Intended Users; Definition Of Symbols - Integra CUSA Excel Bedienungsanleitung

Intended Use
Sterile Tips are intended for use with the CUSA®
Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator
System, CUSA® Handpiece and accessories.
The CUSA Excel System is indicated for use in
these surgical procedures where fragmentation,
emulsification and aspiration of soft and hard
tissue is desirable:
• Neurosurgery
• Gastrointestinal and affiliated organ surgery
• Urological surgery
• Plastic and reconstructive surgery
• General surgery
• Orthopedic surgery
• Gynecological surgery
• Thoracic surgery
• Laparoscopic surgery
• Thoracoscopic surgery

Intended Users

The intended users of this guide and the
equipment it describes are qualified medical
professionals who are trained in the particular
surgical technique and surgical procedure to
be performed, and trained in the use of this
equipment.

Definition of Symbols

Symbol Definition
Mandatory action: Read
instructions before use.
Do not reuse.
Sterilized using ethylene oxide.
Operating Temperature: +10oC
to +35oC
Transport & Storage
Temperature: -34oC to + 65oC
Operating Humidity: +15% to
+80 %.
Transport & Storage
Humidity: +25% to +85%.
Keep Dry.
Do not use if package is
damaged.
Manufacturer.
LOT
R O
X NLY
Warnings for All Tips
Warning
No modification of this equipment is allowed.
Warning
Touching of the tip of the handpiece by the
operator, while powered, can result in personal
injury.
Warning
When the handpiece is powered on, contact of the
tip with a hard surface (e.g. a metal instrument
tray, staples, clips, instruments, etc.) may damage
the tip of the handpiece and require replacement
before use.
Warning
CUSA Excel tips utilize silicone flues. Compressing
the flue against the side of the vibrating surface
along the length of the tip can cause excessive
heating and potential hazard to adjacent tissue,
such as burns.
Warning
Excessive loading of CUSA Excel Tips at the
surgical site can induce heating due to vibration
and acoustic power transmission. Thermal
management of the surgical site with the aid of
appropriate irrigation and aspiration settings is
essential.
Warning
Avoid excessive lateral loading of CUSA Excel
sterile tips.
Warning
Avoid contacting bone with the CUSA Excel tips
(excluding SaberTip™)
Warning
Avoid activating ultrasonics when using the tip
cleaner to clean a tip during a surgical procedure.
Warning
The handpiece and handpiece accessories must be
sterile before surgical use.
Warning
Only use Integra handpieces and accessories with
the CUSA Excel System. Non-Integra handpieces
and accessories are not supported.
Catalogue Number.
Use By.
Batch Code.
Caution: Federal (USA) law
restricts this device to sale by or
on the order of a physician.
EN
3