Manual CPC 8-Ch Multipurpose Coil - Noras MRI products
Contents
1. eee 43 n D E wer ele E oc E 44 Te e A 48 GD e EE 48 8 Technical S5 DEC M GAtON rusu imes nasi me ma enem ECG endam 49 ol DEVE DNI PE PE RR EMARE 49 O Penone RT EE 50 oe WR E 51 9 important AdrESSEOS sirkesi dai ae yil A a al Alli 54 10 OperatorlrainingOutline 0 een 55 NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts Content NORAS mrr NORAS 8 Channel Multifunctional Coil CPC D ro duc ts 4 General Information 1 General Information To ensure safe and failure free operation of this high quality medical device please carefully read and follow the instructions of this Operator s Manual and pay particular attention to the following information e The CPC 8 Channel Multifunctional coil can be used with the following MRI systems MR8150 113471 Siemens 1 5T o Avanto Espree Sonata Symphony Aera MR8300 113495 Siemens 3T Trio Trio a Tim System Verio a Tim Sys tem Skyra Prisma e Prior to using this device for patient examinations you should complete a training with the device using a phantom e Take care that only the coils have direct contact with the skin of the patient The coil holder and the base plate have to be covered with clinic clothes cushion or a beanbag Bodily harm of the patient Prior to each use of the coil injured skin surface must be cov ered with sterile drapes e f you2. Resonance frequency 1 51 63 6 MHz 3 0T 123 2 MHz Interfaces Electrical SIEMENS MRI Mechanical MRI Patient Cradle Maximum Operating Time of Coils Continuous operation Technical Specifications CPC 8 Channel Multifunctional Coil consisting of two 4 channel arrays with integrated amplifiers CPC Type 1 5T 3 0T Frequency 63 6 MHz 123 2 MHz Penetration Depth per Coil System 130 mm 130mm NORAS NORAS 8 Channel Multifunctional Coil CPC MRI products 50 Technical Specification 8 3 Parts List CPC Coils Article No MR8150L left Left Coil for 1 5 Tesla Siemens MRI systems Article No MR8150R right Right Coil for 1 5 Tesla Siemens MRI systems Article No MR8300L left Left Coil for 3 Tesla Siemens MRI systems Article No MR8300R right Right Coil for 3 Tesla Siemens MRI systems NORAS Jup NORAS 8 Channel Multifunctional Coil CPC produc ts 54 Technical Specification CPC Coils with Retainer Ball Joint see Ball Joint Sets on the following pages Coil 1 5T right MR8150R Coil 3 0T right MR8300R Coil 1 5T left MR8150L Coil 3 0T left MR8300L Retainer with Scale 2x 113081 Retainer Slide Screw 2x 113083 Cable Bushing 113144 Spider consisting of Spider with Scale 1x 113096 Bracket 1x 113074 Height Adjustment Screw 1x 113084 Slide Screw 1x 113107 Base Plate 1x 111827 NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 52 Technical
3. after the described time 5 minutes and rinse by water the quality of water must be at least equal to drinking water better would be using aqua Demineral ized water Changing in color due to continu ous disinfection cannot be exclud ed but can be largely prevented by sufficient rinsing after each use NORAS mre products NORAS 8 Channel Multifunctional Coil CPC ball joint screw clamping Ball joint set 3 consist ing of ball joint screw ball joint holder plate 38 Cleaning Disinfection and Sterilization When drying is achieved as part of washer disinfector cycle do not exceed 50 C Maintenance _Inspec Blunt or damaged parts should be tion and Testing discarded Hinged parts Check for smooth movement of hinge with out excessive play Locking ratchet mechanism should be checked for action All parts Visu ally inspect for damage and wear Cutting edges should be free of nicks and present a continuous edge Check components with long slender features particularly rotating components for distortion Where components form part of a larger assembly check assembly with mating components Singly A standard packaging ma terial may be used Ensure that the pack is large enough to contain the instrument without stressing the In sets The parts may be loadec into dedicated instrument trays o general purpose sterilization trays Ensure that cutting edges are pro tected and do not
4. echo sequence axially centered through the bot tles You can find this sequence under Siemens Sequence Region Siemens Sequenc es Default Protocols gre et T o zap garaiz A E UT Tele He Ul E Utd L PLL Aur Woes RS mm VS SSES Wa VIDE to eI yr er er se L ET i m f Sequence Siemens Sequence Region Siemens Sequences Default Protocols gre NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 45 Maintenance Storage and Waste Disposal Choose the option save uncombined Patent Atyweadiigen Trersfe cearkecen vy lange Protokell Ansicht ile We e auswertune Cazen 1 acdOn LD nen ie nyons 9juf 3 lal bala al lala 3 lal ba ala al halal pr ti D Sg L gt ogl z2r 2101 g reis 2007 07 05 01 01 1990 TA 0 14 PM RCT DAT Aus Voxelgrohe 2 9 2 9 5 0 mm Re Uberishmer Asbrazin FDS Justagen Sundur Er sr Uruk vrun speise LecaierStat 00 YI bos tionierungs Modus Fer Maz spula cers Suto CHI gre li3z1 3353tion In Sarak nba ui Sal alsurrr Teel pesiliunsyedactiinis IF l Bildnummenerung MENA lt T E Sayia H cet Coronar A zz Tratzoktad F gt gt A L LU J f ee SISA ii Routin Arin Genmetrir Inline Sequenz 3209799797 enqec 15 17 7117 12 5355 N t r E i Watan au Sc ich lt os iion erun save uncombined Now you can start the measurement MRI NORAS 8 Channel Multifunctional Coil CPC produc ts 4
5. would like to receive up to date information about the further development of our new accessories for your CPC 8 Channel Multifunctional Coil please send an e mail with the serial number of your coil to mri noras de NORAS mrr NORAS 8 Channel Multifunctional Coil CPC pr od ucts 5 General Information e 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 In case of inflexible coils the influence parameters are especially the reprocessing and the mechanical wear of moving parts The reprocessing may cause only a discoloration of the material which has no influ ence on the material properties and the lifetime The mechanical wear again de pends on the frequency of application and cannot assess quantitatively due to above mentioned reasons e 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 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 part
6. 6 Maintenance Storage and Waste Disposal If the signal of each channel is shown approximately following result should arise mee jarsic 200 705 combined signal The illustration shows that eight coil channels are producing a good quality artifact free signal The picture down to the right shows the combined signal 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 SST Bi Ei V S as m eg y T E WK it d l H j k SH d ZS d d BR WW gt dP SE 2 m SW f 4 _ gt E i ie we ees ge ig a e SL oe Ga NORAS 8 Channel Multifunctional Coil CPC oldelelilaeads co VW Tse Gg kl kaf WK dp E en d A vb ra m See Pky Sen Wieder ey See A Ki S pian A Gi Geh E Maintenance Storage and Waste Disposal 7 2 Storage When the CPC 8 Channel Multifunctional 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 10 C max 30 C in a dust free UV radiation protected loca tion e Relative Humidity Min 10 Max 95 e Air Pressure Min 500 hPa Max 1060 hPa 7 3 Waste Disposal All of the materials used in the production of the syste
7. 8 Ch Multifunctional Coil Clothespincoil CPC for Diagnostic Imaging with Siemens MR8150 113471 MR8300 113495 Operator s Manual Revision 05 O O fe O C O 5 Ko C D E SS 00 Y ef oO O L NORAS mr Date Issued May 2015 p r O d u C ts Technical changes reserved NORAS mrr NORAS 8 Channel Multifunctional Coil CPC pr od ucts 2 Content Content 1 General Information ccccccceeceeceeeceeeeeeeeeeeeeeeesenseenseneeneeneeaeenseneeeeseeeas 5 2 Inteended sel indicationforU se 7 Zo AP ge EE ZZ GORI GIC AON ce dace akaid Sabi O kl Bnb nl nana 8 3 Operating Nd Te ein Game alanla anan nan damladan 9 Det lt lt e pe lt A E MRP EE YE EYE ER EM 9 4 DEVICE DESC DELO N BN 10 Ad I CTIMINOMS and VAIO ONS eeror nEn E EEE EEE 10 e SC a Bern ee un CC 13 43 CombinationwitihotherDevices 14 5 Gin ET AR EN 17 Sek Elle 23 5 1 1 InstallationwithRetainersandSpider 23 5 1 2 Installation witihRetainers 28 Safetyinformation eee 32 6 Cleaning DisinfectionandsSterilization 33 7 Maintenance StorageandWasteDisposal 43 Tl VVC Un Le 43 7 1 1 General Maintenance
8. PC 8 Channel Multifunctional Coil by NORAS MRI products or its responsible company representatives This coil may only be used in combination with accessories supplied by NORAS MRI products You may only use this coil with accessories supplied by other manufacturers with the express written approval of NORAS MRI products Do not use a coil showing visible damage to the housing or its connection ca bles The CPC 8 Channel Multifunctional Coil must not be opened by the user In case of proper use all materials subject no significant wear NORAS mre NORAS 8 Channel Multifunctional Coil CPC produc ts 32 Cleaning Disinfection and Sterilization 6 Cleaning Disinfection and Sterilization WARNINGS Limitations on processing NORAS 8 Channel Multifunctional Coil CPC 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 dam ages 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 re Frequent processing can have an impact on these prod ucts color changes but do not af
9. Specification Ball Joint Set 1 MR8030 consisting of Ball Joint Holder 113116 2 Ball Joint Inner Parts 113117 Ball Joint Set 2 MR8031 consisting of Ball Joint Ball 113114 Ball Joint Locking Nut 113115 m Ball Joint Clamping Screw 113118 Ball Joint Set 3 MR8032 consisting of Ball Joint Screw 111831 Ball Joint Holder Plate 111833 NORAS mrr NORAS 8 Channel Multifunctional Coil CPC D ro duc ts 53 Important Adresses 9 Important Adresses Manufacturer Development and Production NORAS MRI products GmbH eibnizstraRe A 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 www noras de NORAS mrr NORAS 8 Channel Multifunctional Coil CPC D ro duc ts 5A Operator Training Outline 10 Operator Training Outline have reviewed the NORAS 8 Channel Multifunctional Coil Clothespincoil CPC and understood the topics discussed and verify that the training outlined is co The training delivered was reflective of the details in the NORAS 8 Channel Multi functional Coil Clothespincoil CPC will read or have read this appropriate manu al including the Cleaning Disinfecting and Sterilization section of the manual understand the intended use and the functionality of the NORAS 8 Channel Multi functional Coil Clothespincoil CPC and am aware of the components of the 8 Channel Multifunctio
10. aining The data regarding the test performance and its results must be recorded in the medical devices log book NORAS mrr NORAS 8 Channel Multifunctional Coil CPC D ro duc ts 43 Maintenance Storage and Waste Disposal 7 1 2 Functional Tests In case that coil malfunctions are suspected the operator may perform the functional test described below Insert the standard Siemens 21 phantom bottles into the coil as shown on the illustra tion and connect the coil to the MRI scanner Pay attention that the coils are parallel and straight as shown in the picture below Make sure the bottles are positioned in the center of the coils To prepare for the measurement first align the laser sight on the bottles centrally and transport the coil into the iso center Position the ch Multi Function coil Noras and the plastic bottle 2000 ml in the center of the measurement field as shown on the picture below Take care that cable outlets are positioned as in the picture Position the laser marker at the middle of the phantom and along scale position 3 of the coil holder All the yi a the end stop Bel Scale Position gt i J Scale Position AS All the way to the end ston NORAS mrr NORAS 8 Channel Multifunctional Coil CPC D roduc ts AA Maintenance Storage and Waste Disposal Take a normal localizer sequence measurement and then position the slice of a standard Siemens ore gradient
11. and then fix these in position with the ball joint locking nuts 3 After loosening the ball joint clamping screws 4 the coils can be pivotally moved To look the coils in place tighten the ball joint clamping screws by hand Using the scales on both retainers it is to advice to adjust the coils in the same height and in a distance between 4 cm min to 20 cm max in the same parallel position NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 30 Start up Prolongation of the examination Take care that all screws are tighten by hand Nonobservance can cause a prolongation of the examination Diagnostic Application Fields Retainers with Vacuum Immobilization Mat available as an option Orthopaedic medical imaging Knee ankle toes NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 31 Start up Safety Information The CPC 8 Channel Multifunctional Coil is not suited for operation in areas subject to explosive hazards in the presence of inflammable anaesthetics or combustible gases such as anaesthetics The CPC 8 Channel Multifunctional Coil has been designed for use with a MRI device in the special examination room provided for it climate controlled electrically shielded It may only be used by medical technical personnel who are familiar with the op erating principle of the MRI device and who have been instructed in the function and use of the C
12. ation of the examination Take care that all screws are tighten by hand Nonobservance can cause a prolongation of the examination Diagnostic Application Fields Retainers and Spider Internal medical imaging Inner ear carotid artery jaw bone NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 27 Start up 5 1 2 Installation with Retainers The installation is performed in the following steps Step 1 Install retainers on the base plate Step 2 Attach coils NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 28 Start up Step 1 Install retainers on the base plate 1 Base Plate 2 Retainer 3 Retainer Slide Screw Install both retainers 2 on the base plate 1 by pushing each retainer into one of the guide rails of the base plate Always ensure that both retainers are aligned in such a way that the inwardly curved side of each retainer faces the other retainer Fix the retainers in place with the retainer slide screws 3 Prolongation of the examination Take care that the base plate is flat on the patient table Nonobservance can cause a prolongation of the examination NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 29 step 2 Attach coils 4 3 1 Coil 2 Retainer 3 Ball Joint Locking Nut outer 4 Ball Joint Clamping Screw inner Attach one coil 1 each to the left and right retainer 2
13. conventional coils during the examination of patients with rheumatic disease and restricted mobility 3 1 Safety Concept The CPC 8 Channel Multifunctional 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 NORAS 8 Channel Multifunctional Coil CPC pr od ucts 9 Device Description 4 Device Description 4 1 Definitions and Symbols The following symbols are used on the CPC 8 Channel Multifunctional Coil or in the Operator s Manual ISO 7000 2493 Item Number Bn nd ISO 7000 2497 Date of Manufacture EN ISO 7010 M002 Operator s Manual Differ to the requirements of EN ISO 701 M002 all laser engravings can only be executed in grey 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 NORAS 8 Channel Multifunctional Coil CPC pr od ucts 10 Device Description Directive 2002 96 EC Waste products should not be disposed of with household waste e g at a local authority collection point ISO 780 This way up DIN 55402 ISO 7000 0621 Fragile handle with care ISO 7000 0626 Store in a dry place ISO 7000 0632 Temperature Limit Conforms with he essential requirements of Mai Directive 93 42 EEC of 14 June 1993 concerning medical devices Warning regardi
14. e alkaline de tergent such as Neodisher MediClean forte 0 2 to 1 0 vol 2 10 mill Dr Weigert at 50 60 C For this purpose all agents which have been approved and released by the Robert Koch Insti tute RKI can be used in accord ance with the instructions on their labels Procedure 1 Load the components such that hinges are open and cannulas and holes can drain 2 Run cycle wash minimum 5 minutes and rinse 5 minutes 3 When removing the parts check the cannulas holes etc for visible soil If necessary repeat the cycle or clean the parts manually Equipment Detergent Example alkaline de tergent such as Neodisher MediClean forte 0 2 to 1 0 vol 2 10 mill Dr Weigert at 50 60 C For this purpose all agents which have been approved and released by the Robert Koch Insti tute RKI can be used in accord ance with the instructions on their labels NORAS mre products NORAS 8 Channel Multifunctional Coil CPC Only for Mounting rack ball joint retainers with scale bracket height adjustment screw slide screw base plate Ball joint set 1 consist ing of ball joint holder and ball joint inner parts Ball joint set 2 consist ing of ball joint ball ball joint locking nut ball joint clamping screw Ball joint set 3 consist ing of ball joint screw ball joint holder plate Only for Mounting rack ball joint retainers with scale bracket height adjus
15. ection instructions may cause the de struction of the coils No warranty service will be provided for damages due to im proper disinfection Improper disinfection may result in malfunc tion of the device NORAS mrr NORAS 8 Channel Multifunctional Coil CPC products 41 Cleaning Disinfection and Sterilization Danger of Destruction No warranty service will be provided for damages due to im proper sterilization Non respect of the sterilization instructions may cause the de struction of the system Steam sterilization will destroy the coils The sterilization agent can cause variations in terms of color This has no influence on the quality of the product NORAS mrr NORAS 8 Channel Multifunctional Coil CPC products 42 Maintenance Storage and Waste Disposal 7 Maintenance Storage and Waste Disposal 7 1 Maintenance 7 1 1 General Maintenance Prior to each use all components of the CPC 8 Channel Multifunctional Coil must be visually inspected The coils and all parts have to be tested regarding breaks and cracks Defective products must not be used In such a case please contact the NORAS MRI products Service Department Comply with the cleaning disinfection and sterilization 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 as described and shown during the product tr
16. ector Symphony The shield trap should lay as parallel as possible to the magnet bore and not verti cal Shield Trap NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 20 Start up While plugging in the coil pair ensure and check that proper contact has been made External Burns of the End User Avoid direct contact between the coil cable and the patient and or place come absorbent natural fiber cloths between the pa tient and the cable In exceptional cases the coil cable may become very warm The CPC 8 Channel Multifunctional Coil is recognized by the MRI software The software operation is described in the SIEMENS MRI Operator s Manual 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 NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 24 Start up Fig a c RX Connector Symphony 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 de G32 G38 struction of the coils To avoid reduced quality image use the scales on both retain ers It is to advice to adjust the coils in a distance between O Mik cm min to 15 cm max in the same parallel position Take care that the coi
17. equest Be j MRI NORAS 8 Channel Multifunctional Coil CPC produc ts 15 Device Description Bodily Harm For patient comfort we recommend the use of cushions or beanbags that are attached to your MRI System Operating errors may cause bodily injuries to the end user Bodily Harm Also MR compatible accessories can cause injuries to the pa tient and or the user Please follow the instructions of the acces sory manufacturer Non compliance with these instructions may lead to injuries of the user and or patient The CPC 8 channel Multifunctional Coil may only be used in combination with those indicated in this Operator s Manual and included devices and coils of NORAS MRI products GmbH ac cessories Use of other accessories is permitted only with written approval by the NORAS MRI products GmbH NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 16 Start up 5 Start up Device Damage Coil Error Only trained personnel may be assigned to handle the CPC 8 Channel Multifunctional Coil Operating errors may cause permanent damages to the device G24 G37 coil Device Damage Coil Error The users must be trained before using the device detailed training of the personnel for existing components Bodily Harm Only trained personnel may be assigned to handle the CPC 8 Channel Multifunctional Coil Operating errors may cause bodily injuries e g contus
18. exceed the max imum loading per tray Wrap the trays using appropriate method NORAS mre NORAS 8 Channel Multifunctional Coil CPC D ro duc ts 39 Cleaning Disinfection and Sterilization Sterilization Hydrogen Peroxide Gas Plasma Sterilization The CPC coils 114371 amp 114395 may be only STERRAD procedure Sterilized according to STERRAD 100S pro Only the following items may be cedures subjected to STERRAD steriliza tion gt P008 CPC coils Procedure STERRAD 1008 7 cycles Total cycle time 55 minutes Cycle Temperature Less than 131 F 55 C Storage No special requirements E Additional Informati When sterilizing multiple instruments in one autoclave cy on cle ensure that the sterilizer s maximum load is not ex ceeded Manufacturer See chapter 9 Contact NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts A0 Cleaning Disinfection and Sterilization 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 de struction of the coils Please always wear protective gloves and comply with the ap plication times for Hepatitis B and HI viruses See the instruc tions for use of the respective disinfectant solution Danger of Destruction The coils must not be cleaned in immersion baths or held under running water Non respect of the disinf
19. fect the function of the product Bodily Harm Prior to start up the coils operators must be informed of the cleaning disinfection and sterilization requirements of the com ponents Operating errors may cause bodily injuries to the end user NORAS mrr products 33 Cleaning Disinfection and Sterilization Please always wear protective gloves and comply with the ap plication times for Hepatitis B and HI viruses See the instruc tions for use of the respective disinfectant solution INSTRUCTIONS Individual parts Point of Use Remove excess soil with disposa ble cloth paper wipe Containment and No particular requirements It is Transportation recommended to reprocess the product as soon as possible after its use Preparation for Clean No particular requirements If nec ing essary the assembly must be dismantled in its individual compo nents NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 34 Cleaning Disinfection and Sterilization Automated Cleaning Al parts can be cleaned automatically excepted the following coil cables and plugs CPC coils right left coil cover Manual Cleaning Coil cables and plugs CPC coils may not be cleaned in immersion baths and may not be held under running wa ter The mentioned prod ucts above can be wiped cleaned with a moistened cloth solu Equipment Washer disinfector Detergent Exampl
20. he solution immediately after use NORAS mre products NORAS 8 Channel Multifunctional Coil CPC Only for Mounting rack ball joint retainers with scale bracket height adjustment screw slide screw base plate Ball joint set 1 consist ing of ball joint holder and ball joint inner parts Ball joint set 2 consist ing of ball joint ball ball joint locking nut ball joint clamping Screw Ball joint set 3 consist ing of ball joint screw ball joint holder plate Only for Mounting rack ball joint retainers with scale bracket height adjustment screw slide screw base plate Ball joint set 1 consist ing of ball joint holder and ball joint inner parts Ball joint set 2 consist ing of ball joint ball ball joint locking nut 37 Cleaning Disinfection and Sterilization The solution is distribut ed on the surfaces by a cloth The disinfectant permeates the dirt parti cles and because of mechanical forces pressure abrasion this ensures effective cleaning Additionally the wiping motion ensures that the spores which are re sistant to the disinfect ant will be removed The cloth must be re placed after the disinfec tion in order to prevent the spreading of the spores on other areas Moreover it is essential that the wiping solution is renewed regularly Ensure that the parts are com pletely submerged in the solution Take the parts from the solution
21. ies 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 li censed practioners or to persons who have a prescription or other order from a licensed practioner to purchase it NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 6 Intended Use Indication for Use 2 Intended Use Indication for Use The CPC 8 Channel Multifunctional Coil Clothespin Coil 1 5T Model No 113471 and 3T Model No 113495 has been designed for diagnostic imaging with an MRI system Image similiar 2 1 Function Diagnostic imaging with an MRI system for detection of lesions and other clinical pic tures NORAS mrr NORAS 8 Channel Multifunctional Coil CPC pr oduc ts Intended Use Indication for Use 2 2 Contraindication All patient examinations are contraindicated with this system which is also contraindi cated 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 Please be sure to pay attention to and comply with the safety information and instructions of the MRI device manufactu
22. ions to the user and or end user 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 NORAS mrr NORAS 8 Channel Multifunctional Coil CPC pr od ucts 17 Start up Incorrect handling can cause damage to the coil and to the connection cables 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 a training with the system but also train with a phantom to become fa miliar with its use NORAS mre NORAS 8 Channel Multifunctional Coil CPC produc ts 18 Coil installation Start up Bodily Harm of the End User Prior to each patient examination you should make a careful visual inspection of the system components In the case of un usual findings and or damage found the system must not be used Damaged coils must not be used Do not produce images with a defective coil g Patient is lying on the patient table of the MRI system d Coil coil pair has been installed as de scribed Plug in both coil plugs in the connections provided for them in the MRI patient table While plugging in the coil pair ensure and check that proper contact has been made NORAS mrr NORAS 8 Channel Multifunctional Coil CPC products Fig a c RX Conn
23. ls are parallel adjusted and the phase coding is perpendicularly to the coil level NORAS mrer NORAS 8 Channel Multifunctional Coil CPC produc ts 22 Start up 5 1 Installation 5 1 1 Installation with Retainers and Spider The installation of the coil arm and spider is performed in the following steps Step 1 Install bracket with spider Step 2 Install retainers Step 3 Attach coils NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 23 Start up Step 1 Install bracket with spider 4 6 5 3 1 1 Base Plate 5 Height Adjustment Screw 2 Slide with Bracket 6 Rotation Nut 3 Slide Screw 7 Rotation Bolt 4 Spider Position the slide with bracket 2 on the base plate 1 by pushing the slide of the bracket into the slide rails of the base plate Always push the slide all the way into the guide rails of the base plate The spider 4 for fastening and aligning the retainers has already been factory in stalled on the bracket Fix the slide with bracket to the base plate using the slide screw 3 Tighten the height adjustment screw 5 and the rotation nut 6 on the bracket by hand By doing so the spider can be rotated Prolongation of the examination Take care that the base plate is flat on the patient table Nonobservance can cause a prolongation of the examination NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 24 Start up s
24. m components can be conven iently recycled and therefore do not present any particular or unusual hazards during their disposal Prior to disposal the system must be disinfected as described above to eliminate any risk of infection Disposal of CPC 8 Channel Multifunctional Coil are to be handed back to the man ufacturer We would be happy to provide you with additional information about disposal upon request NORAS mre NORAS 8 Channel Multifunctional Coil CPC produc ts 48 Technical Specification 8 Technical Specification 8 1 Device Data Designation Model Type Product Type Device Type according to UMDNS DIMDI 8Ch Multifunctional Coil CPC Surface coil MR 17 542 1 5T 113471 3T 113495 Manufacturer NORAS MRI products GmbH Leibnizstrasse 4 97204 Hoechberg products Germany Device Type Test Control Time limit Type activex non activel_ Product Class Device Class Intended Purpose according to Infor mation provided by the Manufacturer Class Ila MDD Annex IX Chapter III Clause 3 Paragraph 3 2 Rule 10 2 x 4 channel coil system for diagnostic imaging in MRT Identification no of Notified Body Serial Number Marking 0123 NORAS mrr NORAS 8 Channel Multifunctional Coil CPC p ro duc ts 49 Technical Specification 8 2 Performance Data Operating Temperature Corresponding with the air conditioned room temperature of the MRI room
25. nal Coil Clothespincoil CPC the installation of the 8 Channel Multifunctional Coil Clothespincoil CPC the set up of the 8 Channel Multifunctional Coil Clothespincoil CPC the connection with the MRI system the intended use of the medical device the cleaning instruction the disinfection instruction the sterilization instruction that it is NOT NORAS responsibility for timely replacement of worn out parts NORAS mre NORAS 8 Channel Multifunctional Coil CPC pr od ucts 55 Operator Training Outline Date and Signa ture E Mail Address Contact Person Phone No w OOOO Trained by NORAS Application Trainer Date and Signa ture NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 56 Your Notes NORAS mre NORAS 8 Channel Multifunctional Coil CPC produc ts 57 Your Notes NORAS mre NORAS 8 Channel Multifunctional Coil CPC produc ts 58
26. ng 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 _ 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 mre NORAS 8 Channel Multifunctional Coil CPC produc ts 11 Device Description Rating Plates Coils The rating plate is located on the rear side of the coil Image similar Base Plate The rating plate is located on the bottom side of the base plate Image similar NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 12 Device Description 4 2 System Components Coils Retainer Various Plugs 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 NORAS mrr NORAS 8 Channel Multifunctional Coil CPC D roduc ts 13 Device Description 4 3 Combination with other Devices The CPC 8 Channel Multifunctional coil can be used with the following MRT sys tems Siemens 1 5T Avanto Espree Sonata Symphony Aera Siemens 3 0T Trio Trioa Tim System Verio a Tim System Skyra Prisma Vacuum Immobilizati
27. on Mats We offer different Vacuum Immobilization Mats which are easy to handle and thanks to its chamber system always ensure stable immobilization of the patient in the MRI unit The mats are compatible with all magnetic resonance imaging units and do not cause any artefacts Our mats are available in many different forms and sizes The Vacuum Fixation Mat is filled with a high quality micro granulate which cannot slip and therefore also permits fixation in a vertical position Even the sliding of the pump hose does not cause any vacuum loss Thanks to the adaptor provided with the Fixation Mat the latter can be connected to all customary vacuum pumps The form which is simultaneously compact and comfortable offers a very high lateral and longitudinal stability The Vacuum Fixation Mat can be used as a fixation support for foot ankle knee wrist elbow head and babies The Vacuum Fixation Mats are not allowed to get in contact with open wounds or sensitive skin areas We recommend an intermediate located biocompatible blanket MRI NORAS 8 Channel Multifunctional Coil CPC produc ts 14 Device Description MRI Trolley The NORAS MRI Trolley is an equipment vehicle ideal for the MRT area It serves as storage option for our CPC 8 channel Multifunctional Coil It offers beside its usa ble work surface a lot of additional storage space and a vacuum pump for the use of our Vacuum Fixation Mats We build this Trolley on your r
28. rer for operators patients and third parties NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 8 Operating Principle 3 Operating Principle The CPC 8 Channel Multifunctional Coil described in this document has been de signed depending upon model type for use with a MRI system with a 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 in duced into precession by the transmitting coil of the MRT device The precessing magnetization induces potential differences in the CPC 8 Channel Multifunctional Coil which are digitized and further processed in the MRI system Thanks 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 ar tery jaw bone or in the orthopedic field of the finger wrist elbow shoulder knee ankle or toes Parallel diagnostic imaging procedures are made possible by the two 4 channel ar rays facing each other on the coil which are able to accelerate diagnostic imaging or increase resolution The wide range of coil positioning possibilities enables the per formance of motion studies such as the imaging of an elbow in stretched and inflect ed positions With its accessibility in three axes the CPC 8 Channel Multifunctional Coil offers significant advantages vs
29. tep 2 Install retainers 1 1 2 1 Retainer 2 Spider 3 Retainer Slide Screw Now push on retainer 1 each into the guide rail on the left and right side of the spi der 2 and fix them in position with the corresponding retainer slide screw 3 Using the scale on both sides of the spider you can adjust the distance between the two retainers Tighten the retainer slide screws on the spider by hand The scale on the spider has not been calibrated and therefore is only used for ap proximate positioning Prolongation of the examination Take care that the guide rail is pushed in completely Nonobservance can cause a prolongation of the examination NORAS mrr NORAS 8 Channel Multifunctional Coil CPC produc ts 25 Start up Step 3 Attach coils 1 2 3 4 2 Coil Retainer Ball Joint Locking Nut outer Ball Joint Clamping Screw inner Attach one coil 1 each to the left and right retainer 2 and then fix these in position with the ball joint locking nuts 3 After loosening the ball joint clamping screws 4 the coils can be pivotally moved To lock the coil in place tighten the ball joint clamping screw by hand Using the scales on both retainers it is to advice to adjust the coils in a distance be tween 0 cm min to 15 cm max in the same parallel position NORAS mrr NORAS 8 Channel Multifunctional Coil CPC products 26 Start up Prolong
30. tion and Sterilization Automated Disinfec tion All parts can be cleaned automatically excepted the following coil cables and plugs CPC coils right left coil cover Manual Disinfection Coil cables and plugs CPC coils may not be disinfected in immersion baths and may not be held under running wa ter The mentioned products above can be wiped disinfected with a mois tened cloth solution of 30 of the above men tioned disinfectant and 70 water Disinfectant example Sekusept PLUS Ecolab 4 0 vol 3 0 vol Korsolex Plus with ex posure 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 Procedure lf automated disinfecting is em ployed a final rinse at 50 C for 5 minutes may be used to effect thermal disinfection The assembly should be dis assembled into its individual components so that an optimal disinfection is guaranteed Disinfectant example Sekusept PLUS Ecolab 4 0 vol 3 0 vol Korsolex Plus with ex posure 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 Procedure For manual disinfection it is ad visable to insert the parts in t
31. tment screw slide screw base plate Ball joint set 1 consist ing of ball joint holder and ball joint inner parts 35 Cleaning Disinfection and Sterilization tion of 30 of the above mentioned cleaning agent and 70 water Du to possible material incompatibility abra sive cleaners or other organic solvents and solvent based cleaning agent e g benzene alcohol stain removers may not be used The cleaning of the parts could be Ball joint set 2 consist done manually in immersion orling of ball joint ball ultrasonic bath for 5 10 minutes preferably at temperatures of up to 50 C Procedure 1 Rinse excess soil from compo nents 2 Using soft brush apply deter gent solution to all surfaces ensur ing that hinged components are cleaned in both open and closed positions Note Clean cannulas and holes using an appropriate brush ensur ing that full depth of the feature is reached 3 Rinse under clean running wa ter for 5 minutes Ensure that running water passes through cannulas and that blind holes are repeatedly filled and exhausted 4 The parts must be cleaned as long as no viewable blood or tis sue residues are visible on the products NORAS mre products NORAS 8 Channel Multifunctional Coil CPC ball joint locking nut ball joint clamping screw Ball joint set 3 consist ing of ball joint screw ball joint holder plate 36 Cleaning Disinfec
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