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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

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.

November 11, 2004

!

Printed in the United States of America

This document was originally prepared in English

Contents

1. Introduction................................................................................. 1

1.1. 1.2. 1.3. 1.4. 1.5. Welcome .................................................................................................................................1 CDRPan System......................................................................................................................1 Installing the CDRPan System................................................................................................1 Installing Software for the CDRPan System...........................................................................3 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. 3.2. 3.3. 3.4. 3.5. Introduction...........................................................................................................................14 General Operating Instructions .............................................................................................14 Acquiring Panoramic Images................................................................................................15 Panoramic Acquisition Control Properties ...........................................................................16 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. A-2. A-3. A-4. A-5. Specification Table ...............................................................................................................19 Electrical Summary Table.....................................................................................................19 Image Characteristics............................................................................................................20 Timing Characteristics ..........................................................................................................20 EMC Tables ..........................................................................................................................20

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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.

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

The CDRPan system requires the following software: · ·

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.

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Table 1. List of Documents for Installing CDRPan

Procedure Install Sensor and Codestrip Install Remote Module and Power Supply Install PCI Board Install PCI Device Driver Install CDR and CDRPan driver

Document (Installation Guide) (Installation Guide) (Installation Guide) This Manual This Manual

Table 2. List of Installation Guides

Panoramic Machine Panoramic Corporation PC-1000 Planmeca PM 2002 CC/EC Siemens/Sirona Orthophos 3200 Instrumentarium OP-100 Villa Rotograph Siemens OP-10 Gendex GX-Pan Yoshida-Kaycor Panoura SU-10 GE Panelipse Belmont X-Caliber Gendex Orthoralix 9000 Soredex Cranex 2.5+

Installation Guide Part Numbers (B1051101) (B1051102) (B1051103) (B1051104) (B1051105) (B1051106) (B1051107) (B1051108) (B1051109) (B1051110) (B1051111) (B1051112)

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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. 2. 3. Install CDR DICOM software (Section 2.1 ) Install PCI Device Driver (Section 2.2) 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.

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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 singleuser installation. If correct, click Yes.

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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.

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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.

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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.

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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.

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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.

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2.2.2. Installing CDRPan PCI Driver on Windows 2000 1. A. After turning on the computer, you will receive a momentary message saying that Windows has detected new hardware. 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.

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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.

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2.2.3. Installing CDRPan PCI Driver on Windows XP 1. A. After turning on the computer, you will receive a momentary message saying that Windows has detected new hardware. 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.

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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.

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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.)

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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.

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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)

· · · · · · ·

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3.5. Remote Module LED Indications

INDICATORS STATUS

OFF ON

GREEN ON YELLOW OFF

Green Yellow

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

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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.

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Appendix A. Reference

A-1. Specification Table

Mechanical CDRPan Remote Module Size Weight CDRPan Drum Type Sensor Package Size Weight CDRPan Cassette Type Sensor Package Electrical CAN/CSA C22.2 No.601.1M90 Safety and EMC Standards Compliance IEC60601-1 IEC60601-1-2 UL60601-1 Maximum Line Current And Voltage Environmental Operating Temperature Storage Temperature Humidity Highest Permissible Temperature Limit General Image Sensor Active Area Calibration Scan Time 6.05 x 0.38 in (15.36 x 9.6 cm) Automatic 10 ­ 20 seconds (dependent on host machine) 70° - 85° F (21°- 29° C) 41° - 113° F (5° - 45° C) 20% to 80% 150° F (65.5° C) Medical Electrical Equipment Part 1: General Requirements for Safety Medical Electrical Equipment Part 1: General Requirements for Safety Medical Electrical Equipment Part 1: General Requirements for Safety 2.Collateral Standard: Electromagnetic Compatibility ­ Requirements and Tests Medical Electrical Equipment: General Requirements for Safety 125 VAC, at 300 mA 250 VAC, at 150 mA Size Weight 6.75 x 4.8 x 0.875 in (17.15 x 12.19 x 2.22 cm) 1.2 lb (0.54 kg) 6.4 x 3.5 x 0.3 in (16.26 x 8.89 x 0.762 cm) 0.5 lb (0.23 kg) 14 x 7 x 1 in (35.56 x 17.78 x 2.54 cm) 2.2 lb (0.99 kg)

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

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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 Effective pixel size Static resolution Signal to noise ratio 8 bits per pixel (256 gray levels) 96 microns 5 line pairs per millimeter 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 Timeout when starting acquisition Time to display image after acquisition Time to display archived image 7 seconds (or user-defined interval specified by the Early Stop Timeout setting in Panoramic Acquisition Control Properties) 15 seconds (or user-defined interval specified by the Initial Timeout setting in Panoramic Acquisition Control Properties) 30 seconds 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

RF emissions CISPR 11

Compliance

Group 1

Guidance

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.

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RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3

Class B Class A 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

Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 610004-4 Surge IEC 61000-4-5

IEC 60601 Test Level

±6 kV contact ±8 kV air ±2 kV for power supply lines ±1 kV for input/output lines ± 1 kV differential mode ± 2kV common mode

Compliance Level

±6 kV contact ±8 kV air ±2 kV for power supply lines ±1 kV for input/output lines ± 1 kV differential mode ± 2kV common mode < 5% UT

(>95% dip in UT) for 0.5 cycle

Guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 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.

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

< 40% UT

(>60% dip in UT) for 5 cycles

< 70% UT

(>30% dip in UT) for 25 cycles

< 70% UT

(>30% dip in UT) for 25 cycles

NOTE: UT is the AC mains voltage prior to application of the test level.

< 5% UT

(>95% dip in UT) for 5 sec

< 5% UT

(>95% dip in UT) for 5 sec

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

3A/m

3A/m

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Immunity Test

Conducted RF IEC 61000-4-6

IEC 60601 Test Level

3 Vrms 150 kHz to 80 MHz

Compliance Level

3 Vrms

Guidance

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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

b

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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=1.17xP 800 MHz to 2.5 GHz d= 2.3 x P 0.23 0.73 2.30 7.27 23.00

0.01 0.1 1 10 100

0.12 0.37 1.17 3.69 11.7

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.

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