Faxitron OR and BioVision + Users Manual Ver 052

Faxitron™ OR and BioVision+ Specimen Radiography System

© 2005-2019 Faxitron Bioptics, LLC

All rights reserved. No parts of this work may be reproduced in any form or by any means - graphic, electronic, or mechanical, including photocopying, recording, taping, or information storage and retrieval systems - without the written permission of the publisher. Products that are referred to in this document may be either trademarks and/or registered trademarks of the respective owners. The publisher and the author make no claim to these trademarks. Read all this information carefully before operating the system. Follow all warnings and precautions as stated in this manual. Keep this manual available during procedures. Always follow all the instructions in this manual. Faxitron Bioptics, LLC does not accept responsibility for injury or damage from incorrect system operation. Faxitron Bioptics, LLC can arrange training at your site.

Printed: December 2019

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Table of Contents ... 0-3 Forward ... 0-5 Indications for Use ... 0-5 SECTION 1: 1.0.0 1.1.0 1.1.1

User’s Manual – Faxitron OR & BioVision+ ... Introduction ... Warning and Caution Symbols in this Manual... Warning and Caution Symbols on the Label ...

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SECTION 2: 2.0.0 2.1.0 2.2.0 2.3.0 2.3.1 2.3.2 2.3.3 2.3.4 2.4.0 2.5.0 2.6.0

Radiation Safety and X-Rays ... Introduction ... X-rays ... Sources of Radiation ... Biological Effects of Radiation... Deterministic and Stochastic Effects ... Radiosensitivity ... Risks from Radiation Exposure ... Conclusions on Health Risks ... ICRP Dose Limits... Risk Management ... References...

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SECTION 3: 3.0.0 3.0.1 3.0.2 3.0.3 3.1.0 3.2.0 3.3.0 3.4.0 3.5.0

About Your Faxitron OR / BioVision+ ... Overview ... DICOM Version ... Service and Troubleshooting ... Schedule of Maintenance ... Specifications ... Compliance Requirements and Safety Measures ... X-Ray Control System ... Shielding and Attentuation ... ALARA ...

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SECTION 4: 4.0.0 4.1.0 4.2.0

Faxitron OR & BioVision+ Installation and Set-up ... System Warnings & Precautions... BioVision Setup... Moving the BioVision ...

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SECTION 5: 5.0.0 5.1.0 5.1.1 5.1.2 5.2.0 5.2.1 5.2.2 5.3.0

Quick Start – Basic Operation of the Faxitron OR & BioVision+ DR System 5-1 Quick Start Overview ... 5-2 Power Up Sequence ... 5-3 System Start Up ... 5-3 Calibration ... 5-4 Image Acquisition... 5-5 Entering Patient Data Manually ... 5-5 Starting Exposure ... 5-6 System Shut Down ... 5-6

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SECTION 6: 6.0.0 6.1.0 6.2.0 6.2.1 6.3.0 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.4.0 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.5.0 6.6.0 6.6.1 6.7.0 6.8.0 6.9.0 6.10.0

Vision Software Operation ... Overview of Vision Software ... Software Start-up ... Camera Calibration Overview ... Advanced Calibration ... Patient Data ... Select from Work List ... Continue with Current Patient... Manual Entry ... Select from Database ... Patient Data Icon ... Tool Bar and Menus ... Side Tool Bar... Top Menu Bar... View Menu... Tools Menu... Image Tools... Current Patient Images Browser ... Database... Database Additional Options ... DICOM Functionality ... User Annotations ... About Help ... About Faxitron Vision Software ...

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Revision History Table ... 7-1

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Foreword This manual was created by Faxitron Bioptics, LLC. It is intended to guide the advanced user on how to setup, install and use the Faxitron OR and BioVision+ hardware and the Vision Software System, both developed by Faxitron Bioptics, LLC. The user must first setup the hardware, then initiate the Faxitron Vision Software. Please review the required setup procedures in Section 4 of this manual before continuing.

Indications for Use The Faxitron OR (and BioVision+) Digital Specimen Radiography (DSR) System is a cabinet digital x-ray imaging system intended to generate and control X-rays for examination of harvested specimens from various anatomical regions, and to provide rapid verification that the correct tissue has been excised. Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.

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SECTION 1

User’s Manual

Faxitron™ OR & BioVision+

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This manual was created by Faxitron Bioptics, LLC. It is intended to guide the user on how to setup, install and use the Faxitron OR & BioVision+ hardware and Vision Software, both developed by Faxitron Bioptics, LLC.

SECTION Introduction and Symbols

1

1.0.0 Introduction

The Faxitron OR and BioVision+ operate in virtually identical ways so throughout this manual the system will be referred to as BioVision unless specific features are unique to one system or the other. The user must first setup the hardware, then initiate the Faxitron Vision Software. At a minimum, please review the required setup and safety procedures in this manual before attempting to operate the system. Thank you from all of us at Faxitron Bioptics, LLC.

Additional Information For further technical assistance contact: Faxitron Bioptics, LLC (a Hologic company) 3440 E. Britannia Dr. Suite# 150 Tucson, AZ 85706, USA Tel: +1 (877) 910-0030 www.hologic.com

Authorized European Representative (for regulatory information) Hologic BVBA Da Vincilaan 5 1930 Zaventem Belgium Tel: +32 2 711 46 80 Fax +32 2 725 20 87

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

The following symbols are used in this manual and online help system: Warns the reader of potential electrocution should the reader ignore the warning and deliberately use specialized tools to open a sealed electrical cabinet and handle its contents. Note: No tools are provided by Faxitron Bioptics, LLC.

1.1.0 Warning and Caution Symbols in this Manual

Warns the reader of a hazardous condition. This symbol is generally accompanied by a more specific symbol and appropriate instructions as to the nature of the hazard, the expected outcome of the hazard, and information on avoiding the hazard. Cautions the reader to use care in lifting heavy equipment in order to avoid personal injury and damage to the equipment.

Warns the reader that ionized radiation is emitted into the labelled area when the x-ray beam is energized. The Faxitron BioVision has safety interlocks to prevent the labelled area from being accessed while the x-ray beam is energized. Warns the reader to use appropriate protection (such as surgical gloves or an approved specimen container) to avoid exposure to potentially infections materials such as patient tissue samples.

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Symbol

Description "ON" for part of the equipment

SECTION Introduction and Symbols

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1.1.1 Warning and Caution Symbols On Labels

Potential Equalization terminal

Discard electrical and electronic equipment separately from standard waste. Send decommissioned material to Hologic or contact your service representative. Manufacturer

Date of Manufacture

Caution-Radiation (X-Rays Produced) or Caution - Potentially infectious materials

Warning Electricity

Caution

Follow or consult instructions for use or This system transmits radio frequency (RF) energy (non-ionizing radiation) Catalog number Serial number

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2 SECTION 2

Radiation Safety and X-rays

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Faxitron™ OR and BioVision+ Specimen Radiography System

Radiation is energy in the form of waves or particles. High frequency, high energy radiation, which has sufficient energy to displace an electron from its orbit around a nucleus, is referred to as ionizing radiation. X-rays, gamma rays, beta particles, alpha particles, and neutrons are all forms of Ionizing radiation and can be given off by radioactive material, stars, and highvoltage equipment.

SECTION Radiation Safety and X-Rays

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2.0.0 Introduction

We cannot see, feel, taste, smell, or hear ionizing radiation, so monitoring equipment is required for us to detect it. X-rays X-rays are high frequency, high energy radiation having sufficient energy to displace an electron from its orbit around a nucleus, and are called “ionizing” radiation. X-rays are capable of traveling long distances through air and most other materials. The amount of energy carried by radiation is directly proportional to the frequency, and inversely proportional to the wavelength. X-rays have a relatively short wavelength and high frequency, thus possess a great deal of energy.

2.1.0 X-rays

X-rays can produce biological changes in tissue that can be beneficial when used in radiation therapy. However, X-rays can also be harmful to biological organisms because of their ability to damage chromosomes. Sources of X-ray radiation in medical facilities include: X-ray Machines. X-ray machines are used for treatment (radiation therapy) and diagnostic purposes. Diagnostic X-ray machines are used to X-ray various parts of the body, chest, leg, breasts, etc for diagnostic purposes. Today, in the US alone, diagnostic radiology accounts for two-thirds of our dose from man-made sources. X-ray machines can produce high levels of ionizing radiation. Cabinet machines. Cabinet X-ray machines are enclosed, self-shielded, interlocked irradiation chambers. The machine can only operate when the chamber door is securely closed. The exposure rates at every location on the exterior meets the rate specified for uncontrolled areas. Sources of Radiation We are all exposed to radiation every day. According to the NCRP, National Council on Radiation Protection, the average background dose in the United States is 360 mrem/year (3.6 mSv/yr). These exposures are mostly from natural sources of radiation, such as radon, cosmic radiation, and natural deposits in the earth. Even our bodies contain natural radioactivity!

2.2.0 Sources of Radiation

There are 2 sources of radiation: Natural and Man-Made. Natural Sources of Radiation include Cosmic rays, Terrestrial gamma rays, Radionuclides in the body (except radon), and Radon and its decay products. The worldwide average annual effective dose from natural sources is estimated to be 2.4 mSv (240mrem). There are factors that affect the effective doses from these natural sources of radiation: The cosmic ray dose rate depends on height above sea level and latitude, the terrestrial gamma-ray dose rate depends on local geology, and the dose from radon decay products depends on local geology and housing construction and use. See Table 1 for annual effective doses from these natural sources. Table 1 Annual effective dose to adults from natural sources Annual effective dose (mSv) Typical Elevated * Cosmic Rays 0.39 2.0 Terrestrial gamma rays 0.46 4.3 Radionuclides in the body (except radon) 0.23 0.6 Radon and its decay products 1.3 10 TOTAL (rounded) 2.4 *The elevated values are representative of large regions. Even higher values occur locally . Source of exposure

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Medical X-rays are a major source of man-made radiation. Medical X-rays utilize ionizing radiation for both the diagnosis and treatment of injuries and disease. UNSCEAR (United Nations Scientific Committee on the Effects of Atomic Radiation) estimates that individual exposure to medical radiation ranges from 0.4 to 1 mSv annually. Exposure from medical radiation exceed those from all other man-made sources, but amount to less than half the exposure to natural background radiation,

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2.2.0 Cont.

The chart below shows the contributions from various sources of radiation.

Figure 2.2.1 Sources of Radiation Dose in the Unites States From NCRP 160, Fig. 1.1. Percent contribution of various sources of exposure to the total collective effective dose (1,870,000 person-Sv) and the total effective dose per individual in the U.S. population.

Exposure to ionizing radiation can have adverse health effects by causing atoms and molecules to change. When ionizing radiation passes through tissue, large amounts of energy are transferred to individual molecules. This energy transfer causes electrons to be dislodged from atoms, initiating a variety of chemical and physical effects. The most critical of these effects is damage to DNA molecules. The body has mechanisms in place that normally repair this damage, but extensive or certain types of damage may not be repaired. When the body is unable to repair the damage the cell may die or be mutated. Mutated cells have the potential to turn into cancers. The extent of damage is proportional to the energy imparted, or the dose of ionizing radiation received.

2.3.0 Biological Effects of Radiation

Health effects of exposure to X-ray radiation come in two general types, direct or indirect. Xrays are thought to create radicals in exposed cells of your body that may break or modify chemical bonds within critical biological molecules.

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As a result:

SECTION Radiation Safety and X-Rays

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2.3.0 Cont.

(1) cells may be injured or damaged, although many cells repair themselves, resulting in no residual damage, (2) cells may die, which millions of body cells do every day and are replaced in a normal biological process, (3) or cells may incorrectly repair themselves resulting in a biophysical change. Finally, X-rays may pass through the body with no interaction.

The damage to cells from ionizing radiation can result in: • • • •

Production of free radicals Breakage of chemical bonds Production of new chemical bonds and cross-linkage between macromolecules Damage to molecules which regulate vital cell processes (e.g. DNA, RNA, proteins)

Dose Rate, Total Dose Received, Energy of the radiation, Area of the body exposed, the individual’s sensitivity, and Cell sensitivity, are all factors that determine the biological effects of radiation exposure. There are two types of effects from exposure to ionizing radiation: deterministic effects and stochastic effects.

DETERMINISTIC AND STOCHASTIC EFFECTS Potential biological effects depend on how much and how fast a radiation dose is received. Radiation doses can be grouped into two categories, acute and chronic dose.

2.3.1 Deterministic and Stochastic Effects

Acute Dose and Deterministic Effects Acute radiation exposure is a high radiation dose occurring over a short period of time, normally seconds to days. The effects caused by acute radiation doses are called deterministic; the severity of the effect is determined by the amount of dose received. Deterministic effects usually have some threshold level - below which, the effect will probably not occur, but above which the effect is expected. Above the threshold, the severity of the effect increases as the dose increases. For example, a whole body dose of about 300 rems (3 Sv), 60 times the annual occupational dose limit, if received within a short time period (e.g., a few hours) will cause vomiting and diarrhea within a few hours; loss of hair, fever, and weight loss within a few weeks; and about a 50 percent chance of death without medical treatment. These effects would not occur if the dose 300 rems (3 Sv) were accumulated gradually over many years. There is also a difference between whole body and partial body exposures. Where an acute dose of 600rem (6 Sv) to the hand would cause skin reddening; recovery would occur over the following months and no long-term damage would be expected. However, an acute dose of that magnitude to the whole body could cause death within a short time without medical treatment. The utilization of appropriate radiation protection mechanisms and occupational exposure dose limits reduce the likelihood of these effects occurring. The occupational dose limits are far below the thresholds for deterministic effects.

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Chronic Dose and Stochastic Effects

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2.3.1 Cont.

A chronic dose is a relatively small amount of radiation received over a long period of time (e.g. years). The body is better equipped to tolerate a chronic dose than an acute dose, since the body has time to repair damage because a smaller percentage of the cells need repair at any given time. The body also has time to replace dead or non-functioning cells with new, healthy cells. However, this does not mean there is no risk related to chronic radiation exposure. The term stochastic means ‘random’, with the implication that low levels of radiation exposure are not certain to produce an effect. These low levels, below the threshold for deterministic effects, may or may not result in detrimental effects to the body. However, keep in mind that: 1) there is no threshold level of radiation exposure below which we can say with certainty that effects will NOT occur, and 2) Doubling the radiation dose, doubles the probability that effects will occur. Chronic exposure may produce only effects that can be observed some time following initial exposure. These may include genetic effects and other effects such as cancer, precancerous lesions, benign tumors, cataracts, skin changes, and congenital defects. Generally, the greatest concern is the development of some form of cancer. Immediate effects are not seen below doses of 25 rem (0.25 Sieverts). Latent effects may appear years after a dose is received. It has been found through studies of populations exposed to ionizing radiation (> 0.5 Sv) that the probability of a fatal cancer occurring from radiation exposure is approximately 5 percent per Sv.

RADIOSENSITIVITY Radiosensitivity is the probability of a cell, tissue, or organ suffering an effect per unit dose of radiation. Radiosensitivity is highest in cells which divide rapidly (highly mitotic) or are relatively non-specialized (undifferentiated). For this reason, the basal epidermis, bone marrow, thymus, gonads, and lens cells are highly radiosensitive. Muscle, bones, and nervous system tissues have a relatively low radiosensitivity. Also, radiosensitivity is greatest during the fetal stage and becomes progressively smaller through adolescence and adulthood.

2.3.2 Radiosensitivity

Basic Law of Radiobiology: Biological effects are directly proportional to the mitotic index and the mitotic future of the exposed cell, and inversely proportional to the degree of differentiation. Mitosis refers to the natural division of a cell nucleus during cell reproduction; differentiation refers to the cell’s degree of specialization to perform a specific function in an organism.

RISKS FROM RADIATION EXPOSURE It is estimated that approximately 20% (1 in 5) of all deaths in the United States are due to some type of cancer. If every member of a population of 1 million were to receive 10 mrem (0.1 mSv) of radiation, it is possible that 5 additional deaths would be observed. Remember that out of this population of 1 million, about 200,000 will die of cancer, making these few additional deaths statistically impossible to detect.

2.3.3 Risks from Radiation Exposure

Additionally, the risk of cancer death is 0.08% per rem (10 mSv) for doses received rapidly (acute) and might be 2 times (0.04%, or 4 in 10,000) less than that for doses received over a long period of time (chronic).

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From currently available data, the NRC has adopted the risk value for an occupational dose of 1 rem (0.01 Sv) as representing a risk of 4 in 10,000 of developing a fatal cancer.

SECTION Radiation Safety and X-Rays

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2.3.3 Cont.

The International Commission on Radiological Protection (Publication 103, 2007) indicates a value of 5.5 % per sievert for cancer and 0.2 % per sievert for heritable effects after exposure to radiation at low dose rate The risk associated with the diagnostic uses of ionizing radiation are normally limited to late stochastic effects, which are estimated to occur at a frequency of perhaps 0.01% for an average examination (deterministic skin damage may occur after fluoroscopy in extreme cases). At the individual level, these risks are almost always small compared to the benefit of diagnosis and treatment.

CONCLUSIONS ON HEALTH RISKS We assume that any radiation exposure, no matter how small, carries with it some risk. However, we know that on average these risks are comparable to or smaller than risks we encounter in other activities or occupations that we consider safe. Since we have extensive control over how much radiation exposure we receive on the job, we control and minimize this risk. The best approach is to keep our dose As Low As Reasonably Achievable, or ALARA – a term we will discuss in detail later. Minimizing the dose minimizes the risk.

ICRP DOSE LIMITS The international Commission on Radiological Protection (ICRP) has established radiation dose limits based on available data. These dose limits are maximum allowed values for whole body exposures. The dose unit of measure is called the Sievert (Sv) which accounts for various factors to determine a quantity called effective dose. The dose limits were last updated in 2007.

2.3.4 Conclusions on Health Risks

2.4.0 ICRP Dose Limits

For members of the public the dose limit is 1mSv/yr (0.001 Sieverts per year) For occupational workers (those who work in the nuclear industry the dose limit is 20 mSv/yr (0.02 Sieverts per year) The dose limits exclude the effects of background radiation.

ICRP Recommended annual dose limits for individual organs or tissues Radiation weighted dose in Workers Public Lens of the eye 150 mSv 15 mSv Skin 1,2 500 mSv 50 mSv Hands and feet 500 mSv 1. The limitation on effective dose provides sufficient protection for the skin against stochastic effects. An additional limit is needed for localised exposures in order to prevent tissue reactions. 2. Averaged over 1 cm2 area of skin regardless of the area exposed.

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Determining Factors The effects of X-ray exposure depend upon the duration of exposure, how fast the dose is delivered, Energy – How much energy was in the X-ray, the total dose – the magnitude of the dose, and whether the exposure is whole body or localized. Low energy (<50KeV) X-rays can cause damage only to skin or outer part of body while high energy X-rays can penetrate the body to the internal organs. A large acute dose delivered at once would have a greater effect than the same dose administered over time as incremental fractions.

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2.5.0 Risk Management

In medical environments risk of radiation exposure can be minimized by: •

Avoiding all unnecessary exposures to radiation

•

Using Doses that are AS LOW AS REASONABLY ACHIEVABLE (ALARA)

•

Following equipment manufacturers operating instructions

•

Following equipment manufacturers preventive maintenance instructions

•

Utilizing appropriate shielding

ALARA The ALARA concept is based on the assumption that any radiation dose, no matter how small, can have some adverse effect. Under ALARA, every reasonable means of lowering exposure is used. There are three general rules to reduce a person's exposure to any type of ionizing radiation. 1.

Reduce the time you are exposed to the radiation source.

2.

• Reducing the exposure time reduces the radiation dose. Increase the distance between yourself and the radiation source.

3.

•

Increasing the distance from a source of radiation significantly reduces the radiation dose.

•

Doubling the distance from a radiation source means one-fourth the dose rate.

• Tripling the distance gives one-ninth the rate. Increase shielding between yourself and the radiation source. •

The use of appropriate shielding greatly reduces dose.

•

The material used and thickness of the shied depends on the source of the radiation.

•

Lead is a common shielding material.

Consult your Radiation Safety Officer for the rules and guidelines of specific to your facility.

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REFERENCE SOURCES Radiation Safety Training and Reference Manual, California Institute of Technology, Training and Reference Manual, March 1995 (Revised June, 1996)

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2.6.0 References

Radiation Safety Manual(Revised March 2010), Stanford University, Veterans Affairs Palo Alto, Health Care System, Environmental Health and Safety, Stanford University, Stanford California Radiation and X-ray Training - Environmental Health and Safety - University of North Carolina at Chapel Hill USF (University of Southern Florida) Radiation Safety – Research X-ray Safety Manual, Radiation Safety Office – 2003 University of Oklahoma Chemical Crystallography Lab, 11-APR-2011 European Nuclear Society – Glossary of Nuclear Terms http://www.euronuclear.org/info/encyclopedia.htm United Nations Scientific Committee on the Effects of Atomic Radiation, UNSCEAR 1993, Report to the General Assembly, With Scientific Annexes, UNITED NATIONS PUBLICATION, Sales No. E.94.IX.2, ISBN 92-1-142200-0 JEFFERSON LAB - Thomas Jefferson National Accelerator Facility (Jefferson Lab) Ionizing Radiation Effects and Their Risk to Humans, T.R. Goodman, MD Yale University School of Medicine, New Haven, CT IMAGE WISELY – Radiation Safety in Adult Medical Imaging http://www.imagewisely.org/Imaging-Professionals/Imaging-Physicians/Articles/IonizingRadiation-Effects-and-Their-Risk-to-Humans.aspx Seibert 2004: Seibert J A “X-ray imaging physics for nuclear medicine technologists.” Part1: Basic principles of X-ray production J Nucl Med Technol32 139-47 Shultis 2005: Shultis J K and Faw R E 2005 Radiation shielding technology Health Phys 88 297-322 Simpkin 1995: Simpkin D J 1995 Transmission Data for Shielding Diagnostic X-ray Facilities Health Phys 68 704-709

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SECTION 3

About Your Faxitron OR / BioVision+ System

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Faxitron™ OR and BioVision+ Specimen Radiography System

The Faxitron OR (and BioVision+) Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of harvested specimens from various anatomical regions, and to provide rapid verification that the correct tissue has been excised.

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3.0.0 Overview

Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite. Both the Faxitron OR and BioVision+ employ the use of Vision, a full featured and powerful image acquisition and data manipulation software, developed by Faxitron Bioptics. Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Vision software is the central part of this system. Vision software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with the ability to do DICOM Print and Store functions and follows the Modality Work List (MWL) protocol for image transfer.

3.0.1 DICOM Version

DICOM Version

Faxitron uses the latest DICOM standard: ACR-NEMA Digital Imaging and Communications in Medicine (DICOM) v3.0, Final Draft, Aug. 1993 And complies with: NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communications In Medicine Set Storage Classes Faxitron_DR provides Standard Conformance to the following DICOM V3.0 SOP Class as a SCU. SCU SOP Class SOP Class

SOP Class UID

Computed Radiography Image Storage SOP Digital X-ray Image Storage Presentation Digital X-ray Image Storage Processing Digital X-ray Mammography Image Storage Presentation Digital X-ray Mammography Image Storage Processing Study Root Query/Retrieve Info. Model -FIND Patient Root Query/Retrieve Info. Model -FIND Modality Worklist information Model-FIND Greyscale Softcopy Presentation Storage

1.2.840.10008.5.1.4.1.1.1 1.2.840.10008.5.1.4.1.1.1.1 1.2.840.10008.5.1.4.1.1.1.1.1 1.2.840.10008.5.1.4.1.1.1.2 1.2.840.10008.5.1.4.1.1.1.2.1 1.2.840.10008.5.1.4.1.2.2.1 1.2.840.10008.5.1.4.1.2.1.1 1.2.840.10008.5.1.4.31 1.2.840.10008.5.1.4.1.1.11.1

For further details refer to the full DICOM Conformance Statement stored on the system. The file is in C:Faxitron and a shortcut is provided on the desktop. If required, a copy of the DICOM Conformance Statement is available from Faxitron on request

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Service There are no serviceable parts in Faxitron equipment. Please contact your authorized Faxitron representative for servicing.

SECTION About Your BioVision System

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3.0.2 Service and Troubleshooting

Faxitron Bioptics, LLC 3440 E. Britannia Drive, Suite 150 Tucson, AZ 85706 USA T (520) 399-8139 F (520) 399-8182 E-mail: [email protected] Website: www.hologic.com

Troubleshooting Refer to the Faxitron OR or BioVision+ Technical Manual, contact your Faxitron representative, or contact Faxitron Customer Service.

SCHEDULE OF MAINTENANCE Refer to the Faxitron OR or BioVision+ Technical Manual, contact your Faxitron representative, or contact Faxitron Customer Service.

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3.0.3 Schedule of Maintenance

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3.1.0 Specifications Figure 3.0.1 Dimensions & Weight

SOURCE-to-IMAGER (SID) and SOURCE-to-OBJECT (SOD) DISTANCES: Distances Faxitron OR BioVision+ Top of Camera to Imager 0.23” [5.8mm] 0.26” [6.6mm] Tube Target to Imager 23.2” [589mm] 15.9” [405mm] Tube Target to Sample Position (No Mag) 22.7” [577mm] 15.6” [396mm] Tube Target to Lower Position (1.5 Mag) 15.8” [403mm] 10.7” [270mm] Tube Target to Middle Position (2.0 Mag) 11.1” [282mm] 8.0” [203mm] Tube Target to Top Position (3.0 Mag) N/A 5.3” [135mm] Imager to Sample Position 0.5” [12mm] 0.35” [9mm] Imager to Lower Tray Position 7.4” [187mm] 5.3” [134mm] Imager to Middle Position 12.1” [307mm] 8.0” [202mm] Imager to Top Position N/A 10.6” [270mm]

WEIGHT: 200 lbs (90 kg) INPUT POWER:

120VAC 60Hz 600W Max 100VAC 50/60Hz 600W Max

230VAC 50Hz 600W Max 230VAC 60Hz 600W Max

HEAT OUTPUT: 2000 BTU/hr Max X-RAY DUTY CYCLE: 50% EXPOSURE CONTROL: Automatic or Manual

FAXITRON OR & BIOVISION+ USERS MANUAL | HOLOGIC | REVISION 052

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