3-, 5-, 10-leadwire

Describes the number of ECG patient leadwires of a patient cable or the number of conductors of an ECG trunk cable. «

Applied Standards

Our company applies a quality assurance system for medical devices which fulfills the requirements of EN ISO 13485:2000 (particular requirements for the application of ISO 9001).

We produce accessories for medical electrical devices and are affected by the IEC / EN 60601 standards. The conformity with the general requirements of IEC / EN 60601-1 and the particular requirements of IEC / EN 60601-2, which focusses on the type of equipment, has to be assesed by our customer, the equipment manufacturer, for the finished device including the accessories. «

Artifacts

Sporadically appearing signal portions, which are not a result of the physiological process that is under exam, having their origin in other sources. Muscle artifacts and movement artifacts are commonly seen in the ECG trace. Asking the patient to relax and using a good cable fixation technique avoids these artifacts. «

Biocompatibility

In our application: suitability of a cable for direct contact with healthy skin. «

Cable material

For cable jacket and yoke overmolds usually polyurethane is used. The advantages are high durability, resistance against mechanical damage and best skin tolerance. «

CE marking

With the CE mark a manufacturer of medical devices certifies the conformity of his product with the MPG (German Medical Products Act) and the Medical Device Directive (MDD) 93/42/EC. «

Colour coding

Assignment of standardized colours to the electrode connections or ECG patient leadwires to avoid accidental misconnection. The common colour codes for ECG are the codes submitted by IEC (International Electrical Commission) or AAMI (Association for the Advancement of Medical Instrumentation). The colour code may only be used in conjunction with a letter code, see chart "Conventional ECG electrode nomenclature". «

Compatibility

Fitness of an accessory for the intended use with the equipment mentioned in the context. «

Complete cable

Cable assembly having the trunk cable and patient leadwires inseparably overmolded in the yoke. The electrode connection is not exchangeable. The robust construction is ideal for the use in emergency medicine. Disconnection or mismatch of leadwires is excluded by design. «

Conformity

Compliance with or fulfillment of a Standard or Directive. «

Conventional ECG electrode nomenclature

Defibrillation

Treatment of the heart using electric shocks in case of cardiac arrest or ventricular fibrillation. A special form of defibrillation is the cardioversion, an ECG-sincronized (planned) defibrillation. The defibrillation imposes increased requirements to the construction of ECG cables. «

Defibrillation protection

Electronic protection from the detrimental effects of defibrillation currents of patient connected equipment and its operators. «

Diagnostic ECG

Serves the detailled analysis of the electrical activity of the heart by a cardiologist.
It is performed either during inactivity (Resting ECG) or during exactly defined physical exercise (Stress-test ECG). Commonly a cable with 10 patient leadwires is used to obtain the 12 standard ECG leads. The 10 patient leadwires are composed by 4 extremity leadwires (limb leadwires) and 6 precordial leadwires (chest leadwires). «

DIN safety connection

Touch-proof 1,5 mm pin connector and its receptacle for medical use according to industry standard DIN 42802-1. «

ECG

Electrocardiography. Recording of the electrical activity of the heart. «

ECG cable

Harness of electrical conductors used to collect ECG signals from the body.
It is connected on one side to the ECG electrodes and on the other to an ECG recording device. «

ECG channel

Representation of a lead in form of a write-out or display. A one-channel-ECG machine is able to write one lead at the time. If more than one lead is needed, they have to be written one after another. Three-channel-ECG machines can write 3 leads simultaneously. Term is often confused with ECG lead. In the Holter ECG the term channel is commonly used. «

ECG electrodes

Electrically conductive sensors, mostly made of silver compositions, built as self-adhesive, suction or plate electrodes which are attached to the body surface on clearly defined locations. See chart „Conventional ECG electrode nomenclature“ at the end of this glossary. «

ECG lead

Since the ECG trace results from a subtraction of two signals collected from the patient, several combinations of electrodes can be used to produce a trace. This combinations are named ECG leads. The 12 standard ECG leads are:
· I, II, III ( Einthoven leads)
· aVR, avL, aVF (Goldberger leads)
· V1, V2, V3, V4, V5, V6 (Wilson leads).
The term is not to be confused with ECG patient leadwire, even if the leadwires are marked i.e. with V1, a precordial electrode name of the AAMI code. «

ECG patient leadwire

One conductor shielded (coaxial) or unshielded leadwire from the yoke to the electrode connectors. «

ECG trunk cable

Multiconductor cable, mostly shielded, from the equipment connector to the yoke. «

EEG

Abbreviation for Electroencephalography, the recording of the electrical activity of the brain. «

EEG electrodes

Electrically conductive sensors, mostly made of gold or silver compositions, for the collection of electrical potentials of the brain from the scull. «

EEG patient leadwire

Single conductor leadwire from the EEG electrode to a distribution box or yoke connected to the EEG recording device. «

Electrode connection

The connector of the ECG patient leadwire to the ECG electrode, often built as pinch clamp, 4 mm banana or snap connection. «

EMC

Electromagnetic Compatibility. Capability of a device, equipment or a system to function satisfactorily in its electromagnetic environment without itself causing unacceptable electromagnetic disturbance to any devices, equipments or systems present in that environment. «

EP

Abbreviation for Electrophysiology, the medical science that studies the electrical processes in living organisms. «

EP catheter connection cable

Cable for the connection of electrophysiology catheters. These catheters are used for the collection of physiological signals from the inside the vascular system and for treatment applying HF currents into the body. The catheter connection cables are used sterile. If adequate materials are used in the manufacture, a limited reuse can be acchieved through re-sterilisation. «

HF choke

Electronic component that can be included in an ECG cable assembly to reduce the disturbance of high frequency electrosurgery during ECG monitoring. The HF energy coupled into the ECG cable can cause signal distortion, monitoring interruptions and eventually burns at the electrode site, if no precautions are taken. «

High frequency electrosurgery

Procedure using a high frequency generator with high power to cut, coagulate and fulgurate tissue using an electrode handpiece. The HF currents that are applied have a significant potential of electromagnetical disturbance. «

Holter ECG

Ambulatory ECG recording. The ECG is recorded over a period of 24 hours using miniaturized equipment with built-in data storage (magnetic tape, RAM or flashcard). Purpose is the detection of abnormalities that occur during the daily routine of the patient. The patient has the possibility to set an event-mark in the recording using a push-button when circumstances, that were agreed with the doctor, occur. «

Low-noise cable

When a cable is moved, electrical charges are built up and discharged inside the cable structure. This electrical phenomena can disturb the low level signal collected from the body. Our cables are optimized in this regard and can also be used when the patient is in motion. «

Monitoring ECG

Surveillance of vital parameters in the OR, wake-up room, ICU or emergency environment. Usually only one ECG lead is monitored, therefore 3 patient leadwires are needed. ECG cables with 5 patient leadwires are optional with many monitors and allow additional monitoring features. «

OR version

ECG cable version equipped with HF chokes. «

Resistor

Electronic component that can be included in an ECG cable to avoid excessive current flow trough the cable in case of defibrillation or electrosurgery. «

Shielding

Since ECG signals are of very low voltage and current, they are extremely sensitive to electromagnetical disturbance. Common sources of disturbance are neon lamps, power lines and cables, HF surgery generators, X-ray units, radio transmitters, etc. Shielded cables are required for many applications to reduce electromagnetic interference from these sources. «

SpO2

Abbreviation for Pulse Oximetry Oxygen Saturation, the oxygen saturation of the red blood cells determined with the method of pulse oximetry. The SpO2 of a healthy adult is between 95 und 100%. The SpO2 parameter has evolved to a standard parameter in the patient monitoring. «

SpO2-sensor

A device with light emitting diodes (LED) and photodiodes working at diferent wavelengths to produce a signal that relates with the oxygen saturation of the red blood cells. There are many different models of sensors depending on measurement site on the body, body size and measurement environment. The sensor has a cable attached that plugs into the pulse oximeter directly or using a SpO2 extension cable. «

SpO2-extension cable

Cable to enlarge the distance from a sensor to the equipment. «

VR system

Detachable cable system for shielded patient leadwires. They can be disconnected in form of a block from the yoke connector. Offers a cost efficient solution because single patient leadwires can be replaced. Allows a standardisation of leadwires in the hospital leading to further savings. «

Yoke

Cable junction with molded or detachable shielded or unshielded patient leadwires. Detachable leadwires allow the exchange of damaged patient leadwires or of plural leadwires forming a block in case of patient transportation between monitors with compatible trunk cables. «

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