Pre-Treatment - Josef Ganter Feinmechanik 1000204 Mode D'emploi

FB-EV 064 GA Ratsche Rev. 2 (Version: 25.11.2020) | (Translation: 25.11.2020)
The preparation and pre-treatment described below must be carried out in both cases.
5.2.2 Preparation for decontamination
Heavy contamination must be removed from the implements directly after use (within 2 hours maximum).
The ratchet must be disassembled into its individual parts before being cleaned (regardless of the selected cleaning method). This can be
done without tools. The handle must be completely removed. (see Figure 3)
Make sure not to lose the spring during disassembly and cleaning. Furthermore, the tools and ratchet wheels must be removed from the
ratchet head. (see chapter 4.2).
Pawl
Ratchet wheel Ratchet head
Figure 3
5.2.3

Pre-treatment

5.2.3.1 Procedure / pre-treatment process
Pre-cleaning must always be performed regardless of the following cleaning method. Rinse the products under cold municipal water (drink-
ing water quality, <40°C) until all visible contamination has been removed. Any dirt still adhering to the product must be removed with a soft
brush. Hollow spaces and lumens must be intensively (>30 seconds) rinsed out using a water pistol (or similar) with cold municipal water
(drinking water quality <40°C).
Mechanical process – thermal disinfection
5.2.4
Evidence of the fundamental suitability of the implements for an effective mechanical cleaning and disinfection was provided by an inde-
pendent and accredited testing laboratory that is recognised by the ZLG [Central Authority of the Länder for Health Protection with regard to
Medicinal Products and Medical Devices] (§15 (5) MGP [Medical Products Directive]) under use of the Miele G7835 CD cleaning and disin-
fection unit (thermal disinfection, Miele & Cie. KG, Gütersloh) and the pre-cleaning and cleaning agents neodisher ® mediClean (Dr. Weigert
GmbH & Co. KG, Hamburg). For this, the procedure described above was used.
5.2.4.1 Cleaning and disinfection unit and media
When choosing a cleaning and disinfection unit, it should be ensured:

that the effectiveness of the unit has been verified (e.g. DGHM [German Association for Hygiene and Microbiology] or FDA [Food and Drug Admin-
istration] approval / clearance / registration or CE label in accordance with DIN EN ISO 15883),

that where possible a tested thermal disinfection programme (A
(with chemical disinfection there is a risk of disinfecting agent residue on the implements),

that the programme used is suitable for the implements and has enough flush cycles,

that only demineralised water is used for rinsing,

that the air used to dry has been filtered (oil-free, low-microbiological contamination and particle-free) and,

that the cleaning and disinfection unit is regularly serviced and tested.
The materials, concentrations, temperatures and treatment times, as well as rinsing requirements, specified by the cleaning and disinfection
agent manufacturer must be adhered to at all times.
Mechanical cleaning / disinfection (→ RECOMMENDED)
5.2.4.2
Programme parameters used during certification (Programme: Des-Var-TD / Miele G7835 CD cleaning and disinfection unit):

The parts must be placed on a tray and put in the mobile injection unit (E450/1)

1 minute pre-cleaning
(cold municipal water, drinking water quality <40°C)
water

10 minutes cleaning at 55±5°C with 0.2% alkaline cleaning agent (0.2% Neodisher

1 minute rinsing with demineralised water <40°C → Drain water → 2 minutes rinsing with demineralised water <40°C → Drain water

Automatic disinfection > 5 minutes at 92±2°C with demineralised water.

Automatic drying process 90±2°C of the cleaning and disinfecting unit for at least 30 minutes (≙ 60±5°C in the washing compartment).
(Re-)preparation process:

Place the implements in the cleaning and disinfection unit. Make sure that the implements are not touching each other.

Start the programme.

When the programme ends, immediately remove the implements from the cleaning and disinfecting unit and ensure that they are dry enough before
packaging.

Inspect and package the implements as soon as possible after removing them from the unit.
5.2.4.3 Manual subsequent drying
If a manual subsequent drying is required, do so with a lint-free cloth and blow-out the lumens with sterile, oil-free pressurised air.
5.2.5 Manual process
Evidence of the fundamental suitability of the implements for an effective manual cleaning and disinfection was provided by an independent,
accredited and ZLG-recognised (§15 (5) MGP) testing laboratory under use of the cleaning and disinfection agents named below. For this,
the procedure described above was used.
5.2.5.1 Manual cleaning
1. Place products in an alkaline cleaning agent (for example, 0.5% Neodisher ® MediClean) in an ultrasonic bath for approx. 10
minutes. Do not exceed the maximum temperature of 40°C. Here, the instructions provided by the cleaning agent manufacturer
must be followed.
2. Thoroughly clean the product with a soft brush afterwards. If there are any hollow spaces and lumens, intensively (>30 seconds)
rinse them out using a water pistol (or similar).
User instructions
Ratchets
Spring Handle
value > 3000 or – with older devices – at least 5 minutes at 90°C / 194°F) is used
0
→ Drain water → 3 minutes pre-cleaning
®
MediClean) → Drain water
Page 3 of 5
(cold municipal water, drinking water quality <40°C)
→ Drain