950-0047-04A
Page 4 of 69
1.0
Introduction
It is recommended that personnel study this
manual before attempting to operate, clean,
and/or sterilize the Arthrex Synergy
Synergy
UHD4
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
UHD4
System is
comprised of:
•
AR-3200-0020 [Synergy
UHD4
Console
with Matrix]
•
AR-3200-0021 [Synergy
UHD4
Console]
•
AR-3200-0022 [SynergyUHD4
Console with Matrix, HCRI]
•
AR-3200-0023 [SynergyUHD4
Console, HCRI]
•
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]
NOTE: AR-3200-0020/AR-3200-0022
Synergy
UHD4
Consoles or Camera Control Units
(CCU) are identical to AR-3200-0021/AR-3200-
0023 CCUs except that AR-3200-0020/AR-
3200-0022
incorporate the Matrix PWA for
transmission of UHD4 data by fiber optic.
1.1
Intended Use
This system is designed for use by
physicians and surgeons and is intended for
endoscopic camera use in a variety of
endoscopic surgical procedures, including
but not limited to, orthopedic, laparoscopic,
urologic, sinuscopic and plastic surgical
procedures. It is also intended to be used as
an accessory for microscopic surgery.
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,