| Details of Equipment: |
 |
| Product Type: |
Active implantable medical device |
| Brand Name: |
Medtronic |
| Model Number: |
Sphera L DR MRI SureScan |
| NCA Equipment No.: |
ZRO-M8-7E3-12C |
| Product Name: |
Medtronic Sphera L DR MRI SureScan |
| Intended Use: |
Active implantable medical device |
| Additional Details for Radio Equipment: |
| Frequency Range: |
150-200 kHz |
| RF Output Power Radiation: |
1.5 dBuA/m at 10m |
| RF Output Power Conducted: |
N/A |
| RF Channel Spacing: |
single channel, <50 kHz |
| RF Output Impedance: |
50 Ohm |
| Type Of Modulation: |
Pulse Position modulation |
| Bandwidth: |
<50 kHz |
| Software Version: |
N/A |
| Antenna Type: |
585 μH Reflowable Antenna |
| Antenna Gain: |
N/A |
| Technical Variants: |
N/A |
| Details of Certificate of Compliance: |
| Issuing Body: |
FCC/ISED exempt; CE |
| Issuing Date: |
06/06/2017 |
| Validity: |
no expiration |
| Standards: |
| EMC: |
EN 301 489 |
| Radio: |
EN 302 195 |
| Health And Safety: |
EN 45502-1 and EN 45502-2-1 |
| Manufacture's Information: |
| Name Of Manufacturer: |
Medtronic, Inc. |
| Address Of Manufacturer: |
710 Medtronic Parkway, Minneapolis, MN-55432, USA |