About This Guide
This user guide is intended for users of the v-TAC Standalone software. It provides essential information for the safe and effective operation of the software.
The guide covers:
- Routine operation
- Safety information
- Troubleshooting
- System requirements
Important Safety Information
Users must carefully review all instructions and safety information to avoid incorrect results. Pay close attention to all safety notices and follow the guidelines provided in this publication.
For reporting any serious incidents that may occur in relation to the use of this product, users should contact their Roche representative and the relevant competent authority.
Product Overview
The v-TAC Standalone software is designed for in vitro diagnostic medical devices. It automatically converts venous blood gas values (pH, p₄O₂, p₁CO₂) along with venous oximetry values (S,O₂, tHbv, MetHb, COHb) and arterial saturation values (SpO₂), using pulse oximetry, to quantitatively assess arterial blood gas values (p₂O₂, PaCO₂, PH₂).
It assists in the calculation of arterial blood gas values for hemodynamically stable adult patients (18 years or older).
The software is intended for use with blood gas analyzers that meet Roche's analytical performance and operational requirements, and with pulse oximeters certified according to ISO 80601-2-61.
Intended Use
The v-TAC Standalone software is for use by healthcare professionals in point-of-care testing and laboratory settings. It is not intended for self-testing.
Contact and Support
For any feedback regarding this publication, please contact your Roche representative. For further information or assistance, contact a local Roche subsidiary or Roche service representative.
Additional electronic documentation can be accessed via the eLabDoc web service on the Roche DiaLog portal at: dialogportal.roche.com
For a list of all Roche subsidiaries, visit: www.roche.com/about/business/roche_worldwide.htm
