ulrich medical uCentrum Instructions For Use Manual page 10

ƒ at 3.0 T: Distance from outer edge of implant to the iso-center of the MRI device > 20 cm OR scan time of a maximum of 15 min
Note: Under experimental conditions, 6.1°C heating was measured at 3.0 T and with a 15-minute scan time at 2 W/kg. At 1.5 T with a 20-cm
distance from the iso-center with a 15-minute scan time, 3.0°C maximum heating was measured. These scan conditions allow low-risk exami-
nation of patients. To minimize heating, the scan time should be as short as possible and the SAR should be kept as low as possible.
Artifacts: MR imaging in the area of the implants can be impaired by artifacts. In the test, artifacts up to 28 mm were detected radially around
the implant. The scans were performed with the following parameters:
ƒ FFE sequence: TR 100 ms, TE 15 ms, flip angle 30°
ƒ SE sequence: TR 500 ms, TE 20 ms, flip angle 70°
The SE sequence showed reduced artifacts (≤ 17 mm).
The attending physician should conduct a careful risk/benefit assessment.
10 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 implants and instruments.
11 Identification and traceability
Implants are labeled with the catalogue number and batch code on the packaging label and, if technically feasible, these are marked on the implant itself.
To ensure traceability, these data must be correspondingly documented in the hospital.
12 Disposal of used products
Follow country-specific regulations regarding disposal of hospital waste when disposing of used medical devices.
13 Cleaning, disinfection and sterilization
The product is delivered non-sterile and must be sterilized before its first use.
For cleaning, disinfection and sterilization of non-sterile implants and instruments the "Processing manual implants and instruments"
UH 1100 that was provided in the overall documentation of the system must be used. For individual instruments which are correspondingly
marked in the surgical technique, the "Assembly and disassembly instructions with special cleaning instructions" that was provided in the
overall documentation of the system have to be considered.
These are also available at: www.ifu.ulrichmedical.com.
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.
10
2019-05-06