Page 3 - reprocessing

e English e also applies to the first use after receipt of the products, which are minutes (e.g. INSTRU PLUS liquid cleaner for in-
delivered non-sterile and must be sterilized. struments and endoscopes from Dr. Schumacher,
Meoplant® Medical Implant System concentration 5mg/L). If the components can be
The hygiene regulations of the individual national and inter- dismantled, they must first be disassembled into
Reprocessing instructions for the national legal provisions of the dentistry/medical practices, their individual parts.
Meoplant Medical Implant System the hospitals as well as the dental laboratories must be com- 6. Remove any other visible residue with a nylon in-
plied with.
DISCLAIMER strument brush. Cavities, bushings and con-
For cleaning, disinfection and sterilization, only devices that strictions must be treated twice.
The products mentioned here are components of a comprehensive can demonstrate a validated procedure may be used. The fol- 7. Rinse all components under cold, running water
treatment concept and may only be used in combination with the lowingmeters for cleaning and sterilization must be complied (drinking water quality).
associated original products in accordance with the instructions with, as they have been subjected to a validated process. 8. Visual inspection of the purity of all individual parts.
and recommendations of Meoplant® Medical GmbH. The non-rec- When carrying out the preparation with different parameters, Magnifying glasses can be added as a support.
ommended use of third-party products in combination with Meo- the cleanliness of the product cannot be guaranteed.
plant products will void the warranty and any other express or im- All Meoplant Medical implants are intended for single use and Repeat steps 1 through 4 if residue is
plied obligations of Meoplant will be void. The user of Meoplant are delivered sterile. These must not be cleaned, disinfected still visible on the components.
products must determine whether the product is suitable for a par- and sterilized again: they are marked as follows:
ticular patient under the given conditions. Meoplant assumes no Machine cleaning and disinfection
liability, express or implied, for direct or indirect damages, penal-
ties including damages or other damages arising from or in con- 5. Place all components in an appropriately approved
nection with errors in professional judgment or practice in the con- (small) parts holder in the washer-disinfector (ac-
text of the use of Meoplant products. The user is also obliged to Do not re-sterilize Do not reuse Sterilized by irradia- cording to ISO 15883). Previously dismantled com-
regularly inform himself about the latest developments with re- tion ponents must be reassembled.
gard to Meoplant products and their application. If in doubt, con- All products must be arranged in such a
tact Meoplant. Since the use of the products is under the control INSTRUCTIONS FOR CLEANING AND STERILIZING way that they can be hit directly by the
of the user, the user assumes responsibility. Meoplant accepts no spray.
liability whatsoever for damage resulting from the use of the prod-
uct. 6. Cleaning and disinfection must be started using the
Any reprocessing must be carried out Vario TD program and a cleaning agent for me-
SCOPE OF APPLICATION OF THE INSTRUCTIONS FOR USE by trained personnel in a room specially chanical cleaning (e.g. Neodisher MediClean Den-
equipped for this purpose (with a clean tal from Dr. Weigert). Other cleaning programs are
These instructions for use are valid for all components of the Meo- and unclean zone). not covered by the validation.
plant implant system that may be reprocessed (reusable instru- 7. Drying of the instruments with purified compressed
ments) in accordance with their intended purpose and label- Successful sterilization is preceded by efficient cleaning and air. Pay attention to hard-to-reach areas such as
ling,taking into account the Medical Devices Regulation 2017/745. disinfection. Before/after each application to the patient, the bushings.
Reusable products include all insertion tools of the Meoplant Med- instruments and prosthetic components must be cleaned, dis- 8. Visual inspection of the purity and integrity of all
ical Implant System (drill extension, hexagonal instruments, im- infected and sterilized. components. Magnifying glasses can be added as
plant insertion instruments, torque ratchet, depth stops and surgi- a support.
cal trays). The implants, abutments and impression tools are for Dirty/used instruments must be separated from the (still) Repeat steps 1 through 4 if residue is
clean instruments during use. These are not to be put back
single use and are not designed for reuse.
into the surgical tray. After successful cleaning and disinfec- still visible on the components.
SAFETY tion, the instruments are sorted back into the surgical tray and
then sterilized as a set. Packaging and sterilization
For reasons of hygiene and health protection, all reusable medical Manual pre-cleaning
devices distributed by Meoplant Medical (see scope of the instruc- All components supplied non-sterile
tions for use) must be cleaned, disinfected and sterilized before/af- 5. Immediately after use, place all componentsto be must not be sterilized in their original
ter each application to the patient or in the patient's mouth. This cleaned in a liquid instrument cleaner for 30 packaging.
Side 3 from 26