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1.0
Introduction
It is recommended that personnel study this
manual before attempting to operate, clean,
and/or sterilize the Arthrex Synergy
ID
System
and accessories. The safe and effective use
of this equipment requires the understanding
of and compliance with all warnings,
precautionary notices, and instructions
marked on the product, and included in this
manual.
The Arthrex Synergy
ID
System is comprised
of:
•
AR-3200-0025 [Synergy
ID
Console]
•
AR-3210-0018 [HD, SynergyUHD4
Camera Head, autoclavable]
•
AR-3210-0021 [HD SynergyUHD4
C-Mount Camera Head,
autoclavable]
•
AR-3210-0022 [HD SynergyUHD4
C-Mount Camera Head, 0 Degree,
autoclavable]
•
AR-3210-0023 [4K SynergyUHD4
Camera Head, autoclavable]
•
AR-3210-0025 [4K SynergyUHD4 C-
Mount Camera Head, autoclavable]
•
AR-3210-0026 [4K SynergyUHD4 C-
Mount Camera Head, 0 Degree,
autoclavable]
•
AR-3210-0028 [4K SynergyUHD4 C-
Mount w/20 foot cable, autoclavable]
•
AR-3210-0029 [4K SynergyUHD4
Broadband Camera Head,
autoclavable]
•
AR-3210-0030 [4K SynergyUHD4 C-
Mount Broadband Camera Head,
autoclavable]
•
AR-3210-0031 [4K SynergyUHD4
Ultra Camera Head, autoclavable]
•
AR-3210-0032 [4K SynergyUHD4
Ultra C-Mount Camera Head,
autoclavable]
•
AR-3210-0033 [4K Synergy
ID
4MOS
Camera Head, autoclavable]
1.1
Intended Use
Indications for Non-CE Accepting Countries
The Synergy
ID
Endoscopic Imaging System is
indicated for use to provide real time endoscopic
visible and near-infrared fluorescence imaging.
The Synergy
ID
System enables surgeons to
perform minimally invasive surgery using
standard endoscope visible light as well as
visualization of vessels, blood flow and related
tissue perfusion, and at least one of the major
extra-hepatic bile ducts (cystic duct, common
bile duct or common hepatic duct), using near-
infrared imaging. Fluorescence imaging of biliary
ducts with the Synergy
ID
System is intended for
use with standard of care white light, and when
indicated, intraoperative cholangiography.
The device is not intended for standalone use
for biliary duct visualization.
Indications for CE Accepting Countries
The Synergy
ID
Endoscopic Imaging System is
indicated for use to provide real time endoscopic
visible and near-infrared fluorescence imaging.
1.2
Contraindications
Do not use the device if endoscopic surgery
is contraindicated.
Do not use the device if the environmental
conditions for use do not meet the standards
or regulations defined in the accompanying
documents.
1.3
Warnings and Precautions
The words
WARNING
,
PRECAUTION
, and
NOTE
carry special meanings and they should
be read carefully.
WARNING:
The safety and/or health
of the patient, user, or a third party is
at risk. Comply with this warning to
avoid injury to the patient, user, or
third party.
PRECAUTION:
This contains
information concerning the intended
use of the device or accessory.
Damage to the equipment is possible
if these instructions are not followed.
NOTE:
A note is added to provide additional,
focused, information.