Owners Manual for ophthalmic instruments
Contents
1. Josef Haas Weg 1 D 78532 Tuttlingen Phone 49 700 7732 4736 Fax 49 7461 962 3781 Email office precisemed de2. Precisemed GmbH Owners Manual for ophthalmic instruments Warning These instruments are only intended for the use by professional ophthalmic sur geons who are familiar with the use of these instruments Application Range Medical devices are manufactured for medical use only and should be not misused They are designed for various eye operations The attending surgeon is re sponsible for the selection of the medical devices The doctor or Hospital is responsible for the adequate training of the surgical staff and for sufficient experience in handling of medical devices Information on Use General Information Please make sure the instrument is suitable for the intended use Preparation Before First Use Before the first use an instrument must be cleaned thoroughly tested and sterilized i e it must be subjected to the same reprocessing procedure as an instrument after the operation Please make sure the instrument has not been damaged in transit or storage Instruments may only be reprocessed by personnel who have undergone the relevant train ing The recommendations issued by the German Commission for Hospital Hygiene and In fection Prevention at the Robert Koch Institute RKI concerning Hygiene Requirements for the Reprocessing of Medical Devices must be observed We assume that trained personnel will have knowledge of these recommendations Reprocessing of Instruments According to EN ISO 17664 the manufacturer of medical devi
3. ces is obliged to draw attention to at least one method of cleaning by machine The process of cleaning by machine ex plained below was validated in a Miele GD 7735CD with the chemical Deconex 28 AlkaOne Borer Zugwil Switzerland using the radioisotope method Of course other detergents and machines can also be used for reprocessing In such cases ask your chemical supplier or machine manufacturer whether their products are just as effec tive as the products with which the method was validated Reprocessing Instructions 1 Preliminary Cleaning Manual Preliminary Cleaning Rinse all the instruments carefully using warm water as soon as the operation has been completed Remove any stubborn deposits with a cotton swab Use soft cleaning brushes for cavities Rinse out cannulas with a water jet 1 8 bar for 5 sec Never use metal brushes or scouring powder Dismantle take apart instruments In the case of forceps clamps and other instruments with a locking mechanism open the lock Ultrasonic Cleaning As an alternative to or in addition to manual cleaning you can soak the instruments in an ul trasonic cleaning bath for 5 minutes We recommend ultrasonic cleaning systems with a fre quency of at least 40 kHz Rinsing and Drying After cleaning rinse with purified water Aqua purificata Allow the water to drain off prop erly Dry carefully with soft cloths or sponges 2 Cleaning by Machine cleaning cycle with chemical thermal disinfec
4. tion Place the instruments in suitable holders in the washing machine in accordance with the op erating instructions issued by the washing machine manufacturer Miele Connect cannulas up to the special nozzles Run the following cleaning cycle 4 min Pre wash with cold water 6 min Clean at 70 C deconex 28 Alka One 0 5 Borer Zuchwil 3 min Neutralize with warm water gt 40 C 2 min Rinse with warm water gt 40 C Dry Functional Test Determination of pH with indicator paper for at least one instrument per cycle Functional test in accordance with Miele s operating instructions Visual examination for cleanliness Check the instruments for loose parts cracks rust and function In the case of scissors forceps and other instruments with joints lubricate the joints with a suitable oil or grease available from us Packaging Use suitable packaging for sterilization Either use transparent sterile packaging or a suit able sterilization box observe the instructions for use issued by the manufacturer of the ster ilization box Sterilization We recommend that our instruments be sterilized in an autoclave at 134 C Observe the operating instructions for the autoclave and the DIN 58946 standard Flash sterilization is not permitted for instruments with a lumen Storage Store the sterilized instruments in a dry clean and dust free environment at moderate tem peratures PRECISEMED GMBH Medical Device Mfg
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