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©2018 Innovasis Inc.
Page 3 of 4
L00022 Rev G
PREOPERATIVE:
The implant components should be handled and stored carefully and protected from damage.
The instruments and implants must be cleaned and sterilized before use. The surgeon must confirm that all
necessary implants and instruments are on hand for the planned surgical construct. They should be examined for
damage prior to use.
INTRAOPERATIVE:
Extreme caution must be taken around the spinal cord and nerve roots, especially when
inserting screws and cross connectors. Breakage, slippage or mishandling of the instruments or implant
components, such as sharp edges, may cause injury to the patient or operative personnel. The Implants must be
handled and contoured carefully so as to avoid notching or scratching the surface. Prior to closing the soft tissues, all
caps and screws should be tightened firmly according to the surgical technique guide. Recheck the tightness of all
caps and screws after finishing ensuring that none have loosened during the tightening or manipulation of other
components.
POSTOPERATIVE:
The patient must be adequately instructed as to the risks and limitations of the implant as well
as postoperative care and rehabilitation. The patient should be instructed in the limitations of physical activities,
which would place excessive stresses on the implant or cause delay in the healing process. The patient should be
instructed in the proper use of weight-bearing or assist devices as well as the proper methods of ambulation, climbing
stairs, getting into/out of bed or other daily activities while minimizing rotational and bending stresses.
The surgeon must consider the removal of the implant after healing as the implant can loosen, fracture or corrode
even after fusion has occurred. The risks and benefits of a second surgery must be carefully evaluated.
MATERIAL SPECIFICATION:
Implants are manufactured out of Titanium 6AL-4V ELI which complies with ASTM
F-136 or CoCr per ASTM F-1537. INNOVASIS expressly warrants that these devices are fabricated from material
specifications. No other warranties express or implied, are made. Implied warranties of merchantability and fitness
for a particular purpose or use are specifically excluded.
Do not re-use or re-implant under any circumstances. Components of this system should not be used with
components from any other manufacturer.
CLEANING AND DECONTAMINATION:
All non-sterile implants, instruments and trays must be thoroughly cleaned
using neutral cleaners before use and must be visibly clean before sterilization and subsequent introduction into a
sterile surgical field or (if applicable) return of the product to INNOVASIS. Cleaning and disinfecting of instruments
can be performed with aldehyde-free solvents at higher temperatures. Cleaning and decontamination must include
the use of neutral cleaners followed by deionized water rinse.
Note: certain cleaning solutions such as those containing formalin, gluteraldehyde, bleach and/or other
alkaline cleaners may damage some devices, particularly instruments; these solutions should NOT be used.
Also, many instruments require disassembly before cleaning.
Detailed cleaning recommendations for reusable instruments are in the Innovasis
Surgical Instrument Reprocessing
Instructions
LG01. A copy of this guide is available at
www.innovasis.com
or by request via telephone, fax or e-mail.
Contact information appears at the heading of this document.
All products should be treated with care. Improper use or handling may lead to damage and/or possible improper
functioning of the device.
STERILIZATION:
The INNOVASIS
®
EXCELLA
®
SPINAL SYSTEM implants are supplied
NON-STERILE
. The
metal implants and instruments used in surgery MUST be sterilized by the hospital prior to use. FDA cleared wraps
are recommended for use with the sterilization tray. Remove all packaging materials prior to sterilization. Only sterile
products should be placed in the operative field. For a 10
-6
Sterility Assurance Level, it is recommended that the
Excella
®
Spinal System implants be steam sterilized by the hospital using one of the two sets of process parameters
below:
METHOD
CYCLE
TEMPERATURE
EXPOSURE TIME
DRY TIME
Steam
Pre-vacuum (Wrapped)
270
0
F (132
0
C )
4 Minutes
60 Minutes*
Steam
Gravity Displacement
(Wrapped)
270
0
F (132
0
C )
30 Minutes
60 Minutes*
*This dry time sterilization cycle (60 minutes) is not considered by the Food and Drug Administration to be a standard
sterilization cycle.
It is the end user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization
pouches, chemical indicators, biological indicators, and sterilization cassettes) that have been cleared by the Food
and Drug Administration for the selected sterilization cycle specifications (time and temperature).
NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and
verify the sterilization process (e.g. temperatures, times) used for their equipment.
CAUTION: Federal Law (U.S.A.) restricts these devices to sale by or on order of a physician.
