Medtronic TREON User Manual

TREON® Treatment Guidance System
System Manual

Part Number 9680169, revision 10

A Guide to Understanding the
TREON

®

Treatment Guidance

System

Read this manual completely prior to
using this device.

c

Explanation Of Symbols On Package Labeling

The following symbols may appear on system equipment, system packaging, or in this reference guide.

c

The device complies with European Directive MDD 93/42/EEC.

Classified by Underwriters Laboratories Inc. with respect to electric shock, fire, mechanical, and other
specified hazards only in accordance with UL60601-1/CAN/CSA C22.2 NO.601.1.

Control number 87HJ.

Prescription only. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician

.

w

When found in this reference guide, this symbol means: “Warning! Failure to observe could result in
injury or death.” When found on equipment, this symbols means: “Attention: consult accompanying
documentation.”

#

Caution! Failure to observe could result in damaged equipment, forfeited time or effort, or the need to
abort use of the system.

y

Type BF applied equipment, in compliance with IEC60601-1.

Type B applied equipment, in compliance with IEC60601-1.

F

Fragile contents

H

Keep upright

U

Keep dry

Power on. Connect to main power.

Power off. Disconnect from main power.

D

Power on for part of the system (typically energizes the Isolation Transformer and UPS).

Power off for part of the system.

Freeze caster

Lock caster angle

f

Use by date specified

k

Single use only. Do not reuse.

_

Quantity

r

Sterilized by ethylene oxide

J

Non-sterile

Protective Earth (Ground)

L

Radio frequency device. Interference may occur in the vicinity of the device.

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according
to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this
product.

China RoHS compliant. Environmental protection use period of 50 years.
Environmental protection use period of 5 years.

Tr eo n® Treatment Guidance System Manual v

Table of contents

Table of contents

1. Introduction

Description of the Treon® Treatment Guidance System 1-2
Content of This Manual 1-2
Related Documents 1-3
Conventions 1-3
Intended Use 1-4
Contraindications 1-4
Warnings and Cautions 1-5
Contact Information 1-7

2. System Overview

How the System Works 2-2

Optical System 2-2
System Carts 2-5
Input/Output Panel 2-8
Touchscreen Monitor 2-9
Keyboard and Mouse 2-10
Breakout Box 2-10

Optical Instruments 2-11
System Specifications 2-12
System Classifications 2-13
System Electromagnetic Emissions and Immunity Declarations 2-14
System Set Up 2-20

3. Inside the Cart

Component Locations 3-2
Opening the Viewing Cart 3-5
Opening the Nav Cart 3-6
Docking and Separating the Carts 3-6
Component Connections 3-7

System Computer 3-8

Device Connectivity Diagrams 3-9

vi Tr eo n® Treatment Guidance System Manual

Table of contents

Tr eo n® Treatment Guidance System Manual 1-1

1

Introduction 1

Description of the Treon® Treatment
Guidance System 1-2

Content of This Manual 1-2

Related Documents 1-3

Conventions 1-3

Intended Use 1-4

Contraindications 1-4

Warnings and Cautions 1-5

Contact Information 1-7

1-2 Tr e on® Treatment Guidance System Manual

Introduction

Description of the Treon® Treatment Guidance System

Description of the Treon® Treatment Guidance System

The Treon® Treatment Guidance System is a hardware platform that enables real-time
surgical navigation using radiological patient images. The application software
reformats patient-specific CT or MR images acquired before surgery and displays them
on-screen from a variety of perspectives (axial, sagittal, coronal, oblique). Prior to
operating, the surgeon may then create, store, and simulate progression along one or
more surgical trajectories. As an aid to visualization, the surgeon may also create and
manipulate one or more 3D models of the anatomy. During surgery, the system tracks
the position of specialized surgical instruments in or on the patient anatomy and
continuously updates the instrument position on these images.

If desired, the application software can also show how the actual position and path
during surgery relate to the pre-surgical plan, and can help guide the surgeon along
the planned trajectory. While the surgeon’s judgement remains the ultimate authority,
real-time positional information obtained through the Treon

®

Treatment Guidance

System can serve to validate this judgement as well as guide.

This system manual is intended as a reference document for biomedical engineers or
other qualified personnel who require familiarity with and details about the Treon

®

Treatment Guidance System. This manual is not a software usage manual. For
complete instructions on using a specific software application, refer to the specific
application’s instructions for use (pocket guide).

Content of This Manual

This system manual is intended as a reference document for users who require
familiarity with and details about the Treon

®

Treatment Guidance System. This manual
is not an application usage manual. For complete instructions on using a specific
software application, refer to the specific application pocket guide.

Tr eo n® Treatment Guidance System Manual 1-3

Introduction

Related Documents

Related Documents

Consult application-specific pocket guides for software application instructions.
Consult instrument -specific package inserts for instrument instructions. Consult the
Medtronic Navigation Equipment Cleaning and Sterilization sheet (pn 9730713) for
equipment and instrument cleaning and sterilization instructions.

Refer to manufacturer’s guides for information on peripheral devices.

Conventions

This document employs the following conventions:

w

■

Warnings are indicated by the symbol at left. Failure to observe a warning may
result in physical injury to the patient or operator. Pay special attention to these
items.

#

■

Cautions are indicated by the symbol at left. Failure to observe a caution could
result in damaged equipment, forfeited time or effort, or the need to abort use of
the system.

♦

■

Procedures are preceded by diamond symbol at left.

■

References to buttons that appear on the system display are enclosed in square
brackets. For example:

Click the

[Edit...] button.

■

References to menu options that appear on the system display are printed in bold
letters. For example:

Choose

Clear from the list.

■

Instructions to click an object on the screen means to tap the object on the
touchscreen with your finger or some other blunt object. Alternatively, it means to
place the pointer over the object using the system mouse, and depress and release
the left mouse button. Click, Select, and Highlight are used interchangeably.

■

Right-click means click with the right mouse button instead of the left button.

■

Double-click means click twice in rapid succession.

1-4 Tr e on® Treatment Guidance System Manual

Introduction

Intended Use

Intended Use

Your Medtronic computer-assisted surgery system and its associated applications are
intended as an aid for precisely locating anatomical structures in either open or
percutaneous procedures. Their use is indicated for any medical condition in which the
use of stereotactic surgery may be appropriate, and where reference to a rigid
anatomical structure, such as the skull, a long bone, or vertebra, can be identified
relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of
the anatomy.

Contraindications

Medical conditions which contraindicate the use of a Medtronic computer-assisted
surgery system and its associated applications include any medical conditions which
may contraindicate the medical procedure itself.

Tr eo n® Treatment Guidance System Manual 1-5

Introduction

Warnings and Precautions

Warnings and Precautions

w

Warnings :

■

The system and its associated applications should be used only by qualified
medical professionals who are thoroughly trained and experienced in performing
surgery with Medtronic computer-assisted surgery systems.

■

The system and its associated applications should be used only as an adjunct for
surgical guidance. They are not a replacement for the surgeon’s knowledge,
expertise, or judgement.

■

If system navigation seems inaccurate and recommended steps to restore accuracy
are not successful, abort use of the system.

■

Accessory equipment connected to the analog and digital interfaces of the
Medtronic computer-assisted surgery system must be certified according to the
respective IEC standards (e.g. IEC 60601-1 for medical equipment). Furthermore
all configurations shall comply with the system standard IEC 60601-1-1. Any
person who connects additional equipment to the signal input part or signal
output part configu res a medical system, and is therefore responsible for ensuring
that the system complies with the requirements of the system standard
IEC 60601-1-1. If in doubt, contact technical support or your local representative.

■

The system is not suitable for use in the presence of a flammable, anesthetic
mixture with air or oxygen or nitrous oxide. Position the system at least 25cm
from any source of flammable gas.

■

Some system components may contain batteries. Do not recharge or disassemble
batteries. Do not dispose of batteries in fire. Observe local regulations concerning
battery disposal.

■

Discard before use any pre-sterilized component whose sterile packaging appears
to be compromised.

■

There is currently no effective sterilization method for components that are
tainted with the infectious agent that causes Creutzfeld-Jakob Disease (CJD).
Therefore, you must discard immediately after surgery any components that
come into contact with biologic material from patients who carry or are suspected
to carry this infectious agent. As a precaution, drape all non-disposable
components that could otherwise come into contact with such material.

1-6 Tr e on® Treatment Guidance System Manual

Introduction

Warnings and Precautions

#

Precautions:

■

Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

■

The system and its associated applications contain no user-repairable parts. For
repair or replacement of any part of the system or application, contact a technical
support representative.

■

Verify that all relevant instrumentation has been properly cleaned and sterilized
before surgery. Clean and sterilize the components according to the parameters in
the Equipment Cleaning and Sterilization sheet (pn 9730713). Clean non­sterilizable equipment according to the parameters in the Non-Sterilizable
Equipment Cleaning sheet (pn 9733025).

■

The system has been successfully tested against the requirements of
IEC 60601-1-2. However, RF interference could hamper its operation or the
operation of other nearby electrical devices. If you suspect either of these
conditions, move the conflicting equipment farther apart, separate the equipment
with an RF barrier, or discontinue use of the system.

■

Do not exceed the recommended electrical ratings for the system. Exceeding the
ratings could damage the system.

■

The system mouse is not designed for sterilization, and may be damaged if
sterilization is attempted.

■

System components are fragile. Use care when handling system components.

■

Before moving the system cart(s), shut down all components, remove any loose
items from the top of the cart(s), and dock the carts together (if applicable). To
avoid contaminating the inside of the cart(s), clean the power cord(s) before
retracting.

■

Cart storage drawers have a maximum load capacity of ten pounds each.

Tr eo n® Treatment Guidance System Manual 1-7

Introduction

Contact Information

Contact Information

Telephone

[phone] (technical support)

[phone] (general)

[phone] (fax)

Regular Mail

Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville, CO, U.S.A.
80027

Medtronic E.C. Authorized Representative

Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
NETHERLANDS
Tel. [phone]

World Wide Web

www.medtronicnavigation.com

E-mail

E-mail product enhancement requests to: [e-mail]

1-8 Tr e on® Treatment Guidance System Manual

Introduction

Contact Information