TELEMED ClarUs User Guide, REV 4.0 2013.12.04
12
2.
SAFETY
CAUTION :
Please read this information before using the diagnostic system. It
applies to the ultrasound system, transducers, accessories and
peripherals.
2.1.
Electrical safety
This system complies with the applicable medical equipment requirements and
meets IEC601-1, Class I Type BF safety requirements.
NOTE :
All persons connecting computer equipment as medical appliance
are configuring a medical system and are therefore responsible for
ensuring that the system complies with IEC 601-1-1. The
achievement of PC compliance with the IEC 601-1 requirements is
based on electrical safety. A standard PC power supply is almost
certain to not comply with IEC 601-1 electrical requirements in
several ways , e.g. leakage current requirements, dielectric strength
requirements.
One possible solution is powering the PC (and computer monitor)
via a 1:1 medical insulation transformer, which has been designed
to meet IEC 60601-1 requirements. The best solution is a fully IEC
601-1 certified PC or
a battery operated portable PC and wireless
peripheral devices.
All systems (including monitors and other connected parts) must
be configured to comply with IEC 601-1-1. If in any doubt please
contact
the
technical
service
department
of
your
local
representative.
Note that regardless of the above stipulations all personal
computers used should be approved regarding the IT (information
technology) safety standards for electrical ) equipment (such as.
IEC 60950 or equivalent) .
The electrical specification is shown below and can be found labelled on the
rear panel of scanner.
To avoid electrical shock only use the supplied power cables and connect it to
a properly earthed power socket. Do not use a three pin - two pin adapter. This
defeats the whole purpose of earthing for safety reasons. Systems should be
operated within the voltage limits.
WARNING:
In the event of detecting a discrepancy regarding patient safety
requirements (occurrence or probability of risk) you must to inform
the local dealer and the manufacturer immediately (for single
European customers
– inform the EC representative labeled on the
rear panel).
