Connecting Peripheral Equipment - Siemens Acuson S1000 Instructions For Use Manual

Connecting Peripheral Equipment

WARNING: Equipment connected to the ultrasound system and in the patient environment must
be powered from a medically-isolated power source or must be a medically-isolated device.
Equipment powered from a non-isolated source can result in chassis leakage currents
exceeding safe levels. Chassis leakage current created by an accessory or device connected to
a non-isolated outlet may add to the chassis leakage current of the ultrasound system.
WARNING: Non-medical grade report printers cannot be used within a patient environment.
WARNING: During use of a non-medical grade report printer or when a non-medical grade
report printer is connected to the ultrasound system, the ultrasound system cannot in any way
be in contact with a patient.
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 and IEC 60601-1 (Medical Electrical Equipment, Part 1: General
Requirements for Basic Safety and Essential Performance) 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:
Equipotential connector located on AC tray panel of the ultrasound system.
– 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 or IEC 60601-1, Annex I.
Note: The above information is based on current EN 60601-1 and IEC 60601-1 standards. If your
country's regulatory standards for medical equipment do not correspond to EN 60601-1 and
IEC 60601-1, your local requirements may be different.
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