Manual Variety Multipurpose Coil - Noras MRI products
Contents
1. Halswirbels ule nco loop 00 51 Brustwirbelsaule 32 f nema 01 19 m Lendenwirbelsaule erden mig ria IB phantom shim 00 09 m TimCT Gesamte Wirbels uf 34 2 rf field 01 18 Halsweichteilgewebe Herz m Thorax 35 Au T map 00 44 rf loop 00 51 If noise 05 95 Becken Schulter 386 JH If noise spectrum 00 30 i Ellenbogen m Handgelenk H fte Al cal 04 16 rf pulse 00 26 Knie 41 f rfcal pali 00 03 Sprunggelenk T Spektroskopie chara 00 13 Onkalagie mehrere_Regiog 43 C DO C Ganzk rper Diffusion limCT Onkolagie m Angiographie 45 X serv data rate 01 21 m kM Angiographie Tim Angiographie ce Intervention A A sil D rot 01 19 i adjustments AQ 4 ame Eee 01 18 Mamma i SequenceRegion AQ A spike 00 06 EN a Mi se multiecho shim array 00 02 spike resonant 01 02 split echo 00 21 stab fl 01 22 stab se 01 22 tuncal DOE Q2 Sequence Siemens SequenceRegion ServiceSequences DefaultProtocols sn NORAS mr Variety 16 Channel Multipurpose Coil 1 5T 3T pro duc ts 50 Maintenance Storage and Waste Disposal Select the function save uncombined TA 1 16 PM REF voxelgr e 1 2x1 2x3 0 mm Rel SNR 1 00 Spulen Yerschiedenes Justagen Justagevolumen Tx Rx Kanalkombination Givadratsumme Fositionierungsmodus REFR v Unkombiniert speichern Tischpasition H Tischpasitionsgedachtnis j Optimierung Aus Spulenfokus Konstant M Bildnummerierung2. MSMA S C T Save uncombined Sagittal R L Coronal A 22 P M AutoAlign Ud Transversal F H Y Spulenamwahl Default Programm Routine Kontrast Aufl sung Geometrie system Inline Sequenz Furthermore the coil elements must be selected in the coil options Verschiedenes Justagen Sander Empf nger NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T pr Oo d uc ts 51 Maintenance Storage and Waste Disposal Now you can start the measurement If the signal of each channel is shown approximately the following result should arise for each coil half 2115 14 30 3rd Party variety ne kale lng 2135 14 32 Jrd Party vark ty Pie kallckes Ihstttt 1203 Ad 1203 A 10 10 1990 0 20 I 2p I 7 i 2p HR B17 HF HFS 15 04 30 3rd Par e Patient 2115 04 30 3rd Party varie d 2115 04 31 3rd Party Vark nekallsches 2115 04 00 3rd Party Vark H 12073 ry ad pi dd 1am3 de Y 0 247 AR Bi 10 10 1980 0 2 7 HFS UDYS MF 100 TR ADI LTE 10 21504 A 3rd Party Variety 2015 14 XI 3rd Party Variety P n re 12073 WF 10 TR 3nn TE 100 TA 01 16 Buy 1300 WND ammany The illustration shows that all 8 channels of the coil half receive reasonable signal Variety 16 Channel Multipurpose Coil 1 5T 3T 52 Maintenance Storage and Waste Disposal This picture shows the combined signal from all 8 channels of one coil half Patient Anwendungen Transfer Bea
3. approx 200 mm 1 5 T 63 6 MHz Resonance frequency 3T 123 2 MHz Electrical SIEMENS MRT Mechanical MRT Patient Table NORAS mrr products Variety 16 Channel Multipurpose Coil 1 5T 3T Technical Specification 8 3 Parts Lists 8 3 1 Scope of delivery of the Variety 16 Channel Multipurpose Coil 1 5T 117235 Variety 16 Channel Multipurpose 117410 2 Coil 1 5T Variety Positioning 118398 2 Multipurpose Velcro Fastener 500 back to back 118408 118398 Variety Positioning Aid Multipurpose 117410 Variety 16 Channel Multipurpose Coil 1 5T 117981 Variety Clip 117407 Operator s Manual i 118408 Velcro Fastener 500 back to back 117542 Velcro Fastener 300 bu 117530 Velcro Fastener 500 NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T p ro d uc ts 57 Technical Specification 8 3 2 Scope of delivery of the Variety 16 Channel Multipurpose Coil 3T 117234 Variety 16 Channel Multipurpose 117404 2 Coil 3T Variety Positioning 118398 2 Multipurpose Velcro Fastener 500 back to back 118408 118398 Variety Positioning Aid Multipurpose q p CA 117981 Variety Clip 117407 Operator s Manual AE 118408 Velcro Fastener 500 back to back 117542 Velcro Fastener 300 N 117530 Velcro Fastener 500 N 117404 Variety 16 Channel Multipurpose Coil 3T N NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T pr Oo d uc ts 58 Technical Specification 8 4
4. A Arsen een 26 5 5 Positoning OF tHe COll een een 31 5 5 1 Diagnostic application fieldS cccccceccsecceeeeecseeceeeeeeseeteeeeeeeeeeeeeeaes 32 5 5 2 Arrangement of the coil slots ccc cecs eee eeeseeteeeeeeeseteeeeseseeeeeenaes 39 6 Cleaning and Disinfection eere eee nun ree 41 7 Maintenance Storage and Waste Disposal 46 7 1 Functional TOSS unseren 4 7 2 OGE ee ee E 54 7 3 Waste DISPOSA nennen 54 8 Technical Specification ccsscssccsscceccnecnecenscnscnssenscnseensenscnsenness 55 8 1 rustorical DEVICE DAL essercene E EEE 55 8 2 Perormance Dale ann 56 8 3 RoE E E H HM of 8 3 1 Scope of delivery of the Variety 16 Channel Multipurpose Coil 1 5T 72 57 NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 3 Content 8 3 2 Scope of delivery of the Variety 16 Channel Multipurpose Coil 3T u 58 8 4 ACCESSOllES ee MEAE 59 9 Important Addresses 20 200200000n00n00n0nnunnunnunnunnun nun nun nun nun nun 61 10 Bn c oils OUE e 62 NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 4 General Information 1 General Information To ensure safe and failure free operation of this high quality medical device please caref
5. GmbH Danger of infection Prior to start up of the devices or parts thereof all components must be treated as described in chapter Cleaning and Disinfection Non compliance with the above instructions may lead to infection of the patient NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 41 Cleaning and Disinfection Hygiene Despite the prescribed wipe disinfection we recommend for a double safety to insert a sterile MR compatible drape between the coil and the skin surface Generally the user is responsible for hygiene Please always wear protective gloves and comply with the application times for Hepatitis B and HI viruses See the instructions for use of the respective disinfectant solution INSTRUCTIONS Individual Parts Point of Use Remove excess soil with disposable cloth paper wipe Containment and No particular requirements It is re Transportation commended to reprocess the product as soon as possible after its use The products should be transported in a closed container Preparation _ for No particular requirements Cleaning NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T p ro d uc ts 42 Cleaning and Disinfection Cleaning and Disinfection Manual The Variety 16 Channel Multipurpose Coil may not be cleaned in immersion baths and may not be held under running water Only wipe disinfection IS allowed Equipm
6. with care ISO 7000 0626 Store in a dry place ISO 7000 0632 Temperature Limit Conforms with the essential requirements of Council Directive 93 42 EEC of 14 June 1993 concerning medical devices Warning regarding risks that may result in minor physical injury or material damage Warning regarding risks that may result in death or serious physical injury Information regarding the optimal use of the product On the following page we describe where you can find our various rating plates on your product In addition to the above described symbols you will also find the model designation as well as the product and serial number NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 10 Device Description 4 1 1 Rating Plates The laser engraving is located on one half of the shield trap housing The term 16Ch on the labeling refers to the standard delivery of two identical halves coils each half coil includes 8 channels Eos 16Ch Multipurpose Coil Variety 1 5T SI yes 16Ch Multipurpose Coil Variety 3T SI NORAS MRI products GmbH NORAS MRI products GmbH Leibnizstrasse 4 117410 e A N Leibnizstrasse 4 117404 e A N DE 97204 Hoechberg DE 97204 Hoechberg SN 0000 G 111 MM Rev 02 e H Ce VEMM Rev 02 Jer N CE 1 0123 4 2 System Components The Variety 16 Channel Multipurpose Coil consists of the following components 118398 Variety Positioning Aid Multipurpose 117410 Variety 16 Cha
7. 2 Start Up Positioning of the coil at the magnet by means of the laser sight Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 33 Start Up 9 9 1 2 Elbow Plug the coil connector into the TIM adapter box applies to Aera and Skyra For Avanto Espree Symphony a TIM Trio a TIM and Verio a TIM systems the coil connector can be plugged directly into the slot of the MR table Fig 2 Variety 16 Channel Multipurpose Coil 1 5T 3T pr oduc ts 34 Start Up 5 5 1 3 Carotid If you have to use the both halves of the coil simultaneously please use two TIM adapter boxes Depending on the anatomy the Variety Coil should be fixed to the patient s body for example using the Velcro strips as needed it should be stabilized using sandbags Depending on the individual anatomy the patient should be positioned comfortably by means of support aids cushion wedges sand bags etc Please note that the cable do not cross each other or form loops Variety 16 Channel Multipurpose Coil 1 5T 3T pr Oo d uc ts 35 Start Up 5 5 1 4 Hand Wrist NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T pr od uc ts 36 Start Up Positioning of the coil at the magnet by The laser sight has to be aligned with the means of the laser sight center of the coil NORAS mri Variety 16 Channel Multipurpose Coil 1 5T 3T pro duc ts 37 Start Up 5 5 1 5 Shoulder Variety 16 C
8. Accessories Positioning Aid Knee Feet 118463 Ni Positioning Aid Shoulder 118413 e Positioning Aid Elbow 118468 Positioning Aid Pediatrics small 118465 ES NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 59 Technical Specification Positioning Aid Pediatrics a medium Positioning Aid Pediatrics large Ca Positioning Aid Inlay Mi Positioning Aid Multipurpose BEL 1 NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 60 Important Addresses 9 Important Addresses Manufacturer Development and Production NORAS MRI products GmbH Leibnizstrasse 4 products 97204 Hoechberg Germany Phone 49 0 931 2 99 27 0 Fax 49 0 931 2 99 27 20 E Mail mri noras de Web www noras de NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 61 Training Outline 10 Training Outline have reviewed the Variety 16 Channel Multipurpose Coil Training Outline and understand the topics discussed and verify that the training outlined is complete The training delivered was reflective of the details in the Variety 16 Channel Multipurpose Coil user manual will read or have read this appropriate manual including the Cleaning and Disinfecting section of the manual understand the intended use and the functionality of the Variety 16 Channel Multipurpose Coil and am aware of the components of Variety 16 Channel Multipurpose Coil the i
9. Variety 16 Channel Multipurpose Coil 1 5T 3T Siemens for Diagnostic Imaging Operator s Manual Revision 04 Y C D Y 9 ym e O D Y O O NE oO C dem B o v gt gt lm L ev gt NORAS uni CE Date issued August 2015 p r Oo du C ts Technical changes reserved NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T p ro d uc ts 2 Content Content 1 General InformatlOHn uiie sede sieascdvciawsiateicanedeicensnduciausndubiousedacieasndeeians 5 2 Intended Use Indication for Use 7 2 1 Seniciaeie io cz T 3 Operating Principle sous ose nee 8 3 1 SMEV CINE nennen 8 4 Device Description 2 20 2002000200n00n0nn0nnunnunnun nun nun nun nun nun nun nnn nns 9 4 1 IJerinitions ard SyITIDOIS uunenneee 9 NN RAMNO I AUC ENTE 11 4 2 SYSTEM Componentis 024s020002n00enonnnonnnennnnnnnnnennnennnennnnnnn nennen 11 4 3 Combination with other D VICES cccccceeceeeeeeceeeeeeeeeteeeeeeeeeeeenees 12 5 NENNE URHEBER 13 5 1 STA SI AL TE E E E N E E UDIE 13 5 2 vicisse nee 16 5 9 Preparation OF tne COI una AR ANA AA 18 5 4 Remove Siemens Spine Coil ccc eccecceccseeceeeseeceeceeeeeeeeeeeeeeeeteeeeeeees 20 5 4 1 Avanto Espree Trio 7 Verio ic sccsrscsacasrscdsearsnnreenseniwccrensisarssanaannnarees 20 94 2
10. anks to its variable mechanical support system this coil can be used for a wide variety of examinations such as the diagnostic imaging of the inner ear carotid artery jaw bone or in the orthopedic field of the finger wrist elbow shoulder knee ankle or toes 3 1 Safety Concept The Variety 16 Channel Multipurpose Coil is subject to the same multi stage safety concept as for other MRI local coils and has fuses which minimize the patient hazard as much as possible NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 8 Device Description 4 Device Description 4 1 Definitions and Symbols The following symbols are used on the Variety 16 Channel Multipurpose Coil or in the Operator s Manual ISO 7000 2493 Item Number ISO 7000 2498 Serial Number nm wo ISO 7000 2497 Date of Manufacture EN ISO 7010 Operator s Manual MOO2 gt Differ to the requirements of EN ISO 701 M002 all laser engravings can only be executed in gray instead of blue due to technical unfeasibility ISO 7000 0434B Caution read the accompanying documents IEC 60417 5172 Protective Insulation IEC 60417 5333 Type BF NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 9 Device Description Directive Waste products should not be disposed of 2002 96 EC with household waste e g at a local authority collection point ISO 780 This way up DIN 55402 ISO 7000 0621 Fragile handle
11. ce is placed centrally in the phantom bottle in coronal direction For a better understanding The coil half is hereby located underneath the phantom bottle shown in the first MR image Patient Anwendungen Transfer Bearbeiten Warteschlange Protokoll Ansicht Bild Werkzeuge Auswertung Bl ttern System Add On Optionen Hilfe 2015 04 30 3rd Party Variety 2015 04 30 3rd Party Variety H 2015 04 30 3rd Party Variety H 12073 12073 12073 4 IMA 175 41MA375 90 04 2015 30 04 2015 c D E o c z 1015 04 30 3rd Party Variety TA 1 18 PM REF Voxelgr e 1 2x1 2x3 0 mm Rel SNR 1 00 Sender Empf nger a Unkombiniert speichern Positionierungsmodus SINN Matrix Spulen Modus Auto CP Tischposition Ba Kanalkombination Quadratsumm v Tischpositionsgedachtnis Bildnummerierung MSMA S C T Sagittal R gt gt L Coronar A gt gt P Transversal F gt gt H v SAR NM All images in the graphic segments have been replaced by new im a Ale 30 04 2015 15 46 06 Warten auf Schichtpositionierung NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 49 Maintenance Storage and Waste Disposal This sequence can be found as following olemens SequenceRegion ServiceSequences DefaultProtocols sn Untersuchungs Explorer WSIEMENS SequenceRegion SerriceSequences DefaultProtocols Objekt Bearbeiten Werkzeuge Einf gen Hilfe a mar Se ele E TR SIEMENS nca 00 53 kopf
12. cessories supplied by other manufacturers with the express written approval of NORAS MRI products e Do not use a coil showing visible damage to the housing or its connection ca bles e The Variety 16 Channel Multipurpose Coil must not be opened by the user Improper fixation of the coil The coil must be fixed properly at the body part under examination Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 16 otart Up Permanent damage of the system The system may only be assembled by trained medical personnel Incorrect assembly and operator errors made by untrained personnel can permanently damage individual parts of optional components and of the device itself Variety 16 Channel Multipurpose Coil 1 5T 3T p ro d uc ts 17 Start Up 5 3 Preparation of the Coil Prolongation or termination of the treatment While plugging in the coil ensure and check that proper contact has been made Check the display of the MRI If the coil pair is not properly plugged in no images can be produced Bodily harm of the patient Velcro tape may not protrude Otherwise it can clamp while retracting the MR table Danger of destruction The coils must not be cleaned in immersion baths or held under running water Non respect of the cleaning and disinfection instructions may cause the destruction of the coils Variety 16 Channel Multipurpose Coil 1 5T 3T p ro d uc ts 18 Start Up Device Damage Co
13. ent Disinfectant Example Sekusept PLUS Ecolab 4 0 vol Korsolex Plus 3 0 vol with exposure time of 15 minutes For this purpose all aldehyde free surface disinfectants which have been approved and released by the Robert Koch Institute RKI can be used in accordance with the instructions on the label The solution is to be distributed on the surfaces by a lint free cloth The disinfectant permeates the dirt particles and due to mechanical forces pressure abrasion this ensures effective cleaning Additionally the wiping motion ensures that the spores which are resistant to the disinfectant will be removed The cloth must be replaced after the disinfection in order to prevent the spreading of the spores on other areas Moreover it is essential that the wiping solution is renewed regularly Only for Coil cable surface Coil NORAS mrr products Variety 16 Channel Multipurpose Coil 1 5T 3T Cleaning and Disinfection Danger of Destruction The coils must not be cleaned in immersion baths or held under running water Non respect of the cleaning instructions may cause the destruction of the coils Danger of Destruction The coils must not be cleaned in immersion baths Non respect of the disinfection instructions may cause the destruction of the coils Danger of Destruction Non respect of the disinfection instructions may cause the destruction of the coils No warran
14. found the system must not be used Damaged coils must not be used Do not produce images with a defective coil Variety 16 Channel Multipurpose Coil 1 5T 3T pr Oo d uc ts 14 Start Up Incorrect handling can cause damage to the coil and to the connection cable The loops of the flexible coil must not be subject to mechanical stress e g by carrying lifting the coil or by fixating the coil to the patient s body using Velcro Strips NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 19 Start Up 5 2 Safety Information While using the Variety 16 Channel Multipurpose Coil please follows the below safety information e The Variety 16 Channel Multipurpose Coil is not suited for operation in areas subject to explosive hazards in the presence of inflammable anesthetics or combustible gases such as anesthetics e The Variety 16 Channel Multipurpose Coil has been designed for use with a MRI device in the special examination room provided for it climate controlled electrically shielded e t may only be used by medical technical personnel who are familiar with the operating principle of the MRI device and who have been instructed in the function and use of the Variety 16 Channel Multipurpose Coil by NORAS MRI products or its responsible company representatives e This coil may only be used in combination with accessories supplied by NORAS MRI products You may only use this coil with ac
15. hannel Multipurpose Coil 1 5T 3T produc ts 38 otart Up 5 5 2 Arrangement of the coil slots The coil slots are arranged at the foot and head end of the patient table lan Patient table with slots arrangements a a sez ae en ___ am 6 slot 6 6 channels of san scan 0 sos ems 0 Variety 16 Channel Multipurpose Coil 1 5T 3T pr oduc ts 39 otart Up see Correct connection of the coil Please pay attention to select the correct coil slots The 8 channel coils should only be plugged into slots 1 4 8 and 10 Variety 16 Channel Multipurpose Coil 1 5T 3T p ro d uc ts 40 Cleaning and Disinfection 6 Cleaning and Disinfection The instructions must be followed as described In case of inadequate cleaning or disinfection you have to carry the risk of infection Non respect of the disinfection instructions may cause the destruction of the coils Non compliance with the cleaning instructions may destroy the system No warranty service will be provided for damages due to improper disinfecting Please always wear protective gloves and carefully comply with the application times for Hepatitis B and HI viruses See the instructions for use of the respective disinfectant solution Limitations on Frequent processing can have an impact on these products reprocessing color changes but do not affect the function of the product Spare parts can be purchased from NORAS MRI products
16. il The Variety 16 Channel Multipurpose Coil is a multifunctional coil which can be used for the examination of many different parts of the human body It may either be used as a single coil half for example for the wrist thin elbow ankle surface array etc or as combined coil halves for the knee shoulder thicker elbow ankle etc The coils are fastened on the body by means of Velcro straps In addition the usual positioning aids foam wedges cushions covers sandbags etc should be used to support the patient for more comforting NORAS MRI products GmbH also offers dedicated positioning aids for specific anatomies to be used with our Variety 16 Channel Multipurpose Coil Following the application of the coil will be shown exemplary for some individual body area Disinfect the coil surface before and after each patient examination by disinfecting wipes only with slightly moist not wet wipes See also Chapter 6 Cleaning and Disinfection Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 31 Start Up 5 5 1 Diagnostic application fields 5 5 1 1 Knee Ankle The dedicated positioning aid is supposed to be used for examination of knee or ankle The two coil halves are then to be connected using the two slots on the left and right side of the MR table for Aera Skyra the use of two TIM adapter interfaces is required NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 3
17. il Error To remove the plugs only push on the plug cover themselves do not pull on the plugs or the cables Non respect may cause cable cracks or plug cracks Defective coils this includes cables and plugs must not be used Device Damage Coil Error Don t carry the coils on their cables or plugs Furthermore don t knot the cables Operating errors may cause permanent damages to the device coil Use of wrong components The use of components not listed and described in this Operators Manual provided by NORAS is expressly prohibited Variety 16 Channel Multipurpose Coil 1 5T 3T p ro d uc ts 19 Start Up 5 4 Remove Siemens Spine Coil 5 4 1 Avanto Espree Trio Verio otarting position with Siemens Spine Coil Remove the additional cushions at foot and top Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 20 Start Up Loose the Spine Coil plug on both sides Insert the cable connector into the recess of the Spine Coil existing at the foot end Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 21 Start Up Remove the Spine Coil from the patient table Stable the Spine Coil NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T pr oduc ts 22 Start Up Put the positioning cushions original Siemens on the patient table Insert the plastic covers Original Siemens for head area Variety 16 Channel Multipurpose Coil 1 5T 3T pr
18. nnel Multipurpose Coil 1 5T or 117404 Variety 16 Channel Multipurpose Coil 3T 117981 Variety Clip 117407 Operator s Manual AE 118408 Velcro Fastener 500 back to back N 117530 Velcro Fastener 500 117542 Velcro Fastener 300 NORAS mr Variety 16 Channel Multipurpose Coil 1 5T 3T pr Oo d uc ts 11 Device Description 4 3 Combination with other Devices The Variety 16 Channel Multipurpose Coil can be used with the following MRI systems Siemens 1 5T Avanto Espree Symphony a TIM System Aera Siemens 3T Trio a Tim System Verio a Tim System Skyra Prisma Bodily Harm Also MR compatible accessories can cause injuries to the patient and or the user Please follow the instructions of the accessory manufacturer Non compliance with these instructions may lead to injuries of the user and or patient The Variety 16 Channel Multipurpose Coil may only be used in combination with those indicated in this Operators Manual and included devices and coils of NORAS MRI products GmbH accessories Use of other accessories is permitted only with written approval by the NORAS MRI products GmbH Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts Start Up 5 Start Up 5 1 General The Operator s Manual must be read by each operator prior to using this device In order to become skilled in the proper handling of this system you should not only participate in training with the system but also train with a phantom t
19. nstallation of the Variety 16 Channel Multipurpose Coil NEM the complete setup of the Variety 16 Channel Multipurpose Coil EM the application on patients the cleaning instructions the disinfection instructions that it is NOT NORAS responsibility for timely replacement of worn out parts NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 62 Training Outline Date amp Signature O Contact Person E Mail Adress Phone No Customer Trained by NORAS Application Trainer Date amp Signature Quality System Document It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use This document contains confidential or proprietary information of NORAS MRI products GmbH Neither the document nor the information therein is to be reproduced distributed used or disclosed either in whole or in part except as specifically authorized by NORAS MRI products GmbH NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 63 Notes NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 64
20. o become familiar with its use Only trained personnel may be assigned to handle the Variety 16 Channel Multipurpose Coil Operating errors may cause permanent damages to the device G21 G32 coil The users must be trained before using the device detailed training of the personnel for existing components Device Damage Coil Error G22 G37 Bodily Injuries Only trained personnel may be assigned to handle the Variety 16 Channel Multipurpose Coil Operating errors may cause bodily injuries e g contusions to the user and or the patient NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T p roduc ts 13 Start Up Danger of Infection Prior to start up of the devices or parts thereof all components must be treated as described in chapter 6 Cleaning and Disinfection Noncompliance with the above instructions may lead to infection of the patient Bodily harm of the patient Prior to each use of the coil injured skin surface must be covered with sterile drapes Please be sure to pay attention to and comply with the safety information and instructions of the MRI manufacturer for operators patients and the third party Bodily harm of the patient Prior to each patient examination you should make a careful visual inspection of the system components Damaged parts can be sharp edged and cause injuries to the patient and or to the user In the case of unusual findings and or damage
21. oduc ts 23 Start Up Apply the three part cushion original Siemens NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T pr oduc ts 24 Start Up Starting position after remove of the Siemens Spine Coil Now the NORAS customer coils can be connected Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 29 Start Up 5 4 2 Aera Skyra Starting position with Siemens Spine Coil S Remove the additional cushions at foot and top MRI Variety 16 Channel Multipurpose Coil 1 5T 3T pr oduc ts 26 Start Up Release the Spine Coil by pressing a lock button under the lever in the center of foot end Remove the Spine Coil from the patient table MRI Variety 16 Channel Multipurpose Coil 1 5T 3T pr oduc ts 27 Start Up Stable the Spine Coil Apply the cushions on the MR table original Siemens Variety 16 Channel Multipurpose Coil 1 5T 3T pr oduc ts 28 Start Up Insert the foam covers Original Siemens for head area Apply the three part cushion original Siemens Starting position after remove of the Siemens Spine Coil Now the NORAS customer coils can be connected Variety 16 Channel Multipurpose Coil 1 5T 3T pr oduc ts 29 Start Up Connect the two TIM adapter boxes original Siemens at the two desired slots MRI Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 30 Start Up 5 5 Positioning of the co
22. ostic imaging device to produce transverse sagittal coronal and oblique images of the internal structures of special regions of the human body When interpreted by a trained physician these images provide information that can be useful in determining diagnosis The outcome of this is diagnostic images of toes feet ankle knee finger hand wrist elbow shoulder carotid artery inner ear and other parts of the body with similar structure can be taken 2 1 Contraindication All patient examinations are contraindicated with this system which is also contraindicated in the proximity of the MRI device according to the information provided by the manufacturer Furthermore the responsibility lies with the examining physician in case of unclear or critical clinical picture Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 7 Operating Principle 3 Operating Principle The Variety 16 Channel Multipurpose Coil described in this document has been de signed depending upon model type for use with a SIEMENS MRI system with field strength of 1 5T or 3T The coil system serves solely as a receiving coil for the reception of high frequency signals from the hydrogen H nuclei The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device The processing magnetization induces potential differences in the Variety 16 Channel Multipurpose Coil which are digitized and further processed in the MRT system Th
23. quently Visual marks do not have an impact on functionality As long as the user takes the intended use into consideration and pays attention to the warnings and measures specified in the user manual regarding the visual inspection of all components before each application there is no significant risk NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 5 General Information Please be sure to pay attention to and comply with the safety information and instructions of the MRI device manufacturer for operators patients and third parties Prescription use only Country specific laws restrict this device to sale by or on the order of a physician or with the descriptive designation of any other practitioner licensed by the law of the country in which he practices to use or order the use of the device This device may only be distributed to persons who are licensed practitioners or to persons who have a prescription or other order from a licensed practitioner to purchase it The coil must not be bent or be stored buckled Handling error can cause permanent damages of the device Variety 16 Channel Multipurpose Coil 1 5T 3T pr Oo d uc ts 6 Intended Use 2 Intended Use Indication for Use The intended use of the Variety 16 Channel Multipurpose Coil 1 5T and 3T is in conjunction with a Magnetic Resonance Scanner body imaging for diagnostic with a MRI system It is indicated for use as a diagn
24. rbeiten Ansicht Bild Extras Bl ttern Auswerung System Optionen Hilfe 2015 04 30 3rd Party Variety H Physikalisches N 40 10 1990 O 24Y STUDY 5 30 04 2015 15 46 41 10 IMA 1 1 IMF 1 00 TR 300 0 10 0 Tp SP P10 7 SL 3 0 FoV 300 300 256256 SAR NM D 30 04 2015 15 49 14 If the images produced during your measurement appear significantly different from the above e g the image contains band or one channel with a clearly weaker signal then a coil may be defective In this case please contact the NORAS MRI products GmbH A n u M Te F2 I i n N a Variety 16 Channel Multipurpose Coil 1 5T 3T Maintenance Storage and Waste Disposal 7 2 Storage When the Variety 16 Channel Multipurpose Coil is not in use we recommend that it be stored on the shelves provided for this purpose in MRT room 30 After use the device should be stored dry and at room temperature min 50 F 10 C max 86 F 30 C in a dust free UV radiation protected location e Relative Humidity Min 10 Max 95 e Air Pressure Min 500 hPa Max 1060 hPa The coil must not be bent or be stored buckled otherwise it can lead to coil loop breaking 7 3 Waste Disposal All of the materials used in the production of the system components can be conveniently recycled and therefore do not present any particular or unusual hazards during their disposal Prior to disposal the system mus
25. t be disinfected as described above to eliminate any risk of infection Disposal of Variety 16 Channel Multipurpose Coil are to be handed back to the manufacturer We would be happy to provide you with additional information about disposal upon request NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T p ro d uc ts 54 Technical Specification 8 Technical Specification 8 1 Historical Device Data Designation Model Type Product Type Device Type according to UMDNS DIMDI Variety 16 Channel Multipurpose Coil 1 5T Surface Coil MR 17 542 Variety 16 Channel Multipurpose Coil 3T Manufacturer Supplier NORAS MRI products GmbH NORAS MRI products GmbH Leibnizstrasse 4 Leibnizstrasse 4 97204 Hoechberg 97204 Hoechberg Germany Germany Operation Type Test Control Time Limits Type active non active Product Class Device Class Intended Use according to information ided by the Manufacturer lla MDD Annex IX Chapter PT Clause 3 Paragraph 3 2 Rule 10 2 x 8 channel coil system for diagnostic imaging in MRT Identification no of Notified Body Serial Number C Marking 1001 incremental 0123 NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T produc ts 99 Technical Specification 8 2 Performance Data Corresponding with the air conditioned room temperature of the MRI room ProtecionClass w Width approx 220 mm Height approx 35 mm Depth
26. ty service will be provided for damages due to improper disinfection Improper disinfection may result in malfunction of the device Danger of Destruction Non respect of the cleaning instructions may cause the destruction of the coils No warranty service will be provided for damages due to improper cleaning Improper cleaning may result in malfunction of the device NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T pr o d uc ts ga Cleaning and Disinfection Maintenance Inspection Damaged parts should be discarded and Testing All parts Visually inspect for damage and wear Storage Safe dry dust free and protected from light Constant temperature min 50 F 10 C max 86 F 30 C Constant air humidity min 10 max 95 Manufacturer Contact See Chapter 9 NORAS mrr products Variety 16 Channel Multipurpose Coil 1 5T 3T Maintenance Storage and Waste Disposal 7 Maintenance Storage and Waste Disposal Prior to each use all components of the Variety 16 Channel Multipurpose Coil must be visually inspected Cable and Plug Defective products must not be used In such a case please contact NORAS MRI products GmbH Comply with the cleaning and disinfection instructions We recommend that you have a single channel test of the coils performed on a monthly basis using the specified test program of the MRI system Injury of the patient Prior to each patient e
27. ully read and follow the instructions of this Operator s Manual and pay particular attention to the following information The Variety 16 Channel Multipurpose Coil can be used with the following MRI systems 117235 Variety 16 Channel Multipurpose Coil Avanto Espree Symphony a TIM 1 5T for SIEMENS Scanner system Aera 117234 Variety 16 Channel Multipurpose Coil Trio a TIM System Verio a TIM 3T for SIEMENS Scanner system Skyra Prisma lf you would like to receive up to date information about the further development or new accessories for your Variety 16 Channel Multipurpose Coil please send an e mail with the serial number of your coil to mri noras de Prior to using this device for patient examinations you should complete a training with the device using a phantom The application conditions have a major impact on the life time of the product Since these conditions can vary greatly from user to user an estimation of life time from our point of view is not possible The most important factors have to be considered are the frequency of use and the preparation processes cleaning disinfection and sterilization Especially for flex coils the frequency of use as well as the type of application e g bending radius depending on the anatomy to be examined have major influence on the life time of the coated printed circuit board inside the foam pad It is common with flexible coils that visual marks of use appear while using them fre
28. xamination a visual inspection of all components is mandatory In case of unusual findings and or damage the coil must not be used Damaged parts can be sharp edged and can cause injuries to the patient and or the user Do not use damaged coils and do not produce images with a defective coil NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T p roduc ts 46 Maintenance Storage and Waste Disposal 7 1 Functional Tests In case that coil malfunctions are suspected the operator may perform the functional test described below Initially place one coil half in the support cushion Fixate the coil tightly around the standard Siemens 2000ml phantom bottle by using a Velcro strip see picture below Prior to starting the functional test the coil connector has to be plugged in NORAS mrr Variety 16 Channel Multipurpose Coil 1 5T 3T pr oduc ts AT Maintenance Storage and Waste Disposal New patient registered Isocenter NORAS Variety NORAS Variety EM mR Se To prepare for the measurement first align the laser sight on the bottles centrally and transport the coil into the ISO center The following measurements have to be performed for both coil halves Variety 16 Channel Multipurpose Coil 1 5T 3T pr oduc ts 48 Maintenance Storage and Waste Disposal Take a normal localizer sequence measurement Subsequently a slice of the standard Siemens sn measuring sequen
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