| Details of Equipment: |
![image of product]() |
| Product Type: |
Active Implantable Medical Device |
| Brand Name: |
Medtronic |
| Model Number: |
Sphera DR MRI SureScan |
| NCA Equipment No.: |
|
| Product Name: |
Sphera DR MRI SureScan |
| Intended Use: |
Active Implantable Medical Device |
| Additional Details for Radio Equipment: |
| Frequency Range: |
175 kHz |
| RF Output Power Radiation: |
1.5 dBuA/m at 10m |
| RF Output Power Conducted: |
N/A |
| RF Channel Spacing: |
N/A, single channel operation |
| RF Output Impedance: |
50 Ohm |
| Type Of Modulation: |
Pulse Position Modulation |
| Bandwidth: |
<50 kHz |
| Software Version: |
N/A |
| Antenna Type: |
585 uH Reflowable Antenna |
| Antenna Gain: |
N/A |
| Technical Variants: |
N/A |
| Details of Certificate of Compliance: |
| Issuing Body: |
EU DoC |
| Issuing Date: |
06/25/2021 |
| Validity: |
no expiration |
| Standards: |
| EMC: |
EN 301 489-1
EN 301 489-31 |
| Radio: |
EN 302 195 |
| Health And Safety: |
EN 45502-1
EN 45502-2-1
EN IEC 62311 |
| Manufacture's Information: |
| Name Of Manufacturer: |
Medtronic, Inc. |
| Address Of Manufacturer: |
710 Medtronic Parkway, Minneapolis, MN-55432, USA |