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University of DelawareCenter for Biomedical and Brain Imaging

Standard Operating Procedures

Index..................................................................................................................................................................... 1

Glossary of Terms................................................................................................................................................2

Personnel and Emergency Contacts....................................................................................................................4

SOP #10-01 Restricted Access Policy.................................................................................................................5

SOP #20-01 Research Protocols: Ethics Review and Other Related Procedures.............................................7

SOP #21-01 Pilot Study Request Policy..............................................................................................................8

SOP #30-01 Safety Training Procedures..........................................................................................................10

SOP # 31-01 General Safety Procedures...........................................................................................................12

SOP #40-01 Medical Emergency Procedure.....................................................................................................15

SOP #41-01 Emergency Fire Procedure...........................................................................................................17

SOP # 42-01 Emergency Quench Procedure.....................................................................................................20

SOP # 50-01 General Experimental Procedures................................................................................................22

SOP # 51-01 MRI Equipment Handling Procedures..........................................................................................25

SOP # 52-01 MRI Data Handling........................................................................................................................26

SOP # 53-01 Incidental Findings........................................................................................................................27

SOP # 60-01 MRI System Start-Up....................................................................................................................28

SOP # 61-01 MRI System Shutdown/Standby...................................................................................................29

SOP # 62-01 MRI Black/Brown Out...................................................................................................................30

SOP # 63-01 Oxygen Sensor Alarm Response..................................................................................................31

SOP # 64-01 Compressor Alarm Response.......................................................................................................32

SOP # 65-01 Quality Assurance Testing............................................................................................................33

SOP # 70-01 System Billing Guide and Standard Rates....................................................................................34

SOP # 80-01 Animal Handling and Decomtamination Procedures....................................................................34

Appendix ............................................................................................................................................................ 41

University of Delaware for Biomedical and Brain Imaging

Glossary of Terms

Facility University of Delaware’s Center for Biomedical and Brain Imaging located at 75 East Delaware Ave. in Newark, DE.

Waiting Room Room 121. The area located at the entrance of the Facility (Appendix A1)

Equipment Room Room 129A. Houses Siemens electronics cabinets. (Appendix A1)

Control Room Room 146. Contains MR operator console, stimulus computers and controls for peripheral devices. (Appendix A1)

Magnet Room Room 146A. RF shielded room that contains the magnet/scanner.(Appendix A1)

Magnet/Scanner Siemens 3T MAGNETOM Prisma MRI scanner. (Appendix A1)

MRI Technologist One who is highly trained in the very specialized field of MRI. Along with their technical expertise, as healthcare workers they are also licensed with a federal licensing board (appendix A6)

Operator One who has completed all required training to safely and effectively operate the MRI scanner. Operator status must be authorized and approved by the MRI manager, the safety officer, and the Facility Director. See SOP #30-01.

Phantom A specially designed object that is scanned or imaged to evaluate, analyze, and tune the performance of various imaging coils. Many are fluid based and may contain hazardouschemicals.

Principal Investigator (PI) Investigator with overall responsibility for the research project. The PI is responsible for the research support personnel compliance with these SOPs, as well as the timely attendance of the research participants as scheduled to be scanned.

Research Subject One who has consented to participate in a research study and who comes into the CBBI to be scanned in the MRI.

Research Support Personnel Member(s) of a research team conducting a study under the supervision and responsibility of a PI. Research support personnel may assist in different aspects of the MRI scanning process only after successful completion of the appropriate training.

Safety Officer The MRI Safety Director develops, implements, and manages the MRI safety program, policies, and procedures, including screening, access controls, and staff training. He/she directs the organization's MRI safety program- including ancillary staff education and record maintenance of such education, in accordance with the established continuous safety training recommendations. The MRI Safety Officer is responsible for annual MRI technologist safety competency assessments. The MRI Safety Officer is responsible for MRI safety level assignments of personnel based on organizational approved guidelines.

Screening Form Magnetic Resonance Safety Screening Form provided by the CBBI for screening all individuals needing access to the magnet room.

User Researcher needing access to the MRI at CBBI. Users may become operators after the successful completion of the appropriate training and the required approvals have been obtained.

University of Delaware

Center for Biomedical and Brain Imaging77 East Delaware Ave.

Newark, De. 19716

Personnel and Emergency Contacts

Facility Director Keith Schneider Office: 302.831-7148 Cell: 302.300-7043 Email: keithas@udel.edu

MRI Technologist/Safety Officer John Christopher, BA;RT(R)(MR)Manager Office: 302. 831-0910

Cell : 434.566-8974Email: jchr isto@udel.edu

Life Threatening Emergencies UD Admin. phone /blue light phone call 911 Cellular phone call 302.831-2222

UD Security: Urgent Matters UD Admin. phone /blue light phone call 911 cellular phone call 302.831-2222

UD Facilities: Non-Urgent Matters call 302.831-1141

Siemens Uptime Service Center 1-800-888-7436 / Site #: 400-490-429

SOP # 10-01

Restricted Access P olicy

1. Introduction:

1.1 The 3T MRI scanner at the UD Center for Biomedical and Brain Imaging is used primarily for in-vivo studies of human and animal structure and function. These studies may include assessment of anatomical structure, cognitive function and vascular dynamics, metabolism and/or physiology in research subject populations. The Center’s resources are available to peer-reviewed, grant funded scientific collaborators with appropriate Institutional Review Board (IRB), and/or Institutional Animal Care and Use Committee (IACUC), approved protocols in place, see SOP #20-01 “Research Protocols: Ethics Review and Other Related Procedures”.

1.2 Research involving Magnetic Resonance Imaging (MRI) at high magnetic field strengths presents unique hazards to both research subjects and individuals working within and around the MRI system. Consequently, the potential for serious personal injury is present due to the sheer size and strength of the static magnetic field along with the versatility of the research system and associated peripheral hardware.

1.3 The static magnetic field in the 3T MRI facility is always present. It is important that all those entering the facility be aware of the presence of the field, as it cannot be detected in any way, i.e. magnetic fields cannot be felt, seen or smelled. Ferromagnetic objects brought into the magnet room could quickly become dangerous projectiles, and the magnetic field can also interfere with the operation of certain medical implants.

2. Zones (Floor Plan shown in Appendices A1 and A2)

2.1. The MRI facility is divided into separate safety zones, labeled I-IV as per the ACR standard convention.

2.1.1. Zone I consists of all areas outside the MRI suite that are accessible to the general public. These are areas outside the building.

2.1.2. Zone II is located inside the first secure access door to the building and includes the waiting room and back hallway to the Life Science building.

2.1.3. Zone III is located inside the second secure access door and includes rooms 129A (Equipment), 131 and 131A (Large Animal Holding and Prep), and 146 (MRI Control). The magnet is located in room 146A and the door to this room must be kept locked when the scanner is not in use. Zone III contains areas where magnetic fields exceed 5 gauss (rms. 129A and 146) as well as training rooms. People with certain medical implants, such as pacemakers, should not enter areas with magnetic field strengths of 5 gauss or greater.

2.1.4. Zone IV is the magnet room.

3. Entry requirements

3.1. Zone I

3.1.1. Entry to Zone I is not restricted in any way. The general public has access to Zone I.

3.2. Zone II

3.2.1. Entry to Zone II is within the confines of the CBBI building and after hours is controlled by access doors and is limited to authorized users , those under the supervision of an approved operator, and authorized users of the UD Life Science Research Facility.

3.3. Zone III

3.3.1. Entry to Zone III (including the magnet room, Zone IV) is restricted to authorized operators (level 1 and 2), and those accompanying Level 2 personnel.

3.3.2. All those needing to enter the magnet room MUST complete a “Magnetic Resonance Safety Screening Form” and have it reviewed and approved by an approved operator before entering the magnet room. Research subjects will need to fill out a new form each time they are scanned. Auxiliary staff’s screening forms will be kept on file here and at their home department. It is the responsibility of those individuals to notify their supervisors and the CBBI technologist of any changes in their MRI-safety related status. (Appendix A4)

4. Security Access Procedure

4.1. Security access to Zone III. (Approved Level 2 Operator)

4.1.1. Present your request in writing by email to the MRI Manager(or the Center’s Director including the following information: your name, UD I.D. access card number and a reason for the request.

4.1.2. Those wishing to obtain access to Zone III, with the exception of research subjects, must complete Level 1 Safety Training as described in SOP #30-01 “Safety Training Procedures”.

4.1.3. All operators of the 3T MRI scanner must obtain security access to the control room door by following the procedures outlined in #30-01 “Safety Training Procedures”. Operators wishing to scan phantoms and human subjects on the 3T MRI scanner must complete Level 2 Safety Training.

4.1.4. Security access to the control room will not be granted to any individuals with medical devices, implants or objects as listed in SOP #31-01 “General Safety Procedures”.

4.1.5. If a person displays inappropriate and/or unsafe behavior in the center he/she may be denied access by the operator, MRI Technologist or Facility Director.

SOP #20-01

Research Protocols: Ethics Review and Other Related Procedures.

1. Access to MRI for Research Protocols:

1.1. Any Investigator wishing to conduct a new research study using the 3T MRI scanner at the Imaging Center must complete the following:

1.1.1. All research studies involving human subjects or animals must be approved by the University of Delaware Institutional Review Board (IRB) or the Institutional Animal Care and Use Committee ( IACUC), respectively. A copy of the relevant Ethics Board approval must be submitted to the MRI Technologist prior to commencing the study. All scheduling will be done by the MRI technologist for efficiency and appropriateness.

1.1.2. In addition to the IRB approval letter, studies involving human subjects must provide a copy of the approved and IRB-stamped informed consent document(s). Only IRB-approved research team members may administer the informed consent process to research participants and obtain the participant’s signature on the informed consent form.

1.2. Research participants may only be screened for their safety by the MRI technician, or approved operator, after they have consented to participate in the research and signed the informed consent document. The MRI technician is responsible for verifying that a signed informed consent for that participant has been collected and is on record.

1.3. Only properly trained and qualified operators can operate the MRI. Researchers needing access to Zones II, III and IV must complete the required training and safety screening prior to entry.

1.4. The PI is responsible for coordinating with the MRI operator to ensure MRI-related procedures are performed as prescribed by the IRB or IACUC approved protocol.

1.5. The Account Code to be charged for scan time must be submitted to the MRI Manager.

1.6. Data obtained in the MRI for research purposes is to be managed as prescribed in the approved research protocol.

1.7. MRI images are not to be shown or shared with research participants unless the IRB has approved such practice in the pertinent research protocol.

2. Reporting of Unanticipated Problems and Adverse Events:

2.1. Any event that requires an emergency response and/or may indicate research subjects were/are exposed to unanticipated risks must be reported to the principal investigator responsible for the study as well as the appropriate oversight committee (IRB or IACUC) within 24 of the incident.

SOP #21-01Pilot Study Request Policy

1. Introduction

1.1. The purpose of pilot and feasibility studies is to evaluate novel methods or to collect preliminary data that could be useful in obtaining external grant support. Investigators may submit a short application to the CBBI requesting a set number of hours on the magnet for this purpose. Applications will be evaluated by the center’s executive committee.

1.2. Conducting research, whether basic or clinical, with a 3T magnet requires a significant investment of time, energy, and resources. A typical imaging study requires a considerable amount of training in data analysis techniques and may easily involve 6 or more months of a full-time analysis technician. Any study conducted at the CBBI a t U D must fulfill strict safety requirements for all participating personnel.

1.3. The CBBI will provide all required equipment for imaging (e.g., coils and stimulus presentation hardware) and technical personnel (e.g., MR operator during regular hours), as well as consultation on experimental design and preliminary data analysis. However, for custom applications (e.g., those requiring specialized coils), the PI may be required to pay for the necessary hardware. In addition, the PI will be responsible for all recruitment and scheduling of t h e i r human participants (and/or care and treatment of animals) in coordination with the technologist, t h e analysis of t h e i r data and programming of all stimulus displays and response recording systems.

2. Applying for Pilot Time

The following items must be submitted to the Director when applying for pilot time:

2.1. Updated CVs (for the PI and all relevant personnel).

2.2. A 1-page synopsis of the background and goals of the proposed research.

2.3. A 2-page summary of the experimental design, data collection protocol (including any special equipment) and data analysis method, including a description of which personnel will perform which tasks.

2.4. A 1-page summary of the PI’s level of expertise and past experience using MR imaging.

2.5. A timeline for data collection and analysis.

2.6. A funding summary, including:

2.6.1 A list of other funds (if any) available to supplement the pilot time and to pay subject fees and other expenses

2.6.2. The amount of time being requested (maximum 30 hours) and a justification for the time required—is the pilot time likely to be sufficient to gather data for an external grant submission, if not, how much additional pilot data will be needed?

2.6.3. A description of the tentative timeline for submitting an external grant application and indication of the granting agency

3. Evaluation

3.1. The CBBI executive committee will review all requests for scanner time and make recommendations to the Facility Director for allocation of hours.

3.2. The general criteria for evaluation include the scientific merit of the proposed research, the ability of the PI and colleagues to successfully conduct an imaging study (including technical experience), and the likelihood that the pilot project will generate external funding in the future.

3.3. If approved, the PI must obtain review and approval from the relevant University ethics review committee (IRB or IACUC) to conduct the proposed research with humans or animals before scanning can begin.

SOP #30-01

Operator Levels and Safety Training Procedures

1. Level 1 User (Appendix A3)

1.1. To be eligible for Level 1 operator authorization, candidates must be screened and deemed safe by a qualified safety officer to enter the MR environment and successfully complete the Level 1 Safety Training. Annual retraining and reviews will be required to maintain Level 1 user authorization.

1.2. Level 1 Safety Training consists of the following:

1.2.1. Watch the Siemens MRI Safety Video and the Manny Kanal Safety video on the center’s website.

1.2.2. Read the UD CBBI’s Standard Operating Procedures and sign the SOP agreement form (Appendix A5) indicating that you understand the procedures and agree to adhere to them.

1.2.3. Read Operator Manual section on “System, coils and scanning” located in the MRI control room.

1.2.4. Attend a Safety Instruction Session with the MRI Safety Officer. This session will include:

1.2.4.1. Overview of all Emergency Procedures and locations of Table Stop, Electrical Stop and Quench buttons.

1.2.4.2. Thorough review of how to ensure oneself safe to enter the magnet room.

1.2.5. Complete the Level 1 Safety Training test. A grade of 90% or better must be obtained to pass the test.

1.3. After completion of Level 1 Safety Training the trainee will:

1.3.1. Know how to ensure his or her personal safety to enter the MR environment.

1.3.2. Understand the risks associated with a static magnetic field.

1.3.3. Be familiar with the Standard Operating Procedures.

1.3.4. Know all emergency procedures including the operation of the table/sequence stop, electrical stop and quench buttons.

1.3.5. Pass the Level 1 training test.

1.4. Restrictions of Level 1 User include:

1.4.1 The individual may not screen others for safety to enter the MR environment.

1.4.2 The individual may not operate the MR scanner on human or animal subjects; they may only operate the MR scanner on phantoms after additional training.

1.5. The individual must be authorized as a Level 1 User by either the Facility Director or the MRI Safety Officer.

1.6. Card access to Zone III (the Control Room, room 146) will be granted only after successful completion of Level 2 Safety Training. (Appendix A3)

2. Level 2 and Operator (Appendix A3)

2.1. To be eligible for Level 2 operator authorization, candidates must already be authorized Level 1 user and successfully complete the Level 2 Safety Training. Successful completion of Level 1 Safety training is a prerequisite to take Level 2 Safety training.

2.2. Level 2 Safety Training consists of the following:

2.2.1. Watch the Siemens Safety Video focusing on the last 11 minutes (Subject Preparation and Examination, etc.) as well as the Manny Kanal LEVEL II video (both videos on the center’s website.

2.2.2. Read “Part A: Safety” of the Operator Manual.

2.2.3. Complete the Level 2 Safety Training Test. A score of 90% or higher is required to pass.

2.2.4. Shadow and receive supervision from an Authorized Level 2 Scanner Operator for approximately 10 scanning sessions (adjusted based on past education and experience). This time must include the following tasks:

2.2.4.1. Thorough review of how to screen others to ensure their safety into the magnet room.

2.2.4.2. Assisting in MR system preparation.

2.2.4.3. Supervised execution of scanning procedures.

2.2.4.4. Research participant registration.

2.2.4.5. Starting and Stopping measurements.

2.2.4.6. Communicating with participant during scan session.

2.2.4.7. Transfer of data to server.

2.3. After completion of Level 2 Safety Training the trainee will:

2.3.1 Know how to administer the safety screening form.

2.3.2 Know the risks associated with rapidly changing (dynamic) magnetic fields.

2.3.3 Be able to explain the MRI-specific language on the informed consent forms and the non-research waiver.

2.3.4 Know how check for the MRI safety of medical implants

2.3.5 Know how to screen subjects to ensure their MRI safety including the acceptability, or need for removal, of foreign objects.

2.3.6 Be familiar with procedures for incidental findings.

2.3.7 Pass the Level 2 training test with a grade of 90% or better

2.4 The individual must then be authorized as a Level 2 Operator by the MRI manager, the MRI Safety Officer and the Facility Director. Annual re-training and reviews will be required.

SOP #31-01

General Safety Procedures

1. Introduction

1.1. Research involving Magnetic Resonance Imaging (MRI) at high magnetic field strengths present unique hazards to both research subjects and individuals working within and around the MRI system. Consequently, the potential for serious personal injury is present due to the sheer size and strength of the static magnetic field along with the flexibility of the research system and associated peripheral hardware. Scanning of human or animal subjects requires a Level 2 operator and a level 2 assistant present in the event of any emergency.

1.2. The static magnetic field in the 3T MRI facility is always present. It is important that all those entering the facility be aware of the presence of the field, as it cannot be detected in any way, i.e. magnetic fields cannot be felt, seen or smelled. Ferromagnetic objects brought into the magnet room could quickly become dangerous projectiles, and the magnetic field can also interfere with the operation of certain medical implants.

1.3. During MRI data acquisition the subject being imaged is also exposed to rapidly changing magnetic fields due to pulsed magnetic field gradients, and fields oscillating at radiofrequencies (around 128 MHz for 3 T). These time-varying fields are much weaker than the static field (up to 10 mT or 100 gauss) but create additional safety risks and all personnel working with the MRI equipment must be aware of these risks.

1.4. During certain types of MRI data collection, there exists high, and therefore potentially dangerous, acoustic sound pressure levels (SPL). All those entering the facility must be made aware of this risk and be instructed as to the proper precautionary measures to be taken. Any research subjects and/or research personnel present in the magnet room during an MRI session must wear appropriate hearing protection as outlined in section 4.3. below.

1.5. As a result of the potential for serious injury, access to the 3T MRI Facility is restricted, and requires permission. See SOP #10-01 “Restricted Access Policy”.

1.6. Any person needing to enter the Magnet Room must complete a “Magnetic Resonance Safety Screening Form” and have it reviewed and approved by an approved operator before entering the magnet room.

2. Incompatible Medical Devices

2.1 There are medical devices, implants and objects that are incompatible with the MR environment. A copy of Frank Shellock’s “Reference Manual for Magnetic Resonance Safety, Implants, and Devices” is available in the Control Room at the UD Imaging Center. Any individual with a device listed as Not Safe or that is not listed in this reference manual may not proceed beyond the 5 Gauss line.

2.2 The 5 Gauss line is marked at the entry door into the magnet room and extends through the observation window at the operators console. There are also areas exceeding 5 Gauss in the equipment room, thus access must be controlled to this area as well.

3. Safety Issues – Due to High Static Magnetic Field Strengths

3.1. High static magnetic field strengths are present in the 3T MRI Facility. These strong magnetic fields pose potential risks to those working, volunteering, or touring in the environment. Medical safety is extremely important hence, everyone entering the environment must be aware of the potential hazards.

3.2. All metallic objects have the potential to become projectiles in the MR environment, as they may contain ferrous components. This could potentially cause serious injury to anyone near the magnet, as well as damage to the MRI system. As a result, there are stern restrictions to follow as to what objects can be brought into the magnet room.

3.3. The operator is responsible to screen all objects to be brought in the magnet room for ferrous components.

3.3.1. All objects not already in the magnet room, should not be brought into the magnet room unless they are necessary for the successful execution of the experiment, and have been tested using a permanent magnet in the control room, or have been viewed and cleared for entry by the safety officer and/or Facility Director.

3.3.2. There are several metals that are non-ferrous. These metals include titanium, copper, gold, silver, aluminum, brass and lead. It is extremely important to note that all metal objects must be tested or cleared for entry by the safety officer and/or Facility Director, even if they are thought to have no ferrous components.

3.4. It is mandatory to remove all personal objects made of, or potentially containing, metal from any person before they cross the 5 Gauss line as marked by the door threshold and on signs on the magnet room door. This includes but is not limited to the following list of articles:

Medical Devices Hearing aids, dentures, braces, eyeglasses, prosthetics, foiled backed medication patches or packets, et.

ClothingMetal studded clothing, belt, steel toe shoes/boots, athletic/sports clothing containing metal (e.g., clothing items made of metal containing fabrics of brands like Athleta, Columbia, Omniheat, Lululemos, and TommyCopper), etc.

Accessories jewelry (including metal body piercings), watch, hair pins, barrettes, wigs and hair extensions, etc.

Other pagers, cell phones, keys, coins, magnetic strip cards, pocket knives, nail clippers, pens, safety pins, paper clips, tools, etc.

3.5. It is extremely important that no large metal objects be brought into or near the magnet room at any time. All large metal objects must not go beyond the 5 Gauss line as marked on the floor and on signs on the walls, unless specifically directed by the Siemens Service Technician, MRI Safety Officer or the Facility Director. A large metal object with ferrous properties, placed near the magnet, will fly toward the magnet with great force, potentially causing serious injury to anyone near the magnet and damage to the MRI system.

3.5.1. In such an instance, if someone is pinned to the magnet, trapped or potentially in a life-threatening situation as the result of a large ferrous object coming too near to the magnet, the operator, or if the operator is pinned, one of the experimental support personnel, must follow SOP #42-01 “Emergency Quench Procedure”, and provide first aid as responder principles.

4. Safety Issues – Due to Rapidly Changing Magnetic Fields

4.1. Rapidly changing magnetic fields are generated by gradient and RF coils in the MRI scanner during data acquisition. These fields pose potential risks for volunteers being scanned and for personnel working in the bore during the scan. To minimize the risk of burns it is important to prevent skin-to-skin contact points and the formation of “closed-loops” r es u l t i ng from body parts in contact with each other. Contact between skin and the transmitting body coil must also be avoided. This can be achieved by using foam padding available on the shelves in the magnet room.

4.2. Objects with good electrical conductance must not be permitted to rest against the skin of the subject within the region spanned by the body coil, and should not be permitted within the body coil unless essential for the successful execution of the study.

4.3. During certain types of MRI data collection, there exists high, and therefore potentially dangerous acoustic sound pressure levels (SPL). It is mandatory for the subject, and all others who are present in the magnet room during the scan session to wear hearing protection in the form of high rated NRR earplugs and/or headphones provided by the 3T MRI Facility. Instruction will be provided on proper fitting and use.

5. Safety Issues – Due to Electrical Power

5.1. There exist dangerous and potentially lethal levels of electricity in the 3T MRI system. As such, it is important that all individuals working around the MRI system be aware and knowledgeable regarding the r e l e v a n t danger and safety issues. There is a risk of electric shock from extremely high voltages, possibly causing severe injury or death, and damage to the MRI system. Only trained personnel should set up hardware in the magnet room and plug in or change the placement of any cables. High currents in wires also pose a risk of fire.

5.1.1. If someone is electrocuted in the 3T MRI Facility, the operator, or if the operator was electrocuted, one of the experimental support personnel, must follow the procedure outlined in SOP #40-01 “Medical Emergency Procedure”.

5.1.2. In the case of a fire, the operator must follow the procedure outlined in SOP #41- 01 “Emergency Fire Procedure”. The operator must keep his/her own safety in mind as a priority while removing the volunteer/patient from the magnet. If the volunteer/patient is not responding, not breathing and has no pulse, the operator must follow the procedure outlined in SOP #40-01 “Medical Emergency Procedure”. After all parties are safe, it is appropriate to seek to minimize damage to the system.

SOP #40-01

Medical Emergency Procedure

1. Introduction

1.1. Because of the potential for serious injury, access to the 3T MRI Facility is restricted, and requires permission. See SOP #10-01 “Restricted Access Policy”.

1.2. Working within and around the high field MRI requires in-depth training on safety and Standard Operating Procedures, and documented proof of other necessary training. See SOP #30-01 “Operator Levels and Safety Training Procedures”.

1.3. It is imperative that all personnel who are within and around the 3T MRI Facility always keep in mind the potential safety risks, and act in accordance with the guidelines set out in the CBBI Standard Operating Procedures.

2. Medical Emergency

2.1. A medical emergency is specifically defined as a situation in which a person requires immediate medical attention, because of an acute injury or illness that poses an immediate risk to a person's life or long-term health.

2.2. Medical emergencies encountered in the MRI environment may include stroke, cardiac arrest, impaled objects, crush wounds or burns.

2.3. If a medical emergency arises, the procedure set out below must be followed.

3. Emergency Procedure

3.1. Immediately STOP the scan (if in progress).

3.2. Remove the research subject from the scanner.

3.2.1. Either use the “Home” button to advance the bed out of the scanner, or

3.2.2. Pull the Emergency Release located under the support frame of the bed to unlock the clutch, and pull the bed out manually.

3.3. Assess the condition of the injured person.

3.4. If immediate medical assistance is required:

3.4.1. Call 911 from a UD admin phone or 302.831-2222 from a cellular phone

3.4.2. Prop open the Control Room door to facilitate access for the emergency response team.

3.4.3. Have someone wait at the entrance to the Imaging Center to let the paramedics into the facility when they arrive.

3.4.4. The paramedics or other emergency responders must not enter the magnet room unless they have been fully screened, and have removed all metal.

3.5 Remove the injured person from the magnet room either by aiding them while walking or by using the non-magnetic stretcher as follows:

3.5.1 Place the stretcher next to the MRI bed.

3.5.2 Lock wheels in place to avoid movement of the stretcher.

3.5.3 Slide the person onto the stretcher using the sheet to help you.

3.5.4 Protect the person’s head at all times.

3.5.5 Raise the side-rails of the stretcher, unlock the wheels and move the stretcher into the control room.

3.5.6 Close the magnet room door.

3.6 Provide first aid or help the injured person according to your skills, knowledge and comfort level. Follow instructions of emergency personnel when they arrive.

3.7 Once the emergency situation has been responded to, report the incident to the Facility Director, Safety Officer and UD’s EHS. In addition, complete the first Report of Injury, a copy of which can be obtained from the following link: (http://www.udel.edu/ehs/generalhs/downloads/FirstReportInjury.pdf.)

3.8 All medical emergencies involving human or animal research subjects must also be reported to the principal investigator responsible for the study and the applicable ethics review committee (IRB or IACUC) within 24 hours of the incident.

SOP #41-01Emergency Fire Procedure

1. Introduction

1.1. Research involving Magnetic Resonance Imaging (MRI) at high magnetic field strengths present unique hazards to both research subjects and individuals working within and around the MRI system. The static magnetic field in the 3T MRI facility is always present. It is important that all those entering the facility be aware of the presence of the field, as it cannot be detected in any way. It is imperative that first responders are educated in the potential dangers. Ferromagnetic objects brought into the magnet room could quickly become dangerous projectiles. Working within and around the high field MRI requires in depth training on safety and Standard Operating Procedures, and documented proof of other necessary training. See SOP #30-01 “Operator Levels and Safety Training Procedures”. All personnel who are within and around the 3T MRI Facility must always keep in mind the potential safety risks, and act in accordance with the guidelines set out in the CBBI Standard Operating Procedures. Early and quick response to a fire on or around the MR scanner is critical. Report both minor and major fire incidents by calling UDPD at 911 from a UD Admin phone or a blue light phone or 302.831-2222 from a cellular phone and activate the alarms manually to initiate building evacuations. Also notify the Facility Director, Safety Officer and UD’s EHS. Quarterly drills will be required to sensitize the Center’s personnel to incidents that may occur elsewhere in the building (e.g., Life Sciences) that may generate a fire alarm. CBBI personnel will follow appropriate actions to the alarms including subject care, shutting doors, etc.

2. First Signs of Potential Fire

2.1. In most instances, there are signs of a potential fire present before a fire occurs. Awareness of these early signs can be cri t ical in the prevent ion of injury to the subject and other research support personnel in the magnet room, equipment room and the control room during a scan.

2.2. The first sign of a potential fire is often an irregular noise, for example a loud popping sound or a sudden stop of the gradients. It is imperative that the operator determine the cause of the irregular noise before continuing with the scan session.

2.3. The second sign of a potential fire is often the detection of a subtle odor.

2.4. The third sign of a potential fire is small amounts of smoke. There may not be enough smoke to set off the detector, so it is important to always be aware of the possibility of the presence of smoke. If anyone in the control room, equipment room, or the magnet room notices smoke, even if the smoke detector alarm is not sounding, the procedure below must be followed.

2.5. The final case is one in which the smoke detector has gone off and an alarm is sounding in the magnet room.

2.6. In each of the above circumstances the operator must:

2.6.1. Immediately STOP the scan (if in progress).

2.6.2. Shut-down the electrical power to the MRI equipment by pressing one of the red electrical stop buttons labeled “EMERGENCY STOP SIEMENS EQUIPMENT”. They are located:

2.6.2.1. On the wall to the right of the operator console,

2.6.2.2. Immediately to the left after entering the magnet room,

2.6.2.3. Immediately to the right after entering the equipment room.

2.6.3. Remove the volunteer from the scanner.

2.6.4. Quickly investigate the source of the irregular noise, odor or smoke without putting yourself at risk.

2.6.5. Close the magnet room door.

2.6.6. Activate alarms manually and immediately notify University of Delaware Police Department from a UD Admin phone or a blue light phone at 911, or 302.831-2222 from a cellular phone, also notify the Facility Director, the MRI Safety Officer, and UD’s EHS.

2.7. It is important to keep in mind that any smoke or odor caused by heat can contain chemicals that are harmful if inhaled. Limit your exposure and close the magnet room door to prevent the noxious fumes from permeating the rest of the building.

3. Emergency Fire Procedure

3.1. Remember to use common sense! There are three basic steps to follow:

3.1.1.Ensure your own safety.

3.1.2. Ensure the safety of others in the facility.

3.1.3.Contain the fire if possible. If it is not possible to contain the fire, follow the procedure in section 4 “Emergency Fire Procedure for Uncontrollable Fires”.

3.2. Shut-down the electrical power to the MRI equipment by pressing one of the red electrical stop buttons labeled “EMERGENCY STOP SIEMENS EQUIPMENT” (this will NOT quench the magnet). They are located:

3.2.1. In the Control Room, on the wall to the right of the operator console,

3.2.2. Immediately to the left after entering the magnet room,

3.2.3. Immediately to the right after entering the equipment room.

3.3. Remove the subject from the scanner.

3.3.1.There will not be power to the bed because the electrical stop button will have been pushed, so the bed must be withdrawn manually.

3.3.2.Pull the Emergency Release located under the support frame of the bed to unlock the clutch, and pull the bed out manually.

3.3.3 If the subject is not responding, not breathing, or shows signs of being in respiratory or cardiac distress, follow the procedure set out in SOP #40-01 “Medical Emergency Procedure”.

3.4 Contain the fire. First ensure all volunteers and personnel are safely outside the magnet room.

3.4.1 The sprinkler system will only activate if there is sufficient heat and smoke being emitted by the fire. If the sprinklers have not yet activated and it is safe to do so, use the non-magnetic fire extinguisher to put out the fire. The non-magnetic fire extinguisher is located to the right as you enter the control room. Only trained individuals should operate a fire extinguisher.

3.4.2 If there are flames that are not being extinguished by the non-magnetic fire extinguisher, exit the magnet room and pull the fire alarm located in the front waiting room. This will activate the building fire alarm. When there is sufficient heat and smoke the sprinkler heads will begin to spray water.

3.4.3 If the fire has not been contained by the non-magnetic fire extinguisher or the automatic fire suppression system, proceed to Section 4. “Emergency Fire Procedure for Uncontrollable Fires”.

3.5. Close the magnet room door.

3.6. Activate the alarms manually from the pull station and call University of Delaware Police Department from a UD Admin phone or a blue light phone at 911, or 302.831-2222 from a cellular phone and explain that there was a small, controllable fire that has been extinguished in the 3T MRI, UD Center for Biomedical and Brain Imaging.

3.7. Evacuate the building to avoid smoke or if the fire alarm is sounding and Report the incident to the Facility Director, the Safety Officer and UD’s EHS.

3.8. Scanning should not be restarted until integrity of all safety and MRI operation systems have been checked by the MRI Safety Officer.

4. Emergency Fire Procedure for Uncontrollable Fires

4.1. Always remember to:

4.1.1. Ensure your own safety.

4.1.2. Ensure the safety of the subject in the magnet.

4.2. Follow steps 3.2 – 3.5 in section 3 “Emergency Fire Procedure”.

4.3. If the fire cannot be contained using the non-magnetic fire extinguisher, close the magnet room door and Quench the magnet following SOP #42-01 “Emergency Quench Procedure”.

4.4. Pull the fire alarm if it is not already sounding and evacuate the building. There is a pull station located in the waiting room near the front door, as well as at each exit.

4.5. From a safe place (UD admin phone or a blue light phone) call 911 or from a cellular phone call 302.831-2222. UD Police will help guide the Fire Department to the correct location. CBBI address location is 75 East Delaware Ave., Newark, DE.

4.6 Meet UD Police and/or the fire department at the exterior door.

4.6.1 Give them details regarding the incident including the specific location of the fire and whether or not the magnet has been quenched.

4.6.2 If the magnet has not been quenched the fire fighters must be informed that the magnet is still on. The fire fighters must not enter the magnet room with their gear donned; doing so could cause serious injury to themselves or anyone near the magnet at the time.

4.6.3 If the fire fighters deem it necessary to enter the magnet room with their gear donned, the magnet must be quenched following SOP #42-01 “Emergency Quench Procedure”.

4.6.4 Inform the fire department that there are plastic bottles (phantoms) containing nickel sulfate in the southwest corner of the magnet room. The phantom fluids may produce nickelous aerosols. Notify the Facility Director, MRI Safety Officer and UD’s EHS.

SOP #42-01

Emergency Quench Procedure

1. Introduction

1.1. Research involving Magnetic Resonance Imaging (MRI) at high magnetic field strengths present unique hazards to both research subjects and individuals working within and around the MRI system. Consequently, the potential for serious personal injury is present due to the sheer size and strength of the static magnetic field along with the flexibility of the research system and associated peripheral hardware.

1.2. The static magnetic field in the 3T MRI facility is always present. It is important that all those entering the facility be aware of the presence of the field, as it cannot be detected in any way, i.e. magnetic fields cannot be felt, seen or smelled. Ferromagnetic objects brought into the magnet room could quickly become dangerous projectiles, and the magnetic field can also interfere with the operation of certain medical implants.

1.3. As a result of the potential for serious injury, access to the 3T MRI Facility is restricted and requires permission. See SOP #10-01 “Restricted Access Policy”.

1.4. Working within and around the high field MRI requires in depth training on safety and Standard Operating Procedures, and documented proof of other necessary training. See SOP #30-01 “Operator Levels and Safety Training Procedures”.

1.5. It is imperative that all personnel who are within and around the 3T MRI Facility always keep in mind the potential safety risks, and act in accordance with the guidelines set out in this Standard Operating Procedures.

2. Description of a Quench

2.1. To quench means to put out or extinguish. In the context of a superconductive magnet a quench is a sudden halt of the magnetic field caused by a rapid increase in the resistance of the magnet coil windings that causes a loss of superconductivity. This process generates heat, which causes the rapid evaporation, or boil-off, of the magnet’s coolant (liquid helium). This evaporated coolant is extremely hazardous and requires an emergency ventilation system, consisting of a bursting disk and quench pipe through the building’s roof, in order to protect facility staff and subjects. Note that once initiated, a quench cannot be stopped, and will cause complete magnet failure. All personnel and subjects would need to be out of the magnet room at the time.

2.2. There are two situations in which a quench may occur:

2.2.1. Spontaneously, due to some force or disruption of the magnet system.

2.2.2. Intentionally, when the emergency quench button is pressed.

3. Spontaneous Quench

3.1 In the event of a spontaneous quench

3.1.1. Immediately abort the current scan.

3.1.2. Evacuate the magnet room.

3.1.3. Close the door to the magnet room.

3.1.4. Notify the Facility Director, MRI Safety Officer and U.D. Police at - 911 from a UD Admin phone or 302.831-2222 from a cell phone, immediately following the incident. Also contact UD’s EHS at 302.831-8475.

4. Intentional Quench: Pressing the Quench Button

4.1. The emergency quench button must be pressed in the following situations:

4.1.1. There is a fire in the magnet room that CANNOT be contained with the non- magnetic fire extinguisher and/or the automatic fire suppression system, and requires the fire department to enter the magnet room. Refer to SOP #41-01 “Emergency Fire Procedure”.

4.1.2. An individual is pinned, impaled, or in a life-threatening situation because of a large ferromagnetic object and no other method can prevent further injury or free the person.

4.1.2.1. Do NOT attempt to pull large magnetic objects away from the magnet. The object may reorient itself to the magnet field lines and become a projectile, potentially causing a serious or fatal injury.

4.1.2.2. If the situation is not life-threatening, it may be possible to have a Siemens Service engineer ramp the magnet down slowly.

4.1.2.3. Always put a person’s immediate well-being first.

4.2. In the situations described above press one of the emergency quench buttons. They are located:

4.2.1. In the Control Room, to the left of the operator console at the center of the Siemens Alarm Panel. The button is red and is labeled STOP. It is covered by a plastic protective guard with a yellow sticker and a “no-magnet” symbol.

4.2.2. In the magnet room, immediately right to the side door in the room. The button is red and is labeled STOP. It is covered by a plastic protective guard with a yellow sticker and no-magnet symbol.

5. Emergency Quench Procedure5.1. In the event of a quench (spontaneous or intentional) evacuate the magnet room if possible, and

close the magnet room door.

5.2. If the magnet was quenched because someone was pinned, and they are injured, the operator must provide first aid to the extent possible according to their skills and comfort level (follow procedures outlined in SOP #40-01 “Medical Emergency Procedure”).

5.3. Notify the Facility Director or MRI Safety Officer and U.D. Police from a UD admin phone or blue light phone at 911 or cellular phone at 302.831-2222, immediately following the incident. Also contact UD’s EHS at 302.831-8475.

SOP #50-01

General Experimental Procedures

1. Introduction

1.1. It is imperative that all personnel who are within and around the 3T MRI Facility always keep in mind the potential safety risks, and act in accordance with the guidelines set out in the Standard Operating Procedures.

2. General Set Up Procedure

2.1. The Operator must log their time on the “3T MRI Log Sheet” located on the counter of the operator console. See SOP #70-01 “System Billing Guide and Standard Rates”.

2.2. Research subjects, all research support personnel, the operator, and anyone going into the magnet room, must be screened for incompatible medical devices by completing the “Magnetic Resonance Safety Screening Form”, and must remove all metallic objects from their person before crossing the 5 Gauss line at the door and on signs in the 3T MRI console room. For a list of articles see SOP #31-01 “General Safety Procedures”.

2.2.1. The operator is responsible to screen all objects entering the magnet room for ferrous components.

2.2.2. All objects not already in the magnet room, should not be brought into the magnet room, unless they are necessary for the successful execution of the experiment, and have been tested using a permanent magnet in the control room, or have been viewed and permitted for entry by either the CBBI Director or Safety Officer

2.3. It is mandatory for the research subject, and all others who will be present in the magnet room during the scan session to wear hearing protection either in the form of earplugs or headphones provided by the 3T MRI Facility.

2.4. It is imperative that all research support personnel present in the magnet room be aware of the responsibilities and risks associated with equipment as it is operating. This includes areas of high electrical activity and potential mechanical failure points. A safe operating distance from these designated areas must always be maintained. Failure to do so could result in severe injury or death.

2.5. The Operator will advance the subject into the magnet at his/her own discretion. If the operator notices at any time that the subject is not comfortable and/or shows signs of distress, the operator may refuse to advance them into the magnet and may cancel the scan session.

3. Responsibilities of the Principal Investigator and Research Personnel:

3.1. The principal investigator or research personnel must inform their operator of a cancelation of scan time as soon as possible. The operator will then immediately remove the entry from the online schedule so that another user may book the time.

3.2. It is the responsibility of the principal investigator or research personnel to ensure that their scanning session ends punctually at the specified time as listed on the online schedule.

An experiment will not be allowed to exceed the scheduled time unless:

3.2.1. There is time available on the schedule following the session and the operator agrees to stay and operate the scanner for the extra time.

3.2.2. OR the researcher and operator scheduled in the subsequent scanning slot both agree to allow the extra time.

4. Responsibilities of the Operator

4.1. The Operator is responsible for the safety and well-being of all research personnel and subjects. This includes wearing proper hearing protection in the scanning room for both volunteers and any personnel in the room during a scanning session.

4.2 The operator is responsible for ensuring that all necessary safety devices are operational for a scan session. It is at the discretion of the operator to cancel the scan session at any time if any or all of the safety devices are not operational. All safety devices are listed below:

4.2.1 Emergency squeeze ball4.2.2 Audio system4.2.3. Camera4.2.4. Fire extinguisher4.2.5. Smoke detector4.2.6. Oxygen Sensor

4.3. The operator is responsible for notifying the Facility Director or Safety Officer of any safety device that is not operational.

4.4. The operator is responsible for notifying the Facility Director or MRI Technician of any peripheral device that is not operational. Peripheral devices include but are not limited to:

4.4.1. Stimulus Projection Systems4.4.2. Task Feedback Systems4.4.3. Control or Stimulus Presentation Computers4.4.4. Projection Screens4.4.5. RF Coils4.4.6. Cardiac, skin conductance, and heart rate monitors

4.5. It is the responsibility of the operator to screen all items entering the magnet room for ferrous components. A strong hand held magnet is available for such testing.

4.6. The operator is responsible for placing any soiled linen in the laundry hamper.

4.7. The operator is responsible for returning all peripheral devices including RF Coils and any other items used during the scan session to their original holding places upon completion of the scanning session.

5. Responsibilities of the CBBI Personnel

5.1. CBBI personnel are responsible for checking all Primary devices daily. Primary devices are as follows:

5.1.1. The magnet system.5.1.2. All safety devices.

5.2. The CBBI personnel will inform operators and investigators of malfunctions of Primary devices and if their scan time will be affected.

5.3. Secondary devices will not be checked daily. Secondary devices are all peripheral devices as listed in section 4.4. If one of these devices fails, the CBBI personnel may, out of courtesy, inform operators and investigators. If the CBBI personnel are aware of failure of a specific secondary device that will affect upcoming scan time, they will notify the appropriate operators and investigators.

SOP #51-01

MRI Equipment Handling Procedures

1. Introduction

1.1. Execution of an MRI study often requires the utilization of a number of pieces of equipment aside from the MRI system itself. There are many different stimulus and monitoring devices available of which one or more may be used in any given experiment.

1.2. Many pieces of equipment in the 3T MRI Facility are supplied by the center and shared amongst the investigators. There is also equipment stored in the facility that is specific to a certain fMRI study and is owned by the investigator and/or group performing the study.

2. Equipment Handling and Procedures

2.1. Equipment owned by CBBI may be used by all investigators for studies performed at the 3T MRI Facility. It is the responsibility of the investigator and/or research support personnel to ensure that the equipment they use is functional before beginning the experiment and after completion of the experiment.

2.2. If a piece of equipment is found to be not working, it is the responsibility of the operator to inform the CBBI safety officer and/or manager of the equipment malfunction.

2.3. Equipment that is labeled as belonging to a specific group is to be used by that group only. Other investigators are not permitted to use labeled items unless they have received consent from the owning group.

2.4. Please use courtesy in handling all equipment in the 3T MRI Facility. Many of the items are very expensive and some are irreplaceable. Upon completion of a study, please turn off every piece of equipment that was turned on for use during the study.

3. New Equipment

3.1. A quality assurance test must be performed before and after the installation of any new electronic equipment or equipment that passes through the patch panel. This test will validate the system performance and ensure the absence of artifacts or increases in noise or geometric distortion.

SOP #52-01

MRI Data Handling

1. Introduction

1.1. The 3T MRI scanner at the CBBI is used primarily for in-vivo studies of human and animal structure and function. These studies may include assessment of anatomic structure, cognitive function and vascular dynamics, metabolism and physiology. The facility resources are available to peer-reviewed grant funded scientific collaborators with the appropriate Ethics Board review and approval of their research protocols in place, see SOP #20-01.

1.2. Full-time technical support for scanner operation is provided and included in hourly rates (see SOP #70-01 “System Billing Guide and Standard Rates”) during regular weekday hours Monday through Friday, 9 am – 5 pm.

2. Data Handling

2.1. All data collected in the 3T MRI Facility is initially stored in a DICOM database on the MRI console computer. These files will be distinguished by numerical and/or alphabetical identifiers that do not directly reflect the identity of the participant who was scanned. The PI will maintain a list in a locked location linking the participant’s identity with the identifier in the file name. At the end of the study the Operator will transfer the images in DICOM format to the Investigator’s directory on the DICOM server.

2.2. Each Investigator will be given a User Account on the DICOM server, and is responsible for transferring data off of the DICOM server to their local systems using sFTP.

2.3. Data will remain available on the MRI console for a maximum of two weeks’ time.

2.4. Data will remain on the DICOM server for 6 months.

2.5. Data older than 6 months will be deleted.

SOP #53-01

Incidental Findings

1. Introduction

1.1. The 3T MRI scanner at the CBBI is used primarily for in-vivo studies of human and animal structure and function. These studies may include assessment of anatomic structures, cognitive function, vascular dynamics, metabolism and physiology. The facility resources are available to peer-reviewed grant funded scientific collaborators with the appropriate Ethics Board review and approval of their research protocols in place, see SOP #20-01.

1.2. The operators at the CBBI are not trained or qualified to detect or diagnose pathologies, and a radiologist will not routinely review acquired images.Therefore detection of abnormalities that could indicate medical problems is limited by the training and experience of the MRI operators and study investigators.

1.3. In general, Principal Investigators and Operators should not make any comments about a participant’s brain or any other body part being scanned.

2. Incidental Findings

2.1. If an operator or study investigator detects a potential anomaly during a scanning session, the procedure below should be followed:

2.1.1. Continue the scan session as usual and do not inform the participant.

2.1.2. After the completion of the scan session, show the images to the MRI Technologist or the CBBI Director.

2.1.3. If the MRI Technologist or the Facility Director concur that further assessment of the scan is warranted, they will send the images to a radiologist for review.

2.1.4. The radiologist will determine if additional medical attention or follow up is required.

2.1.4.1. If additional attention is required, this information will be conveyed to the Principal Investigator who will then inform the participant.

SOP #60-02

MRI System Start-Up

1. Introduction

1.1. Research involving Magnetic Resonance Imaging (MRI) at high magnetic field strengths present unique hazards to both research subjects and individuals working within and around the MRI system. Consequently, the potential for serious personal injury is present due to the sheer size and strength of the static magnetic field along with the versatility of the research system and associated peripheral hardware.

1.2. Working within and around the high field MRI requires in depth training on safety and Standard Operating Procedures, and documented proof of other necessary training. See SOP #30-01 “Safety Training Procedures”.

2. Start-up Procedure for the Powered Down or Standby State

2.1. Press the “SYSTEM ON” button located on the Siemens control panel.

2.2. Do not plug in or unplug any RF coils or move the bed while the system is booting. This may cause system errors and may necessitate a system reboot.

2.3. When the system is fully operational:

2.3.1. You will hear 3 knocks from the magnet.2.3.2. A “System Online” message will appear in the Magnet Status window.2.3.3. The red line will disappear from the Magnet Status icon.

2.4. The system is now booted and ready to scan.

SOP #61-02 MRI System Shutdown/Standby

1. Introduction

1.1. If you are unsure of any of the steps in any of the following procedures, DO NOT CONTINUE. Contact the Facility Director or MRI Technologist for further instruction.

2. Shutdown Procedure

2.1. On the operator console:

2.1.1. Select System ! End Session

2.1.2. A window will pop up with the following options:

Log Off, Shutdown System, Restart System or Restart Application

2.1.3. Select “Shutdown System”.

2.1.4. A verification window will pop up. Click “Yes”.

2.1.5. Wait for the message, “It is now safe to turn off your computer”.

2.1.6. Press the “System Off” button on the Siemens control panel.

2.1.7. The system should be OFF at this point.

3. Standby Procedure

3.1. There are 2 ways to put the system into Standby.

3.2. First method: On the operator console:

3.2.1. Select System ! Control

3.2.2. The System Manager window will pop up

3.2.3. Select the MR Scanner tab

3.2.4. Click the “Stand By” button

3.2.5. A verification window will pop up. Click “Yes”.

3.3. The second method: press the Standby button on the Siemens Alarm Panel.

3.4. An error window may pop up as the system is shutting down the RF amplifier. This message can be disregarded.

3.5. The operator console will remain on but the gradient and RF amplifiers and magnet controls will be shut down.

3.6. The system is now in the Standby state.

SOP #62-01

MRI Black/Brown Out

1. Introduction

1.1. Research involving Magnetic Resonance Imaging (MRI) at high magnetic field strengths present unique hazards to both research subjects and individuals working within and around the MRI system. Consequently, the potential for serious personal injury is present due to the sheer size and strength of the static magnetic field along with the versatility of the research system and associated peripheral hardware.

1.2. Working within and around the high field MRI requires in depth training on safety and Standard Operating Procedures, and documented proof of other necessary training. See SOP #30-01 “Safety Training Procedures”.

2. Black/Brown Out Procedure

2.1. If power is lost to the 3T MRI scanner as a result of a black/brown out, none of the systems will be functional; however the cold-head compressor will be on the UPS system.

2.2. Remove the subject from the scanner.

2.2.1. Pull the Emergency Release located under the support frame of the bed to unlock the clutch, and pull the bed out manually.

2.2.2. Communicate with the subject to reassure him/her during the process.

2.3. Cancel the scan session currently in progress.

2.4. If the compressor LED turns red on the Siemens Alarm Panel an alarm will sound while the power is off. T h i s m e a n s t h e U P S i s d o w n . The compressor will restart automatically when the power and/or UPS are restored.

2.5. If the compressor fails to restart once the power has been restored, follow the procedure outlined in SOP #64-01 “Compressor Alarm Response”.

2.6. Report the situation to the UD facilities, CBBI Director and/or MRI Technologist

Center for Biomedical and Brain Imaging

SOP #63-01Oxygen Sensor Alarm Response

1. Introduction:1.1. If leaked, the cryogenic gases used to maintain the cold head at the needed temperature, can

displace oxygen in the magnet room. Constant monitoring of the oxygen level in the MRI room is an important safety measure.

2. Oxygen Sensor Monitoring Panel2.1. There is an oxygen sensor present in the magnet room. This sensor is connected to the Toxgard

II monitoring panel in the control room. The monitoring panel in the control room is located on the wall to the right of the operator console and is constantly monitored and maintained by the University in accordance with manufacturer’s recommendations.

2.2. The monitoring panel contains:

2.2.1. A LED reading in the range of 20.7 – 20.9 is a normal reading2.2.2. A reading below 19.8 will activate an alarm to UD police.2.2.3. An acknowledge button located on the bottom of the panel, labeled “ACK”.

2.3. Under normal conditions the LED reading will be illuminated.

2.4. If there are low levels of oxygen in the magnet room the red light on top of the panel will be illuminated and an audible alarm will sound as well as UD police being notified.

3. Oxygen Sensor Error State3.2. The oxygen sensor is in an error state if the LED readings are not illuminated on the panel. If

an error state occurs, immediately call the UD facilities at 302.831-1141. Inform them that an emergency repair is required on the oxygen sensor in the MRI console room 146 at the Center for Biological and Brain Imaging, 75 East Delaware Ave, Newark, DE.

3.3. Notify the Facility Director and Safety Officer regarding the incident and cease all operations until the sensor is properly functioning.

4. Oxygen Sensor Alarm Procedure4.1. Oxygen levels in the magnet room could decrease as the result of an improperly vented

quench. Helium levels will saturate the air, and will cause the oxygen sensor to go into an alarm mode. If the red light on the oxygen sensor monitoring panel is red and the alarm is sounding, follow the steps below.

4.2. Immediately turn ON the “Magnet Room Exhaust Fan” located to the left of the oxygen sensor monitoring panel. This engages a roof top ventilation fan that will draw the air out of the magnet room.

4.3. Evacuate the magnet room. If any individual is not responding, not breathing and has no pulse, follow the procedure outlined in SOP #40-01 “Medical Emergency Procedure”.

4.4. Once the magnet room has been evacuated, close the magnet room door.

4.5. Notify the Facility Director or Safety Officer and UD Police at 911 from UD Admin or Blue light phone, 302.831-2222from cellular phone, immediately following the incident.

4.6. Also contact UD’s EHS at 302.831-8475.

SOP #64-01

Compressor Alarm Response

1. Introduction

1.1. The compressor is part of the Cold Head system that refrigerates and re-liquefies the liquid helium in the MRI scanner. A soft “chirping” sound indicates it is functioning. The MRI scanner cannot be run if the Cold Head/compressor is not functioning properly.

2. Compressor Alarm

2.1. There is an LED light for the Compressor on the Siemens round power and quench box located on the wall to the left of the operator console.

2.2. If the compressor goes down and is no longer functioning properly the compressor LED will turn red and an audible alarm will be emitted from the Siemens Alarm Panel.

3. Compressor Alarm Response Procedure

3.1. In the event of a compressor alarm the following actions must be taken.

3.1.1. Press the “Acknowledge” button on the Siemens Alarm Panel to quiet the audible alarm.

3.1.2. In the equipment room reset the cold-head compressor.

3.1.3. In the equipment room, check the temperature of the chilled water in the primary loop (water cooled by University of Delaware). The temperature should read 50◦F. If the chilled water temperatures are below 46◦F or above 69.8◦F, call UD facilities at 302. 831-1141.

SOP #65-01Quality Assurance Testing

1. Introduction

1.1. If you are unsure of any of the steps in any of the following procedures, DO NOT CONTINUE. Contact the Facility Director or MRI Technologist for further instruction.

2. Weekly Quality Assurance Tests

2.1. Quality Assurance Tests are completed on a weekly basis on Monday mornings. General system QA tests and RF coil tests are performed on alternating weeks.

2.2. To perform the General System QA or RF coil tests:

2.2.1.Select Options ! Service ! Local Service.2.2.2. Type in the password.2.2.3. Click the Quality Assurance button.2.2.4. In the menu on the left you will see “Quality Assurance” followed by “General Quality

Assurance” and “Coil Quality Assurance”.2.2.5.Click on either “General Quality Assurance” or “Coil Quality Assurance”. A list will appear on

the right.2.2.6. Click the check boxes for the tests you want to run.2.2.7. Click Go on the bottom right of the screen.2.2.8. Follow the instructions as they appear in the pop-up windows.

3. Quality Assurance Tests for New Equipment

3.1. Any time a new piece of electronic equipment is installed in the MRI room a Quality Assurance test should be performed both before and after the installation to validate system performance and ensure the absence of deleterious effects due to the presence of the new device.

3.2. The Quality Assurance test in this case will include SNR, spike, RF noise, and gradient distortion tests. These tests should be performed as follows:

3.2.1. Select Options ! Service ! Local Service.3.2.2. Type in the password.3.2.3. Click the Quality Assurance button.3.2.4. Select “General Quality Assurance”.3.2.5. From the list on the right select:

3.2.5.1. Coil Check3.2.5.2. Spike Check3.2.5.3. Gradient Sensitivity Check

3.2.6. Click Go on the bottom right of the screen.3.2.7. Follow the instructions as they appear in the pop-up windows.

3.3 If the tests performed after installation of the equipment do not pass the Quality Control specifications, then further investigation is required to diagnose the source of the noise or distortion. If the reason for failing the Quality Assurance test is not determined, the equipment must be uninstalled and removed. The equipment may be reinstalled and retested at any time, following the above procedure.

SOP #70-01System Billing Guide and Standard Rates

1. Introduction1.1. The 3T MRI scanner at the CBBI is used primarily for in-vivo studies of human and animal

structure and function. These studies may include assessment of anatomic structures, cognitive function vascular dynamics, metabolism and physiology measurements in a research population. The facility resources are available to peer-reviewed grant funded scientific collaborators with the appropriate Ethics Board (IRB or IACUC) review and approval of their research protocols in place, see SOP #20-01

1.2. Full-time technical support for scanner operation is provided and included in hourly rates during regular weekday hours Monday through Friday, 9 am – 5 pm.

1.3. Rates are periodically discussed and adjusted by the CBBI Committee. These rates are determined through careful consideration of the facility operating costs and overhead.

2. Billing Guide2.1. All billing begins at the start time indicated on the 3T MRI Schedule. It is the responsibility of the

PI and/or experimental support personnel to ensure that the session begins promptly at the time indicated on the schedule.

2.2. The Operator must log their time on the “3T MRI Log Sheet” located on the counter of the operator’s console.

2.3. It is the responsibility of the principal investigator or research personnel to ensure that their scanning session ends punctually at the specified time as listed on the online schedule. An experiment will not be allowed to exceed the scheduled time unless:

2.3.1. time is available on the schedule following the session and the operator agrees to stay and operate the scanner for the extra time.

2.3.2.OR the researcher and operator scheduled in the subsequent scanning slot both agree to allow the extra time.

2.3.3. Billing time will be based on the actual time spent in the scanner

3. Standard Rates3.1. All rates are determined by the fMRI Executive Committee and the UD research office and are as

follows:

3.1.1.For University of Delaware investigators or collaborators from other Educational Institutions, the rate is $500/hr.

3.1.2.Rates for industry/commercial/clinical trial use are $TBA/hr.

4. Scheduling4.1. Access for editing the 3T schedule is restricted to operators. Investigators and/or research

support personnel are required to contact their operator to book time on 3T MRI schedule.

4.2. The principal investigator or research personnel must inform their operator of a cancelation of scan time as soon as possible. The operator will then immediately remove the entry from the online schedule so that another user may book the time.

Center for Biomedical and Brain Imaging

SOP #80-01

Animal Handling and Decontamination Procedures

1. Summary:

1.1. At no time should human research subjects have any contact with animal subjects. This includes:

1.1.1. No visual contact1.1.2. They should not be able to hear or smell the animal1.1.3. They should not be able to identify anything associated with animal experiments

1.2. All waste and supplies brought in and used in the animal experiment must leave with the animal

1.3. All surfaces if/where animals had contact (this will usually be limited to inside the magnet only) must be disinfected by the MR technologist with an EPA-registered disinfectant.

1.4. Imagers may only be operated by the MR technologists trained in the CBBI procedures

1.5. Animals cannot use the same medical gas or scavenging equipment as humans

1.6. Everyone involved in animal handling must review and complete the animal handlers health questionnaire.

1.7. Any person who is required to enter the magnet room must complete the training requirements for CBBI safety.

2. General Overview:

2.1 The main principle to safely operating a dual-subject use facility is to ensure physical and temporal separation between human and animal subjects. Human subject research use must be the first priority. Animal use of the scanners can occur only when it will not conflict with human subjects being scanned.

2.2 Human subjects should never be able to directly see or hear, or otherwise identify that animals are nearby or were or are about to be used in the facility. This means that all supplies for animal work, and any waste generated from animal work, must be removed before the facility is returned to human use. It also means that animals must be anesthetized prior to transport into the facility, or the facility must be closed to the public.

2.3 The MR technicians will coordinate all movement of human subjects and animals in the CBBI magnet area.

3. Transport:

3.1. Animals transported into the CBBI must enter through the side entrance of the facility.

3.2. The MRI technologists must be contacted prior to arrival at 434-566-8974 or 302.831-0910.

3.3. Upon entering the rear hallway in the CBBI, one transport personal must go and check with the technologists to ensure that the magnet space is clear of human subjects.

3.4. Upon getting clearance from the technologist, the animal may be moved into the magnet bay without delay.

3.5. At no time should the animal be station outside the magnet control rooms.

3.6. No equipment associated with the animal should remain in the hallway outside the control room.

3.7. The control room doors should remain closed while the animal is in the MRl room.

3.8. Upon completion of the MR imaging session the technologist will first ensure that no research participants are in the hallway and that all the other operators are aware the animal will soon be transported out of the magnet area.

3.9. When the hall is clear, the animal and all associated equipment can be transported out the rear entrance following the path it came in.

4. Room air ventilation:

4.1. University of Delaware’s Project Mgt assures that the entire MR suite in CBBI operates on 100% exhaust, meaning that none of the air is re-circulated back to any space inside the magnet room .It takes 3.33 minutes to exchange the air in the MR room using the emergency exhaust.

4.2. Air clearance requirements

a. Goats and Sheep: it is required that 99.9% of the air is replaced in the room following a study imaging goats and sheep. This currently requires 41 minutes of clearance time after the animal has been removed. No human subjects are allowed to enter the magnet room until that time has elapsed.

b. Dogs, pigs and rabbits: Although the risks may not be as severe, following animal removal and cleaning as outlined below, the room will still require 41 minutes of air circulation.

5. Surface protection:

5.1. All surfaces that animals come in contact with inside the facility and scanner must be covered with impermeable draping or covering. Equipment and devices that will regularly be used for animals such as trays and carts should be dedicated to animal use only, labeled as such, and stored elsewhere.

6. Technologists:

6.1 Technologists must where gowns, masks, and gloves when dealing with sheep and goats. Gowns and gloves are sufficient with dogs, pigs and rabbits. Although not required, it is recommended to wear masks with these animals as well due to allergens.

6.2 Scrubs, gowns and other personal protective clothing and equipment wore by the MRI technologist to conduct work with animals must be disposable or properly laundered and exclusively used for animal work.

7. Disinfection:

7.1 All surfaces where animals had contact, even with impermeable coverings, must be disinfected after use with 10% bleach (1 part bleach + 9 parts water, made at least weekly). This is followed by a wipe down with water or 70% alcohol. Responsibility for the disinfection of used surfaces lies with the MR technologist that ran the scan.

8. Waste:

8.1 Animal excrement, blood or body fluids, hair, and any medical waste generated during the procedure or while in the dual use area must be appropriately packaged and removed from the facility after animal procedure is completed. This also applies to sharps containers, so that no potentially infectious materials from the animal(s) remain after they are removed. If any of these materials are spilled or otherwise contaminate areas inside the MR facility, the surface must be cleaned and decontaminated as a human blood spill would be.

8.1.2 All the above waste should be transported out of the CBBI with the animal.

9. Medical Gases and Vacuum:

9.1 Animals can use the same medical gas, scavenging, or vacuum systems used for humans provided that different hoses and apparatus from the wall box out to the subjects are kept separate and dedicated to either human or non-human use.

9.2 In all cases hoses must not be re-used and in the case of animals the hoses must be removed from the CBBI with the animal at the end of the experiment.

10. MR Equipment Operation:

10.1 Operation of MR equipment must be limited to knowledgeable and authorized CBBI personnel. All individuals involved must be trained in MR safety and understand other health and safety issues related to the facility.

11. Lab Animal Allergy Issues:

11.1 Everyone involved in animal handling must review and complete the animal handlers’ health questionnaire, distributed through either IACUC or the Employee Health Office. Since LAA’s are fairly common, steps to minimize exposure to potential animal allergens must be considered in all aspects of animal work, including imaging and preparatory steps for imaging.

12. Lab Animal Scheduling:

12.1 All non-human studies whether animals or specimens will be scheduled by the MRI technologist and coordinated appropriately. If an animal is being delivered to the center, then there will be assurance that no subjects or any individual from the public will be in the waiting area.

APPENDIX

A1. Floor Plan of the CBBI building: 1st Floor

A2. Safety Zones at the CBBI

A3. Chart: Summary of MRI Zones and Training

Zone Who can enter Locations

Zone I Anyone Outside building

Zone II

Level 1 worker Level 2 worker Anyone supervised by Level 2 worker LSCF workers

Waiting Room Some Hallways Back Hall to LSCF

Zone III Level 1 worker Level 2 worker Anyone supervised by Level 2 worker

Control Room (146) 129A, 131, 131A

Zone IV

Level 1 worker (w/screening) Level 2 worker (w/screening) Anyone supervised by Level 2 worker (w/screening)[Note: Any Level 2 worker can approve a screening form]

Magnet Room

User Training Level

Access/Authorizations Training

Level 1

Can enter any zone unescorted (for Zone IV must be screened)

Can operate scanner on phantoms with proper training on magnet use (no humans or animals)

Watch Siemens and Kanal videos Read SOPs and sign that they understand them Read Operator Manual “Systems, coils, and scanning” Attend safety instruction with MRI Safety Officer covering

emergency procedures and location of table stop, electrical stop, quench buttons

Complete Level 1 test with grade of 90% Screened as safe to enter MR environment Be certified by the Facility Director or the MRI Safety Officer

Level 2

Can enter any zone unescorted (for Zone IV must be screened)

Has card access to Zone III Can approve screening forms Can escort any untrained person into any

zone (if Zone IV, person must be screened)

Can operate scanner on any person/object with proper training on magnet use

Complete Level 1 training Watch Siemens video section on patient preparation and

examination Watch Kanal Level II video Read Safety section of Operator Manual Complete Level 2 test with 90% grade Shadow and receive supervision from Scanner Operator for 10

scanning sessions Be certified by the Facility Manager, Chief Technologist, and

Facility Director

A4. MRI Safety Screening Form

A.6 Organizational Chart

index [cbbi.udel.edu]€¦ · web view1.1 the 3t mri scanner at the ud center for biomedical and...

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