Olympus CV-180 - Cardiac Applications

Important Information — Please Read Before Use
11
EVIS EXERA II VIDEO SYSTEM CENTER CV-180
Cardiac applications
• Use only the devices listed in the “System chart” in the
Appendix for endoscopic observation or treatment of the
heart or areas near the heart. Other combinations of
equipment may cause ventricular fibrillation or seriously
affect the cardiac function of the patient.
• For cardiac applications, never support the endoscope with a
metal surgical arm which is not electrically isolated from the
ground. If not isolated, the endoscope will be connected to
the ground through the surgical arm and bed, and will
conduct unexpected leakage current which may seriously
affect the cardiac function of the patient.
• The use of medical devices not specifically designed for
cardiac applications may cause ventricular fibrillation or
seriously affect the cardiac function of the patient. As
specified by the international standard IEC 60601-1, any
applied part used for observation or treatment of the heart or
areas near the heart must meet “TYPE CF applied part”
requirements for low electrical leakage current. When using
endoscopes for endoscopic cardiac applications, the applied
part requirements include all devices directly connected to
the endoscope, such as the light guide cable, camera head
and telescope holder. Each of these devices must
individually meet the “TYPE CF applied part” requirements
for leakage current limits if they are to be used for cardiac
applications.
The OLYMPUS light guide cables and camera heads listed in
the “System chart” in the Appendix (TYPE CF applied part)
which are suitable for cardiac applications bear a mark.