Safety Requirements; Classification - natus Dantec Keypoint G4 User's And Service Manual

New reference values are required when changing the algorithm. If you use the reference value system, the
values must reflect the algorithm you select.
New settings require new reference values.
If you use the reference value system, the values must reflect the settings you select.
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 use additional multiple socket outlets or extension cord.
Pay attention to the intensity indicator during the use of the program. See the section
the section

Safety Requirements

This device has been designed and tested in accordance with IEC 60601-1 Medical Electrical Equipment, cf. the text on IEC 60601-1 further
below in this section.
The device has been designed for indoor use at temperatures between +10°C and +35°C (+50°F to +95°F).
The mains plug must only be inserted in a mains socket outlet provided with a protective earth contact.
• It is forbidden to use extension cords.
• It is forbidden to use multiple portable socket outlets (MPSO).
Adhere to the following recommendations for safe operation of the device:
• When connecting medical equipment being supplied from an outlet located in a non-medically used room, or when connecting
non-medical electrical equipment to this device, please pay attention to the requirements of IEC 60601-1, Safety Requirements for
medical electrical systems, cf. the text on IEC 60601-1, is found below in this section.
• When the device is connected to its mains supply, connectors may be live, and any opening of covers or removal of parts possible
only with the aid of a tool is likely to expose live parts.
• The device must be disconnected from all voltage sources before being opened for any adjustment, replacement, maintenance or
repair.
• Service must be referred to Natus authorized service personnel, except for such works described in this manual as being
performed by the operator.
• Make sure that only fuses with the required rated current and of the specified type are used for replacement. The use of
makeshift fuses and the short-circuiting of fuse holders are prohibited.
• Where more than one piece of equipment is connected to the patient, attention must be paid to the summation of patient
leakage currents.
Whenever it is likely that the protection has been impaired, the device shall be made inoperative and be secured against any
•
unintended operation. Call qualified service personnel to conduct at least a functional test and a safety check that should include
the following:
o Insulation test
o Ground continuity test
Leakage current test, according to IEC 60601-1
o
The protection is likely to be impaired if, for example, the device:
•
Shows visible damage
o
o Fails to perform the intended function(s)
o Has been subject to severe transport stresses

Classification

Type of protection against electric shock: class I:
• Equipment in which protection against electric shock does not rely on basic insulation only, but which includes an
additional safety precaution in that means are provided for the connection of the equipment to the protective earth conductor in
the fixed wiring of the installation in such a way that accessible metal parts cannot become live in the event of a failure of the
basic insulation.
Stimulators for further information.
14
Stimulator Overload, and