Important Information — Please Read Before Use
11
CLV-190 INSTRUCTION MANUAL
Cardiac applications
• Use only the devices listed in the “ System chart” on page 109 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
that 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 that 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”
on page 109 (TYPE CF applied part) that are suitable for cardiac applications bear
a mark.
• The Olympus Surgical Holder for Telescope (SH-1) has an electrically isolated arm
structure that isolates the endoscope from the ground. This design makes the SH-1
suitable for cardiac applications.
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