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CDRPanXUserGuide

The CDRPanX User Guide provides comprehensive instructions for operating and maintaining the CDRPanX digital panoramic X-ray device, including system operation, patient positioning, and safety precautions. It emphasizes the importance of using qualified personnel for installation and maintenance, as well as adhering to local regulations regarding ionizing radiation. Additionally, the guide outlines compliance with the Waste Electrical and Electronic Equipment Directive for proper disposal of the system components.

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0% found this document useful (0 votes)
4 views41 pages

CDRPanXUserGuide

The CDRPanX User Guide provides comprehensive instructions for operating and maintaining the CDRPanX digital panoramic X-ray device, including system operation, patient positioning, and safety precautions. It emphasizes the importance of using qualified personnel for installation and maintenance, as well as adhering to local regulations regarding ionizing radiation. Additionally, the guide outlines compliance with the Waste Electrical and Electronic Equipment Directive for proper disposal of the system components.

Uploaded by

rafaelcastro905
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 41

CDRPanX User Guide

Schick Technologies, Inc.


30-00 47th Avenue
Long Island City, NY 11101

(718) 937-5765
(718) 937-5962 (fax)

PART NUMBER B1051404 REV. -


Copyright © 2005 by Schick Technologies, Inc.
All Rights Reserved

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 caps.

September 23, 2005

Printed in the United States of America

This document was originally prepared in English


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 Operation....................................................................................................................3
2.2. Control Panel ..........................................................................................................................5
2.3. Control System........................................................................................................................7
3. Operation .................................................................................................... 11
3.1. Turning On the System .........................................................................................................11
3.2. Ready / Not Ready Indications .............................................................................................11
3.3. Turning Off the System ........................................................................................................12
4. Panoramic Imaging................................................................................... 13
4.1. Panoramic Projection and Technique Factors.......................................................................13
4.2. Patient Positioning and Panoramic Imaging .........................................................................14
4.3. Focal Trough Adjustments....................................................................................................17
4.4. TMJ Projections ....................................................................................................................18
4.5. Maxillary Sinus Projections ..................................................................................................19
4.6. Operator Positioning and Panoramic Exposures...................................................................21
5. Maintenance............................................................................................... 22
5.1. Periodic Maintenance............................................................................................................22
5.2. Scheduled Maintenance ........................................................................................................22
6. Cleaning ...................................................................................................... 23

7. Maintenance............................................................................................... 24
7.1. Visual Inspection ..................................................................................................................24
7.2. Periodic Maintenance............................................................................................................24
Appendix A. Error Codes............................................................................... 25

Appendix B. Technical Data.......................................................................... 26

CDRPanX User Guide B1051404 Rev - i


List of Figures
Figure 1. Panoramic Imaging Area ................................................................................................. 1
Figure 2. CDRPanX (Patient View) ................................................................................................ 3
Figure 3. CDRPanX (Operator View) ............................................................................................. 4
Figure 4. CDRPanX Control Panel ................................................................................................. 5
Figure 5. Correct Beam Alignment for Mid-Sagittal, Frankfort, and Lateral Planes .................... 10
Figure 6. Correct Beam Alignment for Frankfort and Lateral Planes ........................................... 10
Figure 7. Location of CDRPanX Power, Exposure, and Alignment Controls .............................. 11
Figure 8. Examples of Correct and Incorrect Patient Positioning ................................................. 16
Figure 9. Displayed Focal Trough Adjustments........................................................................... 17
Figure 10. Examples of TMJ and Maxillary Sinus Exposures and Positioning ............................ 20
Figure 11. Operator Safety Zone ................................................................................................... 21

List of Tables

Table 1. CDRPanX Control Panel Description ............................................................................... 5


Table 2. Voltage and Current Settings Based on Patient Type...................................................... 13
Table 3. Control Panel Error Codes .............................................................................................. 25
Table 4. Summary of PanX Technical Data .................................................................................. 26
Table 5. Compliance Specifications .............................................................................................. 26
Table 6. Guidance and Manufacturer's Declaration - Electromagnetic Emissions ....................... 27
Table 7. Guidance and Manufacturer's Declaration - Electromagnetic Immunity ........................ 27
Table 8. Recommended Separation Distance Between Portable and Mobile RF Communications
Equipment and the CDRPanX System ................................................................................. 28

ii B1051404 Rev. - CDRPanX User Guide


Safety Issues
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.

Avoid Operating Equipment in the Presence of Interfering RF


Devices and Equipment
We recommend that you do not use the equipment in the presence of external
electromagnetic fields, even if compliant with specifications for electromagnetic
compatibility. Noise, generated by cellular phones, might interfere with the electronic
circuits of the system.

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, Sterilizing, and


Disinfecting the Equipment
Safe and proper operation of the equipment requires that a regular schedule of preventive
maintenance be followed. In addition, the use of sterile sheaths and appropriate
disinfecting procedures must be observed to minimize patient exposure to cross-
contamination from bacterial or other infection. Use new sheaths with each new patient.
Dispose of sheaths properly after use.

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 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 B1051404 Rev. - iii


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.

RF Interference Considerations
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 5 feet (1.5m) 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.

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.

iv B1051404 Rev. - CDRPanX User Guide


Symbols
Explanation of Symbols
Refer to the following table for symbols found on the CDRPanX itself, or on the
packaging in which the equipment is shipped, or in text of this or other documents
provided with the system.

SYMBOL DESCRIPTION

Compliance to European Community Requirements

Type B Equipment

Attention, Consult Accompanying Documents

Warning, Read Carefully

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

Inherent Filtration

Fragile, Handle With Care

Humidity Limitation

This End Up, Do Not Turn Over

Stacking Limit

CDRPanX User Guide B1051404 Rev. - v


Label Locations

vi B1051404 Rev. - CDRPanX User Guide


Waste Electrical and Electronic Equipment
(WEEE)
Background
The European Union’s Waste Electrical and Electronic Equipment Directive
(2002/96/EC) will be implemented in member states starting August 13, 2005. 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 and shipped starting August 13, 2005
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 EE 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.

CDRPanX User Guide B1051404 Rev. - vii


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 that the equipment was put on the market after
August 13, 2005.

Information for Reuse Centers, Treatment and Recycling Facilities


After August 13, 2005, and 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)

viii B1051404 Rev. - CDRPanX User Guide


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).

4 4
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.

CDRPanX User Guide B1051404 Rev. - 1


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.

2 B1051404 Rev. - CDRPanX User Guide


2. General Information
2.1. 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.
Refer to Figure 2 for the following references.
CDRPanX consists of the following principal parts. A Vertical Carriage (1), to which the
power supply cord, Exposure Hand 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. (Detailed
information on positioning may be found in Section 4.2.)

2
1

4*
6
5

Figure 2. CDRPanX (Patient View)

(Location of Asterisked Item is Approximate)

CDRPanX User Guide B1051404 Rev. - 3


Refer to Figure 3 for the following references.
For proper patient positioning, use the pushbutton on the Control Panel to activate the
laser alignment beams — Mid-Sagittal Plane (1), Frankfort Plane (2), and Lateral Plane
for the center of the Focal Trough (3).

Instruct the patient to grasp the patient handles (4) during the setup procedure as this will
help maintain correct positioning, even after the alignment adjustments are made. The
adjustment Knob (5) and Scale (6) are used during patient setup to change the distance
between the Bite Block (7) and the Vertical Carriage. Handle (8) is used with the
Magnetic Brake button (9) to adjust the Rotation unit vertically, along the Column.

Also accessible from the side of the CDRPanX are the Exposure Hand switch (10) and
connector (11), On / Off switch (12), and AC cable (13) for electrical service to the unit.

9
1
8

7
2
3 6

4* 5

13

10

12*
11

Figure 3. CDRPanX (Operator View)

(Locations of Asterisked Items are Approximate)

4 B1051404 Rev. - CDRPanX User Guide


2.2. Control Panel

Descriptions of Control Panel pushbuttons and indicators can be found by referring to


Figure 4 and Table 1 that follows.

1
7 11
2 8 12
9 13
3 14
10 15

4
16 17 18 19 20 21 22 23

6 24

Figure 4. CDRPanX Control Panel

Table 1. CDRPanX Control Panel Description

No. Item Description Additional References

System Pushbuttons and Indicators

1 READY Indicates that system is ready to take —


an X-ray

2 TEST Indicates test status condition is on / —


off

3 Returns Rotation unit to ready —


position and resets errors

4 Activates the laser alignment beams —


for 15 seconds

5 Rotation Test - Operates system —


without X-ray source active

CDRPanX User Guide B1051404 Rev. - 5


No. Item Description Additional References

6 Resets system to initial settings —

kV Pushbuttons and Indicators

7 kV kV and Error code display —

8 kV kV indicator Tube voltage displayed in Item No. 7

9 ERROR Error status indicator Error code displayed in Item No. 7

10 Decrease (-) or increase (+) Adjusts value displayed in Item No. 7

mA and mAs Pushbuttons and Indicators

11 mA / mAs mA /mAs and Service code display —

12 mA mA Indicator Tube mA value displayed in Item No. 11

13 mAs mAs Indicator mAs value displayed in Item No. 11

14 SERVICE Service Indicator Service code displayed in Item No. 11

15 Decrease (-) or increase (+) Adjusts value displayed in Item No. 11

Panoramic Program Pushbuttons and Indicators

16 Adult selected —

17 Child selected —

18 Right side of dentition selected —

19 Left side of dentition selected —

20 Anterior part of dentition selected —

21 TMJ selected: mouth closed —

22 TMJ selected: mouth open —

23 Anterior view of nasal (maxillary) —


sinuses selected

24 Program selection Selects program displayed in Items Nos. 16 to


23

6 B1051404 Rev. - CDRPanX User Guide


2.3. Control System

2.3.1. Setup for Exposure

IMPORTANT! Never move the Rotation Unit manually as permanent damage to the CDRPanX
system may result. To reset or reposition the Rotation Unit, ALWAYS use the Exposure hand
switch with the system in TEST mode.

The Rotation unit can be at rest in one of four positions:


1. Patient Entry Position – Rotation unit at rest with the Control Panel on the left, X-ray
generator on the right (when viewed facing the mirror).
2. Ready Position – Rotation unit positioned at rest at the start of its travel waiting for
start of exposure.
3. End of Exposure Position – Rotation unit at rest at the end of its travel at the
completion of an exposure.
4. Patient Exit Position – Rotation unit at rest with the Control Panel on the right, X-ray
generator on the left (when viewed facing the mirror).

The Return button on the Control Panel or the Exposure hand switch is used to initiate the
positioning of the Rotation unit. Assuming the Rotation unit is at the Patient Exit position
from a prior exposure, momentarily pressing either the Return button or Exposure hand
switch sends the Rotation unit to the Patient Entry position.

2.3.2. Exposure

After the patient is properly positioned in the machine, momentarily pressing either the
Return button or Exposure hand switch again sends the Rotation unit to the Ready
position. The READY indicator illuminates when the unit has reached the Ready
position.

A. To start exposing an image: Press the Exposure hand switch to initiate the exposure
and keep the switch depressed during the entire travel of the Rotation unit

B. To stop an exposure immediately at any time: Release the Exposure hand switch,
which terminates the exposure immediately. Interrupting an exposure illuminates the
Error indicator and sounds an alarm. Pressing either the Return button or the
Exposure hand switch extinguishes the Error indicator and silences the alarm.
Pressing either button a second time moves the Rotation unit to the Patient Exit /
Entry position.

CDRPanX User Guide B1051404 Rev. - 7


2.3.3. Monitoring During Exposure

During the exposure, the Control System monitors movement of the Rotation unit and X-
ray generation according to the selected projection.

2.3.4. Reset for Next Exposure

After the exposure the Rotation unit comes to rest at the End of Exposure position.
Momentarily pressing either the Return button or Exposure hand switch at this time sends
the Rotation unit to the Patient Exit position.
When the kV indicator is on, the X-ray tube anode voltage value is selected using Item
10, Table 1. The anode voltage can be set from 60 to 86 kV in steps of 2 kV.

2.3.5. Anode Current Setting

When the mA indicator is on, the X-ray tube anode current value is selected using Item
15, Table 1. The anode current can be set to 4, 5, 6.3, 8 or 10 mA.

2.3.6. Panoramic Projections

Program Selection buttons Item 24, Table 1, are used to select the desired panoramic
projection. Adult and Child selections, Items 16 and 17, are used to select respectively
longer or shorter exposure durations for full panoramic images. Please refer to Items 18
through 24 for available partial projections. Please refer to Table 4 in Appendix B for
exposure durations for the various projections.

2.3.7. Reset Function

CDRPanX is initialized each time the system is turned on and whenever the Reset
pushbutton is pressed. Initializing the system performs the following actions:

A. Sets the proper values for control signals, stops all motors, sets anode voltage to 60
kV, sets anode current to 8 mA, and selects the Adult Panoramic program.

B. Performs CDRPanX system testing and displays any detected errors on the Control
Panel.

2.3.8. Error Handling

In the event CDRPanX detects an error during operation or testing, the Error indicator on
the Control Panel illuminates, accompanied by an error message code, and an audible
alarm to alert the operator. The kV indicator is extinguished. To reset the system and
clear the error condition, press the Return pushbutton or the Exposure handswitch.

8 B1051404 Rev. - CDRPanX User Guide


2.3.9. Laser Alignment Beams

The laser alignment beams ensure proper patient positioning along three separate
anatomical planes (Figure 5 and Figure 6).
WARNING: The source of the alignment beams is a Class 1 Laser.
Operators are advised to avoid exposing their eyesight and that of
their patients to unnecessary laser radiation by positioning the patient
correctly and limiting the number of times the alignment beams are
activated.

2.3.10. Mid-Sagittal Plane

This is a vertical plane that is used to distinguish the right from left sides of the patient.
When set correctly, the beam should fall in the middle of the patient’s head.

2.3.11. Frankfort Plane

This is a horizontal plane that is used to distinguish the forward and backward orientation
of the patient’s head. When set correctly, the beam should follow a line emanating from
the upper border of the tragus, running along the Zygomatic Arch, to the lower border of
the orbit. Using the laser positioning beam as a guide, the operator should ensure that the
patient’s head is not tilted forward or back.

2.3.12. Lateral Plane

This is a vertical plane used to indicate the relationship of the Rotation unit to the patient.
When the Rotation unit is set correctly, the patient’s teeth and / or related structures will
be exposed within the focal trough. The beam should be positioned interproximally
between the lateral and canine teeth.

CDRPanX User Guide B1051404 Rev. - 9


Figure 5. Correct Beam Alignment for Mid-Sagittal, Frankfort, and Lateral Planes

Figure 6. Correct Beam Alignment for Frankfort and Lateral Planes

(Laser Indications are Highlighted for Legibility on this Page and Elsewhere in this Document)

10 B1051404 Rev. - CDRPanX User Guide


3. Operation
3.1. Turning On the System

Please Note: CDRPanX must be operated only by personnel qualified to operate the equipment
safely and correctly and with full knowledge of applicable laws and regulations.

Turn on power at the CDRPanX On / Off switch (Figure 7). Initial turn-on conditions are
displayed at the Control Panel (Figure 4):
• X-ray Tube Anode voltage is 60kV
• X-ray Tube Anode current is 8 mA
• Adult Panoramic program is selected

On/ Off Power Switch

Connector for
Exposure Hand
switch

Figure 7. Location of CDRPanX Power, Exposure, and Alignment Controls

3.2. Ready / Not Ready Indications

Ready / Not ready indications are displayed at the Control Panel (Figure 4):

A. READY indicator is illuminated


The Rotation unit is in the Ready position and ready for movement. CDRPanX
is considered ready for normal operation
B. READY indicator is blinking
After each exposure, this indication occurs automatically as the CDRPanX
enters a waiting period during which the Tube head cools down (6 minutes,
maximum). When the cooling cycle ends, the Ready indicator stops blinking
and an audible alarm alerts the operator that usage can be resumed. During the
period when the Ready indicator is blinking, only TMJ projections can be made;
all other panoramic programs are unavailable.

CDRPanX User Guide B1051404 Rev. - 11


C. READY indicator is not illuminated
Press the Exposure hand switch or Return pushbutton to perform the Return
function.
3.3. Turning Off the System

Turn off power at the CDRPanX On / Off switch. When power is off, all indications at
the Control Panel are extinguished.

12 B1051404 Rev. - CDRPanX User Guide


4. Panoramic Imaging
4.1. Panoramic Projection and Technique Factors

Please Note: The CDRPanX can be operated without X-ray generation in TEST mode.
This test, described in the following steps, is performed to convey the sequence for taking
a panoramic X-ray and is suitable as either a training tool for practitioners or as a pre-
exam demonstration for patients.

1. Start CDR software and create a new panoramic exam (refer to the CDR User Guide
for details).
2. Select the appropriate exposure duration according to the patient's size by selecting
either the Adult icon (Item 16, Figure 4) or the Child icon (Item 17).
3. Set the anode voltage and current using Table 2 as a guide.
4. The CDRPanX can be operated without X-ray generation by pressing the Rotation
Test pushbutton Item 5, Table 1. Pressing the Exposure hand switch under Test
conditions causes the system to perform normally, except that X-rays are not
generated. The TEST indicator on the Control Panel is illuminated and the kVp and
mA displays are set to zero to indicate that X-rays are disabled in this mode.
5. Once the testing session has been completed, the Rotation unit can be brought to the
ready position by pressing the Return pushbutton or the Exposure hand switch.
6. Pressing the TEST pushbutton again terminates test mode, extinguishes the TEST
indicator, and restores the previous values to the kVp and mA displays. CDRPanX
returns to normal status, ready to operate with X-ray emission.

Table 2. Voltage and Current Settings Based on Patient Type

Patient X-ray Tube Anode Voltage (kV) X-ray Tube Anode Current (mA)
Child 60-62-64-66 4
Woman 60-62-64-66 5
Man 66-68-70-72-74-76 6.3

CDRPanX User Guide B1051404 Rev. - 13


4.2. Patient Positioning and Panoramic Imaging

IMPORTANT! Proper setup procedures and correct patient positioning is essential for good
panoramic images. For TMJ or Maxillary Sinus projections, refer to Sections 4.4 and 4.5,
respectively. Examples of patient positioning are supplied in Figure 8.

Patient Evaluation

1. Ask the patient to remove any metal item (non-permanent denture, earrings, or
necklace) that might cause ghost images on the radiograph. Start CDR and create /
open an exam with at least one empty Panoramic viewbox.
2. If a protective apron is to be used, leave the neck area clear so as not to interfere with
the X-ray beam (radiation is entering from sides and back of the patient). If the bite
block is to be used, ensure that it is covered securely by a sheath.
3. At the Control Panel, select the proper kV and mA settings. Choose the appropriate
projections and technique factors.
4. Examine and classify the patient’s teeth, which will help determine the position of the
bite block. Please note that in some cases, class I and class II teeth cannot be
completely shown on a single panoramic image. For these patients, expose the upper
or lower jaw first, then use the projection of the front teeth to represent the missed
jaw, either upper or lower.
• Class I (normal teeth): 0 mm shift
• Class II (protruded teeth): 2 mm shift towards the vertical column
• Class III (retruded teeth): 2 mm shift away from the vertical column
5. At the Control Panel, turn on the laser alignment beams. Verify that the Lateral beam
displays over the patient’s canine teeth and corresponds to the roots of the incisors.
The Lateral beam identifies the center of the focal trough as described in Figure 9.

Patient Positioning

6. Walk the patient to the X-ray unit so he / she is facing the mirror and holding the
lower handles firmly.
7. Raise the Rotation unit so the narrow point of the bite block aligns with the patient’s
nose, between the upper lip and nose. In this position, instruct the patient to bite in the
middle part of the sheathed bite block.
8. Direct the patient’s bite into the groove on the bite block so that the chin is resting on
the chin holder and the patient can remain in a stable position.
9. Turn on the laser alignment beams again and re-verify correct positioning. The beams
will remain on for 15 seconds and then turn themselves off automatically. If you need
additional time for positioning, activate the beams again.

14 B1051404 Rev. - CDRPanX User Guide


10. Instruct the patient to close his / her lips with the tongue relaxed against the palate.
The patient should also move his / her feet forward, leaning on the handles slightly,
stretching the spine.
Panoramic Image Exposure

11. Turn on the laser alignment beams again, verifying proper patient position (Lateral,
Frankfurt, and Mid-sagittal planes) in preparation for image exposure.
12. Instruct the patient to remain still and look at the mirror facing him / her.
13. Press the Exposure hand switch to move the Rotation unit to the Ready position. The
READY indicator illuminates.
14. At the computer, click on an empty Panoramic viewbox in a CDR exam. Ask the
patient to: (a) swallow and keep the tongue lightly pressed to the palate, and (b)
remain calm and avoid movement until the end of the exposure.
15. Press the Exposure hand switch to initiate the exposure and keep the switch depressed
during the entire travel of the Rotation unit. See Section 4.6 for proper operator
positioning during exposure.
16. When the Rotation unit has completed its scan, press the Exposure hand switch once
more. This will move the Rotation unit to its Exit / Entry position so the patient can
exit easily.

CDRPanX User Guide B1051404 Rev. - 15


Correct position, Frankfort plane is horizontal

Wrong position, head tilted forward, V shaped dental arch

Wrong position; head tilted backward, flat dental arch

Figure 8. Examples of Correct and Incorrect Patient Positioning

16 B1051404 Rev. - CDRPanX User Guide


4.3. Focal Trough Adjustments

INDICATION: Precisely displayed focal trough.


The laser beam is directed on the canine.The roots
of the incisors are exactly in the center of the focal
trough. Front teeth are displayed sharply.

No adjustment needed.

INDICATION: The laser beam (dash line) is


posterior to the canine (dotted line).

PROBLEM: The roots of the incisors fall outside


the focal trough. The front teeth appear blurred and
proportionally narrower (reduction).

ADJUSTMENT: Use the Knob to move the


Rotation unit forward (towards the Column) to
correct.

INDICATION: The laser beam (dash line) is


anterior to the canine (dotted line).

PROBLEM: The roots of the incisors fall outside


the focal trough. The front teeth appear blurred and
proportionally wider (magnification).

ADJUSTMENT: Use the Knob to move the


Rotation unit backward (further from the Column)
to correct.

Figure 9. Displayed Focal Trough Adjustments

CDRPanX User Guide B1051404 Rev. - 17


4.4. TMJ Projections

Position the patient for panoramic images (Section 4.2) and perform the following steps.

Please Note: When taking TMJ images, two exposures will each be displayed in their own viewbox.

1. Select the TMJ Closed Mouth projection on the Control Panel (Item 21, Table 1).
2. The chin support is below the nose. The patient is to have normal occlusion with
closed mouth (Figure 10).
3. Increase X-ray tube voltage by 4 kV above what would be normally used for full
panoramic images.
4. Adjust the lateral alignment beam approximately 0.6 in (15 mm) backwards — away
from the column — when compared with a typical position for a panoramic image
(on the external edge of the eye).

Please Note: In the following step, press and hold down the Exposure hand switch during the entire
interval in which the Rotation unit is in motion. No radiation is emitted during the middle part of the
movement and the audible alarm is cancelled.

5. Create a new CDR exam with 2 viewboxes. Click on the first viewbox, then press and
hold the Exposure hand switch to take the image. The image displays in the first
viewbox. CDRPanX advances automatically to the TMJ Open Mouth projection.
6. Press the Exposure hand switch or Return pushbutton to move the Rotation unit to the
Patient Exit position. The patient may exit if the TMJ Open Mouth projection is not
desired.
7. If the TMJ Open Mouth projection is desired, ask the patient to open his / her mouth
and check the position again. Press the Exposure hand switch or Return pushbutton
again to return the Rotation unit to the Patient Entry position.
8. Press the Exposure hand switch or Return pushbutton again to move the Rotation unit
to the Ready position. The Ready indicator will be lit
9. Click on another viewbox in CDR, then press and hold the Exposure hand switch to
take the image. The image displays in the second viewbox.

18 B1051404 Rev. - CDRPanX User Guide


4.5. Maxillary Sinus Projections

Position the patient for panoramic images (Section 4.2) and perform the following steps.
1. Select the nasal (maxillary) sinus program code on the Control Panel.
2. The chin support is below the nose. The patient is to have normal occlusion with
closed mouth (Figure 10).
3. Increase X-ray tube voltage by 4 kV above what would be normally used for full
panoramic images.
4. Set the focal trough by 1.1 in (30 mm) backwards — away from the Column — when
compared with a typical position for a panoramic image.
5. Click on the appropriate viewbox in CDR, then press and hold the Exposure hand
switch to take the image. The image displays in the viewbox.

CDRPanX User Guide B1051404 Rev. - 19


TMJ Exposures Closed (Top) and Open (Bottom)

Maxillary Sinus Exposure

Figure 10. Examples of TMJ and Maxillary Sinus Exposures and Positioning

20 B1051404 Rev. - CDRPanX User Guide


4.6. Operator Positioning and Panoramic Exposures

Please Note: Always observe the patient during examination and be ready to terminate the
exposure, if necessary, at any time.

1. The proper position for the operator during panoramic exposures is:
• Behind the patient, 10 ft (3 m) from the column (in the designated safe zone, as
described in Figure 11), or
• Outside the exam area or operatory

10 FEET
(3 METERS)

SAFE ZONE
FOR OPERATOR

Figure 11. Operator Safety Zone

CDRPanX User Guide B1051404 Rev. - 21


5. Maintenance
It is the responsibility of the user to maintain the equipment. Failure of the user to
properly maintain the equipment may relieve the manufacturer, or its agent, from
responsibility for any injury, damage, or non-compliance that may result.
5.1. Periodic Maintenance

Always disconnect the main power supply before cleaning the system. Any defect or
malfunction should be corrected immediately by qualified personnel with adequate
training. To be performed regularly:

• Cleaning and disinfecting of the parts in contact with the patient. These parts must
be cleaned with a detergent (such as 2% solution of ammonia) and then
disinfected, making sure not to use solvents or corrosive agents. The bite block
can be sterilized at 250°F (121°C).

• Check all cables, any cables in deteriorated condition should be replaced.

• Use a mild soap to clean the equipment, take care not to allow liquid into the
equipment

• Plastic covers can be wiped with a soft cloth and mild detergent.
WARNING: Any defective item affecting the safe use of CDRPanX
equipment must be repaired or replaced immediately. Refer to the
CDRPanX Service and Installation Guide for general service
information and specific procedures for repair and / or replacement.

5.2. Scheduled Maintenance

Qualified personnel must perform maintenance of the equipment at least once a year.
• Complete check of system performance (kV, mA)

• Check proper working condition of all mechanical and electrical safety features.

• Lubrication of accessible parts.

Specific lubrication of movable parts has to be done at least every two years of operation.

22 B1051404 Rev. - CDRPanX User Guide


6. Cleaning

6.1.1. General

Observe the following precautions to perform cleaning and disinfecting procedures and to
provide proper hygiene within the patient area.
• Before cleaning any part of the PanX USB system, refer to the manufacturer’s
service guide for proper turn off / power disconnection at the host panoramic
machine.
• Use a soft, lint-free cloth when wiping exterior surfaces of the PanX USB
equipment. For stronger action, use a neutral soap to clean coated surfaces.
• Make sure that water or other liquids do not seep into the PanX USB equipment,
causing potential damage to internal, electrical, and mechanical components.
• Never use solvents (such as alcohol and Trichloroethylene), corrosive, or abrasive
substances when cleaning.
When the surfaces that were cleaned have dried sufficiently, connect and restore power to
the system, following the turn-on procedures provided in this document or in the
appropriate service guide.

CDRPanX User Guide B1051404 Rev. - 23


7. Maintenance
7.1. Visual Inspection

Like all electrical equipment, the PanX USB system requires not only correct use, but
also visual inspection prior to operation, and routine checks at regular intervals. These
precautions will help ensure that the PanX USB equipment operates accurately, safely,
and efficiently.
There are no user-serviceable components in the PanX USB system. However, before
operating the system, users shall check it for any signs of physical damage or defect. If
detected, contact your local distributor of Schick Technologies products for further
instructions.
7.2. Periodic Maintenance

Periodic maintenance is performed as needed, but at least once a month. It consists of


various checks performed by the operator or by a qualified service technician.
• Check that the labels are intact, readable, and adhere well to the surfaces
on which they are positioned
• Check that all of the cables that connect equipment in the PanX USB
system are undamaged
• Check that there is no external damage to the PanX USB equipment which
could compromise its ability to operate safely and to provide the proper
emission of X-rays
• Check the operation of the audible alarm during normal operation

24 B1051404 Rev. - CDRPanX User Guide


Appendix A. Error Codes
Table 3. Control Panel Error Codes

Code Description
1 Microprocessor error
2 EPROM error
4 RAM error
7 Rotation unit cannot move: stepper motor control error
11 Digital imaging software not ready to acquire image
12 Invalid limit switch status
13 Exposure exceeds maximum time permitted
14 X-ray high voltage error
15 Undervoltage condition at main power
17 Tube filament heating current exceeds range permitted
18 No current in X–ray tube
19 Exposure switch released during exposure time: incomplete image
20 Exposure switch released prior to X-ray emission: exposure was unsuccessful
21 Exposure switch released after X-ray emission, but rotation motor movement was not complete
23 Rotation unit steps do not match in half of the track
25 Rotation unit steps do not match in half of the track
28 Rotation unit steps do not match at the end of the track
31 Rotation unit does not move
33 Tube filament heating current active during off status
34 X–ray tube current active during off status
60 Control unit microcontroller or memory error
62 Software error while Rotation unit is in motion
63 Tube head temperature exceeds value permitted
64 15V power supply error
65 24V power supply error
66 5V power supply error

Please Note: The table above describes error codes that appear when the Error indicator on the Control Panel is
illuminated. For service codes, refer to the CDRPanX Service and Installation manual.

CDRPanX User Guide B1051404 Rev. - 25


Appendix B. Technical Data
Table 4. Summary of PanX Technical Data

Item Description
IEC Classification Class I, type B
Power Supply 230V, 50/60 Hz, 8 A
115V, 50/60 Hz, 16 A
Mains Resistance < 2 ohm at 230V
X-ray Generator Multipulse at 20 kHz
Anode Voltage 60 - 86 kV, Constant Potential
Anode Current 4 - 10 mA, Direct Current
Focus Size 0.5 IEC 336
Inherent Filtration 0.098 in (2.5 mm) Al
Column Height 7.68 ft (234 cm)
Displacement 3.05 ft (93 cm), from 2.9 ft to 5.95 ft (88.5 to 181.5 cm)
Vertical Movement Manual Adjustment
Patient Positioning Manual Carriage Adjustment
Positioning lasers Lateral, mid-sagittal, frankfort
Centering Reference Chin rest with bite stick
Focus Film Distance 1.67 ft (51 cm)
Exposure time 19 s
Projections Adult (19 s)
Children (15 s)
Half Left (10 s)
Half Right (10 s)
Frontal Teeth (8 s)
TMJ opened and closed mouth (4 x 4 s)
Frontal Sinuses (8 s)
Cooling Pause Automatically controlled, 6 minutes maximum
Weight 473 lbs (215 kg)

Table 5. Compliance Specifications

Item Description

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


Medical Electrical Equipment Part 1: General Requirements for Safety
IEC60601-1-2 2.Collateral Standard: Electromagnetic Compatibility – Requirements and
Tests
EN 60601-1-3 Medical Electrical Equipment. Part 1: General requirements for safety.
3 - Collateral Standard: General requirements for radiation protection in
diagnostic X-ray equipment

26 B1051404 Rev. - CDRPanX User Guide


EN 60601-2-7 Medical Electrical Equipment. Part 2: Particular requirements for the
safety of high voltage generators of diagnostic X-ray generators
EN 60601-2-28 Medical Electrical Equipment. Part 2: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for medical
diagnosis

Table 6. Guidance and Manufacturer's Declaration - Electromagnetic Emissions

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

Emissions Test Compliance Electromagnetic Environment


RF emissions Group 1 The CDRPanX system uses RF energy only for its
CISPR 11 internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions Class B The CDRPanX system is suitable for use in domestic
CISPR 11 establishments and in establishments directly
connected to the low-voltage power supply network
that supplies buildings used for domestic purposes.
Voltage fluctuations/ Complies The CDRPanX system is suitable for use in all
flicker emissions establishments directly connected to the public low-
IEC 61000-3-3 voltage supply network.

Table 7. Guidance and Manufacturer's Declaration - Electromagnetic Immunity

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

EN 60601-1-2 Electromagnetic
Immunity Test Compliance Level
Test Level Environment
Electrostatic discharge ±6 kV contact EN 60601-1-2 Test Level Residential
(ESD)
IEC 61000-4-2
±8 kV air
Electrical fast ±2 kV for power EN 60601-1-2 Test Level Residential
transient/burst supply lines
IEC 610004-4 ±1 kV for input/output
lines
Surge ± 1 kV differential EN 60601-1-2 Test Level Residential
IEC 61000-4-5 mode
± 2kV common mode
Voltage dips, short 0% UN EN 60601-1-2 Test Level Residential
interruptions and voltage
for 0.5 cycle
variations on power
supply input lines

CDRPanX User Guide B1051404 Rev. - 27


EN 60601-1-2 Electromagnetic
Immunity Test Compliance Level
Test Level Environment
IEC 61000-4-11 40% UN
for 5 cycles

70% UN
for 25 cycles

0% UN
for 5 sec

Power frequency (50/60 3A/m EN 60601-1-2 Test Level


Hz) magnetic field
IEC 61000-4-8

Conducted RF 3V EN 60601-1-2 Test Level Residential


IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 3 V/m EN 60601-1-2 Test Level Residential


IEC 61000-4-3 80 MHz to 2.5 GHz
Interference may occur in the
vicinity of equipment
marked with the following
symbol.

Table 8. Recommended Separation Distance Between Portable and Mobile RF


Communications Equipment and the CDRPanX System

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

RF Source Typical rated power (W) Distance (m)


Microcellular phone (CT1, CT2, CT3) 0.01 0.3
DECT cellular phone, wireless information 0.25 2
technology equipment (modems, LANs)
Cellular phone, handheld (USA) 0.6 2
Cellular phone, handheld (GSM and NMT, Europe; 2 4
DECS 1800) 8 7
Walkie-talkies (rescue, police, fire, maintenance) 5 3
Cellular phone, bag 16 10
Mobile radio (rescue, police, fire) 100 30

28 B1051404 Rev. - CDRPanX User Guide


For transmitters using frequencies below 800 MHz, the DISTANCE can be estimated using the following equation:
d=1.2x√P

For transmitters using frequencies between 800 MHz and 2 GHz, the DISTANCE can be estimated using the
following equation:
d=2.3x√P

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.

CDRPanX User Guide B1051404 Rev. - 29


Index

A H
Anode Current Setting, 8 High Voltage Setting, 8

C L
CDRPanX Laser Alignment Beams
Control Panel, 5 Frankfort Plane, 9
Control Unit, 7 Lateral Plane, 9
General Information, 3 Mid-Sagittal Plane, 9
Indications for Use, 1
Introduction, 1
Maintenance, 22
M
Operation, 11 Maintenance
Purpose and Features, 1 Periodic, 22
Ready/Not Ready Indications, 11 Scheduled, 22
System Operation, 3 Maxillary Sinuses, 19
Technical Data, 26 Picture of, 20
Turn Off, 12 Monitoring During Exposure, 8
Turn On, 11
CDRPanX Control Panel
Picture of, 5 N
CDRPanX Principal Units Notice
Picture of, 3 Installers, 1
CDRPanX System Users, 2
Electromagnetic Emissions, 27
Electromagnetic Immunity, 27
Recommended Separation Distance Between O
Portable and Mobile RF Communications
Operator
Equipment, 28
Location of Safety Zone, 21
Specifications, 26
Positioning, 21
Control Panel, 5
Error Codes, 25
Table Describing, 5 P
Control Unit, 7
Anode Current Setting, 8 Panoramic Imaging, 13
Exposure, 7 Exposures, 21
High Voltage Setting, 8 Maxillary Sinus Program, 19
Monitoring During Exposure, 8 Patient Positioning, 14
Reset for Next Exposure, 8 Projections and Techniques, 13
Setup for Exposure, 7 TMJ Program, 18
Panoramic Imaging Areas
Picture of, 1
E Panoramic Projections, 8, 13
PanX USB
Error Codes, 25
Cleaning, 23
Table Describing, 25
Interface Maintenance, 24
Error Handling, 8
Patient Positioning, 14
Exposure, 7
Steps for Maxillary Sinuses Projection, 19
Steps for Panoramic Exam, 14
F Steps for TMJ Projection, 18
Purpose and Features of CDRPanX, 1
Focal Trough Adjustments
Pictures of, 17
R
Ready/Not Ready Indications, 11

30 B1051401 Rev. A CDRPanX User Guide


Reset for Next Exposure, 8 TMJ
Reset Function, 8 Picture of, 20
RF Interference, iv Projections, 18
Turning Off the CDRPanX System, 12
Turning On the CDRPanX System, 11
S
Setup for Exposure, 7 V
Summary of Technical Data, 26
Symbols Voltage and Current Settings
Explanation of, v Table Describing, 13

T W
Technical Data, 26 Waste Electrical and Electronic Equipment (WEEE),
Table Summarizing, 26 vii
Technique Factors, 13

CDRPanX User Guide B1051404 Rev. - 31

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