User's Manual

Table Of Contents
13
2 enin
 Electrical Safety
InnoSight Ultrasound System
P6992-4, EN, 16/12/6
Electrical:
» IEC 661-1:2AMD1:212, EN 661-1:26A12:214, Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance
» IEC 661-1-2:2 Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and
tests CISPR 11: 21 AMD1:216 Industrial, scientific and medical equipment - Radio-frequency
disturbance characteristics - Limits and methods of measurement
» IEC 661-2-3:2AMD1:21, Medical electrical equipment - Part 2-3: Particular requirements
for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment
EMC/EMI:
» IEC 661-1-2:2/AC:21, CISPR 11 Group I Class B
Harmful liquid protection:
» For the main system: IP22
» For the transducer: IPx
» For the power adapter: IP21
» For maximum safety, observe the following guidelines strictly:
The system and patient-applied parts meet the standard IEC 661-1 Applied voltages exceeding
the standard, although unlikely, may result in electrical shock to the patient or operator
Shock hazards exist if the power adapter is damaged or is not properly grounded Use only the supplied
medical grade power adapter
Do not remove or try to circumvent the grounding wire If the protective grounding of the system
is questionable, disconnect the system from the power source and run it on its internal battery
Plug the system into a hospital-grade, three-hole outlet, and do not circumvent the power cord
To avoid the risk of electric shock, connect the system only to properly grounded wall (wall/mains)
outlets
Only authorized service technicians can make internal replacements of the system
Do not operate the system in the presence of flammable gases or anesthetics Explosion can
result The system is not compliant in AP/APG environments as defined by IEC 661-1
Do not use a transducer if the transducer or cable is damaged Contact technical support for
replacement of the damaged equipment (See Customer Service on page 3)
All peripheral devices connected to the system must comply with IEC 661 or IEC 69-1
To avoid risk of electrical shock hazards, always inspect the transducer before use Check the face,
housing, and cable before use Do not use if the face is cracked, chipped, or torn the housing is
damaged or the cable is abraded
Transducer cables have strain reliefs at terminations Inspect cables regularly to detect
damaged, frayed, or broken cables that might contact a patient
C9-4v are invasive transducers The operator should immediately stop using the C9-4v
transducer when its surface temperature reaches 43C