Users Manual Part 1
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Nerve Integrity Monitor
B. System safety check according to IEC/EN60601-1
Medtronic recommends System Safety Checks to be scheduled at yearly intervals.
IEC/EN60601-1 safety analysis
In accordance with local procedures, perform a complete Safety Analysis for a Class 1, Type BF Device on the NIM Console.
Utilize “Equipotential Ground” connector found on rear of console as Chassis ground.
For Patient Leakage and Mains on Applied Parts tests, a Patient Interface must be attached to the NIM Console with electrodes
connected to each channel.
Ensure Ground Impedance is less than 0.252 Ωs when measured with a 25 Amp source.
High potential (Hi-Pot) testing (B. a - c) ________( )
In accordance with local procedures, perform the following Hi-Pot tests on the NIM Console.
Note: Perform Test at voltages indicated and record values in space as needed.
Safety ground to Line/Neutral:
Apply Hi-Pot to Line and Neutral of Power Inlet of NIM® Console while monitoring Ground.
Applied Parts to line/neutral:
Apply Hi-Pot to Line and Neutral of Power Inlet while monitoring Applied Parts.
Precaution: use DC voltage only when performing Applied Parts Hi-Pot test. AC Hi-Pot voltage to applied parts will damage
the device.
System Safety Check Manufacturers Specications Recorded Value
a. Ground impedance <0.252Ω @ 25 Amps ______________
b. Safety ground to Line/Neutral <5.0 mA @ 1500 Vac ______________
c. Applied Parts to line/neutral <1.0 mA @ 3535 Vdc ______________
Accessories
System description
The Medtronic NIM Universal Patient Simulator provides for testing some of the features of the NIM system without the need for
patient interaction. In addition, the NIM Universal Patient Simulator is a convenient means of testing various aspects of instrument
operability prior to patient application.
This section describes the NIM Patient Simulator and pertinent components of the NIM system used during a test.
On the NIM Vital Universal Patient Simulator, there are 8 channel stimulation contact pads, one (1) for each channel. These contacts
are the points for activating individual circuits. A monopolar probe is recommended for use during testing.
Simulator set-up
Simulator use requires prior setup of the NIM Vital unit as previously described.
1 Electrode ground
2 Auxiliary stimulator STIM2 or Nervassure jack
Note: You cannot use the Nervassure Stimulating Electrodes
with the Simulator.
3 Incrementing Probe control jack
4 Stimulator STIM1 jack
5 Stimulus return jack
6 Positive electrode jacks
7 Negative electrode jacks
FCC use only, not for Medical use