Extensive methodological and image analysis development will only be provided on the basis of scientific cooperation.

Transcription

1 User Guidelines 7T Experimental MRIs 0. Preamble Two experimental 7 Tesla magnetic resonance imaging (MRI) machines were purchased by the Center for Stroke Research (CSB) (Device 1) and the Cluster of Excellence NeuroCure (Device 2) with the aim of creating an experimental platform for small animal imaging. The facilities will service projects in the areas of A) Experimental Neuroimaging and B) Molecular Imaging, but projects in other fields of research are explicity encouraged. The Core Facility is available to all public research institutions and interested industrial partners. The User Guidelines are binding for all users of the 7T MRIs. The following two devices of the company Bruker Biospin are available: Device 1 7T PharmaScan (installation 03/2003; upgrade 04/2013) Device 2 7T BioSpec (installation 08/2013) Our services include the following support from the Core Facility staff: MRI consultation study design, selection of appropriate device and sequences Use of standard sequences with marginal modifications Carrying out measurements Performing measurements under guidance Training in independent MRI operation Advice on appropriate image analysis strategies Extensive methodological and image analysis development will only be provided on the basis of scientific cooperation. 1. Access Rules Requests for MRI projects or single measurements are to be addressed to the technicaloperational management (TOL, Dipl. Ing. Susanne Mueller; contact Appendix 1) for review and approval. The TOL also advises on which device is suitable for the requested examination. In unclear cases, a second review by the scientific management will take place (Appendix 1). The scientific management also decides on the appropriate device in case of doubt. Bookings are made via to the TOL by naming the device, date and requested time. Seite 1 von 8

2 1.1. Licence for animal testing At the start of the actual MRI testing, users must have an approved licence for animal testing (by the LaGeSo Berlin) with permission for MRI under anaesthesia. The user confirms this with his/her signature on the User Rules short form Proof of health of laboratory animals Before the start of MRI investigation, a current health certificate from the respective animal facility must be submitted to the TOL. Possible risks of infection between different animal facilities must be kept to a minimum. In the event of a negative health assessment, new animals must be purchased and put directly in our in-house animal facility. If in doubt, consultation with the relevant animal protection officer of the Charité is required ( ). 1.3 Declaration of GMOs When working with genetically modified organisms (GMOs), the documentation sheet for genetically modified laboratory animals has to be provided to the S1-project leader of the MRI lab (Susanne Mueller). For long-term and regular MRI examinations of GMOs, the rooms of the MRI facilities must be included in the user s own S1-facility (informal notification of extension can be made via to Hr. Norbert Andree, Geschäftsbereich Rechtsabteilung, Stabsstelle Ordnungsbehördliche Angelegenheiten) Cost The use of the 7T MRI machines is subject to fees for all users. A price list can be found in Appendix 2. For final payment with internal service accounting (ILV, interne Leistungsverrechnung ), a cost center ( Kostenstelle ) to which the fees can be charged must be provided. External users must provide a billing address. If the time slot booked is not canceled up to 24 hours in advance, the full fee will be charged Access authorization Users are permitted entry to the rooms of 7T MRIs only after safety briefing by the TOL. Advanced Users are entitled to independently operate the MRI machines after extensive briefing and training by the TOL. Only Advanced Users receive transponder access to the MRI labs (approval by the TOL). It is not permitted to give the transponder to third parties. The Advanced User has to ensure that no unauthorized persons have access to the rooms. Basic Users and other members of staff are not entitled to independently operate the MRI machines. They may participate only in the presence of an Advanced User or the TOL. Seite 2 von 8

3 2. Booking Conditions Measuring time is reserved and administered by the TOL. Current bookings can be seen in the online calendar. Bookings must be made via to the TOL (for details Appendix 3). Users must adhere to the measuring times booked. Cancellations must be made no later than 24 hours in advance, otherwise the full fee will be charged. Projects under the direction of NeuroCure and CSB PIs have MRI booking priority. At full capacity, priority will be given as follows: 1. CSB / NeuroCure; 2. other Charité scientists; 3. external academic institutions; 4. industrial partners. 3. Safety No one is permitted to enter the 7T MRI laboratories without prior safety briefing. All users and guests must be introduced to the TOL for safety briefing. All users must attend an MRI safety briefing once each calendar year. For safety reasons, in vivo measurements on the MRI (with use of inhalation anesthesia) may not be performed alone; two people are required to be present Magnetic fields The experimental MRI machines are superconducting, actively shielded magnets with magnetic field strengths of 7 Tesla (approx. 140,000 times the geomagnetic field). According to safety regulations, it is not permitted to take magnetic or magnetizable objects, or any technical devices, into the radio frequency (RF) cabins without prior consultation with the TOL S1-Laboratory The safety regulations for genetic engineering work at security level 1 as defined in GenTSV Appendix V apply. These can be found in the operating instructions posted on the wall in laboratories K1 010 for Device 1 and E1 014 for Device Laboratory Regulations The TOL is responsible for the technical-operative care of the 7T MRIs. Users are individually responsible for the proper conduct of investigations in accordance with the Animal Protection and Genetic Engineering Act and compliance with hygiene measures Operation of MRIs The MRI machines and associated equipment are to be kept in perfect condition. Technical malfunctions and/or defective equipment must be reported to the TOL immediately. Users may install or change measuring coils only after prior briefing by the TOL. Seite 3 von 8

4 The instructions for coil installation, operation of the scanner and electronic control units serve as a reminder after training and must be consulted if in doubt. Before each measurement, users are required to read the lab book next to the work stations to stay updated on current operational changes. After completing the investigation, MRI rooms are to be left in an orderly and sanitary condition in accordance with the hygiene plan (Appendix 5). All gases must be turned off Consumables The following consumables will be made available by the Core Facility: Examination gloves Tape Gas for inhalation anesthesia (Isofluran, N 2 O) Other working materials are to be provided by the user Data Each user is required to secure his/her own data responsibly and in a timely manner. For data backup, various means are available (Appendix 4). Publication-relevant data should be stored in the native Bruker format, as only this format is guaranteed. MRI data remain approximately half a year on the MRI workstations. They are then archived and deleted by the TOL. There is one lab book for each MRI machine (next to the corresponding work station) in which all users are instructed to enter their measurements and, when appropriate, current observations, errors, defects, etc. 5. Disclaimer Claims for damages against the Core Facility 7T Experimental MRI are limited to intent and gross negligence. Liability for consequential damages is excluded. The Core Facility 7T Experimental MRI is not liable for damages resulting from the fact that the facility cannot be maintained to the extent intended, or that their operations must be restricted or discontinued due to regulatory requirements. Seite 4 von 8

5 5.1. Severability clause Should individual provisions of the User Guidelines be invalid, the validity of the remaining provisions shall not be affected thereby. The invalid provision shall be replaced by a valid one that comes closest to what the Core Facility Experimental 7T MRI intended or would have intended, if it had been aware of the invalid provision. The same applies to any contractual gaps. Date, Signature (Scientific Director) Seite 5 von 8

6 Appendix 1 - Contact Details The 7T experimental MRIs are located at the Campus Charité Mitte, Neurowissenschaftliches Forschungszentrum (NWFZ), Hufelandweg 14: Device 1 (PharmaScan) Room K1 010 Device 2 (Biopec) Room E1 014 (entry through E1 017) Scientific Director: Dr. Tracy Farr phone: 030 / tracy.farr@charite.de User Board: Prof. Dr. Ulrich Dirnagl, Prof. Dr. Britta Eickholt, Juniorprof. Dr. Eyk Schellenberger, Dr. Roland Kälin The User Board meets once a year to make decisions regarding the further development of the systems (if necessary), vote on the annual budget, and assess the range of services (annually). Support and bookings are done by the technical-operational management (TOL). TOL: Susanne Mueller phone: 030 / susanne.mueller1@charite.de Substitute: Philipp Böhm-Sturm phone: 030 / philipp.boehm-sturm@charite.de Laboratory phone: Device 1 (PharmaScan) 030 / Device 2 (BioSpec) 030 / Web presence: In the absence of the TOL and her substitute, the Bruker BioSpin hotlines can be contacted for fast telephone support for acute problems: Hardware hotline for: Hardware problems Spare parts delivery Service visits Magnet, periphery, and siting Please contact mri-hardware-support@bruker-biospin.de or call Software hotline for: All ParaVision No XWIN-NMR /TopSpin Linux /Net configuration (Bruker PCs only!) Seite 6 von 8

7 Please contact or call Application hotline for: Parameter/protocol optimization Image artifacts Animal accessories General system handling Please contact or call Should repairs be necessary, a repair order to CFM-medical technology should be initiated in consultation with the TOL. CFM Helpdesk 030 / or Hr. Blesin 030 / Appendix 2 - Pricing The usage fees for 7T MRI are graduated by device and user status. User Device 1 (PharmaScan) Device 2 (BioSpec) Charité including CSB and Neurocure PIs 20,00 / h 35,00 / h External research institutions 30,00 / h 45,00 / h Industrial partners 60,00 / h 60,00 / h Appendix 3 - MRI Booking / Online Calendar Bookings can be made via to the TOL (susanne.mueller1@charite.de) by naming the device, date and intended time. Online reservation calendar: Reservations for both MRI devices can be seen in the online calendar. Entries can only be made by the TOL. Appendix 4 Data Backup Currently, the following resources are available for data backup / data transfer: DICOM export and archiving of the Bruker native data Data transfer on your own computer via SSH or WinSCP - access data can be obtained from the TOL USB-Stick / CD Seite 7 von 8

8 Appendix 5 - Hygiene Plan 5.1 Preparation rooms Animals brought in and out in locked cages with secure filter attachment Transport of animals from cage to scanner and back Preparation and/or killing of animals 5.2. Scanner room Pre-medication of animals in an anaesthesia box Positioning of animals on examination bed under gas anesthesia; control of vital functions by the monitoring system. Warming blankets are covered with foil. MRI study 5.3. Disinfection and hygiene measures The following measures must be taken when finished with the MRI study: The foil around the warming blanket has to be removed and disposed of The anesthesia box, animal examination bed, breathing mask and mouth guard must be cleaned with Descosept or Sterilium Disinfection of work space with Descosept (table at MRI scanner, tables where cages were placed and/or animals prepared) As necessary and/or following contact with animals without using gloves Clean and disinfect hands with soap, water and Sterilium Computer keyboard and mouse may only be touched with clean and disinfected hands. When necessary, wipe computer keyboard and mouse with Sterilium Cadavers Cadavers are to be wrapped in plastic bags and disposed of in a freezer provided for this purpose in the NWFZ basement, Room 012. Seite 8 von 8