VetPro® VDX Digital Sensor System

User and Installation Guide

Manufacturer: Midmark Corporation

Address: 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A.

Contact: Phone: +1 (847) 415-9800 | Toll Free: (888) 924-3800 (U.S. Only) | Fax: +1 (847) 415-9810

Website: www.progenydental.com

Document Number: 00-02-1673 Rev. C

General Information

Indications for Use

The VetPro® VDX is intended for use by veterinarians and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws, and other oral structures.

Contraindications

None known.

Warnings/Precautions

Radiation Safety

Electrical Safety

Patient Safety

Product Description

The VetPro® VDX is a digital imaging system for dental radiographic applications, used for routine dental examinations such as bitewings and periapicals. It is available in two sensor sizes (size 1 and size 2) to image different anatomy and for different patient sizes. The CMOS sensor connects directly to a PC via a USB connection, eliminating the need for an intermediate electrical interface. The VetPro® VDX operates with a standard dental intraoral X-ray source without direct connection to it. The system captures an image automatically upon sensing X-ray production and transfers it to an imaging software program on the PC. Disposable sheaths are used with each patient to prevent cross-contamination. The VetPro® VDX Sensor is a state-of-the-art intraoral X-ray detector for digital imaging of teeth and the oral cavity.

The system provides:

The components of the VetPro® VDX sensor system include the Digital Sensor, internal USB Cables, and Sensor Calibration Files.

Digital Sensor

The digital sensor transforms a two-dimensional X-ray picture into an electrical signal. It is constructed with a phosphor material (scintillator) layer that emits luminous radiation when exposed to X-rays. This light is transferred to photosensitive elements within the Sensor, where it is converted into an electrical potential. The electrical signal is then sent to the computer for processing.

Sensor Calibration Files

During installation, files specific to the sensor's serial number are stored on each computer where the sensor will be used. For more details, refer to the VetPro® VDX Installation section of this manual.

Progeny Imaging

This software provides the user interface to acquire, store, retrieve, transmit, review, and post-process images captured by the VetPro® VDX sensor system. For more details, refer to the VetPro® VDX Installation section of this manual or the Progeny Imaging User Manual.

NOTE: The VetPro® VDX digital sensor is sensitive to intense UV light. Therefore, the sensor should be stored in its provided box and never exposed to direct sunlight for extended periods.

Explanation of Symbols on Technical Labels

[Caution Symbol] Caution, consult accompanying documents
[Information Symbol] Refer to operating instructions
[Class II Equipment Symbol] Class II equipment – provides double isolation to protect against electric shock
[Type BF Applied Part Symbol] Type BF – provides additional protection against electric shock
IP67 Degree of protection – IP67 means that the sensor casting is: totally protected against dust, protected against the effect of immersion between 15 cm and 1 m.
[Direct Current Symbol] Direct current
SN Serial number
REF Catalogue number
[Date of Manufacture Symbol] Date of manufacture
[Place of Manufacture Symbol] Place of manufacture (manufacturer)

Compliance with Applicable Standards

The following regulatory documents apply:

General Safety

EMI/EMC

Degree of Protection

Imaging Performance

EMC Statement

Information regarding potential EMC interference and advice for avoidance:

Guidance and Manufacturer's Declaration - Electromagnetic Emissions

The VetPro® VDX is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment.

Emission Test Compliance Electromagnetic Environment – Guidance
RF emission (CISPR 11) Group 1 The VetPro® VDX uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference in nearby electronic equipment.
RF emission (CISPR 11) Class B The VetPro® VDX is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emission (IEC 61000-3-2) Not Applicable
Voltage fluctuations/flicker emissions (IEC 61000-3-3) Not Applicable

Electromagnetic Immunity and Separation Distances

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The VetPro® VDX is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance
Electrostatic discharge (ESD) (IEC 61000-4-2) ± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, relative humidity should be at least 30%.
Electrical fast transient/burst (IEC 61000-4-4) ± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines
± 1 kV for input/output lines
Mains power quality should be that of a transient/burst supply lines typical commercial or hospital environment.
Surge (IEC 61000-4-5) ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Not Applicable.
Voltage dips, interruptions, and voltage variations on power supply input lines (IEC 61000-4-11) < 5% UT (>95% dip in UT) for 0.5 cycle
< 40% UT (60% dip in UT) for 5 cycles
< 70% UT (30% dip in UT) for 25 cycles
< 5% UT (>95% dip in UT) for 5 s
Not Applicable.
Power frequency (50/60 Hz) magnetic field (IEC 61000-4-8) 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

Guidance and Manufacturer's Declaration - Electromagnetic Immunity (Continued)

The VetPro® VDX is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance
Conducted RF (IEC 61000-4-6) 3 V
150 kHz to 80 MHz
3 V Portable and mobile RF communications equipment should be used no closer to any part of the VetPro® VDX equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Radiated RF (IEC 61000-4-3) 3 V/m
80 MHz to 2.5 GHz
3 V/m

Recommended separation distance:

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: [Electromagnetic Interference Symbol]

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where the VetPro® VDX is used exceeds the applicable RF compliance level above, the VetPro® VDX should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the VetPro® VDX.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and VetPro® VDX

The VetPro® VDX is intended for use in an electromagnetic environment where radiated RF disturbances are controlled. The customer or user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the sensor, as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum Output Power of Transmitter, W Separation Distance According to Frequency of Transmitter (m)
150 kHz to 80 MHz
d = 1.2 × √P
80 MHz to 800 MHz
d = 1.2 × √P
80 MHz to 2.5 GHz
d = 2.3 × √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.34
10 3.69 3.69 7.38
100 11.67 11.67 23.34

For transmitters rated at a maximum output power not listed above, the recommended separation distance 'd' in meters (m) can be determined using the equation applicable to the transmitter's frequency, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Obtaining Technical Support

Contact: Midmark Corporation

675 Heathrow Drive, Lincolnshire, IL 60069

Phone: +1 (847) 415-9800 | Toll Free: (888) 924-3800 (U.S. Only)

Fax: +1 (847) 415-9810

To facilitate your service call, please have the following information ready:

NOTE: It is recommended that the installing technician review the complete instructions before attempting to install or upgrade any component.

Authorized Representatives

Europe

CE Partner 4U
Esdoornlaah 13
3951DB Maarn
The Netherlands
Phone: +31 (343) 442-524
Fax: +31 (343) 442-162

Installation

Overview

The VetPro® VDX Sensor System is an intraoral digital sensor used with an intraoral X-Ray generator to capture digital images of dentition and surrounding skeletal structures. The Sensor is available in two configurations:

NOTE: The integrated version is available as a retrofit kit for certain existing Progeny products.

Before You Begin

Computer and Software Requirements

You must have a dedicated Computer with a 32-bit or 64-bit Windows operating system and at least one High-speed USB port available. The computer requirements are listed in Table 1.

Image capture and management software must be installed on all computers that will host the VetPro® VDX. The performance of this software is affected by the amount of RAM and storage memory available to the system for acquisition, displaying, storing, and printing digital X-Ray images. The recommended requirements are listed as a guideline only.

NOTE: Be aware that patient volume and specific practice demands may require adjusting these guidelines. The system requirements of other programs operating on the same computer or network may also affect these guidelines.

Table 1: Recommended System Requirements

Component Requirement
Computer Hardware PC - compatible Pentium 4 / 1.4 GHz or greater computer
Memory System 2 GB RAM or higher recommended (minimum 1 GB)
Operating System Microsoft Windows XP Professional with Service Pack 3; Microsoft Vista (Business or Ultimate editions); Microsoft Windows 7 (Professional or Ultimate editions)
Disk Space 450 MB minimum
NOTE: Additional disk space is needed depending on the size of the practice, the number of images, and other information you plan to store. Each image is approximately 4 MB. For example, approximately 300 GB are needed to store 75,000 images.
Display Settings 1024 x 768 (16-bit or higher) with 32 MB (or higher) of Video RAM
NOTE: It is possible to increase these settings based on the actual video adapter installed. As a rule, the better your video adapter or capture card, the better your images.

Installation Procedure

Installing Together with Progeny Imaging Software

When installing the VetPro® VDX sensor drivers and associated software, it is assumed that previous versions of the Progeny Device Suite and Progeny Imaging image management software are not present.

NOTE: Proper operation requires any previous version of Progeny Device Suite and Progeny Imaging to be removed (uninstalled) prior to the installation process.

Execute the following steps:

NOTE: The installation software requires Microsoft .NET Framework revision 3.5. This software will be installed if it is not yet present on the operating system. Follow all on-screen prompts.

NOTE: If the intended configuration is based on Windows XP, the Service Pack 3 update is required. This update is included on the USB flash drive and can be installed from the folder named 'Utilities'. Alternatively, use the Windows update tool provided by Microsoft.

[Description of Figure 2: Main screen of the Installation software, showing options to Install Progeny Device Suite, Install Progeny Imaging, Add Calibration Files, and View Manuals.]

NOTE: The installed software requires multiple software components that may already be available in your system. These components will be installed if they are not yet present. Follow all on-screen prompts.

[Description of Figure 3: Starting the Progeny Device Suite installation, highlighting the 'Install Progeny Device Suite' button.]

[Description of Figure 4: Selecting the device families to be installed, showing checkboxes for Vision DX 500, Vision DX 600, and VetPro VDX.]

[Description of Figure 5: Enable Midmark software installation dialog box, with 'Always trust software from "Midmark"' checkbox and 'Install' button.]

[Description of Figure 6: Starting the Progeny Imaging installation, showing the 'Install Progeny Imaging' button.]

[Description of Figure 7: Progeny Device Suite and Progeny Imaging are installed, showing green check marks next to both installation options.]

Installing Sensor Calibration Files

The VetPro® VDX sensor requires a calibration file to be installed for each device to operate correctly. This calibration file is unique for each sensor and is provided on the USB flash drive.

NOTE: The USB flash drive contains the unique sensor calibration file, operation instructions, and sensor support software. Do not discard or reuse it. Save and store the USB flash drive in a convenient location for future reference.

The calibration files for the VetPro® VDX sensor are installed during the Progeny Device Suite installation from the provided USB flash drive. No additional installation is needed if only one sensor will be used in the installed configuration and the sensor support software was installed from the provided USB flash drive.

Install the sensor calibration file by executing the following steps, if more than one sensor is needed, or if the current sensor is installed after the support software, or if you are uncertain whether the sensor calibration file was installed:

NOTE: Do not run the Progeny Device Suite installation again, as that software is now installed.

[Description of Figure 8: Main screen of the calibration file installation, similar to Figure 2 but focused on calibration.]

[Description of Figure 9: Calibration file installation screen, highlighting the 'Add Calibration Files' button.]

[Description of Figure 10: Select the source folder for the calibration file dialog box, showing a file browser interface.]

[Description of Figure 11: Calibration files are installed, showing a green check mark next to 'Add Calibration Files' and an 'Exit' icon.]

Sensor Installation

If a Standalone version is installed, plug the sensor into an available High-speed USB port on the computer with installed sensor support software. Attach the Sensor Holder to a secure location near the computer and use it as a sensor storage location.

If an Integrated version is installed, plug the sensor into the USB port available at the end of the Articulated Arm, near the tube-head. Verify also that the USB hub embedded in the integrated system is connected with the provided cable to a High-speed USB port of the computer that contains the sensor support software. This connection must be present for the Sensor to be operational. Attach the Sensor Holder to the Articulated Arm near the tube-head if it is provided separately. Use the Sensor Holder as a sensor storage location.

A Windows device driver installation message will be displayed when the sensor is connected to a USB port for the first time.

NOTE: A Windows device driver installation message will be displayed every time the sensor is connected to a new USB port for the first time.

No additional interaction is needed when the VetPro® VDX sensor is used in a Windows Vista and Windows 7 environment. If the VetPro® VDX sensor is used in a Windows XP environment, an installation device wizard may appear (Figure 12). Follow the steps below to complete the installation.

[Description of Figure 12: Found New Hardware Wizard in Windows XP (first screen), showing options for searching for software.]

[Description of Figure 13: Found New Hardware Wizard in Windows XP (second screen), showing options for automatic or manual software installation.]

Sensor Selection in Progeny Imaging

The VetPro® VDX sensor can be used once the Progeny Imaging software is started, as described in the Progeny Imaging Installation Manual. To select the VetPro® VDX sensor, use the 'Device Control Toolbar' by following the steps below.

[Description of Figure 14: Selecting VetPro® VDX sensor in Progeny Imaging, showing a dropdown list with 'VetPro VDX' selected.]

[Description of Figure 15: Successful VetPro® VDX sensor selection, showing a green LED indicator.]

Operating the VetPro® VDX Sensor

Acquiring Images

Prerequisites

Connect the Sensor

  1. Connect the VetPro® VDX X-Ray Sensor to the computer (standalone configuration) or to the USB Interface connector on the Progeny Articulated Arm (in the case of the integrated system configuration).

NOTE: Always attach the sensor and the integrated system to a USB port that complies with the USB specification and supports High-speed transfer. Use only USB certified components that support High-speed transfer if an additional USB hub or USB cable is needed. Attaching the sensor to a different port or using different components and cables will degrade sensor performance. (Contact Progeny technical support or refer to the Service and Installation manual for further information).

Taking Images

  1. Refer to the specific imaging software manual for X-ray image acquisition.

NOTE: We recommend the use of Progeny Imaging image management software. Incompatible software will not allow sensor operation.

  1. Verify that the X-ray system exposure parameters are adequate for the desired examination.
  2. Insert the X-ray sensor into a sensor sheath and then position the sensor inside the patient's mouth in the desired position.
  3. Position the tube head of the X-ray system to the patient, using standard positioning procedures.
  4. Activate the VetPro® VDX via the imaging software (refer to the software guide).
  5. Repeat steps 1-5 for additional images.

Using the Sensor Sheaths

A sample pack of sanitary sheaths is included with your sensor. Sheaths are necessary to avoid patient cross-contamination. Care must be exercised when placing sheaths on sensors or in a positioning device. If you suspect the sheath integrity has been compromised, discard and do not use. The sheaths are not sterile and are intended as a single-use item. Dispose of used sheaths appropriately.

To order more sheaths, contact Progeny or your Progeny dealer.

Follow the procedure below prior to every use of the sensor:

  1. Hold the sheath and insert the sensor into the opening between the white tab and the paper.
  2. Gently slide the sensor into the sheath until it reaches the tip of the sheath. Do not force it.
  3. Peel back the protective cover.
  4. Peel away the paper backing. The sensor is now protected and ready for normal use.

[Description of Figure 16: Using protective sensor sheath, illustrating the process of inserting the sensor into a sheath.]

  1. After use, slide the sensor out of the sheath delicately using the thumb. DO NOT pull the cable while removing the protective sheath.

Recommended Maintenance

VetPro® VDX sensors do not require maintenance. Disinfection is recommended between every use.

Cleaning and Disinfecting

NOTE: Disinfection of the VetPro® VDX sensor is the sole responsibility of the user according to their practice protocol and the instructions, requirements, and limitations of the disinfecting agent being used, as per the manufacturer of the agent.

The VetPro® VDX sensor should be cleaned according to the following procedure:

  1. The VetPro® VDX sensor and associated cables may be disinfected by wiping with a high-level EPA registered hospital disinfectant as per manufacturer's directions.
  2. Use personal protection equipment during the disinfecting process.
  3. Disinfect the sensor and the first 10 centimeters of the sensor cable only, before first use, and before any new patient.
  4. Use a new sanitary sheath for each patient. The sheath must be biocompatible following the standard ISO 10993-1. Sheaths provided by Progeny meet this standard.
  5. Wipe the sensor surface (not the cable) with a gauze sponge moistened with a disinfecting solution.
  6. Disinfection by immersion with a disinfecting solution is preferred. Follow the disinfectant manufacturer's recommended immersion time and other instructions.
  7. The sensor cable can be soaked in a disinfecting solution as long as there is no mechanical damage to the sensor or the cable. If mechanical damage is recognized, consult with Progeny technical support before attempting to immerse the sensor or cable.
  8. Dry the sensor before placement in the next sanitary barrier.

Important:

Preferred Disinfecting Liquids:

Never use:

Specifications

X-Ray Sensor

Property Specification
Film Size Equivalent Size 1 (37 mm x 24 mm)
Size 2 (43 mm x 30 mm)
Active Area (Size 1) 600 mm²
(Size 2) 900 mm²
Number of Pixels 1.65 million Pixels (Size 1)
2.59 million Pixels (Size 2)
Pixel Size 19 µm x 19 µm
Theoretical Resolution 27 lp/mm
Dynamic Range 72 dB
Sensor Cable 3 m or 0.9 m
Connection Type High Speed USB
Power Supply +5 V, per USB 2.0 specification
Level of Protection IP67 (sensor only, per IEC 60529)

Environmental

Property Specification
Operating Temperature between +5 °C and +35 °C (between +41 °F and +95 °F)
Storage Temperature between -40 °C and +70 °C (between -40 °F and +158 °F)
Operating Humidity 5% to 85% operating humidity
Storage Humidity 10% to 90% non-condensing, storage humidity

Terms

Warranty

A separate Warranty Registration form has been included with your system. Please complete and return it immediately to validate your warranty and receive technical support. Progeny cannot offer technical support or assistance unless your product has been registered.

Extended Warranty Options are available. For more details, contact Progeny or your dealer.

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