OBI Medical

When can v-TAC be used?

v-TAC can be used on patients age 18 and above who are hemodynamically stable and who have been clinically assessed with sufficient peripheral perfusion so that a venous blood sample can be taken and pulse oximetry can be used. Pulse oximeters used for v-TAC shall be certified according to ISO 80601-2-61.

v-TAC has not been validated outside the following ranges (venous values and SpO2):

  • SpO2 (measured by pulse oximetry): 80 – 100%
  • pH: 7.23 – 7.55
  • pO2: 2.2 – 10.8 kPa (16.5 – 81 mmHg)
  • pCO2: 4.1 – 12.5 kPa (31 – 94 mmHg)
  • sO2: 0.20 – 0.95 fraction
  • tHb: 5.0 – 11.0 mmol/l
  • MetHb: 0.000 – 0.012 fraction
  • COHb: 0.000 – 0.065 fraction

v-TAC has not been validated for:

  • Premature and full-term neonates
  • Children and adolescents (up to the age of 18)
  • Pregnant women
  • Haemodynamically unstable patients (including cardiac assist device and extra corporeal life support devices)
  • Symptomatic haemoglobinopathies
  • Central and mixed venous blood
  • Pulse oximetry indications and limitations for use shall be followed.
  • Blood gas analyser indications and limitations for use shall be followed.

If one or more venous input values exceed the validated ranges but are within input and output min and max limits, v-TAC will calculate and report arterialised values, but all parameters will be displayed with a flag, see figure below (yellow area) and v-TAC printed report.

Utilizing v-TAC results that are outside the validated ranges lies within the responsibility of the health care professional.

In general, we recommend obtaining arterial blood gas results from an arterial blood sample.

If any of the venous input values exceed input min/max limits or the calculated v-TAC results do not pass the output check, results will not be reported, and an error message will be produced, see figure below (blue area) and v-TAC printed report.