midmark AC2 Intraoral Digital Sensor Instruction Manual

AC2 Intraoral Digital Sensor

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Specifications

Product Name: Midmark DR Sensor

User and Installation Manual: 003-10569-00
Revision AC2 March 2024

Caution: Federal law restricts this device to
sale by or on the order of a veterinarian.

Product Information

Introduction

The Midmark DR Sensor is a digital sensor designed for use in
medical imaging applications. It provides high-quality imaging
results for accurate diagnosis.

Sensor Labels

The sensor labels provide important information about the
device, including serial numbers, manufacturing date, and other
relevant details for tracking and maintenance purposes.

Sensor Configurations

The sensor is available in different configurations to suit
various imaging setups and requirements. Refer to the user manual
for details on different sensor configurations.

Key Components

The key components of the Midmark DR Sensor include the digital
sensor itself, accessories, supplemental parts, and applied parts
for risk management.

Overview

The digital sensor provides high-resolution images for detailed
analysis and diagnosis. It is a crucial component in medical
imaging systems.

Accessories and Supplemental Parts

Various accessories and supplemental parts are available to
enhance the functionality and performance of the sensor. These
include sensor sheaths, positioning devices, and more.

Product Usage Instructions

Installation

Before beginning the installation process, carefully read and
follow the instructions provided in the user manual. Ensure proper
setup and calibration for optimal performance.

Using the Sensor Sheaths

When using the sensor sheaths, make sure to securely attach them
to the sensor to maintain hygiene standards and protect the device
from contamination.

Using a Sensor Positioning Device

Utilize a sensor positioning device to ensure accurate
positioning of the sensor during imaging procedures. Follow the
guidelines for proper placement and alignment.

FAQ

Q: Can the Midmark DR Sensor be used with all imaging

systems?

A: The compatibility of the sensor with different imaging
systems may vary. Refer to the user manual or contact customer
support for specific compatibility information.

Q: How often should the sensor be calibrated?

A: It is recommended to calibrate the sensor periodically as per
the manufacturer’s guidelines to maintain accuracy and
performance.

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Midmark DR Sensor
User and Installation Manual 2
003-10569-00 Revision AC2 March 2024
Caution: Federal law restricts this device to sale by or on the order of a veterinarian.

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Contents
Introduction ………………………………………………………………………………………………………………………….. 5
About This Manual………………………………………………………………………………………………………………………………………………… 7 Safety-Related Notation ………………………………………………………………………………………………………………………………………… 7 Related Manuals ………………………………………………………………………………………………………………………………………………….. 7 Authorized Representatives …………………………………………………………………………………………………………………………………… 8
Europe …………………………………………………………………………………………………………………………………………………………………………….. 8 Indications for Use………………………………………………………………………………………………………………………………………………… 8 Guidelines for Patient Selection ……………………………………………………………………………………………………………………………… 8 Contraindications………………………………………………………………………………………………………………………………………………….. 8 Adverse Reactions ……………………………………………………………………………………………………………………………………………….. 8 Indications of Sterility…………………………………………………………………………………………………………………………………………….. 9 Warnings and Precautions …………………………………………………………………………………………………………………………………… 10
Radiation Safety………………………………………………………………………………………………………………………………………………………………. 10 Electrical Safety ………………………………………………………………………………………………………………………………………………………………. 11 Electromagnetic Compatibility ……………………………………………………………………………………………………………………………………………. 12 Explosion Safety ……………………………………………………………………………………………………………………………………………………………… 13 Thermal Safety………………………………………………………………………………………………………………………………………………………………… 14 Damage and Injury …………………………………………………………………………………………………………………………………………………………… 14 Imaging Software …………………………………………………………………………………………………………………………………………………………….. 15 Connectivity to IT Networks ……………………………………………………………………………………………………………………………………………….. 15 Environmental Conditions…………………………………………………………………………………………………………………………………….. 17 Operational Environment…………………………………………………………………………………………………………………………………………………… 17 Transportation Environment ………………………………………………………………………………………………………………………………………………. 17 Storage Environment………………………………………………………………………………………………………………………………………………………… 17 Units of Measure ………………………………………………………………………………………………………………………………………………… 18 Disclaimer………………………………………………………………………………………………………………………………………………………….. 18 Warranty……………………………………………………………………………………………………………………………………………………………. 18 Obtaining Technical Support ………………………………………………………………………………………………………………………………… 18
Symbols Glossary …………………………………………………………………………………………………………………20 Midmark® DR Sensor Labels ………………………………………………………………………………………………….25
Sensor Labels …………………………………………………………………………………………………………………………………………………………………. 27
Glossary of Terms ………………………………………………………………………………………………………………..29 Midmark® DR Sensor Types …………………………………………………………………………………………………..35
Sensor Configurations …………………………………………………………………………………………………………………………………………. 37
Key Components ………………………………………………………………………………………………………………….39
Overview …………………………………………………………………………………………………………………………………………………………… 41 Digital Sensor …………………………………………………………………………………………………………………………………………………….. 43
Accessories and Supplemental Parts……………………………………………………………………………………….44
Accessories…………………………………………………………………………………………………………………………………………………………………….. 46 Supplemental Parts ………………………………………………………………………………………………………………………………………………………….. 47
Applied Parts From Risk Management……………………………………………………………………………………..49
Applied Parts…………………………………………………………………………………………………………………………………………………………………… 51
Installation …………………………………………………………………………………………………………………………..53
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Overview …………………………………………………………………………………………………………………………………………………………… 55 Before Beginning ………………………………………………………………………………………………………………………………………………… 55
Computer and Software ……………………………………………………………………………………………………………………………………………………. 55 Check System Contents ……………………………………………………………………………………………………………………………………………………. 56 Tools Required………………………………………………………………………………………………………………………………………………………………… 57 Installation Procedure………………………………………………………………………………………………………………………………………….. 57 Installing Midmark Device Suite Together with Midmark Imaging Software………………………………………………………………………………… 57 Installing the Sensor Holder ………………………………………………………………………………………………………………………………………………. 69 Installing the Sensor Calibration Files………………………………………………………………………………………………………………………………….. 70 Device Configuration ………………………………………………………………………………………………………………………………………………………… 72 Device Operation Verification …………………………………………………………………………………………………………………………………………….. 75
Using the Sensor Sheaths ……………………………………………………………………………………………………..76
Using the Sensor Sheaths……………………………………………………………………………………………………………………………………. 78 Overview ………………………………………………………………………………………………………………………………………………………………………… 78 Placing a Sensor in a Sheath …………………………………………………………………………………………………………………………………………….. 78 Removing a Sensor from a Sheath……………………………………………………………………………………………………………………………………… 81
Using a Sensor Positioning Device ………………………………………………………………………………………….84
Using a Sensor Positioning Device………………………………………………………………………………………………………………………… 86
Operating the Midmark® DR Sensor ­ Acquiring Images …………………………………………………………….88
Operating the Midmark® DR Sensor ­ Acquiring Images ………………………………………………………………………………………….. 90 Prerequisites …………………………………………………………………………………………………………………………………………………………………… 90 Connect the Sensor………………………………………………………………………………………………………………………………………………………….. 90 Taking Images…………………………………………………………………………………………………………………………………………………………………. 90 Taking Images using a “Low Emitting” X-Ray Source …………………………………………………………………………………………………………….. 91 After Using the Sensor ……………………………………………………………………………………………………………………………………………………… 91
Appendices ………………………………………………………………………………………………………………………….93
Appendix A : Maintenance……………………………………………………………………………………………………………………………………. 95 Overview ………………………………………………………………………………………………………………………………………………………………………… 97 Maintenance Schedule……………………………………………………………………………………………………………………………………………………… 97 Hygiene………………………………………………………………………………………………………………………………………………………………………….. 97 Parts Breakage ……………………………………………………………………………………………………………………………………………………………….. 99 Cleaning and Disinfection………………………………………………………………………………………………………………………………………………….. 99 Safe Disposal Methods …………………………………………………………………………………………………………………………………………………….102
Appendix B : Technical Specification……………………………………………………………………………………………………………………. 104 Electrical Specification ……………………………………………………………………………………………………………………………………………………..106 X-Ray Sensor………………………………………………………………………………………………………………………………………………………………….106 Source to Skin Distance (SSD)…………………………………………………………………………………………………………………………………………..107 Imaging Workstation Specification………………………………………………………………………………………………………………………………………108 Monitor Specification ………………………………………………………………………………………………………………………………………………………..108 Intraoral X-ray Sources …………………………………………………………………………………………………………………………………………………….108 Sensor Positioning Devices……………………………………………………………………………………………………………………………………………….108
Appendix C: Dose Data ……………………………………………………………………………………………………………………………………… 110 Dose Information……………………………………………………………………………………………………………………………………………………………..112
Appendix D: Troubleshooting Procedures …………………………………………………………………………………………………………….. 114 Error Message Conventions ………………………………………………………………………………………………………………………………………………116 Error Messages……………………………………………………………………………………………………………………………………………………………….117
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Introduction

About This Manual ………………………………………………… 7 Safety-Related Notation …………………………………………. 7 Related Manuals …………………………………………………… 7 Authorized Representatives ……………………………………. 8
Europe……………………………………………………………………. 8 Indications for Use…………………………………………………. 8 Guidelines for Patient Selection ………………………………. 8 Contraindications ………………………………………………….. 8 Adverse Reactions ………………………………………………… 8 Indications of Sterility …………………………………………….. 9 Warnings and Precautions ……………………………………. 10
Radiation Safety …………………………………………………….. 10 Electrical Safety ……………………………………………………… 11 Electromagnetic Compatibility …………………………………… 12 Explosion Safety …………………………………………………….. 13 Thermal Safety ………………………………………………………. 14 Damage and Injury …………………………………………………. 14 Imaging Software……………………………………………………. 15 Connectivity to IT Networks ……………………………………… 15 Environmental Conditions …………………………………….. 17 Operational Environment …………………………………………. 17 Transportation Environment……………………………………… 17 Storage Environment ………………………………………………. 17 Units of Measure …………………………………………………. 18 Disclaimer ………………………………………………………….. 18 Warranty…………………………………………………………….. 18 Obtaining Technical Support …………………………………. 18

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About This Manual
Welcome to advanced dental imaging technology from Midmark. This manual describes the Midmark® DR Sensor and the Midmark® Bite-Resistant DR Sensor (also referred to as “the Sensor”). It explains system components and provides instructions on getting started, installing the software and calibration files, acquiring images, and disinfecting the device.
Safety-Related Notation
Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.
Addresses practices and issues not related to personal injury.
Indicates specific safety-related instructions, procedures, or locations of safety equipment.

Related Manuals

Title

Description

003-10679-00: User and Installation Describes how to install Midmark Imaging, acquire and

Manual ­ Midmark Imaging Soft- work with images using Midmark Imaging, and generally

ware

how to use the features of Midmark Imaging.

003-10454-00: MantaProp User Manual

Conveys information regarding the MantaProp intraoral mouth prop accessory, including indications for use, contraindications, and instructions for use.

003-10585-00: Midmark DC Generator User Manual

Identifies requirements for using the DC Generator Dental X-ray System, as well as quality control, cleaning, and disposal.

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Authorized Representatives
Europe CE Partner 4U Esdoornlaah 13 3951DB Maarn The Netherlands Phone: +31 343.442.524 Fax: +31 343.442.162
Indications for Use
The Sensor is intended to be used by veterinarians and other qualified professionals for producing diagnostic X-ray radiographs of dentition, jaws, and other oral structures in anesthetized patients. The Sensor consists of a sensor head, cable, and USB connector. It is recommended to be used in conjunction with a sensor holder and sensor sheaths.
Guidelines for Patient Selection
The Sensor must only be operated for the intended use as indicated by the prescription of a qualified veterinary practitioner. The device may be applied to the general animal patient population without limitation. See the upcoming “Dose Data” beginning on page 110 for detailed exposure information.
Contraindications
None known.
Adverse Reactions
None known. The Sensor may affect patients with pacemakers. The safety risk related to such use has not been analyzed.
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Indications of Sterility
This product is not provided sterile. For patient safety, always cover the Sensor with a disposable hygienic protective cover prior to use. A new cover must be used for each patient. It is recommended to disinfect the Sensor between uses. Refer to the section Using the Sensor Sheaths beginning on page 76 of this manual.
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Warnings and Precautions
Read the following warnings and precautions before operating the Sensor. Not following the instructions in this manual may cause harm to the patient, operator, or others.
Midmark’s Sensor must be prescribed by a veterinary practitioner skilled in the art of applying radiography in dentistry. Midmark’s Sensor must be applied only by a qualified person, based on clinical examination, the consideration of the patient’s signs, symptoms, oral and medical histories, and consideration of the patient’s vulnerability to environmental factors that may affect oral health. The danger to X-ray use requires the prescriptions to include individual justification of the related risk factors and apply the device only when the additional diagnostic information is expected to improve patient care.
Examine radiological images and consider whether the diagnostic information sufficiently supports the diagnosis or planned treatment. If its information is insufficient, use supplemental information from other X-ray modalities or reapply the Sensor.
The certified components of the Sensor comply with Radiation Performance Standards 21 CFR, Part I, Subchapter J.
Do not modify the Sensor without manufacturer authorization. Modifying the safety mechanisms could result in previously unidentified risks to operators, patients, and third parties.

Radiation Safety

X-rays may be dangerous to patient and operator unless safe exposure factors, operating instructions, and maintenance schedules are observed. Only qualified and authorized personnel may operate the Sensor, observing all laws and regulations concerning radiation protection.

· Stand at least 2 m (approx. 7 ft) away from the focal spot and out of the X-ray beam path during radiography. No significant zone of occupancy is defined.
· Make full use of all radiation safety equipment features, accessories, and procedures available to protect the patient and operator from X-ray radiation.
Use a rectangular cone and sensor positioning devices whenever possible in order to reduce the X-ray dose to the patient.

Maintain audio-visual communication with the patient during X-ray exposure.

Verify the device operation with a radiological image test of a phantom or a test object after installation, servicing, or maintenance.
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Warnings and Precautions (Cont.)
Electrical Safety The Sensor is powered by the USB port. · The Sensor is not serviceable. Contact Midmark Technical Support for service. · Do not replace the Sensor when the patient is in the vicinity of the computer. Do not touch the patient when connecting or disconnecting the Sensor. · The Sensor cable should be handled with care. Do not sharply bend or crimp the Sensor cable. Doing so could permanently damage the Sensor. · The device installation must comply with all local legal requirements concerning electrical safety in rooms used for medical purposes. · Before cleaning or disinfecting, this equipment must always be disconnected from the electrical supply. · The computer and any other associated equipment (like USB hub) shall be placed outside the patient’s environment (i.e., more than 1.8 meters away from the chair). The operator shall not access the patient and such devices at the same time. · The computer and any other associated equipment shall be compliant with IEC 62368 or IEC 60601 (latest edition). · The Sensor is sensitive to ultraviolet (UV) light. Therefore, the Sensor should never be exposed to direct sunlight for extensive periods of time. The storage location should be protected from direct sunlight. · The Sensor enclosure meets IP68 per standard IEC 60529. This allows the Sensor to be placed in cleaning solution for up to 30 minutes. Do not immerse the USB connector. Reference “Appendix A: Cleaning and Disinfection” on page 99.
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Warnings and Precautions (Cont.)
Electromagnetic Compatibility

· Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that all are operating normally.
· Using accessories or cables other than those specified in Sensor product documentation or provided by Midmark could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
· Portable radio frequency (RF) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Sensor, including network and power cables. Otherwise, degradation of the performance of this equipment could result.
· Interference may occur in the vicinity of equipment marked with this sym-
bol . Stop using or reposition the disturbing device if image distortion occurs.

The medical use of the Sensor is exempt from the specific technical standards and other requirements contained in Federal Communications Commission (FCC) Part 15. This exemption requires the user to stop operating the device upon a finding by the Commission or its representative that the device is causing harmful interference.

The Sensor is intended for use in all establishments, including those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Disturbance RF emission Harmonic distortion Voltage fluctuations/ flicker emission

Standard CISPR 11:2019 IEC 61000-3-2:2009
IEC 61000-3-3:2013

Compliance Level Group 1, Class B
Class A
Class A

Guidance
The Sensor is unlikely to cause interference to other medical devices intended to provide electromagnetic compatibility similar to this device.

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The device is designed to be resistant to electromagnetic interferences typical for domestic, commercial, or hospital environments, and it is unlikely to cause interference to other medical devices designed to operate in the same environment.

Immunity Electromagnetic discharge: – Contact – Air Electrical fast transient/burst: – Power supply lines – Input/output lines Surge: – Line to line – Line to earth – Input/output lines Voltage dips, short interruptions, and voltage variations on power supply input lines Power frequency magnetic field:
Conducted RF: – 150 kHz to 80 MHz – ISM band
Radiated RF: – 80 MHz to 2.7 GHz – Proximity fields
from RF wireless communications equipment

Standard IEC 61000-4-2:2008 IEC 61000-4-4:2012 IEC 61000-4-5:2017
IEC 61000-411:2017
IEC 61000-4-8:2009
IEC 61000-4-6:2013
IEC 61000-4-3:2010

Compliance Level
± 8 kV ± 15 kV
± 2 kV ± 1 kV
± 1 kV ± 2 kV ± 1 kV 0 % UT for 0.5 cycles 0 % UT for 1 cycle 70 % UT for 0.5 s 0 % UT for 5 s 30 A/m
3 V 6 V
3 V/m

Guidance The floor must be wood, concrete, or ceramic tile. It is recommended to maintain the relative humidity above 30 % when the floor is covered with synthetic material not treated to reduce the accumulation of static charges.
It is recommended to use an external uninterruptable power supply if continuous device operation is required.
Stop using or reposition the disturbing device if image distortion occurs. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Sensor, including network and power cables. Otherwise, degradation of the performance of this equipment could result. Stop using or reposition the disturbing device if image distortion occurs. Interference may occur in the vicinity of equipment marked with symbol . Stop using or reposition the disturbing device if image distortion occurs.

Explosion Safety
The device is not intended for use in oxygen-rich environments, critical care units, and in the presence of flammable and potentially explosive fluids, gases, or vapors. The safety risk related to such use has not been analyzed. Such use may cause personal injury and damage to the equipment. If flammable disinfectants are used, the vapor must be allowed to disperse before using the equipment.

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Warnings and Precautions (Cont.)
Thermal Safety · The maximum Sensor temperature in the patient’s mouth may reach a temperature of 10 °C higher than the patient’s temperature. · The Sensor surface may remain above 41 °C (106 °F) for up to 10 minutes after the Sensor is removed from the patient’s mouth.
Damage and Injury Prevent damage and injury by observing the following:
· General o Follow all instructions within this manual. o Do not use any materials which are not directly approved. o Do not attempt to modify or repair the Sensor. Modification of the device could damage it and void the warranty. o Do not use the Sensor if it is suspected to be unsafe. Contact Technical Support. o Keep packaging out of reach of children. o Do not use an autoclave or a UV oven to sterilize the Sensor. o Do not allow the temperature of applied parts to exceed 45°C (113°F) in normal conditions. o Leave the Sensor plugged in the computer (if possible).
· Handling o Do not drop the Sensor or allow it to strike a hard surface. Do not pinch it severely. Handle the Sensor with care. o Avoid contact with solvents, flammable liquids, and sources of strong heat, which can damage the plastic enclosure of the Sensor, the cable, and the connector. o Use protective gloves when using and disinfecting the Sensor. o Do not bite the Sensor or cable. o Handle the Sensor carefully when removing it from a positioning system (if used).
· Operation o Do not use the Sensor unless authorized and trained. o Remain at a proper distance from the X-ray beam. o Do not use the device in an inflammable anesthetic gas environment. o Place computer and other associated equipment out from the patient area (more than 1.8m (5.9ft)). o Use electromechanically safe certified computers (IEC 62368-1 or IEC 60601 compliant). o Keep the patient within view while the Sensor is in the patient’s mouth.
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o Do not leave the Sensor inside a patient’s mouth for longer than 10 minutes. o If a positioning system is used, follow the manufacturer’s instructions for use. o Do not touch the patient and computer/associated equipment at the same time. o Double-check the Sensor/X-ray output tube position to reduce the need to reshoot and
thus reduce X-ray doses received by the patient. o If using a Sensor with a 3-meter cable, plug the Sensor into a computer rather than into
the X-ray source. This reduces the risk of power/data loss, therefore reducing the likelihood of needing to reshoot and expose the patient to additional X-ray doses. · Safety and integrity of the cable o Do not pull, bend, or pinch the cable severely. o Plug and unplug the Sensor by holding the USB connector, not the cable. o Do not allow the cable to lay on the floor or across a passageway. o Coil the cable in large loops (1 or 2 loops) if needed during storage and transport. Do not wrap the cable in tight loops (e.g., around a hand). o Do not use computer furniture with drawers that can pinch the cable. o Ensure the cable is not tangled when using the Sensor. o Do not pull the cable when removing protection sleeves/sheaths. o Do not walk over the cable or roll a chair over it. · Storage o Store the Sensor on a holder or a hook fixed on the wall if possible (with no more than 2 sensors on the same hook). Do not coil the cable around the holder. o If storing the Sensor in a wallet, choose a package that allows large cable loops (20cm diameter if possible). Do not use a very tight wallet to store the Sensor. o Do not store the Sensor freely on a table or a shelf.
Imaging Software · The Sensor is designed to interoperate with imaging software through direct integration or by using
TWAIN. Recall the last image if the software interface fails.
Incorrect patient name and tooth number identification may lead to diagnosis or treatment errors. Verify and correct the marking on the recalled image.
Connectivity to IT Networks · The Sensor, computer, and provided cables comprise a medical electrical system. The computer is not intended to be located in the patient environment (within a 1.5m radius of the patient). · The Sensor requires a high-speed USB port for power and communication. Connect to the USB port of a computer or the dedicated port of the Midmark intraoral X-ray source if working with an integrated system.
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· The intraoral sensors are designed to work together in a system with a wide range of equipment, and the following minimum safety requirements must be met for safe operation: o The USB connectivity must meet the requirements of the USB 2.0 or later standard, as evident, for example, by the USB.org logo. o The computers and IT equipment must comply with IEC 62368-1 or IEC 60601-1 standards, as evidenced by the marking on the device or by the manufacturer- provided declaration of conformity. o System installation shall be in accordance with the requirements of IEC 60601-1, the Standard for Safety Requirements of Medical Electrical Systems.
· Note that the sensor interoperation was evaluated with multiple off-the- shelf devices, and the safety of various systems was considered as described in this manual. However, Midmark cannot analyze the safety risk of all available choices, and the responsible organization must ensure the correct and safe equipment interoperation after any non-Midmark device installation or service.
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Environmental Conditions

Operational Environment
The Sensor is intended to operate in temperature-controlled locations, where heating or cooling may be switched off for periods, but the occurrence of extremely low temperatures is prevented. The expected operational environment is:

Description Temperature Relative humidity Atmospheric pressure Maximum altitude

Value + 5 °C to + 35 °C (+ 41 ºF to + 95 ºF)
5 % to 85 %, non-condensing 70 kPa to 106 kPa 3000 m (9842 ft)

To maintain this environment: · Use appropriate heating or cooling equipment. · Use additional humidification where necessary to avoid extremely dry conditions. · Use dehumidification where necessary to avoid extremely humid conditions.

Transportation Environment
The Sensor is intended to be transported for a limited time in weather- protected, heated, and ventilated conditions, or ventilated weather-protected conditions without heating in the general openair climates, excluding Cold and Cold Temperate climates. The expected transportation environment is:

Description Temperature Relative humidity Atmospheric pressure

Value – 25 °C to + 60 °C (- 13 ºF to + 140 ºF)
5 % to 95 %, non-condensing 70 kPa to 106 kPa

Storage Environment
The Sensor is intended to be stored in enclosed locations with no control over humidity. The expected storage environment is:

Description Temperature Relative humidity Atmospheric pressure

Value – 40 °C to + 70 °C (- 40 ºF to + 158 ºF)
10 % to 90 %, non-condensing 70 kPa to 106 kPa

To maintain this environment, use heating to raise low temperatures, especially where there is a large difference between the conditions of this class and the open-air climate.

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Units of Measure
Numeric indications of parameters on the Sensor are expressed in International System of Units (SI) units. Symbols and may be used for marking the angle units, minute and second of angle. When provided, approximate converted values in U.S. customary units are listed in parentheses. The distances in customary units use the abbreviations “ft” and “in” to denote foot and inch units.
Disclaimer
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. Midmark reserves the right to make changes without prior notice. The original language of this manual is English. Translations to other languages are also available.
Warranty
A Warranty Registration Form has been included with the system. Please complete and return it immediately to validate the warranty. Failure to return the completed Warranty Registration Form may result in delays when contacting Technical Support for assistance. For warranty information, visit https://www.midmark.com/warranty-information/dental-warranty.
Obtaining Technical Support
Upon request, qualified installation personnel can obtain part lists, descriptions, and additional Sensor information from Midmark. Contact Midmark for a list of authorized installers.
Midmark Corporation 1001 Asbury Drive, Buffalo Grove, IL 60089 U.S.A. Phone: 1.800.MIDMARK (1.800.643.6275) Direct: + 1.844.856.1232 Fax: + 1.847.415.9801 imagingtechsupport@midmark.com Hours: 8:00 a.m. to 5:00 p.m. Central Time
To facilitate the service call, the following information should be ready and available: · Computer operating system · Version of Midmark Imaging software · Serial number of the Sensor · Type of Midmark Imaging installation (standalone, peer-to-peer network, client-server network)
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Symbols Glossary
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Symbol

Description
Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

Addresses practices and issues not related to personal injury.

Indicates specific safety-related instructions, procedures, or locations of safety equipment.
The manufacturer affirms the product’s conformity with European health, safety and environmental protection standards.

Warns of ionizing radiation.

Signifies that the instruction manual must be read.
Identifies the location where the operator’s manual is stored. Identifies information that relates to the operating instructions. Indicates that the operating instructions should be considered when operating the device or control close to where the symbol is placed.
Identifies a type BF applied part complying with IEC 60601-1.

Class II equipment ­ provides double isolation to protect against electric shock
Degree of protection. IP68 means that sensor casing is totally protected against dust and protected against the effect of immersion as specified in “Appendix A: Cleaning and Disinfection” on page 99.
Identifies the product catalog number or model.

Identifies the product serial number.

Indicates the date on which a product was manufactured.

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Symbol

Description

Identifies the manufacturer of a product.

Indicates that the marked item or its material is part of a recovery or recycling process.
Indicates the maximum and minimum temperature limits at which the item shall be stored, transported, or used.
Indicates the acceptable upper and lower relative humidity limits for transport and storage.
Indicates the acceptable upper and lower atmospheric pressure limits for transport and storage.

Indicates that the items shall not be vertically stacked.

Indicates that the contents of the transport package are fragile, and the package shall be handled with care.
Indicates that the transport package shall be kept away from rain and in dry conditions.

Indicates mass.

Indicates the correct upright position of the transport package.

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Midmark® DR Sensor Labels
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Sensor Labels
Sensor Label Placement Overview
Flag Label on Sensor Cable
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Glossary of Terms
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Term Active Area Beam-limiting Device (BLD)

Meaning
The equivalent sensor area used to produce an image, measured in square millimeters (mm2). The larger the number, the larger the active area.
A device that provides a means to restrict the dimensions of the X-ray field.

Collimator

See [Beam-limiting Device] above.

Connection Type Dynamic Range Exposure (of an object)

Specifies the connection type used to attach the sensor system to the computer.
Represents the largest output of the device as a ratio to the smallest output, measured in decibels (dB). A larger number shows a greater X-ray exposure range in which the Xray sensor system can produce an image without degradation.
See [Irradiation] below.

Exposure (of an X-ray tube)

See [Loading] below.

Exposure Switch

See [Irradiation Switch] below.

Exposure Time (to radiation)

See [Irradiation Time] below.

Field of View (FOV) Film Size Equivalent Flash Memory Interlock

The anatomical area included in the imaged volume or the area of the patient that is irradiated.
The size of the X-ray sensor active area in relation to traditional film-based X-ray systems available to the dentistry profession.
A non-volatile, reprogrammable memory used for data and program storage.
A device preventing the start or the continued operation of equipment unless certain pre-determined conditions prevail.

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Term Intermediate-Level Disinfectant

Meaning
Agent that destroys all vegetative bacteria, including tubercle bacilli, lipid and some nonlipid viruses, and fungi, but not bacterial spores.

Irradiation

In radiology, exposing a living being or matter to ionizing radiation.

Irradiation Switch Irradiation Time Loading Loading Factors Low-Level Disinfectant Number of Pixels Patient Database Patient Information Pixel Size Region of Interest (ROI)

In radiological equipment, a control device provided to initiate and stop irradiation.
The duration of irradiation determined according to specific methods, usually the time a rate of a radiation quantity exceeds a specified level.
In an X-ray generator, the act of supplying electrical energy to the anode of an X-ray tube.
A factor influencing by its value the X-ray tube load, such as X-ray tube current, loading time, continuous anode input power, X-ray tube voltage, and percentage ripple.
Agent that destroys all vegetative bacteria (except tubercle bacilli), lipid viruses, some nonlipid viruses, and some fungi, but not bacterial spores.
The total number of pixels in the sensor active area. It has no unit value; however, a larger number results in a finer image.
An organized collection of data stored and accessed electronically that contains medical information about individual patients.
An informational record that uniquely describes each patient. It contains the patient’s first name, last name, and ID.
The size of the smallest discrete picture element used in the process of image acquisition, measured in micrometers (µm). The smaller the pixel size, the finer the image.
Localized part of an image that is of particular interest at a given time.

Sensor Cable

Identifies the type and length of the sensor cable.

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Term

Meaning

Technique Factors

See [Loading Factors] above.

Theoretical Resolution
Useful Beam (X-ray Imaging Device)
X-ray Tube

Measures the maximum level of detail that the sensor system is capable of acquiring, measured in line-pairs per millimeter (lp/mm). The larger the number, the finer the image.
The radiation which passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch is activated.
An electron tube, which is designed for the conversion of electrical energy into X-ray energy.

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003-10569-00 Midmark® DR Sensor User and Installation Manual Revision AC2 Sensor Configurations………………………………………….. 37
Midmark® DR Sensor Types
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Sensor Configurations

The DR Sensor is available in multiple configurations:

· Midmark® DR Sensor (Size 2 ­ external size of 42.8 x 30.5 x 5.7 mm)

· Midmark® Bite-Resistant DR Sensor (Size 2 ­ external size of 42.8 x 30.5 x 5.7 mm)

· Short cable ­ 1.1 m

· Long cable ­ 3 m

· Standalone system ­ A system in which the Sensor is plugged into a USB port on a computer.

· Integrated system ­ A system in which the Sensor is plugged into the USB port on the intraoral X-ray device. (Note: Refer to 003-10585-00, the user manual for Midmark’s DC Generator X-Ray System, for catalogue numbers of integrated systems.)

The following standalone configurations are available:

Catalogue Number XSVN-06 XSVS-06 XSVS-06/L XSVN-08 XSVS-08 XSVS-08/L

Description
Midmark IO DR Sensor, Size 2, 1.1M Cable, Vet Midmark IO DR Sensor, Size 2, 3M Cable, Vet Midmark IO DR Sensor, Size 2, 3M Cable, w/laptop, Vet Midmark Bite- Resistant IO DR Sensor, Size 2, 1.1M Cable, Vet Midmark Bite-Resistant IO DR Sensor, Size 2, 3M Cable, Vet Midmark Bite-Resistant IO DR Sensor, Size 2, 3M Cable, w/Laptop, Vet

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Key Components

Overview ……………………………………………………………. 41 Digital Sensor ……………………………………………………… 43

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Overview
The Sensor is a digital imaging system for dental radiographic application. The product is to be used for routine veterinary dental radiographic examinations. Two different versions (standard and bite-resistant) are utilized to image patients in accordance with veterinary professional expertise. The Complementary Metal Oxide Semiconductor (CMOS) sensor connects directly to a USB connection in a personal computer (PC) without the need for an intermediate electrical interface. The Sensor works with a standard dental intraoral X-ray source without any connection to the X-ray source. The Sensor captures an image automatically upon sensing the production of X-ray, and after the X-ray is complete, transfers the image to an imaging software program on the PC. Disposable sheaths are used with each use to prevent cross- contamination between patients. The Sensor is a state-of-the-art intraoral X-ray detector intended for digital imaging of teeth and the oral cavity. The components of the Sensor system are a computer, the Digital Sensor, USB connectivity, and an X-ray source.
Key components of a standalone system.
Key components of an integrated system.
1 Computer A computer with imaging software used to initiate radiography, view radiographs, and store the images together with patient data in a database.
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2 Digital Sensor The digital sensor is designed to transform a two-dimensional X-ray picture into an electrical signal. The structure of the Sensor is assembled with a first layer of phosphor material (scintillator) which, when exposed by incident X-rays, emits a luminous radiation. This light is then transferred to the photo sensitive elements of the Sensor, where it is transformed to electrical potential. The electrical signal is sent to the computer for processing.
3 USB Connectivity The means by which the Sensor connects to a power source and the imaging software. The USB connector at the end of the Sensor cable is inserted into a USB port on either a computer (standalone system) or the intraoral X-ray device (integrated system)
4 X-Ray Source The source of the X-ray radiation used to create the radiographic image; i.e., the intraoral Xray device.
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Digital Sensor
1 Imaging Receptor The imaging receptor is the portion of the device that is placed in the patient’s mouth to receive X-rays and transform them into an electrical signal. (Also sometimes referred to as just “the sensor.”)
2 Sensor Cable The sensor cable is the portion of the device that transmits the electrical signal from the imaging receptor to the computer for processing.
3 USB Connector The USB connector is the portion of the device that connects the Sensor to a USB port on either a computer (standalone system) or the intraoral X-ray device (integrated system).
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Accessories

and

Supplemental Parts

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Accessories Part

Description

Protective Sheath ­ PN 500-435 (size #2 sample pack)
­ PN 500-433 (size #2 500 CT pack)
Protective liner sheaths that provide a safe and effective barrier between the Sensor and the patient. They are consumable and non-sterile.

X-Ray Source
Any intraoral X-ray source suitable for producing diagnostic X-ray radiographs of dentition, jaws, and other oral structures. Refer to 003-10585-00, the user manual for Midmark’s DC Generator Dental X-Ray System, for Midmark part numbers.

MantaProp ­ PN 8597 (box of 10, size small) ­ PN 8598 (box of 10, size medium) ­ PN 002-10747-00 (kit of PN 8597 and 8598)
A single-use mouth prop accessory intended for use during veterinary intraoral radiography performed under general anesthesia. It offers added protection to a digital dental sensor should an animal patient attain a lighter stage of anesthesia and regain a bite reflex.

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Supplemental Parts Part

Description

Sensor Holder ­ PN 45-A2018, 45-A2018-W, 45-A2019, or 45-A2019-W
Plastic holder to store the Sensor when not in use. Available with either a straight back or a curved back for mounting on either a flat surface or a curved surface (e.g., articulated arm). Available in both gray and white.

Laptop with Installed Midmark Imaging ­ PN 002-11068-00
A laptop that comes with Midmark Imaging software pre-installed for use with the Sensor.

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Applied Parts From Risk Management
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Applied Parts Because the Sensor is covered with a sheath during use, there are no applied parts. However, the Sensor head and the first 10cm of the cable are treated as applied parts. Refer to highlighted portions of the image below.
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Installation

Overview ……………………………………………………………. 55 Before Beginning…………………………………………………. 55
Computer and Software …………………………………………… 55 Check System Contents ………………………………………….. 56 Tools Required ………………………………………………………. 57 Installation Procedure…………………………………………… 57 Installing Midmark Device Suite Together with Midmark
Imaging Software …………………………………………… 57 Installing the Sensor Holder ……………………………………… 69 Installing the Sensor Calibration Files ………………………… 70 Device Configuration ………………………………………………. 72 Device Operation Verification……………………………………. 75

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

The Sensor is an intraoral digital sensor used with an intraoral X-ray generator to capture digital images of dentition and the surrounding skeletal structures. The Sensor is available in two configurations:
· Standalone ­ Sensor, connected directly to a PC. (Note: This Sensor can be used with any intraoral X-ray source.)
· Integrated ­ Integrated into and part of the Midmark Complete System (Midmark DC Generator + Sensor).
If using a laptop that was purchased from Midmark as part of a combination sensor/laptop catalogue number, the following steps have already been completed at the factory and can be skipped:
· Installing the Midmark Device Suite
· Installing Midmark Imaging

Before Beginning

Computer and Software

The dedicated computer must have a 64-bit Windows operating system and at least one Highspeed USB port available. The computer requirements are listed in the table below.

Parameter

Recommended

Minimum

Windows Operating System

Windows 11 Pro or Enterprise

Windows 10 Pro or Enterprise

Apple Support Intel®-based Apple® hardware running native Windows Platform using Boot Camp

Processor

Intel i5 (or better)

Intel i3

Memory

16 GB RAM (or greater)

8 GB RAM

Storage*

512 GB Hard Drive (or greater)

256 GB Hard Drive

Video

32 bit, 1920 × 1080 resolution capable 32 bit, 1024 × 768 resolution capable

Display

1920 × 1080, 32 true bit color

1024 × 768, 32 true bit color

USB Ports

High Speed USB 3.0

High Speed USB 2.0

*A back-up storage device is recommended (DVD, external hard drive, etc.)

The installer must have administrator privileges on the computer (or the administrator must be available to enter admin credentials) in order to install the software.

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Image capture and management software must be installed on all computers that will host the Sensor. The performance of that software is affected by the amount of random access memory (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. The host computer used with the Sensor must have a declaration of conformity for class A compliance with CISPR 32 or EN 55032 and their national deviations for the market in which the Sensor was distributed.
Be aware that the patient volume and the specific demands of a given practice may require adjusting these guidelines accordingly. The system requirements of other programs operating on the same computer or network may affect these guidelines as well.
Midmark requires the use of Midmark Imaging and Midmark Device Suite software. It must be installed on every computer that will interface with the Sensor. If it is not intended to use Midmark Imaging, then compatible image capture and management software must be installed on all computers to be used. This software may support direct integration with the Sensor or may use TWAIN interface through the Midmark Device Suite software. This manual covers the basics for installing the Midmark Imaging software. However, the Midmark Imaging Software User and Installation Manual (003-10679-00) should be consulted for further information on how to install and use the software. Contact Technical Support if needed. For installation and use of third-party software that supports direct integration, refer to that software’s installation and user manuals.
Check System Contents Verify that all items listed on the Packing List are contained in the system order. If any item appears to be missing, contact Technical Support immediately. Use the image below as a guide.
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Tools Required No tools are required to install the Sensor.
Installation Procedure
Installing Midmark Device Suite Together with Midmark Imaging Software The Midmark Imaging software was formerly known as Progeny Imaging. The Progeny Imaging name still appears in some places, such as file paths. Existing customers may have Progeny Imaging installed. Midmark Imaging and Progeny Imaging are the same software, just with different branding. Midmark Imaging is the more up-to-date version.
When installing the Sensor drivers and associated software, it is assumed that previous versions of the Midmark Device Suite and Midmark Imaging image management software are not present.
Proper operation requires any previous version of Midmark Device Suite and Midmark Imaging to be removed (uninstalled) prior to the installation process to begin.
IMPORTANT: If both Midmark Device Suite and Midmark Imaging are installed, Midmark Imaging must be uninstalled BEFORE Midmark Device Suite is uninstalled. Uninstalling Midmark Device Suite first will cause an error that prevents Midmark Imaging from being uninstalled.
For computers with legacy programs installed, Progeny Imaging may be present instead of Midmark Imaging, and there may be only one Midmark Device Suite instead of two. These should be uninstalled as applicable and in the same order as indicated in the previous paragraph.
Execute the following steps: 1. Log on to the Windows computer with administrator privileges (or ensure that the administrator is available to enter admin credentials). 2. Insert the Midmark USB flash drive into an available USB port on the computer and allow the computer to recognize the flash drive. If the software on the USB flash drive does not start automatically, navigate to Windows ExplorerTM and select the MIDMARK_VP drive
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letter. Browse to the content of the flash drive and double-click on setup.exe. This step begins the installation process.
3. A “User Account Control” pop-up window appears confirming the choice to make changes to the device. Click Yes.
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4. The main window of the Midmark Device Suite installation software opens. Click on the Install Midmark Device Suite button.
The installed software requires multiple software components that may already be available in the system. These components will be installed if they are not yet present. Follow all on-screen prompts. See below for an example. If a step requires the computer to be restarted and the installation process does not automatically resume upon restart, navigate to setup.exe as previously described and double-click on it again. Repeat the previous steps as necessary.
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5. After clicking on the Install Midmark Device Suite button, the Select Devices to Install pop-up will be displayed. Check all available options. An Install button will appear. Click that.
6. The “Driver Installation” pop-up appears with a green progress bar that loads from left to right as installation occurs. Wait for the bar to finish loading.
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7. When the green bar has fully loaded, the driver installation window will automatically close, and the setup wizard pictured below will appear. Click on the Next button.
8. A license agreement appears with the default of “I Do Not Agree” selected and the Next button grayed out. Scroll through the agreement and read it by clicking the downward arrow towards the right-side edge of the window. If the terms are acceptable, click the radio button next to “I Agree,” then click the Next button.
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9. The window shown below appears. Default options are populated automatically as shown below. These options can be changed according to user preference. When satisfied with the selections, click the Next button.
10. The “Confirm Installation” window appears. Click the Next button.
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11. A window showing a loading bar indicating the progress of the installation may briefly appear. When the installation is complete, the loading bar window closes and the “Installation Complete” window appears. Click the Close button.
12. The setup wizard pictured below appears. Click Next >.
13. A license agreement appears with the default of “I Do Not Agree” selected and the Next > button grayed out. Scroll through the agreement and read it by clicking the downward
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arrow towards the right-side edge of the window. If the terms are acceptable, click the radio button next to “I Agree,” then click the Next > button.
14. The window pictured below appears. Default options are populated automatically as shown below. These options can be changed according to user preference. When satisfied with the selections, click the Next > button.
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15. The “Confirm Installation” window appears. Click the Next > button.
16. A window showing a loading bar indicating the progress of the installation may briefly appear. When the installation is complete, the loading bar window closes and the “Installation Complete” window appears. Click the Close button.
17. On the main installation screen, there will now be two green check marks next to the Install Midmark Device Suite button, indicating that installation of the device suite is
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complete. Continue by clicking on the Install Midmark Imaging button to install Midmark Imaging software.
18. The “Midmark Imaging Setup” window appears. Click the Next > button.
19. A license agreement appears with the default of “I Do Not Agree” selected and the Next > button grayed out. Scroll through the agreement and read it by clicking the downward
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arrow towards the right-side edge of the window. If the terms are acceptable, click the radio button next to “I Agree,” then click the Next > button.
20. The “Confirm Installation” window appears. Click the Next > button.
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21. A window showing a loading bar indicating the progress of the installation may briefly appear. When the installation is complete, the loading bar window closes and the “Installation Complete” window appears. Click the Close button.
22. The main installation window will now show a green checkmark next to the Install Midmark Imaging button to indicate that Midmark Imaging has been successful installed. Click on the door icon in the lower-right corner to close out the window.
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Do not discard or reuse the USB flash drive. It contains the operation instructions and the sensor support software. Save and store the USB flash in a convenient location to allow future references to its content.
Installing the Sensor Holder · Choose a location for the sensor holder. This is where the sensor will be stored when not in use. The location is flexible based on user preference. However, it should be confirmed that the intended holder location is close enough to the intended USB port that the cable can reach between the two. · The Sensor is sensitive to intense ultraviolet (UV) light. Therefore, the Sensor should never be exposed to direct sunlight for extensive periods of time. Accordingly, if it is intended to use the sensor holder for long-term storage, the chosen location should not be in the path of direct sunlight. o If installing a standalone system, this location will likely be near the computer that has the sensor support software installed. o If installing an integrated version, this location will likely be on the articulated arm of the X-ray-emitting device. · Ensure that the chosen location is clean, dry, and free of debris. · Select a sensor holder based upon the chosen location. The sensor holders are available in two colors (gray and white) and two shapes (curved back and straight back) depending upon the surface of the chosen location. See below. (Note: This image is for illustrative purposes only. The color(s) and shape(s) of sensor holders received depend upon the model of sensor that was ordered.)
· Remove the backing from the sensor holder.
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· Press the sticky side of the sensor holder against the chosen location. See below for an example of a sensor holder installed on an articulated arm (pictured here with a Sensor inside).
Installing the Sensor Calibration Files The Sensor requires a calibration file to be installed for each Sensor to operate correctly. This calibration file is unique for each Sensor, and it is provided on the Sensor itself. 1. Use the sensor holder as the Sensor storage location. 2. Plug the Sensor into an available high-speed USB port. o If installing a standalone system, plug the Sensor into an available high-speed USB port on the computer that has the sensor support software installed. o If installing an integrated system, plug the Sensor into the USB port available at the end of the articulated arm (near to the tubehead; refer to images below). Also verify that a high-speed cable on the control unit is connected to the PC that has the imaging software. That connection has to be present for the Sensor to be operational. Power loss and/or data loss can result from plugging a Sensor with a 3-meter cable into the articulated arm. Do not plug a Sensor with a 3-meter cable into the articulated arm. Doing so exceeds the connection length specification. 3-meter Sensors should only be plugged into a computer. 1.1-meter Sensors can be plugged into either a computer or an articulated arm.
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3. Start the Midmark Imaging program by double-clicking on the Midmark Imaging icon on the computer desktop (pictured below). There may be a slight delay before it opens.
4. In the Device Controls Toolbar at the top of the Midmark Imaging screen, locate the drop-down field that is next to the circular red device status indicator. “” is displayed in the field. Click on the drop-down arrow to the right of this field.
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5. A drop-down menu appears with a list of devices. Click on the name that corresponds to the device that was just plugged in. (Note: the below image is an example for illustrative purposes only. The names of sensors may vary depending upon device(s) purchased.)
6. A pop-up window appears showing the progress of the calibration file download. Wait for the download to complete. The “Downloading” window will automatically close when it is done.
7. The circular device status indicator is now green. (See image below.) This confirms that the Sensor is now connected to the computer and the calibration files are now downloaded.
Device Configuration · Click on the green device status indicator. See image below.
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· The Device Configuration Window opens.
· Make changes to the configuration settings as desired. The available options are described and explained in the table below. Additional details are available in the Midmark Imaging Software User and Installation Manual, 003-10679-00.
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Settings options: Name: Description: Timeout:
X-Ray Source: Sensitivity:
Sensor Info: Type: Serial Number: USB Interface: Firmware Version: Sensor Size: Screen Buttons: Filters Setup: Reset to Defaults: Download Calibration File
Recall Last Image Close

This is the Sensor name that will appear in the Device Menu. (This field cannot be changed.) This allows user to enter more information about the Sensor. This option allows the user to adjust the length of the timeout period (in seconds). If image is not taken within the timeout period, the sensor returns to “unarmed” state. This option allows the user to change the X-ray source (AC or DC). This option allows the users to adjust the “Trigger Level” (sensitivity) of the Sensor. The “Sensitivity” (Selector) is default to the setting of “200.” (Note: This setting is useful when acquiring images with a “low-emitting” X-ray source; however, lowering the sensitivity below 200 may result in the sensor triggering without an exposure.)
Displays the Sensor type Displays the serial number Displays the USB Interface Displays the firmware version Displays the Sensor Size
This allows the user to configure the filter settings that are applied automatically to an image upon acquisition. This allows the user to restore the “Device Configuration” (Window) to default factory settings. Can be used to manually download the calibration files in the case that the Sensor becomes disconnected during the calibration process or that the calibration files are not automatically downloaded. This will retrieve the last image taken and import said image to the currently opened Patient. This closes the “Device Configuration” window.

· If the user makes changes and then clicks Close, a pop-up will appear asking to confirm whether changes should be applied. Select the desired option.

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Device Operation Verification Once installed, device operation must be verified with a radiological image of a test phantom or test object. See section Maintenance Schedule beginning on page 97 of this manual for instructions and details.
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Using the Sensor Sheaths

Using the Sensor Sheaths…………………………………….. 78 Overview ………………………………………………………………. 78 Placing a Sensor in a Sheath……………………………………. 78 Removing a Sensor from a Sheath ……………………………. 81

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Using the Sensor Sheaths
Overview The following procedures are examples only. Procedures may differ slightly based on the manufacturer of the sheath used. Always consult the manufacturer’s instructions for sheath use and placement.
Use a new sanitary sheath for each patient. The sheath must be biocompatible following the standard ISO 10993-1. Sheaths provided by Midmark meet this standard. A sample pack of sanitary sheaths is included with the Sensor. (Refer to image below.)
Sheaths are necessary to avoid patient cross contamination. Care must be exercised when placing sheaths on Sensors (or in a positioning device, if used; follow the instructions of the positioning device’s manufacturer). If there is reason to suspect the sheath integrity has been compromised, do not use the affected sheath; discard it and replace with a fresh one. The sheaths are not sterile and are intended as a single-use item. Dispose of used sheaths appropriately. To order more sheaths, contact Midmark or a Midmark dealer. Placing a Sensor in a Sheath Follow the procedure below prior to every use of the Sensor.
Gloves should be worn when placing the Sensor in a sheath.
1. Obtain a sheath and inspect it for any holes, tears, or other integrity issues. Discard and obtain a fresh sheath if any issues are identified.
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2. Hold the sheath and insert the Sensor into the opening between the white tab and the paper.
3. Gently slide the Sensor into the sheath until it reaches the tip of the sheath. Do not force it.
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4. Peel back and remove the protective cover. 5. Peel away the paper backing.
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It may be helpful to wrap the loose sheath material around the Sensor cable. If so, take care not to twist the cable itself.
6. Double-check the sheath for any holes, tears, or other integrity issues. Discard and obtain a fresh sheath if any issues are identified.
7. The Sensor is now protected and ready for normal use. Removing a Sensor from a Sheath
Gloves should be worn when removing the Sensor from a sheath. 1. If the loose sheath material was wrapped around the Sensor cable, gently untwist it, tak-
ing care not to twist the cable itself. 2. Using the thumb, delicately slide the Sensor out of the sheath. DO NOT pull the cable
while removing the protective sheath; damage to the Sensor can result.
3. Dispose of the sheath properly.
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Wastes containing blood and saliva used in dental procedures are considered regulated waste. Such waste must be placed in containers which are:
· Closable · Puncture resistant · Leakproof on sides and bottom · Labeled or color-coded per 29 CFR§1910.1030(g)(1) · Closed before removal to prevent spillage or protrusion of
contents during handling, storage, transport, or shipping.
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Using a Sensor Positioning Device

Using a Sensor Positioning Device ………………………… 86

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Using a Sensor Positioning Device
If a positioning device is used, refer to the manufacturer’s manual for instructions for optimal usage.
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Operating the Midmark® DR Sensor ­ Acquiring Images

Operating the Midmark® DR Sensor ­ Acquiring Images ………………………………………………………………….. 90
Prerequisites………………………………………………………….. 90 Connect the Sensor ………………………………………………… 90 Taking Images ……………………………………………………….. 90 Taking Images using a “Low Emitting” X-Ray Source……. 91 After Using the Sensor…………………………………………….. 91

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Operating the Midmark® DR Sensor ­ Acquiring Images
Prerequisites · Install the imaging software following the installation steps provided with the product. · The Sensor has undergone image verification using a test phantom or test image after installation. · Consult 003-10454-00, the MantaProp User Manual, to determine whether use of the intraoral mouth prop accessory is appropriate. Follow the instructions given.
Connect the Sensor 1. Connect the Sensor to the computer (standalone configuration) or to the USB interface connector on the DC Generator articulated arm or elsewhere as applicable (integrated system configuration).
Power loss and/or data loss can result from plugging a Sensor with a 3-meter cable into the articulated arm. Do not plug a Sensor with a 3-meter cable into the articulated arm. Doing so exceeds the connection length specification.
3-meter Sensors should only be plugged into a computer. 1.1-meter Sensors can be plugged into either a computer or an articulated arm.
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 prevent the imaging software from recognizing the Sensor. (Contact Midmark technical support for further information.)
Taking Images 1. Refer to the specific imaging software manual for X-ray image acquisition.
Midmark recommends the use of Midmark Imaging image management software. Incompatible software will not allow Sensor operation.
2. Verify that the X-ray system exposure parameters are adequate for the desired examination. Refer to the dose table in section Dose Information beginning on page 112 of this manual for guidance.
3. Insert the Sensor into a sensor sheath. Refer to the Using the Sensor Sheaths section beginning on page 76 of this manual.
4. Position the Sensor inside the patient’s mouth in the desired position.
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5. Position the tubehead of the X-ray system to the patient using standard positioning procedures.
6. Activate the Sensor via the imaging software (refer to the software manual). 7. Radiate the Sensor. 8. Repeat steps 1-7 for additional images.
Taking Images using a “Low Emitting” X-Ray Source 1. Refer to the specific “Low Emitting” X-Ray Source manual for X-ray image acquisition settings. 2. Verify that the X-ray system exposure parameters are adequate for the desired examination. 3. Insert the Sensor into a sensor sheath. 4. Position the Sensor inside the patient’s mouth in the desired position. 5. Position the X-ray system to the patient using standard positioning procedures. 6. Activate the Sensor via the imaging software (refer to the software manual). 7. Radiate the Sensor. 8. Repeat steps 1-7 for additional images. See the section Device Configuration beginning on page 72 of this manual to adjust the sensitivity (trigger level) of the Sensor.
After Using the Sensor 1. Once all desired images are acquired, remove and discard the sensor sheath. (Refer to the section Removing a Sensor from a Sheath beginning on page 81 of this manual.) 2. Disinfect the Sensor. (Refer to the section Cleaning and Disinfection beginning on page 99 of this manual.) 3. Place the Sensor back in the sensor holder.
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Appendices

Appendix A : Maintenance ……………………………………. 95 Appendix B : Technical Specification ……………………. 104 Appendix C: Dose Data………………………………………. 110 Appendix D: Troubleshooting Procedures……………… 114

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Appendix A: Maintenance

Overview ………………………………………………………………. 97 Maintenance Schedule ……………………………………………. 97 Hygiene ………………………………………………………………… 97 Parts Breakage ………………………………………………………. 99 Cleaning and Disinfection ………………………………………… 99 Safe Disposal Methods ………………………………………….. 102

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Overview
The maintenance schedule of the Sensor to be performed by the user is defined in the Maintenance Schedule section beginning on page 97 of this manual. Disinfection is recommended between every use. The Sensor does not require periodic calibration. Required cleaning and disinfecting described in this appendix may be performed by a person designated by the responsible organization. That person needs to be knowledgeable about the Sensor operation and the clinical practices adopted by the dental office.

Maintenance Schedule
Action Imaging receptor operation inspection Sensor cable integrity On-product labeling inspection Imaging performance verification

Frequency
At least semi-annually
At least monthly
Annually
Quarterly, with a frequency specified by the user based on the risk related to the performed treatments and whether the sensor has been dropped, mishandled, or bitten by a patient.

For operation inspection, ensure the Sensor is reliably detected by the software and reliably captures images of the test object. Consult this manual for troubleshooting.
For cable verification, verify the cable jacket is not damaged and there is no exposed wire. Replace the Sensor if the cable is pinched or visibly damaged.
For label verification, verify that the text is legible. Contact Technical Support if the label is damaged.
For imaging performance verification, purchase qualification phantom per IEC 61223-3-4. Replace the Sensor if the performance does not meet the minimum performance specified in the standard.

Hygiene
The applied parts listed in the Applied Parts section beginning on page 49 of this manual require cleaning and disinfection after every patient, including the Sensor head and the first 10cm of the cable. The methods described here protect operators and patients and also will not damage the Sensor.
· Wear disposable gloves when taking X-ray patient scan images. · Wear disposable gloves when performing cleaning and disinfection procedures.

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· If patient positioners are used, clean and disinfect per manufacturer’s instruction. · Clean and disinfect the Sensor and the first 10cm of the cable.
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Parts Breakage
Handle and store the Sensor with care to prevent breaking it during use or storage. Replace broken parts before the next use.
The Sensor’s enclosure is designed to minimize X-ray attenuation and may break more easily during cleaning or use.
Cleaning and Disinfection
Disinfection of the Sensor is the sole responsibility of the user according to their practice’s protocol and the instructions, requirements, and limitations of the disinfecting agent being used as per the manufacturer of the agent.
Do not use an autoclave or a UV oven to sterilize the Sensor. Doing so may damage the electronics and closure, thus voiding the warranty.
Always use protective gloves when disinfecting the Sensor.
Before cleaning or disinfecting, this equipment must always be disconnected from the electrical supply.
When to Clean/Disinfect the Sensor
· After each instance of installation, servicing, or use of the device. · Prior to each usage with a new patient. · Clean and periodically disinfect parts that may accidentally have come into contact with pa-
tients’ skin or been cross-contaminated by the operator. Selecting a Disinfectant
· Do not use cleaning or disinfecting chemicals that produce flammable and potentially explosive fluids, gasses, or vapors on the device or in its vicinity. If such use is needed, wait for the flammable and potentially explosive fluids, gasses, or vapors to evaporate before using the device.
· Centers for Disease Control and Prevention (CDC) recommends using an Environmental Protection Agency- (EPA-) registered hospital disinfectant with a low-level to intermediate-level activity after each patient. (Refer to the section Glossary of Terms beginning on page 29 of this manual.)
· For all surfaces visibly contaminated with blood, CDC recommends using an intermediatelevel disinfectant. (Refer to the section Glossary of Terms beginning on page 29 of this manual.)
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· Preferred disinfectants: o Sani-cloth AF3 o Cavi-Wipes o Opti-Cide3 Wipes o Opti-Cide3 Spray o Clorox Healthcare wipes o Clorox Healthcare spray
· Forbidden products: o ALCOHOLS (Isopropyl Alcohol, Methanol, etc.) o SEKUSID-NTM (ECOLAB PARAGERM Laboratories) o SEKUSEPT EasyTM or AktivTM (Ecolab Paragerm Labs) o FD333TM or FD322TM (DÜRR DENTAL Laboratories) o Bleach o Autoclaves and UV ovens
Cleaning/Disinfection Process · Put on fresh gloves before cleaning the Sensor. · Clean surfaces of all applied parts for any apparent contaminants before disinfecting. Always disinfect the applied parts listed in the section Applied Parts beginning on page 49 of this manual, including the parts after removing the protective sheath. To clean or remove any gross bioburden, use a soft disposable towel moistened with water. · There are two methods for disinfecting the sensor: wiping and immersion. · Wiping disinfection: o Apply disinfecting solution on a sterile compress. Do not use an abrasive material. o With the sterile compress, wipe all surfaces of the Sensor’s head. Take care to wipe the part between the cable and the Sensor shell. o With the sterile compress, wipe the first 10cm of the Sensor cable. o Respect recommendations provided by the manufacturer of the disinfecting solution. · Immersion disinfection: o Inspect the Sensor’s head for nicks. If any are present, do NOT use the immersion method. o Prepare the disinfection solution according to the manufacturer’s recommendation. Respect the accurate titration. o Immerse the Sensor head according to the manufacturer’s recommendation. Do NOT immerse the end with the USB connector. o It is not recommended to exceed a maximum immersion time of 35 minutes. o Respect recommendations provided by the manufacturer of the disinfecting solution. · Whichever disinfection method is used, following disinfection, clean any remaining disinfectant and cleaning product from surfaces using a soft disposable towel moistened with warm water.
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· Dry the Sensor before placing it in the next sheath. Post-Disinfection Requirements
· Inspect the labels affixed to the applied and patient or operator-accessible parts. Verify that all product labels remain intact and are legible.
· Wastes containing blood and saliva used in dental procedures are considered regulated waste. If any such waste is generated as a result of cleaning/disinfecting the device, the waste must be placed in containers which are: o Closable o Puncture resistant o Leakproof on sides and bottom o Labeled or color-coded per 29 CFR§1910.1030(g)(1) o Closed before removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping.
· Always change gloves between patients to avoid cross-contamination risks.
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Safe Disposal Methods
Wastes containing blood or saliva used in dental procedures are considered regulated waste and must be placed in containers that are:
· Closable. · Puncture resistant. · Constructed to contain all contents and prevent leakage of fluids during handling, storage,
transport, or shipping. · Labeled/color-coded per OSHA requirement 29 CFR§1910.1030(g)(1). · Close before removal to prevent spillage or protrusion of contents during handling, storage,
transport, or shipping. Consult other local, state, territorial, and national requirements. Caution must be applied when disposing of a medical device containing patient information. This includes files on the imaging workstation. The Sensor (and workstation, if provided) are electrical equipment. Contact a waste disposal service provider, the distributor or dealer where the Sensor was purchased, or the local regulatory or public health authority for information on the safe electrical and electronic equipment disposal that complies with local, state, territorial, and national requirements.
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Appendix B: Technical Specification

Electrical Specification …………………………………………… 106 X-Ray Sensor ………………………………………………………. 106 Source to Skin Distance (SSD) ……………………………….. 107 Imaging Workstation Specification …………………………… 108 Monitor Specification …………………………………………….. 108 Intraoral X-ray Sources ………………………………………….. 108 Sensor Positioning Devices ……………………………………. 108

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Electrical Specification

Parameter

Specification

Sensor Cable

3 m or 1.1 m

Connection Type/Computer In- High-Speed USB. This includes ports marked as USB SS

terface

(superspeed).

Power Supply

+5 V, per USB 2.0 specification

Level of Protection
Degree of Protection for the Applied Parts

IP68 (sensor only, per IEC 60529) Class II, Type BF

X-Ray Sensor
Parameter Film Size Equivalent Active Area Number of Pixels Pixel Size

43 mm x 30 mm

Specification

920.48 mm2

4.77 million Pixels

14 µm x 14 µm

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Source to Skin Distance (SSD)

Parameter

SID Specification

Short cone (standard)

minimum 20 cm (8 in)

Long cone (optional)

minimum 30 cm (12 in)

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Imaging Workstation Specification

Parameter

Recommended

Minimum

Windows Operating System

Windows 11 Pro or Enterprise

Windows 10 Pro or Enterprise

Apple Support Intel®-based Apple® hardware running native Windows Platform using Boot Camp

Processor

Intel i5 (or better)

Intel i3

Memory

16 GB RAM (or greater)

8 GB RAM

Storage*

512 GB Hard Drive (or greater)

256 GB Hard Drive

Video

32 bit, 1920 × 1080 resolution capable 32 bit, 1024 × 768 resolution capable

Display

1920 × 1080, 32 true bit color

1024 × 768, 32 true bit color

USB Ports

High Speed USB 3.0

High Speed USB 2.0

*A back-up storage device is recommended (DVD, external hard drive, etc.)

Monitor Specification
Parameter Resolution

Specification 1280 pixels × 1024 pixels

Intraoral X-ray Sources
Parameter Compatible parts

Specification
Any intraoral X-ray source suitable for producing diagnostic X-ray radiographs of dentition, jaws, and other oral structures.

Sensor Positioning Devices

Parameter Compatible parts (optional)

Specification
Any sensor positioner suitable for dental intraoral X-ray radiography and designed to support X-ray imaging sensors with size of 43 × 31 mm (1.7 × 1.2 in).

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Appendix C: Dose Data
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Dose Information
The following table provides recommendations for typical loading factors needed for the intended use of the Sensor depending upon the model of Sensor. These values are applicable to a 20 cm (8 in) cone.

Although the terms “cat” and “dog” are used, the intent is to categorize by patient size. E.g., for a small dog, it may be appropriate to use the “cat” settings.

Anatomy

Settings

Midmark DR Sensor ­ DC Generator at 65kV 7mA

Cat

Dog

Midmark Bite-Resistant Sensor ­ DC Generator at 65kV 7mA

Cat

Dog

Upper Incisor
Upper Canine Upper Premolar & Molar (cats only) Upper Premolar 1, 2, 3 (dogs only) Upper Premolar 4 (dogs only) Upper Molar (dogs only)
Lower Incisor
Lower Canine Lower Premolar & Molar (cats only) Lower Premolar (dogs only) Lower Molar (dogs only)

s mGy
s mGy
s mGy
s mGy
s mGy
s mGy
s mGy
s mGy
s mGy
s mGy
s mGy

0.064 0.699 0.064 0.699 0.064 0.699 N/A N/A N/A N/A N/A N/A 0.064 0.699 0.064 0.699 0.064 0.699 N/A N/A N/A N/A

0.100 1.092 0.160 1.747 N/A N/A 0.125 1.365 0.160 1.747 0.200 2.184 0.125 1.365 0.160 1.747 N/A N/A 0.125 1.365 0.125 1.365

0.080 0.874 0.080 0.874 0.080 0.874 N/A N/A N/A N/A N/A N/A 0.064 0.699 0.064 0.699 0.064 0.699 N/A N/A N/A N/A

0.100 1.092 0.160 1.747 N/A N/A 0.125 1.365 0.160 1.747 0.200 2.184 0.125 1.365 0.160 1.747 N/A N/A 0.125 1.365 0.125 1.365

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Appendix D: Troubleshooting Procedures

Error Message Conventions……………………………………. 116 Error Messages ……………………………………………………. 117

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Error Message Conventions
Error messages appear as pop-up windows in the format shown below.
Some error messages guide possible suitable action to resolve the condition. Arrange for service if the issue persists or is not resolved after following the displayed guidance.
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Error Messages

Error Name Low Disk Space Disconnected in armed state Sensor timeout Sensor USB Speed Recall Last Image Device used by another process Device Transfer Failed

Description and Recommended Action
Message: “Sensor cannot arm due to less than 100 MB of free hard drive space available. Please free up more hard drive and try again.” 1. Create more disk space to arm Sensor. 2. If there is more than 100 MB of remaining disk space, the sen-
sor will arm.
Message: “ Sensor disconnected while in armed state. Acquisition halted ” 1. If the Sensor is armed and ready for X-ray, and then the Sensor
abruptly disconnects, a message will appear notifying the user that the Sensor was disconnected while in an armed state. 2. Reconnect the Sensor and try again.
Message: “Sensor acquisition error: timed out.” 1. If the Sensor is in an armed state and meets the maximum
timeout period (default: 5 minutes), the Sensor will disarm and notify the user that the Sensor timed out. 2. Ensure all equipment is turned on and ready, then try again.
Message: “Sensor cannot arm due to being connected to a USB port lower than USB 2.0. Please connect the device to a USB 2.0 or higher port and/or hub.” 1. If the USB speed is less than “High Speed,” or USB 2.0, a mes-
sage will notify the user that the Sensor cannot arm due to slow USB speeds. 2. Connect the Sensor to a USB port/hub that meets the stated requirements.
Message: “No image present in cache for recall.” 1. If the user requests to recall last image, but there is no image in
the cache, it will notify the user that there is nothing to recall. 2. No action needed. Take images in order for images to be pre-
sent in the cache.
Message: “Device Used By Another Process.” 1. If another application or process is using the device, the user
will be notified. 2. Close any other applications that are using the Sensor.
Message: “USB Transfer Failed.” 1. If, during an image transfer, the device fails to continue sending
data, the user will be notified of the failed transfer. 2. Check Sensor connections. 3. Take another image if deemed appropriate.

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Error Name Max temperature reached

Description and Recommended Action
Message: “Device Auto Disarmed Max Temp” 1. If the device has reached the maximum allowable operating
temperature (48 degrees Celsius), the Sensor will not arm, preventing the user from taking an acquisition. 2. Lower the temperature in the surrounding area, or move the Sensor to an area with lower ambient temperatures.

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Midmark Technical Support
Upon request, qualified installation personnel can obtain part lists, descriptions, and additional Sensor information from Midmark. Contact Midmark for a list of authorized installers.
Midmark Corporation
Phone: 1.800.MIDMARK (1.800.643.6275) Direct: + 1.844.856.1232 Fax: + 1.847.415.9801
imagingtechsupport@midmark.com
Hours: 8:00 a.m. to 5:00 p.m. Central Time

Manufacturer: Midmark Corporation 1001 Asbury Drive Buffalo Grove, Illinois 60089 USA Phone: +1 847.415.9800 Fax: +1 847.415.9801 www.midmark.com

Windows and Microsoft are trademarks of Microsoft Corporation. Intel is a trademark of Intel Corporation. All trademarks are property of their respective owners.
Technical Library https://technicallibrary.midmark.com © Midmark Corporation

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References

• technicallibrary.midmark.com
• Dental Warranty - Midmark Dental

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