TRIGEN SURESHOT User Manual
Contents
1. 22 Environmental protection 000 cece eee 22 lee een e EE EE 23 Product Label and Transportation Case Label 25 Technical Specifications 0 0 0 0 0 ccc cee eee 26 Electrical safety EENEG 26 Parts and Accessories List 27 Guidance and Manufacturer s Declaration 28 Electromagnetic emissions immunity and separation distances 28 Compliant cables and accessortes n nunana 28 Waranty EE kas web es Back Cover Service Replacement Units Warranty Back Cover Service Replacement Program Back Cover Repair Service Program 000 Back Cover TRIGEN SURESHOT Distal Targeting System User Manual Device Description TRIGEN SURESHOT Distal Targeting System Device Description The Smith amp Nephew TRIGEN SURESHOT Distal Targeting System is intended to be an intraoperative image guided localization system It is a computer assisted orthopaedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary IM nail implantation It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data Indications for Use The TRIGEN SURESHOT Distal Targeting System is designed for use only with the indicated implants and instruments Implants and instruments must be used in accordance with the instructions as describe2. Radiated RF 3 Vim IEC 61000 4 3 80 MHz to 2 5 GHz d 1 2 P 80 MHz to 800 MHz d 2 34 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in metres m b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following Dol NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the TRIGEN SURESHOT Distal Targeting System is used exceeds the applicable RF compliance level above the patient table THS or IGS Trauma should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or
3. TRIGEN SURESHOT Targeter connection When the display prompts for tool connections connect the TRIGEN SURESHOT Targeter 7169 2801 to the Targeter port on the Trauma Interface SURESHOT Probe nal foung SURESHOT Tatgetar ret Tome The SURESHOT Targeter will change color to orange upon successful connection to the Trauma Interface SURESHOT Probe not found SURESHOT Targetor 10 7118 1540 Rev B CAUTION The Targeter body may have contact with the patient and must remain in the sterile field at all times Only the cable and connector may be removed from the sterile field CAUTION Connect the Targeter at least 10 minutes prior to targeting in order to ensure proper accuracy Note When oriented as shown the connector should assemble easily Do not force the connector into the port Note If the Targeter is properly connected to the system and the application remains in this screen for more than 30 seconds the Targeter may have been damaged during cleaning sterilization In this case another Targeter has to be used Note It is possible at any time to disconnect and reconnect tools when the application is running The display will show a screen reporting the missing instrument TRIGEN SURESHOT Distal Targeting System User Manual Surgical Procedure After IM Nail Assembly to the Drill Guide Surgical Procedure After IM Nail Assembly to the Drill Guide Probe selection and assembly Assemble the ap
4. Note Product returned that is found to have been serviced by an unauthorized third party repair facility and or sterilized with a sterilization method other than one approved by Smith amp Nephew will incur additional costs regardless of warranty status Electrical interference This equipment is designed and tested to minimize interference with other electrical equipment However if interference occurs with other equipment it may be corrected by one or more of the following measures e Reorient or relocate this equipment the other equipment or both e Increase the separation between the pieces of equipment e Connect the pieces of equipment into different outlets or circuits e Consult a biomedical engineer Environmental protection This equipment contains electronic printed circuit assemblies At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional policy relating to obsolete electronic equipment 22 7118 1540 Rev B TRIGEN SURESHOT Distal Targeting System User Manual Troubleshooting Troubleshooting Trauma Interface unit is without power Mains power plug is not inserted Insert mains power plug into reliable properly or there is no mains power power supply No power on the wall outlet Try another power outlet One or both mains power fuses are blown Replace mains fuses Buttons or items are difficult to selecton Touchscreen is not c
5. Sleeve Long 3 When screw insertion is complete remove the probe from the IM nail 18 7118 1540 Rev B Navigation Screen Operation Overview mode When the Targeter is greater than 5 cm 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 tind the general location of the interlocking holes CAUTION If the desired hole in the nail is not oriented to be viewed on the screen then the orientation of the Targeter is not aligned closely enough to that specific hole Try holding the Targeter generally anterior posterior AP or generally mediolateral ML to orient the desired view Tibia 10 mm Drilling mode When the Targeter is moved within 5 cm of the interlocking holes the navigation screen will display the IM nail in the drilling mode This provides the user with a smaller field of view that automatically zooms in to the interlocking holes The white lines displayed on either side of the IM nail can be used for targeting blocking screws These lines are located 2 5 mm from the side of the IM nail for all IM nails 10 mm or larger in diameter These lines are located 2 mm from the sides of 8 5 mm IM nails Pul Tegas bock fully bo eddie Gett Tita 10 mm TRIGEN SURESHOT Distal Targeting System User Manual Shutting Down the System Storage and Transport Drilling mode manual rotation Each IM nai
6. TAN FAN Drill Guide Probe 7169 2803 Sensor META NAIL Semi extended Drill Guide Probe 7169 1152 Sensor Humeral Drill Guide Probe 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 Emissiontest Compliance Electromagnetic environment guidance The TRIGEN SURESHOT Distal Targeting System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The TRIGEN SURESHOT Distal Targeting System is suitable for use in all establishments other than domestic Harmonic emissions and those directly connected to the public low voltage IEC 61000 3 2 Class A power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions IEC 61000 3 3 RF emissions CISPR 11 Complies 28 7118 1540 Rev B TRIGEN SURESHOT Distal Targeting System User Manual Guidance and Manufacturer s Declaration Guidance and manufacturer s declaration electromagnetic immunit 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 enviro
7. To avoid fire hazard use only fuses of the correct Replacing fuses type voltage rating and current rating See the Technical Specifications section for replacement fuse CAUTION Disconnect the power cord before exchanging any DES fuse 1 Disconnect main power cord 2 Use a screwdriver to open the fuse compartment door Technical information on the AC receptacle Smith amp Nephew will make available on request a list of all repairable exterior parts with descriptions Interior schematics and circuit diagrams will be made available to qualitied personnel only CAUTION Service can only be performed by authorized Smith amp Nephew personnel TRIGEN SURESHOT Distal Targeting System User Manual 7118 1540 Rev B 21 Service Service TRIGEN SURESHOT Distal Targeting system There are no user serviceable components inside the TRIGEN SURESHOT Trauma Interface Repairs and adjustments are to be performed only by Smith amp Nephew authorized service centers If service becomes necessary call an authorized Smith amp Nephew customer service representative prior to returning the device and request a Return Authorization RA number Your representative can also explain the available service replacement and repair programs The device should be packaged in its original transportation case and returned postage paid A Smith amp Nephew customer service representative will provide additional instructions for shipment
8. relocating the TRIGEN SURESHOT Distal Targeting System b Over the frequency range 150kHz to 80MHz field strengths should be less than 10 V m 30 7118 1540 Rev B TRIGEN SURESHOT Distal Targeting System User Manual Guidance and Manufacturer s Declaration Recommended separation distances between portable and mobile RF communications equipment and the TRIGEN SURESHOT Distal Targeting System 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 portable and mobile RF communications equipment transmitters and the TRIGEN SURESHOT Distal Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Rated maximum output power of transmitter d 1 2 4P d 12 4P d 23VP For transmitters rated at a maximum output power not listed above the recommended separation distance din metres m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80MHz and 800MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations El
9. to ogd u2e dapi Fea D s Note The Drill Depth Measurement software feature can be cancelled at any time by rotating the Targeter about the drill bit axis After a successful Drill Depth Measurement is performed the software will display the measured length at the drilled location Tita 10 men Pl Tegete back fully So madass dapi Tva 10 mm Note A Drill Depth Measurement software operation can be repeated on a drilled hole at any time The newest measurement will be displayed at that location 7118 1540 Rev B 17 Navigation Screen Operation The user can delete a measurement at any time by tapping the measurement number on the touchscreen A button will appear allowing the user to delete the measurement Screw insertion Using the TRIGEN SURESHOT Hexdriver 7169 2809 or 7169 1153 the screw may be inserted using the Targeter WARNING The standard TRIGEN Hexdrivers are made from magnetic stainless steel that will cause interference with the system and cannot be used Using the Combo Drill Sleeve nee TRIGEN SURESHOT Inner Drill Sleeve Long 7169 1165 TRIGEN SURESHOT Outer Screw Sleeve Long 7169 1166 1 While holding the Targeter to bone remove the SURESHOT Inner Drill Sleeve Long 7169 1165 from the SURESHOT Outer Screw Sleeve Long 7169 1166 2 Use the TRIGEN SURESHOT Hexdriver 7169 2809 or 7169 1153 to insert the appropriate length screw through the SURESHOT Outer Screw
10. System User Manual the first time Should there be any doubt regarding correct functioning the targeting should be verified or a switch made to a traditional X Ray technique Warnings and Cautions WARNING The maximum temperature of the Targeter body can reach 47 Celsius at ambient room temperatures above 30 C The Targeter body should not remain in constant contact with a patient s exposed skin for more than one minute WARNING Verify there are no other metal objects including metal triangles in the immediate targeting area Metal interference will cause the system to be inaccurate Accessibility of documentation Please ensure that all instructions are kept in an easily accessible place for operating personnel The operator checks and decides All the information provided by the TRIGEN SURESHOT Distal Targeting System is to help the operator make decisions during the operation The operator must check all the suggestions made by the system and is responsible for all decisions taken Responsibility of Smith amp Nephew In the event of improper use Smith amp Nephew accepts no responsibility or liability whatsoever for the functioning or utility of the TRIGEN SURESHOT Distal Targeting System when used in the operating theater Cleaning and sterilization All instruments must be sterilized before use Detailed information on the cleaning and sterilization of components is contained in the separate Cleaning and Ste
11. User Manual gt K smith amp nephew TRIGEN SURESHOT Distal Targeting System V3 0 Tibia 10 mm 0086 CE 7118 1540 Rev B Glossary of Symbols BH Consult instructions for use Equipment classification Patient lsolation Type BF Applied Part Power ON connection to the mains amp Power OFF disconnection from the mains Catalog number Yo umorry Humidity limit Ge Authorized representative in the European community TRIGEN SURESHOT Distal Targeting System User Manual Serial number Testing Lab certitication Fuse CE Mark Temperature range EU Not for general waste 7118 1540 Rev B Table of Contents Table of Contents Glossary of Symbols 0 cece eee eee eens 3 Table of Eege eg e rd AE E 4 DEVICE Deet dese eeneg 5 Indications for Hee eg SEN deste Mgr nee ba ak 5 Contraindications EE 5 WANING EE eee tate caw eae eases 5 Plausibility Check Re pve gidiceaiew e EA 4 5 Warnings and Cautions 5 QUICK Stat Guide EE 7 Where to find the components 0000005 7 Front panel layout 7 Rear panel EE 7 Applied Parts for Targeting 0 eee eee eee 7 Surgical Procedure OR preparation 8 Trauma Interface sep 8 Software Configuration 2 eee eee 9 TRIGEN SURESHOT Targeter connection 10 Surgical Procedure After IM Nail Assembly tothe DAU Guide ee eos eee dee 11 Probe selection and ass
12. al standards Please Distal Targeting unit contact your customer service representative in the event of Smith amp Nephew reserves the right to make any technical any queries changes WARNING This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide CAUTION The system may reboot after a power line surge greater than IKV This is considered a normal condition and the system will automatically reboot to the software application 26 7118 1540 Rev B TRIGEN SURESHOT Distal Targeting System User Manual Parts and Accessories List Parts and Accessories List TRIGEN SURESHOT Humeral Set Stop CAUTION Inspect all components regularly for wear CAUTION Use only Smith amp Nephew disposables and accessories with the Smith amp 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 After use the probe should be discarded per hospital policy procedures for biohazard material disposal TRIGEN SURESHOT Distal Targeting System User Manual 7118 1540 Rev B Guidance and Manufacturer s Declaration Guidance and Manufacturer s Declaration Electromagnetic emissions immunity and separation distances Changes or modifications to this system not expressly approved by th
13. alibrated Access calibration software by selecting the touchscreen Administration from the About option under the Menu button From the Administration screen select the Settings button then select the Calibrate touch screen button VGA video out not functioning VGA port not activated on Trauma Connect VGA cable to both Trauma Interface Interface and video monitor before powering on Trauma Interface Damaged VGA cable Replace VGA cable Video monitor not on correct input Select proper input on video monitor TRIGEN SURESHOT Targeter not Error reading data from Targeter Unplug Targeter wait 10 seconds and recognized plug back in Damaged Targeter Replace Targeter with new unit Probe not recognized Error reading data from probe Unplug probe wait 10 seconds and plug back in Damaged probe Replace probe with new unit Probe will not insert to the proper depth in Obstruction within the nail cannulation Re insert the ball tip guide rod into the nail the nail cannulation to clear any obstruction Nail not visible on the screen Metal interference within the TRIGEN Remove any metal objects from the SURESHOT electromagnetic tield targeting field TRIGEN SURESHOT Targeter and probe not Move the TRIGEN SURESHOT Targeter within range of each other closer to the sensor end of the probe Drill bit too short Short drill bit being used and long drill Press Menu Drill Sleeve and select the sl
14. amp Nephew Inc 1450 Brooks Road 1 800 821 5700 Toll free in the U S All rights reserved Memphis TN 38116 1 800 238 7538 U S Customer Service USA Orders and Inquiries 08 2013 7118 1540 Rev B
15. be is not recognized after its connection to the system the probe is defective and must be exchanged See also instrument connection CAUTION Broken or damaged instruments must be exchanged immediately and sent back to Smith amp Nephew Inc 8 7118 1540 Rev B Surgical Procedure OR preparation 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 After the sterile areas have been established place the Trauma Interface 7169 2802 in the desired non sterile location and turn on the power switch CAUTION No other electrical devices should be placed near the Trauma Interface See the Guidance and Manufacturer s Declaration Separation Distances table at the end of this document Note If the Trauma Interface does not power on make sure the switch is in the on position Note The means for mains disconnection of power to the Trauma Interface is the appliance inlet located below the power switch The Trauma Interface should not be positioned such that it is difficult to reach this location TRIGEN SURESHOT Distal Targeting System User Manual Surgical Procedure OR preparation Software configuration 4 Press the Settings button in the upper r
16. bled for performing drill depth measurements the following message will be displayed at the top of the screen Pull Targeter back fully to measure depth Begin drilling the hole at the near cortex Before drilling through the far cortex pull the Targeter back to the drill connection while keeping the drill bit in place This action will trigger the software to display the Drill Depth Measurement window TRIGEN SURESHOT Distal Targeting System User Manual Surgical Procedure Drill Depth Measurement Drill Depth Measurement Note Do not excessively rotate the Targeter while sliding it along the drill bit as this movement is used to cancel the Drill Depth Measurement software feature If the Targeter distance pulled back does not match the distance pushed back to bone then a warning message is displayed Push the Targeter drill sleeve forward to the bone to verity the length measured This action verifies the drill bit did not change position during the Targeter movement If the distance the Targeter was pulled back equals the distance pushed back to bone a confirmation message indicating an accurate measurement is displayed Note After measuring the length on the drill bit prior to drilling the far cortex add the appropriate screw length in order to account for the thickness of the far cortex TRIGEN SURESHOT Distal Targeting System User Manual Drill Depth Measurement Depih con fanned Pv Tegete back fully
17. d in this manual and or in the non navigated surgical procedure The TRIGEN SURESHOT Targeting System V3 0 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate Contraindications The screw targeting software application for this system is contraindicated for all IM nails other than Smith amp Nephew TRIGEN META NAIL TAN FAN Humeral Pediatric and Adolescent nails Do not operate the TRIGEN SURESHOT Targeter within 200 mm of an installed pacemaker The magnetic field produced by the Targeter may interfere with the operation of the pacemaker Training Only trained operators are allowed to use the TRIGEN SURESHOT Distal Targeting System The various operating instructions must be fully read and understood as part of the training If any part of the instructions is not clear please contact your local representative Plausibility Check As with all technical equipment malfunctions may occur due to improper use or more rarely technical failure To reduce the risks involved with such technical malfunction the operation can be completed using manually controlled instruments providing the malfunction is detected without delay It is therefore important to check the plausibility of the steps as indicated by the system and to carry out verification of the software targeting particularly when using the system for TRIGEN SURESHOT Distal Targeting
18. e 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 CAUTION Use of portable phones or other radio frequency RF emitting equipment near the system may cause unexpected or adverse operation CAUTION The presence of certain metal objects within the electromagnetic tracking volume system may cause unexpected or adverse operation CAUTION The equipment or system shall not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the equipment or system shall be tested to verify normal operation in the configuration in which it is being used CAUTION The use of accessories transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system Compliant cables and accessories The table below lists cables transducers and other applicable accessories for which the manufacturer claims EMC compliance Note Any supplied accessories that do not affect EMC compliance are not listed 7169 2801 Field Generator TRIGEN SURESHOT Targeter 7169 2814 Sensor META NAIL Standard Drill Guide Probe 7169 2815 Sensor Percutaneous
19. ectromagnetic propagation is affected by absorption and reflection from structures objects and people TRIGEN SURESHOT Distal Targeting System User Manual 7118 1540 Rev B Warranty Smith amp Nephew products are guaranteed to be free from defects in Smith amp Nephew Orthopaedics GmbH material and workmanship for the warranty period for a particular product EE E beginning from date of invoice Refer to the current Smith amp Nephew 78532 Tuttlingen Germany Product Catalog or contact Smith amp Nephew Customer Service for specitic Tel 07462 208 0 warranty information Fax 07462 208 135 This limited warranty is restricted to repair or replacement by Smith amp Nephew at its option of any product found to be defective during the warranty period Damage inflicted to a product by the user that causes it to be unsuitable for refurbishment may result in additional charges regardless of warranty status All warranties apply to the original buyer only In no event shall Smith amp Nephew be liable for any anticipated profits consequential damages or loss of time incurred by the buyer with the purchase or use of any product NO OTHER WARRANTY EXPRESSED OR IMPLIED IS GIVEN Service Replacement Units Warranty Smith amp Nephew service replacement units are warranted to be free from defects in material workmanship for the warranty period for a particular product beginning trom date of invoice Refer to the current Smith am
20. eeve option selected within software short drill sleeve option to use the short drill bit Drill bit too long Long drill bit being used and short drill Press Menu Drill Sleeve and select the sleeve option selected within software long drill sleeve option to use the long drill bit Red and Green targeting circles Incorrect drill sleeve length selected Verify the correct drill sleeve length is representing the drill sleeve appear selected from the software menu incorrect Metal interference within the TRIGEN Remove any metal objects from the SURESHOT electromagnetic field targeting field Probe not inserted correctly within set Verify probe is oriented and seated stop correctly in the notches of the set stop Damaged probe Verify probe accuracy with Field Accuracy Gauge TRIGEN SURESHOT Distal Targeting System User Manual 7118 1540 Rev B 23 Troubleshooting Suggested action Targeting missed the intended hole Drill sleeve cannot be removed from TRIGEN SURESHOT Targeter The 4 7 mm 4 0 mm step drill will not fit through the drill sleeve Field accuracy check fails Drill Depth Measurement will not trigger Drill Depth Measurement triggers but cancels Combo Drill Sleeve selection button is not available on the drill sleeve selection screen 24 7118 1540 Rev B Metal interference within the TRIGEN SURESHOT electromagnetic field Probe not inserted correctly within set stop Damaged probe Over tighte
21. embly 11 PIODECONNECHON e erersarara iea e paa Aa A 12 Drill sleeve selection 0 0 0 0 eee 12 Implant selection screen 13 Drill sleeve attachment 0 00000002 c cece 13 Locking hole accuracy check in the operative field 14 Optional Field accuracy check 14 Surgical Procedure Distal Targeting 15 Probe and set stop insertion 0 000 000 e ee 15 SKID INCISION EE 15 Targeting the locking hole 0002 00005 15 Surgical Procedure Drill Depth Measurement 16 Option 1 Measure off Drill Bit Calibrations 16 Option 2 Measure Using Drill Depth Software 16 SCIOW INSCRUON 4 ett Bet emis Said eng 18 Using the Combo Drill Sleeve 020000 18 4 7118 1540 Rev B Navigation Screen Operation 18 Overview mode 18 DHUNE MOJE aie a ae es ee eA ea 18 Drilling mode manual rotaiton aaa 19 Shutting Down the System Storage and Transport 19 Shutting down the system 00 eee eee 19 Storage and transport 0022 cece eee eee 19 MaINICNANCes EE 19 Field accuracy CHECK a8 ugh ahaa dead oa eae ees 19 Field accuracy check SIGNS g et de 20 Software upgrades 20 Cleaning and disinfection 0022000 20 Replacing Ee ee Keres 21 TECHMICALINIGHNANON MER 21 SEMC rb EE EE E 22 TRIGEN SURESHOT Distal Targeting System 22 Electrical interference
22. eve attachment Tightly secure the selected drill sleeve to the Targeter ei IS TAN FAN 7169 2804 and 7169 1166 can be loosened from the Targeter using the slot in the TRIGEN Hammer 7167 4082 Note The Humeral Drill Sleeve 7169 1154 can be loosened from the targeter using the slot in the TRIGEN Slotted Hammer 7175 1135 Note A different TRIGEN IM Nail and or size can be selected at any time during the procedure by choosing the Implant option from the drop down menu OR by pressing the implant tab located in the lower left corner of the navigation screen TRIGEN SURESHOT Distal Targeting System User Manual 7118 1540 Rev B Note The short long and long combo drill sleeves 7169 2805 Surgical Procedure After IM Nail Assembly to the Drill Guide Locking hole accuracy check in the Optional Field accuracy check operative field An optional field accuracy check can be performed at this point using the instructions in the Maintenance section Insert the probe with the assembled set stop through the drill guide and cannulation of the TRIGEN IM Nail Place the IM nail with inserted probe directly beside the patient s limb Position the Targeter over the locking holes and verity the accuracy on the Trauma Interface Attach the set stop to the drill guide ensure that the probe is oriented correctly and that the set stop position and IM nail length match E ei For META NAIL Fo
23. grades Software upgrades are performed using a Smith amp Nephew Inc supplied USB memory stick and a Work Instruction document The Work Instruction document should be filled out and returned to Smith amp Nephew Customer Service upon completion of the upgrade Cleaning and disinfection The TRIGEN SURESHOT Trauma Interface is used in the non sterile area of the operating theater and is cleaned and disinfected using commercial cleaning and disinfectant products such as a mild detergent and water or a bactericidal cleaning solution such as 70 isopropyl alcohol 20 7118 1540 Rev B TRIGEN SURESHOT Distal Targeting System User Manual Maintenance CAUTION Care must be taken not to allow any liquid to pass 4 Reinsert fuse carriers using the arrows on the inside of the into any electrical connections or the interior of the unit Let the fuse compartment door as a guide surfaces dry thoroughly before plugging in the unit DO NOT steam sterilize the system DO NOT submerge the system for any reason All other reusable instruments shall be cleaned and sterilized according to the Cleaning and Sterilization Instructions Smith amp Nephew document 7138 1339 WARNING Observe the manufacturer s instructions for dilution exposure time etc WARNING DO NOT sterilize with ethylene oxide gas or steam sterilize the Trauma Interface WARNING Probes are NOT reusable 5 Snap the fuse compartment door closed e WARNING
24. hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the table requires continued operation during power mains interruptions it is recommended that the TRIGEN SURESHOT Distal Targeting System is powered from an uninterruptible power supply or a battery If image distortion occurs it may be necessary to position the TRIGEN SURESHOT Distal Targeting System further from sources of power frequency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the intended location to assure that it is sufficiently low 7118 1540 Rev B 29 Guidance and Manufacturer s Declaration Guidance and manufacturer s declaration electromagnetic immunit 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 IEC 60601 Compliance Electromagnetic environment Immunity test test level Level guidance Portable and mobile RF communications equipment should be used no closer to any part of the TRIGEN SURESHOT Distal Targeting System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz d 1 2 4P
25. ight corner of the screen To enable or disable specitic software features use the following steps to make the desired changes These software features could include but are not limited to the Japan nail option the Drill Depth Measurement option and the Combo Drill Sleeve option For this software version 3 0 the Drill Depth Measurement and Long Combo Drill Sleeve features are enabled by default 1 Press the Menu button 2 Select the About button from the dropdown 5 Select Application on the left to bring up the following screen i j Lies am CH Dita Geist VAAD O Emtee Jaren he Sines E Enoet e Ceti Depi Measured E Enatze Leng Comes Bier DH Conte Sien Bien Fei Ch Ain ali Tibia 10 mm Laer 3 Select the Administration button Okai Tia O es Epen Log Files to Women en mee Bebe j Sek eet pee eh Ltb Lopes Recent Lea Files AN Log Fisa ai 6 Press the feature to be changed to enable or disable that feature Enabled features appear in black text with a filled check box disabled features appear in gray text with an EE unfilled check box 7 Press the Return button in the upper left corner when finished 8 Press the TRIGEN SURESHOT Distal Targeting button in the center of the screen to return to the targeting application TRIGEN SURESHOT Distal Targeting System User Manual 7118 1540 Rev B Surgical Procedure OR preparation
26. l has several predefined views that are automatically selected depending on the position of the Targeter to the IM nail Depending on the operating environment these predefined views might not be appropriate and can be manually adjusted Tiha 10 mm To rotate the view Touch the screen near the outside and drag the view in a clockwise or counterclockwise direction To reset the view The default view settings can be restored by touching the center of the screen Shutting Down the System Storage and Transport Shutting down the system 1 Shut down the Trauma Interface by selecting the Exit option from the on screen Menu button 2 Switch off the main power switch on the rear of the unit 3 Unplug the power supply cable CAUTION Shut down the Trauma Interface using the on screen Exit option and wait for the system to power down before switching off power or unplugging from the main power supply CAUTION The internal fan of the Trauma Interface runs continuously whenever the rear power switch is in the ON position Switch power off whenever the unit is not in use TRIGEN SURESHOT Distal Targeting System User Manual Storage and transport e Place the Trauma Interface screen up in the transportation case e Coil the power cord and store in the transportation case e Consider the temperature and humidity range for storage and transportation on the transportation case Caution Do no
27. lb 81068365 Rev B J Trauma Interface case label TRIGEN SURESHOT Distal Targeting System User Manual 7118 1540 Rev B Technical Specifications Technical Specifications System power supply Voltage 100 240 VAC Frequency 50 60 Hz Connected load lt 2 2 Amps Type T3 15A H 250V Quantity 2 Classification Protection class Class with protective earth ground IPXO continuous operation Type BF with hand held FG targeting probe Humidity No protection Explosion No protection Ambient conditions Temperature 10 35 C Humidity 30 75 RH non condensing Air pressure 700 1060 HPa Storage and transport Temperature 20 50 C in original packaging Humidity 10 90 RH non condensing Air pressure 700 1060 HPa System Dimensions DxWxH 40 cm x 38 cm x 20 cm Weight 9 kg Transportation case Dimensions DxWxH 63 cm x 50 cm x 35 cm Weight 20 kg Complies with standards USA Canada Europe IEC 60601 1 3rd edition IEC 60601 1 2 2007 CSA C22 2 601 1 2nd edition Electrical safety CAUTION Only use 110V 60Hz AC connection when powering the The system meets IEC standards EC 6060 AI a vir ie contigurations comply with standard IEC 60601 1 Any person p l connecting equipment to the system is responsible for the CAUTION To ensure proper operation no other electrical configuration and must ensure that it complies with system components should be located near the TRIGEN SURESHOT standard 60601 1 1 or equivalent nation
28. nd or a warning message will be displayed If the interference is excessive the IM nail image on the navigation screen will disappear Ful Tage back War E measure dagi Tag 10 nem A Field Quality meter is located at the bottom of the screen There are three field quality states OK Warning and Error OK Field Quality is adequate for proper function Field Quality e Fjeld Ouality Warning Possible measurement error due to metal or electrical interference Error Interference is excessive IM nail tracking not possible Field Gatty If interference cannot be avoided a standard X Ray technique must be used CAUTION All tool cables should be uncoiled completely and any excess cables should be kept out of the Targeter measurement volume 16 7118 1540 Rev B Surgical Procedure Drill Depth Measurement Option 1 Measure off Drill Bit Calibrations Begin drilling the hole at the near cortex Before drilling through the far cortex measure the length using the calibrations on the TRIGEN SURESHOT 4 0 mm Drill Bit 7169 2810 or 7169 2811 or the TRIGEN SURESHOT Humeral AO Drill Bit 7169 1155 After measuring the length on the drill bit prior to drilling the far cortex add the appropriate screw length in order to account for the thickness of the far cortex Ensure the Targeter and the sleeve are pushed against the bone Option 2 Measure Using Drill Depth Software When software is ena
29. nd set stop insertion circle until both the green and red circles are concentric and drill Insert the probe and set stop into the IM nail as described in the through to the far cortex locking hole accuracy check on the previous page Note Reference the cautions in the Locking hole accuracy check section Skin incision Position the serrated tip of the drill sleeve represented by the green circle over the desired locking hole and make the initial incision The accuracy may be verified using the C arm WARNING The standard TRIGEN Drill Bits are made from magnetic stainless steel that will cause interference with the system and cannot be used Be sure to use the gold non magnetic TRIGEN SURESHOT Drill Bit or long gold non magnetic drill bit Note The green ring must be fully within the hole of the IM nail Note If performing this procedure using any of the TRIGEN displayed on the navigation screen to ensure accurate drilling femoral antegrade nails TAN FAN Pediatric Adolescent the Anteversion Locking Guide 7169 2816 should be used along with a 4 0 mm Drill Sleeve Drill Bit to keep the IM nail from rotating TRIGEN SURESHOT Distal Targeting System User Manual 7118 1540 Rev B 15 Surgical Procedure Drill Depth Measurement When the Targeter is out of the preferred range or there is metal or electrical interference the green and red Targeter circles on the navigation screen may become unstable a
30. ning of drill sleeve Not compatible with the TRIGEN SURESHOT Distal Targeting System Metal interference within the TRIGEN SURESHOT electromagnetic field Field Accuracy Gauge improperly installed on largeter META Set Stop improperly installed on Field Accuracy Gauge Probe is incorrectly inserted within META Set Stop Probe is damaged Targeter is damaged Drill Depth Measurement Software is not enabled Targeter is being rotated during action The angle to the nail hole is greater than 15 degrees Combo sleeve software feature is not enabled Remove any metal objects from the targeting field Verify probe is oriented and seated correctly in the notches of the set stop Verify probe accuracy with Field Accuracy Gauge Use the Slotted Hammer trom the instrument tray as a wrench to unscrew the drill sleeve counter clockwise trom the Targeter Only use the long 7169 2811 and short 7169 2810 drills designed for use with the TRIGEN SURESHOT Distal Targeting System Remove any metal objects from the targeting field Verity Field Accuracy Gauge is fully seated within Targeter port and knob is hand tightened to Targeter Verify META Set Stop is correctly oriented and tightened securely to Field Accuracy Gauge Verify probe is oriented properly and inserted to the REF notches on probe body Replace probe with a new probe Replace Targeter with a new Targeter and return old one for service Follow the i
31. nment IEC 60601 Compliance Immunity test Electromagnetic environment guidance test level level Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 Uz 60 dip in Uy for5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Uy for 5s 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 Uz 60 dip in Uy for5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Uy for 5s not tested Note Ur is the a c mains voltage prior to application of the test level TRIGEN SURESHOT Distal Targeting System User Manual Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or
32. nstructions in the manual to enable the Drill Depth Measurement software Do not rotate Rotation is used to reset the Drill Depth Measurement Maintain alignment when targeting circles Follow the instructions under Software configuration in the manual to enable the Combo sleeve feature TRIGEN SURESHOT Distal Targeting System User Manual Product Label and Transportation Case Label Product Label and Transportation Case Label SC smith amp nephew Trauma Interface Kommunikationsschnittstelle f r Trauma e Interfaz de trauma e Interface trauma e Interfaccia Trauma e Traumagranssnitt e Trauma interface e Interface para Traumatismo e Traumeinterface Traumegrensesnitt steen 71692802 TA AA i D C FUSE SHOC INSTRUCTIONS PROTECTION ETL CLASSIFIED MEDICAL ELECTRICAL Smith amp Nephew Inc EQUIPMENT WITH RESPECT Memphis TN 38116 USA TO ELECTRICAL SHOCK FIRE www smith nephew com J AND MECHANICAL HAZARDS Tel 901 396 2121 International US 800 238 7538 USA Customer Service S LisTeD Xi NOT FOR N GENERAL WASTE 100 240V 50 60 Hz 2 2A ge ee Made in USA 81068350 Rev E Trauma Interface label SS eee Trauma Interface Case A smith amp nephew REF NuMBER 71692817 Storage and Transport Contains 50 C 90 Trauma Interface 122 F So HUMIDITY CATALOG TEMP REF NUMBER 71692802 20 C LIMIT LIMIT 4 F Dimension 63 x 50 x 35 cm o DxWxH 25x20x14 in C T Weight 20KG 44
33. p Nephew Product Catalog or contact Smith amp Nephew Customer Service for specific warranty information Service Replacement Program Smith amp Nephew offers a 24 hour Service Replacement Program for its products to minimize downtime in the operating room Our goal is to ship a service replacement unit within 24 hours of a call during normal business hours For a Return Authorization RA number or for additional information on this program call Customer Service at 1 800 238 7538 in the U S or contact an authorized representative 24 hour shipment is not offered in all countries Repair Service Program For devices no longer under warranty repairs can be made by Smith amp Nephew or by an authorized agent Non warranty repairs will be made at the list price of replacement parts plus labor If requested we will provide an estimate of repair cost and time required for the repair before any work is done Repair items should be carefully disinfected repackaged marked with the Return Authorization RA number and returned postpaid to the appropriate Smith amp Nephew Service Center Smith amp Nephew Customer Service or a local authorized representative can provide shipping information BR WU EAT H43571181540B1L Trademark of Smith amp Nephew Certain marks Registered US Patent amp Trademark Office Orthopaedics www smith nephew com Smith amp Nephew Inc 1 901 396 2121 International 2010 2013 Smith
34. perated at the user s own risk Recycling Old electrical and electronic equipment must be disposed of separately and may not be included in the regular domestic waste Alternatively the unit can be handed over to Smith amp Nephew Orthopaedics for correct recycling 6 7118 1540 Rev B WARNING Do not unplug the power while the system is running WARNING Danger of damage and tipping over Note Place the unit on a firm level surface capable of holding at least 10 kg 22 lbs WARNING To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth TRIGEN SURESHOT Distal Targeting System User Manual Quick Start Guide Quick Start Guide Where to find the components 1 Trauma Interface Cat No 7169 2802 2 Power cord country specific Front panel layout 1 Probe sensor ports 2 Targeter port 3 Touch screen interface _ 3 gt smith amp nephew TRIGEN SURESHOT Distal Targeting System TRIGEN SURESHOT Distal Targeting System User Manual Rear panel layout 1 Power switch Power connection Appliance Inlet USB connections service only VGA video output 1024 x 768 resolution VESA mounting posts 10 32 thread pitch 100 mm screw pattern om A O N Applied Parts for Targeting TRIGEN SURESHOT Targeter A Body Applied Part Type BF WARNING The maximum temperature of the Targeter body can
35. propriate probe and set the stop for the TRIGEN IM Nail and Drill Guide that will be used CAUTION Proper orientation of the probes to the set stops as shown is required Failure to do so may result in inaccurate targeting TRIGEN SURESHOT TRIGEN SURESHOT TRIGEN SURESHOT TRIGEN SURESHOT META NAIL META NAIL Percutaneous Humeral Nail Drill Standard Drill Semi extended TAN FAN Drill Guide Probe Guide Probe Drill Guide Probe Guide Probe 7169 1152 7169 2814 7169 2803 7169 2815 i i i m m hi W vn wll wll wm E Red probe Blue probe Green probe Dark Green probe Use only with Use only with Use only with Use only with META NAIL META NAIL Semi Percutaneous Humeral Drill Guide Standard Drill Guide extended Drill Guide TAN FAN Drill Guide 7175 1129 7169 2814 7169 2803 7163 1021 Set the probe to the length of the TRIGEN IM Nail For META NAIL notches For TAN FAN notches For Humeral notches should face anteriorly should face medially should face laterally TRIGEN SURESHOT Distal Targeting System User Manual 7118 1540 Rev B 11 Surgical Procedure After IM Nail Assembly to the Drill Guide Probe connection Connect the probe to either of the probe sensor ports on the Trauma Interface Confirm that the tool connection has been verified SURESHOT Probe META connected Note When oriented as shown the connector should assemble easily Do not force the connector into the port Simply try ro
36. r TAN FAN For Humeral nail notches should notches should notches should face anteriorly face medially face laterally Use only with the Use only with the Use only with the META Standard Percutaneous TAN Humeral Drill Guide 7165 4502 or FAN Drill Guide Probe 7169 1152 Semi extended Drill 7163 1021 Guide 7165 4524 CAUTION The TRIGEN SURESHOT Distal Targeting System cannot be used with the META NAIL Extension Drill Guide 7165 4503 or the Standard TRIGEN Drill Guide 7163 1134 CAUTION All tool cables should be uncoiled completely and any excess cables should be kept out of the Targeter measurement volume CAUTION To guarantee system accuracy the accuracy check has to be performed directly in the operative field 14 7118 1540 Rev B TRIGEN SURESHOT Distal Targeting System User Manual Surgical Procedure Distal Targeting Surgical Procedure Distal Targeting Targeting the locking hole With the appropriate length TRIGEN SURESHOT 4 0 mm 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 WARNING Verify there are no other metal objects including metal triangles in the immediate targeting area Metal interference will cause the system to be inaccurate Adjust the trajectory of the Targeter represented by the red Probe a
37. reach 47 Celsius at ambient room temperatures above 30 C The Targeter body should not remain in constant contact with a patient s exposed skin for more than one minute 7118 1540 Rev B Surgical Procedure OR preparation WARNING Verify that the Targeter housing is not damaged holes tears cracks If the housing or the connector is damaged the Targeter is no longer safe to use WARNING This device is provided non sterile and must be cleaned and sterilized per Cleaning and Sterilization Smith amp Nephew document 7138 1339 prior to use CAUTION The Targeter will be operated within the sterile field and may have contact with the skin of the patient The drill sleeve inserts will be used in the incision and have direct bone contact CAUTION If the Targeter is not recognized after its connection to the system the Targeter is defective and must be exchanged See also instrument connection CAUTION Broken or damaged instruments must be exchanged immediately and sent back to Smith amp Nephew Inc BR eec a SURESHOT Probes A Body Applied Part Type BF esch TRIGEN SURESHOT META NAIL Standard Drill Guide Probe The probe will be used as an intramedullary tool inside the nail placed in the patient s bone WARNING This device is provided sterile by ethylene oxide gas and is single use WARNING In case the packaging is compromised please replace with new sterile packaged probe CAUTION If the pro
38. rilization Instructions Smith amp Nephew document 7138 1339 Repair or modifications to the system The user is not permitted to modify or service the equipment There are no serviceable parts inside the unit Refer all service to authorized personnel Modifications additions to the software The user is not permitted to install or uninstall software Any new software must be installed by the manufacturer or by authorized personnel It is only allowed to connect equipment to the interface and power supply connections of the TRIGEN SURESHOT Distal Targeting System which are IEC 60601 1 approved and which are approved by Smith amp Nephew Orthopaedics 7118 1540 Rev B 5 Warnings and Cautions Do not modify this equipment without authorization of the manufacturer Electrical safety warning To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth ground Avoid spilling water or other liquids on electronic electrical equipment Use only Smith amp Nephew disposables and accessories with the Smith amp Nephew TRIGEN SURESHOT Distal Targeting System Maintenance To verify accurate functionality the device should be checked per the Maintenance section of this document This accuracy check must be performed at least once every 12 months If this accuracy check is not performed as defined in the previous paragraph all warranty claims expire and the device is o
39. t place any objects on top of the screen when the Trauma Interface is stored in the shipping container Damage to the screen may occur Maintenance Field accuracy check 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 verity all components are working correctly prior to their use on a patient CAUTION This step should be performed at least once a year to ensure that the device is working properly 7118 1540 Rev B 19 Maintenance Field accuracy check steps 4 A software window will appear informing the user if the TRIGEN SURESHOT Targeter and Probe combination is within the predefined accuracy parameters Pass or Fail message 1 Attach TRIGEN SURESHOT Field Accuracy Gauge 7169 2808 to the TRIGEN SURESHOT Targeter The knob on the Field Accuracy Gauge should be hand tightened only 2 Attach the META Set Stop 7169 2806 to the end of the Field Accuracy Gauge insert a TRIGEN SURESHOT probe into the set stop and set the depth to the REF mark on the probe body If the field accuracy check fails check the Troubleshooting section of this document for possible solutions 3 From the software Menu button located in the upper left corner of the screen select the Field Check option Software up
40. tating the connector until the keys are oriented in the 12 o clock position Note If the probe is properly connected to the system and the application reports Probe not found for more than 10 seconds the probe may be damaged or defective In this case the probe has to be exchanged Note It is possible at any time to disconnect and reconnect tools when the application is running The display will show a screen reporting the missing instrument 12 7118 1540 Rev B When a humeral probe is connected the following warning message will appear dd ar ni pm g ee Te UO Ta Heli E D if i OO imi ail A mera WARNING Do not operate the TRIGEN SURESHOT Targeter within 200 mm of an installed pacemaker Drill sleeve selection Select the length of the drill sleeve 7169 2804 7169 2805 or 7169 1165 and 7169 1166 that will be used Drill Sleeve Selection Sree A different sleeve can be selected at any time during the procedure by choosing the drill sleeve option from the drop down menu OR by pressing the drill sleeve tab located in the lower right corner of the navigation screen Note For humeral nails only one drill sleeve option will appear 7169 1154 TRIGEN SURESHOT Distal Targeting System User Manual Surgical Procedure After IM Nail Assembly to the Drill Guide Implant selection screen Humeral Nail Select the TRIGEN IM Nail and size that will be used META NAIL Tea Drill sle
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