Brainlab AG
Kapellenstraße 12
85622 Feldkirchen
Germany
Customer Support:
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BL-IL-60912-06-Rev1.0
a
STI Robotics OEM
49703
Safety Technical Inspection
ENGLISH
1.
General
The device shall be maintained and serviced on a regular basis,
at least once a year, based on the requirements of IEC62353 -
Medical electrical equipment - Recurrent test and test after
repair of medical electrical equipment.
For details about performance of the inspection as well as the
assessment of the results of the tests strictly follow the
requirements of IEC62353.
The following sections refer to referenced chapters in the
above mentioned standard and serve to support the inspection
accordingly.
Use only certified testing equipment intended and designed to
perform tests according IEC62353.
2.
Visual inspection (5.2 – IEC62353)
-
All Warning Labels as defined in the
Hardware User Guide
Robotics OEM
are complete, legible and show no
damage.
-
The
Robotics
housing, including the bellows is not
damaged or loose. All parts are securely fastened.
-
The cover of the Auxiliary Power Supply does not show
any cracks or other damage.
-
No twists or cracks in cable jacket and no damage to
connectors
Open the left cover shell of
Robotics OEM
. Inspect the
functional earth conductor (FE) connecting the upper
and lower metal housing plate and verify the
connection is not impaired by wear or fatigue (see
figures1/2/3 for details):
-
There are no obvious cracks in the isolation or sharp
bending of the conductor
-
The mechanical connection of the conductor to upper
AND
lower housing plate is not loose
3.
Measuring of protective earth (PE) resistance (5.3.2 –
IEC62353)
Disconnect the Auxiliary Power Supply.
Verify that the resistance of the protective earth connection
between upper and lower metal housing plate of
Robotics OEM
complies with the requirements of IEC62353 (see figure4 for
details).
-
The measured internal PE-resistance shall not exceed
0.2
Ω
.
4.
Leakage currents (5.3.3 – IEC62353)
Perform an Equipment Leakage Current test with
Robotics OEM
and verify the Equipment Leakage Current from accessible
conductive parts complies with the requirements of IEC62353
(see figure5 for details).
-
The Equipment Leakage Current shall not exceed the
limits as specified in IEC62353
-
Allowed limits differ depending on the type of
measurement setup. For details please refer to
IEC62353
5.
Measurement of insulation resistance (5.3.4 – IEC62353)
The insulation resistance shall only be measured at the
Auxiliary Power Supply. Therefore disconnect the Auxiliary
Power Supply from
Robotics OEM
.
Verify the insulation resistance between the primary and
secondary circuits of the Auxiliary Power Supply in accordance
with the requirements of IEC62353 (see figure 6 for details).
-
The insulation resistance shall meet as a minimum the
limits as specified in IEC62353
6.
Functional test (5.4 – IEC62353)
The safety related functions of the equipment shall be tested
as follows:
-
Test the Service Lock mechanism:
Both arresting bolts can be operated easily to both the
‘Locked’ and the ‘Unlocked’ position.
The indicator lights in the ‘Lock All’ are lit on both sides
of Robotics if an arresting bolt is not in its normal
‘Unlocked’ position.
-
Test the Service Brake Release:
Follow the instructions in the
Hardware User Guide
Robotics OEM
to perform a Service Brake Release.
The function works as described. After the test
Robotics indicates the occurrence of a Service Brake
Release and a ‘Homing’ procedure is required.
-
Test the Emergency OFF (EMO):
-
Danger of damage to the Linac system if the
Emergency Off switch is activated while the Linac is
in operation!
Contact local service specialist to attend and
supervise the testing!
Perform a
Robotics
maneuver. During movement press
the Emergency OFF push button of the Linac:
Robotics
stops immediately.
7.
Reporting of results (6.1 – IEC62353)
All tests performed as stated above shall be documented
comprehensively.
For further information please see the
Hardware User Guide
Robotics OEM
or consult Brainlab customer support.
figure 1:
Opening left cover shell
figure 2:
No obvious cracks in the isolation or sharp bending of the
conductor
figure 3:
Die mechanische Verbindung des Schutzleiters zur oberen
und unteren Gehäuseplatte ist nicht locker
