Peripherals - GE Venue Fit Technical Publication

P R E L I M I N A R Y
DIRECTION 5854713-100, REVISION 2
1-4-4-2

Peripherals

1-4-4-2-1 Safety and Environmental Guidelines
Do not attempt to use different peripherals & accessories (brand and model connected
WARNING WARNING
via USB ports) other than approved and provided by GE Healthcare! The Ultrasound
system is extremely sensitive and complex medical system. Any unauthorized
peripherals may cause failure or damage!
Environmental Dangers
WARNING WARNING
ALL DEVICES MEETING IEC60950 MUST BE KEPT OUTSIDE THE PATIENT
ENVIRONMENT AS DEFINED IN IEC60601-1-1, UNLESS THE DEVICES, ACCORDING TO
IEC60601-1-1, ARE EQUIPPED WITH THE FOLLOWING:
A) ADDITIONAL FIXED EARTH PROTECTION
OR:
B) AN EXTRA ISOLATING TRANSFORMER
Commercial devices such as laser cameras, printers, VCRs and external monitors,
WARNING WARNING
usually exceed allowable leakage current limits and, when plugged into separate
AC outlets, are in violation of patient safety standards. Suitable electrical isolation of
such external AC outlets, or the provision of extra protective earth for the device, is
required in order to meet UL60601-1 and IEC60601-1-1 standards for electrical leakage.
• Patient Vicinity UL 60601-1
Sub clause 2.12.20DV - D2 Addition
An area in which patients are normally cared for, the patient vicinity is the space with surfaces likely
to be in contact with the patient or attendant who can touch the patient. This encloses a space within
the room of 1.83 m (6 ft.) beyond the perimeter of the bed (examination table, dental chair,
treatment booth, and the like) in its intended location, and extending vertically 2.29 m (7.5 ft.) above
the floor.
• Patient Environment IEC 60601-1-1
Sub clause 2.204
Such an area is an environment in which medical diagnosis, monitoring or treatment is carried out.
It is very difficult to attach unique dimensions to the PATIENT ENVIRONMENT. In practice a
distance of 2,5 m (8.2 ft.) above the floor on which the medical personnel stand and a horizontal
distance of 1,5 m (4.9 ft.) have justified themselves as indicative of the dimensions of the Patient
Environment. The patient environment/vicinity is depicted as a dashed line in this procedure - see
the example in
1-14 Chapter 1 - Introduction
VENUE FIT™ SERVICE MANUAL