Evaluation of a New Blood Pressure Measuring Device.

A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.

• A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer.
• Up to 100 subjects with various levels of blood pressure values will be tested.

The study will comprise 85 to 100 subjects with blood pressure values ranging between 90 and 170mmHg -systolic and 65-95 -diastolic.

• Three sets of measurements will be performed on each subject. The measurement with the tested device placed between twh determinations with a mercury sphygmomanometer.
• Each measurement will be performed simultaneously by two examiners specially trained.
• Informed consent will be obtained from all participants.
• The results will be evaluated by a standard statistical plan ANSI/AAMI SP-10 2002.

Inclusion Criteria:

• Male or female, age 18 years or above
• Signed written informed consent

Exclusion Criteria:

• A history of cardiac arrythmia
• Wrist circumference smaller than 13cm or larger than 19.5cm
• Documented peripheral vascular disease
• Damage or injury to the left wrist
• Participation in any other clinical study
• Any acute coronary of cardiovascular illness