Arthrex AR-3200-1018, Instructions For Use Manual

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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 Laser
Light Source (AR-3200-1018) 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.
1.1 Intended Use
The Synergy Laser Light Source is intended to
be used as an accessory to the Synergy
ID ™
Endoscopic Imaging System.
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.
1.3.1 WARNINGS
• This equipment is designed for use
by medical professionals completely
familiar with the required techniques
and instructions for use of the
equipment. Prior to using the device,
read and follow all warning and
precautionary notices and
instructions marked on the product
and included in this manual. Become
familiar with the operation and
function of this device and
associated accessories. Failure to
follow these instructions can lead to:
• Life-threatening injuries to the patient
• Severe injuries to the surgical team,
nursing or service personnel, or
• Damage or malfunction of the device
or accessories.
1. Caution: Federal law restricts this device
to sale by or on the order of a physician.
2. Do not open or attempt to service
this system, as this may void your
warranty. There are no user-
serviceable parts inside. Removing
the cover may introduce an electric
shock hazard by exposing you to
dangerous high voltages or other risks. If
the system malfunctions, return it for
service immediately.
3. For the protection of the patient it is
recommended that a back-up laser light
source for the Synergy laser light source
be maintained, cleaned, and ready to be
implemented.