User Guide
105 Pages
Preview
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Progeny Vantage Panoramic X-ray System
User Guide For Vantage units manufactured during or after October 2012 0120
Part Number: 00-02-1607 REV. H ECN: P3244
Contents Contents ... 2 1 Regulatory Information ... 4 Indications for Use ... 4 Contraindications ... 4 Warnings and Precautions ... 5 Compliance with Applicable Standards ... 7 Certified Components ... 8 Device Labeling ... 9 Optional Cephalometric Extension Labeling ... 10 EC Declaration of Conformity ... 11 EMC Statement... 13 Authorized Representatives... 13 2 Introduction ... 14 Product Description ... 14 Disclaimer about the Manual ... 14 Symbols and Conventions ... 15 Obtaining Technical Support ... 16 3 System Overview ... 17 About the Vantage System ... 17 About the Panoramic X-ray Device ... 17 About the Optional Cephalometric Extension ... 19 4 Projection Summary ... 23 Overview ... 23 Panoramic Standard Projection ... 24 Panoramic Pediatric (Pedo) Projection ... 24 Panoramic Enhanced Projection ... 25 TMJ Projection ... 25 Panoramic Bitewing Projection ... 26 Cephalometric AP/PA Projection ... 26 Cephalometric Lateral Projection... 27 5 System Walkthrough ... 28 Touch Control Panel ... 28 Tools for Patient Positioning ... 47 Cephalometric Positioning Tools ... 52 Entry and Exit, and Ready for Imaging Positions ... 53 Demo Mode ... 53 6 Preparing to Receive the Image ... 54 About Imaging Software ... 54 Using Progeny Imaging Software ... 54 Using Other Software ... 57 7 Getting Started ... 59 Turning the Vantage System On ... 59 Setting the Technique Factors ... 60 Configuring Device Options ... 63 Configuring the Touch Control Panel ... 64 8 Positioning the Patient ... 65 About Patient Positioning and Image Quality ... 65 Preparing the Patient ... 65 2
Progeny Vantage Panoramic X-ray System User Guide
Contents
Setting the Height of the Vantage System ... 66 Inserting the Chin Rest and Bite Guide ... 67 Inserting the TMJ Positioner ... 68 Adjusting the Positioning Wands ... 68 Using the Positioning Lasers ... 69 Cephalometric Positioning (Option) ... 73 Using the Demo Mode ... 77 9 Acquiring a Panoramic Image ... 78 Acquiring an Image ... 78 10 Acquiring a TMJ Image ... 81 About the TMJ Image ... 81 Acquiring a TMJ Image ... 81 11 Acquiring a Cephalometric Image ... 84 Acquiring an Image ... 84 12 Recalling the Last Image... 87 About Image Preview ... 87 Recalling the Last Image ... 87 13 Troubleshooting ... 89 Characteristics of a Quality Panoramic Image ... 89 Characteristics of a Quality Cephalometric Image ... 90 Resolving Image Problems ... 92 13 Maintenance ... 95 Regular Maintenance ... 95 Cleaning and Disinfecting ... 95 14 Error Messages ... 96 Message Overview ... 96 Messages and Actions ... 98 Message Center Interactive Screen ... 100 15 Technical Data Sheet ... 101 Vantage System Function Checklist ... 101 System Specifications Sheet ... 103 Appendix ... 104 X-Ray Tube Information ... 104
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1 Regulatory Information In this Chapter • • • • • • • • •
Indications for Use Contraindications Warnings and Precautions Compliance with Applicable Standards Certified Components Device Labeling EC Declaration of Conformity EMC Statement Authorized Representatives
Indications for Use Statement of Indications for Use The indications for use of the Progeny Vantage Panoramic X-ray System are to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. When the system is equipped with the Cephalometric option, the system will also provide cephalometric radiographic examinations for the use in orthodontic treatment planning and evaluation.
Guidelines for Patient Selection The guidelines for use of the Progeny Vantage Panoramic Extraoral X-ray System are described in the “ADA/FDA Guide to Patient Selection for Dental Radiographs.” This device is to be operated only for the intended use as indicated by prescription of a qualified dental practitioner.
Contraindications None known at this time.
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Progeny Vantage Panoramic X-ray System User Guide
1 Regulatory Information
Warnings and Precautions Radiation Safety Only qualified and authorized personnel may operate this equipment observing all laws and regulations concerning radiation protection. •
The operator during X-ray production must remain 2 m (6 ft.) from the focal spot and the X-ray beam for protection.
•
Full use must be made of all radiation safety features on the equipment.
•
Full use must be made of all radiation protection devices, accessories, and procedures available to protect the patient and operator from X-ray radiation.
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Only qualified and authorized service personnel should remove covers on the equipment.
•
This equipment must only be used in rooms or areas that comply with all applicable laws and recommendations concerning electrical safety in rooms used for medical purposes, e.g., IEC, US National Electrical Code, or VDE standards concerning provisions of an additional protective earth (ground) terminal for power supply connection.
•
Before cleaning or disinfecting, this equipment must always be turned off.
•
The Progeny Vantage X-ray System is ordinary medical equipment without protection against ingress of liquids. To protect against short-circuit and corrosion, no water or any other liquid should be allowed to leak inside the equipment.
Electrical Safety
Explosion Safety This equipment must not be used in the presence of flammable or potentially explosive gases or vapors, which could ignite, causing personal injury and/or damage to the equipment. If flammable disinfectants are used, the vapor must be allowed to disperse before using the equipment.
Damage and Injury Do not place permanent or non-mobile structures beneath the device. Device movement may result in damage to the device or structure, or in injury to the operator or patient.
Cleanliness To prevent cross contamination, always clean the patient contact areas and always install a fresh protective sheath over the bite guide before positioning a patient. The sheath recommended for this application is the TIDI Products, part number 21008.
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1 Regulatory Information
Laser Safety Do not stare into the beam. Do not place eyes closer than 100 mm. This equipment contains class 2 lasers of 3 mW output at 650 nm. The beam is a 40° fan line. The lensing on the laser is not removable. Laser on time does not exceed 100 seconds.
CAUTION! Use of procedures other than those contained within this manual may result in exposure to damaging laser light.
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1 Regulatory Information
Compliance with Applicable Standards Radiation Protection The certified components of the Progeny Vantage Panoramic Dental X-ray System comply with Radiation Performance Standards 21 CFR, Subchapter J, at the time of manufacture.
Performance Standards Standard
Content
IEC 60825-1:2001
Safety of Laser Equipment
IEC 60601-1
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-1
Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-2-7
Medical electrical equipment - Part 2-7: Particular requirements for the safety of highvoltage generators of diagnostic X-ray generators
IEC 60601-2-28
Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-1-3
Medical electrical equipment – Part 1-3: General requirements for radiation protection in diagnostic X-ray equipment
IEC 60601-1-2
EMI/RFI
CAN/CSA 22.2 No. 601.1-M90
Canadian standard for medical electrical equipment
IEC 60601-2-32: 1994
Medical electrical equipment - Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment
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Progeny Vantage Panoramic X-ray System User Guide
1 Regulatory Information
Certified Components Component
Reference Number
Pan tubehead assembly
60-A1014
Pan collimator assembly
60-A2009
Pan X-ray control assembly
60-A2035
Ceph (Option) sensor assembly
60-A1004
Ceph (Option) secondary collimator assembly
60-F4051
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1 Regulatory Information
Device Labeling
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1 Regulatory Information
Optional Cephalometric Extension Labeling
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1 Regulatory Information
EC Declaration of Conformity Name and Description of Product
Progeny Vantage Panoramic Dental X-ray System Catalog V5000 US Domestic Market Model 60-A0001 system Catalog V5100 Export Market Model 60-A0001 system Catalog: V5050 Progeny Vantage Panoramic with Ceph Sensor, Domestic Model: 60-A0008 Catalog: V5150 Progeny Vantage Panoramic with Ceph Sensor, Export Model : 60-A0008 Catalog: V5000C Progeny Vantage Panoramic with Cephalometric Extension, 2 Sensor System, Domestic Model: V5000 + C6000 Catalog: V5100C Progeny Vantage Panoramic with Cephalometric Extension, 2 Sensor System, Export Model: V5100 + C6000 Catalog: V5050C Progeny Vantage Panoramic with Cephalometric Extension, 1 Sensor System, Domestic Model: V5050 + C4000 Catalog: V5150C Progeny Vantage Panoramic with Cephalometric Extension, 1 Sensor System, Export Model: V5150 + C4000 Catalog: Model:
C6000 Cephalometric Extension with Sensor 60-A1009
Catalog: Model:
C4000 Cephalometric Extension without Sensor 60-A1019
Catalog: Model:
Ceph Sensor only 60-A1004
Catalog: Model:
Panoramic Sensor 60-A1010
Class: llb
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Progeny Vantage Panoramic X-ray System User Guide
Reference Numbers to which Conformity is Declared
Declaration
Contact
1 Regulatory Information
The following regulatory documents apply: UL 2601-1 IEC 60601-1-2 IEC 60601-1-3 IEC 60601-2-7 IEC 60601-2-28 IEC 60601-2-32 IEC 60825-1 Medical Device Directive ISO 13485 Machinery Directive Midmark Corporation declares that the products described herein meet all the applicable Essential Requirements of the EC Medical Device Directive 93/42/EEC in Annex I. For Class IIb products described herein, the product is manufactured, inspected, tested, and released in accordance with the approved quality assurance system established in accordance with ISO 13485 and Annex II of the EC Medical Device Directive under the Supervision of the SGS United Kingdom Ltd., a Notified Body. Technical Support Midmark Corporation Phone: 888-924-3800 (Press 3) (U.S. and Canada) +1 847-415-9800 (Press 3) (International) Fax: 847-415-9810 [email protected] Hours: 8:00 a.m. – 5:00 p.m. CT
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Progeny Vantage Panoramic X-ray System User Guide
1 Regulatory Information
EMC Statement Information Regarding Potential EMC Interference and Advice for Avoidance •
Magnetic and Electrical fields are capable of interfering with the proper performance of this device. For this reason, make sure that all external devices operated in the vicinity comply with the relevant EMC requirements.
•
Mains power quality should be that of a typical commercial or hospital environment.
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Power frequency magnetic fields should be at levels characteristic of a typical location in a commercial or hospital environment.
•
If the above criteria cannot be verified, precautions shall be taken when using this equipment as the device may inadvertently operate.
Authorized Representatives North America MIDMARK CORPORATION 675 Heathrow Dr. Lincolnshire, Illinois 60069 U.S.A. Phone: 888-924-3800 (Press 3) (U.S. and Canada) +1 847-415-9800 (Press 2) (International) Fax: 847-415-9810
Europe CE Partner 4U Esdoornlaah 13 3951DB Maarn The Netherlands Phone: +31.343.442.524 Fax: +31.343.442.162
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2 Introduction In this Chapter • • • •
Product Description Disclaimer about the Manual Symbols and Conventions Obtaining Technical Support
Product Description The Progeny Vantage Panoramic X-ray System is an easy to use and easy to install digital panoramic X-ray system. The panoramic X-ray provides a broad overview of the teeth, jaw, and oral structure of the entire mouth. The X-ray image supplies information about the teeth, upper and lower jawbone, sinuses, and other hard and soft tissues of the head and neck. The panoramic digital receptor is contained in a C-arm that moves around the patient’s head. The Vantage System has many applications that include evaluation of third molars, evaluation of patients with past and present TMJ (temporomandibular joint) problems, patients who require full or partial removable dentures, dental implants, or braces, those who are at risk or suspected of having oral cancer or other tumors of the jaw, those who have impacted teeth, and those who have had any recent trauma to the face or teeth (i.e., can help identify a fractured jaw). The optional Cephalometric Extension allows for lateral and PA views of oral structures. The ceph digital receptor is mounted on a transit rail which scans horizontally during ceph examinations. Cephalometric images are typically useful in orthodontic evaluation and treatment.
Disclaimer about the Manual Midmark pursues a policy of continual product development. Although every effort is made to produce up-to-date product documentation, this publication should not be regarded as an infallible guide to current specifications. We reserve the right to make changes without prior notice. The original language of this manual is English.
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Progeny Vantage Panoramic X-ray System User Guide
2 Introduction
Symbols and Conventions Symbol
Explanation Type B: Protection against electric shock (IEC 60601.1-1988). Consult written instructions in the User Guide.
ATTENTION RAYONS-X: OPERATION SEULEMENT PAR DU PERSONNEL AUTORISE. VOIR MANUEL DE L’OPERATEUR. WARNING X-RAY THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED. X-RAY EMISSION
Mains HOT WIRE
Mains NEUTRAL WIRE
Earth Ground
LASER RADIATION DO NOT STARE INTO BEAM CLASS 2 LASER PRODUCT. 650 nm, 3 mW Power off (circle) Power on (line)
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Progeny Vantage Panoramic X-ray System User Guide
2 Introduction
Obtaining Technical Support For Technical Support, contact: MIDMARK CORPORATION 675 Heathrow Drive Lincolnshire, Illinois 60069 U.S.A. Phone: 888-924-3800 (Press 3) (U.S. and Canada) +1 847-415-9800 (Press 2) (International) Fax: 847-415-9810 [email protected] Hours: 8:00 a.m. – 5:00 p.m. CT
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3 System Overview In this Chapter • •
About the Vantage System About the Panoramic X-ray Device
About the Vantage System The Progeny Vantage Panoramic X-ray System consists of the panoramic X-ray device, the exposure button, and the Progeny client software which is installed on computer system(s) within the dental office network. These computer systems are not provided by Progeny Dental.
About the Panoramic X-ray Device The panoramic X-ray device consists of the telescoping column, the overhead assembly, the patient positioning table, and the touch control panel.
Telescoping Column The telescoping column has two main parts: the fixed section and the moving or telescoping section. The fixed section contains the actuator to control up and down movement of the panoramic X-ray device. The telescoping section mounts the patient positioning features. Optical sensors in the telescoping section define the maximum and minimum extension of the column.
Overhead Assembly The overhead assembly consists of an overhead arm and C-arm. The overhead arm supports the C-arm, which rotates. The C-arm includes the tubehead and the removable sensor. The tubehead produces the X-ray beam, and the sensor is a digital image receptor.
Patient Positioning Table The patient positioning table guides and supports the patient’s head during acquisition of panoramic X-ray images by means of the chin rest, bite guide, and positioning wands. The positioning control on the side of the patient positioning table has 4 buttons for the operator to control the up/down movement of the telescoping column, to apply and release the positioning wands, and to turn on positioning lights. The patient positioning table also contains a storage compartment.
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Progeny Vantage Panoramic X-ray System User Guide
3 System Overview
Touch Control Panel The touch control panel is mounted on the fixed column section under the patient positioning table. It is the main user interface for taking X-ray images with the Vantage System and is activated by touch.
Exposure Button The exposure button is used by the operator to take the X-ray. The basic configuration consists of an exposure button connected to the panoramic X-ray device by a coil cord.
Bite Guide A bite guide helps the patient keep his or her jaw correctly positioned. Additional bite guides may be obtained from Progeny. Always install a fresh protective sheath over the bite guide before positioning a patient. The sheath for this application is the Progeny part number 60-S0027.
Chin Rest An easily removable chin rest fits into an opening on the patient positioning table. Additional chin rests may be obtained from Progeny.
TMJ Positioner A TMJ positioner for TMJ X-rays fits into the patient positioning table. TMJ positioners are included with the Vantage.
Emergency Stop Switch The stop switch, mounted under the left side of the patient positioning table near the telescoping column, is for use by the patient. Depressing the button will immediately halt all motor movement. Touching the control panel surface will also abort any movement. The button can be released by turning the knob.
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Progeny Vantage Panoramic X-ray System User Guide
3 System Overview
About the Optional Cephalometric Extension The Cephalometric Extension consists of the support arm, the cephalometric scanning mechanism and the cephalometric sensor.
Support Arm The support arm is an aluminum casting that mounts to the panoramic column’s inner (mobile) component. It mounts via a support casting that allows vertical adjustment of the position of the cephalometric mechanism. The arm can be mounted either to the right, or to the left of the column.
Cephalometric Scanning Mechanism The cephalometric scanning mechanism is comprised of the rail and the transit assembly. The rail supports the transit mechanism, and houses the motor and bearings that cause the transit mechanism to move. The transit assembly mounts the cephalometric sensor and the secondary collimator, and maintains the alignment of the sensor and secondary collimator to the panoramic tubehead. The rail also supports the cephalostat, used to position the patient. The cephalostat is comprised of two otic positioning posts which adjust to conform to the width of the patients head, and a nasion locator, which adjusts vertically and laterally to align the patients head. The entire cephalostat rotates in 22.5° increments to support many cephalometric imaging positions.
Cephalometric Sensor The cephalometric sensor is similar in appearance to the panoramic sensor, but houses within a 21cm long digital detector instead of the 14cm digital detector used for normal panoramic exam. The cephalometric sensor can be used in place of the panoramic sensor, but the panoramic sensor will not operate as a cephalometric sensor.
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Progeny Vantage Panoramic X-ray System User Guide
3 System Overview
Vantage System Panoramic X-ray Device
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