IGC-MEDICAL ADVANCES INC. QUADRATURE LOWER
Contents
1. Patients who work in environments in which there is a risk of having embedded metallic fragments in or near the eye should be carefully screened before having an MR exam SAFETY EMERGENCY PROCEDURES 1 3 In the unlikely event that a coil creates smoke sparks or makes an unusually loud noise or if the patient requires emergency assistance l 2 Stop the scan if one is in progress Disconnect the coil Remove the coil from the patient Remove the patient from the scan room if medical treatment is needed Contact IGC Medical Advances Inc as soon as possible to inform us about the details of the incident M473PH 64A Rev 1 COIL INSTRUCTIONS 2 1 SHIPPING LIST Table 2 1 lists the Quadrature Lower Extremity Coil parts Check that all parts have been shipped TABLE 2 1 SHIPPING LIST FOR THE QUADRATURE LOWER EXTREMITY COIL QTY ITEM PART NO 1 Quadrature Lower Extremity Coil 19700P1 1 Foot Support Pad 14626 1 Leg Foot Support 14627 1 1 1 Phantom Bottle contains NaCl amp 19829 CuSO4 5H20 MSDS 10818 Tips Sheet 19706 1 Operator s Manual M473PH 64A The use of the Quadrature Lower Extremity Coil requires the Philips cable trap Figure 2 1 For more information please contact your Philips representative Figure 2 1 M473PH 64A Rev 1 Quadrature Lower Extremity Coil COIL INSTRUCTIONS The Quadrature Lower Extremity Coil is comprised of a coil a positioning base and a set of pos2. IGC MEDICAL ADVANCES INC QUADRATURE LOWER EXTREMITY COIL 473PH 64A Compatible with Philips Gyroscan NT and Intera 1 5T MRI Systems 05 25 04 Rev l Federal Law restricts this device to sale distribution and use by or on the order of a physician Proper performance of this coil is guaranteed only while the coil is being used on the MR system hardware software level specified at the time of purchase Upgrades or other modifications to the system software and or hardware may affect compatibility Prior to upgrading your MR system please contact IGC Medical Advances Inc Customer Service Department to discuss coil compatibility issues Failure to do so may void your warranty US Headquarters IGC Medical Advances Inc 10437 Innovation Drive Milwaukee WI 53226 4815 USA 414 258 3808 800 657 0891 Fax 414 258 4931 E mail mrcoils medadv com Web www medadv com A subsidiary of Intermagnetics General Corporation NOTICE A Attention Consult Accompanying Documents TRANSPORT AND STORE THIS PRODUCT UNDER Type BF Equipment 0 Class II Equipment C Conforms to European Medical Device Directive 93 42 EEC Non Condensing 0086 THE FOLLOWING ENVIRONMENTAL CONDITIONS ONLY FOR A PERIOD NOT EXCEEDING 4 WEEKS AMBIENT TEMPERATURE OF 34 C TO 60 C RELATIVE HUMIDITY OF 15 TO 95 ATMOSPHERIC PRESSURE OF 765hPa TO 101 1hPa M473PH 64A Rev 1 CONTENTS Safety Coil Instructions Quality
3. Assurance Patient Preparation amp Positioning Protocols Troubleshooting Maintenance 1 Train engines Mesh et 1 1 QUAY Assurance use 1 1 A ON 1 1 ContramdicatiO se 1 1 PEE CAUTIONS ari is 1 1 CAMA na 1 2 Emergency Prodi e 1 3 Shipping A ne 2 1 Coil DESCHB MON lot 2 2 Pad Description ats ei arsch 2 2 OT Positioning er reellen 2 3 System Coll Connection ak 2 4 Coil Alameda 2 5 AN E NI 2 5 Reconstitution Instructions for Phantom Bottle 3 1 Image Quality A A utdnasunneal earns 3 1 Evaluation of the Ca anne ee be 3 4 Original SNR Data Table 3 5 Periodic Quality Assurance Check nnnen 3 6 Periodic SNR Data Table es 3 6 Patient Proporta rd einen 4 General Patient Positioning Guidelines ee 4 POC elegante 5 1 Troubleshooting unse ade eu 6 1 Receiving No Dlonals umge as cuneeuaseeaeas en anieluntia eaten Saaeeatalinade 6 1 A E R A a i EE 6 2 ATI nennen nennen 6 3 Mamtenanee tara 6 4 O 6 4 TIS Pe A O nee and 6 4 A A AA 6 4 M473PH 64A Rev 1 SAFETY TRAINING QUALITY ASSURANCE INDICATIONS CONTRAINDICATIONS PRECAUTIONS l 1 This manual contains detailed information on the set up positioning and use of the IGC Medical Advances Inc MAI coil The instructions should be read carefully and thoroughly before attempting to scan patients with the coil The procedure described in the Quality Assurance Section of this manual should be
4. MAINTENANCE The ratio obtained in the periodic quality assurance check is not greater than 85 or the image quality is not what you expect it should be given the parameters selected Review the selected protocol If you are performing the Periodic Quality Assurance be sure your protocol is identical to the protocol provided on Page 3 2 of this manual If you are performing diagnostic images you may need to increase NSA or FOV Verify that there are no loops in the cables Verify that there are no metal or ferromagnetic objects close to the coil patient or magnet i e safety pin hair pin Verify that the coil is properly positioned Verify that your center frequency is within the frequency adjustment range for your system TROUBLESHOOTING MAINTENANCE 6 3 ARTIFACTS PROBLEM POSSIBLE SOLUTION PROBLEM POSSIBLE SOLUTION For quadrature coils For phased array coils PROBLEM POSSIBLE SOLUTION There is a black line or signal void on the image Verify that there is no metal present in the area being scanned in or on the patient Some or all of the images appear shaded or exhibit uneven signal or banding Confirm that no metallic objects are located nearby outside the FOV This is especially important on images utilizing Fat Saturation If Fat Saturation is being used verify that the center frequency has been optimized Verify that the coil is positioned with the cable exiting away from the
5. a comfortable position either over the chest or at the sides Utilize additional pillows or sponges to support the patient and make them comfortable M473PH 64A Rev 1 M473PH 64A Rev 1 PATIENT PREPARATION amp POSITIONING Refer to the images below for the two most common applications using the Quadrature Lower Extremity Coil knee imaging Figure 4 1 and ankle foot imaging Figure 4 2 Position the knee within the Quadrature Lower Extremity Coil Figure 4 1 For ankle or foot imaging place the ankle in the coil with the foot flexed so that it will extend up into the foot extension of the coil and position with the ankle foot pad Utilize additional padding to immobilize the toes and foot within the chimney portion of the coil Support the leg as needed Immobilize the ankle and foot as needed For knee imaging place the knee in the coil so that the apex of the patella is located in the center of the coil Adjust the rotation of the leg so that the patient is comfortable and positioned according to department protocol Support the leg above and below the coil Immobilize the knee as needed Position the foot and ankle within the coil Note Ankle foot pads not shown for detail Figure 4 2 PROTOCOLS PROTOCOL Make certain to use MC MAL as the coil selection Always specify the coil connection port either SC1 or SC2 Do not use the d default option Proceed to scan using your designate
6. bore and that all connections are fully secured Confirm that all phased array channels are functioning properly Perform a Quality Assurance scan with another similar phased array coil Review the images to confirm that all channels are operating If the above checks out it is possible the coil has failed Contact IGC Medical Advances Inc for assistance There is a single pixel width line running across the image Confirm that the coil connection is specified as SC1 or SC2 depending on which port the coil is plugged into and not d for default M473PH 64A Rev 1 6 4 MAINTENANCE STORAGE INSPECTION CLEANING M473PH 64A Rev 1 TROUBLESHOOTING MAINTENANCE Coils should be stored and used at the same room temperature as your MR system Inspect the coil weekly for mechanical breakage damage DO NOT USE A COIL WHICH HAS SUSTAINED MECHANICAL DAMAGE Return the coil to IGC Medical Advances Inc for service repair This coil contains no user serviceable parts All repairs must be performed by factory trained personnel The cleaning solutions listed below have been tested and are recommended with comments noted for cleaning the coil s and strap s Spray or pour the cleaning liquid onto a soft cotton cloth and proceed to clean Solution Comments 1 Warm water Safe for all areas of the coil s or strap s 2 Commercial dishwashing Safe for all areas liquid water combination of the coil s or 1 oz per gallo
7. c d e Display the image on the image screen i e using the sign Select Scan control Select Scan list Delete scout scan from scan list Select planscan on scan C11 T and check modify the next scan parameters Coil selection MC MAI FOV 300 mm Connection SCl Position the slice in the center of the bottle as indicated in Figure 3 1 QUALITY ASSURANCE 3 3 Figure 3 1 Slice Positioning g Press Proceed h Select Start scan i Press return for default scanname 8 When the scan is finished a Display the image on the image screen i e with the sign M473PH 64A Rev 1 Sid QUALITY ASSURANCE EVALUATION OF THE SCAN Select a Rectangular ROI in the center of the bottle according to the next procedure l Position the mouse pointer in the image area and press right mouse button 2 Select ROI rectangular in the displayed menu NOTE The shape of the ROI can be set via this menu under More ROI settings ROI 2 Figure 3 2 Positioning of ROIs 3 Draw a square ROI in the image The ROI will get a number automatically 4 Position the mouse pointer on this number and press right mouse M473PH 64A Rev 1 button A menu will appear a Select Statistics Statistics b Modify the size of the ROI to 1200 mm 100 mm but keep it a square NOTE The size of the ROI can be changed by dragging the marked points of the ROI individually QUALITY ASSURANCE 3 5 c Position the
8. E IN STANDARD COLUMN 4 DEVIATION DIVIDED BY ORIGINAL VALUE X 100 M473PH 64A Rev 1 PATIENT PREPARATION amp POSITIONING 4 1 PATIENT PREPARATION The following are some patient preparation considerations to be aware of before positioning for the exam 1 Have the patient remove any jewelry or clothing that may interfere with the study 2 Be aware of skin tattoos that may contraindicate scanning 3 Apply skin markers as requested by your Radiologist GENERAL PATIENT POSITIONING GUIDELINES Here are additional general positioning guidelines to consider 1 Position the coil at the end of the table closest to the magnet bore Place the table pad on the table superior to the coil to provide a more even positioning surface 2 Position the base of the coil centered on the table Offset the coil within the base to adjust for patient size and comfort Lock the coil down when in position and record the offset distance for use during the exam 3 Be sure not to pinch any gowns or bedding material between the coil halves when attaching the top half of the coil This would cause poor image quality and possibly result in damage to the coil 4 Padding is provided that is designed for either knee imaging or for specific ankle and foot imaging Additional padding or towels from the department may be required for patient comfort and immobilization depending on the anatomy to be imaged and patient size 5 Position the patient s arms in
9. ROI in the center of the bottle see ROI 1 in Figure 3 2 d Write down the Mean value in Table 3 1 below e Position the ROI in the image area below the bottle ROI 2 f Change the size of the ROI to approximately 7000 mm and position the ROI as indicated in Figure 3 2 ROI 2 g Verify by using the window width and window level of the image that the measured area is free of artifacts h Write down the Standard Deviation in Table 3 1 i Calculate the SNR MEAN Standard Deviation j Log the SNR in Table 3 1 Table 3 1 Original SNR Data Obtained at Initial Coil Installation Signal Mean Value Standard Deviation SNR Value of Phantom of Noise Once the Original Image Quality Scan has been completed and the values recorded in Table 3 1 the Quadrature Lower Extremity Coil is ready to be used for clinical imaging M473PH 64A Rev 1 3 6 QUALITY ASSURANCE PERIODIC QUALITY ASSURANCE CHECK On a periodic basis such as during Preventative Maintenance perform the quality assurance check outlined previously to ensure that the Quadrature Lower Extremity Coil is operating properly with no appreciable degradation of image quality It is also advisable to carry out this procedure if any system software or hardware upgrades are installed to ensure consistent performance Record the results of the periodic quality assurance check in Table 3 2 TABLE 3 2 PERIODIC SNR DATA 2 3 4 5 SIGNAL MEAN NOISE SNR VALUE VALU
10. STITUTION INSTRUCTIONS FOR PHANTOM BOTTLE IMAGE QUALITY SCAN l 2 Unscrew the cap from the phantom bottle Fill the phantom bottle approximately half full with distilled water The proper amount of sodium chloride NaCl and copper sulfate CuSO4 5H20 has been added to the bottle Securely screw the phantom bottle cap back on Shake the bottle vigorously to dissolve the sodium chloride and copper sulfate Unscrew the cap from the phantom bottle Fill the bottle completely with distilled water so that no air bubbles are present all the way to the rim Securely screw the bottle cap back on Position the extremity coil on the patient table Position the coil in the middle of the base Place the supplied phantom bottle inside the coil Connect the coil to the cable trap and connect the cable trap to Surface coil connector 1 SC1 Align the lightvisor lights with the marker on the coil and move the coil to the isocenter of the system by using the travel to scan plane function M473PH 64A Rev 1 M473PH 64A Rev 1 QUALITY ASSURANCE Create a new patient i e MAI E a b c d e f g h Select Scan control Select Anatomy Select Phantom studies Select SC Use planscan for the scout scan and modify the next scan parameters Coil selection MC MAI FOV 300 mm Connection SCl Press Proceed Select Start scan Press return for default scanname After the scan is finished a b
11. d protocol If you need assistance with protocol selection when using your Quadrature Lower Extremity Coil call our Applications Specialist at 1 800 657 0891 M473PH 64A Rev 1 TROUBLESHOOTING MAINTENANCE 6 1 TROUBLESHOOTING The following is a list of common problems and solutions for those problems If you cannot solve a problem by following the procedures in the manual contact IGC Medical Advances Inc Customer Service at 1 800 657 0891 between the hours of 7 30 AM and 5 30 PM United States Central Standard Time Monday through Friday to arrange for service repair or to speak with an Applications Specialist Further correspondence can be sent to the following address Customer Service IGC Medical Advances Inc 10437 Innovation Drive Milwaukee WI 53226 4815 USA Tel 1 414 258 3808 Fax 1 414 258 4931 RECEIVING NO SIGNAL PROBLEM You are unable to scan or are scanning and yet receiving no signal POSSIBLE SOLUTION Verify that the connector is plugged in fully and that the two halves of the coils are secured together properly Verify that the system recognizes the coil identity Verify that the scan locations and any Shift Means entered are correct Verify MC MAT is the selected coil Verify the coil connection is set to SC1 or SC2 depending on which port the coil is plugged into and not set to d M473PH 64A Rev 1 6 2 IMAGE QUALITY PROBLEM POSSIBLE SOLUTION M473PH 64A Rev 1 TROUBLESHOOTING
12. itioning pads Figure 2 2 The Quadrature Lower Extremity Coil is a quadrature receive only imaging coil The unique chimney design of the upper half of the coil allows imaging of the foot and ankle in a comfortable neutral position Several features make patient positioning particularly easy COIL DESCRIPTION 1 om 3 4 PAD DESCRIPTION The top half ofthe coil disconnects from the bottom half for ease of patient entry and exit The base allows you to move the coil left or right into alignment with the anatomy to be scanned A locking device on the support keeps the coil in place A numbering scale allows you to estimate the lateral offset Four pads are supplied with the Quadrature Lower Extremity Coil One pad supports the knee during examinations of the knee one pad supports the foot ankle during foot ankle examinations one pad stabilizes the forefoot and one pad supports the unaffected extremity The pads are designed to raise the knee or ankle to isocenter in the coronal plane If more padding is necessary to align the extremity with isocenter or to increase patient comfort use additional pads from the department M473PH 64A Rev 1 COIL INSTRUCTIONS 2 3 COIL POSITIONING l Place the Quadrature Lower Extremity Coil on the patient table The coil cable should exit away from the magnet The coil base should be centered on the table right to left 2 Release the coil centering lever s and slide the coil latera
13. lips cable trap Figure 2 3 For more information please contact your Philips representative COIL INSTRUCTIONS Figure 2 3 1 Connect the Quadrature Lower Extremity Coil to the cable trap 2 Connect the cable trap to one of the receive coil ports Be sure the connector plug inserts completely 3 MC MAI should appear as a coil selection If it is not within your system s coil choices please refer to the installation instructions included in the Philips Service Manual The procedure is as follows a b c d e f g h Login Gyrotool Enter Password when required Select Select Set Select Select Select Modify system configuration Coil administration MAI coil version to NT lt Proceed gt to activate the new selection Exit to main menu EXIT from Gyrotool COIL INSTRUCTIONS 2 5 COIL ALIGNMENT FOV RANGE l Press the alignment light button Lift the tumble switch Upward In and keep it lifted until the light cross hairs are fully aligned with the mark on the anterior portion of the coil 2 If the coil is offset laterally record the numerical amount from the numbered scale on the coil base Enter the offset distance in your protocol The field of view coverage available from the coil in each scan plane is as follows Axial Plane 18 cm Axial through vertical extension 28 cm Coronal Plane 22 cm Sagittal Plane 22 cm M473PH 64A Rev 1 QUALITY ASSURANCE 3 1 RECON
14. lly to its desired position Secure the coil in its desired position to ensure that the coil will not move during imaging Always position the coil as close to magnet isocenter on the base as possible Image quality decreases the further off center the coil is positioned This is especially important if fat saturation techniques will be employed 3 Remove the top half of the coil Apply downward pressure on the latches located on either side of the coil to release the latches and separate the two halves of the coil 4 Position the Quality Assurance Phantom or the patient within the coil Refer to either the QUALITY ASSURANCE or PATIENT PREPARATION amp POSITIONING Sections for more detailed positioning information de Put the top half of the coil back in place Be sure to align the coil pins on the top half with the receiver holes on the coil bottom half note that there is only one way in which it can connect Secure the anterior portion of the coil NOTE The anterior portion of the Quadrature Lower Extremity Coil must be clamped completely to the posterior portion Failure to do so may cause severe anterior signal drop off or coil damage 6 Raise the patient table to full up position Ensure that the RF cable does not get caught in the table or system while the table is being raised M473PH 64A Rev 1 2 4 SYSTEM COIL CONNECTION M473PH 64A Rev 1 The use ofthe Quadrature Lower Extremity Coil requires the Phi
15. n strap s of water 3 Alcohol mixture 70 Do not apply to isopropyl alcohol adhesive backed materials 30 water such as labels decals or Velcro fasteners 4 Break Thru all purpose Do not apply to cleaner 25 oz per gallon adhesive backed materials of water such as labels decals or Velcro fasteners IMPORTANT Do not spray or pour cleaning liquid directly onto the coil or cables Apply to a soft cotton cloth and proceed to clean
16. performed upon receipt of the coil to establish a baseline for coil performance The procedure should be repeated at regular intervals IGC Medical Advances Inc magnetic resonance coils are indicated for use as either receive only or transmit and receive antennae of RF energy at a specific frequency The signal received by the coils is dependent upon MRI parameters T1 or Spin lattice relaxation time T2 or spin spin relaxation time density of nuclei flow velocity and chemical shift The images produced by the imaging coil correspond to the distribution of nuclei exhibiting nuclear magnetic resonance The MR coil is tuned by MAI at the manufacturing site to the approximate resonant frequency of the magnetic resonance system The operator should be aware of the following contraindications for use related to the strong magnetic field of the MR system Scanning is contraindicated for patients who have electrically magnetically or mechanically activated implants for example cardiac pacemakers because the magnetic and electromagnetic fields produced by the MR device may interfere with the operation of these devices Scanning patients with intracranial aneurysm clips is contraindicated Precautions should be taken when scanning patients with the following conditions A greater than normal potential for cardiac arrest An increased likelihood for developing seizures or claustrophobia Unconscious heavily sedated conf
17. used patients or those with whom no reliable communications can be maintained M473PH 64A Rev 1 l 2 CAUTIONS M473PH 64A Rev 1 SAFETY The following general warning statements apply to scanning with a magnetic resonance system For further details review the warnings included in your MR system operations manual Cables should not be looped or crossed Arcing and patient burns could result If a patient complains of burning tingling stinging or other burn type sensations promptly stop the scan procedure examine the patient and contact the responsible physician before continuing the procedure Pay special attention to very young sedated or other patients who may not be able to communicate effectively Route all cables out of the magnet so that they do not contact the patient Patients with ferromagnetic metal should not be scanned because the magnetic field may interact with implanted surgical clips or other ferromagnetic materials Persons with cardiac pacemakers or other implanted electronic devices should not enter the magnetic field zone delineated by the system s manufacturer There is a risk to scanning feverish or decompensated cardiac patients Facial makeup should be removed before scanning because many eye makeups contain metal flakes which can cause skin and eye irritation Permanent eye liner tattoos may cause eye irritation due to the presence of ferromagnetic particles
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