NEURO PLATING SYSTEM INSTRUMENT IFU Instructions for Use

Aesculap, Inc. Quality-AIC

- AIC-Instructions for Use NEURO PLATING SYSTEM IMPLANT IFU

- 다른 멸균 방법을 사용하여도 가능하지만, 사용 전에 멸균 유효성을 검증을 하여 야 한다. 멸균 방법에 따른 유효성 확인은 멸균하는 병원에서 수행하여야 하며, 정기적으로 멸균시간 및 권장 멸균 온도를 보장하도록 점검해야 한다. - 종이 여과지를 사용하는 경우 멸균할 때마다 새로운 여과지를 사용하여야 하며, 만일 멸균 후에 멸균 용기나 제품 등에 물기가 남아 있다면 다시 멸균을 해야 한 다. 8. 저장방법 실온 보관

ENGLISH 1. Purpose of use 1) Materials for Neuro surgery: Medical device for repairing cranial defect 2) Neuro Plating system is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure. 2. Contraindication - Patient who has active infection or potential infection - Patient who has bad bone quality or has disease which may cause bone weakness. - Patient who has problem with an Immune system. - Patient who has an allergy against titanium and titanium alloy (if an allergy is suspected, an allergy test is recommended.) - Blood poisoning patient - Patients who can’t take care of them selves after the surgery (mentally or physically) 3. Side Effects - Heavy physical exercise or pressure and incomplete treatment can damage an implant. - Implant loosening or moving -An allergy against titanium or titanium alloy - Pain caused by implant - Neural damage caused by surgical surgery - Bone necrosis or bone absorption or incomplete treatment 4. Material Screw:Ti-6Al-4V ELI (ASTM F136) Plate: Pure Titanium (ASTM F67) 5. Warning or Caution - Do not use it for those patients who are in such condition as low healing ability or long healing period. Ex: Too old, mental illness, alcohol addicted patients. - Do not use the products other than its purpose mentioned on IFU. - If an allergy against titanium or titanium alloy is suspected, an appropriate test should be done before using the products on the patient. - Dispose all risky products or wrongly handled products. -Warn patients that side effect might be occur if the patient doesn’t follow surgeon’s treatment instruction after surgery. - Always follow appropriate precautions. - All the instruments used together with the implants should be reused after sterilization. - Use most suitable size product for a patient - Excessive and repetitive bending may cause fracture -It’s function can’t be carried out properly if it is used in a wrong or improper purpose. -There are possibilities of implant loosening or implant moving caused by improper transplant. Therefore, informing patient about possibility of implant moving or loosening and possible side effect should be done. - MRI examinations using magnetic fields of 1.5 and 3.0 Tesla do not present an additional risk to implant wearers. - Implants produce moderate MRI artifacts. - The intraoperatively used instruments must be cleaned and disinfected separately from the implants - Do not reuse surgically contaminated implants. - Intraoperatively contaminated implants must be disposed. 6. Direction for use 1) Pre-operative preparations (1) Check if there is any damage of the product or its package. (2) Before surgery, select the screws and plates after checking patient’s bone condition and any problem expected after surgery. (3) Surgeon should know how to operate by using the instruments, what the clinical indication is, what the contraindication is and so on. (4) Check if there is any biochemical and biological factors which take a bad effect on surgery. (5) Carefully read IFU before using the products. (6) Since the product is supplied in a non-sterile condition, it must be sterilized before use. (7) Surgeons/physician should clearly inform the patient about risks related to surgery.

Effective

Document ID: SOP-AIC-5001949 Version: 1.0 Effective Date: 2019-10-01 (CET)

(3) Screw handling - In case of Self-Tapping, make a pilot hole for easy screw insertion. - Use manual or Power hand driver to pick up screw (4) Drilling pilot holes. - Making a pilot hole before screw insertion can reduce bone loss and the risk of screw fracture. - Use a minimum RPM to prevent bone necrosis during Pilot Drill. (5) Plate & screw fixation. - Insert screws by using screw driver and shaft. - Shaft can be removed from Screw Driver. - Use a shaft that corresponds to the size of the cross groove on the screw head. - In case of high density bone, pilot drill needs to be done before screw insertion. (6) Screw Removal - Select the driver for the screw. - Fix the screwdriver to the screw head firmly, then slowly rotate the screw opposite to the direction of screw insertion. Then, remove the screw completely from the bone. 7. Cleaning and sterilization recommendations for use of non-sterile medical devices (1) Inadequate cleaning detergent - Strongly acidic and basic (sulfuric acid, nitric acid, hydrochloric acid, etc.) cleaning solutions are inappropriate. Washing the products for a long time in high temperature is also improper. (2) Caution -Use of abrasive products or equipment (sandpaper, metallic brush, etc.) is prohibited. After the cleaning, the performance and operation status of the instrument, and the presence of foreign substances in the Implant product should be verified. To do this, the cleaning facilities and cleaning methods used at each hospital should be validated (3) Dry - Surgical instruments and products are thoroughly dried before sterilization. Validated mechanical alkaline cleaning and thermal disinfecting Phase Step T t Water Remark [°C/°F] [min] quality I Prerinse <25/77 3 D–W II Cleaning 55/131 10 FD-W 0.5 % working solution – pH = 11* III IV V

Intermediate rinse Thermal disinfecting Drying

>10/50

1

FD-W

-

90/194

5

FD-W

-

-

-

-

According to the program for cleaning and disinfection device

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: Dr. Weigert neodischer MediClean forte (4) Sterilization - The product is packaged in non-sterile condition and delivered. Thus, the product must be sterilized before use. - Remove all packaging material before sterilization. - Use a sterilization and storage tray for sterilization and pre-operative storage. Steam autoclaving is recommended as a sterilization method. * Validated sterilization process -Steam sterilization using fractional vacuum process -Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 -Sterilization using fractional vacuum process at 132℃/holding time 4min(Wrapped) * Medical devices used with this device must be declared, certified and approved. - Other sterilization methods may be used, but the effectiveness of sterilization should be verified before use. Validation according to the sterilization method should be performed at the hospital where sterilization is performed and sterilization time and the recommended sterilization temperature should be regularly checked. - If paper filter is used, a new filter paper should be used for each sterilization. If there is any water left in the sterilization container or product after sterilization, it should be sterilized again. 8. Storage Store at room temperature

2) Direction for use Plate & Screw (1) Plate & Screw Selection - Select appropriate screws and plates according to the treatment area and the patient’s bony anatomy. (2) Plate handling - Be careful not to deform the screw hole when bending the plate. - Plate Bending or Contour need to be done by Plate Bender but for some plates, hand can be used. - Depending on the thickness of the plate, use an appropriate treatment device (cutter, etc.). - Remove sharp edge by using Diamond file after Plate Cutting. - Use forceps to place a plate at the bone fixation site.

Document No.: NA - Version: 1.0 - Document ID: SOP-AIC-5001949 Date/Time Printed/Viewed: 2019-10-15 14:19 (CET) PNEU-IFU-N01(Rev.01) 2019.05