Surgical Guides Instructions for Use
Immeuble Vecteur Sud - 70-86, avenue de la République 92320 Châtillon (France) Tél. : +33(0)1 46 56 31 52 – Fax : +33(0)1 46 54 14 04 Email : [email protected]
INSTRUCTIONS FOR USE SURGICAL GUIDES Manual cleaning :
DESCRIPTION OBL PATIENT SPECIFIC surgical guides are medical devices specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient during a surgical operation. Patient specific surgical guides are made in polyamide or in implantable titanium grade 2 (conforms to standard NF ISO 5832-2 and ASTM F67: Products based on metals, unalloyed titanium). Patient specific surgical guides are provided NON STERILE, SINGLE USE and are NON BIODEGRADABLE. INDICATION OBL patient specific surgical guides are intended for surgical operations (maxillary, neurosurgery, esthetic plastic and reconstructive surgery) and include all the products described here below with the following indications: - Positioning guide: Tool helping the surgeon while the placement of a patient specific implant. - Osteotomy guide: Tool supporting the surgeon while cutting a bone piece. It enables to plan in advance and with a high precision the anatomical piece section. During the surgery, the guide affixes on the anatomical work piece gives precise landmark for the surgeon to perform the gesture. - Fibula section guide: Tool employed for maxillary or mandibular reconstruction. It is used as fibula osteotomy guide and as drilling guide in some cases. - Drilling guide: This guide allows the patient specific implant positioning. Several functions could be combined in one guide.
CONTRAINDICATION - Doubt on the reliability of patient’s anatomical scanner data, the scanner data does not guarantee patient’s anatomy representativeness, - Patient with a high sensibility to materials used.
Step 1 2 3 4
Cleaning instructions Prepare a fresh, newly-made solution using warm de-ionized (DI) or purified water (PURW) and enzymatic cleaner or detergent Carefully wash the guide or model manually Rinse the guide or model thoroughly with DI or PURW Dry the guide or model using a clean, soft, lint-free cloth or clean compressed air
Manual pre cleaning : Step 1 2
Minimum duration 1 minute 2 minutes
Cleaning instructions Rinse the guide or model under running cold tap water Manually clean the guide or model in a newly-made enzymatic cleaner or detergent solution Rinse the guide or model using cool to lukewarm running tap water. Use a syringe, pipette or water pistol to flush cylinders, slots, and other hard-to-reach areas Clean the guide or model ultrasonically per manufacturer’s recommended temperature (usually 32°-60°C or 90°-140°F) and specially formulated detergents. Follow manufacturer’s recommendations for proper cleaning solution formulated specifically for ultrasonic cleaners and medical equipment Rinse the guide or model using DI or PURW. Use a syringe, pipette or water pistol to flush cylinders, slots and other hardto-reach areas.
Automated cleaning in a washer-disinfector: Step Pre-wash Wash Neutralize Rinse Thermal disinfection
Minimum Duration 2 minutes 10 minutes 2 minutes 2 minutes 7 minutes
Cleaning instructions Cold tap water Warm tap water (>40°C) ; use detergent Warm tap water with neutralizer, if necessary Rinse with warm DI or PURW (>40°C) At minimum 94°C
At minimum 90°C
Before the cleaned products are packaged and sterilized, carefully examine them to see if they are cleaned and undamaged.
ADVERSE EFFECTS Sterilization Patient should be warmed by the surgeon of the limits and risks linked to the surgical guide utilization. The surgical guide is designed to fit patient’s anatomy. Consequently, if during the surgery it is not possible to place the guide in the position defined during the pre-operative phase, the planning transfer cannot be guarantee.
GENERAL INSTRUCTIONS FOR USE OBL only guarantee compatibility between OBL patient specific surgical guides and his instrumentation for utilization of patient specific surgical guides. Surgical guides must be placed by a surgeon with the necessary training.
PATIENT SPECIFIC SURGICAL GUIDES USE/HANDLING Generally, patient specific surgical guides should be kept in their initial packaging until being cleaned and sterilized for use. Surgical guides mustn’t be in contact with objects that may damage the surface.
Sterilize the guide using pre-vacuum steam sterilization before use. During sterilization of single devices pouches may be used. For US: only legally marketed, FDA cleared and validated sterilization pouches should be used by the end-user for packaging the devices during sterilization. Outside US: only standard medical grade steam sterilization polyethylene or Tyvek pouches should be used. Ensure that the pouch is large enough to contain the devices without stressing the seals or tearing the pouch. Use one of the following standards steam sterilization settings: Pre-vacuum Cycle US: Minimum temperature : 132°C (270°F) Minimum exposure time: 4 minutes Minimum vacuum drying time: 30 minutes Pre-vacuum Cycle UK,NL: Minimum temperature : 134°C Minimum exposure time: 3 minutes Minimum vacuum drying time: 30 minutes Word Health Organization Pre-vacuum Cycle: Minimum temperature: 134°C (273.2°F) Minimum exposure time: 18 minutes Minimum vacuum drying time: 30 minutes
STORAGE Patient specific surgical guides must be stored in a dry and clean place at ambient temperature protected from sunlight, source of heat.
DECONTAMINATION, CLEANING AND STERILIZATION OF TITANIUM GUIDES Patient specific surgical guides are delivered NON STERILE: Under a protective packaging and into a box that couldn’t be used as a sterile packaging.
The package label indicates a reference and a unique batch number. It is recommended to register these numbers on the patient’s protocol because these numbers allow tracking the manufacturing processes of the implant, until the raw material. OBL, as manufacturer of these devices does not assume any responsibility related to immediate or subsequent defects caused by failure or no respect of the intended use conditions, improper use or handling. Symbols associated to OBL patient specific surgical guides labels:
Protocols and instructions related to decontamination, cleaning and sterilization of titanium patient specific surgical guides are provided in a document attached to this IFU: Decontamination-Cleaning-Implant Sterilization OBL Products (if this instruction is missing please get in touch immediately with OBL or your retailer).
DECONTAMINATION, CLEANING AND STERILIZATION OF POLYAMIDE GUIDES Patient specific surgical guides are delivered NON STERILE: Under a protective packaging and into a box that couldn’t be used as a sterile packaging. Polyamide patient specific surgical guides must be clean and sterilize before using. Whenever possible a washer-disinfector (according to ISO 15883) and ultrasonic cleaning equipment should be used to clean the guides and models. The detergent and/or enzymatic cleaner should be of neutral or near neutral pH (pH 7 - 9, 5). The guides and models can be cleaned using manual cleaning and/or automated cleaning in a washer-disinfector with a manual pre cleaning and ultrasonic cleaning.
For any information, contact OBL or your retailer
Revision date : 10-23-2014