Johnson & Johnson Medical
11 Fr. Suction Tube Retractor, SPOTLIGHT Access System
SPOTLIGHT Access System Instructions for Use
204 Pages
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0902-90-047 Rev. G 2797
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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 2021-10-05 04:45:15
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. The expandable retractor is comprised of four components: • Stainless steel handle with a rigid arm attachment connection and a lever lock to prevent inadvertent 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.
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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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 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.
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• 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.
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.
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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• 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.
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).
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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: Product Device Description Code 2nd Dilator 2929-00-002 3rd Dilator 2929-00-003 4th Dilator 2929-00-004 5th Dilator 2929-00-005 6th Dilator 2929-00-006 7th Dilator 2929-00-007 Introducer 2929-00-008 Dilator, 27 mm 2929-00-010 27 mm Dilator Introducer 2929-00-011 12 mm Port 2829-12-XXX 15 mm Port 2829-15-XXX 18 mm Port 2829-18-XXX 21 mm Port 2829-21-XXX 24 mm Port 2829-24-XXX 27 mm Port 2829-27-XXX F2 Sm and Lg Washer 2757-10-072 Dilator Shaft 2757-10-078 F2 Sm Washer Port 1st Dilator 2757-10-072 F2 Sm Washer Port 2nd Dilator 2757-10-073 F2 Lg Washer Port 1st Dilator 2757-10-078 F2 Lg Washer Port 2nd Dilator 2757-10-079 F2 Sm Washer Port 2757-10-074 F2 Lg Washer Port 2757-10-080 9F Suction Tube 2929-08-009 9F Suction Tube Retractor 2929-08-109 11F Suction Tube 2929-08-011 11F Suction Tube Retractor 2929-08-111
Lumen Size 7 mm 10 mm 13 mm 16 mm 19 mm 22 mm 17 mm 25 mm 27 mm 12 mm 15 mm 18 mm 21 mm 24 mm 27 mm
Brush Diameter 8 mm 10 mm 15 mm Toothbrush Toothbrush Toothbrush Toothbrush Toothbrush Toothbrush 15 mm 15 mm Toothbrush Toothbrush Toothbrush Toothbrush
2.15 mm
3mm
7.3 mm 8 mm 11.1 mm 12 mm 7.3 mm 8 mm 13 mm 14 mm 14.6 mm 15 mm 16.5 mm Toothbrush 9F or 3 mm 3 mm 9F or 3 mm 3 mm 11F or 4 mm 4 mm 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.
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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• 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 Pre-Wash Enzyme Wash Wash Rinse Dry
Recirculation Time Water Temp Detergent Type 2:00 Cold Tap Water N/A 1:00 Hot Tap Water Enzymatic Cleaner Neutral pH Detergent 2:00 65.5°C 0:15 Hot Tap Water N/A N/A 15:00 66°C
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. 2021-10-05 04:45:15
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 Pre-Vacuum Pre-Vacuum*
Temperature 270°F (132°C) 273°F (134°C)
Exposure Time 4 minutes 3 minutes
Dry Time 30 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 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.
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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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.
SYMBOL TRANSLATION STERILE STERILE
LOT LOT NUMBER REF REF CATALOG NUMBER
SINGLE USE
DO NOT RESTERILIZE
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
T2
ATTENTION. SEE INSTRUCTIONS FOR USE
T1
Lower Limit of temperature = T1 Upper Limit of temperature = T2
PACKAGE CONTAINS FLAMMABLE LIQUID
25°C
STERILE A Sterile medical device processed using aseptic technique STERILE R STERILIZATION BY IRRADIATION STERILE EO STERILIZATION BY ETHYLENE OXIDE LATEX FREE LATEX FREE
STORE AT ROOM TEMPERATURE
KEEP AWAY FROM SUNLIGHT
DO NOT USE IF PACKAGE IS DAMAGED
NON STERILE
MSR MEASURING DEVICE
NONSTERILE NONSTERILE
MANUFACTURER
DATE OF MANUFACTURE US REP US REPRESENTATIVE EC REP AUTHORIZED EUROPEAN REPRESENTATIVE DIST DISTRIBUTED BY XXXX-XX USE BY
MATERIAL MATL A/T ACROFLEX®/Ti ACROFLEX®/Titanium
P/F PL/FOAM Plastic/Foam
A AI Aluminum
PY Polyester
A/P Al/PL Aluminum/Plastic
PEEK/C PEEK/CARBON FIBER COMPOSITE Polyether Ether Ketone/ Carbon Fiber Composite
B/R Ba/RADEL® Barium/RADEL® Ba/PEEK Barium Sulfate (BaSO4)/ PEEK Polymer CaP CALCIUM PHOSPHATE Calcium Phosphate
PEEK OPTIMA® Polyether Ether Ketone P
POLYMER Polymer
P/CM PE/CoCrMo Polyethylene/Cobalt Chromium Molybdenum
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
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 P/C Stainless Steel/Silica Glass/ STA SS/Ti Al Nitride This document is valid only on the date printed. If unsure of the print date,Plastic please/Silicone POLYMER/CARBON Stainless Steel/ CMTC FIBER 2021-10-05 04:45:15 re-print to ensure use of COMPOSITE the latest revision Titanium of the IFU (available at www.e-ifu.com). Aluminum Nitride CoCrMo/Ti/CALCIUM Polymer/ The onus resides with the user to ensure that the most up-to-date IFU isSS/SILICA used. GLASS/ PHOSPHATE RADEL® /SILICONE Carbon Fiber Composite S/U SS/ULTEM Cobalt Chromium Stainless Steel/Silica Glass/ Stainless Steel/Ultem CM CoCrMo Cobalt Chromium Molybdenum
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to sale by or on the order of a physician
NONSTERILE NONSTERILE
MSR MEASURING DEVICE
KEEP AWAY FROM SUNLIGHT
USE BY
MATERIAL MATL A/T ACROFLEX®/Ti ACROFLEX®/Titanium
P/F PL/FOAM Plastic/Foam
A AI Aluminum
PY Polyester
A/P Al/PL Aluminum/Plastic
PEEK/C PEEK/CARBON FIBER COMPOSITE Polyether Ether Ketone/ Carbon Fiber Composite
B/R Ba/RADEL® Barium/RADEL® Ba/PEEK Barium Sulfate (BaSO4)/ 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 F
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FOAM Foam
PEEK OPTIMA® Polyether Ether Ketone P
POLYMER Polymer
P/CM PE/CoCrMo Polyethylene/Cobalt Chromium Molybdenum P/C POLYMER/CARBON FIBER COMPOSITE Polymer/ Carbon Fiber Composite Si/NITINOL Silicone/Nitinol S SS Stainless Steel S/A SS/Al Stainless Steel/Aluminum SS/Ba/RADEL®
HA Hydroxyapatite
SBR Stainless Steel/Barium/ RADEL®
NiTi Ni/Ti Nickel/Titanium
S/P SS/PHENOLIC Stainless Steel/Phenolic
PL Plastic
S/PL SS/PL Stainless Steel/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 T Ti Titanium and its alloys S/R SS/RADEL® Stainless Steel/RADEL® R/T POLYOLEFIN RUBBER/Ti Polyolefin Rubber/Titanium T/A Ti/Al Titanium/Aluminum Ti/CoCrMo Titanium/Cobalt Chromium Molybdenum
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/SI SS/SILICONE Stainless Steel/Silicone SS/WC/SILICONE Stainless Steel/Tungsten Carbide/Silicone W/C Tungsten Carbide
This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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*
*
DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767-0350 USA
Medos International SÀRL Chemin-Blanc 38 2400 Le Locle, Switzerland
* For recognized manufacturer, refer to product label. Revised February 2021 © DePuy Synthes 2013-2021. All rights reserved.
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This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.
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