MRI Checklist for MED EL CI and ABI models

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MRI Checklist for MED EL CI and ABI models Mi1200 SYNCHRONY Mi1200 SYNCHRONY PIN Mi1210 SYNCHRONY ST...1 Mi1200 SYNCHRONY ABI Mi1200 SYNCHRONY PIN ABI...2 Mi1000 CONCERTO Mi1000 CONCERTO PIN SONATA...3 Mi1000 CONCERTO ABI Mi1000 CONCERTO PIN ABI...3 PULSAR C40+ C40...4 PULSAR ABI C40+ ABI...4 Please visit us at www.medel.com/isi Help and assistance are always available from your local office. (English EU) 1

Mi1200 SYNCHRONY Mi1200 SYNCHRONY PIN Mi1210 SYNCHRONY ST MRI Checklist for MED EL CI models Mi1200 SYNCHRONY Mi1200 SYNCHRONY PIN Mi1210 SYNCHRONY ST VALID for all intracochlear electrode variants VALID for all body regions PERMITTED, static magnetic field strength 0.2 T, 1.0 T, 1.5 T, 3.0 T MAXIMUM PERMITTED SAR (at 0.2 T, 1.0 T, 1.5 T) NORMAL OPERATING MODE, i.e. MAXIMUM PERMITTED SAR (at 3.0 T) Head Whole Body <35 cm from the top of the head Whole Body 35 cm from the top of the head 1.6 W/kg 1.0 W/kg 2.0 W/kg (next bullet point) decide if the magnet should be removed Mi1200 SYNCHRONY Mi1200 SYNCHRONY PIN Mi1210 SYNCHRONY ST MAGNET REMOVAL Has the implant magnet been surgically removed? NOTE: The likelihood and intensity of auditory sensations can be reduced by selecting sequences with a lower Specific Absorption Rate (SAR) and slower gradient slew rates. HEAD ORIENTATION (only applicable at 1.0 T, 1.5 T, 3.0 T) OPTIONAL: HEAD BANDAGE A supportive head bandage over the implant using an elastic bandage wrapped tightly around the head for at least three times can optionally be used. PATIENT POSITIONING (only applicable at 1.0 T, 1.5 T, 3.0 T) Ensure straight head orientation. NOTE: When lower extremities are to be examined, it is recommended that patient s legs are positioned in the scanner first. OPERATING MODE (only applicable at 0.2 T, 1.0 T, 1.5 T) Run sequences in Normal Operating Mode only. OPERATING MODE (only applicable at 3.0 T) Apply maximum permitted SAR according to following table only: SAR (Head) SAR (Whole-Body) <35 cm from the top of the head 35 cm from the top of the head 1.6 W/kg 1.0 W/kg 2.0 W/kg ACCESSORIES (only applicable at 3.0 T) Do not utilise head transmit coils or multi-channel transmit coils. 1

Mi1200 SYNCHRONY ABI Mi1200 SYNCHRONY PIN ABI MRI Checklist for MED EL ABI models Mi1200 SYNCHRONY ABI Mi1200 SYNCHRONY PIN ABI VALID for ABI electrode variant VALID for all body regions PERMITTED, static magnetic field strength 0.2 T, 1.0 T, 1.5 T MAXIMUM PERMITTED SAR NORMAL OPERATING MODE, i.e. (next bullet point) decide if the magnet should be removed MAGNET REMOVAL Has the implant magnet been surgically removed? Mi1200 SYNCHRONY ABI Mi1200 SYNCHRONY PIN ABI NOTE: The likelihood and intensity of auditory sensations can be reduced by selecting sequences with a lower Specific Absorption Rate (SAR) and slower gradient slew rates. HEAD ORIENTATION (only applicable at 1.0 T, 1.5 T) OPTIONAL: HEAD BANDAGE A supportive head bandage over the implant using an elastic bandage wrapped tightly around the head for at least three times can optionally be used. PATIENT POSITIONING (only applicable at 1.0 T, 1.5 T) Ensure straight head orientation. NOTE: When lower extremities are to be examined, it is recommended that patient s legs are positioned in the scanner first. OPERATING MODE Apply Normal Operating Mode only. 2

Mi1000 CONCERTO Mi1000 CONCERTO PIN SONATA Mi1000 CONCERTO ABI Mi1000 CONCERTO PIN ABI MRI Checklist for MED EL CI and ABI models Mi1000 CONCERTO Mi1000 CONCERTO PIN SONATA Mi1000 CONCERTO ABI Mi1000 CONCERTO PIN ABI VALID for all electrode variants VALID for all body regions PERMITTED, static magnetic field strength 0.2 T, 1.0 T, 1.5 T MAXIMUM PERMITTED SAR NORMAL OPERATING MODE, i.e. NOTE: The likelihood and intensity of auditory sensations can be reduced by selecting sequences with a lower Specific Absorption Rate (SAR) and slower gradient slew rates. HEAD ORIENTATION (only applicable at 1.0 T, 1.5 T) Mi1000 CONCERTO Mi1000 CONCERTO PIN SONATA Mi1000 CONCERTO ABI Mi1000 CONCERTO PIN ABI HEAD BANDAGE (only applicable at 1.0 T, 1.5 T) Place a supportive headband over the implant. NOTE: The bandage may be an elastic bandage wrapped tightly around the head at least three times. PATIENT POSITIONING (only applicable at 1.0 T, 1.5 T) Align longitudinal axis of patient`s head parallel to the main magnetic field. NOTE: When lower extremities are to be examined, it is recommended that patient s legs are positioned in the scanner first to minimize any risk of weakening the implant magnet. OPERATING MODE Run sequences in Normal Operating Mode only. 3

PULSAR C40+ C40 PULSAR ABI C40+ ABI MRI Checklist for MED EL CI and ABI models PULSAR C40+ C40 PULSAR ABI C40+ ABI VALID for all electrode variants VALID for all body regions VALID for unilateral as well as bilateral implant provision PERMITTED, static magnetic field strength 0.2 T, 1.0 T, 1.5 T MAXIMUM PERMITTED SAR NORMAL OPERATING MODE, i.e. IMPLANT CONDITION Is the implant housing mechanically intact? (not fractured or shattered) IMPLANTATION STATUS Has the implant been implanted for at least six months? BONE THICKNESS Is the bone underneath the implant at least 0.4 mm thick? NOTE: The likelihood and intensity of auditory sensations can be reduced by selecting sequences with a lower Specific Absorption Rate (SAR) and slower gradient slew rates. HEAD ORIENTATION (only applicable at 1.0 T, 1.5 T) HEAD BANDAGE (only applicable at 1.0 T, 1.5 T) Place a supportive headband over the implant. NOTE: The bandage may be an elastic bandage wrapped tightly around the head at least three times. PULSAR C40+ C40 PULSAR ABI C40+ ABI PATIENT POSITIONING (only applicable at 1.0 T, 1.5 T) Align longitudinal axis of patient`s head parallel to the main magnetic field. NOTE: When lower extremities are to be examined, it is recommended that patient`s legs are positioned in the scanner first to minimize any risk of weakening the implant magnet. OPERATING MODE Run sequences in Normal Operating Mode only. 4

MED EL Elektromedizinische Geräte GmbH Fürstenweg 77a 6020 Innsbruck, Austria office@medel.com 5 medel.com