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Section 1
1-3
User Safety Information
Safety Regulations
Surveyor Central and Surveyor Central Repeater are medical devices
labelled, according to
European directive 93/42/EEC (MDD), as a class IIb and class I medical devices respectively. Telemetry
versions contain the radio receiver device “PCI-RF” produced by Mortara Instrument and marked
according to European directive 99/5 R&TTE. Telemetry transmitters and antenna network components
are produced by Mortara Instrument, and marked
per the MDD directive. Various other
accessories, like the monitor and printer are
marked by the respective manufacturers according to
the applicable European directives. See respective declarations of conformity for details.
Surveyor Central cannot be classified as Medical Electrical Equipment according to the definition of
safety standard IEC 60601-1. The Surveyor Central, together with all accessories that have a physical or
logical connection with it, forms part of a Medical Electrical System. The Surveyor Central complies with
various safety and performance regulations as defined in the user manual.
The device is UL classified:
WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE
WITH UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1,
AND
IEC60601-2-25
WARNINGS
Before attempting to use the device for clinical applications, the operator must read and understand
the contents of the user manual and any documents accompanying the device.
The Surveyor Central was
not
designed to be used in the patient environment as defined in IEC
60601-1-1
(1.5 m from the patient’s bed and 2.5 m from the floor). The use of an isolation
transformer between mains and Surveyor Central is not a sufficient safety measure for use in the
patient environment because of data connections (antenna network, data network) that might cause
excessive leakage currents in some conditions. Any other equipment that has a physical connection
between Surveyor Central, and that is in the patient environment, must have additional protection
against electrical shock (e.g., a separation device between the equipment and Surveyor Central). In
addition, it must be in compliance with UL 2601-1, IEC 60601-1 or equivalent safety standards.
The Surveyor Central is not battery operated. For uninterrupted use, we recommend an appropriate
uninterruptible power supply (UPS); note that, for uninterrupted use, the antenna network (telemetry)
as well as any active network components (connection with laser printer and monitors) also need to
be powered from the UPS. If power is interrupted, Surveyor Central will resume monitoring
automatically with the same settings when power returns. Loss of stored data is possible if power is
interrupted to the system that stores the data.
Summary of Contents for Surveyor Central 3.x
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