Gambro AK 98 Service Manual

212 AK 98™ Dialysis Machine - Electrical safety inspection
HCEN12630 Revision 07.2015
Program version 1.xx
9.1 General
Toensureproperoperation,aqualifiedservicetechnicianshallperform an Electrical
Safety Inspection (ESI) of the dialysis machine at regular intervals.ESI should be
performed at every maintenance service (Base-service) but also after replacements of
some components in the dialysis machine according to the service manual, Section 6
“Replacements” on page143.Additionally if the equipment has been exposed to
unexpected electrical events on the main supply or unintentional ingress of fluid has
occurred, a full Electrical Safety Inspection shall be performed.The information
needed to perform ESI is provided in thisinstruction.
Included in the ESI procedures are checks to verify normal machine operation. Should
the machine fail to pass any of these sub-tests, repair or calibration might be needed,
then repeat the tests until the specifications are met.
Following sub-tests are included in the ESI of the dialysis machines:
● Visual inspection
● PET - Protective earth test
● ELT - Earth leakage current test
● PLT - Patient leakage current test
To avoid premature aging of isolation material no insulation test shall be performed
during ESI. Spare parts dependent on insulation are tested at manufacturing and
therefore no further test shall be performed with high voltage.
During the visual inspection of the equipment, the service engineer shall look for
potential faults related to the electrical safety of the machine.
The purpose of the PET test is to verify that the protective earthed parts of the
machine are properly connected to protective earth, providing a safe low electrical
potential on these in case of insulation failure.
The purposes of the ELT/PLT tests are to verify that non-functional leakage currents to
operator and patient are within safe limits.
When performing the ESI, which requires access to the interior of the machine, the
service technician shall have proper electrostatic safety devices (i.e. wrist grounding
straps or grounding mats) in place to prevent damage to electrostatic sensitive
components within the machine.
During repair of any of the parts in the flow path, special care should be taken and a
good hygiene should be kept.
Recordsforeach sub-testareincluded inthe end ofthisinstruction. The purpose of
these records is to documentthe work done and to trend the readings from the tests.
NOTE!
If the machine is tested according to IEC 60601-1
1
, this complies with the
requirements in IEC 62353
2
1
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance.
2
IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical
equipment.

Gambro AK 98 Specifications

General

Brand	Gambro
Model	AK 98
Category	Medical Equipment
Language	English