user guide - schick by sirona · this user guide is one of two documents you will need to install...

CDRPan®

FOR PANORAMIC SYSTEMS

User Guide

Schick Technologies, Inc. 31-00 47th Avenue Long Island City, New York 11101 (718) 937-5765 (718) 937-5962 (FAX)

Part Number B1051008 Rev. B

Copyright 2004 by Schick Technologies, Inc. All Rights Reserved

November 11, 2004

!

Printed in the United States of America

This document was originally prepared in English

Many of the designations used by manufacturers and sellers to distinguish their products are claimed as trademarks. Where those designations appear in this document, and Schick Technologies, Inc. was aware of a trademark claim, the designations have been printed in caps or initial caps.

CDRPan User Guide B1051008 Rev. B i

Contents

1. Introduction................................................................................. 1 1.1. Welcome .................................................................................................................................1 1.2. CDRPan System......................................................................................................................1 1.3. Installing the CDRPan System................................................................................................1 1.4. Installing Software for the CDRPan System...........................................................................3 1.5. System Requirements..............................................................................................................3

2. Software Installation.................................................................. 4 2.1. Installing CDR DICOM Software...........................................................................................4 2.2. Installing CDRPan PCI Driver................................................................................................7

3. Operation...................................................................................14 3.1. Introduction...........................................................................................................................14 3.2. General Operating Instructions .............................................................................................14 3.3. Acquiring Panoramic Images................................................................................................15 3.4. Panoramic Acquisition Control Properties ...........................................................................16 3.5. Remote Module LED Indications .........................................................................................17

4. Cleaning and Maintenance.....................................................18 4.1. Sensor....................................................................................................................................18 4.2. Remote Module.....................................................................................................................18

Appendix A. Reference...............................................................19 A-1. Specification Table ...............................................................................................................19 A-2. Electrical Summary Table.....................................................................................................19 A-3. Image Characteristics............................................................................................................20 A-4. Timing Characteristics ..........................................................................................................20 A-5. EMC Tables ..........................................................................................................................20

B1051008 Rev. B CDRPan User Guide ii

Safety Issues

Electrical Concerns

CDRPan conforms to national (U.S.) and international standards for electromagnetic compatibility and electrical safety. A complete list of specifications can be found in Appendix A-1 of this document.

Mechanical Considerations

The Sensor package, the Remote Module, and the cables of the CDRPan system are mounted outside of the patient area to ensure patient safety and reliable equipment operation.

Radiation Concerns

No adjustments or alterations are made to the X-ray source of the panoramic equipment.

RF Interference Considerations

Although the CDRPan equipment is designed to provide a reasonable degree of protection from electromagnetic interference, according to IEC International regulations, it must be installed at an adequate distance from electricity transformer rooms, static continuity units, two-way amateur radios and cellular phones. To ensure proper operation, the latter can be used only at a minimum distance of 5 feet (1.5m) from any part of the equipment.

Any instrumentation or equipment for professional use located near CDRPan equipment must conform to Electromagnetic Compatibility regulations. Non-conforming equipment, with known poor immunity to electromagnetic fields, may not operate properly unless they are installed at a distance of at least 10 feet (3m) from CDRPan equipment and supplied by a dedicated electric line.

CDRPan User Guide B1051008 Rev. B 1

1. Introduction

1.1. Welcome

The CDR Panoramic X-ray System (�CDRPan�) is an electronic imaging system that integrates with panoramic machines to acquire, display, store and print digital X-rays. Because of its digital format, the X-ray can be enhanced for more detail using CDR tools, and it can be archived for patient histories and retrieved for comparisons.

1.2. CDRPan System

The CDRPan system consists of the following hardware:

• CDRPan Sensor, Codestrip, Remote Module, Power Supply, PCI Board, and other attaching parts and accessories.

The CDRPan system requires the following software:

• CDR DICOM software • CDRPan installation disk, which includes the CDRPan PCI board device

driver

1.3. Installing the CDRPan System

This User Guide is one of two documents you will need to install the CDRPan system completely. Before performing the procedures in this document, you should complete the steps in the Installation Guide for your panoramic machine. Table 1 provides a list of procedures and the document where they are covered in detail.

All of the procedures for installing CDRPan hardware may be found in your Installation Guide. This guide includes step-by-step instructions for installing the CDRPan hardware for your panoramic machine.

Table 2 provides a list of installation guides and their document numbers. Procedures for installing CDR DICOM and CDRPan driver can be found in this User Guide.

B1051008 Rev. B CDRPan User Guide 2

Table 1. List of Documents for Installing CDRPan

Procedure Document Install Sensor and Codestrip (Installation Guide) Install Remote Module and Power Supply (Installation Guide) Install PCI Board (Installation Guide) Install PCI Device Driver This Manual Install CDR and CDRPan driver This Manual

Table 2. List of Installation Guides

Panoramic Machine Installation Guide Part Numbers

Panoramic Corporation PC-1000 (B1051101) Planmeca PM 2002 CC/EC (B1051102) Siemens/Sirona Orthophos 3200 (B1051103) Instrumentarium OP-100 (B1051104) Villa Rotograph (B1051105) Siemens OP-10 (B1051106) Gendex GX-Pan (B1051107) Yoshida-Kaycor Panoura SU-10 (B1051108) GE Panelipse (B1051109) Belmont X-Caliber (B1051110) Gendex Orthoralix 9000 (B1051111) Soredex Cranex 2.5+ (B1051112)


1.4. Installing Software for the CDRPan System

After installing the hardware for the CDRPan system, perform the following procedures to install the software.

1. Install CDR DICOM software (Section 2.1 ) 2. Install PCI Device Driver (Section 2.2) 3. Start using your CDRPan System (Section 3)

1.5. System Requirements

The minimum system requirements for CDR workstations are:

• Compatible operating system (Windows 98 SE, 2000, or XP)

• 64 MB RAM

• Pentium-based processor

• 1 GB free disk space

The recommended system requirements for CDR workstations are:

• Compatible operating system (Windows 2000 or XP)

• 128 MB RAM or higher

• Pentium IV: 1 GHz or better

• Minimum of 20 GB free disk space 1

1 Storage requirements will vary depending on the patient volume for each practice.


2. Software Installation

We suggest that you install CDR DICOM software first. Follow the directions provided in Section 2.1 to install the software. Then, turn off your computer and install the CDRPan PCI board, following the steps we have supplied with the installation guide for your particular panoramic machine. (A list of installation guides is provided in Table 2.)

Once you�ve installed the PCI board, turn on your computer again, and follow the steps provided in Section 2.2 to install the driver for the PCI board.

2.1. Installing CDR DICOM Software

1. A. Insert the CDR DICOM CD. (For the following procedure, CDR DICOM 3.5 is used as an example.)

B. The setup wizard starts automatically and displays the Welcome screen.

C. Click Next.

2. A. At the Product License screen, complete all of the text boxes. The Product License key, attached to the CD sleeve, identifies either a Standalone or Client / Server installation.

B. Click Next.

C. A message box confirms a single-user installation. If correct, click Yes.


3. A. At the Choose Destination Location screen, select the folder location where the CDR DICOM files will be installed. (The default path is C:\ . . . Schick Technologies \ CDR DICOM for Windows.)

B. Click Next.

4. A. At the Image Folder screen, browse to the folder where image data will be stored. (A typical folder name might be C:\Images.)

B. Click Next.

5. A. At the Select Features screen, verify the checked items the setup program will install. These features are selected by default and unless there are other issues to be considered, we recommend installing all of them.

B. Click Next.


6. A. At the Start Copying Files screen, review the setup information.

B. Click Next.

7. A. Verify that the Medium setting is selected if you intend to use CDR Reports.

B. Click Next.

8. A. Installation complete.

B. Click Finish.


2.2. Installing CDRPan PCI Driver

NOTE – Please perform the appropriate procedure for your system after installing the CDRPan PCI board. Directions for installing this device may be found in your installation guide.

2.2.1. Installing CDRPan PCI Driver on Windows 98 Second Edition

1. A. After turning on the computer, you will receive a momentary message saying that Windows has detected new hardware.

B. Windows prompts you to install the driver for the CDR Panoramic device.

C. Click Next.

2. A. Click the �Display a list of all the drivers in a specific location, so you can select the driver you want� option.

B. Click Next.

3. Click Have Disk.


4. A. Insert the CD containing the CDRPan Panoramic Device Driver.

B. Click OK.

5. A. Browse the CD to locate the driver configuration file.

B. Verify the correct name of the driver configuration file: cdrpan9x.inf.

C. Click OK.

6. A. Confirm the path to the appropriate driver.

B. Click OK.

7. A. The CDR Panoramic Device Driver is listed.

B. Click Next.


8. A. Verify the location of the driver.

B. Click Next.

9. A. If you receive a message that Windows could not locate the driver, click Browse to select the cdrpan9x.vxd

B. Click OK.

10. A. Windows confirms that it has finished installing the CDR Panoramic Device Driver.

B. Click Finish.


2.2.2. Installing CDRPan PCI Driver on Windows 2000


B. The Found New Hardware Wizard welcome screen is displayed.

C. Insert the CD containing the CDR Panoramic Device Driver

D. Click Next.

2. A. Select the option to �Search for a suitable driver for my device (recommended).�

B. Click Next.

3. A. Verify that the CD-ROM drives option is selected.

B. Click Next.


4. A. Windows locates the CDR Panoramic Device Driver.

B. Click Next.

5. Click Yes.

6. A. Windows confirms that it has finished installing the CDR Panoramic Device Driver.

B. Remove the disk after Windows has copied the CDR Panoramic Driver to your system.

C. Click Finish.


2.2.3. Installing CDRPan PCI Driver on Windows XP


B. The Found New Hardware Wizard welcome screen is displayed.

C. Insert the disk containing the CDR Panoramic Device Driver.

D. Select the �Install the software automatically (Recommended)� option.

E. Click Next.

2. The Found New Hardware wizard searches for the appropriate driver.

3. A. Select the CDR Panoramic Device Driver for Windows 2000.

B. Click Next.


4. Click Continue Anyway.

5. Windows copies the driver to your system.

6. A. Remove the disk after Windows has copied the CDR Panoramic Driver to your system.

B. Click Finish.


3. Operation

3.1. Introduction

The CDRPan System is designed to fit seamlessly into the normal operation of panoramic equipment. CDRPan�s hardware components are simple to install and the software interface is easy to learn and use with all X-ray procedures. For operators this means quick setups with no significant changes to their routines for taking panoramic X-rays.

3.2. General Operating Instructions

Follow the steps listed below as a general guide when using CDRPan to acquire X-ray images. For setup and patient positioning information on specific panoramic machines, refer to that product documentation.

1. CDRPan Setup

• Ensure CDRPan PCI board and driver, CDR DICOM software, Sensor, and Codestrip are installed.

• Ensure the computer is on and the Remote Module is receiving power (Green LED on Remote Module is illuminated, as described in Section 3.5).

• Refer to Section 3.3 and perform Steps 1 through 3 to ensure CDR DICOM software is running normally and is ready to acquire X-ray images.

2. Panoramic Equipment Setup

• Turn on the panoramic equipment normally. • Select the appropriate X-ray exposure value. • Refer to Section 3.3 and perform Steps 4 through 7 to take the X-ray and review

the X-ray image on the computer. (When image data is being transferred from the Remote Module to the PC, the Yellow LED on the Remote Module will remain solid, as described in Section 3.5.)


3.3. Acquiring Panoramic Images

Perform the following steps to acquire panoramic X-ray images.

1. Turn on the computer and wait for the Windows desktop to display. Launch the CDR DICOM program from the Start button at the Windows desktop.

2. When the exam window appears, click File > New Exam or just click the New Exam button on the toolbar.

3. If there are already exams for the patient, click the List button to retrieve that information, or enter patient data in the spaces provided. Click on Panoramic Series and select a panoramic viewset.

4. (Manual mode) Take an X-ray image by clicking once on the target frame or by pressing either the Insert or Enter keys. Activate the X-ray source when the message �Waiting to take X-ray� appears.

5. (AutoTake mode) If you�ve turned on the AutoTake feature, the target frame will be flashing green (default setting) when the system is ready. Activate the X-ray source. The message �Reading image from Sensor� is displayed momentarily.

6. The image appears inside the zoom window for review, editing, and printing. For a complete discussion of features available in the zoom window, refer to the CDR DICOM User Guide, which is available on our website.

7. When the image is accepted, the exam window appears with the image displayed inside the target frame.


3.4. Panoramic Acquisition Control Properties

Please Note: Casual changes to the Acquisition Modules section can adversely affect the performance of the CDR system. We do not recommend making changes in this section unless directed to do so by authorized support personnel.

• Panoramic Device Driver Name (Displays the name of the device driver for the panoramic system)

• Scan Direction (Drop-down menu displays list of travel options for the panoramic machine)

• Image Width (Numeric value for the number of rows in the panoramic image. Also called LX)

• Image Height (Numeric value indicates the number of columns in the panoramic image. Also called LY)

• Initial Timeout (Numeric value indicates the amount of time CDR will wait for the panoramic machine to start motion when CDR is in acquisition mode.)

• Early Stop Timeout (Numeric value indicates the maximum number of seconds CDR can take to read a column of pixels before it times out.)

• Calibrate Image (When checked, indicates that CDR loads the calibration file for the connected panoramic Sensor.)

• Equalize Image (When checked, indicates that Equalize is applied automatically each time a panoramic image is acquired.)

• Apply Spot Remover (When checked, indicates that Spot Remover is applied automatically each time a panoramic image is acquired.)

• Subtract Dark Image (When checked, indicates that CDR applies subtraction to eliminate the noise caused by dark signal in the Sensor)

• Acquire 12 bit image (When checked, indicates that the image is acquired at a higher 12-bit depth)

• Perform non-linear map (When checked, indicates that non-linear mapping is used during calibration)


3.5. Remote Module LED Indications

INDICATORS

OFF ON STATUS

GREEN ON YELLOW OFF

Remote module is receiving power.

GREEN ON YELLOW ON

System is ready to take X-ray.

Both LEDs remain on while image data is being sent from the Remote Module to the PC.

Yellow LED turns off when panoramic machine has completed its cycle (or CDR has timed out).

Green Yellow

Green Yellow


4. Cleaning and Maintenance

4.1. Sensor

The CDRPan Sensors cannot be autoclaved. To clean and disinfect the Sensor, use a clean lint-free cloth and a small amount of alcohol or similar sterile solution. Do not soak the Sensor and be sure to dry it completely before usage. If the Sensor is not in use and has been disconnected from the Remote Module, be sure to store it in a safe place and avoid exposing it to extreme temperatures. Do not apply excessive pressure to the Sensor and be careful to avoid damaging or nicking the Sensor cable when handling it.

4.2. Remote Module

To clean and disinfect the Remote Module, use a clean lint-free cloth and a small amount of alcohol. Although the Remote Module is enclosed to protect its components, it is not watertight, so be sure to use only enough solution to clean the unit safely.


Appendix A. Reference

A-1. Specification Table

Mechanical

Size 6.75 x 4.8 x 0.875 in (17.15 x 12.19 x 2.22 cm) CDRPan Remote Module

Weight 1.2 lb (0.54 kg)

Size 6.4 x 3.5 x 0.3 in (16.26 x 8.89 x 0.762 cm) CDRPan Drum Type Sensor Package


Size 14 x 7 x 1 in (35.56 x 17.78 x 2.54 cm) CDRPan Cassette Type Sensor Package


Electrical

CAN/CSA C22.2 No.601.1-M90

Medical Electrical Equipment Part 1: General Requirements for Safety

IEC60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety

IEC60601-1-2 Medical Electrical Equipment Part 1: General Requirements for Safety 2.Collateral Standard: Electromagnetic Compatibility � Requirements and Tests

Safety and EMC Standards Compliance

UL60601-1 Medical Electrical Equipment: General Requirements for Safety

Maximum Line Current And Voltage 125 VAC, at 300 mA 250 VAC, at 150 mA

Environmental

Operating Temperature 70° - 85° F (21°- 29° C)

Storage Temperature 41° - 113° F (5° - 45° C)

Humidity 20% to 80%

Highest Permissible Temperature Limit 150° F (65.5° C)

General

Image Sensor Active Area 6.05 x 0.38 in (15.36 x 9.6 cm)

Calibration Automatic

Scan Time 10 � 20 seconds (dependent on host machine)

A-2. Electrical Summary Table

System and Component Information

Input electrical ratings 115 VAC systems: 115 VAC, 300 mA, 50/60 Hz 230 VAC systems: 230 VAC, 150 mA, 50/60 Hz


Equipment type Type B equipment (on system power supply).

Fuses 250 VAC, 400 mA SLO BLO 250 VAC, 2A, 130° C thermal (No User Replaceable Fuses)

Restricted service statement Unless otherwise specified, this unit should be serviced only by the manufacturer. It contains no user-serviceable parts.

A-3. Image Characteristics

Images acquired by the CDRPan System meet the following criteria.

Color depth 8 bits per pixel (256 gray levels)

Effective pixel size 96 microns

Static resolution 5 line pairs per millimeter

Signal to noise ratio 80:1

A-4. Timing Characteristics

The CCDs in the Sensor package employ TDI (Time Delay Integration) to generate a single image of the subject as it travels past the Sensor package. For the resulting exposure to be clear (not �smeared� or �blurred�), the image readout at the CCD level and the panoramic machine�s motion must be exactly synchronized by CDRPan. Other timing intervals supported by the software are listed below.

Timeout after loss of synchronization 7 seconds (or user-defined interval specified by the Early Stop Timeout setting in Panoramic Acquisition Control Properties)

Timeout when starting acquisition 15 seconds (or user-defined interval specified by the Initial Timeout setting in Panoramic Acquisition Control Properties)

Time to display image after acquisition 30 seconds

Time to display archived image 10 seconds

A-5. EMC Tables

Table 3. Guidance and Manufacturer's Declaration - Electromagnetic Emissions

PLEASE NOTE: The CDRPan system is intended for use in the electromagnetic environment specified below. The user of the CDRPan system must ensure that it is used in such an environment.

Emissions Test Compliance Guidance

RF emissions CISPR 11

Group 1 The CDRPan system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.


RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

The CDRPan system is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes.

Table 4. Guidance and Manufacturer's Declaration - Electromagnetic Immunity

PLEASE NOTE: The CDRPan system is intended for use in the electromagnetic environment specified below. The user of the CDRPan system must ensure that it is used in such an environment.

Immunity Test IEC 60601 Test Level

Compliance Level Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 610004-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV for power supply lines

±1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV differential mode

± 2kV common mode

± 1 kV differential mode

± 2kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5% UT

(>95% dip in UT)

for 0.5 cycle < 40% UT

(>60% dip in UT)

for 5 cycles < 70% UT

(>30% dip in UT)


(>95% dip in UT)

for 5 sec

< 5% UT

(>95% dip in UT)

for 0.5 cycle < 40% UT

(>60% dip in UT)


(>30% dip in UT)


(>95% dip in UT)

for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the CDRPan system requires continued operation during mains interruptions, it is recommended that the CDRPan system be powered from an uninterruptible power supply or battery. NOTE: UT is the AC mains voltage prior to application of the test level.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3A/m 3A/m


Immunity Test IEC 60601 Test Level

Compliance Level Guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms Portable and mobile RF communication equipment should be used no closer to any part of the CDRPan system, including its cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

d= 1.2 √ P Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m d= 1.2 √ P for 80 MHz to 800Mhz

d= 2.3 √ P for 800 MHz to 2.5Ghz Where P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range. b

Interference may occur in the vicinity of equipment marked with the following symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CDRPan system is used exceeds the applicable RF compliance above, the CDRPan system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CDRPan system. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m


Table 5. Recommended Separation Distance between Portable and Mobile RF Communications Equipment and the CDRPan System

PLEASE NOTE: The CDRPan system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the CDRPan system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of the transmitter

(W) Separation distance according to the frequency of the

transmitter (m)

150 kHz to 800 MHz d=1.17x√P

800 MHz to 2.5 GHz

d= 2.3 x √P 0.01 0.12 0.23

0.1 0.37 0.73

1 1.17 2.30

10 3.69 7.27 100 11.7 23.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.