Project Type
Instructions
Date: February 12 2021
Customer: Thermor Ltd
Job Number: TH6151
Item Number: BD353
Designer: Alex Vranjesevic
Revision: C
Artwork is not to be amended or scaled. If any changes
are required please send through Thermor oce with
instructions, and we will amend here and resend artwork
through. PLEASE RETURN WITH SIGNATURE
Contact: Graphic’s Department
graphics@thermor-ins.com
Colour Breakdown
Reason For Project:
New Item:
New Branding:
Design Update:
N/A: X
UPC (For Reference Only)
1.2C Comparing Readings to Other Blood Pressure Devices
Many questions arise when two blood pressure devices are compared in an effort to check accuracy.
An accurate comparison requires repeatable measurements under the same conditions to a “reference
device” with known accuracy. Significant time is required to reduce naturally occurring blood pressure
variability during the test. The subject should be seated comfortably with feet flat on the floor, and
have rested for 5 minutes before the first reading to allow blood pressure levels to stabilize.
The patients back, elbow and forearm should be supported, and the middle of the cuff should be at
the level of the right atrium. There should be no talking or moving during the measurement and if
comparing to an aneroid gauge or mercury column, observers should avoid parallax and be careful not
to round measurements.
The most accurate way to compare devices is to take two readings at the same time. However,
most people and doctor’s offices do not have the equipment necessary to measure blood pressure
from two devices simultaneously. To take sequential measurements properly requires a pair of initial
measurements to determine the subjects blood pressure level: first with the reference equipment,
followed by 60 seconds, then with the monitor-under-test. The actual accuracy test requires three
pairs of measurements with 60 seconds between measurements. These measurements are averaged
and a comparison can be made. Since most people tend to relax and their blood pressure falls with
subsequent measurements, following this protocol reduces these natural changes in Blood Pressure
levels. The standard technical error of both consumer and professional devices is normally ±3
mmHg, so a discrepancy of 6 mmHg is acceptable even when the devices are working within their
specifications.
Any comparisons without a known “reference device” and not following the procedures described
above will yield unreliable results. In addition, to do an accuracy test properly the reference device
must also be tested to a known reference to confirm its accuracy, prior to being used as the reference
for comparisons.
1.2D Calibration
Digital blood pressure monitors do not require regular recalibration. Unless the product has been
dropped and internal parts have been damaged. If the unit turns on and does not display an error
code, the product is working properly. In extremely rare cases, the cuff may have developed a pin-hole
leak, or the gasket where the cuff connector enters the monitor may not have a proper seal; both of
these leaking air issues will potentially cause errors in accuracy, but otherwise the product will work
accurately without drifting out of calibration.
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