BEMA MEDICAL
Micro Surgical Instruments Instructions for Use
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Instructions for use Manufacturer: BEMA GmbH + Co. KG Rudolf-Diesel-Str.12 78576 Emmingen/Germany
Medical Devices:
Distributor:
Micro Surgical Instruments Arthroscopy and Antroscopy Instruments
With the purchase of this instrument, you have acquired a high-quality product. The proper handling and use is described below. In order to minimize hazards to patients and users, we ask that you carefully observe the instructions for use. Only trained professionals may use, disinfect, clean and sterilize the instruments. Tests The instruments must be checked to make sure they work properly before every use. Damage to the surface, such as scratches, cracks, nicks, dents, etc., as well as bent parts, is a indication that they may not be used. The products are then to be repaired or are to be disposed of according to hospital procedure. Do not use any damaged products! Area of use We manufacture our instruments as standard instruments for operative use in the endoscopy. The instruments will be use in combination and in connection with other instruments, e. g. Trocars, Endoscopes. The products may be used only by those persons who possess the necessary knowledge and training and assess the emerging risks to the corresponding effects. Indication The indication depends on the kind of the investigation and the operation. The surgeon shall be responsible for the proper selection of the instruments for each application, for obtaining the appropriate training, knowledge and experience, and for their operative use. Contra- Indication Special contra-indications are not known. The use of Micro Surgical Instruments and Arthroscopy/ Antroscopy Instruments is contra-indicated, if the procedure is contraindicated. Risks Injury to nerves, vessels and tissue Bleeding Infections Complications In general, complications seldom occur. The frequency and severity of the complication depends on the type of examination. The most frequently complications are infections due to defective preparation. Combination with other products / instruments Combinations with products from other manufacturers may negatively affect the result of the operation, since the used components might not be compatible with one another. It is recommended to only use instruments and accessories from BEMA GmbH + Co. KG. Liability claims arising from improper use or combination with other devices and instruments will be not accepted. Disposal If the instruments should no longer be reparable and treatable, these are to be disposed of according to hospital procedure. Used materials The used materials are stainless steels according to EN ISO 7153-1 or biocompatible plastics. Procedure:
Automated Cleaning Process
ADVICE:
Reprocessing procedures have only limited implications to a surgical instrument. The limitation of the numbers of reprocessing procedures is therefore determined by the function / wear of the device. In case of damage the device should be reprocessed before sending back to the manufacturer for repair.
Reprocessing Instructions Dateiname mit Revisionsstand: Bema Medical Instruction for use.doc
erstellt von: jw
erstellt am: 17/09/2012
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Preparation at the Point of Use:
Remove gross soiling by submerge the instrument into cold water (<40°C) immediately after use. Don’t use a fixating detergent or hot water (>40°C) as this can cause the fixation of residua which may influence the result of the reprocessing process.
Transportation:
Safe storage and transportation in a closed container to the reprocessing area to avoid any damage and contamination to the environment.
Preparation for Decontamination:
The devices must be reprocessed in an opened or disassembled state.
Pre-Cleaning:
Immerse the instrument into cold tap water for at least 5 minutes. Dismantle the instruments If possible and brush under cold tap water until all visible residues are removed. Inner lumens, threads and holes are flushed each with a water jet pistol for minimum 10 seconds in the pulsed mode Immerse the instrument into an ultrasonic bath with alkaline (enzymatic) detergent (0,5%) and treat with ultrasonic for 15 minutes at 40°C. The instrument is taken out of the bath and rinsed with cold tab water again. Put the instruments opened and or, if possible, in a disassembled state on an instrument tray. Put the tray on an instrument rack in the washer disinfector and start the cycle: 1. 1 min. pre-cleaning with cold water 2. draining 3. 3 min. pre-cleaning with cold water 4. draining 5. 5 min cleaning at 55°C with 0,5 % alcaline detergent 6. draining 7. 3 min neutralisation with warm water (>40°C) and neutralizer 8. draining 9. 2 min rinse with warm water (>40°C) 10. draining
Automated Cleaning:
Disinfection:
Automated Disinfection: Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to A0-Value (see ISO 15883)
Drying:
Automated Drying: Drying of outside of instrument through drying cycle of washer/disinfector. If needed, additional manual drying can be performed through lint free towel. Insufflate cavities of instruments by using sterile compressed air.
Functional Testing, Maintenance:
Visual inspection for cleanliness, assembling and functional testing according to instructions of use. If necessary perform reprocessing process again until the instruments are visibly clean.
Packaging:
Appropriate packaging for sterilization according ISO 11607-1. Another packaging must be validated. Sterilization of instruments by applying a fractionated pre-vacuum process (according. ISO 13060 / ISO17665) under consideration of the respective country requirements.
Sterilization:
Parameters for the pre-vacuum cycle: 1. 3 prevacuum phases with at least 60 milli bar 2. Heat up to a minimum sterilization temperature of 134°C; maximum temperature 136°C 3. Minimum Holding time: 3.5 min 4. Drying time: minimum 10 min Storage of sterilized instruments in a dry, clean and dust free environment at modest temperatures of 5°C to 40°C.
Storage: Reprocessing validation study information
The following testing test devices, materials & machines have been used in this validation study; Detergent: Neodisher Mediclean forte; Dr. Weigert; Hamburg (Alkalisch) Neutralizer: Neodisher Z; Dr. Weigert, Hamburg Washer / Disinfector: Miele G7835 CD Program: Design Vario TD AD
Additional Instructions: If the described chemistry and machines are not available, it is the duty of the user to validate his process The user must ensure that the biological compatibility of the products can be guaranteed by selecting appropriate cleaning chemicals and preparation processes. The user is in charge of for the removal of the used cleaning chemicals by the employed cleaning process. The complete removal of the cleaning chemicals must be specified and validated for the employed cleaning process. It is the duty of the user to ensure that the reprocessing processes including resources, materials and personnel are capable to reach the required results. State of the art and often national law requiring these processes and included resources to be validated and maintained properly. For with Creutzfeldt-Jakob agents contaminate instruments sometimes the holding time at the sterilization cycle will be increase to a higher time of 30 min. This is known to cause problems on many instruments. It’s better to use a proper disinfectant before and use common holding time for instruments. But if a safe sterilization of with Creutzfeldt-Jakob agents contaminates instruments is not possible, the instruments must be disposed of according to hospital procedure. Consult the national and regional rules and regulations in respect of the handling of with Creutzfeldt-Jakob agents contaminate surgical instruments Dateiname mit Revisionsstand: Bema Medical Instruction for use.doc
erstellt von: jw
erstellt am: 17/09/2012
geändert von: -
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Maintenance of instruments Maintenance of surgical instruments means lubrication with physiologically inert instrument oil (acc. to DAB 8 or Ph.Eur. or Usp) particularly of the joints. Make it a basic rule to thoroughly lubricate surgical instruments prior to checking for function. All movable parts (joints) and cutting blades of scissors have to be lubricated. This avoids metal abrasion when checking for function. Lubricants used must guarantee that even after frequently repeated use a “sticking” of joints through a multiplying effect is avoided.
Dateiname mit Revisionsstand: Bema Medical Instruction for use.doc
erstellt von: jw
erstellt am: 17/09/2012
geändert von: -
geändert am: -
Seite 3 von 2