EN
Testing the electrical safety
Limit value
Target value
Actual value
Passed?
Measurement of PE resistance
< 0.2 Ohm
Yes
No
Measurement of earth leakage current (NC)
< 500 µA
Yes
No
Measurement of earth leakage current (SFC)
< 1000 µA
Yes
No
Measurement of housing leakage current
< 100 µA
Yes
No
If the device is operated in combination with other devices, these measurements must be carried out with the maximum
configuration using adapted limit or target values (also see
IEC/EN 60601-1 3
rd
ed.
).
Check of patient leakage current
Each connector shall be connected with an applied part and the check should be done according to
IEC/
EN62353
. This check should be done in maximal configuration. For the determination of the maximum leakage
current group all CF and all BF applied parts together and measure according the following scheme:
Patient leakage current in
combination with
Type applied
part
Serial- no.
(SN)
Limit
value
Typical
value
Actual
value
Passed?
Clamp-On Transducer 1
NC
BF
< 100 µA
Yes
No
Clamp-On Transducer 2
Clamp-On Transducer 1
SFC
BF
< 5000 µA
Yes
No
Clamp-On Transducer 2
NC: normal condition; SFC: single fault condition
Checking Functionality according the Operating Instructions
Switch the device on and check the following points:
Function check
Passed?
Did the unit boot successfully when turned on?
Yes
No
Perform a function check in accordance with the Operating Instructions
Yes
No
Test the various settings in the Setup mode.
Yes
No
Clamp-On Transducer:
Check coupling value with tube:
The coupling display must be greater than 60%
Yes
No
When using the alarm system: Check alarm function
(simulation of alarm conditions: see Function Check of Alarms)
Yes
No
SonoTT
TM
Ultrasonic FlowComputer
Copyright em-tec GmbH
D108-702 SonoTT
TM
Ultrasonic FlowComputer - Operating Instructions V4.0
•
Page 85