smith&nephew TRIGEN SURESHOT User Manual
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smith&nephew TRIGEN SURESHOT User Manual

Distal targeting system
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Summary of Contents for smith&nephew TRIGEN SURESHOT

  • Page 1 User Manual V2.1...

  • Page 3: Table Of Contents

    TRIGEN™ SURESHOT™ Distal Targeting System User Manual Table of Contents Introduction ...................2 Glossary of symbols ................3 Warnings and cautions................4 Quick start guide ...................6 Applied parts for targeting ..............7 Surgical procedure – OR preparation............8 Surgical procedure – After IM nail assembly to the drill guide .....10 Surgical procedure –...

  • Page 4: Introduction

    Intended use The TRIGEN SURESHOT Distal Targeting System is only designed for use with the indicated implants and instruments. Implants and instruments must be used in accordance with the instructions, as described in this manual and/or in the non-navigated surgical procedure.

  • Page 5: Glossary Of Symbols

    Glossary of symbols Trauma Interface Kommunikationsschnittstelle für Trauma • Interfaz de trauma • Interface trauma • Interfaccia Trauma • Traumagränssnitt • Trauma-interface • Interface para Traumatismo • Traumeinterface • Traumegrensesnitt Consult instructions for use 71692802 T3.15A 250V 5 x 20mm 100-240V~, 50/60 Hz RECOGNIZED 2.2A...

  • Page 6: Warnings And Cautions

    Responsibility of Smith & Nephew Orthopaedics In the event of improper use, Smith & Nephew accepts no responsibility or liability whatsoever for the functioning or utility of the TRIGEN SURESHOT Distal Targeting System when used in the operating theatre. Cleaning and sterilization All instruments must be sterilized before use.
  • Page 7 Note Do not unplug the power while the system is running! Note Danger of damage and tipping over! Tip Place the unit on a firm, level surface capable of holding at least 10kg (22 lbs). Note To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

  • Page 8: Quick Start Guide

    Quick start guide Where to find the components Trauma Interface (Cat. No. 7169-2802) Power cord (country specific) Front panel layout Probe sensor ports Targeter port Touch screen interface Rear panel layout Power switch Power connection USB connections (service only) VGA video output (1024 x 768 resolution) VESA mounting posts (10-32 thread pitch, 100mm screw pattern)

  • Page 9: Applied Parts For Targeting

    7138-1339) prior to use. TRIGEN SURESHOT Probes (Body Applied Part Type BF) TRIGEN SURESHOT META-NAIL™ Standard Drill Guide Probe Note The probe will be used as an intramedullary tool inside the nail placed in the patient’s bone. Note If the probe is not recognized after its connection to the system, the probe is defective and must be exchanged.

  • Page 10: Surgical Procedure - Or Preparation

    Surgical procedure – OR preparation Note This procedure will cover only the specific steps of freehand targeting of intramedullary locking holes using the TRIGEN™ SURESHOT™ Distal Targeting System. For the full surgical procedure, please refer to the specific surgical technique for the TRIGEN IM Nail System being implanted. Trauma Interface setup Tip If the Trauma Interface does not power on, After the sterile areas have been established,...
  • Page 11 When the display prompts for tool connections, all times. Only the cable and connector may be connect the TRIGEN SURESHOT Targeter removed from the sterile field. (7169-2801) to the Targeter port on the Trauma Interface.

  • Page 12: Surgical Procedure - After Im Nail Assembly To The Drill Guide

    Assemble the appropriate probe and set stop stops as shown is required. Failure to do so may for the TRIGEN™ IM nail and drill guide that will result in inaccurate targeting. be used. TRIGEN SURESHOT™ TRIGEN SURESHOT TRIGEN SURESHOT TRIGEN SURESHOT META-NAIL™...
  • Page 13 Probe connection Tip When oriented as shown, the connector Connect the probe to either of the probe sensor should assemble easily. Do not force the ports on the Trauma Interface. connector into the port, simply try rotating the connector until the keys are oriented in the 12 o’clock position.
  • Page 14 Implant selection screen Tip A different TRIGEN IM nail and/or size can Select the TRIGEN™ IM nail and size that will be selected at any time during the procedure by be used. choosing the Implant option from the drop down menu.
  • Page 15 Locking hole accuracy check in the operative field Insert the probe with the assembled set stop Note The TRIGEN SURESHOT™ Distal Targeting through the drill guide and cannulation of the System cannot be used with the META-NAIL™ TRIGEN™ IM nail.

  • Page 16: Surgical Procedure - Freehand Interlocking

    With the appropriate length SURESHOT™ 4.0mm Drill Bit (7169-2810 or 7169-2811) or the TRIGEN SURESHOT Humeral AO Drill Bit (7169-1155) inserted into the Targeter, insert the tip of the drill sleeve (represented by the green circle) through the incision and down to bone.
  • Page 17 (7163-1189) through the Targeter after removing the drill sleeve. Screw insertion Tip If the Targeter is placed too close to the Using the TRIGEN SURESHOT Hexdriver bone, the image of the IM Nail on the display (7169-2809 or 7169-1153), the screw may be might disappear.
  • Page 18 The depth of the screw can be verified by placing a 9.0mm Gold Drill Sleeve (7163-1152 or 7175-1128) down to bone over the hexdriver. The screw head will be flush with bone when the groove on the hexdriver is even with the end of the 9.0mm Gold Drill Sleeve.

  • Page 19: Navigation Screen Operation

    Navigation screen operation Overview mode When the Targeter is greater than 5cm from the interlocking holes, the navigation screen will display the IM nail in the overview mode. This provides the user with a larger field of view in order to help find the general location of the interlocking holes.

  • Page 20: Shutting Down The System, Storage And Transport

    Shutting down the system, storage and transport Shutting down the system Note Shut down the Trauma Interface using Shut down the Trauma Interface by selecting • the “Shut Down” option from the on-screen the on-screen “Shut Down” option and wait for “Menu”...

  • Page 21: Maintenance

    A field accuracy check procedure should be performed at least once a year or whenever the accuracy of a TRIGEN™ SURESHOT™ probe or TRIGEN SURESHOT Targeter needs to be verified. This procedure can also be performed during surgery to verify all components are working correctly prior to their use on a patient.
  • Page 22 Smith & Nephew Customer Service upon completion. Cleaning and disinfection The TRIGEN SURESHOT Trauma Interface is used in the non-sterile area of the operating theatre and is cleaned and disinfected using commercial cleaning and disinfectant products such as a mild detergent and water or a bactericidal cleaning Note Observe the manufacturer’s instructions for...
  • Page 23 Replacing fuses Note Disconnect the power cord before See the “Technical Specifications” section for exchanging any fuse. replacement fuse type. Note To avoid fire hazard, use only fuses of the correct type, voltage rating, and current rating. Disconnect main power cord. Use a screwdriver to open the fuse compartment door on the AC receptacle.

  • Page 24: Service

    There are no user-serviceable components inside facility and/or sterilized with a sterilization method the TRIGEN SURESHOT Trauma Interface. Repairs other than one approved by Smith & Nephew and adjustments are to be performed only by will incur additional costs, regardless of Smith &...

  • Page 25: Troubleshooting

    Nail not visible on the screen Metal interference Remove any metal objects from within the TRIGEN SURESHOT the targeting field electromagnetic field TRIGEN SURESHOT Targeter Move the TRIGEN SURESHOT and probe not within range of...
  • Page 26 Verify probe accuracy with Field Accuracy Gauge Targeting missed the Metal interference Remove any metal objects from intended hole within the TRIGEN SURESHOT the targeting field electromagnetic field Probe not inserted correctly Verify probe is oriented and within set stop...

  • Page 27: Product Label And Transportation Case Label

    Product label and transportation case label Trauma Interface label Trauma Interface Kommunikationsschnittstelle für Trauma • Interfaz de trauma • Interface trauma • Interfaccia Trauma • Traumagränssnitt • Trauma-interface • Interface para Traumatismo • Traumeinterface • Traumegrensesnitt 71692802 CATALOG NUMBER T3.15A 250V 5 x 20mm SERIAL NUMBER...

  • Page 28: Technical Specifications

    Technical specifications System power supply Voltage 100–240 VAC Frequency 50–60 Hz ≤ 2.2 Amps Connected load Fuses Type T3.15A L 250V Quantity Classification Protection class Class I (with protective earth [=ground]) IPX0, continuous operation Type BF (with hand-held FG, targeting probe) Humidity No protection Explosion...

  • Page 29: Parts And Accessories List

    Caution Use only Smith & Nephew disposables and accessories with the Smith & Nephew TRIGEN SURESHOT Distal Targeting System. Caution The TRIGEN SURESHOT probes are defined as single use items. The risk of reuse includes, but is not limited to, cross contamination between patients, probe malfunction and probe breakage.

  • Page 30: Guidance And Manufacturer's Declaration - Electromagnetic Emissions, Immunity And Separation Distances

    Guidance and manufacturer’s declaration – Electromagnetic emissions, immunity and separation distances Changes or modifications to this system not expressly approved by the manufacturer may result in increased emissions or decreased immunity performance of the equipment or system and could cause EMC issues with this or other equipment. This system is designed and tested to comply with applicable regulations regarding EMC and shall be installed and put into service according to the EMC information stated as follows.
  • Page 31 Guidance and manufacturer’s declaration – electromagnetic emissions The TRIGEN SURESHOT Distal Targeting System is intended for use in the electromagnetic environment specified below. The customer or the user of PiGalileo should assure that it is used in such an environment.
  • Page 32 Guidance and manufacturer’s declaration – electromagnetic immunity The TRIGEN SURESHOT Distal Targeting System is intended for use in the electromagnetic environment specified below. The customer or the user of PiGalileo should assure that they are used in such an environment.
  • Page 33 Guidance and manufacturer’s declaration – electromagnetic immunity The TRIGEN SURESHOT Distal Targeting System is intended for use in the electromagnetic environment specified below. The customer or the user of the tables should assure that they are used in such an environment.
  • Page 34 The TRIGEN SURESHOT Distal Targeting System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the TRIGEN SURESHOT Distal Targeting System can help prevent electromagnetic interference by maintaining a minimum distance between...

  • Page 35: Warranty

    Warranty Smith & Nephew products are guaranteed to be free from defects in materials and workmanship for the warranty period for a particular product, beginning from the date of invoice. Refer to the current Smith & Nephew product catalog or contact Smith & Nephew customer service for specific warranty information.

  • Page 36: Service Replacement Program

    Service replacement program Smith & Nephew offers a 48-hour Service Replacement Program for its products to minimize downtime in your operating room. For a Return Authorization (RA) number, or for additional information on this program, call Customer Service at 800-238-7538 US or +1-901-396-2121 INTL, or contact your authorized representative.
  • Page 37 Notes...
  • Page 38 Notes...
  • Page 40 Orthopaedics EC representative: Smith & Nephew, Inc. Smith & Nephew Orthopaedics GmbH www.smith-nephew.com 7135 Goodlett Farms Pkwy Alemannenstrasse 14 Cordova, TN 38016 78532 Tuttlingen, Germany Tel: 07462/208-0 Fax: 07462/208-135 Telephone: 1-901-396-2121 Information: 1-800-821-5700 Orders and Inquiries: 1-800-238-7538 ©2011 Smith & Nephew, Inc. All rights reserved. ™Trademark of Smith &...

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