1. Introduction

Cardiax is a complete 12-lead electrocardiogram (ECG) system that is personal computer (PC) based. It provides a full-featured, portable ECG that has important advantages compared to traditional ECG machines.

1.1 Features:

• ECG data is easily collected and stored using the standard 12-lead configuration, or using the Frank lead configuration. In the Frank lead configuration, a vector ECG is automatically stored.
• Real-time or stored ECG tracings are clearly displayed on a computer monitor, and may be printed whenever desired on inexpensive standard printer paper. Costly ECG paper is no longer needed.
• Stored ECG data can be accessed at any time. Multiple recordings from a single patient can be easily evaluated and compared.
• The Cardiax database provides a user-friendly interface that can accommodate even the largest clinical and research needs. The system is capable of handling 2 million patients each with a maximum of 1000 ECG tracings.
• ECG recordings can be stored and categorized in patient folders or by common features. Stored recordings can also be easily copied, archived, or re-analyzed.
• Context-sensitive help messages make the system easy to use.
• A built-in text editor can be used to create, edit, store and print notes and comments.
• Automatic evaluation and diagnostics facilitate the physician’s diagnoses.
• The Cardiax system is also designed to readily interface with commonly used peripheral devices in the Exercise Stress Testing or physiology laboratory. The system can automatically control a treadmill or cycle ergometer/bicycle while recording the 12-lead ECG.
• The Cardiax system can be easily installed on any appropriate PC with a USB interface. It can be used in local networks, or can be installed on a portable computer (notebook) for mobile use. The Cardiax system can also be interfaced with medical database systems.

1.2 Main system components

• ECG recorder box, including amplifier
• USB cable for connection to PC
• Cardiax software.

Minimal computer recommendations:

Pentium CPU, 32 MB RAM
Windows 98SE, ME, 2000 or XP (Windows 95 not supported)
SVGA Monitor
1 GB HDD
USB connection
Note: Earlier generation processors and Windows versions may be accommodated through use of optional hardware using a parallel port interface instead of a USB interface.

1.3 General instructions

1. Instructions for storing and transporting
1) Do not operate or store this equipment in places with high humidity, in places with extreme atmospheric pressures or temperatures, in any place where it can contact water, or where poor ventilation, dust or any chemical pollution or industrial gas is present.
2) This equipment must be stored on a flat surface. It should be protected against dropping, vibration, shaking and extreme mechanical forces both during storage and transportation.
3) This equipment complies with IEC 601-1 type class I shock protection; therefore the computer must always be operated with its supplied shock protected voltage connector. Connect the computer’s voltage connector as specified, taking care to match the voltage and frequency of the network with the voltage and frequency of the device. Grounding the equipment is achieved through the network shock protection connector.
4) Cardiax may be used safely in patients with pacemakers or other implanted devices. Like any ECG, the pacemaker or other device will not disrupt or be influenced by the operation of Cardiax. However, equipment operators and supervising physicians should be aware of the presence of pacemakers or other devices.
5) The Cardiax system is designed for external, skin-surface ECG recordings only. It must not be used for intracardiac recordings and must never be directly connected to the pericardium with internal electrodes.

2. Using a defibrillator
1) Although the ECG input is protected against electric discharge, the electrodes must not connect with or otherwise contact the defibrillator pads or paddles.
2) To avoid injury, the patient's bed, the patient, and all equipment or devices being used on the patient must not be touched by any personnel during defibrillation.

3. Using a high frequency device during surgical procedures
1) When the Cardiax system is used simultaneously with a high frequency device such as electrocautery, make sure that the ECG electrodes are placed as far as possible away from the surgical field, to prevent skin injuries that might result from malfunction of the neutral electrodes of the high frequency device. Only experienced personnel should place these neutral electrodes and special care must be taken.

4. Before using the device
1) Check that the device is in its usual state. Verify the correct connection of cables, especially the patient electrodes and lead wires.
2) When operating the Cardiax with other electric devices, care must be taken that the devices do not disturb each other, and that possibly all devices are connected to the same potential equalizer, thus reducing the risk of current infiltrating through to other devices.
3) To avoid polarization voltage, and possible baseline fluctuation, all ECG electrodes applied on the skin surface should be of similar type. Avoid reusing disposable electrodes or using mixed types of electrodes.

5. During usage
1) Do not touch the electrodes and take care that neither the patient nor the electrodes connect with conducting objects (e.g.: metal parts of the examining bed, equipment holding tripods, etc).
2) If one or more electrodes become loose, disconnected or are inexpertly placed, an error message will occur on the computer monitor during ECG recording. Replace these electrodes.
3) If required for patient safety, switch off the device and disconnect the electrodes.

6. After using the device
1) Immediately after use, disconnect the lead wires from the electrodes, then remove and dispose the electrodes.
2) Non-disposable electrodes, if used, should be properly cleaned after each use with alcohol of appropriate clearing materials. If needed, the lead wires may also be cleaned as appropriate.

7. Maintenence and checking
1) The Cardiax system and any accessories should be checked regularly by visual inspection. If the system has been stored or not used for a long period of time, all components accessories must be checked carefully before using it again. The device must be powered off before cleaning and disinfection. The device must not be modified or altered any way.
2) The Cardiax system is calibrated by the manufacturer prior to delivery. No additional calibration or scheduled maintenance needed under normal operation. In case of malfunction, manufacturer or distributor should be informed and the system should be taken out of service and labeled with visually prominent notice to prevent continued use. Repair must be carried out by the manufacturer or a qualified agent of the manufacturer.

1.4 Security instructions

This device complies with IEC601-1-2 international standards for electric medical devices and electromagnetic tolerance of devices.
If the electromagnetic environment exceeds limits specified in IEC601-1-2, the device can be disturbed so that malfunction or failure could occur.
Therefore to prevent malfunction or failure, the nearby interference or noise has to be eliminated before operating the device.
Here are some of the common sources of interference and the steps to be taken to prevent these:

1.5 Technical parameters

1.6 Explanation of signs on machine

	Read User’s Manual before operating!
	System is BF-type, protected against defibrillator.
	This device has Class II shock protection.