Synthes SPOTLIGHT Manual de usuario

SPOTLIGHT®

Access System

0902-90-047

Rev. E

Revised July 2015

DePuy Synthes Spine, a division of DOI 2013-2015.

0086

2 of 152

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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

•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

–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

10 of 152

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 +1-800-365-6633 OR AT +1-508-880-8100.

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

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

Hydroxyapatite

NiTi Ni/Ti

Nickel/Titanium

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

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

Lower Limit of

temperature

Upper Limit of

temperature

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 A

Sterile medical device

processed using

aseptic technique

STERILE R

STERILIZATION BY

IRRADIATION

STERILE EO

STERILIZATION BY

ETHYLENE OXIDE

LATEX FREE

NON

STERILE

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

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