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10. GENERAL BASICS – PROCESSING
Read these instructions carefully before processing your Deflector Shaft for the
first time. This will protect you, the patient and any third parties from damages
possibly caused by incorrect processing!
Keep these instructions in an easily accessible place near the devices.
The Deflector Shaft must be cleaned, disinfected and sterilized before each sur-
gical use; this also applies to initial use after delivery as the product is delivered
in non-sterile condition. For initial cleaning and disinfection, remove Deflector
Shaft from transport packaging. Effective cleaning and disinfection is an impe-
rative prerequisite for effective sterilization.
In principle, only device and product-specific validated procedures are allowed
to be used for cleaning, disinfection and sterilization.
• The applied devices (washer-disinfector unit, sterilizer) have to be regularly
maintained and inspected.
• The validated parameters are mandatory.
Also, observe the legal regulations valid for your country as well as the medical
surgery's or hospital's hygiene regulations. This specifically applies for the vari-
ous regulations regarding effective prion inactivation.
The processing procedure described here is validated in accordance with
DIN EN ISO 17664; the proof of the effectiveness of the cleaning/disinfection
and sterilization procedures is in the operator's responsibility.
It is ensured by the manufacturer that the procedures mentioned below are
suitable for the processing of the Deflector Shaft.
Responsible for processing and validation as well as monitoring the process and
the results is the operator of the system.
Any deviation from the procedures stated here, such as the use of other process
parameters, must be verified and assessed by the processor for their effective-
ness and any adverse effects resulting from this.
11. CLEANING AND DISINFECTION
If possible, use a mechanical procedure (washer-disinfector unit) for cleaning
and disinfection. Due to significantly reduced effectiveness and uncertain repro-
ducibility, manual procedures – even when using an ultrasound bath – should
only be used if a mechanical procedure is unavailable (see chapter 11.4).
Deflector Shafts must be pretreated in both cases. Cleaning and disinfection
of the Deflector Shaft must be validated by the processing site. A successful
validation was achieved by the following processing steps. The manual pre-
treatment is not part of the RKI guidelines. When carrying out the cleaning, the
valid provisions and regulations on health and safety must be observed.
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