9180 Electrolyte Analyzer
Roche Diagnostics
12 Instructions for Use · Version 10.0
What is new in publication version 10.0
Li
+
measurements in whole blood
Determination of Li
+
is usually done in serum or plasma and has therefore been
removed from the list of measurement parameters in whole blood.
u Measurement parameters (p. 35)
Sample type dialysis solutions The sample type "dialysis solutions containing acetate and bicarbonate" has been
removed from the list of supported sample types and from the measurement
parameters because dialysis solutions are not defined as in vitro diagnostic sample
types.
u Sample types (p. 43)
u Measurement parameters (p. 35)
Specification The following specifications have been updated:
u Sample throughput (p. 43)
u Calibrations (p. 43)
u Instrument (p. 44)
u Electrodes (p. 44)
u Solutions (p. 45)
u QC material (p. 47)
u Printer (p. 48)
Incorrect handling of consumables A warning message about the incorrect handling of consumables has been added.
u Consumables (p. 22)
RS232 interface port Information about the RS232 interface port has been removed from the publication.
Verifying performance after
maintenance actions
For the following maintenance actions, a new step has been added to perform QC
measurements on 3 levels to verify the performance of the instrument:
u Cleaning the reference electrode housing (p. 137)
u Exchanging the pump tubing set (p. 140)
u Exchanging main tubing harness (p. 141)
u Checking reagent fluid level and changing the SnapPak (p. 145)
u Replacing sample probe and fill port (p. 147)
u Replacing the mains fuse (p. 149)
Regulatory adaptations The following information was added as part of the adaptation to the EU regulation
2017/746 on in vitro diagnostic medical devices:
o Information about incident reporting
o Link to the worldwide list of Roche affiliates
o Download information about electronic user documentation
Minor changes Minor changes have been applied throughout the publication.
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