Josef Ganter Feinmechanik 1000204 Mode D'emploi page 9

FB-EV 064 GA Ratsche Rev. 2 (Version: 25.11.2020) | (Translation: 25.11.2020)
3. Rinse the product under running municipal water (drinking water quality) to remove the cleaning agent (>15 seconds).
5.2.5.2 Manual disinfection
1. Immerse the product in an RKI- or VAH-listed disinfecting agent. Here, the instructions provided by the disinfecting agent manu-
facturer must be followed. It must be ensured that the disinfecting agent really reaches all areas of the product (move the parts
around in the disinfection bath and, if necessary, rinse hidden areas using a syringe – without a cannula – with the disinfecting
agent).
2. The efficiency verification for the process was done using the disinfecting agent: 3% Korsolex plus (Bode Chemie, Hamburg) 15
minutes.
3. Rinse the products (complete rinsing of the inside, outside and hollow spaces) in demineralised water for >60 seconds.
5.2.5.3 Manual drying
1. Dry manually with a lint-free, single-use cloth. To avoid leaving any water in hollow spaces, blow these out with sterile, oil-free
pressurised air.
5.3 Check
Careful inspections and function tests before and after use are the best way to identify an implement which is no longer functional and to
sort it out. Particular attention must be paid to the working and function areas (e.g. the adapter fixture) and also to moving parts during the
inspection.
Let the parts cool down to room temperature. Parts with damaged surfaces, chips, dirt, discolouration and corrosion must be separated off.
Separate off any deformed, worn out (with regards to their function) or otherwise damaged implements.
Implements which are still dirty must be cleaned and sterilised again.
5.4 Maintenance
Lightly grease areas marked with
Here, care must be taken to ensure that only implement oils (paraffinic white oil, without corrosion inhibitors or any other additions) which – taking into consideration the maximum sterilisation temperature
which can be used – are approved for steam sterilisation and have a tested biocompatibility are used, and that they are only used in the smallest amounts possible.
Assemble the ratchet and perform a functionality test.
5.5 Packaging
The sterilisation of the products must be done in suitable sterilisation packaging. The manufacturer's verification was done using doubled
sterilisation packaging (hospital standard); that means that the single suitable sterilised foil packaging can also be used.
Flash sterilisation and the sterilisation of unpackaged implements is absolutely prohibited!
5.6 Sterilisation
Evidence of the fundamental suitability of the implements for an effective sterilisation was provided by an independent, accredited and ZLG-
recognised (§15 (5) MGP) testing laboratory under use of an EHS3870 pre- and post-vacuum autoclave (Tuttnauer Europe B.V., Breda) and
RB 51-3P and RB52-3P sterilisation packaging (Steriking-foil). For this, the procedure described above was used. These requirements must
be complied with.
3 vacuum cycles | 132°C / 270°F | ≥ 1.5 minutes stop time | Drying in the vacuum for at least 20 minutes
5.6.1 Sterilisation process - Fractionated vacuum procedure
Only the specified sterilisation procedures may be used for sterilisation.
Other sterilisation procedures are not permitted and their efficiency must be certified by the user / preparator themselves.

Fractionated vacuum procedure

Steam steriliser conforming to DIN EN 13060/DIN EN 285 and ANSI AAMI ST 79 (FDA clearance in the USA)

Validated in accordance with DIN EN ISO 17665 (valid IQ/OQ (commissioning) and product-specific performance evaluation
(PQ))

Maximum sterilisation temperature 134°C (273°F) including the tolerance margin in accordance with DIN EN ISO 17665

Sterilisation time (time exposed to the sterilisation temperature)
6 Storage
After the sterilisation, the products must be stored dust-free and dry in the sterilisation packaging.
7 Material resistance
When selecting the cleaning and disinfecting agents, please ensure that they do not contain the following elements:
- Organic, mineral and oxidising acids or strong alkaline solutions
- Organic solvents (e.g. alcohols, ethers, ketones, benzines)
- Oxidising agents (e.g. hydrogen peroxide)
- Halogens (chlorine, iodine, bromine)
- Aromatic / halogenated hydrocarbons
Acidic rinsing agents or neutralising agents should not be used!
All implements should not be subject to temperatures above 138°C (280°F).
8 Product life
The product life ends if the set torque is reached 5000 times. Usually, frequent repreparing has little effect on these implements – if suffi-
cient care is taken, and as long as the implement is undamaged and fully functioning. The end of the product's service life is normally de-
termined by wear and damage caused during use and depends on many factors – including the type, duration and frequency of application,
as well as the handling, storage and transportation of the implements.
1
At least 3 vacuum stages
2
The less effective gravitation procedure may only be used if the fractioned vacuum procedure is not available as an option, as it requires significantly longer sterilisation periods which
must be determined and validated under the responsibility of the user, and specifically for their implements, devices, procedures and parameters.
3
The actual required product drying time depends directly on the parameters, which are solely the responsibility of the user (loading configuration and density, sterilisation status,...) and
must therefore be determined by them. As a general rule, drying times should not be less than 20 minutes.
User instructions
Ratchets
 (see Figure 3) with implement care oil.
1;2
(with sufficient product drying
Page 4 of 5
3
3
)