CARDY® MED: PC-based ECG diagnostics system Operation Manual

Your CARDY® MED PC-based intelligent ECG system provides a double solution:

·         carrying out traditional, laboratory ECG tasks: measurement, analysis, data storing, comparing,

·         plus programming CARDY® HOME, and downloading data from its memory

Installing CARDY® MED

1.       Insert the setup CD in your CD-ROM driver and wait until the installation program starts automatically. If auto run is disabled on your computer, run "Setup.exe" on the CD. Please type your answers to the questions displayed, click on "Next", then "Finish".

2.       Connect the RS IL-200 type infrared connector to a free serial port on your computer. This unit connects your CARDY® MED with your PC. During ECG measurements, this infrared connector is used to send ECG data from CARDY to the PC. The Infrared connector works best if you place CARDY® about 10-20 cms (4-8 inches) in front of the upper infrared window of CARDY®. The infrared connector has a 3.5m (11.5 feet) long cable so that you can comfortably place CARDY® by the patient's bed.

3.       Run "CARDY® Main Program" by double clicking on its icon. The Main Manu will be displayed. When you run this program for the first time, it will establish connection with the infrared unit connected to the PC and displaying the port number. When you run CARDY® Main Program for the first time, start with "Options" (the Hammer icon). Enter the "Doctor's Data" - this would appear on all printed materials. Select "Type": labor if you will use CARDY for laboratory use primarily, or home if you will use CARDY to serve patient CARDY HOME units. This setting will be activated on all measurements; however you can change the Type settings with the "Type" icon on the main menu.

4. The program functions can be found in the main menu: as text in the top row, and as icons below. The right side text fields correspond to the selected patient. The icons below these can be used to erase or modify patient data or to record a new patient. Press F1 for help. A routine measurement is carried out as follows:

• Switch on CARDY by pressing thekey. Put the infrared connector in front of the upper IR window of the device, and place CARDY in a "PC ready" state as follows: if CARDY is empty, press the key. If CARDY is not empty, press the key and hold it for 3 seconds or until "PC ready?" is displayed. Confirm by pressing . "Cardy online!" will be displayed.
• Run the PC program using the "Cardy" icon.
• Check the PC - Cardy connection ("Cardy online" is displayed on the middle bottom line on your PC screen.) If "Cardy offline" is displayed, check Cardy and the infrared connection.
• Record the new patient. Type in the name, nickname, and mother's name - these fields are obligatory. The Case History is displayed on each ECG records. Alternatively, select an existing patient from the list. The heart icon turns red (active.)
• Check the "Type" icon: it should be:
  - a 3 man icon during PC measurement in laboratory state,
  - a 1 man icon during reference measurements in CARDY Home state

If needed, click on the icon to change the state (this change will only affect the current measurement.)

• Enter the monitoring window by clicking on the Heart icon:
• Set the leads to be monitored - right-click on any part of the visualization window to select the leads.
• Start monitoring with the Green light icon:
• If the baseline moves, use the block function
• Amplification and shift can be set with the mouse or the arrow keys.
• Start the measurement with the Tick icon.

1.       Cardy will carry out a 12 second ECG measurement, analysis, and sends the results over to the PC. The computer displays the ECG curves that can also be printed with the Printer icon, or saved with the PC icon.

2.       After saving the data, you can edit the medical opinion text with the "Opinion" tab. The opinion is stored along the ECG measurement and appears on the printout as well. You can display the calculated parameters with the "Parameter" tab.

3.       To display stored data, find the patient (type the first letter of the patient's name to jump forward in the list), then open the patient data by clicking on the + sign. Select the date of the recording by double clicking on it. The ECG curves will be displayed.

4.       To compare ECG curves visually, you can select multiple curves of a particular patient (hold down CTRL while clicking on the curves.) You can view the 6 limb and 6 chest leads separately, but always a maximum of 5 curves at the same time.

5.       Saving and printing "raw ECG" curves

6.       seconds after launching the monitoring function, two icons are displayed: one showing a floppy disk, the other one a printer. The two icons are passive during monitoring, but when you stop monitoring, the icons become active. Use these icons to store or print the last 5 seconds of the ECG curve. You can use these functions by the hot keys "t" and "p". The stored recording is marked "5s". Resume monitoring by clicking on the Green light icon or pressing "s".

7.       Downloading PC recordings to CARDY® for later use as manual equipment

8. You can only use Cardy as a manual equipment (e.g. for measurements at the patient's home) if a reference curve is already stored in Cardy. You can download an existing ECG curve to Cardy from your PC if the curve has an REF or PRC extension. To download a curve, follow these steps:

·         Switch on CARDY by pressing the key. Put the infrared connector in front of the upper IR window of the device, and place CARDY in a "PC ready" state as follows: if CARDY is empty, press the key. If CARDY is not empty, press the key and hold it for 3 seconds or until "PC ready?" is displayed. Confirm by pressing . "Cardy online!" will be displayed.

·         Run the PC program using the "Cardy" icon.

·         Check the PC - Cardy connection ("Cardy online" is displayed on the middle bottom line on your PC screen.) If "Cardy offline" is displayed, check Cardy and the infrared connection.

·         Select the curve to be downloaded from the database (double click on the name, click on the recording - the date of the selected curve will turn blue.)

·         Select "Download recording as reference" from the Cardy menu. The program will complete the download. (If you chose a recording that does not have an REF or PCR extension, the program will display an error code.)

The complete measurement can be carried out from the keyboard as follows:

Help: F1
Select patient: up/down arrows
New patient: Ctrl+N
Modify patient data Ctrl+M
Save and close patient data Ctrl+S
Discard and close patient data "Esc"
Monitoring window: F2
Start/stop monitoring: s
Block: b
Measurement data gathering during monitoring: "Enter"
Exit monitoring window: "Esc":
Display selected recording: F3
Editing opinion for ECG curve: Ctrl+m
Save and close opinion: Ctrl+s
Downloading data from CARDY® HOME Shift+F4
Toggle Cardy type: F5
Printing patient data chart and case history: F6
Settings: F7
Turning Off CARDY®: F8

Using your PC to download data fromand program a CARDY® HOME

Phase one: the doctor programs CARDY® HOME, takes a reference ECG measurement and downloads it to CARDY® HOME. This is when the patient user must be explained the use of Cardy, with special attention to the placement of the electrodes. The doctor also recommends the ideal measurement frequency (e.g. daily, twice weekly, or only when there is a pain). The doctor should also call the attention of the patient to the fact that no matter what Cardy displays, the patient should always consult his or her doctor if the symptoms make this necessary.

Phase two: the patient takes his or her own ECG measurement at home, or office. The measurement is immediately analyzed, and the result is compared with the reference curve. Depending on the differences, CARDY® HOME displays one of the three following messages: "No change", "Small change", "Significant change!" Small change means a minor difference between the current and the reference curve that should be shown to the doctor in a couple of days. Significant change means that the patient must consult a doctor immediately. CARDY® HOME stores these measurements.

Phase three. The patient visits the doctor who downloads the ECG results from CARDY® HOME to his or her PC, then displays these results.

1. Reference ECG measurement. In this mode the Cardy+PC system works as other intelligent ECG devices that analyze, display and print on request. CARDY® takes the ECG cable through a connector, and forwards the ECG signal through the infrared port to the PC. The doctor can monitor the curves on the PC screen, and after the standard signal quality check can initiate the ECG measurement by the push of a button. CARDY® will take a 12 second measurement which it will analyze according to rhythm and form. Results are transferred to the PC. The curves, the calculated time and amplitude values and the diagnosis are displayed on the PC screen. Based on these results the doctor can decide whether to accept the current measurement for a reference curve or not. If the curve is ok as a reference, then after confirmation, CARDY® will store the reference curve in its long term - Flash - memory, and the patient can take it home. The reference curve is also saved on the PC. If the curve is not acceptable as reference, the doctor can re-attempt it. In "Labor" mode data is stored on the PC only.

Measurement steps

1.       Run the program in the usual way: by double clicking on the program icon:

2.       Select the patient with the cursor. Type the first letter of the surname: the program will jump to the first patient whose name starts with that letter. Record a new patient by clicking on the "Patients - New Patient" tab. Type in the name, nickname, and mother's name - these fields are obligatory. The Case History is displayed on each ECG records. Hot keys: Ctrl+N: new, Ctrl+M: edit, Ctrl+S: save.

3.       Place the electrodes on the patient. You can use 4 limb and 6 chest electrodes. Connect a traditional patient cable to CARDY®; it will monitor 12 conventional leads. You can use CARDY's own cable if you use only 6 electrodes (4 limbs along the hip and along the shoulder on the right and the left, plus V2 and V5.)

4.       Switch on CARDY by pressing the O key. Put the infrared connector in front of the upper IR window of the device, and place CARDY in a "PC ready" state as follows: if CARDY is empty, press the key. If CARDY is not empty, press the key and hold it for 3 seconds or until "PC ready?" is displayed. Confirm by pressing . "Cardy online!" will be displayed. The "Cardy type" icon should show a window, meaning the CARDY® should be in "Home" mode.

5.       Select the patient. Start the measurement with the Heart icon (or use hot key: F2). Right click on the raster field, set the leads to be monitored. Default setting: 12 leads; use the left mouse button to remove or reinstall individual leads.

6.       Start monitoring with the Green lights icon (hot key: Ctrl+S)

7.       Check the ECG curve, and if you find it acceptable, click on the Tick icon (hot key: Enter.) If "Connection Error" is displayed, check the CARDY® LCD - it should display "Cardy online". Also, check the infrared connection.

8.       Accept the measurement with the "REF" icon if the ECG and the diagnosis are ok. CARDY® stores the curves and the results as a reference. If storing is successful, the PC switches off CARDY® - the reference measurement is complete.

9.       Teach your patient to carry out measurements at home, with special attention to the placement of the electrodes. You can even draw the place of the V2 and V5 electrodes on the skin. Inform the patient that he or she can have problems where immediate medical attention is needed no matter what CARDY says.

Storing two reference curves for two-user "Home" models

If the PC senses a "Home" model, it displays "Cardy Family ONLINE" at the bottom of the screen. Programming - taking and storing reference measurements - is carried out similarly to the one-user models, with the exception of CARDY® allowing two reference curves to be measured and stored in turns.

Reference measurement steps:
(Make sure that the Cardy Type icon is of one man.)

1.       Start monitoring with the Green lights icon (hot key: Ctrl+S)

2.       Check the ECG curve, and if you find it acceptable, click on the Tick icon (hot key: Enter.) If "Connection Error" is displayed, check the CARDY® LCD - it should display "Cardy online". Also, check the infrared connection.

3.       Accept the measurement with the "REF" icon if the ECG and the diagnosis are ok. CARDY® stores the curves and the results as a reference. If storing is successful, the PC switches off CARDY® - the reference measurement is complete.

4.       Teach your patient to carry out measurements at home, with special attention to the placement of the electrodes. You can even draw the place of the V2 and V5 electrodes on the skin. Inform the patient that he or she can have problems where immediate medical attention is needed no matter what CARDY® says.

Repeat steps a-d for the second patient. CARDY® shows the nickname when switched on. Press to toggle between the two patients and to check the availability of two reference curves. When the patients take measurements at home, they can use the key to toggle between their respective reference curves.

When you upload home measurements to the PC, there is no difference between handling one and two user models: the PC program uses the Hand icon to upload the data and assign it to the proper patient. After the file transfer both reference curves are automatically reloaded to CARDY® and can be overwritten by the doctor. If only one reference must be replaced, choose the "Cardy - replace old reference with new" menu field and save the reference curve the usual way. The old reference curve of the second patient can be transferred from the database (see point b.)

For CARDY® Family models, both users ECG measurement can be uploaded as reference from the PC database, just carry out the instructions of point b.) twice.

1.       Measurements at home - see CARDY® Home Operations Manual

2. Evaluating home measurements in the doctor's office. CARDY® stores each home measurement. These can be downloaded to the PC during a visit. This gives a thorough overview to the doctor about the medical state of the patient.To download CARDY® data to the PC:

·         Switch on CARDY by pressing the key. Put the infrared connector in front of the upper IR window of the device, and place CARDY in a "PC ready" state as follows: if CARDY is empty, press the key. If CARDY is not empty, press the key and hold it for 3 seconds or until "PC ready?" is displayed. Confirm by pressing . "Cardy online!" will be displayed.

·         Run the PC program using the "Cardy" icon.

·         Check the PC - Cardy connection ("Cardy online" is displayed on the middle bottom line on your PC screen.) If "Cardy offline" is displayed, check Cardy and the infrared connection.

·         Download the measurements stored in CARDY® with the Hand icon in the Main Menu. The last record of the downloaded ones is displayed automatically. The program automatically assigns the records to the respective patient. If the program fails to find the patient in the program, it marks it "Unknown". These changes are indicated with a single or double exclamation mark. You can display the reference ECG curves over the home measurements by the Ref icon (all measurements with the exception of the reference curve are erased from the CARDY® memory when download to the PC is complete). The program switches off CARDY® automatically.

·         Use the "Parameters" tab to display time and amplitude values calculated from the curve. Use the "Opinion" tab to add or edit your opinion. This opinion will appear on all printouts. Print by using the "Printer" icon.

·         You can replace the old reference ECG with a new one should this become necessary for medical reasons. Click "Cardy - replace old reference with new" in the "Cardy" menu field of the Main Menu. Take the new reference measurement according to points a-d.

Moving downloaded records

When you download records from CARDY®, the PC program automatically assigns those to the respective patient (when you take a reference measurement, the program uploads the patient id to CARDY® that is used later to identify the patient.) If the PC program cannot find the id of a particular patient - e.g. another PC was used for the reference measurement - the record will be assigned an "Unknown" tag. These records can be transferred to the real patient as follows:

• if the patient does not yet have an id in the PC program (incl. name, nickname, mother's name, etc.) - then create a new patient record
• Click to select the records to be transferred (use Ctrl to select multiple records)
• Right click on the selection to display a special menu.
• Select "Transfer data to another patient"
• Select the desired patient in the "Select patient" table, and accept by clicking on the Tick icon. The program will ask you to confirm the move, answer "Yes".

Displaying diagnostic data in CARDY® HOME units

The diagnosis of home measurements can be displayed without the use of a PC, so that you can check at the patient's home why CARDY® has indicated a change. By using this function, CARDY® becomes a small, mobile, intelligent ECG device. Displaying the diagnosis is not a "one button push" operation, so it is up to you to decide whether you want to train your patient to recall diagnostics data, or not. Follow these steps to display diagnostic data:

• Switch on CARDY by pressing the key, and place CARDY in a "PC ready" state. Hold down the key for 3 seconds, or until "Waiting for PC?" is displayed.
• Press the key to go to the "DG reading?" menu, and confirm by pressing the key.
• The rhythm diagnosis of the last measurement appears in the following format: Susan measurement no. 8 SINUS RHYTHM
• Press the key to display the next diagnosis of the same measurement. By pressing the key you can step over all the diagnostic results. When you reach the last, the first will follow.
• Use the key to change between the measurements, moving from the latest to the oldest. This function also revolves around, meaning that when you reach the oldest record and press , the latest measurement is displayed again.
• Use the key to toggle between users on CARDY® FAMILY models
• Press ("No") to exit diagnosis mode.

In summary, the following keys are used to display diagnosis:

• Select measurement from latest to oldest
• Toggle between users (CARDY® FAMILY models only)
• Select between diagnoses
• Exit diagnosis display mode

Useful tips

Switching off: CARDY® powers off automatically after a 3 minute period of non activity, except for Cardy online state during which automatic power off is disabled. To reserve battery power, you can switch off your CARDY® manually by answering No (press ) to the measurement questions until you see the question "Are you sure to switch off Cardy?" Confirm by pressing Yes

Replacing the battery: A standard alkali battery has an approx. 250 measurement lifetime. A 1000 mAh rechargeable battery can power Cardy for about 120 measurements. After turning on your Cardy, a message will appear if the battery is low.

Restarting Cardy (RESET): Complex electronic devices in Cardy are sensitive to external noise such as static electricity, or electromagnetic waves close to electronic devices. If for any of these reasons Cardy should "freeze" - meaning that the display would not change after 30 seconds, you can reset (reboot) Cardy as follows:

1. Press and hold the switch on key
2. Press and release the key
3. Release switch on key

Neon lights: if there are neon lights in the room, place the infrared connector directly by CARDY® to keep the neon lights from interfering with the infrared connection.