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Mortara S12 - Page 36

Mortara S12
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GENERAL CARE AND MAINTENANCE
30
Safety Testing
If the monitor housing was opened for repair or inspection work, the following safety tests should be
performed in accordance with the IEC 60601-1 or IEC 62353 methods and limits.
The S12 and S19 are considered a Class 1 Type CF devices, intended to be utilized with the Mortara specified
patient modules and product accessories.
DC Hi-pot Testing
Applies to all of the following optional patient inputs (applied parts) installed on the monitor being tested. Test
connectors are required to properly connect test equipment to the applied part inputs to perform Hi-pot testing.
The negative (black) connection of the tester should be connected to the DC Power Input via TF0571 (or
equivalent). The positive (red) lead wire is connected to the connection defined below.
The ECG input should be tested separately, and the other applied parts (SpO2, Temp, CO) can be connected
together via a shorting bar (as shown in the diagram below) to expedite the testing process. This is not a
requirement and the tests can be performed separately.
Connection
Test Connector/Method
ECG
Patient cable 9293-050-60 and shorting bar
SpO2
TF0281
Temp 1, Temp 2
TF0559
Cardiac Output
TF0558
Item
Value
Unit of Measure
Boundary
Applied Potential
5000
Volts DC
Minimum
Ramp Time
3.0
Seconds
Minimum
Dwell Time
1.0
Seconds
Minimum
Current High
0.500 (500 uA)
mA
Maximum
Current Low
0.0
mA
Minimum

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