A Novel Non-interfering Arterial Blood Pressure Monitoring Device
A Novel Non-interfering Arterial Blood Pressure Monitoring Device
The primary purpose of this investigation is to validate the performance and safety of the
 Investigational Device (ID) against a validated and legally cleared device for measuring
 Blood Pressure (BP). The secondary purpose is to validate the performance of the ID over a
 period of 24 hours against a validated and legally cleared device for Ambulatory Blood
 Pressure Monitoring (ABPM).
The clinical investigation is conducted as a controlled (subject as own control),
 prospective, randomised, comparative investigation in a population with a representative
 spread of BPs to ensure that the ID performs as good as current marketed and approved
 devices. The study will be conducted in compliance with the International Standard
 ANSI/AAMI/ISO 81060-2 - Non-invasive sphygmomanometers - Clinical validation of automated
 measurement type.

 This clinical investigation will enrol up to 96 male and female subjects to ensure the
 recording of 85/35 evaluable datasets in accordance with the ANSI/AAMI/ISO standard [11]. All
 measurements will be paired and falls into 2 categories: Auscultatory measurements as gold
 standard reference, oscillometric measurements for clinical practise reference and further
 validation of ambulatory monitoring and pulse shape measurements.
Inclusion Criteria:

 -  At least 30% of the subjects must be males (n=29)

 -  At least 30% of the subjects must be female (n=29)

 -  Age ≥ 18 years old

 -  Limb size circumference ≥ 17 cm

 -  Blood pressure distribution:

 -  At least 25 % of the subjects should be hypertensive

 -  At least 5 % of the subjects should be hypotensive

 Exclusion Criteria:

 -  Breached skin

 -  Acknowledged pregnancy

 -  Pacemaker

 -  Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular
 fibrillation)

 -  Implanted metal in upper limb:

 -  Elbow prosthesis

 -  Shoulder prosthesis

 -  Metal screws

 -  Bone plates

 -  Metal chips

 -  Surgical clips

 -  Implantable Cardiac Defibrillator (ICD)

 -  Cardiac Resynchronization Therapy - Defibrillator (CRT-D)

 -  Premature ventricular contractions (PVC)

 -  Premature arterial contractions (PAC)

 -  Sensitivity or allergy towards adhesives

 -  Presence of an arterial-venous shunt

 -  Recent axillary node dissection