Brainlab Buzz 2.0, Системное и техническое руководство пользователя

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Step Instructions and Conditions
Equipment leakage
current
Test the equipment leakage current according to IEC 62353:2014 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
Touch current (Re-
quired for ME SYS-
TEM)
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.
Functional test
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)
Report results Generate a test report.
Evaluate results Determine whether the device is safe and effective.
Check and prepare
for normal use
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.
Critical Values
Values are limited according to the standards.
Test Step Normal Condition Single Fault Condi-
tion Standard
Protective earth resistance
≤
0.3
Ω
n/a IEC 62353
Equipment leakage current
≤
0.5 mA n/a IEC 62353
Touch current
≤
0.1 mA
≤
0.5 mA IEC 60601-1
Reference Dimension
Use the table below to enter the single measured values at each required measurement point.
Enter the maximum measured values in the table below:
ELECTRICAL SAFETY
System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0 69