Safety
2-18 Vivid S70 / S60 – User Manual
BC092760-1EN
01
Peripheral devices
Internally connected peripheral devices
The system, together with peripheral devices, such as video
printer, meets ANSI AAMI ES60601-1 and IEC/EN 60601-1
standards for electrical isolation and safety. These standards are
applicable only when the specified peripheral devices are
plugged into the AC outlets provided on the system.
External Connection of other peripheral devices
Use only GE Healthcare approved internal equipment when
replacing an internal
peripheral.
External
peripheral equipment must be in compliance with
related IEC/EN standards for safety. The electrical medical
systems conformance to IEC/EN60601-1 Clause 16 must be
verified.
All non-medical electrical equipment must be kept outside of
the patient environment, as defined in IEC/EN60601-1, unless
it is equipped with additional protective earth or extra
separating transformer. Commercial devices such as laser
cameras, printers, VCRs and external monitors, usually exceed
allowable leakage current limits per IEC/EN60601-1 and, when
plugged into separate AC outlets, are in violation of patient
safety standards. Suitable electrical isolation of such external
AC outlets, or providing the device with extra protective earth,
will be required in order to meet IEC/EN60601-1 standards for
electrical leakage currents.
External devices can be used only if CE marked and in
compliance with related IEC or ISO Safety standards.
Conformance to IEC/EN60601-1 Clause 16 requirements for
Medical Electrical systems must be verified.
Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC or
ISO Safety standards (e.g. IEC/EN60950-1 for data processing
equipment or IEC/EN60601-1 for medical equipment).
Furthermore all complete configurations shall comply with the
requirements for Medical Electrical systems of IEC/EN60601-1.
Anybody connecting additional equipment to the signal input
part or signal output part of the ultrasound system configures a
medical electrical system, and is therefore responsible that the
system complies with the requirements of the IEC/EN60601-1
Clause 16. If in doubt, consult the technical service department
or your local GE representative.