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MRI Guidelines

damit die sichere Bildgebung von Patient:innen, die mit dem EASEE®-System behandelt wurden, gewährleistet ist

Dringend zu beachten: Bitte entnehmen Sie dem Implantationsausweis, welche EASEE®-Version die Patient:in trägt!

Information for EASEE®II

Components:
Implanted electrode:
EASEE® Lead - REF: EALE01
UDI-DI 04260479770279
Implanted pulse generator:
EASEE® Power REF: EAPW00
UDI-DI 04260479770064
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ParameterNotes
Item Name / IdentificationEASEE® Power (UDI-DI 04260479770064)
EASEE® Lead (UDI-DI 04260479770279)
Device ConfigurationShut down
Item ManufacturerPrecisis GmbH
Date this labelling was issuedMay 2022
Location of MRI safety informationPDF hier öffnen
Static Magnetic Field Strength1.5 T
Type of NucleiHydrogen
Static Magnetic Field (B0) OrientationHorizontal
Scanner TypeCylindrical-bore
Maximum Spatial Field Gradient15 T/m (1500 Gauss/cm)
Maximum Gradient Slew Rate per axis200 T/m/s (per axis)
RF Transmit Coil Typebody transmit coil
RF Receive Coil TypeAny receive coil may be used
Operating ModeNormal Operating Mode (including FPO:B Mode)
RF PowerWhole Body SAR ≤ 2 W/kg
Head SAR ≤ 2 W/kg
Note: Under the RF scan conditions defined above, the EASEE® neurostimulator is expected to produce a maximum temperature rise of less than 6.2°C after 15 minutes of continuous scanning.
Active Scan TimeScanning for 15 minutes max, followed by 5 min pause
Patient Characteristics
  • the implantation is at least 5 weeks ago
  • uncompromised thermoregulation and under controlled conditions: a medical doctor or a dedicated trained person can respond instantly to heat induced physiological stress.
  • no previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors
  • no broken lead or lead with intermittent electrical contact

Information for EASEE®III

Components:
Implanted electrode:
EASEE® Lead - REF: EALE02
UDI-DI 04260479770446
Implanted pulse generator:
EASEE® Power REF: EAPW01
UDI-DI 04260479770293
Gesamtes PDF öffnen
ParameterNotes
Item Name / IdentificationEASEE® Power (UDI-DI 04260479770293)
EASEE® Lead (UDI-DI 04260479770446)
Device ConfigurationShut down
Item ManufacturerPrecisis GmbH
Date this labelling was issuedMay 2022
Location of MRI safety informationPDF hier öffnen
Static Magnetic Field Strength1.5 T / 3 T
Type of NucleiHydrogen
Static Magnetic Field (B0) OrientationHorizontal
Scanner TypeCylindrical-bore
Maximum Spatial Field Gradient43 T/m (4310 gauss/cm)
Maximum Gradient Slew Rate per axis200 T/m/s
Encoding gradients (dB/dt) rms42 T/s
RF Excitation1.5T: Circularly Polarized (CP)
3T: Circularly Polarized (CP)
RF Transmit Coil TypeIntegrated Whole Body Transmit Coil
RF Receive Coil TypeAny receive coil may be used
Operating ModeNormal Operating Mode (including FPO:B Mode)
RF PowerB1+RMS ≤ 7 μT
or for scanners that do not report B1+rms:
Whole Body SAR ≤ 2 W/kg
Note: Under the RF scan conditions defined above, the EASEE® neurostimulator is expected to produce a maximum temperature rise of less than 2°C at 1.5T and at 3T after 15 minutes of continuous scanning.
Active Scan TimeScanning for 45 minutes max
Patient Characteristics
  • the implantation is at least 5 weeks ago
  • uncompromised thermoregulation and under controlled conditions: a medical doctor or a dedicated trained person can respond instantly to heat induced physiological stress.
  • no previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors
  • no broken lead or lead with intermittent electrical contact
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