15
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.
50 +/- 2 °F. Soaking time, 2 min. Neutralization detergent, Sekumatic FNZ. Concentration, 0.1% (1 ml/l). Post treatment (Rinsing): Rinsing
temperature, 50 +/- 2°F. Soaking time, 2 min. Solution, deionized water. Thermal disinfection: Disinfection temperature, 200 +/- 2°F. Soaking
time, 10 min. Solution, deionized water.
The cleaning/disinfection parameters were validated in a Miele disinfector type G7836 CD and the DES-VAR-SEKUMAT program. This program
is based on the Miele DES-VAR-TD program under worst case conditions.
STERILIZATION
The products are to be sterilized appropriately after cleaning/disinfection.
Exact compliance is required with the manufacturers´ user instructions for sterilizers.
It is the responsibility of the user facility to make sure that appropriate sterilization methods are used where ulrich medical recommendations
are not followed to account for potential differences in sterilization chambers, wrapping methods and load configurations.
Non-sterile products are sterilizable by steam sterilization (autoclaving). NOTE: CS 2934/CS 2938 measuring templates for x-rays are not steril-
izable! For initial sterilization and resterilization of multiple-use products, the following parameters can be used:
STEAM STERILIZATION
Cycle: Pre-Vacuum
Temperature:
270°F (132°C)
Exposure time: 4 min.
Drying time:
minimum 30 min.
Validation was performed with products packaged twice in hospital common sterilization packaging (paper/foil bag), inserted with repre-
sentative load into sterilization trays. The trays were inserted into common hospital sterilization containers and placed into sterilizers with
hospital common load using a hospital sterilization program. Validation was performed in half cycle (2 min).
MATERIAL STABILITY
When choosing the cleaning agent and disinfectant, make sure that they do not contain the following components:
Anticorrosives/corrosion inhibitors (triethanolamines are particularly problematic)
Strong organic, mineral and oxidizing acids
Stronger alkalis (pH > 12 is not permissible for implants, pH > 10.5 is not permissible for aluminum trays; neutral or weakly alkaline
cleaning agents are recommended)
Solvents (such as alcohols and acetone) and gasoline
Oxidizing agents
Ammonia
Chlorine and iodine
2019-09-10
