Accoson greenlight 300 International Protocol validation
Validation of the greenlight 300 to the International Protocol

The validation of the greenlight 300 to the International Protocol by Graves et al from the Mayo Clinic and Mayo Foundation, Rochester, was published in the journal Blood Pressure Monitoring in early 2004.

It was reported that the objective of the study undertaken was ‘to determine whether the greenlight 300 is an accurate replacement for the mercury sphygmomanometer in auscultatory blood pressure measurement using passage of the International Protocol as a valid test of device performance’ 1.

The International Protocol2 was published in 2002 in an aim to update and simplify previous protocols for evaluating the accuracy of blood pressure measurement devices without sacrificing their integrity.

The validation procedure detailed in the International Protocol is carried out in two phases, allowing elimination of very inaccurate devices at an early stage in the procedure. Phase 1 requires the recruitment of 15 subjects, with phase 2 requiring a further 18 (33 in total). Subjects are selected to fulfill the criteria set out in the protocol. These include specifications regarding sex, age and blood pressure range.

A number of blood pressure measurements taken with the device being tested are compared with a standard mercury sphygmomanometer. The results from the validation of the greenlight 300 to the International Protocol are shown below.

Phase 1 results (15 subjects, 45 readings)1
  Within 5mmHg Within 10mmHg
Within 15mmHg
 Result
Requirement to pass (1 of 3): 25/45 35/45 40/45  
SBP 40/45 44/45 45/45 Pass
DBP 31/45 40/45 44/45 Pass

Phase 2.1 results (33 subjects, 99 readings)1
  Within 5mmHg Within 10mmHg
Within 15mmHg
 Result

Requirement to pass (2 of 3):

65/99 80/99 95/99  

Requirement to pass (all 3):

60/99 75/99 90/99  
SBP 84/99 95/99 98/99 Pass
DBP 74/99 90/99 96/99 Pass

Phase 2.2 results (33 subjects, 3 readings each)1
  2/3 readings within 5mmHg 3/3 readings >5mmHg
Result

Requirement to pass (both):

22/33 ≤3  
SBP 33/33 0 Pass
DBP 27/33 3 Pass

The greenlight 300 passed all phases of the International Protocol validation procedure. It was concluded in the paper by Graves et al that this demonstrated that the greenlight 300 provides accuracy comparable to the mercury sphygmomanometer in auscultatory blood pressure measurement and that it is the first device to fulfill the AHA experts’ quest for a reliable replacement for the mercury manometer in auscultatory blood pressure measurement1.

The full ESH International Protocol for validation of blood pressure measuring devices in adults can be accessed from the guidelines section of the ESH website.

The paper by Graves et al detailing the validation of the greenlight 300 to the International Protocol can accessed online from the
Blood Pressure Monitoring website

1. Graves JW et al. The Accoson Greenlight 300TM, the first non-automated mercury free blood pressure device to pass the International Protocol for blood pressure measuring devices in adults. Blood Pressure Monitoring 2003;9:13-7

2. O’Brien E et al. Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults. Blood Pressure Monitoring 2002;7:3-17

Accoson greenlight 300 sphygmomanometer - self-calibrating upon switch-on
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