- Do not use any fixing agents or hot water (> 40 ° C), Detergent for automated cleaning in washers and

WARNINGS AND PRECAUTIONS as this leads to the fixing of residues and can affect disinfectors (WD)
- RUDOLF Medical instruments must be cleaned, the success of the cleaning procedure.
INSTRUCTIONS FOR USE (EN) disinfected, and sterilized before first use. - Defective instruments must be identified and clearly Process Detergent pH Manufacturer
REUSABLE SURGICAL INSTRUMENTS Protective caps and transport packaging must be marked. They are also to be reprocessed. Type value
removed beforehand. Alkaline Neodisher® 12.2 Dr. Weigert
FA
- A complete functional check must be carried out Transportation
Enzymatic deconex® 9.7 Borer
before each use. - Safe storage and transport of the instruments to the
23
- Improper use and overstraining due to twisting / reprocessing site in a closed receptacle / container Neutrazym
levering can lead to breaks and permanent system to avoid damage to the instruments and
deformation. contamination to the environment. Automated cleaning program with thermal
- Do not use metal brushes or abrasives, as there is disinfection in the WD using an alkaline OR
a risk of corrosion due to surface damage. Preparation for decontamination enzymatic process
- The safe combination of instruments with each - The instruments must be disassembled or opened
other or of instruments with implants must be for reprocessing as far as possible without using Time / Temp
checked by the user before clinical use. tools. Process Reagents
min / °C
- Be careful when handling sharp tips and cutting Pre-cleaning Water 1 cold
edges - risk of injury. Manual pre-cleaning Drain
- In the case of patients with Creutzfeldt-Jakob - Instruments with difficult to access areas such as
Pre-cleaning Water 3 cold
disease (CJK), suspected CJK or possible variants lumens, cavities, bores, threads, and slots must be
Drain
of this disease, the applicable national regulations soaked in cold water for at least 5 minutes and
RUDOLF Medical GmbH + Co. KG Water, 0.5% alkaline
regarding the preparation of instruments must be rinsed under water with a water jet gun for at least
Zollerstr. 1, 78567 Fridingen, detergent 55
applied. 10 seconds (pulsed procedure).
Germany Cleaning OR 5
- Never leave instruments in disinfectant solution too - To support manual cleaning and before automated
Tel. +49 7463 9956-0 Water, 0.5% enzymatic
long. Follow the instructions of the respective cleaning in case of heavily encrusted soiling, 45
Fax +49 7463 9956-56 detergent
manufacturer. cleaning must be carried out in the ultrasonic
sales@RUDOLF-med.com
cleaning device (cleaning solution < 40 ° C, Drain
- Automated cleaning / disinfection should be
www.RUDOLF-med.com Neutralization Water 3 cold
preferred to manual cleaning / disinfection, since sonication time min. 10 min.).
automated processes can be standardized, - Observe the manufacturer's instructions for the Drain
D0462 / Rev. J / ACR00358 / 2022-07-18 0297
reproduced and thus validated. cleaning agent (concentration, temperature, and Rinsing Water 2 cold
sonication time). Drain
PRIOR TO EACH USE: - Vibration can loosen small parts such as screws Disinfection * Demineralized water >5 > 90
PLEASE READ BEFORE PROCESSING AND KEEP VISUAL AND FUNCTIONAL INSPECTION and nuts. After ultrasound treatment, ensure that max.
Drying ** > 20
IN A SAFE PLACE Check for: the instruments are complete and pay attention to 93
- External damage (shaft deformed, dents or sharp loosened small parts.
edges) * Carry out mechanical thermal disinfection by considering the
PRODUCTS
Automated cleaning national requirements regarding the A0 value from ISO 15883-1
This reprocessing instruction applies to reusable surgical - Correct functioning
(A0 = 3000).
and endoscopic instruments supplied by RUDOLF - Detergent or disinfectant residues - Clean and disinfect the instrument only in suitable
** If necessary, manual drying with a lint-free cloth can also be
Medical. - Free passage through working channels. washers and disinfectors (WD) and with a carried out. Dry instrument cavities with sterile compressed air.
procedure / program validated for the WD and this
GENERAL REPROCESSING INSTRUCTIONS type of instrument (EN ISO 15883). MAINTENANCE, CONTROL AND INSPECTION
Reusable surgical instruments from RUDOLF Medical Restrictions - Instruments with cavities (tubes, shafts, hoses) must - After cleaning and disinfection, the instruments
can be used by medical professionals for a surgical - Repeated / frequent reprocessing according to be connected to appropriate flushing devices to must be subjected to a visual and functional
procedure and can be reused after qualified these instructions has only little effect on the ensure that these cavities are flushed. inspection. The instruments must be
reprocessing. durability of the instruments. - The operating and loading instructions of the WD macroscopically clean (free of visible residues).
The professional user selects the appropriate - The durability of a reusable instrument is essentially manufacturers must be observed. Particular attention should be paid to slots, ratchets,
instruments according to the intended function, the determined by wear and damage caused by the - Instruments with joints must be opened approx. 90 ° locks, and other areas that are difficult to access.
tissue to be manipulated and the anatomical structures. application. for cleaning. - If dirt residues / liquids are still visible, the cleaning
- When choosing the cleaning agent, please observe and disinfection process must be repeated.
Initial treatment at the place of use the material and properties of the instrument, the - Before each sterilization, the instrument must be
- The instruments must be reprocessed within 1 hour cleaning agents recommended by the WD assembled and checked for function, wear, and
after use, to prevent dirt from drying on the manufacturer for the respective application and the damage (cracks, rust) and replaced, if necessary.
instruments. relevant lists and recommendations of the Robert - Close instruments with a ratchet only in the first
- Heavy soiling on the instrument must be removed Koch Institute (RKI) and of the Deutsche notch of the ratchet before sterilization or keep them
with a disposable rag, cloth, or tissue immediately Gesellschaft für Hygiene und Mikrobiologie (DGHM, open.
after use. German society for hygiene and microbiology). - After each cleaning and before sterilizing, the
- Working channels and lumens must be flushed moving parts must be oiled and maintained with a
through at least 3 times immediately after use to physiologically harmless oil (paraffin oil according to
avoid blockages.

D0462 Page 1 of 2
 DAB or Ph. Eur. Or USP); especially locks, joints, INFORMATION REGARDING THE VALIDATION OF SYMBOLS
and ratchets. THE REPROCESSING PROCEDURE
- Defective products must have gone through the The following materials & machines have been used Consult instructions for use.
entire reprocessing process before being returned during the validation procedure:
for repair or complaint.
Table 1: Materials and machines Batch code
PACKAGING Alkaline detergent Neodisher® FA
- Packaging of the instruments for sterilization Article no.
Enzymatic deconex® 23 Neutrazym
according to standards ISO 11607 and EN 868. detergent
- Pointed and sharp cutting edges must not perforate QTY No. per package
Washer / G 7735 CD (Miele)
the sterilization packaging. Disinfector
- In case of individual packaging, care must be taken Non-sterile
Slide-in cart Slide-in cart E 327 – 06
to ensure that the packaging is large enough to hold
MIS–Slide-in cart E 450
the product without putting tension on the sealing Lubricate with silicon-free,
seam or tearing the packaging. biocompatible white medical oil
ADDITIONAL NOTES
- If the described chemical agents and machines are approved for steam sterilization.
STERILIZATION
not available, it is the duty of the user to validate his
- Sterilization has to be carried out according to DIN Caution
process.
EN ISO 13060 / ISO 17665 or a validated steam
sterilization method (fractionated vacuum method) CE marking, according to EG directive
DISPOSAL
in a sterilizer according EN 285 / DIN 58946. 93/42/EWG and Medical Device
- Products may be disposed of correctly, only after
Regulation (EU) 2017/745 (MDR)
they have been cleaned and disinfected properly.
Sterilization Minimum Drying time CE marking according to EG directive
- Comply with national regulations when disposing of
temperature holding 93/42/EWG with the identification
or recycling the product or its components. 0297
time number of the notified body
- Dispose of the product in an environmentally
(exposure
friendly manner in accordance with the applicable Manufacturer
time)
hospital guidelines.
134 °C - 137 °C 3-5 minutes Minimum of
- Be careful with sharp tips and cutting edges. Use
10 minutes Manufacture date
suitable protective caps or containers to prevent
third parties from being injured.
or
Sterilization according ANSI AAMI ST77 Medical Device
RETURNS
Sterilization Minimum Drying time - If an instrument is damaged, it should go through
temperature holding the complete reprocessing process before it is sent
time back to the manufacturer for repair. No own repairs
(exposure may be carried out on the instrument.
time) - Be careful with sharp tips and cutting edges. Use
suitable protective caps or containers to prevent
132°C - 135°C 4 minutes 20 minutes
third parties from being injured.
(270°F - 275°F)

PROBLEMS / EVENTS
Please observe the manufacturers’ instructions of the
- The user should report any problems with our
sterilizer.
products to the respective specialist dealer.
- In the event of serious incidents with the products,
STORAGE
he must report this to RUDOLF Medical as the
- Storage of the sterilized instruments in a low-germ,
manufacturer and the competent authority of the
dry, clean and dust-free environment at 5 - 40°C.
member state in which the user is established.

WARRANTY
- The instruments are made of high-quality materials
and are subjected to a strict quality control before
delivery. If there are any discrepancies, please
contact RUDOLF Medical.

D0462 Page 2 of 2