Roche Diagnostics
Instructions for Use · Version 10.0 23
9180 Electrolyte Analyzer 1 Safety information
Safety precautions
Fire and burns Alcohol is a flammable substance.
o Keep all sources of ignition (such as sparks, flames, or heat) away from the system
when you perform maintenance or checks that involve alcohol.
o When you use alcohol on or around the system, use no more than 20 mL at a
time.
Incorrect results
Poor accuracy and precision Incorrect results may lead to errors in diagnosis, posing danger to the patient.
o For the proper use of the system, run QC tests and monitor the system during
operation.
o Do not use reagents or consumables that have exceeded their expiry date,
otherwise you may obtain inaccurate data.
o For diagnostic purposes, always assess the results with the patient’s medical
history, clinical examination, and results from other consultations.
Incorrect reagent handling Incorrect reagent handling may cause an undetectable loss of reagent.
o Always store reagents according to the specified storage conditions as stated in
the Instructions for Use for the test.
Damaged electrodes Installing damaged electrodes may cause incorrect results.
o Do not install damaged electrodes.
Foam, clots, films, or bubbles Incorrect results may occur due to foam, fibrin clots, films, or bubbles in reagents or
samples.
o Avoid the formation of foam, clots, and bubbles in all reagents, samples,
calibrators, and controls.
Evaporation of samples or
reagents
Evaporation of samples or reagents may lead to incorrect or invalid results.
o Sample material may evaporate if left open. Do not leave samples open for any
length of time.
o Do not use improperly stored reagents. Ensure that reagents are stored according
to the Instructions for Use.
Carryover Traces of analytes or reagents may be carried over from one test to the next.
o Take adequate measures (for example, extra wash cycles) to avoid extra testing
and potentially incorrect results.
Software and data security
Unreliable validation due to
unauthorized changes to the
validation settings
Roche shall not be held liable for any consequences resulting from subsequent,
unauthorized modifications to the accepted validation settings included in the system
at the customer’s request.
o Ensure that only authorized personnel can change, if necessary, the validation
settings.
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