programs SCHILLER CARDIOVIT AT-102 SCHILLER CS-200 SCHWARZER Cardos 12
Adult and pediatric resting ECG; stress testing, BP, and spirometry options Yes Up to 45
Adult/pediatric resting ECG, basic stress test Yes Standard up to 40
Adult and pediatric resting ECG, stress testing, BP Yes Unlimited (hardware)
Resting ECG, stress testing, long-term ECG, BP, late potentials Not specified Not specified
NA Name, ID no., age, sex, height, weight, BP, medication, comments, DOB, room no., referring physician
None Name, ID no., DOB, age, sex, height, weight, BP, medication
Unlimited (hardware) Name, ID no., DOB, sex, race, height, weight, BP, date, time, medications, physician, location, comments
Not specified Name, ID no., DOB
MEASUREMENTS
HR, RR, P, PR, QRS, QT, QTC, axis T
HR, RR, P, PR, QRS, QT, QTC, axis T Sokolow
Not specified
Yes No HES program
Analyzed waveform
Signal averaging
10 LCD, 25.4 cm (10 in) Not specified 3, 6, 8 Reversed leads, muscle tremor, loose contact, baseline wander, system status, low battery, hookup test
10 LCD,14x12",120x90 mm Not specified 3 Lead group, loose electrodes, battery operation, low battery, power, paper, filter status
10 PC monitor, CRT Not specified 12 Reversed leads, muscle tremor, loose contact, baseline wander, system status, low battery, hookup test
10 LCD Not specified Not specified Impedance
Colons separate data on similar models of a device. * Summary graphs of BP, speed/elevation, HR, tabular final report, ST-trend graphs, average complex graphs, full-disclosure rhythm of entire stress test, user-customizable, CS-200 model also with VES and arrhythmias.
76

MODEL SCHILLER CARDIOVIT AT-10 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS Yes Yes SCHILLER CARDIOVIT AT-102 Yes Yes SCHILLER CS-200 Yes Yes SCHWARZER Cardos 12 Not specified Not specified
Yes 110/130/230/240 VAC, 50/60 Hz 7 x 32 x 21 (2.8 x 12.6 x 8.2) 4.7 (12) Yes Lead acid 2/12 1 4
Yes 110-115/220-240 VAC; 50/60 Hz 10.1 x 40 x 33 (4 x 15.7 x 13) 5 (11) Built-in charger Lead acid 1/12 4 6
Yes 110/130/220/240 VAC
Not specified 110/240 VAC
H x W x D, cm (in)
153 x 62 x 60 (60.1 x 24.4 x 23.6) 71 (167.7) Yes Lead acid 2/12 3 min Not specified
9 x 34 x 35 (3.5 x 13.4 x 13.8) 4.3 (9.5) Yes Not specified Not specified Not specified Not specified
$5,995+ * 1-3 years 2-4 weeks On request 1993
Not specified 1 year 2-4 weeks On request 1999
$5,000 1 year Not specified Not specified Not specified
Not spec/>10,000 January to December Spirometer function; built-in stress test; rhythm report; laptop design; optional signaling averaging, R-R variability. Meets requirements of BSI, CSA, Homologation, IEC 601-1, ISO 9001, MET, UL 544, and VDE.
Not specified/>240 January to December Spirometry; automatic ECG measurements and ECG interpretation; data transmission and archiving on a PC. Meets requirements of BSI, CSA, Homologation, IEC 601-1, ISO 9001, MET, UL 544, and VDE.
Not specified/>1,900 January to December PC-based system with Windows 98 PC system; 128 MB RAM; 2 RS232 interfaces; parallel interface; QT dispersion; integrated to HIS over exp/imp; optional spirometry, 12channel FD, vector loop, late potential, ergo-spiro. Meets requirements of BSI, CSA, Homologation, IEC 601-1, ISO 9001, MET, UL 544, and VDE.
Not specified Not specified Network; database; visual indicators for connection with Cardos; complete data management for statistics, reimbursement.
Colons separate data on similar models of a device. * Price current as of October 2001.
77

MODEL ST ELECTROMEDICINA ST 563 WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered Worldwide Not specified Yes Adult/pediatric Portable Optional SUZUKEN Kenz-ECG-303 Worldwide Yes No Not specified Portable Optional TEPA EKG Master USB Middle East, Turkey No Submitted Adult/pediatric Mobile and portable Optional VON BERGMEDIZINGERAETE BIOSET 3700 Europe Not specified Yes Adult/ped/neonate Portable Optional
Automatic 5, 10, 20, 40, 80 Automatic
Automatic/manual 5, 10, 20, V/2 changeover Automatic
0.05-150 Notch, EMG, antidrift
0.05-100 Digital filters for AC, drift, and EMG
0.05-300 Notch; baseline, 20, 40, 100 Hz EMG
>100 >90 Yes Thermal dot matrix
100 100 No Digital thermal array Yes 7 x 11" Yes Yes No 5, 10, 20
>5 120 No MS Windows-supported printers No A4 Automatic No No 10, 25, 50
2 x 20 100 Yes Digital thermal array Not specified 110 mm x 18 m Automatic Yes Yes 25, 50
Yes 120 mm Yes Yes No 25, 50
12
12
12
3/6 No NA
3 No NA
12 Yes Modem, local network, Internet
3, 6 Yes RS232C
78

MODEL ST ELECTROMEDICINA ST 563 MICROPROCESSOR Programs SUZUKEN Kenz-ECG-303 TEPA EKG Master USB VON BERGMEDIZINGERAETE BIOSET 3700
HES
Automatic/manual
Resting ECG; optional stress test and high-resolution ECG Yes 10,000/GB memory
Not specified
No 1
Not specified No
Alphanumeric Not specified
Not specified ID no., age, sex
Unlimited Name, ID no., DOB, sex, weight
MEASUREMENTS
QRS, PQ, QTC, ST, QRS axis, Q/R, RIS, P, HR
No
QRS, PR, QT, T, P, durations; R, T, Q, P amplitudes
No
No Not specified Yes
NA NA No
No No No
NA NA No
Analyzed waveform
Yes
NA
Not specified
NA
10 No VGA backlit 3 Power supply, low battery, loose contact, end paper, chart speed, sensitivity, filter
NA No No Not specified None
Not specified Yes Yes 12 Real-time display on PC monitor: 12 channel signals, grid, filters, recording status, HR, display speed and amplitude coefficient
NA Yes LC line Not specified Operating steps
79

MODEL ST ELECTROMEDICINA ST 563 AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS No No SUZUKEN Kenz-ECG-303 Yes Yes TEPA EKG Master USB HR pulse from PC port No VON BERGMEDIZINGERAETE BIOSET 3700 Optional Optional
Yes 115/230 VAC
Yes 110-120/220-240 VAC
Yes From USB port of PC, no battery needed 4 x 19 x 10 (1.6 x 7.5 x 4) without PC and cart 0.4 (0.9) without PC and cart Notebook PC Depends on notebook Depends on notebook Depends on notebook Depends on notebook
Yes 110/230 VAC
H x W x D, cm (in)
Not specified
11 x 24.2 x 34.1 (4.3 x 9.5 x 13.4) 5.3 (11.7) No NA NA NA NA
11.5 x 33 x 24 (4.5 x 13 x 9.5) 3 (6.6) Yes Ni-Cd 1/9.6 0.5-2 2
2 (4.4) Yes Ni-Cd Not specified 1 Not specified
Not specified Not specified 1 month Not specified Not specified
$1,000-5,000 1 year 4-6 weeks Vary (quant & site) 2002
$3,000 1 year 4-6 weeks Optional 1995
Not specified Not specified Backlit VGA display. Meets requirements of EN 60601-1, 1-2, 2-25, and 2-51.
Not specified Not specified ID no., date, and time; 1-touch operation. Meets requirements of IEC and JIS.
Not specified January to December PC-based Windows 98/ 00/XP; up to 1 hr recording, ECG data storage and full disclosure printout; 1,000 sps sampling rate.
NA/1,000 January to December Available in German, English, Russian; remote start-up input for various ergometers; 1 serial interface RS232C for data input from ergometer; 3 analog IV inputs.
80

MODEL VON BERGMEDIZINGERAETE BIOSET 9000 E : G Worldwide Not specified Yes Adult/ped/neonate Portable Not specified
WHERE MARKETED FDA CLEARANCE CE MARK (MDD) ADULT/PEDIATRIC/ NEONATE CONFIGURATION Cart LEADS Switching Sensitivity, mm/mV Calibration signal Frequency range, Hz Diagnostic Filtered
0.05-100 : 250 Main, tremor, drift
Not specified Not specified Not specified Digital thermal array Yes 210 x 60 mm (A4) Not specified Not specified Not specified 5, 25, 50
12
3, 6, 12 Yes RS232C
81

MODEL VON BERGMEDIZINGERAETE BIOSET 9000 E : G
MICROPROCESSOR Programs
Adult and pediatric resting ECG, stress testing Alphanumeric 1 : 40
NA Age, sex : ID no., age, sex, height, medication, physician, comments, BP, pacemaker
MEASUREMENTS
HR, PRx1, PEx2, P area, QT, QRS, PQ, ST axis, R, T area
Yes Yes Diagnosis, reason statements, measurements, stress-testing candidacy, graphical trends Average of 10 sec/ lead
Analyzed waveform
10 Not specified : LCD LED : LCD Not specified LED indicator, loose contact, noise, filter mode, low battery
82

MODEL VON BERGMEDIZINGERAETE BIOSET 9000 E : G Not specified Not specified
AUXILIARY OUTPUT AUXILIARY INPUT DEFIBRILLATOR OVERLOAD PROTECTION POWER REQUIREMENTS
Not specified 115/230 VAC
H x W x D, cm (in)
9.8 x 33.8 x 13.4 (3.9 x 13.3 x 5.3) 5.5 (12.1) : <6 (13.2) Yes Not specified Not specified Not specified 2
See footnote * 1 year Not specified Not specified Not specified
Not specified Not specified Variation/language in English, German, Russian, Czech, French. Meets requirements of DIN, IEC 601-1, TUV, and VDE 0750.
Colons separate data on similar models of a device. * $2,800-4,000 : $3,500-4,500.
83

Electrocardiographs, Multichannel Interpretive: Scope of This Product Comparison

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Electrocardiographs, Multichannel Interpretive: Scope of This Product Comparison

Uploaded by

Copyright:

Available Formats

May 2003

Electrocardiographs, Multichannel; Interpretive

Healthcare Product Comparison System

Electrocardiographs, Multichannel; Interpretive

Bipolar and Augmented Leads

Figure 1. The three standard groups of lead configurations

Healthcare Product Comparison System

QRS R-R Interval VAT T Wave P Wave R Amplitude ST P Amplitude T Amplitude

Electrocardiographs, Multichannel; Interpretive

Healthcare Product Comparison System

Electrocardiographs, Multichannel; Interpretive

Standards and guidelines

Healthcare Product Comparison System

Citations from other ECRI publications

Health Devices Inspection and Preventive Maintenance System

Electrocardiographs, Multichannel; Interpretive

Healthcare Product Comparison System

Electrocardiographs, Multichannel; Interpretive

Healthcare Product Comparison System

Electrocardiographs, Multichannel; Interpretive

About the chart specifications

Healthcare Product Comparison System

Need to know more?

Electrocardiographs, Multichannel; Interpretive

Product Comparison Chart

Automatic/manual 5, 10, 20, 5/10, 10/20 Yes

Automatic/manual 5, 10, 20, 5/10, 10/20 Yes

Automatic/manual 5, 10, 20, 5/10, 10/20 Yes

Automatic/manual 5, 10, 20 Yes

>50 Not specified No Digital thermal array Yes 50 mm roll No No No 25, 50

Channels acquired simultaneously Channels printed simultaneously ECG TRANSMISSION Type

3, 4, 6, 12 Yes Modem, SCP-ECG, and/or fax

3, 4, 6, 12 Yes Modem, SCP-ECG, and/or fax

3, 4, 6, 12 Yes Modem, SCP-ECG, and/or fax

1 Yes SCP-ECG and fax

Colons separate data on similar models of a device.

Healthcare Product Comparison System

Product Comparison Chart

Pediatric and adult resting ECG

Pediatric and adult resting ECG

Pediatric and adult resting ECG

Adult/pediatric resting ECG

Keyboard Storage Normal, no. ECGs

Expandable, no. ECGs PATIENT DATA

40 Same as 850 plus height and QTC formula

NA ID no., sex, age, race, medication, clinical classification, location

HR, PR, QRS, QT/QTC, P, R, T axis

Arrhythmia ID Other printouts INTERPRETATION

Yes Yes Diagnosis, measurements, reason statements

Yes Yes Diagnosis, measurements, reason statements

13 No LCD None Noise, drift, lead fail, low battery

13 LCD 3-lead LCD 3 Noise, drift, lead fail, low battery

10 No LCD Not specified Fail

Colons separate data on similar models of a device.

Electrocardiographs, Multichannel; Interpretive

Product Comparison Chart

Yes 115/230 VAC

Yes 115/230 VAC

Yes 115/230 VAC

Not specified 3 years Not specified Yes 2003

$4,200 * 5 years Not specified Yes 1996

$8,950 * 13 months Not specified Yes 1997