Olympus OTV-SI, Инструкция по эксплуатации, Страница: 15 / 174

Important Information — Please Read Before Use
9
VIDEO SYSTEM OTV-SI
Cardiac applications
• Use only the devices listed in the “System chart” (TYPE CF
APPLIED PART) 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 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 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 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 cable and camera head listed in
the “System chart” (TYPE CF APPLIED PART) in the
Appendix as 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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