Smith & Nephew TRIGEN SURESHOT User manual

User Manual
V2.1

1
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

2
Introduction
Important warnings appear in orange
Tips, tricks and important information appear
in blue
Legend
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.

3
Glossary of symbols
T3.15A 250V
5 x 20mm
0086

Consult instructions for use
Equipment classification – Patient Isolation/Type BF Applied Part
Power ON (connection to the mains)
Power OFF (disconnection from the mains)
Catalog number
Serial number
Testing Lab certification
Fuse
CE Mark
Temperature range
EU Not for general waste
Humidity limit
European representative
Made in USA 81068350 Rev. C
Trauma Interface
71692802
Patents Pending
T3.15A 250V
5 x 20mm
100-240V~, 50/60 Hz
2.2A
2X
Kommunikationsschnittstelle für Trauma • Interfaz de trauma • Interface trauma • Interfaccia
Trauma • Traumagränssnitt • Trauma-interface • Interface para Traumatismo • Traumeinterface •
Traumegrensesnitt
0086
Smith & Nephew, Inc.
Memphis, TN 38116 USA
www.smith-nephew.com
Tel: [phone] International
[phone] USA Customer Service 4000207
RECOGNIZED
COMPONENT MEDICAL ELECTRICAL
EQUIPMENT WITH RESPECT
TO ELECTRICAL SHOCK, FIRE,
AND MECHANICAL HAZARDS.

4
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.
Warnings and cautions

5
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.

6
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
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)
1
1
5
1
24
3
2
3
2

7
Applied parts for targeting
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.
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.
TRIGEN™ SURESHOT™ Targeter
(Body Applied Part Type BF)
TRIGEN SURESHOT Probes
(Body Applied Part Type BF)
TRIGEN SURESHOT META-NAIL™ Standard Drill Guide Probe

8
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.
Surgical procedure – OR preparation
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.
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.
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.

9
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.

10
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 TAN/FAN, notches
should face medially
For Humeral, notches
should face laterally
For META-NAIL, notches
should face anteriorly

11
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.
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.
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 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)

12
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
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).
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.
For TRIGEN Humeral Nail: Select the TRIGEN
Humeral nail size that will be used.

13
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.
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).
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 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.
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.
Use only with
Percutaneous TAN/
FAN Drill Guide
7163-1021
For TAN™/FAN,
notches should
face medially
Use only with
Humeral Drill Guide
Probe (7169-1152)
For Humeral nail,
notches should
face laterally
Use only with
META Standard or
Semi-Extended Drill
Guide 7165-4502 or
7165-4524
For META-NAIL,
notches should
face anteriorly

14
Surgical procedure – Distal Targeting
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.
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 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.
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.

15
Alternatively, the length measurement can be
achieved using the standard Screw Length Gauge
(7163-1189) through the Targeter after removing
the drill sleeve.
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.
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.
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 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.
Screw insertion
Using the TRIGEN SURESHOT Hexdriver
(7169-2809 or 7169-1153), the screw may be
inserted using the Targeter.

16
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.

17
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.

18
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.
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.
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.
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.
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.