Originally posted by Double D:
We have a number units/models by a single manufacturer that has been validated by the BHS. But we find when we test on our simulator that they consistently read low on the systolic. The queston that comes to mind is the unit faulty or is it a design issue or is it my test gear which gets calibrated, wrong?
The way in which both BP monitors and Simulators work, means that you will not normally get an exact result. Most manufacturers of BP simulators make it clear in their documentation that they should not be used as a gold standard.
What you should see is consistency between monitors used on one simulator and the same monitor over an extended period of time.
If you are looking for true clinical performance, then you should ask the manufacturer of the BP Machine for the results from the clinical trials, these are part of the CE marking requirements, so should be available.
There are a number of organisations that lay down standards for clinical trials and the results, the two main ones being AAMI and BHS. The main difference between the two is the AAMI give a Pass/Fail whereas, BHS give a grade. If you can get a copy of the results from the manufacturer it is possible to assimilate this to a BHS grade.
Be careful with manufacturers claiming BHS validation, this in itself does not make the product any more accurate, it just make it more marketable in the UK.
Chilly