ENGLISH Instructions For Use Invivo Magnetic Resonance Imaging Coils

Transcription

1 ENGLISH Instructions For Use Invivo Magnetic Resonance Imaging Coils Rev10

2 Instructions For Use Invivo Magnetic Resonance Imaging Coils Invivo Corporation 3545 SW 47th Avenue Gainesville, FL U.S.A. Phone: (352) Fax: (352) GBM Authorised Representative Ltd. The White House, 2 Meadrow Godalming, Surrey GU7 3HN United Kingdom Phone: +44 (0) Fax: +44 (0) Web: martin.biggs@mba-gbm.com Australian Sponsor: Philips Electronics Australia Ltd 65 Epping Road, North Ryde, NSW, Australia 2113 Page 2 of 16

3 Symbol Reference EXPLANATION OF SYMBOLS MDD 93/42/EEC Annex XII Safety Sign ISO 7010-M002 ISO Symbol 5.4.3, ISO ISO B ISO 7010-W001 IEC Medical Device Directive These products conform with the requirements of council directive 93/42/EEC concerning medical devices when they bear the CE Mark of Conformity. (it is a mandatory action to) Refer to the instruction manual/booklet Attention Refer to Operator's manual; operating instructions Caution Potential damage to the coil may result if instructions are not followed. The symbol can also be used to mean Attention Consult accompanying documents. Potential Hazard To avoid harm, all safety messages that follow this symbol must be obeyed. Type BF Applied Part IEC Class II Equipment IE Splash proof safety rating Ingress protection x meters for x minutes Do not cross or loop cables. Arcing and patient burns could result. Magnetic Field Strength in Tesla Magnetic Field Strength in Tesla Magnetic Field Strength in Tesla Magnetic Field Strength in Tesla Page 3 of 16

4 Magnetic Field Strength in Tesla ISO Symbol 5.3.7, ISO Temperature limitation ISO Symbol 5.3.8, ISO Humidity Limitation ISO Symbol 5.3.9, ISO Atmospheric pressure limitation ICE ( ) RF coil, transmit ICE ( ) RF coil,transmit and receive ICE ( ) RF coil, receive Directive 2012/19/EU for WEEE Annex IX Dispose of in accordance with local regulation ISO Symbol 5.3.4, ISO Keep dry ISO Symbol 5.3.1, ISO Fragile, handle with care ISO Symbol 5.1.1, ISO Manufacturer Page 4 of 16

5 ISO Symbol 5.1.3, ISO Date of manufacture ISO Symbol 5.1.7, ISO Serial Number ISO Symbol 5.1.6, ISO Catalogue number Symbol 5.1.2, ISO Authorized representative in the European Community A hazard exists which could cause serious injury. Symbol ASTM F25.03 MR Safe Poses no known hazards in all MR environments Safety Sign ASTM F25.03 MR Conditional Poses no hazards in an MR environment under specified conditions but which may pose a hazard under different conditions. Rx Only FDA Guidance Document Alternative to Certain Prescription Device Labeling Requirement Prescription device Caution: US Federal law restricts this device to sale by or on the order of a clinician ASTM F , Standard Practice For Marking Medical Devices And Other Items For Safety In The Magnetic Resonance Environment ISO 7000:2014, Graphical symbols for use on equipment Registered symbols ISO 7010:2011+A1:2012+A2:2012+A3:2012+A4:2013+A5:2014+A6:2014, Graphical symbols -- Safety colours and safety signs -- Registered safety signs (not currently FDA recognized) ISO :2012, Medical devices Symbols to be used with medical devices labels - General requirements IEC 60417:2002 DB, Graphical symbols for use on equipment IEC/TR 60878:2015, Graphical symbols for use on equipment Registered symbols Page 5 of 16

6 Caution: Federal law restricts this device to sale, distribution, and use by or on the order of a physician. Page 6 of 16

7 Indications The MR coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician. Contraindications 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 (cardiac pacemakers, for example). The magnetic and electromagnetic fields produced by the MR System and coil may interfere with the operations of these devices. Scanning patients with intracranial aneurysm clips is contraindicated. Precautions Precautions should be taken when scanning patients with the following conditions: Cautions Greater than normal potential for cardiac arrest An increased likelihood for developing seizures or claustrophobia Unconscious, heavily sedated, or confused patients Inability to maintain reliable communications The following general warning statements apply to scanning with a magnetic resonance system. For further details, review the warnings in your MR system operator manual. Page 7 of 16

8 Do not cross or loop cables. Arcing and patient burns could result. Route cables out of the magnet so that they do not touch the patient. Assure that the patient is not touching the bore. If necessary, place pads between the patient and the surface of the bore. If the patient complains of warming, tingling, stinging, or similar 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 compromised patients who may not be able to communicate effectively. Patients with implanted medical devices/components should not be scanned because the magnetic field may interact with the medical device/component. Consult patient s physician Persons with cardiac pacemakers or other implanted electronic devices should not enter the magnetic field zone delineated by the MR system manufacturer. There is a risk to scanning feverish or decompensated cardiac patients. Do not allow the patient to bring magnetic objects or non-magnetic metallic objects such as jewelry, hairpins, prosthetics or clothing containing metal components into the magnet. Such objects will interfere with the imaging capabilities of the system and coil. Certain transdermal patches may cause burns to the underlying skin due to absorption of RF energy. The supplier of the patches should be consulted or the patch should be removed to avoid burns. A new patch should be applied after the examination. Facial makeup should be removed before scanning because it may contain metal flakes which can cause skin and eye irritation. Permanent eyeliner tattoos may cause eye irritation due to ferromagnetic particles. 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 undergoing an MR exam. Visually inspect the cable insulator jackets, strain reliefs, housings and connector boxes before each use. If the insulation or housing is broken, or if the cable is frayed, immediately discontinue use of the device. Ensure that the patient does not form a loop with any body parts. For breast coils in particular, patients are imaged lying prone with both arms extended above the head (superman). Do not allow patients to touch any part of the right hand or arm to any part of the left hand or arm. The loop formed by doing so could cause an RF burn at the point of contact. Use pads to ensure the patient s hands do not touch any metal features of the patient table or cradle. Be sure to educate the patient accordingly and check the patient s position immediately before the scan. Page 8 of 16

9 The following general warning statements apply to interventional procedures performed in conjunction with a magnetic resonance system. Prepare percutaneous sites in accordance with standard surgical technique prior to insertion of any interventional instrument. Obtain target coordinates prior to opening sterile components. Once target coordinates are obtained, using sterile technique, remove the sterile components from package. It is recommended that the position of the biopsy device aperture be visually confirmed by an MR image to be adjacent to the abnormality. Always remove the interventional components from the breast before removing the immobilization system. Products manufactured or distributed by companies not authorized by Invivo Corporation may not be compatible with the immobilization system and targeting devices. Use of such products may lead to unanticipated results and possible injury to the user or patient. Interventional procedures should be performed only by persons having adequate training and familiarity with interventional techniques. Consult medical literature relative to techniques, complications, and hazards prior to performance of any interventional procedure. Interventional instruments may vary in diameter from manufacturer to manufacturer. When interventional instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure. Interventional instruments should only be used by physicians trained in percutaneous needletechniques for tissue collection. All Invivo interventional targeting devices and biopsy instruments should only be used by physicians trained in Magnetic Resonance Imaging (MRI). Always visually confirm that there are no protruding elements from the interventional system that might interfere with the bore of the MRI scanner before sliding the patient into the scanner. Inspect all Invivo instruments for damage prior to use. If any part of the device is damaged or missing, call INVIVO-1 or contact your local sales representative. Do not use an instrument if damaged. Keep the tip protectors of the interventional components in place and only remove when intending to use for tissue sampling. Special care should be taken to avoid bending of the biopsy device. Do not lean on the device while it is attached to the immobilization system. As with any biopsy instrument, there may be a potential for infection. Instruments or devices which come in contact with bodily fluids may require special cleaning instructions or special handling to prevent biological contamination. Dispose of all opened sterile packaged instruments whether used or unused. Dispose of all sharp objects in an appropriate sharps container. Page 9 of 16

10 Scanning Refer to the system manual for installation instructions and proper use of the coil in conjunction with the scanner. Emergency Procedures In the unlikely event that a coil creates smoke, sparks or makes an unusually loud noise, or if the patient requires emergency assistance: Stop the scan if one is in progress. Remove the patient from the scan room if medical treatment is needed. Page 10 of 16

11 Technical Considerations The coil and accessories require special conditions regarding electromagnetic compatibility. The coil should only be installed and used with the MR magnet systems for which it was designed. MR scans should only be performed in the shielded rooms provided with the MR magnet system. Failure to do so may cause reciprocal interference with portable and mobile RF communications equipment, affecting the performance of the MR coil and/or such equipment. The coil should only be used with the cable and accessories specified in the system operator manual. The use of accessories other than those specified in the system operator manual may result in decreased ESD immunity of the coil or MR system, causing damage to the coil and/or system. The equipment should not be used with other coils or equipment present in the MR scanner except as specified in the system operator manual. Tampering with the cable pins and connector may damage the connector and affect coil or system performance. Please verify that connector and pins are not damaged before use. The coil should not be left unplugged in the system during body coil scanning. Reference the system or supplied application guide for coil positioning requirements, specific operating conditions and routine maintenance. Warning: No modification of this equipment is allowed. There are no user serviceable components. At the end of its service life, dispose of the coil in accordance with local regulation. For split coil designs, the user should avoid touching any exposed connector pins and the patient at the same time. Users must be trained on the safe and effective use of the MRI scanner before attempting to operate the coil. After unpacking the coil, allow it to remain under stable atmospheric conditions for several hours prior to using. Extreme temperature and/or humidity during storage and/or transportation could have allowed condensation to form inside the coil. 1.5T and 3.0T ds Breast coils: Be mindful of finger placement when installing lateral plates. Suggest placing hand near activation levers to avoid pinching. Avoid contact with the handle release buttons at the far end of each handgrip as accidental triggering may cause the coil base to release from the handrail. Page 11 of 16

12 Ambient Operating Conditions C % relative humidity Cleaning Detach coil from scanner before attempting to clean. For flexible coils wipe with a cloth that has been dampened in a solution of 0.025% chlorine in tap water, QUAT-64 or Cidex. For rigid coils wipe with Super Sani-Cloth. Do not use bleach based wipes. Do not pour any cleaning solution directly on the coil or baseplate! Care must be taken to avoid contact with any electrical connections during cleaning. Spraying the contacts may cause the devices to malfunction or reduce the life expectancy of the interconnect and will void warranty. Avoid direct use of cleaning agents on any connector contacts and interfaces. Under no circumstances should the coil be placed into any type of sterilizer. Sterilization and exposure to fluids may damage the electrical components of the device. Do not autoclave any components of the coil. Do not heat above 70 C. Do not submerse any of the assemblies in fluids. Submersing in fluids may cause the device to malfunction and will voil the warranty Do not allow pooling of cleaning agents after cleaning. Coil, pads and other accessories must be completely dry before use. Page 12 of 16

13 EMC Declaration, and Guidance Per EN Table a) 3) Guidance and manufacturer s declaration electromagnetic emissions The MRI Coil is intended for use in the electromagnetic environment specified below. The customer or the user of the MRI Coil should assure that it is used in such an environment. Compliance Electromagnetic environment - guidance Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions EN Voltage fluctuations / flicker emissions EN Group 1 Class A Not applicable Not applicable The receive-only coil uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Transmit coils use the same frequency, but lower power than the MR system, and therefore would not cause any unforeseen interference. The MRI Coil is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. The MRI Coil is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Table a) 6) Guidance and manufacturer s declaration electromagnetic immunity The MRI Coil is intended for use in the electromagnetic environment specified below. The customer or the user of the MRI Coil should assure that it is used in such an environment. Immunity test EN test Compliance level Electromagnetic environment - Electrostatic discharge (ESD) EN Electrical fast Transient / burst level +6 kv contact +8 kv air +2 kv for power supply lines +6 kv contact +8 kv air Not applicable guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. N/A Power supplied by MR System N Surge EN kv for input/output lines +1 kv differential mode +2 kv common mode Not applicable N/A Power supplied by MR System Voltage dips, short interruptions and voltage variations on power supply input lines <5% UT (>95% dip in UT) for 0.5 cycle Not applicable N/A Power supplied by MR System 40% UT Page 13 of 16

14 EN (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles Power frequency (50 / 60 Hz) magnetic field <5% UT (>95% dip in UT) for 5 secs 3 A/m Not applicable N/A Power supplied by MR System EN Table c) 4) Guidance and manufacturer s declaration electromagnetic immunity The MRI Coil is intended for use in the electromagnetic environment specified below. The customer or the user of the MRI Coil should assure that it is used in such an environment. Immunity test EN test level Compliance level Electromagnetic environment - guidance Conducted RF EN Radiated RF EN Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2.5 GHz Not applicable Not applicable Page 14 of 16

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