Schick CDRPanX User manual

CDRPanX User Guide
Schick Technologies, Inc.
30-30 47th Avenue
Long Island City, NY 11101
USA
[phone]
[phone] (fax)
PART NUMBER B1051407 REV. A

Copyright ©2008 by Schick Technologies, Inc.
All Rights Reserved
August 18, 2008

Printed in the United States of America
This document was originally prepared in English
CDR is a registered trademark of Schick Technologies, Inc and is
covered by US Patent Numbers 5,912,942 and 6,134,298. Additional
patents are pending.
Trademark designations used by other manufacturers and sellers may
appear in this document also. Where Schick Technologies, Inc. was
aware of a trademark claim, that information has been printed in caps
or initial ca
p
s.

CDRPanX User Guide B1051407 Rev A i
Contents
1. Introduction.................................................................................................1
1.1. Purpose....................................................................................................................................1
1.2. Indications for Use..................................................................................................................1
1.3. Notice to Installers..................................................................................................................1
1.4. Notice to Users........................................................................................................................2
2. General Information...................................................................................3
2.1. System Description.................................................................................................................3
2.2. System Operation....................................................................................................................3
2.3. Control Panel ..........................................................................................................................6
2.4. Control System........................................................................................................................8
3. Installation.................................................................................................13
3.1. General..................................................................................................................................13
3.2. Requirements ........................................................................................................................13
3.3. iPan HS Interface Driver Installation....................................................................................14
4. Controls and LED Indicators..................................................................18
4.1. iPan HS USB Interface .........................................................................................................18
5. Operation...................................................................................................20
5.1. Turning On the System.........................................................................................................20
5.2. Ready / Not Ready Indications .............................................................................................20
5.3. Turning Off the System ........................................................................................................21
6. Panoramic Imaging..................................................................................22
6.1. Panoramic Projection and Technique Factors.......................................................................22
6.2. Patient Positioning and Panoramic Imaging.........................................................................23
6.3. Using the Resend Option......................................................................................................25
6.4. Focal Trough Adjustments....................................................................................................27
6.5. TMJ Projections....................................................................................................................28
6.6. Maxillary Sinus Projections..................................................................................................29
6.7. Operator Positioning and Panoramic Exposures...................................................................31
7. Using the iPan HS Upgrade Utility........................................................32
7.1. Introduction...........................................................................................................................32
7.2. USB Interface Test................................................................................................................33
7.3. USB Interface Firmware Upgrade ........................................................................................34
7.4. Sensor Module Firmware Upgrade.......................................................................................35
8. Cleaning.....................................................................................................36
8.1. CDRPanX Unit .....................................................................................................................36
8.2. iPan HS USB Interface .........................................................................................................36
9. Maintenance..............................................................................................37

ii B1051407 Rev. A CDRPanX User Guide
9.1. Visual Inspection ..................................................................................................................37
9.2. Periodic Maintenance............................................................................................................37
9.3. Scheduled Maintenance........................................................................................................38
Appendix A. Error Codes..............................................................................39
Appendix B. Technical Data..........................................................................40
Appendix C. Cooling Curves........................................................................44
Index..................................................................................................................45

CDRPanX User Guide B1051407 Rev. A iii
List of Figures
Figure 1. Panoramic Imaging Area ................................................................................................. 1
Figure 2. CDRPanX Simplified Block Diagram............................................................................. 3
Figure 3. CDRPanX (Patient View)................................................................................................ 4
Figure 4. CDRPanX (Operator View)............................................................................................. 5
Figure 5. CDRPanX Control Panel ................................................................................................. 6
Figure 6. Correct Beam Alignment for Mid-Sagittal, Frankfort, and Lateral Planes.................... 12
Figure 7. Correct Beam Alignment for Frankfort and Lateral Planes........................................... 12
Figure 8. iPan HS USB Interface .................................................................................................. 18
Figure 9. Location of CDRPanX Power, Exposure, and Alignment Controls.............................. 20
Figure 10. Resend Option Selected in Panoramic Settings ........................................................... 25
Figure 11. Examples of Correct and Incorrect Patient Positioning............................................... 26
Figure 12. Displayed Focal Trough Adjustments.......................................................................... 27
Figure 13. Examples of TMJ and Maxillary Sinus Exposures and Positioning............................ 30
Figure 14. Operator Safety Zone................................................................................................... 31
Figure 15. iPan HS Upgrade Utility.............................................................................................. 32
List of Tables
Table 1. CDRPanX Control Panel Description............................................................................... 6
Table 2. CDRPanX Exposure Switch Description.......................................................................... 8
Table 3. Rotation Unit Positions and READY Light Indications.................................................... 9
Table 4. iPan HS USB Interface LED Indications........................................................................ 19
Table 5. Voltage and Current Settings Based on Patient Type...................................................... 22
Table 6. Control Panel Error Codes .............................................................................................. 39
Table 7. Summary of CDRPanX Technical Data.......................................................................... 40
Table 8. Compliance Specifications.............................................................................................. 40
Table 9. Guidance and Manufacturer's Declaration - Electromagnetic Emissions ....................... 41
Table 10. Guidance and Manufacturer's Declaration - Electromagnetic Immunity...................... 41
Table 11. Recommended Separation Distance Between Portable and Mobile RF Communications
Equipment and the CDRPanX System................................................................................. 43

iv B1051407 Rev. A CDRPanX User Guide
Safety Issues
CAUTION: Federal law restricts this device to sale by or on the order of a
dentist licensed by the law of the State in which that person practices.
Equipment to be Operated and Serviced by Qualified Personnel Only
X-ray equipment produces ionizing radiation that may be harmful if not properly
regulated. It is therefore recommended that the equipment be operated by trained and
qualified personnel only, in accordance with all applicable local and federal regulations.
Only trained and qualified technicians are authorized to service this equipment. Power
supply lines must comply with safety legislation and have ground terminals for protective
earth connection. Always switch the equipment off and, if possible, disconnect it from
main power supply before cleaning or disinfecting the system.
Protecting CDRPanX Equipment from RF Interference
Although the CDRPanX 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 6 feet (1.8m) from any
part of the equipment.
Any instrumentation or equipment for professional use located near CDRPanX 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) and supplied by a dedicated electric line.
Exercise Caution Near and Around Moving Parts
The Vertical Carriage and Rotation unit move during patient setup and panoramic
exposure procedures. Operators must take appropriate precautions for themselves and
their patients to prevent accidental injury during equipment operation.
Apply Recommended Procedures for Cleaning the Equipment
Safe and proper operation of the equipment requires that a regular schedule of preventive
maintenance be followed. Refer to the Cleaning and Maintenance sections of this manual
for details.
Do Not Connect Items that are Not Part of the System
Only items specified for use with the equipment are to be connected to the system. The
equipment should not be used adjacent to, or stacked with, other equipment that is not
part of the system. If, however, use with adjacent equipment is necessary, normal
operation should be observed and verified in that configuration.

CDRPanX User Guide B1051407 Rev. A v
Installers to Ensure that the CDRPanX System Operates Optimally
Installers must ensure that the CDRPanX system, when installed, provides the user with
the optimal use of the equipment. This includes, but is not limited to, ensuring the system
operates in the temperature and humidity range specified in this document. Installers
must also ensure that the system presents no physical obstacles or hazards during
operation and when not in use. To verify this requirement, installers shall confirm that the
CDRPanX system is installed as described in the Installation / Service Guide and shall
perform the appropriate procedures therein.
Take Appropriate Precautions during CDRPanX Operation
Appropriate accessories, such as lead aprons, must be used, where necessary, to protect
the patient and the operator from radiation.
The CDRPanX system has been determined to be in accordance with international safety
standards and is deemed suitable for use within the patient area, which extends from the
patient for a distance of 5 feet (1.5m). Outside the patient area, the presence of approved
non-medical grade equipment and Listed / Approved / Certified Information Technology
Equipment (ITE) computer equipment is acceptable.
Preventive Maintenance
There are no customer-serviceable components in the CDRPanX system. However,
before operating the system, customers shall check it for any signs of physical damage or
defect. If detected, contact your local distributor of Schick Technologies products for
further instructions.
When No Longer Usable, Dispose of System Components Properly
The CDRPanX system is made of a variety of materials, including iron, aluminum, lead,
copper, plastics, electronic components, and dielectric oil in the Tube head. Once the
system is removed permanently from service, such components cannot be abandoned in
the environment. They must be disposed of in accordance with applicable local
regulations.
Ensure Proper System and PC Workstation Installation and Operation
CDRPanX has been determined to be in accordance with international safety standards
and is deemed suitable for use within the patient area, which extends from the patient for
a distance of 5 feet (1.5m). To comply with these standards, do not operate non-medical
equipment (such as a PC workstation) inside the patient area. Outside the patient area, the
presence of approved non-medical grade equipment and Listed / Approved / certified
Information technology Equipment (ITE) computer equipment is acceptable.
The PC workstation that connects to the CDRPanX via compatible USB cable is an
integral part of a Medical Electrical System. The PC must be a CE-approved computer
system conforming with the Low Voltage [73/23/EC] and EMC Directive [89/336/ERC].
Also, to help ensure optimal performance, ensure that all software programs residing on

vi B1051407 Rev. A CDRPanX User Guide
the workstation are virus-free and have been adequately tested so they will not impact
imaging applications after installation.
Please refer to documentation provided by the PC manufacturer for important
information about its safe operation and usage.
Use Only Dedicated Host Computer(s) for Imaging Application(s)
The host computer should be dedicated to imaging and not for general computing use.
Also, prior to installing any software on dedicated workstation(s) and / or server(s),
ensure that such software is virus-free and will not impact the operation and performance
of imaging applications after installation.
Do Not Touch Exposed Connectors on Non-Medical Equipment and the
Patient at the Same Time
When the CDRPanX product is in use, avoid touching exposed connectors on non-
medical electrical equipment and the patient at the same time. The human body is capable
of conducting electrical current and may cause a shock hazard to patients if appropriate
safety practices are not observed.
Only Dentists or Authorized Designees Are Permitted to Operate the
System
To ensure the correct use of CDRPanX in a clinical environment, for purposes that
correspond to its intended design and application, only dentists, or their designees, are
authorized to operate the system.
Use Only Manufacturer-Specified Parts and Accessories for Replacement
Using accessories, transducers, and cables, other than those specified by the Schick
Technologies as appropriate replacement parts for internal components, may result in
increased emissions or decreased immunity of the CDRPanX system.
The following cable configurations have been specified for the CDRPanX system.
SYSTEM COMPONENT CABLE DESCRIPTION CABLE ROUTED TO
CDRPanX USB Sensor CAT-5 iPan HS USB Interface
iPan HS USB Interface USB USB port of compatible laptop or desktop PC

CDRPanX User Guide B1051407 Rev. A vii
Symbols
Refer to the following table for symbols found on the CDRPanX itself, on the shipping
packaging, or in text of this or other documents provided with the system.
SYMBOL DESCRIPTION
Indicates Class II Equipment
Indicates Type B equipment in accordance with applicable medical device safety
standards (IEC/EN/UL 60601-1)
Indicates an attention to users to consult accompanying documents for more information
Indicates that the product complies with EC Directive 93/42/EEC concerning
Medical devices (European Community)
Indicates that this product meets North American safety standards. The ETL mark is a
Nationally Recognized Testing Lab (NRTL) marking and indicates conformance with UL
60601-1 and CAN/CSA STD C22.2 NO 601.1-M90
Indicates that in the European Union, at the end of product life this device must be
disposed of in accordance with the requirements of the Waste Electrical and Electronic
Equipment (WEEE) directive 2002/96/EC
Indicates that under certain ambient environmental conditions (especially low
humidity), this device may be susceptible to electrostatic discharge (ESD).
Appropriate care and handling must be observed to avoid damage.
Green LED located on the iPan HS USB Interface. Displays status as Sensor
transmits images to the iPan HS USB Interface.
Orange LED located on the iPan HS USB Interface. Displays status as iPan
HS USB Interface transmits images to the host computer.
Warning, Read Carefully

viii B1051407 Rev. A CDRPanX User Guide
SYMBOL DESCRIPTION
Warning, Electrical Shock
~ Alternating Current
Protective Earth (Ground)
Power Off (system disconnected from main power supply)
Power On (system connected to main power supply)
Radiography Push Button
Ionizing Radiation Indicator
Inherent Filtration
Fragile, Handle With Care
Humidity Limitation
This End Up, Do Not Turn Over
Stacking Limit

CDRPanX User Guide B1051407 Rev. A ix
Label Locations
System Label (115V Shown)
Label Location
Located near the patient handles
Fuse Label
Label Description
Located near the fuse holder on
the Vertical Carriage
Generator Label
Label Location
Located near the X-ray source
(also duplicated label)

x B1051407 Rev. A CDRPanX User Guide
X-ray Warning Label
Label Location
Located on the Vertical Carriage
Collimator Label
Label Location
Located on the Rotation unit and
duplicated label near the X-ray
Collimator
Laser Label
Label Location
Located near the patient handles
Schick Technologies Inc.
Long Island City, NY USA
CDR PanX Collimator
PN: B4792500
Serial Number 1909LD0000
Manufactured September 2003
CERTIFICATION
Product complies with
radiation performance
standards under the
Federal Food, Drug, and
Cosmetic act.
WARNING This x-ray unit
may be dangerous to patient
and operator unless safe
exposure factors and
operating instructions are
observed

CDRPanX User Guide B1051407 Rev. A xi
Column Label
Label Location
Located near the base of the
Column
Self Standing Base Label
Label Location
Located on the Self-Standing
Base, near the Column
iPan HS USB Interface
Label Location
Regulatory Markings and
Manufacturer Label
(located on bottom)
CDR PanX Self Standing Base
PN: B4792220
Serial Number 1909SB0000
Manufactured September 2003
Schick Technologies Inc., LIC, NY USA
CDR PanX Column Assembl
y
PN: B4792310
Serial Number 1909SC0000
Manufactured September 2003
Schick Technologies Inc., LIC, NY USA

xii B1051407 Rev. A CDRPanX User Guide
Waste Electrical and Electronic Equipment
Background
The European Union’s Waste Electrical and Electronic Equipment Directive
(2002/96/EC) has been implemented in member states. This directive, which seeks to
reduce the waste of electrical and electronic equipment through re-use, recycling, and
recovery, imposes several requirements on producers. Schick Technologies and its
Dealers are committed to complying with the Directive.
WEEE Marking
All Schick products subject to the WEEE Directive will be compliant with the WEEE
marking requirements. These products will be identified with the “crossed-out wheeled
bin” WEEE symbol shown below, as defined in European Standard EN 50419, and in
accordance with WEEE Directive 2002/96/EC.
This “crossed-out wheeled bin” symbol on the product or on its packaging
indicates that this product must not be disposed of with other unsorted municipal
waste. Instead, it is user’s responsibility to dispose of EEE waste equipment by
handing it over to a designated collection point for the reuse or recycling of waste
electrical and electronic equipment. The separate collection and reuse or
recycling of Electrical & Electronic waste equipment will help to conserve
natural resources and ensure that it is recycled in a manner that protects the
environment and human health. For more information about where you can drop
off your waste equipment for recycling, please contact your local officials.
Reporting
According to the WEEE Directive, Schick Technologies or its Dealers will ensure that
information needed to calculate the financial obligations with respect to EEE products
will be provided as required.
WEEE from Users other than Private Households
According to the WEEE Directive, Schick Technologies or its Dealers will fulfill its
obligations for the management of WEEE from users other than private households.
Furthermore, as required by the WEEE Directive, in order to enable the date upon which
the equipment was put on the market to be determined unequivocally, a mark on the
equipment will be placed to specify when the equipment was put on the market.

CDRPanX User Guide B1051407 Rev. A xiii
Information for Reuse Centers, Treatment and Recycling Facilities
As required by the WEEE Directive, Schick Technologies or its Dealers will provide
reuse, treatment, and recycling information for each type of new EEE put on the market
within one year of the date in which the equipment is put on the market.
Information will include the different EEE components and materials as well as the
location of substances in these items. The information will be provided as a printed
document or in electronic media (on CD-ROM or by web download, for example)

xiv B1051407 Rev. A CDRPanX User Guide
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CDRPanX User Guide B1051407 Rev. A 1
1.Introduction
1.1. Purpose
CDRPanX is a digital panoramic X-ray device, representing the latest technology in
dental panoramic X-ray equipment. CDRPanX performs panoramic examinations for
adults, children, left side of dentition, right side of dentition, anterior part of dentition,
TMJ, mouth open and closed, and anterior view of nasal (maxillary) sinuses.
1.2. Indications for Use
CDRPanX is intended for individuals requiring extra-oral dental exams. It exposes and
acquires radiographic images at the dento-maxillofacial region (Figure 1).
Figure 1. Panoramic Imaging Area
(1) Maxillary Region, (2) Dental Arch, (3) Mandibular Region, (4) Temporo Mandibular Joints (TMJ)
1.3. Notice to Installers
It is the responsibility of the Installer:
•To make sure that the line voltage specified by the manufacturer of the equipment
is available and within the specified range
•To verify that a proper switch is available to disconnect the equipment from main
power supply when needed during installation
•To install and test the equipment according to the CDRPanX Installation and
Service Guide and other documentation, as needed.
•To provide the User Guide to the user.
3
4
2
1
4

2 B1051407 Rev. A CDRPanX User Guide
1.4. Notice to Users
It is the responsibility of the User:
•To operate the system following the instructions and recommendations contained
in this User Guide and in other related documentation provided with, or intended
for, the operation and maintenance of the CDRPanX system.
•To maintain the equipment by complying with the maintenance schedule
described in this document. Failure to maintain the equipment properly may result
in personal injury or equipment damage and may relieve the manufacturer, or its
designated agent, from responsibility arising from injury, damage, or non-
compliance.
•To report promptly to the appropriate authority and the manufacturer, or its
designated agent, any accident involving this medical device or any alteration in
features and / or performance that could constitute a health hazard to the patient
and / or operator. Information about your particular CDRPanX system can be
found on the system itself, on labels described in this manual.

CDRPanX User Guide B1051407 Rev. A 3
2.General Information
2.1. System Description
The CDRPanX system consists of the following hardware: CDRPanX panoramic
machine, iPan HS USB Interface, and associated cables. A simplified diagram of the
CDRPanX system is provided below.
PANX
HOST MACHINE
iPAN HS USB
INTERFACE PC
WORKSTATION
CAT-5
CABLE
MAIN
POWER
USB
CABLE
Figure 2. CDRPanX Simplified Block Diagram
The following accessories are applicable to the CDRPanX system and are used for
support during panoramic imaging.
−A4505000 Bite Block
−A4505200 Edentulous Lip Support
−A4505300 TMJ / Sinus Lip Support.
2.2. System Operation
Panoramic imaging is performed by means of a narrow X-ray beam that scans the dento-
maxillofacial area of the patient. To ensure that this region is represented optimally on
the resulting image, proper understanding of the CDRPanX equipment and patient
positioning is required. Figure 3 and Figure 4 provide the location and identification of
patient and operator views of the CDRPanX system.
The CDRPanX system requires the following software and compatible operating systems:
−CDR DICOM for Windows 4.5 and higher, EagleSoft 14.0 and higher, or
Patterson Imaging 14.0 and higher Windows XP Professional or Windows 2000
−Windows Vista (Home Premium, Business, or Ultimate), XP Professional, or
Windows 2000 Professional
−iPan HS Interface Driver (provided with the iPan HS system).

4 B1051407 Rev. A CDRPanX User Guide
This User Guide is one of two documents needed to install the CDRPanX system
completely. Before performing the procedures in this document, you or a qualified
service technician should complete the steps in the Installation Guide (B1051408).
All of the procedures for installing CDRPanX hardware may be found in your Installation
Guide. Procedures for installing the iPan Interface driver can be found in this User Guide
(Section 3.3).
Refer to Figure 3 for the following references.
CDRPanX consists of the following principal parts. A Vertical Carriage (1), to which the
power supply cord, Exposure switch, and digital imaging cable are connected, moves
vertically along the Column (2), permitting adjustments for the height of the patient. A
Rotation unit (3), consisting of a Control Panel (4), Digital Image Sensor system (5), and
X-ray Tube head (6), is connected to the Vertical Carriage.
When positioning the patient for panoramic images, adjust the Rotation unit for patient
access, making the proper adjustments to ensure good panoramic images. (Additional
information on positioning may be found on Table 3 and in Section 6.2.)
Figure 3. CDRPanX (Patient View)
1 2
5
6
3
4