Roche cobas b 123 User Manual

Roche Diagnostics
Instructions for Use · Version 13.0 181
cobas b 123 POC system 7 Quality control
General QC concept
General QC concept
WARNING
Failure to follow QC protocols or ignoring QC results may lead to incorrect patient
results
Failure to follow QC protocols or ignoring QC results may lead to incorrect patient results,
which may endanger patient lives.
r Follow quality control practices according to local regulations.
r Perform a minimum of one QC measurement each day. In addition, alternate through
the 3 levels of available QC materials over the course of 3 days. For example, perform a
QC measurement on day 1 with a level 1 QC material, on day 2 with a level 2 QC
material and on day 3 with a level 3 QC material.
r Perform QC tests on 3 levels after each of these actions: Fluid Pack and
Sensor Cartridge replacement, and installing and turning on the instrument.
r If QC results do not match their expected results, perform the QC measurements again.
If QC results still do not match their expected results, refer to the QC troubleshooting
section (QC troubleshooting (p. 218)). If the error persists, contact your Roche Service
representative.
r Do not use the system for diagnostic purposes until QC results match their expected
results.
q
Remember that a new AutoQC Pack must be adjusted to room temperature for at least
24 hours before use.
Roche always strives to ensure the highest quality standards for its products. This
quality awareness is the result of a sense of responsibility toward the customer and
the well-being of the patient.
To ensure the quality of measurement results, complete a quality control test on 3
levels (1 = low, 2 = normal, 3 = high) after each Sensor Cartridge replacement,
Fluid Pack replacement and after installation of the instrument.
In addition, complete a quality control test on one 1 level between 2 automatic 2P
calibrations. The levels have to be alternated (1 = low, 2 = normal, 3 = high).
For example, (2P calibration interval: 12 hours):
Figure 7-1 Graphic illustration of the general QC concept
q
A system calibration can be performed instead of a 2P calibration. Automatic system
calibrations include a complete 2P calibration.
Complete at least 2 quality control tests on different levels once daily or more often in
accordance with local regulations.
q
QC measurements should not be run immediately before a 2P calibration.
2P-Cal.
Level 1
24 hours
2P-Cal. 2P-Cal.2P-Cal.
Level 2
Level 3 Level 1

Roche cobas b 123 Specifications

General

Brand	Roche
Model	cobas b 123
Category	Medical Equipment
Language	English