Connecting Peripheral Equipment - Siemens ACUSON Antares Instructions For Use Manual

Connecting Peripheral Equipment

On-board peripheral devices must be installed by an authorized Siemens
representative or by a Siemens approved third party. Any use of other
devices with the system will be at the user's risk and may void the system
warranty.
In order to fulfill EN 60601-1-1 and IEC 60601-1-1 (Medical Electrical
Equipment, Part 1: General Requirements for Safety) requirements,
connection of peripheral equipment to your ultrasound system must adhere
to one of the following conditions:
The peripheral equipment itself is a medical device approved according
to EN 60601-1 and IEC 60601-1, or
Non-medical peripheral equipment approved according to any other EN
or IEC standard (EN XXXXX or IEC XXXXX, e.g., equipment complying
with EN 60348 and IEC 60348, EN 60950 and IEC 60950, etc.) must use
the following setup for connection:
Connect the ultrasound system to an independent protective ground
–
terminal, with a ground wire connection to the ultrasound systems
equipotential connector. Ensure that the protective ground wire is
connected to a qualified protective ground connection independent
of the existing system's ground connection (via the power cable).
The peripheral equipment is located at least 1.5 meters (1.8 meters
–
[6 feet] in Canada and the U.S.A.) outside of the patient
environment. A patient environment is defined as the area in which
medical examination, monitoring, or treatment of the patient takes
place.
The peripheral equipment is connected to a main outlet outside the
–
patient environment but still within the same room as the ultrasound
system.
For additional information and other possible combinations, please refer to
the Medical Electrical Equipment Standard EN 60601-1-1 or IEC 60601-1-1,
Annex BBB.7, Scenario 3c.
Note: The above information is based on current EN 60601-1-1 and IEC 60601-1-1
standards, dated 1992. If your country's regulatory standards for medical equipment do
not correspond to EN 60601-1 and IEC 60601-1 as well as EN 60601-1-1 and
IEC 60601-1-1, your local requirements may be different.
[ 1 ] I N S T R U C T I O N S F O R U S E
4 S y s t e m S e t u p
Equipotential connector
located on AC tray
panel of the
ultrasound system.
4 - 2 3