Synthes SPOTLIGHT User manual

SPOTLIGHT®
Access System
0902-90-047
Rev. E
Revised July 2015
© DePuy Synthes Spine, a division of DOI 2013-2015.
All rights reserved.
0086

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en
SPOTLIGHT
®
Access System
IMPORTANT NOTE TO OPERATING SURGEON
The surgeon must be thoroughly knowledgeable in the medical and surgical aspects of the device.
Please refer to the surgical technique manual for specific instructions regarding the use of the
SPOTLIGHT
®
Access System.
DESCRIPTION
The SPOTLIGHT Access System is a set of one-piece, reusable ports that allows surgeons to access
the spine by dilation of the overlying tissues in a minimally invasive fashion without the tissue trauma
associated with traditional dissection techniques. The normal, open operative spinal procedure incurs
significant tissue disruption and increased patient discomfort. The SPOTLIGHT Access System is
offered in a range of diameters and lengths to accommodate surgeon needs and access depths.
Each port size comes in straight and anatomic configurations. The SPOTLIGHT Access System also
contains manual surgical instruments, cases, and trays. The instruments are for use with the ports,
along with general disc endplate preparation instruments. The reusable instruments are supplied
non-sterile and must be sterilized prior to first use.
The SPOTLIGHT Access port is available in Non-Illuminated and Illuminated options. The Non-
Illuminated option is a single piece port design constructed of a radiolucent polymer body and
stainless steel rigid arm attachment that does not contain an integrated light source. The rigid arm
attachment at the proximal end allows the port to be connected to a rigid arm that keeps the port
secure at the operative site. The Illuminated option contains integrated fiber optics encased within
a stainless steel body for added strength. The port is designed with two connections at the proximal
end, a light coupler that allows connection of a transfer cable and external light source (standard
Operating Room equipment) for transmittal of light and a rigid arm connection that allows the port to
be connected to a rigid arm that keeps the port secure at the operative site.
The SPOTLIGHT Access System also includes Non-Illuminated F2 washer ports that can be advanced
over a guidewire in percutaneous procedures. The large and small F2 washer ports are single piece
ports constructed of anodized aluminum alloy that do not contain an integrated light source. The ports
have a straight configuration and include a handle at the proximal end. A cannulated dilator shaft and
two sequential dilators are supplied for use with each of the large and small F2 washer ports.
The SPOTLIGHT PL components of the SPOTLIGHT Access System are a set of instruments
designed to provide access to the posterior and posterolateral bony spinal elements. This set of
minimally invasive tools consists of an expandable retractor, the SPOTLIGHT PL, which does not
require the use of sequential dilation, and reusable decortication instruments designed to be used in
a minimally invasive fashion.

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The expandable retractor is comprised of four components:
•Stainless steel handle with a rigid arm attachment connection and a lever lock to prevent inadver-
tent collapse or expansion
•Stainless steel modular left blade (various sizes)
•Stainless steel modular right blade (various sizes)
•Stainless steel modular middle blade (various sizes)
The middle blade is assembled to the handle by snapping the two tines on the blade into the receiver
on the underside of the handle. The left and right blades insert into the corresponding receivers on
the handle marked “L” and “R”. For instrument assembly and disassembly images please refer to the
surgical technique manual.
The left and right modular blades are offered in both lighted and non‐lighted configurations and the
middle modular blade is non‐lighted. The lighted left and right modular blades are constructed of
stainless steel with proprietary fiber optics in a bonding material. The lighted blades each include
a proprietary fitting for one of the two forked termination ends of the Y cable. Once the Y cable is
attached to both blades, the singular termination end of the Y cable can be plugged into a standard
ACMI light cable. The standard ACMI light cable can then be plugged into a hospital light source in
the surgical suite. The Y cable is constructed of stainless steel, proprietary fiber optics, rigid plastic,
and flexible rubber.
Both the retractor and reusable decortication instruments are supplied non‐sterile and must be
sterilized prior to first use.
INDICATIONS
CAUTION: U.S.A. Law restricts this device to sale by or on the order of a physician.
The SPOTLIGHT Access System and SPOTLIGHT PL are intended to provide the surgeon with
minimally invasive surgical access to the spine by ensuring the placement/positioning of the port or
retractor, down to the posterior and posterolateral bony spinal elements. These ports and retractors
provide access to the spinal site which can be visualized using a microscope or loupes, and through
which surgical instruments can be manipulated.
CONTRAINDICATIONS
Clinical and/or radiographic determinations that exclude the use of the SPOTLIGHT Access
System include:
•Infection-overt or active
•Fever > 101 ° F (38 ° C)
•Local inflammatory signs
POSSIBLE ADVERSE EFFECTS
Risks possibly associated with the use of the SPOTLIGHT Access System are similar to those
associated with any surgery to the planned area of instrument use. The most frequently stated risks
are bleeding, damage to the surrounding soft tissue and infection. Each of these risks has also

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been used to describe the risks associated with conventional surgical intervention. Additional risks
associated with the use of the SPOTLIGHT Access System, other than those described for surgery in
general, may be instrument malfunction, such as bending, fragmentation, loosening and/or breakage
(whole or partial). Breakage in the patient may increase surgical time since this instrument should not
be implanted. Also, surgery may not be effective. Similar risks are associated with the system use
in any part of the body.
Additional risks are attendant to surgery and the use of anesthesia, etc., and are not directly related
to the use of the retractor. These include, but are not limited to:
•Pneumonia,
•Phlebitis,
•Embolism,
•Wound infection, or
•Blood loss with or without anemia.
WARNINGS AND PRECAUTIONS
•Proper selection of the patient and the compliance of the patient will greatly affect the results.
•Ensure the packaging is not damaged prior to use.
•Improper use of this instrument may cause injury to the patient. Due to the Illuminated port’s ability
to transmit radiant energy from high intensity surgical lightsources, soft tissues, which are located
proximal to the port tip and exposed to this energy, may reach temperatures above 41 ° Celsius
(106 ° F). The operator of the port should control the output of the lightsource so as to provide only
as much light as necessary for visualization during procedure and furthermore, irrigate the soft
tissues exposed to the radiant energy to reduce any risk of tissue damage.
•The connection point between the Illuminated port and light cable and lighted retractor blade and Y
cable may also become hot during use. These connections should be handled with caution during
port/retractor manipulation in-situ or while disconnecting the light transferring cable from the port
or Y cable from the lighted retractor blade.
•The retractor port tips are thin-walled and should not be dropped or bent at a sharp angle.
•Proper, secure component connections must be made to assure proper functioning of all aspects
of this device.
•Components of this system should be thoroughly inspected during cleaning and prior to surgery
for possible damage.
•Do not ultrasonically clean any instruments with integrated fiber optics as this may potentially
decrease the instrument life.
•Components should not be immersed in cold water immediately following autoclave as this could
cause fiber breakage and decreased performance.
•Care should be exercised when high speed drills are used inside the access port or retractor as
damage to the inner walls and tip or retractor blades may occur upon contact.
•The handle of the F2 washer ports is not designed to be used with rigid fixation.

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CLEANING AND STERILIZATION
Scope
SPOTLIGHT Access System
WARNINGS
•Follow the instructions and warnings issued by the suppliers of any cleaning and equipment used.
•Do not exceed 140 ° C (284 ° F) during reprocessing steps.
•Avoid exposure to hypochlorite solutions, as these will promote corrosion.
•Manual Cleaning must be performed prior to Automated Cleaning for SPOTLIGHT Access Ports,
Dilators, and Suction Tubes.
•Do not ultrasonically clean any instruments with integrated fiber optics as this may potentially
decrease the instrument life.
•Components should not be immersed in cold water immediately following autoclave as this could
cause fiber breakage and decreased performance.
Limitations on Reprocessing
•Repeated processing has minimal effects on instrument life and function.
•End of useful life is generally determined by wear or damage in surgical use.
•Carefully inspect instruments between uses to verify proper functioning.
•Send damaged instruments to a supplier of authorized repair or refurbishment services.
Decontamination Considerations – Creutzfeldt-Jakob Disease (CJD)
Under certain classifications of risk, the World Health Organization (WHO), or local regulatory
authorities recommend special CJD inactivation processing procedures. Consult WHO and local
regulations for further information.
Care at the Point of Use
•Clean instruments as soon as possible after use. If cleaning must be delayed, immerse instruments
in a compatible detergent solution, spray with an instrument pre-soak solution, or cover instruments
with a towel moistened with purified water to prevent drying and encrustation of surgical soil.
•Avoid prolonged exposure to saline to minimize the chance of corrosion.
•Remove excessive soil with a disposable wipe.
Containment and Transportation
•Reprocess instruments as soon as is reasonably possible after use.
•Place the device in its respective position within the instrument tray.
•The image of the device is marked in its intended position within the tray.

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Preparation for Cleaning
•Remove Stylet from suction tubes: 2929-08-000 (Stylet), 2929-08-009, 2929-08-011, 2929-08-109,
2929-08-111.
•Dismantle the retractor blades from the retractor handle: 2829-50-000 (handle), 2829-51-XXX,
2829-52-XXX, 2829-53-XXX (non-lighted blades), 2829-61-XXX, 2829-62-XXX (lighted blades).
•Dismantle the Y cable from the lighted blades: 2829-50-900 (Y-cable) and 2829-61-XXX, 2829-62-
XXX (lighted blades).
Manual Cleaning
All Instruments:
•Prepare an enzymatic cleaning solution in accordance to the manufacturer’s instructions.
•Soak soiled instruments for a minimum recommended time specified by the enzymatic cleaning
solution manufacturer or 5 minutes, whichever is longer.
•Use a soft bristle scrub brush (plastic bristles, like nylon) to thoroughly remove all traces of blood
and debris from the device surfaces.
SPOTLIGHT Access Ports, Dilators, and Suction Tubes:
•Use a minimum 10 inch (255mm) long, tight fitting, soft lumen brush (plastic bristles, like nylon) to
scrub the lumen of each device. Minimum brush diameters are specified in the table below for each
lumen size. A toothbrush style brush, or equivalent, can be used for large lumen (>15mm) devices:
Device Description Product Code Lumen Size Brush Diameter
2nd Dilator 2929-00-002 7 mm 8 mm
3rd Dilator 2929-00-003 10 mm 10 mm
4th Dilator 2929-00-004 13 mm 15 mm
5th Dilator 2929-00-005 16 mm Toothbrush
6th Dilator 2929-00-006 19 mm Toothbrush
7th Dilator 2929-00-007 22 mm Toothbrush
Introducer 2929-00-008 17 mm Toothbrush
Dilator, 27 mm 2929-00-010 25 mm Toothbrush
27 mm Dilator Introducer 2929-00-011 27 mm Toothbrush
12 mm Port 2829-12-XXX 12 mm 15 mm
15 mm Port 2829-15-XXX 15 mm 15 mm
18 mm Port 2829-18-XXX 18 mm Toothbrush
21 mm Port 2829-21-XXX 21 mm Toothbrush
24 mm Port 2829-24-XXX 24 mm Toothbrush
27 mm Port 2829-27-XXX 27 mm Toothbrush
F2 Sm and Lg Washer Dilator Shaft 2757-10-072
2757-10-078 2.15 mm 3mm
F2 Sm Washer Port 1st Dilator 2757-10-072 7.3 mm 8 mm
F2 Sm Washer Port 2nd Dilator 2757-10-073 11.1 mm 12 mm

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Device Description Product Code Lumen Size Brush Diameter
F2 Lg Washer Port 1st Dilator 2757-10-078 7.3 mm 8 mm
F2 Lg Washer Port 2nd Dilator 2757-10-079 13 mm 14 mm
F2 Sm Washer Port 2757-10-074 14.6 mm 15 mm
F2 Lg Washer Port 2757-10-080 16.5 mm Toothbrush
9F Suction Tube 2929-08-009 9F or 3 mm 3 mm
9F Suction Tube Retractor 2929-08-109 9F or 3 mm 3 mm
11F Suction Tube 2929-08-011 11F or 4 mm 4 mm
11F Suction Tube Retractor 2929-08-111 11F or 4 mm 4 mm
•Push the brush through the entire length of the lumen using a twisting motion to remove debris
at least five times.
•Use a 50ml syringe filled to capacity with enzymatic cleaning solution to flush the lumen of
each device.
All Instruments (cont.):
•Rinse the instrument with warm, 85 ° F –104 ° F (30 ° C –40 ° C), tap water for a minimum of one
minute and until visual evidence of debris, soil, and cleaning solution are gone.
•Pay particular attention to flush the lumen of the dilators, ports, and suction tubes with warm, 85 ° F
–104 ° F (30 ° C –40 ° C), tap water.
•Ultrasonically clean the device components for 10 minutes in neutral pH detergent, prepared in
accordance with the manufacturer’s instructions.
•Rinse the device components with warm, 85 ° F –104 ° F (30 ° C –40 ° C), tap water for a minimum of
one minute and until visual evidence of debris, soil, and cleaning solution are gone.
Dry the device components immediately after final rinse with a clean towel or compressed air until
visibly dry.
— OR —
Automated Cleaning
•Perform Manual Cleaning prior to Automated Cleaning for SPOTLIGHT Access Ports, Dilators,
and Suction Tubes.
•Use a soft bristle brush (plastic bristles, like nylon) to thoroughly remove all traces of blood and debris.
•Load the device components so that the lumens of the ports, dilators, and suction tubes can drain.
•Clean, using the “INSTRUMENTS” cycle in a validated washer disinfector and a pH neutral
cleaning agent intended for use in automated cleaning using the minimum cycle parameters below:
Phase Recirculation Time Water Temp Detergent Type
Pre-Wash 2:00 Cold Tap Water N/A
Enzyme Wash 1:00 Hot Tap Water Enzymatic Cleaner
Wash 2:00 65.5 ° CNeutral pH Detergent
Rinse 0:15 Hot Tap Water N/A
Dry 15:00 66 ° CN/A

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Cleaning Inspection
•Inspect all instruments before sterilization or storage to ensure the complete removal of soil from
surfaces, lumens, holes, and moveable parts.
•If areas are difficult to inspect visually, check for blood by immersing or flushing the instrument in
a 3% hydrogen peroxide solution. If bubbling is observed, blood is present. Rinse instruments for
a minimum of 1 minute with warm, 85 ° F –104 ° F (30 ° C –40 ° C), tap water after using hydrogen
peroxide solution.
•If soil is still present, re-clean the instrument.
Disinfection
Instruments must be terminally sterilized prior to surgical use. See Sterilization instructions.
Maintenance
Carefully inspect instruments between uses to verify proper functioning. Send damaged instruments
to a supplier of authorized repair or refurbishment services.
Inspection and Functional Testing
•Visually inspect the instruments for damage and wear.
•The dilators should be free of bending and distortion.
Packaging
•If desired, use instrument trays to contain instruments that are provided in sets.
•Double wrap instruments in accordance with local procedures, using standard wrapping techniques
such as those described in the current revision of ANSI/AAMI ST79.
Sterilization
•Use a validated, properly maintained and calibrated steam sterilizer.
•Effective steam sterilization can be achieved using the following cycle:
Cycle Type Temperature Exposure Time Dry Time
Pre-Vacuum 270 ° F (132 ° C) 4 minutes 30 minutes
Pre-Vacuum * 273 ° F (134 ° C) 3 minutes 30 minutes
•Post-sterilization drying of the sterilization load within the sterilization vessel is standard practice
in hospitals. ANSI/AAMI ST79:2006, “Comprehensive guide to steam sterilization and sterility
assurance in health care facilities” provides guidance to hospitals for selecting appropriate drying
parameters based on the sterilization cycle that is being conducted. Sterilizer manufacturers also
typically provide recommendations for drying parameters for their specific equipment.
•Only legally marketed, FDA cleared sterilization wrap, pouches, or DePuy Synthes Reusable
Sterilization Containers should be used by the end-user for packaging terminally sterilized devices.
The manufacturer’s instructions for use for the sterilization wrap, pouches, or DePuy Synthes
Reusable Sterilization Containers are to be followed. The use of DePuy Synthes Reusable

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Sterilization Containers are limited to use in the United States only, and are not approved for use
outside of the United States.
•NOTE: Reassembly of instruments is only to occur in the surgical suite.
* This cycle is most consistent with OUS processes.
Storage
Store sterile packaged instruments in a manner that provides protection from dust, moisture, insects,
vermin, and extremes of temperature and humidity.
LIMITED WARRANTY AND DISCLAIMER
PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC. ARE SOLD WITH A LIMITED WARRANTY
TO THE ORIGINAL PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND MATERIALS. ANY
OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS, ARE HEREBY DISCLAIMED.
IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN THE DATE OF ISSUE/REVISION OF THIS
INSERT AND THE DATE OF CONSULTATION, CONTACT DEPUY SYNTHES SPINE FOR CURRENT
INFORMATION AT [phone] OR AT [phone].
MATERIAL
MATL
SYMBOL TRANSLATION
A/T ACROFLEX
®
/Ti
ACROFLEX
®
/Titanium
AAI
Aluminum
A/P Al/PL
Aluminum/Plastic
B/R Ba/RADEL
®
Barium/RADEL
®
Ba/PEEK
Barium Sulfate (BaSO
4
)/
PEEK Polymer
CaP
CALCIUM PHOSPHATE
Calcium Phosphate
CM CoCrMo
Cobalt Chromium
Molybdenum
CMTC
CoCrMo/Ti/CALCIUM
PHOSPHATE
Cobalt Chromium
Molybdenum/Titanium/
Calcium Phosphate
CoNiCrMo
Cobalt Nickel
Chromium Molybdenum
FFOAM
Foam
HA
Hydroxyapatite
NiTi Ni/Ti
Nickel/Titanium
PL
Plastic
SRSI
SS/RADEL
®
/SILICONE
Stainless Steel/RADEL
®
/
Silicone
SRSN
SS/RADEL
®/
SILICONE/Ti Al Nitride
Stainless Steel/RADEL
®
/
Silicone/Titanium
Aluminum Nitride
SS/RADEL
®/
SILICONE/Ti
Nitride
Stainless Steel/RADEL
®
/
Silicone/Titanium Nitride
SRTA
SS/RADEL
®
/Ti Al Nitride
Stainless Steel/RADEL
®
/
Titanium Aluminum Nitride
STA SS/Ti Al Nitride
Stainless Steel/
Titanium Aluminum Nitride
S/U SS/ULTEM
Stainless Steel/Ultem
TTi
Titanium and its alloys
S/R SS/RADEL
®
Stainless Steel/RADEL
®
R/T
POLYOLEFIN RUBBER/Ti
Polyolefin Rubber/Titanium
T/ATi/Al
Titanium/Aluminum
Ti/CoCrMo
Titanium/Cobalt
Chromium Molybdenum
P/F PL/FOAM
Plastic/Foam
PY
Polyester
PEEK/C
PEEK/CARBON
FIBER COMPOSITE
Polyether Ether Ketone/
Carbon Fiber Composite
PEEK OPTIMA®
Polyether Ether Ketone
PPOLYMER
Polymer
P/CM PE/CoCrMo
Polyethylene/Cobalt
Chromium Molybdenum
P/C
POLYMER/CARBON
FIBER COMPOSITE
Polymer/
Carbon Fiber Composite
Si/NITINOL
Silicone/Nitinol
SSS
Stainless Steel
S/A SS/Al
Stainless Steel/Aluminum
SBR SS/Ba/RADEL
®
Stainless Steel/Barium /
RADEL
®
S/P SS/PHENOLIC
Stainless Steel/Phenolic
S/PLSS/PL
Stainless Steel/Plastic
LOT LOT NUMBER
REF REF
CATALOG NUMBER
QTY QUANTITY
SZ SIZE
MADE IN MADE IN
NTI
NEURAL TISSUE
INSTRUMENT
IOM
NEUROMONITORING
INSTRUMENTS
Federal (USA) law
restricts this device
to sale by or on the
order of a physician
DO NOT RESTERILIZE
T2
T1
Lower Limit of
temperature
= T1
Upper Limit of
temperature
=
T2
25°C
STORE AT ROOM
TEMPERATURE
KEEP AWAY FROM
SUNLIGHT
SINGLE USE
ATTENTION.
SEE INSTRUCTIONS
FOR USE
PACKAGE CONTAINS
FLAMMABLE LIQUID
DO NOT USE
IF PACKAGE IS
DAMAGED
MSR
MEASURING DEVICE
STERILE
STERILE
STERILE A
Sterile medical device
processed using
aseptic technique
STERILE R
STERILIZATION BY
IRRADIATION
STERILE EO
STERILIZATION BY
ETHYLENE OXIDE
LATEX FREE
LATEX FREE
NON
STERILE
NONSTERILE
NONSTERILE
MANUFACTURER
DATE OF
MANUFACTURE
US REP
US REPRESENTATIVE
EC REP
AUTHORIZED
EUROPEAN
REPRESENTATIVE
DIST
DISTRIBUTED BY
XXXX-XX
USE BY
Ti/HA
Titanium/Hydroxyapatite
Ti/UHMWPE/HA
Titanium/Ultra-High
Molecular Weight
Polyethylene/Hydroxyapatite
SS/Ti
Stainless Steel/Titanium
SS/Al/SILICONE
Stainless Steel/
Aluminum/Silicone
SS/SILICA GLASS
Stainless Steel/Silica Glass
SS/SILICA GLASS/
PL/SILICONE
Stainless Steel/Silica Glass /
Plastic /Silicone
SS/SILICA GLASS/
RADEL
®/SILICONE
Stainless Steel/Silica Glass /
RADEL
®
/Silicone
SS/SILICA GLASS/
SILICONE
Stainless Steel/
Silica Glass/Silicone
S/SISS/SILICONE
Stainless Steel/Silicone
SS/WC/SILICONE
Stainless Steel/Tungsten
Carbide/Silicone
W/C
Tungsten Carbide