Hardware Instructions for Use
8
Warnings
Do not use this PC-based equipment for anything else other than what it is intended for by the
manufacturer −i.e. carrying out tests on patients and possibly subsequent report generation.
Do not install any other software than the Keypoint.NET Software. Natus assumes no
responsibility when the equipment is not used as described in this manual.
The device is not MRI compatible.
The device is not intended for direct cardiac application.
The device is not suitable for intensive care monitoring use.
Any interruption of the protective earth conductor inside or outside of the device, or
disconnection of the protective earth connector is likely to make the device dangerous.
Intentional interruption is prohibited. The protective earth (ground) conductor should be
checked regularly.
Due to risk of electric shock, the operator and / or patient must not directly or indirectly touch
the metal shield on the LINK cable attached to the rear of the amplifier.
Do not connect the "patient ground" to the protective earth connection on the rear panel of
the
Isolating Transformer or to any other "ground" connections, as the electrode inputs are
galvanically isolated.
Simultaneous connection of a patient to HF surgical equipment may result in burns at the site
of the electrical stimulation or recording electrodes, and possible damage to the electrical
stimulator or the electrode input amplifiers. Operation in close proximity (e.g. 1m) to short
wave or microwave therapy equipment may produce instability in the electrical stimulator
output.
Electrical equipment for medical use requires special EMC precautions and needs to be
installed and serviced according to the EMC documentation of device.
When connecting the integrated LAN port to a network system, the NetBox Ref. 9031G046x
must be properly connected into the LAN line between the LAN port and the network system.
Do not make a direct connection between the PC LAN Port and the Network System!
The NetBox Ref. 9031G046x provides electrical insulation to prevent dangerous electrical
current from reaching the patient in the event that the network system becomes accidentally
electrically shorted to a high voltage line.
Failure to properly install the NetBox Ref. 9031G046x when making the LAN connection
annuls this product’s compliance certification with the IEC 60601-1 international safety
standards for medical electrical equipment.
