Technical Safety Checks And Maintenance For 4008 Hemodialysis Systems And Options; For 4008 Hemodialysis Systems And Options - Fresenius Medical Care 4008 E Technical Manual

2.1 Technical safety checks and maintenance

for 4008 hemodialysis systems and options

2.1.1 Important notes
This chapter lists all necessary technical safety checks (TSC) and maintenance procedures
(MA).
The checks must be performed every 12 months.
Performance of the technical safety checks must be recorded in the Medical Device Register.
Please refer to page 2-5 to page 2-13 for the description of the technical safety checks and
maintenance.
Please refer to page 2-15 to page 2-18 for the checklist of the technical safety checks and
maintenance.
Instructions to be Observed when Servicing the System
Assembly, extensions, adjustments, modifications or repairs may only be carried out by the
manufacturer or persons authorized by him.
The activities described in the Technical Manual require the availability of the necessary technical
test equipment and accessories.
When working on the open system, the following precautions must be respected:
– Protect the components against ingress of fluids.
– Do not touch live parts (e. g. connectors of the power cord or heater).
When repairing and when replacing spare parts, observe the applicable ESD precautions
(e.g. EN 100 015-1).
Fresenius Medical Care 4008 4/09.03 (TM)
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