Manual CC-OBC-O - Noras MRI products
Contents
1. Eccentric 114443 Fixationblock 112266 n a Operator s Manual 114901 n a NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oduc ts 39 Important Adresses 10 Important Adresses Manufacturer Development and Production NORAS MRI products GmbH Leibnizstrakse A 97204 Hoechberg Germany Phone 49 0 931 2 99 27 0 Fax 49 0 931 2 99 27 20 E Mail info noras de www noras de products NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 40 Training Outline 11 Training Outline have reviewed the Cranio Caudal Fixation Unit CC OBC O 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 Cranio Caudal Fixation Unit CC OBC O 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 Cranio caudal Fixation Unit CC OBC O and am aware of the components of the Cranio caudal Fixation Unit CC OBC O the installation of the Cranio caudal Fixation Unit CC OBC O the complete setup of the Cranio caudal Fixation Unit CC OBC O the application on patients the cleaning instructions the disinfection instructions that it is NOT NORAS responsibility for timely replacement of worn out parts NORAS mre Cranio caudal Fixation Unit C2. 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 NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 32 Wartung Lagerung und Entsorgung 8 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 must be disinfected as described above to eliminate any risk of infection Disposal of the Cranio caudal Fixation Unit CC OBC O is to be handed back to the manufacturer We would be happy to provide you with additional information about disposal upon request NORAS mre Cranio caudal Fixation Unit CC OBC O produc ts 33 Technical Specification 9 Technical Specification 9 1 Historical Device Data Model Type Cranio caudal Fixation Unit CC OBC O Manufacturer NORAS MRI products GmbH Leibnizstrake A 97204 Hoechberg Germany Operation Type activel non active X Product Class Device Class Class MDD Annex IX Chapter Ill Clause 1 Paragraph 1 1 1 4 Rule 1 and 4 Identification no of Notified Body C Marking NORAS Cranio caudal Fixation Unit CC OBC O Product Type Device Type according to UMDNS DIMDI Biopsy System Mammograpy 17 833 Supplier NORAS MRI products GmbH Leibnizstrake A
3. the operator and or the patient may be infected NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 30 Cleaning and Desinfection 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 10 NORAS mre Cranio caudal Fixation Unit CC OBC O produc ts 31 Maintenance Storage and Waste Disposal 8 Maintenance Storage and Waste Disposal 8 1 Maintenance Prior to each use all components of the Cranio caudal Fixation Unit CC OBC O must be visually inspected Check the immobilization and fixing unit for breaks or cracks Defective products must not be used In such a case please contact NORAS MRI products GmbH Comply with the cleaning and disinfection instructions Injury of the patient Prior to each patient examination 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 8 2 Storage After use the device should be stored dry and at room temperature 30 min 50 F 10 C max 86 F 30
4. 97204 Hoechberg Germany Test Control Time Limits Type Intended Purpose according to information provided by the Manufacturer Cranio caudal fixation of the female breast both breasts for MRI diagnostic examination Serial Number 1001 incremental MRI products 34 Technical Specification 9 2 Performance Data Operating Temperature Corresponding with the airconditioned room temperature of the MRI room Width approx 460 mm Height approx 140 mm Depth approx 160 mm NORAS mre Cranio caudal Fixation Unit CC OBC O produc ts 35 Technical Specification 9 3 Part List Cranio Caudal Fixation Unit CC OBC O 115011 consists of two units 9 4 Combination with other devices The Cranio caudal Fixation Unit CC OBC O may only be used in combination with those indicated in this Operator s 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 NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oduc ts 36 Technical Specification 9 5 Accessories ii i ES NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oduc ts 37 Technical Specification Handle Bar CC OBC O 114927 Breast Plate left 114930 Breast Plate right 114932 NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oduc ts 38 Technical Specification
5. pushed through the coil opening and attached to the fixing plate Fig 3 and 4 Fig 1 Plug the base plate in the coil NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oduc ts 17 Start Up Fig 2 Slid the fixing screws through the openings Fig 3 Insert both breast plates sidewise NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oduc ts 18 Start Up Fig 4 Turn the eccentric screw on the bottom side in order to position the device into the Insertion Plate Coil CCOO E asians NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oduc ts 19 Start Up You must move the plate with the push rod for fixation of the breast Fig 5 To determine the fixation of the breast you should tighten the screws by hand Fig 6 Fig 6 RI Follow the instructions of the breast coil s manufacturer NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oducts 20 Start Up Position the coil with the immobilization unit on the MRT table in compliance with the instructions of the MRT manufacturer 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 Correct Breast Immobilization The breast must be correctly immobilized Please check this If the breast is not imm
6. 0 0632 Temperature Limit Warning regarding risks that may result in minor physical injury or material damage 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 death or serious physical injury Information regarding the optimal use of the product NORAS mre Cranio caudal Fixation Unit CC OBC O produc ts 10 Device Description 4 1 1 Rating Plates 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 product and serial number on the plates Fees Ae CC OBC O Manufactured and distributed by Part No 114553 NORAS MRI products GmbH Leibnizstrasse 4 SN 1001 97204 Hoechberg Germany Rev 02 The rating plates are located on the bottom side of both plates pm i CC OBC O NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 11 Device Description 4 2 System Components The Cranio caudal Fixation Unit CC OBC O consists of the following components Handle Bar CC OBC O Guidance Bar CC OBC O Base Plate CC OBC O te Breast Plate CC OBC O left Breast Plate CC OBC O right Locking Screw CC OBC O NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oduc ts 12 Device Description The scaling on the base plate is not calibra
7. 1 Training Outline oe cise eee eiet eect erie eee cinde eet ne cees sn vedee tecedeceesecdencesyecteeteetee te 41 NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 3 Contents NORAS Jup Cranio caudal Fixation Unit CC OBC O p r oduc ts 4 General Information 1 General Information To ensure safe and trouble free operation of this high quality medical device please carefully read and follow the instructions in this Operator s Manual and pay particular attention to the following information The Cranio caudal Fixation Unit CC OBC O can only be used with the Invivo OBC O Breast Coil and for the vertical field MRI systems 0 2T up to 1T Patient injuries Place a sterile tissue on the base plate Not covering the base plate with a sterile tissue may lead to infection of the patient If you would like to receive up to date information about the further development or new accessories for your Cranio caudal Fixation Unit CC OBC O please send an e mail with the serial number of your coil to mri noras de The application conditions have a major impact on product life 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 in influencing product life are the frequency of application and processing method cleaning disinfection and sterilization As long as the user takes the intended use into consideration and p
8. C OBC O produc ts 41 Training Outline Date amp Signature E Mail Adress Contact Person 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 products 42 Cranio caudal Fixation Unit CC OBC O Notes NORAS mre Cranio caudal Fixation Unit CC OBC O produc ts 43 Notes NORAS mre Cranio caudal Fixation Unit CC OBC O produc ts 44
9. Q O M Q O O SG ED z x LL w O gt AN rf fe AN I O Cranio caudal Fixation Unit CC OBC O 115011 for Immobilization with the Invivo OBC O Breast Coil and for vertical field MR systems Operator s Manual Revision 03 CE NORAS mrr Date Issued June 2015 p r O d i C ts Technical changes reserved NORAS mrr Cranio caudal Fixation Unit CC OBC O p r odu C ts 2 Contents Contents 1 General Information ccccceeeeeceeecceeeeeeeeeeeeeeeeneeneeseeeeeecueneenseeeeeeeeneeneesaes 5 2 intended USC A A A H 3 Operating Principle E 8 4 DEV CE DISS Ci DU ON RE 9 41 Definitions EE 9 EN gl e EE 11 42 SysteemComponenis m m m m m 12 5 la H o eE 14 6 PROTOS d Le EE 22 6 1 MbR Mammograpby mm 22 02 ep N eeen E E E E A E AE EE E EA E 24 T CleaninganddDesinfection 1 0 ea aaa aaa 29 s WE e e NE KE EN MM AY YE e 27 PZ gg A NN A A E MN MY 28 8 Maintenance StorageandWasteDisposal 32 oT E gp e EE 32 Ce YA O A NE 32 SS TER S ae k 33 9 Technical Specificatlon NENNEN aaa aaa E RENE EN 34 2 NN PIStoncal Device Dala EN ee 34 92 Penomance EE 35 ame E A ee ee 36 9 4 Combinationwitihotherdevices 36 SEENEN 37 10 Important Adresses saiiniminieim n neminin la ik ll ein 40 1
10. al provided by NORAS is expressly prohibited 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 NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 15 Start Up 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 in addition to participation in training use a phantom 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 found the system must not be used Danger of destruction Pay attention to and comply with the cleaning and disinfection instructions contained in this Operator s Manual Chapter 7 Noncompliance with the instructions of the coil s manufacturer regarding the Cleaning Disinfecting and Sterilizing may destroy the coils NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 16 Start Up To compress the breast with the Cranio caudal Fixation Unit CC OBC O you can plug the base plate in the OBC O Breast Coil without the breast plate Fig 1 Following slid the fixing screws through the openings provided at the coil Fig 2 The breast plates are
11. ays 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 Cranio caudal Fixation Unit CC OBC O produc ts 5 General Information 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 NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oduc ts 6 Intended Use 2 Intended Use Intended Use Indication for Use The Cranio caudal Fixation Unit CC OBC O is a medical product and it is indicated for the cranio caudal fixation of the female breast The application must only be performed by trained medical personnel 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 e g breast implants heart pacemakers surgical metallic implants or similar objects Furthermore the responsibility lies with the examining physician in case of unclear or critical clinica
12. ipment Manual Detergent 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 RKI and the VAH can be used in accordance with the instructions on the label The cleaning of the parts could be done manually in immersion or ultrasonic bath for 10 30 minutes preferable at temperatures of up to 50 C Procedure 1 Rinse excess soil from components 2 Using soft brush apply detergent solution to all surfaces ensuring that hinged components are cleaned in both open and closed positions 3 The part is held under running water for 5 minutes In this case the running water must flow through the cannulas The blind holes must be repeatedly filled and emptied NORAS mre products Cranio caudal Fixation Unit CC OBC O 28 Cleaning and Desinfection 4 The parts must be cleaned as long as no visible blood or tissue residues more on the products to be seen For manual disinfection it is advisable to insert the parts for expected parts see left column in the solution immediately after use Ensure that the parts are completely sub merged in the solution Take the parts from the solution after the described time 15 minutes and rinse by water the quality of water must be at least equal to drinking water better would be using aqua Demineralized water Changing i
13. l picture 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 Cranio caudal Fixation Unit CC OBC O produc ts T Operating Principle 3 Operating Principle The immobilization of the breast in the OBC O Breast Coil occurs in cranio caudal access After a diagnostic examination with the Cranio Caudal Fixation Unit CC OBC O the MR guided breast biopsy wire localization of lesion and the minimal invasive intervention could take place with the help of Invivo OBC O Breast Coil for vertical field MRI systems NORAS mrr Cranio caudal Fixation Unit CC OBC O D r O du C ts Device Description 4 Device Description 4 1 Definitions and Symbols The following symbols are used on the Cranio caudal Fixation Unit CC OBC O and in this manual ISO 7000 2493 Item Number ISO 7000 2498 Serial Number o A ISO 7000 2497 Date of Manufacture j EN ISO 7000 1641 Operator s Manual ISO 7000 0434B Caution read the accompanying documents Directive Waste products should not be disposed of 2002 96 EC with household waste e g at a local authority collection point NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts Device Description This way u ISO 780 SR DIN 55402 ISO 7000 0621 Fragile handle with care ISO 7000 0626 Store in a dry place ISO 700
14. loosen the breast plates before withdrawing the mamma That way bruises or injuries to the patient can be avoided Danger of injury Before loosening and withdrawing the mamma you must remove all instruments If all instruments are not removed you may injure the breast of the patient NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 23 Application 6 2 Safety Information While using the Cranio caudal Fixation Unit CC OBC O please follow the below safety information Correct Breast Immobilization The breast must be correctly immobilized Please check this If the breast is not immobilized properly it might slip and the data delivered by the MRI will be incorrect Permanent damage to 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 NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 24 Cleaning and Desinfection 7 Cleaning and Desinfection Danger of destruction Regardless to the cleaning and disinfection instructions in this manual the cleaning instructions of the coil manufacturer are followed strictly Noncompliance with the cleaning instructions of the coils manufacturer may cause the destruction of the coils WARNINGS The instructions must be followed as described In case of inadeq
15. n color due to continuous disinfection cannot be excluded but can be largely prevented by sufficient rinsing after each use The solution is distributed on the surfaces by a fluff free cloth The disinfectant permeates the dirt particles and because of mechanical forces pressure abrasion this ensures effective cleaning Additionally the wiping motion ensures that spores which are resistant to the disinfectant will be re moved The cloth must be re placed 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 daily Follow the disinfection instructions of the OBC O Breast Coil NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 29 Cleaning and Desinfection Please always wear protective gloves and comply with the application times for Hepatitis B and HIV viruses See the instructions for use of the respective disinfectant solution As during the cleaning process leave the fixation unit in its individual parts so that optimum disinfection can be ensured Danger of destruction Improper disinfection may result in malfunction of the device Noncompliance with the disinfection instructions may destroy the system No warranty service will be provided for damages due to improper disinfection Danger of infection The instructions for disinfection must be followed In case of inadequate disinfection
16. obilized properly it might slip and the data delivered by the MRI will be incorrect NORAS mrr products 24 Cranio caudal Fixation Unit CC OBC O Application 6 Application 6 1 MR Mammography Permanent damage to 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 Following the imaging process in cranio caudal direction of two immobilization units for simultaneous diagnosis on the left and right mamma is shown e The Cranio caudal Fixation Unit must be assembled and inserted in the coil such as described in the chapter 5 Start up e Position the patient on the OBC O Breast Coil and immobilize the mamma to be examined by pressing the breast plates against the mamma on the variable position bars loosening or fixation of breast plates is done using the locking screws Be careful to ensure that the patient can lie as comfortable as possible during the entire procedure e Itis important to ensure that as much breast tissue as possible is engaged by the breast plates e Use the toolbox in your MRI for determination of ROI FOV and type of sequence imaging e Perform the MR mammographic procedure NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 22 Application Danger of bruising Be absolutely sure to
17. se The products should be transported in a closed container Preparation for No particular requirements Cleaning NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 26 Cleaning and Desinfection 7 1 Cleaning Immobilization and Fixing Unit Water bath possibly using a soft brush After each patient examination the Cranio caudal Fixation Unit CC OBC O must be cleaned as described above The products used should be cleaned within 30 minutes after use to minimize the danger of the drying of contaminants prior to cleaning We recommend that the components are cleaned immediately after the examination Disassemble the immobilization and fixing unit into its individual parts so that they can be thoroughly cleaned Do not use any scouring cleaning agents or due to possible material incompatibility any organic solvent or solvent containing cleaning agents e g cleaner s solvent alcohol stain remover Follow the cleaning instructions of the OBC O Breast Coil NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 27 Cleaning and Desinfection 7 2 Desinfection All components of the Cranio caudal Fixation Unit CC OBC O must be disinfected after each use Patient examinations may only be performed with disinfected components As during the cleaning process leave the fixation unit in its individual parts so that optimum disinfection can be ensured Cleaning Disinfection Equ
18. ted and should be seen as indicative Always two units will be provided NORAS mrr Cranio caudal Fixation Unit CC OBC O p r oducts 13 Start Up 5 Start Up The users must be trained before using the device Handling error can cause permanent damages of the device Staff Instruction The users must be trained before using the device detailed training of the personnel for existing components Only trained personnel may be assigned to handle the Cranio caudal Fixation Unit CC OBC O Handling error can cause permanent damages of the device Bodily injuries Only trained personnel may be assigned to handle the Cranio caudal Fixation Unit CC OBC O Operating errors may cause bodily injuries e g contusions to the user and or the patient NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 14 Start Up Danger of infection Prior to start up of the devices or parts thereof all components must be treated as described in chapter 7 Cleaning and Disinfection Noncompliance with the above instructions may lead to infection of the patient 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 Use of wrong components The use of components not listed and described in this Operators Manu
19. uate 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 GmbH NORAS mrr Cranio caudal Fixation Unit CC OBC O produc ts 25 Cleaning and Desinfection 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 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 Point of Use Remove excess soil with disposable cloth paper wipe Containment and No particular requirements It is recommended to reprocess the Transportation product as soon as possible after its u
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