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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.
1.5 T and 3.0 T
a 15-minute scan time
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.
CLEANING AND DISINFECTION
The implants are delivered non-sterile. Before use the implants are to be removed from the package and cleaned, disinfected and sterilized.
It is the responsibility of the user facility to make sure that appropriate cleaning methods are used where ulrich medical recommendations
are not followed.
New products must be carefully cleaned/disinfected before initial sterilization. Trained personnel must perform cleaning/disinfection along
with maintenance and mechanical inspection prior to initial sterilization. Implants should be cleaned/disinfected in accordance with the
following manual and/or automatic cleaning and disinfection specifications.
ATTENTION:
The measurement templates for the X-Ray pictures CS 2934/CS 2938 cannot be sterilized.
MANUAL CLEANING/DISINFECTION
Pre-cleaning:
Disassemble movable parts or joints prior to pre-treatment.
Rinse the products under running water.
Remove superficial impurities with a soft plastic brush; products containing lumen rinse appropriately (at least 5 times) with water and using
a syringe.
Cleaning:
Immerse the products for 5 min into the 104°F warm freshly prepared cleaning solution (e.g. Cidezyme LF) and intensively clean them with
a soft plastic brush.
Thoroughly rinse (at least 5 times) products containing lumen at the beginning and end of the brush cleaning with cleaning solution. Then
carefully rinse (at least 3 times for one minute) those products with sterile, deionized water using a syringe.
Disinfection:
Soak the products for 12 min in a disinfection solution. (e.g. Cidex OPA).
Thoroughly rinse (at least 5 times) products containing lumen at the beginning and end of the brush cleaning with disinfection solution. Then
carefully rinse (at least 3 times) those products with sterile, deionized water using a syringe.
Please note the following when selecting the cleaning and disinfecting agents to be used:
The cleaning/disinfecting agents used must be fundamentally suitable for cleaning and/or disinfecting the implants.
If applicable, the cleaning agent should be suitable for ultrasonic cleaning of the implants (no foam formation).
Use a disinfecting agent that has been certified effective (e.g., VAH/DGHM-certified, FDA-approved or bearing the CE label). The disinfecting
agent used must also be compatible with the cleaning agent used.
The chemicals used must be compatible with the implants (see “Material stability” section).
Where possible, avoid using the cleanser and disinfectant in combination.
AUTOMATIC CLEANING/DISINFECTION
Preparation:
The washing machine cleaning process must permit the implants to remain still when they are cleaned/ disinfected. Washing machines should
not be over-loaded.
In accordance with the manufacturer’s instructions, add the necessary amount of washing/disinfecting and rinsing agent into the washing
machine.
Cleaning and disinfection phase (DES VAR SEKUMAT):
Pretreatment (Rinsing): Rinsing temperature, 50 +/- 2°F. Soaking time, 1 min. Solution, cold water. Cleaning: Cleaning temperature, 104
+/- 2°F. Soaking time, 5 min. Cleaning detergent, Sekumatic FR. Concentration, 0.3% (3 ml/l). Neutralization: Neutralization temperature,
2019-09-10
