Important Information — Please Read Before Use
11
VISERA VIDEO SYSTEM CENTER OTV-S7V
Cardiac applications
• Use only the devices listed in the “System chart” 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 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 metal endoscopes for endoscopic cardiac applications,
the “Applied Part” requirements include all devices directly
connected to the endoscope, such as the light guide (LG)
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 LG cables and camera heads listed in the
“System chart” (TYPE CF APPLIED PART) which are
suitable for cardiac applications bear a mark.
• The OLYMPUS surgical holder for telescope (SH-1) has an
electrically isolated arm structure which isolates the
endoscope from the ground. This design makes the SH-1
suitable for cardiac applications.
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