User & Service Manual
Trex™ HD Monitoring Amplifier
15
3. Warnings and Cautions
3.1. General Warnings
NOTE:
It is recommended that all data be stored using redundant storage capabilities. This
can help to minimize data loss in the event of a failure of the primary drive.
Proper use of this device depends on the careful reading of all instructions and labels that
come with or on the system. Inaccurate measurements may be caused by incorrect
application or use.
The amplifier is classified as an IPX0 – ordinary degree of protection against ingress of
water according to IEC 529. The amplifier is classified as a class II device according to
IEC601-1.
The computer used with a Trex HD Monitoring amplifier must either be approved by
Natus
and supplied as part of an IEC 601 approved system, or it must be approved to IEC 950 or
similar and kept outside of the patient environment, (that is, at least 1.5 meters from the
patient laterally and not within a height of 2.5 meters from the floor in the area occupied by
the patient).
Only use the Trex HD Monitoring in conjunction with approved devices and accessories.
Use of cables other than those specified or sold by the manufacturer on the equipment,
may result in increased emissions or decreased immunity of the equipment and may
cause the system to be non-compliant with the requirements of IEC 60601-1-2.
Nonin 8000J pulse oximeter sensors used with the Trex HD Monitoring amplifier are in
compliance with the requirements of 6.1 and 6.2 when used with the Natus Nonin LP Trex
Cable (p/n 010382).
To ensure the validity of signals, do not operate the device near any sources of
electromagnetic interference.
Electrostatic Discharge (ESD) Precaution:
Be sure to take the appropriate
Electrostatic Discharge (ESD) precautions. Disconnect the cables before
moving, cabling, or performing any set up procedures. Connectors marked
with the ESD protection symbol should not be touched. For detailed handling procedures,
see
Turn off all system power and disconnect the power cord from the system and the wall
before attempting to clean the unit. The Trex HD Monitoring unit can be wiped clean with a
soft, damp cloth using non-conductive distilled water, electrically non-conductive inert
surfactants or a Natus
-approved cold sterilizing agent. It is important to dry off the unit
quickly. Avoid letting liquid seep into any of the internal electronics of the system. Do not
use any abrasive cleaner on the system.
When the Trex HD Monitoring amplifier is in the Trex HD Monitoring IPX2-certified pouch
(p/n 021995), it is offered protection from dripping water from above the device for up to
10 minutes in duration.