Brainlab Buzz Navigation System And Technical User Manual page 85

ELECTRICAL SAFETY
Step
Equipment leakage
current
Touch current (Re-
quired for ME SYS-
TEM)
Functional test
Report results
Evaluate results
Check and prepare
for normal use
Critical Values
Values are limited according to the standards.
Test Step
Protective earth resistance
Equipment leakage current
Touch current
Related Links
System Messages on page 51
System and Technical User Guide Rev. 1.2 Buzz Navigation (Ceiling-Mounted) Ver. 1.0
Instructions and Conditions
Test the equipment leakage current according to IEC 62353:2007 Chapter
5.3.3.2.3 using the "differential method" with the following additional con-
ditions:
• Measurements are performed at mains voltage.
• Measurements are performed in both positions of the mains plug, if
possible.
When measuring in the various positions of the mains plug, document the
higher value.
Definition:
Leakage current flowing from the enclosure or from parts thereof, exclud-
ing patient connections, accessible to any operator or patient in normal
use, through an external path other than the protective earth conductor, to
earth or to another part of the enclosure.
Prepare device for normal use.
Connect the required functional connections to create the medical electri-
cal system and switch devices on.
Measure the touch current for all measurement points.
Prepare device for normal use.
Power on the device.
Check if indicator lights are working.
Start a software application.
If applicable, verify the desired function of the ME SYSTEM.
Check that:
• Data is displayed on the screen
• Touch screen interaction is working
• Interfaces are working
• Communication to the network is working (if applicable)
Generate a test report.
Determine whether the device is safe and effective.
After testing, check that the device is restored to the conditions necessary
for normal use before being returned into service.
Remove all devices that have been connected, e.g., measurement device
with probes and lines.
Normal Condition
≤ 0.3 Ω
≤ 0.5 mA
≤ 0.1 mA
Single Fault Condi- Standard
tion
N/A IEC 62353
N/A IEC 62353
≤ 0.5 mA
IEC 60601-1
85