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4 Putting the sterilizer into service
4.6.2 Instructions for maintenance
At a minimum, the instructions for maintenance must include:
a) General functional description;
b) Prerequisites for operation, consumables requirements;
c) Program cycles, including settings;
d) Safety features (function – setting – testing);
e) Inspection, maintenance, cleaning (maintenance intervals);
f)
User repairs (e.g. replacing parts that are subject to wear);
g) Spare parts;
h) Errors (interpretation of error messages, troubleshooting);
i)
Residual risks during correct use;
j)
Hazards during maintenance procedures.
4.7
Device log
According to DIN 58946-6, the user is required to keep a device log where
important events relative to the operation of the device are documented. These
include at least:
a) Installation check;
b) Acceptance testing and commissioning;
c) Performance evaluation;
d) Instruction (including repetitions);
e) Routine testing (daily, monthly, yearly); see Maintenance Manual (included) for
regular maintenance and care;
f)
Inspections;
g) Maintenance tasks;
h) Repairs;
i)
Modifications to the sterilizer or to the consumables supply;
j)
Recommissioning;
k) Repeated performance evaluation;
l)
Repeat testing of the pressure device and related equipment;
m) Extraordinary operation modes.
Thermo Scientific
25
50112712_082007_GB
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