InSight FD User Guide Rev 003 Aug 2017

InSight™ FD Mini C-arm User Guide MAN-05288-001 Revision 003

InSight™ FD Mini C-arm Imaging System

User Guide Part Number: MAN-05288-001 Revision 003 August 2017

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] In Europe, South America, or Asia, contact your local dealer or distributor.

© 2017 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.

InSight FD Mini C-arm User Guide Table of Contents

Table of Contents 1 Indications for Use...1 2 Radiation Safety ...1 2.1 General ... 2 2.2 Radiation Dose and Dose Rate ... 2 2.3 X-ray Shielding ... 3

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

4 EMI...4 5 Accessories ...4 6 InSight FD System Labels...5 6.1 System Main Label ... 5 6.2 X-ray System Warning Label ... 5 6.3 Electric Shock Warning Label... 6 6.4 No Pushing Warning Label... 6 6.5 Field of View ... 6

7 Symbols ...7 8 Safety Hazards...9 9 System Components...14 10 Controls and Indicators ...15 10.1 X-ray Head Control Panel ... 15 10.2 Keyboard Controls ... 16 10.3 InSight FD System Footswitch Functions ... 18 10.3.1 Acquire an X-ray Image ... 19 10.3.2 Display a MegaView Image ... 19 10.3.3 Tag an Image ... 19 10.3.4 Save an Image... 19 10.3.5 Print an Image ... 19 10.3.6 Storage ... 20

11 Using the System ...21 11.1 Moving the System... 21 11.2 Adjusting the C-arm... 23 11.3 Sterile C-arm Drape... 24 11.4 Powering Up the System ... 25 11.5 Powering Down the System... 26

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InSight FD Mini C-arm User Guide Table of Contents

12 Configuring the Application ...27 12.1 System Configuration User Interface ... 27 12.2 System ... 27 12.3 DICOM Send Options... 30 12.3.1 DICOM Print Options ... 32 12.4 Worklist Configuration... 34 12.4.1 Users ... 36 12.5 Physician Preferences... 37 12.6 Physician Preferences - Image Acquisition ... 38 12.7 Physician Preferences - Image Processing... 40 12.8 Physician Preferences - Image Management ... 42 12.9 Administrative Settings Page ... 43

13 Using the Application ...45 13.1 Main Screen ... 45 13.2 Image Acquisition Session ... 50 13.2.1 Select or Enter Patient Window ... 50 13.2.2 Image Acquisition Screen ... 51 13.2.3 Filmstrip Symbols ... 53 13.2.4 Select Reference Images Window... 58 13.3 Review Images Session ... 59 13.3.1 Select Study for Review Window ... 59 13.3.2 Review Screen... 61 13.3.3 Enhanced Displayed Image Screen ... 64 13.4 Maintaining Patient Study Records ... 65 13.4.1 Update Patient Study Information Window... 65 13.5 Export Images ... 66 13.5.1 Export from Review Images Screen ... 66 13.5.2 Export from Review Images Screen ... 67 13.6 Import Images Window ... 70 13.7 Worklist Entry... 72 13.7.1 Option 1 Tools Submenu ... 72 13.7.2 Option 2 Patient Information Screen... 72 13.8 Delete Images Window... 72 13.9 View DICOM Queue Window ... 74

14 System Maintenance ...75 14.1 System Backup ... 75 14.2 System Recover ... 75 14.3 Cleaning ... 75 14.3.1 Recommended Disinfectants... 75 14.4 Preventive Maintenance ... 76

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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 ...5 Figure 3: X-ray System Warning...5 Figure 4: Electric Shock Warning...6 Figure 5: No Pushing Warning ...6 Figure 6: Field of View ...6 Figure 7: Wireless Footswitch ...18 Figure 8: Footswitch Storage ...20 Figure 9: Footswitch in Bracket...21 Figure 10: Keyboard in Down Position...22 Figure 11: C-arm in Transport Position ...22 Figure 12: Rear Casters...23 Figure 13: Adjusting the C-arm...24 Figure 14: Sterile C-arm Drape...25 Figure 15: System Configuration Menu...27 Figure 16: System ...28 Figure 17: DICOM Send Options...30 Figure 18: DICOM Print Options...32 Figure 19: Worklist Configuration...34 Figure 20: Users ...36 Figure 21: Physician Preferences - Image Acquisition ...38 Figure 22: Physician Preferences - Image Processing ...40 Figure 23: Physician Preferences - Image Management ...42 Figure 24: Main Screen ...45 Figure 25: System Configuration Pull-down Menu ...46 Figure 26: Tools Pull-down Menu ...47 Figure 27: Select or Enter Patient Window...50 Figure 28: Image Acquisition Screen...51 Figure 29: Image Effects Menu...52 Figure 30: Filmstrip Symbols...53

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InSight FD Mini C-arm User Guide List of Figures

Figure 31: Configure Image Area Menu ...54 Figure 32: Image Acquisition Screen Buttons ...55 Figure 33: Select Reference Images Window ...58 Figure 34: Study for Review ...59 Figure 35: Review Images Screen ...61 Figure 36: Patient Details ...63 Figure 37: VISTA Details...63 Figure 38: Enhanced Displayed Image Screen...64 Figure 39: Update Patient Study Information Window ...65 Figure 40: Image Export from Review Screen ...66 Figure 41: Export Images Panel ...67 Figure 42: Tool Menu Export...67 Figure 43: Export Images from Tool Menu ...68 Figure 44: Tools Menu...70 Figure 45: Import Images Window ...70 Figure 46: Delete Images ...72 Figure 47: Image Selected for Deletion ...73 Figure 48: View DICOM Queue...74

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InSight FD Mini C-arm User Guide List of Tables

List of Tables Table 1: Symbols ...7 Table 2: Safety Hazards ...9 Table 3: X-ray Head Control Panel ...15 Table 4: Keyboard Controls ...16 Table 5: Footswitch Pedal Functions ...18 Table 6: Conditioning Schedule ...26 Table 7: System Configuration User Interface ...27 Table 8: System Page ...29 Table 9: DICOM Send Options Page ...30 Table 10: DICOM Send Options Page, Button Functions ...31 Table 11: DICOM Print Options Page, Section/Field Descriptions ...32 Table 12: DICOM Print Options Page, Button Functions ...33 Table 13: Worklist Configuration, Section Descriptions ...34 Table 14: Worklist Configuration, Button Functions ...35 Table 15: Users Page, Section/Field Descriptions ...36 Table 16: Users Page, Button Functions ...37 Table 17: Physician Preferences, Section/Field Descriptions ...37 Table 18: Physician Preferences, Button Functions ...37 Table 19: Physician Preferences, Image Acquisition Tab, Section/Field Descriptions ...39 Table 20: Physician Preferences, Image Processing Tab, Section/Field Descriptions ...41 Table 21: Physician Preferences, Image Management Tab, Section/Field Descriptions ..42 Table 22: Administrative Settings, Section Descriptions ...43 Table 23: Administrative Settings, Button Functions ...44 Table 24: Main Screen Options ...45 Table 25: System Configuration Menu ...46 Table 26: Tools Menu ...47 Table 27: Select or Enter Patient Window, Section/Field Descriptions ...50 Table 28: Select or Enter Patient Window, Button Functions ...51 Table 29: Image Acquisition Screen ...51 Table 30: Image Effects Menu ...52

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InSight FD Mini C-arm User Guide List of Tables

Table 31: Filmstrip Symbols ...54 Table 32: Configure Image Area Menu ...54 Table 33: Image Acquisition Screen, Button Functions ...55 Table 34: Tool Set ...57 Table 35: Select Reference Images Window, Section Descriptions ...58 Table 36: Select Reference Images Window, Button Functions ...59 Table 37: Select Study for Review Window, Section/Field Descriptions ...60 Table 38: Select Study for Review Window, Button Functions ...60 Table 39: Review Screen, Button Functions ...61 Table 40: Detailed Image Viewing Screen, Button Functions ...64 Table 41: Update Patient/Study Information Window, Section Descriptions ...65 Table 42: Update Patient/Study Information Window, Button Functions ...66 Table 43: Export Window, Section Descriptions ...68 Table 44: Export Window, Button Functions ...69 Table 45: Import Window, Section Descriptions ...71 Table 46: Import Window, Button Functions ...71 Table 47: Delete Images Window, Section Descriptions ...73 Table 48: Delete Images Window, Button Functions ...74 Table 49: Queue Window, Section Description and Button Functions ...74 Table 50: Recommended Wipes ...75 Table 51: Recommended Chemicals ...76

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InSight FD Mini C-arm User Guide 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

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 operator's 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.

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InSight FD Mini C-arm User Guide Radiation Safety

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. This higher value is known as the maximum Entrance Exposure Rate (EER). 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.

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

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 user 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

IEC/EN 60601-1-3

IEC/EN 60601-2-28

IEC/EN 60601-1-2

IEC/EN 60825-1

IEC/EN 60601-2-54

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InSight FD Mini C-arm User Guide EMI

3.3 Canadian Regulations The InSight FD Mini C-arm Systems comply with CSA C22.2 No. 601.1

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 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.

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InSight FD Mini C-arm User Guide InSight FD System Labels

6 InSight FD System Labels 6.1 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-05309-001.

6.2 X-ray System Warning Label The X-ray System Warning Label is on the front of the base cabinet below the Computer On/Standby switch. Figure 3 X-ray System Warning

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InSight FD Mini C-arm User Guide InSight FD System Labels

6.3 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

6.4 No Pushing Warning Label The No Pushing Warning Label is located on the back of the base cabinet. Figure 5 No Pushing Warning*

*Do not push the system with the casters locked or obstructed and the C-arm extended.

6.5 Field of View Field of View is represented by raised rectangles on the underside of the High Voltage Power Supply. When the Field of View selection lever is positioned at the large rectangle, full field of view is selected. When the Field of View selection lever is positioned at the small rectangle limited field of view is selected. Figure 6 Field of View

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InSight FD Mini C-arm User Guide Symbols

7 Symbols Table 1

Symbols CSA listed device

CE mark

Dangerous voltage

Caution

Type B applied part

X-ray filtration

Warning: Electricity

AC Voltage

Time delay fuse

Protective earth (ground)

Earth (ground)

Equipotentiality

USB connector

Electrostatic sensitive device

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

Computer On/Standby switch

Rear wheels free to move in all directions

Rear wheels move forward and back only

Locking ,general

Manufacturer

Date of Manufacture

Authorized representatives in the European Community

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InSight FD Mini C-arm User Guide Symbols

Table 1

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Symbols (Continued) Radiation of laser apparatus

X-ray source emitting

Store

Print

Increase or decrease kV/mA

Rotate image

Cycle through the noise suppression settings

Serial number

MegaView™ Image

Mode

Catalogue number

No pushing

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InSight FD Mini C-arm User Guide Safety Hazards

8 Safety Hazards Table 2

The following table itemizes various safety hazards. Each hazard is cross referenced with the respective cause and proper course of action. Safety Hazards

Safety Hazard

Cause

Course of Action

Radiation Safety

This system produces Although operating this ionizing radiation and system can result in low scatter may be dangerous to radiation levels, it is patients and operators recommended that protective unless the safety and X-ray clothing be worn and operating instructions in radiation safety precautions be this manual are followed. observed when operating the system. Operators should avoid placing their hands or any part of their bodies in the path of the X-ray beam. When making X-ray exposures, place the anatomy close to the CMOS detector for the best image quality and to reduce exposure to radiation. An alarm sounds after every five minutes of accumulated exposure time.

Electrical Safety

Electrical circuits Safety covers have been inside the system can designed for this system to cause serious injury or mitigate the hazards caused by death. electrical circuits and high This system operates on voltages. Never remove the high voltages. High covers or operate the system voltages are at the while the covers are off. If any following locations: cover is off, request service X-ray tube: 75,000 Volts. before using the system. Unplugging the power cord from the wall is the only way to disconnect main power from this system.

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InSight FD Mini C-arm User Guide Safety Hazards

Table 2

Safety Hazards

Safety Hazard

Cause

Course of Action

Overbalance Hazard Placing too much weight on If weight is to be applied to the the C-arm CMOS detector may C-arm CMOS detector, caution must be used to prevent the cause the system to overbalance. The amount of device from becoming weight that the CMOS detector unstable. Do not place the full can support is highly variable, depending on the position of weight of the lower the flex-arm, C-arm, and other extremity directly on the factors. This hazard is greatest CMOS detector. when the flex-arm is extended and moved to the far left or Do not attempt to move the right of the system. system from the left or right side or by pushing on the system C-arm or the mast when the casters are locked or obstructed. Imaging Function Loss

Detector damage from surgical tools (i.e., drills coming into contact with the detector surface)

Unauthorized Modifications to X-ray Tube

Do not make any changes to Never remove the the X-ray tube. Contact a housing around the X-ray tube or make any Hologic Representative to replace the X-ray tube. changes to the X-ray tube. When the product leaves the manufacturing plant and at the time of installation, the X-ray source and assembly meet the requirements of 21 CFR 1020.30-32. Any unapproved change to the system could cause death, injury or expensive damage to the equipment, and could void the service agreement.

10

Do not use the C-arm CMOS detector as a working surface.

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