CS 8100 and CS 8100 Access User Guide Rev 01 March 2012

Notice Congratulations on your purchase of the CS 8100 and CS 8100 Access. Thank you for your confidence in our products and we will do all in our power to ensure your complete satisfaction. The User Guide for the CS 8100 and CS 8100 Access provides information on complete or segmented tomographic digital panoramic X-ray image features. We recommend that you thoroughly familiarize yourself with this Guide in order to make the most effective use of your system. WARNING: We recommend that you consult the “Safety, Regulatory and the Technical Specification User Guide” before using the CS 8100 and CS 8100 Access.

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 8100 and CS 8100 Access User Guide Part Number: SM784 Revision Number: 01 Print Date: 2012-03 The CS 8100 and CS 8100 Access complies with Directive 93/42/EEC relating to medical equipment. .

0086

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

Chapter 1

Conventions in this Guide... 1

Conventions in This Guide Chapter 2

Mobile Components... 3

CS 8100 Overview

General Functional Components... 4 Head and Chin Rest... 5 Positioning Accessories... 6 Positioning Panel... 7 X-Ray Remote Control Overview... 8

Chapter 3

Computer System Requirements... 9

Imaging Software

General Software Overview... 9

Overview

Imaging Software... 9 Acquisition Interface... 9 Acquisition Interface... 10 Acquisition Interface Overview... 10 Program Pane... 12 Patient Pane... 13 Parameter Pane... 14

Chapter 4

Switching on the Unit... 15

Getting Started Chapter 5

Acquiring a Panoramic, a TMJ x2, or a Sinus Image for the

Acquiring Images

Adult and Pediatric Patient... 17 Accessing the Acquisition Interface... 17 Preparing the Unit and Setting the Acquisition Parameters... 17 Preparing and Positioning the Adult and Pediatric Patient... 20 Launching the X-ray... 23 Acquiring a 2D+ Image for the Adult and Pediatric Patient... 24 Accessing the Acquisition Interface... 24 Preparing the Unit and Setting the Acquisition Parameters... 24

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Preparing and Positioning the Adult and Pediatric Patient... 27 Launching the X-ray... 30 Acquiring a TMJ x4 Image for the Adult and Pediatric Patient... 31 Accessing the Acquisition Interface... 31 Preparing the Unit and Setting the Acquisition Parameters... 31 Preparing and Positioning the Adult and Pediatric Patient... 32 Launching the X-ray... 34 X-Ray Dose Emission Information... 36 Chapter 6 Maintenance

Daily... 37 Cleaning the unit... 37 Cleaning and disinfecting the Accessories... 37 Cleaning and disinfecting the accessories that have contact with the mucous membranes. . . 37 Cleaning and disinfecting the component and accessories that have skin contact... 38 Monthly... 38 Annually... 38 Controlling the Image Quality... 39

Chapter 7 Troubleshooting

iv

Quick Troubleshooting... 41

1

Conventions in 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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2

CS 8100 Overview

The CS 8100 Family includes: 

CS 8100: complete modality CS 8100 Access: modality without the 2D+ feature This document refers to both models as CS 8100 unless otherwise specified. 

The following figures illustrate the general overview of the CS 8100.

Mobile Components Figure 1 illustrates the up and down movement of the unit mobile component and the rotation of the rotative arm. Important: The patient can enter through either the left side or the right side of the unit.

Figure 1 Unit Mobile Components

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General Functional Components Figure 2 illustrates the general functional components of the unit.

Figure 2 Unit Functional Components

1 8 2

3 7

4 9

6 5

10

1

ON/OFF button

8

Unit head

2

Emergency stop knob

9

X-ray remote control

3

Unit rotative arm

10

PC hosting the imaging and the acquisition software

4

X-ray source assembly

5

Unit column

6

Head and chin rest

7

Digital sensor

4

Head and Chin Rest Figure 3 illustrates the functional components of the head and chin rest. Figure 3 Head and Chin Rest Functional Components

1 2 3 4 5 6

1

Positioning Panel

2

Frontal head rest adjustment knob

3

Head rest

4

Bite block

5

Chin rest

6

Hand grips

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Positioning Accessories The following accessories are used when positioning a patient. They are delivered with the CS 8100. Table 1 lists the positioning accessories.

Table 1

Positioning Accessories Accessory

Description

Panoramic chin rest

Sinus chin rest

TMJ nose rest

Standard bite block (x5)

Bite block for edentulous patients (x2)

Single use sheaths for bite block

6

Positioning Panel The positioning panel is a console on the head and chin rest that enables you to correctly position and align a patient before you acquire an image.

Figure 4 Unit Positioning Panel

1

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

2

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

3

Frontal head rest adjustment knob: Positions the up or down inclination of the patient head by turning the knob.

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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 5 X-Ray Remote Control

1

8

Exposure button: launches image acquisition.

3

Imaging Software Overview

Computer System Requirements For the minimum computer system requirements and configuration for the Imaging Software, see the CS 8100 and CS 8100 Access Safety, Regulatory and Technical Specifications User Guide.

IMPORTANT It is MANDATORY to check that the computer system configuration is compatible with the computer system requirements for the CS 8100 software. If necessary you MUST update your computer system configuration. The unit MUST be connected to the computer via a point-to-point Ethernet link and not via a LAN.

General Software Overview The CS 8100 operates with the following software:  

Imaging software Acquisition interface

Imaging Software The imaging software is a user-friendly working interface that was designed and developed specifically to support image diagnosis.

Acquisition Interface The Acquisition interface is a user-friendly interface that was designed and developed specifically for the CS 8100.

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Acquisition Interface Acquisition Interface Overview The Acquisition interface is the main interface of the CS 8100 that provides you with imaging acquisition functions. Figure 6 Acquisition Interface

10

1

Information button:  Show versions ...: Identifies Software and Firmware versions.  Resetting Anatomy setting: Resets to the manufacturing parameter settings.  Memorize Anatomy setting: Memorizes the user preference settings for each patient type (kV, mA and seconds).

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

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

6

Reset button: Resets the unit to the starting position to enable you to position a patient in the unit.

7

Parallel position button: Leaves more free space around the unit when it is not in use by placing the rotative arm in a parallel position to the unit head.

8

X-ray On/Off button: Enables or disables X-ray emission.

9

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

10

Exit button: Closes the Acquisition interface.

11

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

12

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

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Program Pane

The Program pane enables you to choose different radiological exams. The diagram in the Program pane represents a jaw, with the R side of the diagram corresponding to the right side of the patient. Figure 7 Program Pane

Radiological exam options: Segmented panoramic acquisition: Click on the following areas of interest that you want to examine:  

Posterior Anterior

The selected area of interest will highlight. Example (anterior exam): Maxillary Sinus acquisition:

Click

.

TMJ acquisition:

Click

for a TMJ x2 acquisition.

Click

and click

for a TMJ x4 acquisition.

Full panoramic acquisition:

Click on all the areas of interest. Example: 2D+ acquisition:

Click to examine a selected area of interest in 2D+ slices that can be moved in the buccal/lingual direction across a jaw.

NOTE The 2D+ feature is available for CS 8100. It is not available for CS 8100 Access.

12

Patient Pane

The Patient pane enables you to choose different patient parameters. The selection of the patient parameters influences the quality of the image. The selected parameters must be based on the age and morphology of the patient . Figure 8 Patient Pane

1

Patient type parameters: Pediatric mode:

Click

if the patient is a child.

Adult mode:

2

Click

if the patient is small.

Click

if the patient is medium.

Click

if the patient is large.

Patient dental arch morphology:

Click

for a normal shape dental arch.

Click

for a square dental arch.

Click

for a sharp dental arch.

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Parameter Pane

The Parameter Pane enables you to choose exposure parameters for the radiological image acquisition. If the default parameter setting is not adapted to your patient type, you can manually adapt the parameter setting to the patient type and save this setting as the default setting.

To save a parameter setting, click

and select Memorize Anatomy setting.

Figure 9 Parameter Pane

1

Exposure setting options: kilovolt milliampere

2

Fine-tuning buttons:

Click

14

or

to fine-tune the kV and the mA.

4

Getting Started

Switching on the Unit Before switching on the unit, check that:  

The installation of the unit is complete. The computer is switched on.

Important: You must switch on the computer and wait for it to be ready for the connection before switching on the unit.

To switch on the unit, follow these steps: 1. On the unit column, press the ON button. 2. You must wait for a minute for the connection between the unit and the computer to be established. If you start the imaging software before the connection is established an error message is displayed. Click OK, close the imaging software and wait for the connection to be established. 3. You can now proceed to start the imaging software.

Important: To increase the operating life of the X-ray tube, if the unit has not been used for a month, you must follow the following procedures before use.

1. In the Panoramic Acquisition Window, select the Parameter pane. 2. Select the following series of parameter settings:   

70 kV - 6.3 mA 80 kV - 10 mA 85 kV - 10 mA

3. Leave the X-ray room and close the door. For each parameter setting, from the X-ray remote control, press and hold the button to launch the X-ray The unit is now ready to be used for acquisition.

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5

Acquiring Images

Acquiring a Panoramic, a TMJ x2, or a Sinus Image for the Adult and Pediatric Patient Accessing the Acquisition Interface To access the acquisition interface, follow these steps: 1

Select the patient record. See the User Guide for your patient management software.

2

On your desktop, double-click

or

. The Imaging Window is displayed.

3

In the Imaging Window, from the toolbar, click interface.

or

to access the Acquisition

Preparing the Unit and Setting the Acquisition Parameters To set the acquisition parameters, follow these steps: 1

In the Acquisition interface, click the Program button to access the Program pane.

.

Click on one area of interest that you want to examine:



Panoramic: for example,



TMJ x2:



Sinus:

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2

Click the Patient button to access the Patient pane.

Select the patient: 



3

18

Type (1):  Child  Adult: Small, Medium, Large Dental arch morphology (2)

(Optional) If the default parameter setting is not adapted to your patient type, click the Parameter button:



Select the appropriate parameters.



Click and select Memorize Anatomy setting to save the new parameter settings as the default settings.