Childhood Adenotonsillectomy Trial

1.2 Equipment

• Space Lab Monitor Model # 90207 (each site will have three available for use)
• 2 will be purchased by the site and 1 donated by Space Labs.
• Child and adult sized blood pressure cuffs (sent with equipment)
• Space Lab software for transferring AMBP data
• 3 AA batteries per monitor (back up supply should be readily available)
• Stethoscope

1.2.1 Calibration

Prior to each use, a staff member will ensure that the monitor has new batteries for each new exam.

Calibration is checked either by clinical engineering before each use or by auscultation during the deflation of the Spacelab monitor during a blood pressure reading. If done by clinical engineering, the monitor reading must be <3 mmHg difference from the static reading done with a BP simulator. A list of systolic (from 60 to 255) and diastolic (40 to 120) are generated by the simulator and compared to readings displayed on the monitor. Blood pressure leaks will be tested at a systolic blood pressure of 280 mmHg.

If calibration is to be checked by auscultation, then the RC (or designate) will listen by stethoscope for the Korotkoff sounds. The beginning sound on deflation is the auscultated systolic and the cessation of sounds is the auscultated diastolic.

• On auscultated systolic: add 4
• On auscultated diastolic: subtract 4

This revised blood pressure (aus sys +4/ aus dias -4) should be within 10 mmHg points of the Spacelab blood pressure reading.

1.2.2 Subject Device Accountability Log

Monitors must be signed out on the Subject Device Accountability Log [DEVICE], an administrative form available from the DMS. The parent/legal guardian will be provided with a pre-paid shipping container (unless other arrangements have been made) to return the monitor within 2 days (if possible) of the 24 hour reading.