ModPG3 Neo-Infant ISO 81060-2:2018

ModPG3 Blood Pressure Device for Neo-Infants

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today.

Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases.

SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation.

The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

1. Inclusion Criteria

   • Meets the neonatal or infant (less than 3 years of age) subject population.
   • The neonate and infant subjects will already have an indwelling intra-arterial line.
   • Subject's legally authorized representative must consent for the subject to participate.
   • Subject's legally authorized representative must be able to read, write, speak in English and/or Italian.
   • Subject must have an arm circumference in the range of 3.3-15.0 cm.
   • Subject must be able to have blood pressures taken on the upper extremity closest to the arterial line
   • The subject has one upper arm that is free of indwelling catheters or IV lines, shunts, oximetry sensors, dressings, etc. for attachment of a NIBP cuff.

2. Exclusion Criteria

   • Lack of Informed consent.
   • Subjects with deformities or abnormalities that may prevent proper application of the device under test.
   • Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
   • Subjects with known heart dysrhythmias or arrhythmias during the measurement period.
   • Subjects with compromised circulation or peripheral vascular disease.
   • Subjects who have had surgery or have shunts or implants in the upper extremity being tested.
   • Those who have a heart rate that is irregular for any reason other than normal fluctuations in the R-to-R interval associated with respiration.
   • Hospital System Pre-Screening NIBP: those who have a systolic and/or diastolic blood pressures difference > 12 mmHg between the hospital intra-arterial measurement and the hospital blood pressure cuff/automated vital signs monitor are excluded. The device under test cannot be used for this reading.
   • Subjects with clotting disorders or taking prescribed blood thinners.
   • Subjects with a severe contact allergy to sensors or cuff material.
   • Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of NIBP cuff.
   • Subjects whose arm circumference does not fall within 3.3 and 15.0 cm.
   • Arterial line is not properly damped.
   • The subject has an unstable condition in which NIBP cannot be obtained.
   • Subjects who have radial or brachial arterial lines.
   • Subjects who require sedation solely for the purpose of this study and/or prolonged sedation from a prior procedure.