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Samples are automatically transferred from a sample tube or cup to the module where the
measurements are made. All optical measurements use the same transparent plastic containers,
called cuvettes.
The graphical user interface - running under Windows NT - provides quick and easy access to
sample, control, and calibration data, while continuously monitoring all system functions. Color-
coded icons alert you to changes in the system status. Connection to a host system allows for
automatic transfer of results to and from the COBAS INTEGRA 400 plus.
2. SCOPE
This Roche Chemistry analyzer will be used for chemistry and electrolyte testing in the MU-JHU
laboratory. All operators of the machine must be trained in this SOP which will describe procedures
and general operations of the instrument.
4.4. Note: Cleaning the instrument externally – This task will not be listed on the BOD but must
be performed daily (at the end of day) and documented on the “COBAS INTEGRA 400 plus
Maintenance Log”
a. External cleaning can be performed with a cloth and solution of 70% propanol.
b. Clean the instrument only while it is on Stand-by.
I. Do not use organic cleaning solvents, such as petroleum, benzene, petrol, or
other solvents, because they can damage cuvettes, tubing, and other plastic
materials.
II. Do not use an alcohol solution with a concentration greater than 70% alcohol,
because this may damage transparent viewing modules.
III. Do not use sodium hypochlorite solution (i.e., Bleach) because it causes
corrosion on metal parts.
4.8.3. The various status buttons will change color as above when action is needed.
5. CALIBRATION:
5.1. Calibrations are performed at regular intervals, as defined for each analyte/lot#, each reagent
cassette has the calibration intervals information pre-programmed by the manufacturer into its
bar code, and interrupted automatically by the instrument.
5.2. Additional calibrations also have to be performed when certain physical events occur. These
include:
I. A change in cassette
II. A change in cassette reagent lot
III. A change in the defined interval.
IV. Failure of quality control to meet required specifications
V. Major service of equipment
5.8. Any related controls (QC) must ALWAYS be run after a calibration.
5.9. Click Orders on the navigation bar, click calibration tab, click on the tests that you want to
calibrate, save.
NOTE: Position Number 1 is at the end farthest from the rack handle. The
position number is indicated on the right side of the rack.
d. Once all samples loaded, load the sample rack into one of the slots in the sample
area.
9. DOCUMENTATION:
9.1. Quality Control (QC) results should by reviewed daily and documented in the instrument Daily
QC sheet (if any QC didn’t pass must document as “No” and comments in the comment’s
section)
9.2. Quality Control results for each test should be printed daily and saved in the Integra QC file (to
be reviewed weekly by the lab Team Lead/ Lab Supervisor.
9.3. QC results for each month should be printed at the end of each month and submitted to the lab
Supervisor for review.
9.4. All test results should be printed, reviewed by the bench tech and verified by a Sr. Tech.
9.5. All results are kept electronically on the computer.
11. REFERENCES:
11.1. Roche Diagnostics, Reference Ranges for Adults and Children, Pre-Analytical Considerations,
2004.
11.2. Roche Cobas Integra Method Manual, Version 2
11.3. Roche Cobas Integra User Manual, Version 2.1
11.4. RV156 Protocol
12. APPENDICES
12.1. COBAS INTEGRA 400 plus Maintenance Log
12.2. Core Lab Chemistry – Bench Reference list
12.3. Core Lab Chemistry – Processing Reference list