The Cardy ECG device was tested in the National Institute for Sports Medicine between 6th and 10th of May. The results of the tests are arranged according to the following criteria:

1. The functional description of the device,
2. The usability and appearance of the device,
3. Comparison with similar, both Hungarian and international devices.

The Cardy is suitable for two functions:

During traditional laboratory ECG tests the Cardy can be connected to the computer as a PC based device, archiving and diagnostics system.

As a totally new solution the Cardy after the programming by a physician is capable of ECG measurements, diagnostics, and information storage, therefore the Cardy can be taken to the patience's sickbed, or can be used for ECG testing at home.

Cardy as a PC based ECG measuring, archiving and diagnostics system

The Cardy connected to a computer works as an intelligent - diagnostic - ECG system. The services of the Cardy system:

- Conventional (12 electrode) ECG monitoring on a PC monitor.
- ECG monitoring: The calculation of time and amplitude parameters.
- The diagnosis according to rhythm and form analysis.
- Graphic comparison: visualization of more than one graph.
- Saving graphs in database.
- The import/export of graphs.
- Printing of graphs, parameters, and diagnosis in A4 format.
The PC-Cardy connection is achieved through a infra unit: the Cardy's built in infra unit provides communication with the PC with serial infra port. This up-to-date connection also fulfills safety standards: the patient is not in galvanic connection with the computer.

Cardy: Mobile ECG device. General description.

The Cardy is a device, which following a physician's first measurement - which is done in the usual way, in an ECG lab - can be used away from the lab, at the bedside of the patient, or at any other chosen place for comparison ECG measurements. During this the basis diagnosis previously entered by the physician and the actual diagnosis on basis of comparison, the device tells the nurse (at sickbed) or the patient (home measurement) in an understandable manner if there is a change. At this time the device shows "No change", "Small change", or "There is change!" sign which warn the user if there is need for consultation with physician. An important element of Cardy is that each ECG measurement completes a differential diagnostic analysis, and according to the pre-set diagnosis generates a "Red Alarm" (immediate consultation with physician is needed), a "Yellow Alarm" (consultation with physician is needed in the near future). The requirements for generating a "Red Alarm": reason for immediate treatment, new, abnormal ECG diagnosis. "Yellow Alarm" is generated when the patient's actual ECG diagnosis is abnormal, but with prior knowledge of the basic disease it does not show major changes in the patient's state, therefore immediate consultation with physician is not essential. After each measurement - both if there is change, and if there is no change - the ECG and the diagnosis are saved in the device, therefore the physician can rerecord those to his computer, and may be used later, during the determination of treatment.

Automatic determinative parameters:
Heart frequency: QRS width, PQ distance, QT distance.
108 amplitude parameter (PPL, PMI, Q, R1, R2, S, ST, TPL, TMI in all electrodes)
36 timeparameters (Q width, S width, QR distance in all electrodes)
The number of diagnosis categories taken into consideration (according to the manual) Rhythmic analysis: 37, Depolarization: 43 Re-polarization: 37

Basis for evaluation and opinion:

A. Hardware

- if it is in accordance with the medical safety requirements
- how easy is its usage (cables, connections, etc.)
- the quality of produced ECG

B. Software

- the relationship between user and device
- the informational context of enclosed user manual
- the use of database
- the graph measurement
- display functions
- the precision of measurement results
- the correctness of diagnosis.

Evaluation

A. The device according to the given descriptions is in accordance with the relevant standards.

The separation of the infra port fulfills the LIFECARE standards. The tested IL200 type infra unit's 3.5 meter long cable made it possible to use the Cardy and connected PC in a comparatively distant position, therefore it may be used in operating theater, or in other locations where sterile environment is needed. The device is equipped with 2 cables: an original, 12 electrode patient cable (MEDICOR), which is medium quality. The other, which is used next to the sickbed, has reduced electrode number, measurements is of better quality, but not as refined in appearance, as the high quality designed of the device. The operation of Cardy is very simple: the instructions appearing on the large alphanumerical display lead the user, with the 4 button user interface (YES, NO, UP ARROW, DOWN ARROW) it is easy to choose the needed function. The quality of the ECG obtained from the device fulfills the specialist's needs, in both the monitor display and registration.

B. Cardy-PC Software

The relationship between user and device: is good. The devices user interface is easily understood and is pleasurable to look at, so even those persons can learn to use it easily and quickly, who do not have working knowledge of computers. The possibility of the "Hot-key" speeds up its use for those, who do not like to use the "mouse". It is a small disadvantage, that the "Help" option does not recognize the "Hot-keys", we recommend its supplementation. The users manual is brief, in some instances too much so.

The use of database is simple, but could be made more sophisticated with a few minor changes. The advantage of the program, that the anamnesis and actual ECG recording's medical opinion can be edited in a different field, but the anamnesis would need more space on the monitor. This is even more so valid, because in the main menu there is a large unused space for the names of the patients. It is unfortunate, that searching can only be done according to the name of the patient, it would be very useful for other scientific research to have other i.e. according to disease classes search options.

In graph measurement we met with some original ideas: the physician can determine what kind of electrodes to use: the fundamental way in which it monitors the traditional 12 electrodes, and then the Cardy analysis this, but these are optional according to need. The automatic block function is good, but it would be good to keep the manual choice as well. The quality of the resulting graph is good, but the position of the Cardy has to be taken into consideration, if it is too close to the computer, or to other source of noise, the signal becomes scrambled. Since the infra can securely communicate through the infra from about 1 meter, the noise free position could be achieved. It is unfortunate that there is no device to help the "visual connection" between the Cardy and the infra: a simple stand or case could help the measuring process, but with a little attention it does not interfere in the process, that the sender (Cardy) and the receiver (infra) have to "look" at each other.
Display functions are sufficient for the physicians needs. The choice for visual comparison must be mentioned, where the graphs measured at different times can be placed under each other. I would like to call attention to 2 imperfections: it would be more fortunate if the devices' diagnosis correction could not only be corrected in the "Opinion" field, but could be done with editing the diagnosis itself. The beginning and ending point of the graph cannot be seen on the monitor: although the physician can check the summary according to the written parameters, a marker might be more functional, but this is according to preferences.

The correctness of diagnosis reaches the level expected from automatic ECG devices at present. (minimum of 95% of decisions are correct, assuming general internist patients. Evidently with special cardiological patient group - i.e. in the evaluation of cardiological intensive care patients - the results were not as high.) The device is not fitted for the analysis of children's ECG, or for the controlling of pacemaker rhythm or function, which does not pose a problem, but it is not mentioned in the Users manual under diagnosis categories. The Cardy's comparative diagnostic ability is totally new: we do not know of a device in use, that compares a saved reference ECG with a measurement made later and sounds the alarm according to the differences is diagnosis'. Cardy can be used with the patients who are not easily moved from sickbed for Electro-cardiology check-ups, the nurse goes to the bed with the device, and makes a recording, then takes the saved recording its self to the ECG lab, and not the patient. The device also notifies if there is a change in the patients Electro-cardiological status. It would be favorable if this function would be able to save the ECG information, and do the comparative diagnosis of more patients. In its present form, the device is particularly practical in the home monitoring of endangered patients: if there is no change, then the measurements done at home reassure the patient, or Cardy directs him to his physician, if the actual measurement makes it necessary.

Summary:

Cardy is a up-to-date, easily usable device, which, connected to a PC, and can easily be used in a normal Electro-cardiology lab, and on its own can be used in a home environment, or by the sick-bed for fast, simple ECG measurements and for analysis.
I find according to the above the device is SUITABLE for medical use.

Budapest, 12th June, 2002

Zoltán Sidó MD
Chief Medical Officer
Internist, cardiology specialist