TRIGEN SURESHOT User Manual Ver 2.1 Rev A Oct 2011

TRIGEN™ SURESHOT™ Distal Targeting System User Manual

Table of Contents Introduction...2 Glossary of symbols...3 Warnings and cautions...4 Quick start guide...6 Applied parts for targeting...7 Surgical procedure – OR preparation...8 Surgical procedure – After IM nail assembly to the drill guide...10 Surgical procedure – Freehand interlocking...14 Navigation screen operation...17 Shutting down the system, storage and transport...18 Maintenance...19 Service...22 Troubleshooting...23 Product label and transportation case label...25 Technical specifications...26 Parts and accessories list...27 Guidance and manufacturer’s declaration – Electromagnetic emissions, immunity and separation distances...28 Warranty...33 Service replacement units warranty...33 Service replacement program...34 Repair service program...34

Manufacturer Smith & Nephew Orthopaedics 1450 Brooks Rd. Memphis, TN 38116 USA 1-901-396-2121 www.smith-nephew.com

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Introduction Legend Important warnings appear in orange Tips, tricks and important information appear in blue Indications, contraindications, intended use and training The Smith & 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 & 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 & 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 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. 2

Glossary of symbols

Trauma Interface

Kommunikationsschnittstelle für Trauma • Interfaz de trauma • Interface trauma • Interfaccia Trauma • Traumagränssnitt • Trauma-interface • Interface para Traumatismo • Traumeinterface • Traumegrensesnitt

Consult instructions for use 0086

71692802

2X

T3.15A 250V 5 x 20mm 100-240V~, 50/60 Hz 2.2A

Smith & Nephew, Inc. Memphis, TN 38116 USA www.smith-nephew.com Tel: (901) 396-2121 International (800) 238-7538 USA Customer Service

MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE, AND MECHANICAL HAZARDS.

Equipment classification – Patient Isolation/Type BF Applied Part

4000207

Power ON (connection to the mains)

Patents Pending

81068350 Rev. C

Power OFF (disconnection from the mains)

Catalog number

Serial number Testing Lab certification

Fuse T3.15A 250V 5 x 20mm

0086

Made in USA

RECOGNIZED COMPONENT

CE Mark

Temperature range

Humidity limit

EU Not for general waste

European representative

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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 & Nephew Orthopaedics In the event of improper use, Smith & Nephew accepts no responsibility or liability whatsoever for the functioning or utility of the TRIGEN SURESHOT Distal Targeting System when used in the operating theatre. Cleaning and sterilization All instruments must be sterilized before use. Detailed information on the cleaning and sterilization of components is contained in the separate Cleaning and Sterilization Instructions (Smith & 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 IEC60601-1 approved and which are approved by Smith & 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 & Nephew disposables and accessories with the Smith & 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 & Nephew Orthopaedics for correct recycling.

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Note Do not unplug the power while the system is running!

Note Danger of damage and tipping over! Tip Place the unit on a firm, level surface capable of holding at least 10kg (22 lbs).

Note To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

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Quick start guide Where to find the components

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1 Trauma Interface (Cat. No. 7169-2802) 2 Power cord (country specific)

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Front panel layout 1 Probe sensor ports 2 Targeter port

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3 Touch screen interface

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2 Rear panel layout 1 Power switch

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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)

1 2 6

3

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Applied parts for targeting TRIGEN™ SURESHOT™ Targeter (Body Applied Part Type BF) Note 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. 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&Nephew, Inc. Note This device is provided non-sterile and must be cleaned and sterilized per Cleaning and Sterilization (Smith & Nephew document 7138-1339) prior to use. TRIGEN SURESHOT Probes (Body Applied Part Type BF) TRIGEN SURESHOT META-NAIL™ Standard Drill Guide Probe

Note The probe will be used as an intramedullary tool inside the nail placed in the patient’s bone. Note If the probe is not recognized after its connection to the system, the probe is defective and must be exchanged. (See also instrument connection). Note Broken or damaged instruments must be exchanged immediately and sent back to Smith & 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.

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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 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.

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.

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Tip If the Trauma Interface does not power on, make sure the switch is in the “on” position. Note 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.

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.

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 disconnect and reconnect tools when the application is running. The display will show a screen reporting the missing instrument.

Confirmation that the targeter tool has been connected when the center of the Targeter lights up orange.

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Surgical procedure – After IM nail assembly to the drill guide Probe selection and assembly Assemble the appropriate probe and set stop for the TriGEN™ IM nail and drill guide that will be used.

Note Proper orientation of the probes to the set stops as shown is required. Failure to do so may result in inaccurate targeting.

TRIGEN SURESHOT™ META-NAIL™ Standard Drill Guide Probe (7169-2814)

TRIGEN SURESHOT META-NAIL Semi-extended Drill Guide Probe (7169-2803)

TRIGEN SURESHOT Percutaneous TAN™/FAN Drill Guide Probe (7169-2815)

TRIGEN SURESHOT Humeral Nail Drill Guide Probe (7169-1152)

Red probe Use only with META-NAIL Standard Drill Guide

Blue probe Use only with META-NAIL Semi-extended Drill Guide

Green probe Use only with Percutaneous TAN/FAN Drill Guide (7163-1021)

Dark Green probe Use only with Humeral Drill Guide (7175-1129)

Set the probe to the length of the TriGEN IM nail.

For META-NAIL, notches should face anteriorly

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For TAN/FAN, notches should face medially

For Humeral, notches should face laterally

Probe connection Connect the probe to either of the probe sensor ports on the Trauma Interface.

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.

Confirm that the tool connection has been verified.

Drill sleeve selection Select the length of the drill sleeve (7169-2804 or 7169-2805) that will be used.

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)

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Implant selection screen Select the TriGEN™ IM nail and size that will be used.

Tip 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. The selected implant and diameter will be noted on the navigation screen.

Or

For TRIGEN Humeral Nail: Select the TRIGEN Humeral nail size that will be used. 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.

Drill sleeve attachment Tightly secure the selected drill sleeve to the Targeter.

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).

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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.

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.

For META-NAIL, notches should face anteriorly

For TAN™/FAN, notches should face medially

For Humeral nail, notches should face laterally

Use only with Meta Standard or Semi-Extended Drill Guide 7165-4502 or 7165-4524

Use only with Percutaneous TAN/ FAN Drill Guide 7163-1021

Use only with Humeral Drill Guide Probe (7169-1152)

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 optional field accuracy check can be performed at this point using the instructions in the Maintenance section.

Note This step should be performed at least once a year to ensure that the device is working properly. 13

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 (represented by the green circle) over the desired locking hole and make the initial incision.

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.

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. Critical Verify there are no other metal objects (including metal triangles) in the field. Metal interference will cause the system to be inaccurate.

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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. Note The green ring must be fully within the hole of the IM nail displayed on the navigation screen to ensure accurate drilling.

The accuracy may be verified using the C-arm.

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.

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).

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.

Alternatively, the length measurement can be achieved using the standard Screw Length Gauge (7163-1189) through the Targeter after removing the drill sleeve.

Screw insertion Using the TRIGEN SURESHOT Hexdriver (7169-2809 or 7169-1153), the screw may be inserted using the Targeter.

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.

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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.

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

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Shutting down the system, storage and transport Shutting down the system • Shut down the Trauma Interface by selecting

the “Shut Down” option from the on-screen “Menu” button. • Switch off the main power switch on the rear of

the unit. • Unplug the power supply cable.

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.

Storage and transport • Place the Trauma Interface (screen up) in the

transportation case. • Coil the power cord and store in the

transportation case. • Consider the temperature and humidity

range for storage and transportation on the transportation case.

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.

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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 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

Check” option.

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