User Guide
78 Pages
Preview
Page 1
InSight® 2 Mini C-arm User Guide MAN-04536 Revision 002
InSight 2
Mini C-arm Imaging System
User Guide Part Number: MAN-04536 Revision 002 September 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] In Europe, South America, or Asia, contact your local dealer or distributor.
©2015 - 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/patent-information.
InSight 2 Mini C-arm Imaging System User Guide
Table of Contents Indications for Use...1 Radiation Safety ...1 General ... 2 Radiation Dose and Dose Rate ... 2 X-ray Shielding ... 2
Regulations for X-Ray Equipment...3 United States Federal and State Regulations... 3 IEC Regulations ... 3 Canadian Regulations... 3
EMI...4 Accessories ...4 Insight System Labels ...4 Manufacturer Serial Number Label ... 4 X-Ray System Warning Label ... 5 Electric Shock Warning Label ... 5
Symbols ...5 Safety Hazards...7 System Components...11 Controls and Indicators ...12 X-ray Head Control Panel ... 12 Foot Switch Controls... 12
Using the System ...15 Moving the System... 15 Adjusting the C-arm... 16 Sterile C-arm Drape... 17 Powering Up the System ... 18 Powering Down the System... 18
Configuring the Application ...19 System Configuration User Interface ... 19 System ... 19 DICOM Send Options... 21 DICOM Print Options ... 23 Worklist Configuration... 25 Users ... 27 Physician Preferences... 28
MAN-04536 Revision 002
i
InSight 2 Mini C-arm Imaging System User Guide
Physician Preferences - Image Acquisition ... 29 Physicians Preferances - Image Processing ... 31 Physician Preferences - Image Management ... 33 Administrative Settings Page ... 34
Using the Insight Application ...36 Main Screen ... 36 Image Acquisition Session ... 42 Select or Enter Patient Window ... 42 Image Acquisition Screen ... 43 Select Reference Images Window... 49 Review Images Session... 50 Select Study for Review Window ... 50 Review Screen... 53 Enhanced Displayed Image Screen ... 56 Maintaining Patient Study Records ... 57 Update Patient Study Information Window... 57 Export Images ... 58 Export from Review Images Screen ... 58 Export from Review Images Screen ... 59 Import Images Window ... 62 Delete Images Window... 64 View DICOM Queue Window ... 66
System Maintenance ...67 System Backup ... 67 System Recover ... 67 Cleaning ... 68 Preventative Maintenance... 68
ii
MAN-04536 Revision 002
InSight 2 Mini C-arm Imaging System User Guide
List of Figures Figure 1: Fluoroscan Insight 2 Imaging System ... 1 Figure 2: Serial Number ... 4 Figure 3: X-Ray System Warning... 5 Figure 4: Electric Shock Warning... 5 Figure 5: System Components ... 11 Figure 6: Transport Position Knob ... 15 Figure 7: Rear Casters... 16 Figure 8: Adjusting the C-arm... 17 Figure 9: Sterile C-arm Drape... 17 Figure 10: System Menu... 19 Figure 11: System ... 20 Figure 12: DICOM Send Options... 21 Figure 13:
DICOM Print Options ... 23
Figure 14: Worklist Configuration... 25 Figure 15: Users ... 27 Figure 16: Physician Preferences ... 28 Figure 17: Physician Preferences - Image Acquisition ... 29 Figure 18: Physician Preferences - Image Processing ... 31 Figure 19: Physician Preferences - Image Management... 33 Figure 20: Main Screen ... 36 Figure 21: System Configuration Pull-down Menu ... 37 Figure 22: System Configuration Menu ... 38 Figure 23: Tools Pull-down Menu ... 40 Figure 24: Select or Enter Patient Window... 42 Figure 25: Image Acquisition Screen... 43 Figure 26: Image Effects Menu... 44
MAN-04536 Revision 002
iii
InSight 2 Mini C-arm Imaging System User Guide
Figure 27: Configure Image Area Menu... 45 Figure 28: Image Acquisition Screen Buttons ... 46 Figure 29: Reference Images Window ... 49 Figure 30: Select Study for Review ... 51 Figure 31: Review Images Screen ... 53 Figure 32: Patient Details ... 55 Figure 33: VISTA Details... 55 Figure 34: Enhanced Displayed Image Screen... 56 Figure 35: Tools Menu ... 57 Figure 36: Image Export from Review Screen ... 58 Figure 37: Export Images ... 59 Figure 38: Tool Menu Export... 59 Figure 39: Export Images from Tool Menu ... 60 Figure 40: Tools Menu... 62 Figure 41: Import Images Window ... 62 Figure 42: Delete Images... 64 Figure 43: Patient Selected ... 65 Figure 44: Image selected for Deletion... 65 Figure 45: View DICOM Queue... 67
iv
MAN-04536 Revision 002
InSight 2 Mini C-arm Imaging System User Guide
List of Tables Table 1 Symbols ...5 Table 2 Safety Hazards ...7 Table 3 X-ray Head Control Panel ...12 Table 4 Foot Switch Controls ...12 Table 5 Keyboard Controls ...13 Table 6 Conditioning Schedule ...18 Table 7 System Configuration User Interface ...19 Table 8 System Page ...20 Table 9 DICOM Send Options Page ...22 Table 10 DICOM Send Options Page, Button Functions ...22 Table 11 DICOM Print Options Page, Section/Field Descriptions ...23 Table 12 DICOM Print Options Page, Button Functions ...24 Table 13 Worklist Configuration, Section Descriptions ...25 Table 14 Worklist Configuration, Button Functions ...26 Table 15 Users Page, Section/Field Descriptions ...27 Table 16 Users Page, Button Functions ...27 Table 17 Physician Preferences, Section/Field Descriptions ...28 Table 18 Physician Preferences, Button Functions ...29 Table 19 Physician Preferences, Image Acquisition Tab, Section/Field Descriptions ...30 Table 20 Physician Preferences, Image Processing Tab, Section/Field Descriptions ...31 Table 21 Physician Preferences, Image Management Tab, Section/Field Descriptions ...33 Table 22 Administrative Settings, Section Descriptions ...34 Table 23 Administrative Settings, Button Functions ...34 Table 24 Main Screen Options ...36 Table 25 System Configuration Menu ...38 Table 26 Tools Menu ...40
MAN-04536 Revision 002
ix
InSight 2 Mini C-arm Imaging System User Guide
Table 27 Select or Enter Patient Window, Section/Field Descriptions ...42 Table 28 Select or Enter Patient Window, Button Functions ...43 Table 29 Image Acquisition Screen ...43 Table 30 Image Effects Menu ...44 Table 31 Configure Image Area Menu ...45 Table 32 Image Acquisition Screen, Button Functions ...46 Table 33 Tool Set ...47 Table 34 Select Reference Images Window, Section Descriptions ...49 Table 35 Select Reference Images Window, Button Functions ...50 Table 36 Select Study for Review Window, Section/Field Descriptions ...51 Table 37 Select Study for Review Window, Button Functions ...52 Table 38 Review Screen, Button Functions ...53 Table 39 Detailed Image Viewing Screen, Button Functions ...56 Table 40 Update Patient/Study Information Window, Section Descriptions ...57 Table 41 Update Patient/Study Information Window, Button Functions ...58 Table 42 Export Window, Section Descriptions ...60 Table 43 Export Window, Button Functions ...61 Table 44 Import Window, Section Descriptions ...63 Table 45 Import Window, Button Functions ...63 Table 46 Delete Images Window, Section Descriptions ...66 Table 47 Delete Images Window, Button Functions ...66 Table 48 Queue Window, Section Description and Button Functions ...67
x
MAN-04536 Revision 002
InSight 2 Mini C-arm Imaging System User Guide Indications for Use
Indications for Use
The Fluoroscan Insight® 2 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 Fluoroscan Insight 2 Imaging System
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.
MAN-04536 Revision 002
1
InSight 2 Mini C-arm Imaging System 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.
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 is depends upon the power setting used, the density and proximity of the body part to the beam, and the length of exposure time.
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 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. 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.
2
MAN-04536 Revision 002
InSight 2 Mini C-arm Imaging System User Guide Regulations for X-Ray Equipment
Regulations for X-Ray Equipment United States Federal and State Regulations Fluoroscan Insight 2 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 2 Mini C-arm Imaging System complies with 21CFR Subchapter J. The Insight 2 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.
IEC Regulations Fluoroscan Insight 2 Mini C-arm Imaging Systems comply with the requirements of IEC 60601-1. The classification of the Insight 2 Mini C-arm Imaging Systems under this specification is Class 1, Type B. The Insight 2 Mini C-arm Imaging Systems comply with the following IEC standards: IEC/EN 60601-1
IEC/EN 60601-1-3
IEC/EN 60601-2-7
IEC/EN 60601-1-1
IEC/EN 60601-1-4
IEC/EN 60601-2-28
IEC/EN 60601-1-2
IEC/EN 60825-1
IEC/EN 60601-2-32
Canadian Regulations The Insight 2 Mini C-arm Imaging Systems comply with CSA C22.2 No. 601.1
MAN-04536 Revision 002
3
InSight 2 Mini C-arm Imaging System User Guide EMI
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 2 Mini C-arm Imaging System is used, the Insight 2 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 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.
Insight System Labels Manufacturer Serial Number Label The Manufacturer Serial Number Label is on the back of the base cabinet. Figure 2 Serial Number
4
MAN-04536 Revision 002
InSight 2 Mini C-arm Imaging System User Guide Symbols
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
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
Symbols Table 1 R
Symbols CSA listed device
0044
CE marked device
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
MAN-04536 Revision 002
5
InSight 2 Mini C-arm Imaging System User Guide Symbols
Table 1
Symbols WEEE 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
Rear wheels locked
Manufacturer name and location
Manufacturing date
Name and address of authorized representatives
Laser on switch
X-ray on switch
Store
Increase or decrease kV/mA
Rotate image
Cycle through the noise suppression settings
Serial number
Part number
6
MAN-04536 Revision 002
InSight 2 Mini C-arm Imaging System User Guide Safety Hazards
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.
MAN-04536 Revision 002
7
InSight 2 Mini C-arm Imaging System User Guide Safety Hazards
Table 2
8
Safety Hazards
Safety Hazard
Cause
Course of Action
Tipping Hazard
Placing too much weight on the C-arm CMOS detector may cause the system to tip over. The amount of weight that can be supported by the CMOS detector 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 CMOS detector, caution must be used to prevent the device from becoming unstable. Do not place the full weight of the lower extremity directly on the Image Intensiifier
Unauthorized Modifications to X-ray Tube
Do not make any changes to Never remove the the X-ray tube. Contact a housing around the XHologic Representative to ray tube or make any 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.
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. Do not touch a system that is on fire. Leave the area. Only use fire extinguishers approved for electrical fires.
MAN-04536 Revision 002
InSight 2 Mini C-arm Imaging System User Guide Safety Hazards
Table 2
Safety Hazards
Safety Hazard
Cause
Course of Action
Explosion Hazard
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 on the system. 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. The facility specialist must remove the substances and ventilate the area before patients and personnel can return to the facility.
Foot Switch Safety
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 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.
Collision Hazard
If improperly moved or if the Use caution when wheel brakes are not used moving the system on correctly, the system could roll an incline. out of control. Do not move the If the articulating flex arm is system on an incline greater not locked in place during than ten degrees. transport, the C-arm could One person can move the swing out of control and cause system easily on a level injury to the patient or medical surface. personnel. 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 Carm.
MAN-04536 Revision 002
9
InSight 2 Mini C-arm Imaging System User Guide Safety Hazards
Table 2
Safety Hazards
Safety Hazard
Cause
Course of Action
Cleaning Safety
Almost any liquid spilled into electronic equipment automatically becomes a conductor of electricity.
This system is not waterproof. If liquid is spilled on the system, turn the system off immediately. 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 flex-arm, and the C-arm with a soft cloth or disposable lint-free tissue moistened with water, isopropanol or methanol. Wipe surfaces; do not scrub.
Device Safety
Injury could result if unapproved devices are connected to the system. Certain devices were tested for use with the Fluoroscan System, use only these or compatible devices.
Do not connect any devices to the system other than those described in this manual. Internally connected devices should be installed only by persons trained in the servicing of this system.
Electrosurgical Device
This system is shielded from If a strong electrosurgical electrical discharges. However, surge causes the system to there is still a possibility that malfunctions: an electrosurgical device Turn the system off discharged directly into the Wait five seconds. system could adversely affect Turn the system on. system operation. In addition, If the problem persists after shielding might not always resetting the system twice, protect the system from the request service. amount of energy produced by a spark-gap type device.
10
MAN-04536 Revision 002
InSight 2 Mini C-arm Imaging System User Guide System Components
System Components Figure 5 System Components
A X-ray ON light
I
C-arm retainer
B
Touch screen monitor
J
Image printer shelf
C
Keyboard with integrated pointing device
K
CD/DVD RW recorder
D X-ray head
L
E
Collimation switch
M USB port (behind the Image intensifier)
F
Flex-arm
N Foot switch shelf
G C-arm
Computer On/Standby switch
O Wireless Footswitch
H Image Intensifier
MAN-04536 Revision 002
11