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Manufacturer and Service Address

Deutschland:

OCULUS Optikgeräte GmbH
Münchholzhäuser Straße 29
D 35582 Wetzlar
Tel.: +49 (0) 641/2005-0
Fax: +49 (0) 641/2005-299
E-Mail: [email protected]
www.oculus.de

USA:

OCULUS Surgical, Inc.
562 NW Mercantile Place, Ste. 104
Port St. Lucie, FL 34986, USA

Tel.: +1 772-236-2622 (outside of U.S.)
Tel.: +1 855-SDIBIOM (Toll free in U.S.)
Fax: +1 772-336-1984
E-Mail: [email protected]

Содержание BIOM 5

Страница 1: ...OCULUS BIOM 5 CONDITIONING INSTRUCTIONS BIOM 5 and Accessories...

Страница 2: ...to the safety instruc tions This instruction manual describes how to condition the following BIOM 5 models BIOM 5c and 5cl long version BIOM 5m and 5ml long version Due to ongoing development the diag...

Страница 3: ...ion by Machine 9 5 3 1 Information About Cleaning Disinfection by Machine 9 5 3 2 Cleaning and Disinfecting by Machine 10 5 4 Manual Cleaning Disinfection 13 5 5 Cleaning in an Ultrasonic Bath Optiona...

Страница 4: ...Table of Contents iii iii Conditioning Instruction BIOM 5 G 55185 0818 en...

Страница 5: ...Carefully read through the conditioning instructions Keep the conditioning instructions in a safe place You must have access to these during the conditioning process Observe the legal requirements for...

Страница 6: ...use which require special attention 2 2 Safety Instructions for Use Attention Risk of injury or material damage if the conditioning procedure is done incorrectly Observe the following safety instructi...

Страница 7: ...ly understood this instruction manual The BIOM 5 and all sterilisable components of the BIOM 5 must be cleaned disinfected and sterilised prior to initial use and prior to every subsequent use To do s...

Страница 8: ...nditioning Instruction BIOM 5 G 55185 0818 en 3 Conditioning Procedure Cleaning Disinfection Preparation Cleaning disinfection by machine or Manual cleaning disinfection Sterilising Preparation for st...

Страница 9: ...nents and other conditioning accessories is given in sect 11 page 25 BIOM 5c cl 1 BIOM 5cl 5 Cable duct 2 Adaptor plate 6 Reduction lens 3 Drive belt 4 Ophthalmoscopy magnifying loupe Fig 4 1 Componen...

Страница 10: ...e conditioning immediately after receiving the equipment in the conditioning station 5 1 Preparation Dismantle the BIOM 5 You must dismount the BIOM 5 before you condition it Pull the BIOM 5 off the a...

Страница 11: ...5cl only Detach the cable duct from the plug Take off the drive belt Before sterilising check that the drive module is secure If it is loose tighten the Allen screw 2 mm 1 at the drive module or call...

Страница 12: ...ater Water pistol Procedure Place the BIOM 5 in cold water for five minutes The BIOM 5 must be fully covered Flush the gaps joints and cavities the marked locations for 15 seconds with the water pisto...

Страница 13: ...00 must be reached Use water of a quality that meets the requirements of DIN EN 285 including demineralised water with an electrical conductivity of approx 15 S cm Use air that meets the compressed ai...

Страница 14: ...t concentrations specified by the manufacturer Cleaning method The following cleaning method was used for validation of the steam autoclavability of the BIOM optics See sect 12 page 25 Use the cleanin...

Страница 15: ...water Empty Clean for 5 minutes at 55 C with cleaning detergent Empty 3 Minute rinse cycle with cold demineralised water Empty 2 Minute rinse cycle with demineralised water Empty At the end of the pro...

Страница 16: ...one reduction lens at least one front loupe 2 rubber drive belts sterile cap for the knurled screw SDI control knob belong together These components can be put into the special insert and placed into...

Страница 17: ...t specific to the product and the method Cleaning tools Cleaning solution with 0 8 detergent Cidezyme Enzol from Johnson Johnson Water Procedure Perform a manual disinfection in accordance with the re...

Страница 18: ...soaking times at least 3 minutes and concentrations specified by the manufacturer of the cleaning additive Use the quantity of fluid specified by the manufacturer of the ultrasonic bath Heed the follo...

Страница 19: ...ey are macroscopically clean i e free from visible soiling corrosion or damage If impurities are found Clean disinfect the components again If corrosion or damage is found Do not use corroded or damag...

Страница 20: ...g body can be shifted without resistance Slide the safety rod of the loupe holder up and down several times to check that it runs smoothly After the test the rod must be pulled fully down to the stop...

Страница 21: ...are damaged If a component does not pass the function test do not use that component for a surgical procedure Send the components to OCULUS Service or an authorized dealer Before sending Clean disinf...

Страница 22: ...age if oils containing silicone or other substances are used Silicone components can solidify during the subsequent sterilisation process steam sterilisation and cause the instrument to seize up Heed...

Страница 23: ...r te GmbH for autoclaving Use one of the following sterilisation processes Fractionated Pre Vacuum Process Use a steam steriliser validated according to DIN EN 13060 or DIN EN 285 and DIN EN 17665 1 G...

Страница 24: ...ntitled in accordance with the legal provisions This guarantee excludes parts subject to wear such as the drive module of the BIOM 5 and the drive belts The drive module is guaranteed for 100 sterilis...

Страница 25: ...esentatives Manufacturer and Service Address Germany OCULUS Optikger te GmbH M nchholzh user Stra e 29 D 35582 Wetzlar Germany Tel 49 0 641 2005 0 Fax 49 0 641 2005 295 E mail sales oculus de www ocul...

Страница 26: ...sert for sterili sation container 55185 manual by machine x x x x x Insert for sterili sation container 55186 x x x x BIOM 5m 55462 manual by machine x x x x x x BIOM 5ml 55463 manual by machine x x x...

Страница 27: ...lization System1 134 C 273 2 F 132 C 269 6 F 134 C 273 2 F 3 5 min Adaptor Accessories Sterile cap for knurled screw 54580 manual x x x x x x SDI SDI II e SDI II m SDI 3 c SDI 4m SDI 4e SDI 4c 54800 5...

Страница 28: ...ine x x x x x x x Reduction lens for f 200 on BIOM 5ml cl 55404 manual by machine x x x x x x x Reduction lens for f 200 on BIOM 5m c 55405 manual by machine x x x x x x x Front Lenses for BIOM 5 Hi r...

Страница 29: ...rubber cap for SDI II and SDI 3 54335 Sterilisable rubber cap for SDI 4 pack of 5 54580 Sterilisable cap for knurled screw pack of 5 54176 Sterilisable drive belt pack of 10 54178 Cable duct for BIOM...

Страница 30: ...tions at in the conditioning station Dismantle the BIOM 5 Transport and Storage Safe storage in a closed container and transport of the products to the conditioning location Pre Cleaning Material Cold...

Страница 31: ...11607 Sterilising Fractionated Pre Vacuum Process Material Validated steam steriliser in acc with DIN EN 13060 or DIN EN 285 and DIN EN 17665 1 GOST R ISO 11134 Parameters 3 Pre vacuum phases Sterili...

Страница 32: ...2 Wetzlar Tel 49 0 641 2005 0 Fax 49 0 641 2005 299 E Mail support oculussurgical de www oculus de USA OCULUS Surgical Inc 562 NW Mercantile Place Ste 104 Port St Lucie FL 34986 USA Tel 1 772 236 2622...

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