TRIGEN SURESHOT User Manual
Contents
1. Drill sleeve selection Select the length of the drill sleeve 7169 2804 or 7169 2805 that will be used Menu hort Sle Tip When oriented as shown the connector should assemble easily Do not force the connector into the port simply try rotating 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 Tip 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 Tip A different sleeve can be selected at any time during the procedure by choosing the drill Sleeve option from the drop down menu after the implant has been selected The selected sleeve will be noted on the navigation screen Note For Humeral Nails there is only one option provided for the drill sleeve 7169 1154 Implant selection screen Select the TRIGEN IM nail and size that will be used Tibia SescerAne BS e Or Tah Tah Aeiedea erg For TRIGEN Humeral Nail Select the TRIGEN Humeral nail size that will be used Drill sleeve attachment Tightly secure the selected drill sleeve to the Targeter Tip A different TRIGEN IM nail and or size can be selected at any time during the procedure by choosing the Imp2. 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 Ur 60 dip in Uy for5 cycles 70 Uy 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 Uy gt 95 dip in Uy for 0 5 cycle 40 Uy 60 dip in Uy for5 cycles 70 U7 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Uy for 5s not tested Note Uy is the a c mains voltage prior to application of the test level 30 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 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 uninterrupti
3. the drill sleeve screw insertion Using the TRIGEN SURESHOT Hexdriver 7169 2809 or 7169 1153 the screw may be inserted using the Targeter Note The green ring must be fully within the hole of the IM nail displayed on the navigation screen to ensure accurate drilling Note 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 Tip 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 Tip If the Targeter is placed too close to the bone the image of the IM Nail on the display might disappear Note The standard TRIGEN Hexdrivers are made from magnetic stainless steel that will cause interference with the system and cannot be used 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 The positioning of the screw may be verified using the C arm Overview mode When the Targeter is greater than 5cm from the interlocking holes the navigation screen w
4. A HUMIDITY TEMP 20 C LIMIT ees miT 4 F CE3 OQO O 10 81068365 GE 25 Technical specifications System power supply Fuses Classification Ambient conditions Storage and transport System Transportation case Voltage Frequency Connected load Type Quantity Protection class Type Humidity Explosion Temperature Humidity Air pressure Temperature Humidity Air pressure Dimensions DxWxH Weight Dimensions DxWxH System case accessories Weight Complies with standards Electrical safety 100 240 VAC 50 60 Hz lt 2 2 Amps T3 15A L 250V 2 Class with protective earth ground IPXO continuous operation BF with hand held FG targeting probe No protection No protection 10 40 C 30 75 RH non condensing 700 1060 HPa 20 50 C in original packaging 10 90 RH non condensing 700 1060 HPa 40cm x 38cm x 20cm 9kg 63cm x 50cm x 35cm USA Canada Europe IEC 60601 1 2nd edition IEC 60601 1 2 2007 CSA C22 2 601 1 2nd edition The system meets IEC standards eg IEC 60601 All configurations comply with standard IEC 60601 1 1 Any person connecting equipment to the system is responsible for the configuration and must ensure that it complies with system standard 60601 1 1 or equivalent national standards Please contact your customer service representative in the event of any queries Note The system may reboot after a power line surge greater t
5. 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 Field accuracy check steps 1 Attach TRIGEN SURESHOT Field Accuracy Gauge 7169 2808 to 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 3 From the software Menu button select Field Menu Se Check option Reset View Toggle Back View Implant Drill Sleeve Field Check About Shutdown 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 Meng ite 2 eee AETA 5 If the field accuracy check fails check the Troubleshooting section of this document for possible solutions Software upgrades Software upgrades are performed using a Smith amp Nephew Inc supplied USB memory stick and a Work Instruction document The Work Jm Instruction document should be filled out and returned to Smith amp Nephew Customer Service upon completion Cleaning and disinfection The TRIGEN SURESHOT Trauma Interface is used in the non sterile area of the oper
6. each other Short drill bit being used and long drill sleeve option selected within software Long drill bit being used and short drill sleeve option selected within software Suggested action Insert mains power plug into reliable power supply Try other power outlet Replace mains fuses Access calibration software by selecting Maintenance from the About option under the Menu options password required Connect VGA cable to both Trauma Interface and video monitor before powering on Trauma Interface Replace VGA cable Select proper input on video monitor Unplug Targeter wait 10 seconds plug back in Replace Targeter with new unit Unplug probe wait 10 seconds plug back in Replace probe with new unit Re insert the ball tip guide rod into the nail cannulation to clear any obstruction Remove any metal objects from the targeting field Move the TRIGEN SURESHOT Targeter closer to the sensor end of the probe Press Menu Drill Sleeve and select the short drill sleeve option and use the short drill bit Press Menu Drill Sleeve and select the long drill sleeve option and use the long drill bit 23 Problem Red and Green targeting circles representing the drill sleeve appear incorrect Targeting missed the intended hole Drill sleeve cannot be removed from TRIGEN SURESHOT Targeter The 4 7mm 4 0mm step drill will not fit through the drill sleeve Fi
7. 814 TRIGEN SURESHOT META NAIL Standard Drill Guide Probe 7169 2815 TRIGEN SURESHOT Percutaneous TAN FAN Drill Guide Probe 7169 2816 TRIGEN SURESHOT TAN Anteversion Locking Guide 7169 2817 Trauma Interface Case 7169 2819 TRIGEN SURESHOT TAN Set Stop Bolt 7169 2830 TRIGEN SURESHOT Distal Targeting Instrument Tray 7169 2831 TRIGEN SURESHOT Distal Targeting Instrument Tray Lid 6680 0193 Power Cord 125 Volt 10 AMP North America Hospital Grade 6680 0291 Power Cord 250 Volt 10 AMP Continental Europe 6680 0213 Power Cord 250 Volt 10 AMP UK 6680 0303 Power Cord 250 Volt 10 AMP Australia New Zealand 6680 0302 Power Cord 250 Volt 10 AMP South Africa India 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 27 Guidance and manutachurer es 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 issu
8. TRIGEN SURESHOT Distal Targeting System V2 1 Men Teta 10 mri Short Save User Manual Introduction acon sdecsceaccarserqscsatecgnacaewsers ateeu et usenrsnnebeasncueseteesnbesdeotaasects 2 Glossary Of SYMDOIS 0 0ccccccccccesccesccescessecescesseesssesseeseeeseseseeeseeaeens 3 Warnings AINGC ue cccaten cecaceceueucee vacerocacastenreacecanceacmiessuscwanesenceniaes 4 Quick Start e E 6 Applied parts for targeting ccceccccceceeseeseseeseeseescseeseeseeseneeeeseees 7 Surgical procedure OR Dretparaton 8 Surgical procedure After IM nail assembly to the drill guide 10 Surgical procedure Freehand interlocking 0 0 0 0 cece 14 Navigation screen operation sccsssteraaniovinetossscceansnaninerseaestenveemavesteartevacs 17 Shutting down the system storage and Iransport 18 PUVA MS ANC EE 19 Se 22 Ueleg el 23 Product label and transportation case label 0 cece eee cece 25 Technical specifications 0 0 ce eee cccessceesceseeeseceseceseceseeseesecsseeseenees 26 Parts and accessories jet 27 Guidance and manufacturer s declaration Electromagnetic emissions immunity and separation distances 28 EI 1 EE 33 Service replacement units warranty 33 Service replacement program ececececceseeseeseneeseeseeseteeseeseeseteeeeae 34 Repair service program arcaeaystira ve eraecad setizsvesenvessuedeadyeonse lena eege dreet 34 Manufacturer Smith amp Nephew Orthopaedi
9. 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 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 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 Bb QO SN W T3 15A 250V 5 x 20mm Ce HUMIDITY LIMIT lu BANS Consult instructions for use Equipment classification Patient Isolation Type BF Applied Part Power ON connection to the mains Power OFF disconnection from the mains Cata
10. a view are temporarily stored for that view until program exit To reset the view The default view settings can be restored by touching the Menu button and selecting Reset View or double tapping the center of the screen Shutting down the system storage and transport Shutting down the system e Shut down the Trauma Interface by selecting the Shut Down option from the on screen Menu button e Switch off the main power switch on the rear of the unit e Unplug the power supply cable 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 Note Shut down the Trauma Interface using the on screen Shut Down option and wait for the system to power down before switching off power or unplugging from main power supply Note 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 Caution Do not 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
11. ance 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 Emission test Compliance Electromagnetic environment guidance The TRIGEN SURESHOT Distal Targeting System uses RF RF emissions Group 1 energy only for its internal function Therefore its RF CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF issi Ee 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 Complies IEC 61000 3 3 29 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 environment l 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
12. ast 10kg 22 lbs Note To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth 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 lTargeter port 3 3 Touch screen interface m ee 74 smith amp nephew TRIGEN SURESHOT Distal Targeting System Rear panel layout 1 Power switch 2 Power connection 3 USB connections service only 4 VGA video output 1024 x 768 resolution 5 VESA mounting posts 10 32 thread pitch 100mm screw pattern Applied parts tor targeting TRIGEN SURESHOT META NAIL Standard Drill Guide Probe TRIGEN SURESHOT Targeter Body Applied Part Type BF Note The Targeter will be operated within the Sterile tield 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 Note 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 Note If the Targeter is not recognized after its connection to the system the Targeter is defective and must be exchanged See also instrument connection Note Broken or damaged instruments must be exchanged immediately and sent back to Smith amp Nephew Inc Note T
13. ating theatre Gage 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 solution such as 70 isopropyl alcohol dilution exposure time etc Care must be taken not to allow any liquid to Note DO NOT sterilize with ethylene oxide gas or pass into any electrical connections or the steam sterilize the Trauma Interface interior of the unit Let the surfaces dry thoroughly before plugging in the unit DO NOT steam sterilize the system DO NOT submerge the system for any reason Note Probes are NOT reusable All other reusable instruments shall be cleaned and sterilized according to the Cleaning and Sterilization Instructions Smith amp Nephew document 7138 1339 20 Replacing fuses See the Technical Specifications section for replacement fuse type 1 Disconnect main power cord 2 Use a screwdriver to open the fuse compartment door on the AC receptacle 3 Pull out fuse carriers to exchange fuses 4 Reinsert fuse carriers using the arrows on the inside of the fuse compartment door as a guide 5 Snap the fuse compartment door closed Technical information Smith amp Nephew Orthopaedics will make available on request a list of all repairable exterior parts with descriptions Interior schematics and circuit diagrams will be made available to qualified personnel only N
14. ble 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 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 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 12VP Radiated RF 3 Vim IEC 61000 4 3 80 MHz to 2 5 GHz d 1 2 P 80MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz where Pis 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 electroma
15. cs 1450 Brooks Rd Memphis TN 38116 USA 1 901 396 2121 www smith nephew com Introduction Legend Important warnings appear in orange Tips tricks and important information appear in blue Indications contraindications intended use and training 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 nail implantation It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data The Smith amp Nephew TRIGEN SURESHOT Targeting System V2 1 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate An example of a surgical procedure includes but is not limited to locating and drilling the distal holes in an intramedullary nail 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 200mm of an installed pacemaker The magnetic field produced by the Targeter may interfere with the operation of the pacemaker Intended use The TRIGEN SURESHOT Distal
16. eld accuracy check fails 24 Possible cause Incorrect drill sleeve length selected Metal interference within the TRIGEN SURESHOT electromagnetic field Probe not inserted correctly within set stop Damaged probe Metal interference within the TRIGEN SURESHOT electromagnetic field Probe not inserted correctly within set stop Damaged probe Over tightening 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 Targeter META Set Stop improperly installed on Field Accuracy Gauge Probe is incorrectly inserted within META Set Stop Probe is damaged Targeter is damaged Suggested action Verity the correct drill sleeve length is selected from the software menu 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 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 from the instrument tray as a wrench to unscrew the drill sleeve counter clockwise from the Targeter Only use the long 7169 2811 and short 7169 2810 drills designated for use with the TRIGEN SURESHOT Distal Targeti
17. ental 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 related policy relating to obsolete electronic equipment 22 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 Problem Trauma Interface unit is without power Buttons or items are difficult to select on the touchscreen VGA video out not functioning TRIGEN SURESHOT Targeter not recognized Probe not recognized Probe will not insert to the proper depth in the nail Nail not visible on the screen Drill bit too short Drill bit too long Possible cause Mains power plug is not inserted properly or there is no mains power No power on the wall outlet One or both mains power fuses are blown Touchscreen is de calibrated VGA port not activated on Trauma Interface Damaged VGA cable Video monitor not on correct input Error reading data from Targeter Damaged Targeter Error reading data trom probe Damaged probe Obstruction within the nail cannulation Metal interference within the TRIGEN SURESHOT electromagnetic field TRIGEN SURESHOT Targeter and probe not within range of
18. er 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 IEC60601 1 approved and which are approved by Smith amp Nephew Orthopaedics 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 beginning on page 19 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 operated at the user s own risk Recycling Old electrical and electronic equipment must be disposed 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 SSE 4 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 le
19. es 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 Note Use of portable phones or other radio frequency RF emitting equipment near the system may cause unexpected or adverse operation Note The presence of certain metal objects within the electomagentic tracking volume system may cause unexpected or adverse operation Note The equipment or system shall not be used adjacent to or stacked with other equipment lf 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 Note 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 Part No Type Description 7169 1152 Sensor Humeral Drill Guide Probe 7169 2801 Field Generator TRIGEN SURESHOT Targeter 7169 2814 Sensor META NAIL Standard Drill Guide Probe 7169 2815 Sensor Percutaneous TAN FAN Drill Guide Probe 7169 2803 Sensor META NAIL Semi extended Drill Guide Probe 28 Guid
20. gnetic 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 relocating the TRIGEN SURESHOT Distal Targeting System b Over the frequency range 150kHz to 80MHz field strengths should be less than 10 V m 3 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 t
21. han IKV This is considered a normal condition and the system will automatically reboot to the software application Note Only use 110V 60Hz AC connection when powering the Trauma Interface within the United States The Trauma Interface is not certified for 220V 60Hz operation within the United States Note This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Note To ensure proper operation no other electrical components should be located near the TRIGEN SURESHOT Distal Targeting unit Smith amp Nephew reserves the right to make any technical changes 26 Catalog No Description 7169 1151 TRIGEN SURESHOT Humeral Set Stop 7169 1153 TRIGEN SURESHOT Humeral 3 5mm Hexdriver 7169 1154 TRIGEN SURESHOT Humeral 3 2mm Drill Sleeve 7169 1156 TRIGEN SURESHOT Humeral Instrument Caddy 7169 1152 TRIGEN SURESHOT Humeral Drill Guide Probe 7169 1155 TRIGEN SURESHOT Humeral 3 2mm AO Drill 7169 2801 TRIGEN SURESHOT Targeter 7169 2802 Trauma Interface 7169 2803 TRIGEN SURESHOT META NAIL Semi extended Drill Guide Probe 7169 2804 TRIGEN SURESHOT Long Drill Sleeve 7169 2805 TRIGEN SURESHOT Short Drill Sleeve 7169 2806 TRIGEN SURESHOT META Set Stop 7169 2807 TRIGEN SURESHOT Percutaneous TAN FAN Set Stop 7169 2808 TRIGEN SURESHOT Field Accuracy Gauge 7169 2809 TRIGEN SURESHOT Hexdriver 7169 2810 TRIGEN SURESHOT Short AO Drill 7169 2811 TRIGEN SURESHOT Long AO Drill 7169 2
22. he 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 Targeting System as recommended below according to the maximum output power of the communication ipment 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 12VP d 12VP 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 Electromagnetic propagation is affected by absorption and reflection from structures objects and people 32 Smith amp 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 amp Nephew product catalog or contact Smith am
23. his device is provided non sterile and must be cleaned and sterilized per Cleaning and Sterilization Smith amp Nephew document 7138 1339 prior to use TRIGEN SURESHOT Probes Body Applied Part Type BF 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 See also instrument connection Note Broken or damaged instruments must be exchanged immediately and sent back to Smith amp Nephew Inc Note This device is provided sterile by ethylene oxide gas and is single use Note In case the packaging is compromised please replace with new sterile packaged probe 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 make sure the switch is in the on position place the Trauma Interface 7169 2802 in the desired non sterile location and turn on the power switch Note No other electrical devices should be placed near the Trauma Interface See the Guidance and Manufact
24. ill 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 Note 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 AP or generally ML to orient the desired view Drilling mode When the Targeter is moved within 5cm 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 5mm from the side of the IM nail for all IM nails 10mm and larger in diameter These lines are located 2mm from the sides of 8 5mm IM nails Drilling mode manual rotation Each IM nail 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 predetined views might not be appropriate and can be manually adjusted To rotate the view Touch the screen near the outside and drag the view in a clockwise or counterclockwise direction To flip the view Touch the Menu button and select Toggle Back View All changes made for
25. lant option from the drop down menu The selected implant and diameter will be noted on the navigation screen Tip A different TRIGEN Humeral Nail size can be selected at any time during the procedure by choosing the implant option from the drop down menu The selected implant and diameter will be noted on the trauma interface screen Tip The drill sleeve 7169 2804 or 7169 2805 can be loosened from the Targeter using the slot in the TRIGEN Hammer 7167 4082 Tip The drill sleeve 7169 1154 can be loosened from the targeter using the slot in the TRIGEN Slotted Hammer 7175 1135 Locking hole accuracy check in the operative field Insert the probe with the assembled set stop through the drill guide and cannulation of the TRIGEN IM nail Attach the set stop to the drill guide ensure that the probe is oriented correctly and the set stop position and IM nail length match For META NAIL notches should face anteriorly For TAN FAN notches should face medially For Humeral nail notches should face laterally Use only with Use only with Use only with META Standard or Percutaneous TAN Humeral Drill Guide Semi Extended Drill FAN Drill Guide Probe 7169 1152 Guide 7165 4502 or 7163 1021 7165 4524 Place the IM nail with inserted probe directly beside the patient s limb Position the Targeter over the locking holes and verify the accuracy on the Trauma Interface Optional Field accuracy check An o
26. log number Serial number Testing Lab certification Fuse CE Mark Temperature range Humidity limit EU Not for general waste European representative Warnings and cautions 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 Orthopaedics 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 theatre 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 Sterilization 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 manufactur
27. n 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 repackaged marked with the return Authorization RA number and returned postage paid to the appropriate Smith amp Nephew Customer Service Center Smith amp Nephew Customer Service or your local authorized representative can provide shipping information Smith amp Nephew Orthopaedics GmbH Tuttlingen Germany 34 Notes Notes Orthopaedics Smith amp Nephew Inc www smith nephew com 7135 Goodlett Farms Pkwy Cordova TN 38016 USA Telephone 1 901 396 2121 Information 1 800 821 5700 Orders and Inquiries 1 800 238 7538 Trademark of Smith amp Nephew Certain marks Reg US Pat amp TM Off 0086 CE EC representative Smith amp Nephew Orthopaedics GmbH Alemannenstrasse 14 78532 Tuttlingen Germany Tel 07462 208 0 Fax 07462 208 135 2011 Smith amp Nephew Inc All rights reserved 7118 1927 REVA 08 11
28. ng System Remove any metal objects from the targeting field Verify 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 Verity 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 Trauma Interface label Trauma Interface case label 7 Trauma Interface Traumegrensesnitt 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 e MEW 71692802 AA Eae A A F CE 100 St SCH Hz SEE INSERT gt smith amp nephew PROTECTION FUSE RECOGNIZED COMPONENT MEDICAL ELECTRICAL MFG FOR Smith amp Nephew Inc EQUIPMENT WITH RESPECT Memphis TN 38116 USA TO ELECTRICAL SHOCK FIRE www smith nephew com AND MECHANICAL HAZARDS Tel 901 396 2121 International c US es 800 238 7538 USA Customer Service at ate Lei NOT FOR Intertek N GENERAL 4000207 WASTE mm wor in USA 81068350 rev D a WS 7 4 smith amp nephew Trauma Interface Case DEET Wees 71692817 Contains Trauma Interface REF umser 71692802 Dimension 63 x 50 x 35 cm DxWxH 25x 20x14 in en 20KG 44 lb Storage and Transport 50 C 90 rene
29. nted by the green circle over the desired locking hole and make the initial incision Targeting the locking hole With the appropriate length TRIGEN 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 Note Reference the warnings and tips in the locking hole accuracy check on the previous page Tip If performing this procedure using any of the TRIGEN femoral antegrade nails TAN FAN Pediatric Adolescent the Anteversion Locking Guide 7169 2816 should be used along with a 4 0mm Drill Sleeve Drill Bit to keep the IM nail from rotating Critical Verify there are no other metal objects including metal triangles in the field Metal interference will cause the system to be inaccurate Adjust the trajectory of the Targeter represented by the red circle until both the green and red circles are concentric and drill through to the far cortex The accuracy may be verified using the C arm Length measurement Before drilling through the far cortex measure the length using the calibrations on the TRIGEN SURESHOT 4 0mm Drill Bit or the TRIGEN SURESHOT Humeral AO Drill Bit 7169 1155 Alternatively the length measurement can be achieved using the standard Screw Length Gauge 7163 1189 through the Targeter after removing
30. ote Disconnect the power cord before exchanging any fuse Note To avoid fire hazard use only fuses of the correct type voltage rating and current rating Note Service can only be performed by authorized Smith amp Nephew personnel 21 TRIGEN SURESHOT Distal Targeting System service philosophy 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 your 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 Your Smith amp Nephew customer service representative will provide additional instructions for shipment 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 Environm
31. p Nephew customer service for specific warranty information 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 and 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 The Smith amp Nephew TRIGEN SURESHOT Trauma Interface replacement unit assumes the remainder of the original unit s warranty if applicable If the replacement unit is new to the customer or replacing a unit with less than 90 days remaining on the original warranty this unit is warranted to be free from defects in material and workmanship for 90 days from the date of original invoice unless otherwise provided by local law 33 Smith amp 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 For devices no longer under warranty repairs ca
32. ptional field accuracy check can be performed at this point using the instructions in the Maintenance section Note 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 Note All tool cables should be uncoiled completely and any excess cables should be kept out of the Targeter measurement volume Note To guarantee system accuracy the accuracy check has to be performed directly in the operative field Note This step should be performed at least once a year to ensure that the device is working properly Surgical procedure Distal Targeting Note 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 and or a warning message will be displayed If the interference is excessive the IM nail image on the navigation screen will disappear If interference cannot be avoided a standard X Ray technique must be used Note All tool cables should be uncoiled completely and any excess cables should be kept out of the Targeter measurement volume Probe and set stop insertion Following the removal of the Ball Tip Guide Rod insert the probe and set stop into the IM nail as described in the locking hole accuracy check on the previous page Skin incision Position the serrated tip of the drill sleeve represe
33. t and reconnect tools when the application is running The display will show a screen reporting the missing instrument Surgical procedure After IM nail assembly to the drill guide Probe selection and assembly Assemble the appropriate probe and set stop Note Proper orientation of the probes to the set for the TRIGEN IM nail and drill guide that will stops as shown is required Failure to do so may be used 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 b i r P j i 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 Percutaneous Humeral Drill Guide Standard Drill Guide Semi extended TAN FAN Drill Guide 7175 1129 Drill Guide 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 Probe connection Connect the probe to either of the probe sensor ports on the Trauma Interface Confirm that the tool connection has been verified Menu SURESHOT Probe META NAIL Semiextended connected 5
34. urer s Declaration Separation Distances table at the end of this document When start up screen disappears before the display prompts for tool connections a warning screen will appear Do not operate the TRIGEN SURESHOT Targeter within 200mm of an installed pacemaker The magnetic field produced by the Targeter may interfere with the operation of the pacemaker Menu SURESHOT Probe SURESHOT Targeter Humeral connected 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 Confirmation that the targeter tool has been connected when the center of the Targeter lights up orange SURESHOT Targeter connected Note 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 Note This step needs to be performed at least ten minutes prior to targeting in order to ensure proper accuracy Tip 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 Tip It is possible at any time to disconnec
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