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MRI Guidelines
for safe imaging of patients treated with the EASEE®System
Urgent Note:
Please check the implantation card to determine which version of EASEE® the patient is using!
Information for EASEE®II
Components:
Implanted electrode:
EASEE® Lead - REF: EALE01
UDI-DI 04260479770279
EASEE® Lead - REF: EALE01
UDI-DI 04260479770279
Implanted pulse generator:
EASEE® Power REF: EAPW00
UDI-DI 04260479770064
EASEE® Power REF: EAPW00
UDI-DI 04260479770064
| Parameter | Notes |
|---|---|
| Item Name / Identification | EASEE® Power (UDI-DI 04260479770064) EASEE® Lead (UDI-DI 04260479770279) |
| Device Configuration | Shut down |
| Item Manufacturer | Precisis GmbH |
| Date this labelling was issued | May 2022 |
| Location of MRI safety information | open PDF here |
| Static Magnetic Field Strength | 1.5 T |
| Type of Nuclei | Hydrogen |
| Static Magnetic Field (B0) Orientation | Horizontal |
| Scanner Type | Cylindrical-bore |
| Maximum Spatial Field Gradient | 15 T/m (1500 Gauss/cm) |
| Maximum Gradient Slew Rate per axis | 200 T/m/s (per axis) |
| RF Transmit Coil Type | body transmit coil |
| RF Receive Coil Type | Any receive coil may be used |
| Operating Mode | Normal Operating Mode (including FPO:B Mode) |
| RF Power | Whole 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 Time | Scanning for 15 minutes max, followed by 5 min pause |
| Patient Characteristics |
|
Information for EASEE®III
Components:
Implanted electrode:
EASEE® Lead - REF: EALE02
UDI-DI 04260479770446
EASEE® Lead - REF: EALE02
UDI-DI 04260479770446
Implanted pulse generator:
EASEE® Power REF: EAPW01
UDI-DI 04260479770293
EASEE® Power REF: EAPW01
UDI-DI 04260479770293
| Parameter | Notes |
|---|---|
| Item Name / Identification | EASEE® Power (UDI-DI 04260479770293) EASEE® Lead (UDI-DI 04260479770446) |
| Device Configuration | Shut down |
| Item Manufacturer | Precisis GmbH |
| Date this labelling was issued | May 2022 |
| Location of MRI safety information | open PDF here |
| Static Magnetic Field Strength | 1.5 T / 3 T |
| Type of Nuclei | Hydrogen |
| Static Magnetic Field (B0) Orientation | Horizontal |
| Scanner Type | Cylindrical-bore |
| Maximum Spatial Field Gradient | 43 T/m (4310 gauss/cm) |
| Maximum Gradient Slew Rate per axis | 200 T/m/s |
| Encoding gradients (dB/dt) rms | 42 T/s |
| RF Excitation | 1.5T: Circularly Polarized (CP) 3T: Circularly Polarized (CP) |
| RF Transmit Coil Type | Integrated Whole Body Transmit Coil |
| RF Receive Coil Type | Any receive coil may be used |
| Operating Mode | Normal Operating Mode (including FPO:B Mode) |
| RF Power | B1+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 Time | Scanning for 45 minutes max |
| Patient Characteristics |
|