12.1 How to Connect Auxiliary Devices Safely
The first mounting and connecting will usually be performed by a GE system technician.
How to connect peripheral devices:
1.
Ensure that the console is switched off.
2.
Connect the peripheral device to the console.
3.
Switch the peripheral device on by pressing the Power ON button.
Note
Always observe the instructions given in the manual of the peripheral/auxiliary device.
Basic Concept:
The Voluson™ SWIFT / Voluson SWIFT+ is equipped with an isolation transformer to provide
the required separation from AC Mains.
The Voluson™ SWIFT / Voluson SWIFT+ provides several inputs and outputs (I/O) such as
Audio, Video, Ethernet, USB, DICOM and Printer signals. Special care must be taken when
connecting auxiliary devices via these input and output (I/O) connections.
The IEC 60601 standard provides a guideline for safely interconnecting medical devices in
systems.
Each person who connects additional equipment to the signal input portion or signal output
portion configures a medical system, and is therefore responsible that the system complies
with the requirements of the system standard IEC 60601. If in doubt, consult the technical
service department or your local representative.
1.
The medical device may be connected to a single IEC (e.g. IEC 60601-1, IEC 60950-1,
…) device (protection class I) placed in a room which is not medically used.
2.
If the device is to be connected in a medically-used room the following rule applies:
•
IEC (e.g. IEC 60950-1, …) compliant devices (protection class I) may be connected
with an additional safety measure.
•
IEC 60601 compliant devices may be connected as such.
For all situations 1 and 2, the additional device shall be installed outside the typical patient
environment.
Possible additional safety measures are:
Additional protective earth connection between the 2 devices, or a safety isolation mains
transformer for the other device.
Special care has to be taken, if the device is connected to a computer network (e.g., Ethernet),
because other devices could be connected without any control. There could be a potential
difference between the protective earth and any line of the computer network including the
shield.
In this case the only way to operate the system safely is to use an isolated signal link with
minimum air clearance and creepage distance of the isolation device in agreement with
IEC60601 incl. national deviations. For computer networks there are media converters
available which convert the electrical to optical signals. Please consider that this converter has
to comply with the relevant applicable standards (e.g. IEC 60601-1, IEC 60950-1, …) and is
battery operated or connected to the isolated mains output of the Voluson™ SWIFT / Voluson
SWIFT+.
Additionally the IEC 60601 requires control measurement of leakage currents.
The system integrator (any person connecting the medical device to other devices) is
responsible that the connections are safe.
12.1.1 Precautions when using peripherals and network connection
Caution
Possible loss of data during transfer via network from the ultrasound system.
Peripheral Devices
12-2
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4
Содержание Voluson Swift
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