RM InSight FD Mini C-arm System User Guide Rev 001

RM InSight™ FD MAN-06960-001

Mini C-arm Imaging System

User Guide Part Number MAN-06960-001 Revision 001 April 2020

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Customer Support Toll Free in USA: +1.800.321.4659 Email: [email protected]

© 2020 Hologic, Inc. Printed in the USA. This manual was originally written in English. Hologic, Fluoroscan, InSight, MegaView, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the U.S. and/or other countries. Any other product and company names mentioned herein are the trademarks of their respective owners. This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patents.

RM InSight FD Mini C-arm User Guide Table of Contents

Table of Contents 1 Indications for Use...1 1.1 Essential Performance... 1 1.2 Warranty Statement ... 2 1.3 User Profiles ... 2 1.3.1 Education ... 2 1.3.2 Knowledge ... 2 1.3.3 Experience ... 3 1.3.4 Permissible impairments ... 3

2 Radiation Safety ...3 2.1 General ... 3 2.2 Radiation Dose and Dose Rate ... 3 2.3 X-ray Shielding ... 4

3 Regulations for X-ray Equipment ...4 3.1 United States Federal and State Regulations... 4 3.2 IEC Regulations ... 4 3.3 Canadian Regulations... 4

4 EMI...5 5 Cybersecurity ...5 6 Accessories ...5 7 Where to Obtain Copies of the Manuals...5 8 Terms and Definitions ...6 9 InSight FD System Labels...8 9.1 System Main Label ... 8 9.2 X-ray System Warning Label ... 9 9.3 Electric Shock Warning Label... 9 9.4 ISO 7010-M002 Label... 10 9.5 Field of View ... 10

10 Safety Hazards...12 11 System Components...19 12 Controls and Indicators ...20 12.1 X-ray Head Control Panel ... 20 12.2 Keyboard Controls ... 22

13 Footswitch Functions ...24

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RM InSight FD Mini C-arm User Guide Table of Contents

13.0.1 Acquire an X-ray Image ... 25 13.0.2 Display a MegaView Image ... 25 13.0.3 Tag an Image ... 25 13.0.4 Save an Image... 25 13.0.5 Print an Image ... 25

14 Using the System ...26 14.1 Moving the System... 26 14.2 Adjusting the C-arm... 27 14.3 Sterile C-arm Drape... 28 14.4 Powering Up the System ... 29 14.5 Powering Down the System... 29

15 Configuring the Application ...30 15.1 System Configuration User Interface ... 30 15.2 System ... 30 15.3 DICOM Send Options... 33 15.3.1 DICOM Print Options ... 35 15.4 Worklist Configuration... 37 15.4.1 Users ... 38 15.5 Physician Preferences... 40 15.6 Physician Preferences - Image Acquisition ... 41 15.7 Physician Preferences - Image Processing... 43 15.8 Physician Preferences - Image Management ... 44 15.9 Administrative Settings Page ... 46

16 Using the Application ...48 16.1 Patient Positioning ... 48 16.2 Main Screen ... 49 16.3 X-ray Head Control Panel ... 52 16.4 Image Acquisition Session ... 54 16.4.1 Select or Enter Patient Window ... 54 16.4.2 Image Acquisition Screen ... 56 16.4.3 Filmstrip Symbols ... 57 16.4.4 Select Reference Images Window... 62 16.5 Review Images Session ... 64 16.5.1 Select Study for Review Window ... 64 16.5.2 Review Screen... 66 16.5.3 Enhanced Displayed Image Screen ... 68 16.6 Maintaining Patient Study Records ... 69 16.6.1 Update Patient Study Information Window... 69

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RM InSight FD Mini C-arm User Guide Table of Contents

16.7 Export Images ... 71 16.7.1 Export from Review Images Screen ... 71 16.7.2 Export from Review Images Screen ... 72 16.8 Import Images Window ... 75 16.9 Worklist Entry... 77 16.9.1 Option 1 Tools Submenu ... 77 16.9.2 Option 2 Patient Information Screen... 77 16.10 Delete Images ... 77 16.11 View DICOM Queue Window ... 79

17 System Maintenance ...81 17.1 System Backup ... 81 17.2 System Recover ... 81 17.3 Cleaning ... 81 17.3.1 Recommended Disinfectants ... 81 17.4 Preventive Maintenance ... 82 17.5 Troubleshooting... 82 17.6 Disposal... 82

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RM InSight FD Mini C-arm User Guide List of Figures

List of Figures Figure 1: InSight FD Mini C-arm ...1 Figure 2: System Main Label ...8 Figure 3: X-ray System Warning...9 Figure 4: Electric Shock Warning...9 Figure 5: ISO 7010-M002 Label ...10 Figure 6: Field of View ...10 Figure 7: Wireless Footswitch ...24 Figure 8: Transport Position Knob ...26 Figure 9: Rear Casters...27 Figure 10: Adjusting the C-arm...28 Figure 11: Sterile C-arm Drape...28 Figure 12: System Configuration Menu...30 Figure 13: System ...31 Figure 14: DICOM Send Options...33 Figure 15: DICOM Print Options...35 Figure 16: Worklist Configuration...37 Figure 17: Users ...39 Figure 18: Physician Preferences - Image Acquisition ...41 Figure 19: Physician Preferences - Image Processing ...43 Figure 20: Physician Preferences - Image Management ...45 Figure 21: Main Screen ...49 Figure 22: System Configuration Pull-down Menu ...50 Figure 23: Tools Pull-down Menu ...51 Figure 24: Select or Enter Patient Window...54 Figure 25: Image Acquisition Screen...56 Figure 27: Filmstrip Symbols...58 Figure 28: Configure Image Area Menu ...58 Figure 29: Image Acquisition Screen Buttons ...59 Figure 30: Select Reference Images Window ...63 Figure 31: Study for Review ...64

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RM InSight FD Mini C-arm User Guide List of Figures

Figure 32: Review Images Screen ...66 Figure 33: Patient Details ...68 Figure 34: VISTA Details...68 Figure 35: Enhanced Displayed Image Screen...69 Figure 36: Update Patient Study Information Window ...70 Figure 37: Image Export from Review Screen ...71 Figure 38: Export Images Panel ...72 Figure 39: Tool Menu Export...72 Figure 40: Export Images from Tool Menu ...73 Figure 41: Tools Menu...75 Figure 42: Import Images Window ...75 Figure 43: Delete Images ...77 Figure 44: Image Selected for Deletion ...78 Figure 45: View DICOM Queue...79

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RM InSight FD Mini C-arm User Guide List of Tables

List of Tables Table 1 Terms and Definitions ...6 Table 2 Symbols ...7 Table 3 Symbols ...11 Table 4 Safety Hazards ...12 Table 5 X-ray Head Control Panel ...20 Table 6 Keyboard Controls ...22 Table 7 Footswitch Pedal Functions ...24 Table 8 Conditioning Schedule ...29 Table 9 System Configuration User Interface ...30 Table 10 System Page ...31 Table 11 DICOM Send Options Page ...33 Table 12 DICOM Send Options Page, Button Functions ...34 Table 13 DICOM Print Options Page, Section/Field Descriptions ...35 Table 14 DICOM Print Options Page, Button Functions ...36 Table 15 Worklist Configuration, Section Descriptions ...37 Table 16 Worklist Configuration, Button Functions ...38 Table 17 Users Page, Section/Field Descriptions ...39 Table 18 Users Page, Button Functions ...39 Table 19 Physician Preferences, Section/Field Descriptions ...40 Table 20 Physician Preferences, Button Functions ...40 Table 21 Physician Preferences, Image Acquisition Tab, Section/Field Descriptions ...41 Table 22 Physician Preferences, Image Processing Tab, Section/Field Descriptions ...44 Table 23 Physician Preferences, Image Management Tab, Section/Field Descriptions ...46 Table 24 Administrative Settings, Section Descriptions ...46 Table 25 Administrative Settings, Button Functions ...47 Table 26 Main Screen Options ...49 Table 27 System Configuration Menu ...50 Table 28 Tools Menu ...51 Table 29 X-ray Head Control Panel ...52 Table 30 Select or Enter Patient Window, Section/Field Descriptions ...55

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RM InSight FD Mini C-arm User Guide List of Tables

Table 31 Select or Enter Patient Window, Button Functions ...55 Table 32 Image Acquisition Screen ...56 Table 33 Image Effects Menu ...57 Table 34 Filmstrip Symbols ...58 Table 35 Configure Image Area Menu ...59 Table 36 Image Acquisition Screen, Button Functions ...59 Table 37 Tool Set ...62 Table 38 Select Reference Images Window, Section Descriptions ...63 Table 39 Select Reference Images Window, Button Functions ...63 Table 40 Select Study for Review Window, Section/Field Descriptions ...65 Table 41 Select Study for Review Window, Button Functions ...65 Table 42 Review Screen, Button Functions ...66 Table 43 Detailed Image Viewing Screen, Button Functions ...69 Table 44 Update Patient/Study Information Window, Section Descriptions ...70 Table 45 Update Patient/Study Information Window, Button Functions ...70 Table 46 Export Window, Section Descriptions ...73 Table 47 Export Window, Button Functions ...74 Table 48 Import Window, Section Descriptions ...76 Table 49 Import Window, Button Functions ...76 Table 50 Delete Images Window, Section Descriptions ...78 Table 51 Delete Images Window, Button Functions ...79 Table 52 Queue Window, Section Description and Button Functions ...79 Table 53 Recommended Wipes ...82 Table 54 Recommended Chemicals ...83

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RM InSight FD Mini C-arm User Guide 1. Indications for Use

1 Indications for Use The InSight™ FD System is a Mini C-arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations. Figure 1

InSight FD Mini C-arm

1.1 Essential Performance The Insight FD System is a mobile fluoroscopic mini C-arm system that provides fluoroscopic images safely and effectively during diagnostic, treatment, and surgical procedures of patientʹs extremities.

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RM InSight FD Mini C-arm User Guide 1. Indications for Use

1.2 Warranty Statement Except as otherwise expressly stated in the Agreement: i) Equipment manufactured by Hologic is warranted to the original Customer to perform substantially in accordance with published product specifications for one (1) year starting from the date of shipment, or if Installation is required, from the date of Installation (“Warranty Period”); ii) digital imaging X-ray tubes are warranted for twenty-four (24) months, during which the x-ray tubes are fully warranted for the first twelve (12) months and are warranted on a straight-line prorated basis during months 13-24; iii) replacement parts and remanufactured items are warranted for the remainder of the Warranty Period or ninety (90) days from shipment, whichever is longer; iv) consumable Supplies are warranted to conform to published specifications for a period ending on the expiration date shown on their respective packages; v) licensed Software is warranted to operate in accordance with published specifications; vi) Services are warranted to be supplied in a workmanlike manner; vii) non-Hologic Manufactured Equipment is warranted through its manufacturer and such manufacturer’s warranties shall extend to Hologic’s customers, to the extent permitted by the manufacturer of such non-Hologic Manufactured Equipment. Hologic does not warrant that use of Products will be uninterrupted or error-free, or that Products will operate with non-Hologic authorized third-party products. These warranties do not apply to any item that is: (a) repaired, moved, or altered other than by Hologic authorized service personnel; (b) subjected to physical (including thermal or electrical) abuse, stress, or misuse; (c) stored, maintained, or operated in any manner inconsistent with applicable Hologic specifications or instructions, including Customer’s refusal to allow Hologic recommended Software upgrades; or (d) designated as supplied subject to a non-Hologic warranty or on a pre-release or “as-is” basis.

1.3 User Profiles It is anticipated that InSight Flat Detector users may include nurses both sterile and nonsterile, radiological or other technicians, doctors or surgeons with minimal training in fluoroscopic procedures.

1.3.1 Education • Minimum of an associate degree or equivalent radiation technology certificate program • No maximum

1.3.2 Knowledge • Minimum Read and understand the InSight Flat Detector User’s Manual Basic knowledge of computers • No maximum

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RM InSight FD Mini C-arm User Guide 2. Radiation Safety

1.3.3 Experience • Minimum No other special experience is needed • No maximum

1.3.4 Permissible impairments • Mild reading vision impairment or vision corrected to log MAR 0.2 (6/10 or 20/32) • Average degree of aging-related short term memory • Impaired by 40% resulting in 60% of normal hearing at 500 Hz to 2 kHz

2 Radiation Safety Improper imaging procedures or the failure to observe radiation safety and technique factor recommendations could result in increased exposure. It is the operatorʹs responsibility to observe all safety procedures and to keep radiation exposures As Low As Reasonably Achievable (ALARA) and to comply with all national, state and local regulatory requirements. Hologic recommends that all members of the operating staff wear a radiation monitoring device. This is usually a film badge or TLD (thermoluminescent dosimetry) dosimeter which will record any radiation dose over a specific period of time. The physician should wear a ring badge to record any exposure to his/her hands.

2.1 General A fluoroscopic device emits a continuous beam of X-rays in order to view an object in real-time. Primary radiation is present in the space between the X-ray source and the detector screen. The operator should never place his/her own hands in the beam. Secondary radiation or X-ray scatter is caused by X-rays that do not fully penetrate the object placed in the primary beam. X-ray scatter has considerably less energy than the primary beam and is absorbed by other objects in the immediate area. The amount of scatter depends upon the power setting used, the density and proximity of the body part to the beam, and the length of exposure time.

2.2 Radiation Dose and Dose Rate Radiation received by each kilogram of a patient’s body is called dose. Dose rate refers to the dose received per unit time. Distance from the X-ray source reduces dose to both the patient and the operator. For example, at maximum output the dose is 2.6 mGy/minute at the image receptor and 45 mGy/minute at the Tube Housing exit port, or 17 times greater than the dose at the image receptor. This higher value is known as the maximum Entrance Exposure Rate (EER).

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RM InSight FD Mini C-arm User Guide 3. Regulations for X-ray Equipment

Scattered radiation decreases with the square of the distance in exactly the same way as noted previously for X-rays in the primary beam. However, as the dose rate is much less, scatter is usually expressed in mR/hour (1 mR = 0.01 mGy). Dose and scatter data for the InSight FD system is available from Hologic upon request.

2.3 X-ray Shielding The scattered radiation from the InSight FD system is low compared to many other radiological devices, and the requirement to wear protective lead aprons and/or attenuating gloves is governed by applicable facility policy. Also many states, provinces, countries, and individual institutions may require persons in the same room with any operating fluoroscopic device to wear lead aprons. The strict observation of safe operating practices and the use of minimal fluoroscopic times is the key to reducing human exposure.

3 Regulations for X-ray Equipment 3.1 United States Federal and State Regulations InSight FD Mini C-arm Imaging Systems conform to the United States Code of Federal Regulations, 21 CFR 1020.32 “Performance Standards for Ionizing Radiation Emitting Products: Fluoroscopic Equipment.” However, additional state regulations may apply to X-ray products. This may require notifying your state regulatory agency about your installation and/or operator training and certification. It is the responsibility of the user to contact the applicable state radiation control agency to verify that your installation is in compliance with regulations in your state governing installation and use of X-ray equipment. The InSight FD Mini C-arm Imaging System complies with 21CFR Subchapter J. The InSight FD Mini C-arm Imaging System is intended for special surgical applications that would be prohibited at the Source to Skin Distances (SSD) specified in 21CFR 1020.32 (g) but are permitted under 21CFR 1020.32 (g) (2). The SSD is 10 cm minimum.

3.2 IEC Regulations InSight FD Mini C-arm Imaging Systems comply with the requirements of IEC 60601-1. The classification of the InSight FD Mini C-arm Imaging Systems under this specification is Class 1, Type B. The InSight FD Mini C-arm Imaging Systems comply with the following IEC standards: IEC/EN 60601-1:2006

IEC/EN 60601-2-28:2010

IEC/EN 60601-2-54:2009

IEC/EN 60601-1-2:2007 IEC/EN 60601-1-3:2008

3.3 Canadian Regulations The InSight FD Mini C-arm Systems comply with CAN/CSA-C22.2 No. 60601-1:08.

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RM InSight FD Mini C-arm User Guide 4. EMI

4 EMI This instrument is designed to be compatible with the electromagnetic environments specified in IEC60601-1-2 and will operate satisfactorily when placed in an environment that includes other equipment complying with that standard. If equipment that is not electromagnetically compatible is placed into the environment where the InSight FD Mini C-arm System is used, the InSight FD Mini C-arm System or the non-compliant equipment may malfunction or exhibit other anomalous behavior. Consult the appropriate field service engineer.

5 Cybersecurity Hologic continuously tests the current state of computer and network security to examine possible security problems. When necessary, Hologic provides the updates to the product. Please refer to the following documents for Cybersecurity information: • MAN-00734 InSight Cybersecurity Best Practices • MAN-00664 Insight Cyber-Security Product Report These documents are available on the Hologic, Inc. website at: http://www.hologic.com/support/fluoroscan-mini-c-arm

6 Accessories This instrument is supplied with hardware and software accessories that are needed for safe and reliable operation. Additional accessories may be used to perform optional procedures. Do not use any accessories with this instrument other than those approved by Hologic.

7 Where to Obtain Copies of the Manuals To obtain a PDF file of the User Guide or Service Manual, go to the support pages at www.Hologic.com Adobe Acrobat Reader version 5.0 or higher is required to view the PDF file. To order printed manuals, contact Hologic Customer Support. Toll Free in USA: +1.800.321.4659 Email: [email protected]

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RM InSight FD Mini C-arm User Guide 8. Terms and Definitions

8 Terms and Definitions Table 1

Terms and Definitions

Term

Definition

AC

Alternating Current

AKR

Air Kerma, X-ray dose rate displayed in the units of mGy/min on InSight systems

ALARA

As Low As Reasonably Achievable Every reasonable effort to maintain exposures to ionizing radiation as low as practical

Annotations

Graphic or text marks on an image to show an area of interest.

C-ECHO

Confirms network connection to PACS.

CMOS

Complementary metal–oxide–semiconductor

DAP

Dose Area Product (cGy·cm2)

DICOM

Digital Imaging and Communications in Medicine

EER

Entrance Exposure Rate

Last Image Hold

Whenever X-rays are being generated, the yellow X-ray light is ON, and the monitor displays the real time fluoroscopic image. When X-rays are terminated, the image displayed is the Last Image Hold (LIH) and the yellow X-ray light is OFF. This image is visi.ble until the user replaces it with one from the filmstrip or activates another X-ray exposure

Noise

Light and dark areas (speckle) that are not part of the patient anatomy

PACS

Picture Archiving and Communications System A computer and network system that transmits and archives digital medical images.

ROI

Region of Interest

SMPTE

Test pattern for evaluating the quality of video displays produced by the Society of Motion Picture & Television Engineers

SSD

Solid-state Drive A solid-state storage device that uses integrated circuit assemblies as memory to store data persistently.

TLD

Thermoluminescent Dosimetry, a method of measuring cumulative X-ray radiation exposure over time.

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RM InSight FD Mini C-arm User Guide 8. Terms and Definitions

Table 2 Symbol

Symbols Definition Note identifying recommended actions or additional information.

Caution Procedures that you must follow to avoid compromising processes, prevent damage to equipment, loss of data, damage to files in software applications, or minor injury. Warning Procedures that you must follow to prevent death or serious injury.

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RM InSight FD Mini C-arm User Guide 9. InSight FD System Labels

9 InSight FD System Labels 9.1 System Main Label The System Main Label is on the back of the base cabinet.* Figure 2 System Main Label

* Additional labeling information is available in MAN-06961.

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RM InSight FD Mini C-arm User Guide 9. InSight FD System Labels

9.2 X-ray System Warning Label The X-ray System Warning Label is on the left side of the base cabinet opposite the DVD player. Figure 3 X-ray System Warning

9.3 Electric Shock Warning Label The Electric Shock Warning Label is located near the fasteners for panels covering high voltage components. Figure 4 Electric Shock Warning

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