Mri Information; Warnings And Precautions - ulrich medical ADDplus Instrucciones De Uso

MATERIAL INFORMATION
The ADDplus™ implants are manufactured from a titanium alloy according to ISO 5832-3 and ASTM F136. The devices are biocompatible,
corrosion resistant and non-toxic in the intended use as per EN ISO 10993-1.
MR conditional
MR

MRI information

ulrich medical ADDplus implants are classified as "MR conditional" according to ASTM standard F2503.
The "MR conditional" components were tested according to the ASTM standards: F2052; F2182; F2213 and F2119. A patient with a ADDplus
implant can undergo an MRI examination under the following conditions:
ƒ Field strengths of 1.5 T and 3.0 T
ƒ Highest field gradient of 30 T/m (3000 G/cm) or less
ƒ Maximum specific absorption rate (SAR) of 2 W/kg for normal operating mode for a scan time of 30 minutes
Note: In the experimental test, heating of a maximum of 5.0°C was measured at:
ƒ 1.5 T and 3.0 T
ƒ a 15-minute scan time
ƒ SAR 2 W/kg
Under these scan conditions, the risks to the patient during an examination are low. To minimize heating, the scan time should be as brief as
possible and the SAR should be kept as low as possible.
Artefacts: MR imaging in the area of the implants can be impaired by artefacts. In the experimental test, there were artefacts up to 30 mm
radially around the implant.
The scans were performed with the following parameters:
FFE sequence: TR 100 ms, TE 15 ms, flip angle 30°
SE sequence: TR 500 ms, TE 20 ms, flip angle 70°
The SE sequence demonstrates reduced artefacts (≤ 11 mm).
The attending physician should conduct a careful risk/benefit assessment.
Packaging and storage
The product is delivered non-sterile and must be sterilized before its first use. Before a system is used, all components should be meticulously
checked for completeness, damages and defects. Damaged components must not be used. Corrosion may occur when instruments are stored
under unfavorable conditions. In order to avoid this, they should be stored in a dry, dust-free area. Significant temperature fluctuations are to
be avoided, so that no moisture (condensation) accumulates on the instruments. When directly exposed to metal, chemical substances may
destroy this metal or release corrosive fumes. Therefore, instruments must not be stored together with chemical substances. The system-
specific trays are to be used to store the instruments.
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WARNINGS AND PRECAUTIONS

ƒ Implantation should only be considered when all other treatment options have been carefully weighed and ruled out as a possible better
option. A successful implant itself will also be inferior to the healthy moving element(s) of the spine. On the other hand, an implant may
be beneficial for the patient by replacing one or more severely deformed or degenerated moving elements since this eliminates pain and a
good load bearing capacity can be achieved.
ƒ This product may only be used by a physician with experience in spinal surgery.
ƒ The treating physician is responsible for making the proper selection for the patient, and for acquiring the training and experience required
for implant selection and placement. This individual is also responsible for determining whether to leave the implant in following surgery
or to remove it.
ƒ The risks of the procedure and the use of the implant, including any revisions which may be necessary, should be explained to the patient
in detail.
ƒ The treating physician should meet with the patient for a detailed discussion of the results that may be anticipated from the surgery,
particularly with regard to potential physical limitations of the implant. The degree of post-operative activity affects the life of the implant
and the stability of the implant in the bone. As such, the patient must be informed of the limitations and risks inherent in daily activities
and made aware of special guidelines for movement. The patient must absolutely follow the instructions given by the treating physician.
Special attention should be given to post-operative consultation and the need for regular medical monitoring.
ƒ Apply suitable diagnostic procedures both before, during and after surgery to ensure and monitor proper implant selection and placement.
The use of a C-arm is strongly recommended.
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with
the user to ensure that the most up-to-date IFU is used.
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2020-03-13