CS 9000 and CS 9000 3D User Guide Rev 01 March 2012

Notice Congratulations on your purchase of the CS 9000 and CS 9000 3D. Thank you for your confidence in our products and we will do all in our power to ensure your complete satisfaction. The CS 9000 and CS 9000 3D User Guide includes information both on the Panoramic features as well as the 3D features. If you have purchased CS 9000, information relevant to 3D does not apply to your radiological system. We recommend that you thoroughly familiarize yourself with this guide to make the most effective use of your system. CS 9000 and CS 9000 3D are intended to produce panoramic X-ray imaging at the direction of health care professionals of the dento-maxillofacial area. In addition, the 3D systems include a dental volumetric reconstruction mode that is intended to produce 3-dimensional X-ray images of the dento-maxillofacial region. WARNING: We recommend that you consult the “Safety, Regulatory and the Technical Specification User Guide” before using CS 9000 or CS 9000 3D.

The information contained in this guide may be subject to modification without notice, justification or notification to the persons concerned. No part of this guide may be reproduced without the express permission of Carestream Health, Inc. The US Federal law restricts this device to sale by or on the order of a physician. This document is originally written in English. Manual Name: CS 9000 and CS 9000 3D User Guide Part Number: SM764 Revision Number: 01 Print Date: 2012-03 CS 9000 and CS 9000 3D comply with Directive 93/42/EEC relating to medical equipment.

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Manufacturer Care stream Hea lth, Inc. 150 Verona Street Roche ster, NY 1 4 60 8, USA

Authorized Representative in the European Community

EC REP TROPHY 4, Rue F. Pelloutier, Croissy-Beaubourg 77435 Marne la Vallée Cedex 2, France

Contents 1-About This Guide Conventions in this Guide... 1–1 2-CS 9000 AND CS 9000 3D UNIT OVERVIEW General Overview... 2–1 Mobile Components... 2–2 General Functional Components... 2–3 Digital Sensor Locations... 2–4 Laser Locations... 2–5 Unit Control Panel... 2–6 X-Ray Remote Control Overview... 2–7 Positioning Accessories and Replacement Parts... 2–8 Panoramic Positioning Accessories... 2–8 3D Positioning Accessories... 2–9 Patient Positioning Indicators... 2–10 3-IMAGING SOFTWARE OVERVIEW Minimum Computer System Requirements... 3–1 General Software Overview... 3–1 Imaging Software... 3–1 Acquisition Interface... 3–1 Acquisition Interface... 3–2 Panoramic Acquisition Interface Overview... 3–2 Panoramic Program Pane... 3–4 Panoramic Patient Pane... 3–5 Panoramic Parameters Pane... 3–6 3D Acquisition Interface Overview... 3–7 3D Program Pane... 3–9 3D Patient Pane... 3–10 3D Parameters Pane... 3–11 4-GETTING STARTED Switching on the Unit... 4–1 Accessing the Acquisition Windows... 4–2 5-ACQUIRING IMAGES Acquiring a Panoramic, TMJ x2 or Sinus Image for Adult and Pediatric Patients... 5–1 Preparing the Unit and Setting the Acquisition Parameters... 5–1 Preparing and Positioning the Adult and Pediatric Patient... 5–2 Launching the X-ray... 5–5 Acquiring a TMJ x4 Image for Adult and Pediatric Patients... 5–6 Acquiring a 3D Single-Volume Image for Adult and Pediatric Patients... 5–7 Preparing the Unit and Setting the Acquisition Parameters... 5–7

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iii

Contents

Manually Pre-Setting the Single-Volume Position for Adult and Pediatric Patients... 5–9 Preparing and Positioning Adult and Pediatric Patients... 5–10 Launching the X-ray... 5–12 Acquiring a 3D Multi-Volume Image (Stitching) for Adult and Pediatric Patients... 5–13 Preparing the Unit and Setting the Acquisition Parameters... 5–13 Preparing and Positioning Adult and Pediatric Patients... 5–15 Launching the X-ray... 5–17 X-Ray Dose Emission Information... 5–19 6-TROUBLESHOOTING Quick Troubleshooting... 6–1 7-MAINTENANCE Daily... 7–1 Cleaning the CS 9000 or CS 9000 3D Unit... 7–1 Cleaning and Disinfecting the Accessories... 7–2 Cleaning and disinfecting the accessories that have contact with mucous membranes... 7–2 Cleaning and disinfecting the components and accessories that have skin contact... 7–3 Monthly... 7–3 Annually... 7–3 Controlling the Image Quality... 7–4

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Chapter 1

About This Guide Conventions in this Guide The following special messages emphasize information or indicate potential risk to personnel or equipment:

WARNING Warns you to avoid injury to yourself or others by following the safety instructions precisely. CAUTION Alerts you to a condition that might cause serious damage.

IMPORTANT Alerts you to a condition that might cause problems.

NOTE Emphasizes important information.

TIP Provides extra information and hints.

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1–1

Conventions in this Guide

1–2

About This Guide

Chapter 2

CS 9000 AND CS 9000 3D UNIT OVERVIEW The CS 9000 and CS 9000 3D units are designed to carry out the following radiological examinations: • • • •

Panoramic Maxillary Sinus Temporomandibular Joints (TMJ) 3D images

General Overview The CS 9000 unit is composed of the following functional components: • • • • • • • • • • •

Unit Head That Contains All The Electronic Control Rotative arm Fixed arm with a control panel Panoramic digital sensor X-ray source assembly X-ray remote control Chin rest base Panoramic chin rest and bite block Temple supports Hand grips Acquisition interface

The CS 9000 3D unit is composed of the following functional components: • • • • • • • • • • • • •

Unit head that contains all the electronic control Rotative arm Fixed arm with a control panel Panoramic digital sensor 3D digital sensor X-ray source assembly X-ray remote control Chin rest base Panoramic chin rest and bite block 3D chin rest and bite block Temple supports Hand grips Acquisition interface

The following figures illustrate the general overview of the CS 9000 and CS 9000 3D units. CS 9000 and CS 9000 3D User Guide (SM764)_Ed 01

2–1

General Overview

Mobile Components Figure 2-1 illustrates the up and down movement of the CS 9000 and CS 9000 3D mobile component and the 180° rotation of the rotative arm. Figure 2–1

2–2

CS 9000 and CS 9000 3D Unit Mobile Components

CS 9000 AND CS 9000 3D UNIT OVERVIEW

General Overview

General Functional Components Figure 2-2 illustrates the general functional components of the CS 9000 and CS 9000 3D units. Figure 2–2

CS 9000 and CS 9000 3D Unit Functional Components

5b

5 10

1

9 2 7

6 8

11 5a 5 3 4

1

ON/OFF button

6

Temple supports

2

Unit fixed arm

7

Sensor

3

Control panel

8

X-ray source assembly

4

Hand Grips

9

Unit rotative arm

5

Chin rest base

10

X-ray remote control

5a

Panoramic chin rest

11

Computer hosting the imaging and the acquisition software

5b

3D chin rest and bite block

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2–3

General Overview

Digital Sensor Locations Figure 2-3 illustrates the locations of the panoramic and the 3D digital sensor of CS 9000 and CS 9000 3D. IMPORTANT * When the unit is ONLY panoramic, the 3D option is not available. Therefore, the location of the digital sensor indicates that it is ready for the 3D option. Figure 2–3

CS 9000 and CS 9000 3D Unit Panoramic and 3D Digital Sensor Locations

Digital 3D

*

2–4

CS 9000 AND CS 9000 3D UNIT OVERVIEW

General Overview

Laser Locations Figure 2-4 illustrates the location of the CS 9000 and CS 9000 3D lasers. Figure 2–4

CS 9000 and CS 9000 3D Unit Laser Beam Positions

A

3

2

4 1

2 3 4 B

A B

1

1

2

1

3D central positioning laser beam

2

Mid-sagittal positioning laser beam

3

Horizontal positioning laser beam

4

3D Field of View (FoV) positioning laser beam

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2–5

Unit Control Panel

Unit Control Panel The unit control panel is an alphanumeric, digital soft touch console. It allows the operator to control certain unit functions. It also displays the operating parameters and error messages. Figure 2–5

Unit Control Panel 8

kV

mA

1

2

3

S

mem

9

2–6

10

11

4

5

6

7

1

Height Adjustment button: Adjusts the height of the unit to the height of the patient.

2

3D Head Adjustment button: Adjusts the patient head to the X-ray beams.

3

3D Adjustment button: Adjusts the unit rotative arm movements to correctly position the patient for 3D acquisition.

4

Laser Beam button: Activates the beams to correctly position the patient.

5

3D Position Verification button: Positions the unit rotative arm at the selected or memorized 3D position.

6

Reset button: Resets the unit rotative arm to the initial position to enable the patient to enter and exit the unit.

7

3D Memorization button: Memorizes the 3D current positioning parameter settings that override the default parameters.

8

Display Screen: Displays the current acquisition parameters and the error messages.

9

Ready Indicator LED: Green, indicates the unit is ready for acquisition.

10

X-Ray Emission LED: Yellow, indicates the X-rays are being emitted.

11

System Status LED: Red, indicates the error alerts.

CS 9000 AND CS 9000 3D UNIT OVERVIEW

X-Ray Remote Control Overview

X-Ray Remote Control Overview The X-ray remote control enables you to launch a radiological image acquisition via the exposure button from outside the X-ray room. You must press and hold the exposure button until the end of acquisition. Premature release of the exposure button interrupts the acquisition. Figure 2–6

X-Ray Remote Control

1

1

Exposure button: launches image acquisition.

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Positioning Accessories and Replacement Parts

Positioning Accessories and Replacement Parts The following accessories are used when positioning a patient. They are delivered with the CS 9000 and CS 9000 3D digital imaging unit.

Panoramic Positioning Accessories Table 2–1

Panoramic Positioning Accessories and Replacement Parts Accessory

Description • • •

Panoramic chin rest TMJ x2 Sinus TMJ x4 nose rest

Panoramic standard bite block

Bite block for edentulous patients

Single use sheaths for bite blocks (500 pcs box)

2–8

CS 9000 AND CS 9000 3D UNIT OVERVIEW

Positioning Accessories and Replacement Parts

3D Positioning Accessories Table 2–2

3D Positioning Accessories and Replacement Parts Accessory

Description

3D bite block

3D bite block support

3D head rest and head strap

Single use hygienic sheaths for 3D bite block (100 pcs box)

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Positioning Accessories and Replacement Parts

Patient Positioning Indicators Table 2–3

Patient Positioning Indicators represented on the chin rest base Positioning Indicators

Description

For sinus positioning

• •

For TMJ x2 and TMJ x4 positioning For panoramic positioning

For 3D upper jaw positioning

For 3D lower jaw positioning

2–10

CS 9000 AND CS 9000 3D UNIT OVERVIEW

Chapter 3

IMAGING SOFTWARE OVERVIEW Minimum Computer System Requirements For the minimum computer system requirements and configuration for the Imaging Software, see the CS 9000 Family Safety, Regulatory and Technical Specifications User Guide. IMPORTANT It is MANDATORY to check that the computer system configuration is compatible with the minimum computer system requirements for the CS 9000 and CS 9000 3D software. If necessary you MUST update your computer system configuration. CS 9000 and CS 9000 3D MUST be connected to the computer via a point-to-point ethernet link NOT via a LAN.

General Software Overview CS 9000 and CS 9000 3D operate with the following software: • •

Imaging Software Acquisition interface

Imaging Software The imaging software is a user-friendly working interface that is designed and developed specifically for radiological diagnosis. It is the common imaging platform for all our digital systems. The imaging software has the following features: • • •

Patient management Extraoral and intraoral image management 3D image management

Acquisition Interface The Acquisition interface is a user-friendly working interface that was designed and developed specifically for CS 9000 and CS 9000 3D. The Acquisition interface has the following features: • •

Panoramic acquisition interface using Panoramic Acquisition interface 3D acquisition interface using 3D Acquisition interface

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3–1

Acquisition Interface

Acquisition Interface Panoramic Acquisition Interface Overview The Panoramic Acquisition interface is the main panoramic interface with CS 9000 and CS 9000 3D and provides you with imaging acquisition functions. Figure 3–1

1

Panoramic Acquisition Interface

Information button: About: Identifies the software and the firmware versions • Reset of the Values: Resets to the manufacturing parameter settings • Memorize settings: Memorizes the user preference settings for each patient type (kV, mA and seconds) •

3–2

2

Preview Screen: Displays the acquired image in real time.

3

Selected Parameter Display: Displays the current acquisition parameter settings.

4

System Status Screen: Displays various alert or warning messages originating from the unit.

5

X-Rays ON/OFF button: Turns off the X-ray emissions to demonstrate the acquisition process for the patient.

6

Generator Cooling indicator: Indicates the automatic cooling time (mm:ss) required for the generator to reach 0 for a new acquisition.

7

Stop button: Stops the unit rotative arm movement.

8

Ready Indicator LED: • Green indicates the unit is ready to start acquisition. • Black indicates the unit is not ready to start acquisition.

9

Exit button: Closes the Acquisition window.

10

X-Ray Emission indicator: Yellow indicates the X-ray emission status.

IMAGING SOFTWARE OVERVIEW

Acquisition Interface

11

Selector Button: Selects different acquisition setting options. Click: • Program to select examination type options. • Patient to select patient type parameters. • Parameters to select exposure parameter options.

The Selector button enables you to access the following 3 panes: • • •

Program pane: Examination type options Patient pane: Patient type parameter options Parameters pane: Exposure parameter options

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Acquisition Interface

Panoramic Program Pane The Panoramic Program pane enables you to choose different radiological exams. The diagram in the Panoramic Program pane represents a jaw, with the right side of the diagram corresponding to the right side of the patient. Click on a section of the jaw to select an anatomical zone for radiological examination. The selected segment is highlighted. Figure 3–2

1

Panoramic Program Pane

Radiological exam options. Click: for a Maxillary Sinus exam. for an anterior exam.

2

for a Panoramic exam. TMJ exam options. Select: for a TMJ x2. for a TMJ x4 exam and click NOTE The above list of exam types are only a sample of exam options of the Program pane.

3–4

IMAGING SOFTWARE OVERVIEW