Safety, Warnings And Precautions; Contraindications; Warnings - natus Dantec Keypoint G4 User's And Service Manual

Safety, Warnings and Precautions

This chapter defines Safety, Warnings and Precautions applicable to the Dantec Keypoint G4 system. Read all information in this chapter
thoroughly prior to use of the Dantec Keypoint G4 system.
Two labels identify potentially dangerous or destructive conditions and procedures:
WARNING indicates that there is a risk of death or serious injury to the user or
A
Warning
patient.
CAUTION indicates that there is a risk of injury to the user or patient or risk of
A
Caution
damage to the device.
Any serious incident that has occurred in relation to the Natus Keypoint G4 system be reported to the manufacturer and the competent
authority of the Member State in which the user and/or patient is established.

Contraindications

There are no known contraindications under normal clinical use.

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 intended for direct cardiac application.
The device is not suitable for intensive care monitoring use.
Possible explosion hazard, if used in the presence of flammable anesthetics.
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.
Do not connect the "patient ground" to the protective earth connection on the rear panel of the Power Supply
Unit/Isolating Transformer or to any other "ground" connections, as the electrode inputs are galvanically
isolated.
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.
The use of accessories, electrodes, and cables other than those specified by Natus may result in increased
emissions, or decreased immunity of the equipment.
12