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Smith & Nephew TRIGEN SURESHOT User Manual

Smith & Nephew TRIGEN SURESHOT
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TRIGEN™ SURESHOT
Distal Targeting
System V4.0
User Manual

Table of Contents

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Smith & Nephew TRIGEN SURESHOT Specifications

General IconGeneral
BrandSmith & Nephew
ModelTRIGEN SURESHOT
CategoryLaboratory Equipment
LanguageEnglish

Summary

Device Description

Indications for Use

Specifies approved applications for the TRIGEN SURESHOT Distal Targeting System.

Contraindications

Lists conditions or situations where the system should not be used.

Training

Information regarding required operator training for system use.

Plausibility Check

Guidance on verifying system operation and software targeting.

Warnings and Cautions

Critical safety warnings and precautions for operating the system.

Cleaning and sterilization

Instructions for cleaning and sterilizing system components.

Repair or modifications to the system

Policy on system servicing and unauthorized modifications.

Warnings and Cautions

Modifications/additions to the software

Restrictions on software installation and modifications.

Electrical safety warning

Essential precautions to prevent electric shock during operation.

Maintenance

Requirements and recommendations for system maintenance.

Recycling

Guidelines for proper disposal of electronic equipment.

Quick Start Guide

Where to find the components

Identifies the main components of the TRIGEN SURESHOT system.

Front panel layout

Diagram and explanation of the front panel interface.

Rear panel layout

Diagram and explanation of the rear panel connections.

Applied Parts for Targeting

TRIGEN SURESHOT Targeter

Details on the Targeter as an applied part.

TRIGEN SURESHOT Probes

Details on the probes as applied parts.

Surgical Procedure – OR preparation

Trauma Interface setup

Setting up the Trauma Interface in the non-sterile location.

Software configuration

Enabling/disabling software features like nail types and options.

TRIGEN SURESHOT Targeter connection

Connecting the Targeter to the Trauma Interface.

Surgical Procedure – After IM Nail Assembly to the Drill Guide

Probe selection and assembly

Assembling the correct probe and set stop for the IM nail.

Probe connection

Connecting the probe to the Trauma Interface and verifying connection.

Drill sleeve selection

Selecting the appropriate drill sleeve length for the procedure.

Implant selection screen

Selecting the TRIGEN IM Nail and size for use.

Drill sleeve attachment

Securely attaching the selected drill sleeve to the Targeter.

Locking hole accuracy check in the operative field

Verifying the accuracy of the probe and set stop in the operative field.

Optional – Field accuracy check

Performing an optional field accuracy check.

On-screen Nail Rotation

Rotation using Targeter

Manipulating nail rotation by rotating the Targeter.

Rotation using Monitor

Adjusting nail rotation using the monitor display.

Surgical Procedure – Distal Targeting

Probe and set stop insertion

Inserting the probe and set stop into the IM nail.

Skin incision

Making the initial incision over the desired locking hole.

Targeting the locking hole

Positioning the Targeter for accurate locking hole targeting.

Surgical Procedure – Drill Depth Measurement

Option 1: Measure off Drill Bit Calibrations

Measuring drill depth using calibrations on the drill bit.

Option 2: Measure Using Drill Depth Software

Using the software feature to measure drill depth.

Navigation Screen Operation

Overview mode

Displaying the IM nail in overview mode for general location.

Drilling mode

Displaying the IM nail in drilling mode for precise targeting.

Shutting Down the System, Storage, and Transport

Shutting down the system

Procedure for safely shutting down the Trauma Interface.

Storage and transport

Guidelines for storing and transporting the system.

Maintenance

Field accuracy check

Procedure to verify device accuracy annually or as needed.

Field accuracy check steps

Step-by-step guide for performing the accuracy check.

Software upgrades

Process for installing software updates using a USB stick.

Cleaning and disinfection

Recommended methods for cleaning the Trauma Interface.

Replacing fuses

Instructions on how to replace fuses in the unit.

Technical information

Availability of technical details and schematics.

Service

Electrical interference

Measures to correct interference with other electrical equipment.

Environmental protection

Information on the disposal of electronic components.

Troubleshooting

Trauma Interface unit is without power

Diagnosing and resolving power issues with the Trauma Interface.

Buttons or items are difficult to select on the touchscreen

Addressing issues with touchscreen responsiveness.

VGA video out not functioning

Troubleshooting problems with VGA video output.

HDMI video out not functioning

Troubleshooting problems with HDMI video output.

TRIGEN SURESHOT Targeter not recognized (error message)

Resolving issues when the Targeter is not detected.

Probe not recognized

Resolving issues when the probe is not detected.

Probe will not insert to the proper depth in the nail

Troubleshooting probe insertion depth problems.

Nail not visible on the screen

Addressing issues where the nail image is not displayed.

Drill bit too short

Resolving issues when the drill bit is too short.

Drill bit too long

Resolving issues when the drill bit is too long.

Targeting circles incorrect

Correcting inaccurate targeting circle display for the drill sleeve.

Targeting missed the intended hole

Diagnosing and fixing issues with missed target holes.

Drill sleeve removal issues

Resolving problems with removing the drill sleeve.

Step drill compatibility

Troubleshooting compatibility issues with step drills.

Field accuracy check fails

Resolving issues when the field accuracy check fails.

Drill Depth Measurement will not trigger

Troubleshooting why the drill depth measurement feature won't activate.

Drill Depth Measurement triggers but cancels

Resolving issues where drill depth measurement is cancelled.

Combo Drill Sleeve selection unavailable

Enabling the Combo Drill Sleeve option.

META-TAN nail selection unavailable

Enabling the META-TAN nail selection feature.

On-screen Nail Rotation feature not working

Troubleshooting the on-screen nail rotation feature.

Power button malfunction

Resolving issues with the on-screen power button.

On-screen text in foreign language

Changing the on-screen display language.

Product Label and Transportation Case Label

Technical Specifications

Parts and Accessories List

Guidance and Manufacturer's Declaration

Electromagnetic emissions, immunity and separation distances

Guidelines on system emissions and required separation distances.

Compliant cables and accessories

List of accessories that ensure EMC compliance.

Guidance and manufacturer's declaration – electromagnetic immunity

System immunity to electromagnetic disturbances.

Recommended separation distances for RF equipment

Specific separation distances for RF equipment.

Warranty

Service Replacement Units Warranty

Warranty terms for service replacement units.

Service Replacement Program

Details on the 24-hour service replacement program.

Repair Service Program

Information on out-of-warranty repair services.