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I have two questions regarding this standatd:
1. Do you know the rational behind the 13.33kPa of back pressure required in the accuracy testing? If the device infusion site is the subcutaneous tissue and not the blood vessel, can it be tested in lower back pressure? how low?
2. What is the maximum amount of air bubble can be injected to the subcutaneous tissue before alarm activation?
Thanks!
1. Do you know the rational behind the 13.33kPa of back pressure required in the accuracy testing? If the device infusion site is the subcutaneous tissue and not the blood vessel, can it be tested in lower back pressure? how low?
2. What is the maximum amount of air bubble can be injected to the subcutaneous tissue before alarm activation?
Thanks!