Elos Accurate Hybrid Base Gebrauchsanleitung Seite 5

19. MRI Safety Information
MRI Safety Information
A person with an Elos Accurate® Hybrid Base™.Abutment, associated dental
implant and prosthetic screw may be safely scanned under the following conditions.
Failure to follow these conditions may result in injury.
Device Name
Static Magnetic Field Strength (B )
0
Maximum Spatial Field Gradient
RF Excitation
RF Transmit Coil Type
Operation Mode
Maximum Whole-Body SAR
Maximum Head SAR
Scan Duration
MR Image Artifact
20. Disposal
The dental restoration must be disposed as biological waste.
21. Serious Incidents:
If any serious incidents occur in relation with this device they should be
reported to Elos Medtech Pinol A/S and to the competent authorities in the
country where the incident occurred.
A serious incident is a situation where the device directly or indirectly led or
might have led to death, a serious deterioration in the health of a person or a
serious public health threat.
Contact Elos Medtech Pinol A/S at:
complaint.empi@elosmedtech.com
The SSCP is available in the European database on medical
devices (Eudamed), where it is linked to the Basic UDI-DI. URL:
https://ec.europa.eu/tools/eudamed.
22. Symbols
Catalogue number
Batch code
Manufacturer
Consult instructions for use
Do not re-use
Prescription only
Elos Medtech Pinol A/S
Engvej 33
DK - 3330 Gørløse
www.elosmedtech.com
Document ID: DEV-01274 version 14.0 released 2023/03/03
Elos Accurate® Hybrid Base™.
1.5 T or 3.0 T
20 T/m (2,000 gauss/cm)
Circularly Polarized (CP)
For body transmit coil, landmarking at least
30 cm from the implant, or ensuring the
implant is located outside of the coil
Normal Operating Mode
2 W/kg (Normal Operating Mode)
Not evaluated for head landmark
2 W/kg whole-body average SAR for 60
minutes of continuous RF (a sequence or
back-to-back series/scan without breaks)
The presence of passive implant devices
may produce an image artifact that scales
with the device size
Do not use if package is
damaged
Non sterile
Recommended torque
Date of manufacture
Medical Device
Unique Device Identifier
Keep dry
Keep away from sunlight
MR Conditional
5