InSight User Guide V3.X Rev 002 March 2010

InSight Mini C-arm Imaging System User Guide

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

MAN-01567 Revision 002

March 2010 The information contained in this Manual is confidential and proprietary to Hologic, Inc. This information is provided only to authorized representatives of Hologic’s customers solely for the purpose of facilitating the use of Hologic’s products. No information contained herein may be disclosed to any unauthorized person for any purpose whatsoever without the prior written consent of Hologic, Inc. The information in this document is subject to change without notice. ©

2005-2010 by Hologic, Inc. All rights reserved.

InSight™ and Fluoroscan™ are trademarks of Hologic, Inc. Hologic and the Hologic logo are registered trademarks of Hologic, Inc. All other trademarks, registered trademarks, and product names used within this document are the property of their respective owners. The Hologic products described in this Manual are protected by at least some of the following U.S. Patents and foreign counterparts: 6,234,672; 6,236,712; PCT Intl. Application US98/25281 This manual originally drafted in the English language. Printed in the U.S.A.

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730 USA

Hologic Europe Authorized Representative Hologic N.V. Leuvensesteenweg 250A 1800 Vilvoorde Belgium Tel: 32.2.711.4680 Fax: 32.2.725.2087

Tel: (781) 999-7300 Fax: (781) 280-0669 Service: (800) 321-HOLX (321-4659) User Support: (800) 321-HOLX (321-4659

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Contents Indications for Use ... 1 Radiation Safety ... 1 General... 1 Radiation Dose and Dose Rate ... 2 X-ray Shielding... 2 Regulations for X-Ray Equipment ... 2 United States Federal and State Regulations ... 2 IEC Regulations ... 2 Canadian Regulations ... 3 EMI ... 3 Accessories ... 3 Labels ... 3 Symbols ... 4 Safety Hazards ... 5 System Components... 8 Controls and Indicators... 9 X-ray Head Control Panel... 9 Foot Switch Controls ... 9 Keyboard Controls ... 10 Using the System ... 11 Moving the System ... 11 Adjusting the C-arm... 12 The Sterile C-arm Drape... 12 Powering Up the System... 13 Powering Down the System... 13 Using the InSight Application... 14 Main Screen ... 14 Image Acquisition Session... 17 Select or Enter Patient Window... 17 Image Acquisition Screen ... 18 Select Reference Images Window ... 22 Review Images Session ... 23 Select Study for Review Window... 23 Review Screen ... 24 Enhanced Displayed Image Screen... 26 Maintaining Patient Study Records ... 27 Update Patient Study Information Window... 27 Export Images Window ... 28 Import Images Window ... 30 Delete Images Window... 32 View DICOM Queue Window ... 33 Configuring the Application ... 34

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Table of Contents

System Configuration User Interface ... 34 System Page ... 34 DICOM Send Options Page... 35 DICOM Print Options Page ... 36 Worklist Configuration Page ... 38 Users / Passwords Page... 39 Physician Preferences Page ... 40 Physician Preferences Page - Image Acquisition Tab ... 41 Physician Preferences Page - Image Processing Tab... 42 Physician Preferences Page - Image Management Tab ... 43 Administrative Settings Page... 44 System Maintenance ... 45 System Backup ... 45 System Recover ... 45 Cleaning ... 45

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Tables Table 1 System Configuration Menu...15 Table 2 Tools Menu ...16 Table 3 Select or Enter Patient Window, Section/Field Descriptions ...17 Table 4 Select or Enter Patient Window, Button Functions ...17 Table 5 Image Effects Menu...19 Table 6 Configure Image Area Menu ...19 Table 7 Image Acquisition Screen, Button Functions ...20 Table 8 Tool Set...21 Table 9 Select Reference Images Window, Section Descriptions...22 Table 10 Select Reference Images Window, Button Functions ...22 Table 11 Select Study for Review Window, Section/Field Descriptions ...23 Table 12 Select Study for Review Window, Button Functions ...23 Table 13 Review Screen, Button Functions...24 Table 14 Detailed Image Viewing Screen, Button Functions ...26 Table 15 Update Patient/Study Information Window, Section Descriptions ...27 Table 16 Update Patient/Study Information Window, Button Functions...27 Table 17 Export Window, Section Descriptions ...28 Table 18 Export Window, Button Functions ...29 Table 19 Import Window, Section Descriptions ...30 Table 20 Import Window, Button Function...31 Table 21 Delete Images Window, Section Descriptions ...32 Table 22 Delete Images Window, Button Functions ...32 Table 23 Queue Window, Section Description and Button Functions ...33 Table 24 System Page, Section/Field Descriptions ...34 Table 25 DICOM Send Options Page, Section Descriptions ...35 Table 26 DICOM Send Options Page, Button Functions ...36 Table 27 DICOM Print Options Page, Section/Field Descriptions ...36 Table 28 DICOM Print Options Page, Button Functions ...37 Table 29 Worklist Configuration Page, Section Descriptions ...38 Table 30 Worklist Configuration Page, Button Functions ...38 Table 31 Users / Passwords Page, Section/Field Descriptions ...39 Table 32 Users / Passwords Page, Button Functions...39 Table 33 Physician Preferences Page, Section/Field Descriptions...40 Table 34 Physician Preferences Page, Button Functions...40 Table 35 Physician Preferences Page - Image Acquisition Tab, Section/Field Descriptions...41 Table 36 Physician Preferences Page - Image Processing Tab, Section/Field Descriptions ...42 Table 37 Physician Preferences Page - Image Management Tab, Section/Field Descriptions ...43 Table 38 Administrative Settings Page, Section Descriptions ...44 Table 39 Administrative Settings Page, Button Functions ...44

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Fluoroscan InSight User Guide

Indications for Use The Fluoroscan InSight 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.

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. 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.

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 the X-rays which 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 is greatly dependent upon the power setting used and the density and proximity of the body part to the beam, and the length of exposure time.

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Fluoroscan InSight User Guide

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 plays a major role in reducing 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 above 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 InSight is available from Hologic upon request.

X-ray Shielding The scattered radiation from the InSight 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. It should also be noted that many states, provinces, countries and individual institutions may require the use of lead aprons by persons in the same room with any operating fluoroscopic device. The strict observation of safe operating practices and the use of minimal fluoroscopic times is the key to reducing user exposure.

Regulations for X-Ray Equipment United States Federal and State Regulations Fluoroscan InSight 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 for 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 Xray equipment. The InSight Mini C-arm Imaging System complies with 21CFR Subchapter J. The InSight Mini C-arm Imaging System is intended for special surgical applications that would be prohibited at the source to skin distances specified in 21CFR 1020.32 (g) but are permitted under 21CFR 1020.32 (g) (2). The SSD is 10 cm minimum.

IEC Regulations Fluoroscan InSight Mini C-arm Imaging Systems comply with the requirements of IEC 60601-1. The classification of the InSight Mini C-arm Imaging Systems under this specification is Class 1, Type B.

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Fluoroscan InSight User Guide

The InSight Mini C-arm Imaging Systems comply with the following IEC standards: IEC/EN 60601-1 IEC/EN 60601-1-3 IEC/EN 60601-1-1 IEC/EN 60601-1-4 IEC/EN 60601-1-2IEC/EN 60825-1IEC/EN 60601-2-32

IEC/EN 60601-2-7 IEC/EN 60601-2-28

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

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 Mini C-arm Imaging System is used, the InSight Mini C-arm Imaging System or the non-compliant equipment may malfunction or exhibit other anomalous behavior. Consult the appropriate field service engineer.

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

Labels

System Model: InSight 2 Manufactured by: Hologic, Inc. 35 Crosby Drive Bedford, MA 01730 USA

R

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Electrical rating: 100/120/220/240V

The serial number label includes: Model Manufacturer name and address Date of manufacture Serial number Electrical rating Duty cycle This product complies with DHHS rules 21 CFR Subchapter J applicable on date of manufacture. IEC standards

50/60 Hz, 750VA

50% Max Duty Cycle at 75kVp, 100uA

LBL-00377 Rev. 001

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Fluoroscan InSight User Guide

WARNING: This X-Ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are 110365 REV 002 observed.

Class 1 Laser Product Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice number 50 dated July 26, 2001. LBL-00228 REV 002

WARNING: This X-Ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed.

Class 1 Laser Product Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice number 50 dated July 26, 2001.

Symbols CSA listed device

0044

CE marked device

R

Dangerous voltage

Attention - Read the Caution or Warning statement that follows

Type B equipment

X-ray filtration

Time delay fuse

Protective ground

Functional ground

Equipotential ground

USB connector

Electrostatic sensitive device

Dispose of electrical/electronic equipment properly

Computer On/Standby switch

Rear wheels free to move in all directions

Rear wheels move forward and back only

LBL-00270 Rev 001

Rear wheels locked

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Fluoroscan InSight User Guide

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

SAFETY HAZARD

CAUSE

Radiation Safety

This system produces ionizing radiation and may be dangerous to patients and operators unless the safety and operating instructions in this manual are followed.

COURSE OF ACTION Although operating this system can result in low scatter radiation levels, it is recommended that protective X-ray clothing be worn and radiation safety precautions be 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 image intensifier 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 inside the system can cause serious injury or death. This system operates on high voltages. High voltages are at the following locations:

Safety covers have been designed for this system to mitigate the hazards caused by electrical circuits and high voltages. Never remove the covers or operate the system while the covers are off. If any cover is off, request service before using the system.

X-ray tube: 75,000 Volts. Unplugging the power cord from the wall is the only way to disconnect main power from this system. Tipping Hazard

Placing too much weight on the C-arm Image Intensifier may cause the system to tip over. The amount of weight that can be supported by the Image Intensifier is highly variable, depending on the position of the flex-arm, c-arm, and other factors. This hazard is greatest when the flex-arm is extended and moved to the far left or right of the system.

If weight is to be applied to the C-Arm Image Intensifier, caution must be used to prevent the device from becoming unstable. Placing the full weight of the lower extremity directly on the Image Intensifier is NOT recommended.

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Fluoroscan InSight User Guide

SAFETY HAZARD

CAUSE

COURSE OF ACTION Do not make any changes to the X-ray tube. Contact a Hologic Representative to replace the X-ray tube.

Unauthorized Modifications to X-ray Tube Never remove the housing around the X-ray tube or make any 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. Electrical Fire

Fire from any source.

If there is a fire in the area, and it is safe to do so, turn the system off and unplug the power cord from the wall outlet. If the system is on fire, do not touch it. Leave the area. If you use a fire extinguisher, only use one approved for electrical fires.

Explosion Hazard

Foot Switch safety

Flammable and explosive anesthetics, liquids, vapors and gases can cause an explosion when used around electrical equipment

If any of these products are near the system, DO NOT TURN THE SYSTEM ON.

The foot switch can be damaged by falling objects, being rolled over by the wheels, and in other ways.

Remain aware of the foot switch at all times during operation and transport to avoid these hazards.

If any of these products are discovered near the system while it is on, DO NOT TOUCH ANY CONTROL OR TURN THE SYSTEM OFF. Evacuate the facility immediately. Have the facility specialist remove the substances and ventilate the area before allowing patients and personnel to return to the facility.

If the foot switch is tipped, turn it face up immediately. Before moving the system, always unplug the system power cord, and store the cord on the handle.

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Fluoroscan InSight User Guide

SAFETY HAZARD Collision Hazard

CAUSE If improperly moved or if the wheel brakes are not used correctly, the system could roll out of control. If the articulating flex arm is not locked in place during transport, the C-arm could swing out of control and cause injury to the patient or medical personnel.

COURSE OF ACTION

Use caution when moving the system on an incline. Do not move the system on an incline greater than ten degrees. One person should be able to move the system easily on a level surface. Always lock the wheel brakes before procedures. Never leave the system unattended on an incline greater than five degrees. Always lock the flex arm after changing the position of the C-arm.

Cleaning Safety

Almost any liquid spilled into electronic equipment automatically becomes a conductor of electricity.

This system is not water proof. It must be turned off immediately if liquid is spilled on it. Do not turn the system on until the liquid has dried completely. Do not splash or spray cleaning solution on the system. Clean exterior surfaces of the Fluoroscan InSight Console, the flexarm and the C-arm with a soft cloth or disposable lint-free tissue moistened with water, isopropanol or methanol. Wipe surfaces, do not scrub. Do not connect any devices to the system other than those described in this manual.

Device Safety

Injury could result if unapproved devices are connected to the system.

Internally connected devices should be installed only by persons trained in the servicing of this system.

Certain devices were tested for use with the Fluoroscan System, and only these or compatible devices should be used. Electrosurgical Device

This system is shielded from electrical discharges. However, there is still a possibility that an electrosurgical device discharged directly into the system could adversely affect system operation. In addition, shielding might not always protect the system from the amount of energy produced by a sparkgap type device.

If there is a strong electrosurgical surge into the system and it malfunctions, turn the system off, wait five seconds, then turn it back on. If the problem persists after resetting the system twice, request service.

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Fluoroscan InSight User Guide

System Components L

A E

B C D M K

H

F

G

N

J I

8

A

Touch screen monitor

H

DVD RW recorder

B

Keyboard with integrated pointing device

I

Foot switch

C

Flex-arm

J

Foot switch shelf

D

C-arm

K

Image printer shelf

E

X-ray head

L

X-ray ON light

F

Image intensifier

M

C-arm retainer (not shown)

G

Computer On/Standby switch

N

USB port

Fluoroscan InSight User Guide

Controls and Indicators X-ray Head Control Panel Symbol

Label

Function

Rotate

Rotates the image 10 degrees clockwise or counterclockwise.

B/C

Allows adjustment of image brightness and contrast.

X-ray

Acquires an X-ray exposure. Press switch twice to actuate X-rays. A yellow indicator light located on top of the monitor shows that X-rays are being produced.

Laser

Turns on the Positional Laser.

Noise Suppression

Cycles through the Noise suppression settings during image acquisition.

kV/mA

Increases or decreases technique factors based on selected mode (see Table 7 on page 20). Note: Pressing both the up and down power buttons at the same time returns the system to Auto Power mode.

Foot Switch Controls Switch Position Left

Symbol

Name X-ray

Function Acquires an X-ray exposure. A yellow indicator light located on top of the monitor shows that X-rays are being produced.

Center

Print

Prints the current image on the local printer.

Right

Save

To mark the image as a reference image, press and release the foot switch once. To save the image and unmark as a reference, press and release the foot switch a second time. To save the image and mark as a reference, press and release the foot switch a third time.

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Fluoroscan InSight User Guide

Keyboard Controls Icon

10

Function Key

Function

F1

Displays help window.

F2

In Image Acquisition session, displays the Patient Information window. In Review session, displays the Select Study fir Review window.

F3

Flips image horizontally.

F4

Rotates image 10 degrees clockwise.

Shift-F4

Rotates image 10 degrees counterclockwise.

F5

Decreases kV/mA if simultaneous is on, or decreases kV if simultaneous is off. Pressing this key puts the system into manual mode.

Shift-F5

Decreases mA if simultaneous is off. Pressing this key puts the system into manual mode.

F6

Increases kV/mA if simultaneous is on, or increases kV if simultaneous is off. Pressing this key puts the system into manual mode.

Shift-F6

Increases mA if simultaneous is off. Pressing this key puts the system into manual mode.

F7

Resets fluoro alarm timer.

F8

Saves the current image to the patient’s record.

F9

Prints the current image to the local printer.

F10

Toggles Play back of a recorded cine loop on/off.

F11

Restores physician’s defaults.

Shift-F11

Returns the system to Auto Power mode.

F12

Cycles through the Noise suppression settings during image acquisition.

Fluoroscan InSight User Guide

Using the System Note: InSight operators should read the Radiation Safety section before operating the system.

Moving the System Warning: 1. 2. 3. 4. 5.

Before moving the system, the flex-arm and C-arm must be in the locked storage position to prevent tipping.

Ensure that the system is powered off. (See “Shutting Down the InSight System” for details.) Unplug the power cord and wrap it around the cord guides on the back of the cabinet. Store the foot switch in the foot switch shelf. Flip the monitor forward and down. Place the flex-arm and C-arm in the locked position (see below) using the Transport Position Knob on the side of the C-arm housing.

Transport Position Knob

6. Once the system is in position, lock the rear casters down to prevent the system from moving. The swiveling angle of the rear casters can be locked to prevent lateral movement of the system or unlocked to allow lateral movement.

Rear wheels locked

Rear wheels move forward and back only

Rear wheels free to move in all directions

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Fluoroscan InSight User Guide

Adjusting the C-arm Turn the flex-arm lock counterclockwise to loosen; then adjust the flex-arm height. To reposition the C-arm, turn the C-arm lock to loosen. Roll the arm to the desired position, then turn to lock the arm in place. The locking lever can also be positioned between open and locked to provide various levels of resistance to arm roll.

C-arm lock Flex-arm lock

The Sterile C-arm Drape Before using InSight in the operating room, the C-arm should be fitted with a sterile drape. Small labels on the drape indicate how to fit the drape to the X-ray head and to the intensifier. Note: After use, dispose of sterile C-arm drape properly (in a biohazard container).

X-ray Head

Intensifier

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Fluoroscan InSight User Guide

Powering Up the System Warnings:

The InSight system operates on standard 115 Volt, 60 Hz AC power for United States, Japanese and Canadian models, and 240 volt, 50 Hz AC power for other export models. The system should only be plugged into a properly grounded three-wire wall outlet. Never cut the third (grounding) pin from the power cord in order to plug the unit into an ungrounded two wire outlet, and never use a three wire-to-two wire adapter.

The system should be at ambient room temperature. The power cord must be plugged into a standard single-phase three-wire grounded outlet. A special dedicated outlet is not required. To power up the system, press the Computer On/Standby switch. Fluoroscan InSight will prompt the user to login. If the system has been off for more than two weeks it is recommended that the source conditioning procedure described below be used. This conditioning procedure is advised to safeguard and help prolong the life of the X-ray source. Conditioning Schedule Step

kV

mA

Minimum Time

1

40

0.05

2 minutes

2

50

0.10

2 minutes

3

60

0.10

2 minutes

4

70

0.10

3 minutes

5

75

0.10

3 minutes

The system must warm up for FOUR MINUTES before generating X-rays. Failure to provide adequate warm up could result in damage to the system.

Powering Down the System To close the application and place the system in standby: on the InSight main screen, click the Shut Down button or press and hold the Computer On/Standby switch. The system can also be placed in standby by clicking Exit on the Exit menu on the InSight main screen. To shut the system down: unplug the power cord.

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Fluoroscan InSight User Guide

Using the InSight Application Note: In the InSight application, users can select buttons, menus, menu functions, icons, and position the insertion cursor in fields by 1.) positioning the cursor on the respective item and clicking the left mouse button or 2.) touching the item on the touch screen (if enabled). Throughout this manual, “click” will be used to indicate both ways. Once the user is logged into the application, the main screen appears if Audit Mode is on. If Audit mode is off, the user is taken directly to the Image Acquisition screen.

Main Screen D

H

E F G

C B A

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A

Starts an image acquisition session. See “Image Acquisition Session” on page 17.

B

Starts an image review session. See “Review Images Session” on page 23.

C

Exits application and shuts down the system.

D

System Configuration menu. see Table 1 on page 15

E

Tools menu. see Table 2 on page 16

F

About - Displays InSight application’s version number, serial number and copyright data.

G

Exit menu. Allows the user to logout or exit the application.

H

Help - Displays help for using the screen.