Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
Customer Support:
North/South America: +1 800 597 5911
Europe & rest of the world: +49 89 991568 1044
Page 1/10
a
BL-IL-60961-45ML Rev. 2.0
*60961-45ML*
Date of issue: 2021-08-18
STI Robotics
49702
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)
-
The device fuse inserted at the rear end of
Robotics
complies with the data given in the
Hardware User Guide,
Patient Support System
(check imprinting on the fuse).
-
All Warning Labels as defined in the
Hardware User
Guide, Patient Support System
are complete, legible and
show no damage.
-
The
Robotics
housing, including the bellows is not
damaged or loose. All parts are securely fastened.
-
The covers and mechanical parts of the ON/OFF-
switches are not damaged, loose or otherwise impaired
by wear.
-
The covers and mechanical parts of the Lock-All push
buttons are not damaged, loose or otherwise impaired
by wear.
-
The cover of the Battery Charger 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
. 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
figures 1/2/3 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 Battery Charger and switch
Robotics
‘OFF’.
Verify that the resistance of the protective earth connection
between upper and lower metal housing plate of
Robotics
complies with the requirements of IEC62353 (see figure 4 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
and
verify the Equipment Leakage Current from accessible
conductive parts complies with the requirements of IEC62353
(see figure 5 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 Battery
Charger. Therefore disconnect the Battery Charger from
Robotics
.
Verify the insulation resistance between the primary and
secondary circuits of the Battery Charger 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’ push buttons 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,
Patient Support System
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.
-
Inspect and test the correct function of the ON/OFF-
switches:
The device can be turned ‘ON’ and ‘OFF’ by operating
the switches on either side. Both switches are lit to
indicate the ‘ON’-state of
Robotics
-
Inspect and test the correct function of the Lock-All
push buttons:
The device can be ‘Locked’ and ‘Unlocked’ by
operating the push buttons on either side. Both buttons
are lit to indicate the ‘Locked’-state of
Robotics
-
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,
Patient Support System
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:
The mechanical connection of the conductor to upper and
lower housing plate is not loose
