A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode

A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode

It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test products) after 30 minutes (the intended period of use) of the electrodes.

Inclusion Criteria:

• Provide written informed consent
• Be a healthy volunteer and be over 18 years of age
• Willing to attend two scheduled visits for application and removal of the device and adverse event review
• Have healthy unbroken skin

Exclusion Criteria:

• Subjects with a history of sensitivity to any one of the components of the device being studied
• Subjects who have a history of skin related disorders to the chest.
• Subjects who are actively involved in the development, manufacturing, quality and marketing of Unomedical electrodes
• Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
• Subjects who have any current cardiac conditions that may lead to an abnormal ECG trace