OCULUS BIOM 5 Conditioning Instructions
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OCULUS BIOM 5 Conditioning Instructions

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OCULUS
BIOM
5
CONDITIONING INSTRUCTIONS
BIOM® 5 and Accessories

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Summary of Contents for OCULUS BIOM 5

  • Page 1 ® OCULUS BIOM CONDITIONING INSTRUCTIONS BIOM® 5 and Accessories...
  • Page 2 Our service team will gladly assist. OCULUS Optikgeräte GmbH OCULUS is certified according to DIN EN ISO 13485, setting high standards of quality where development, manufacture, quality assurance and service regarding the entire range of products are concerned.

  • Page 3: Table Of Contents

    Table of Contents Table of Contents Applicability..........................1 Safety Instructions........................1 About this Manual ......................1 2.1.1 Used Graphic Symbols.................2 Safety Instructions for Use ..................2 Conditioning Procedure......................4 Components of the BIOM® 5 to be Conditioned ...............5 Cleaning and Disinfection ......................6 Preparation: Dismantle the BIOM® 5 ...............6 Pre-Cleaning ........................8 Cleaning/Disinfection by Machine ................9 5.3.1...
  • Page 4 Table of Contents iii / iii BIOM® 5 (G/55185/0818/en) Conditioning Instruction...

  • Page 5: Applicability

     Heed the supplementary conditioning information supplied with certain products. The current version of this manual can be downloaded at www.oculus.de, or you can request a copy from OCULUS Optikgeräte GmbH, Wetzlar. Conditioning Instruction BIOM® 5 (G/55185/0818/en) 1 / 26...

  • Page 6: Used Graphic Symbols

    2 Safety Instructions 2.1.1 Used Graphic Symbols Attention Denotes a potentially hazardous situation which can easily result in minor physical injury or property damage. Note Denotes situations which could result in incorrect findings, denotes user instructions and useful or other important information. Denotes important information about the product and its use, which require special attention.
  • Page 7 Notes on returning Attention Personal injury caused by contaminated BIOM® and components  Before returning the product to OCULUS: Prepare the BIOM® and sterilisable components according to this treatment instructions.  Send only visibly prepared OCULUS products back to OCULUS Conditioning Instruction BIOM®...

  • Page 8: Conditioning Procedure

    3 Conditioning Procedure Conditioning Procedure  Cleaning/Disinfection Preparation  Cleaning/disinfection by machine  Manual cleaning/disinfection   Sterilising Preparation for sterilisation   Steam sterilisation 4 / 26 Conditioning Instruction BIOM® 5 (G/55185/0818/en)

  • Page 9: Components Of The Biom® 5 To Be Conditioned

    4 Components of the BIOM® 5 to be Conditioned ® Components of the BIOM 5 to be Conditioned ® BIOM 5c/cl BIOM® 5cl Cable duct Adaptor plate Reduction lens Drive belt Ophthalmoscopy magnifying loupe Fig. 4–1: Components of the BIOM® 5cl ®...

  • Page 10: Cleaning And Disinfection

    5 Cleaning and Disinfection Cleaning and Disinfection Recommendation:  Clean or disinfect the BIOM® 5 by machine, as this is much more effective.  Start pre-conditioning immediately after receiving the equipment in the conditioning station. ® Preparation: Dismantle the BIOM You must dismount the BIOM®...
  • Page 11 5 Cleaning and Disinfection For BIOM® 5c and BIOM® 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 in your hospital technician Fig.

  • Page 12: Pre-Cleaning

    5 Cleaning and Disinfection Pre-Cleaning Cleaning tools Cold water   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 pistol.

  • Page 13: Cleaning/Disinfection By Machine

    5 Cleaning and Disinfection Cleaning/Disinfection by Machine 5.3.1 Information About Cleaning/Disinfection by Machine Cleaning/Disinfection Unit (CDU)  Make sure that the CDU meets the following criteria. It must have been tested for efficiency (e.g. DGHM I or FDA approval, or CE ...

  • Page 14: Cleaning And Disinfecting By Machine

    5 Cleaning and Disinfection Note Risk of malfunctions and surface damage if alkaline detergents are used. If you use alkaline detergents:  Properly neutralise after use in accordance with the manufacturer’s specifications.  Check whether the chemicals that are used are compatible with the products.
  • Page 15 5 Cleaning and Disinfection  To prevent water stains on the optics, keep the loupes and reduction lenses as vertical as possible during the cleaning process.  Start the cleaning programme, see sect. 12, page 25, e.g.: 3 Minute pre-wash cycle with cold water ...
  • Page 16 5 Cleaning and Disinfection OCULUS Sterilisation Insert You can use the specially designed sterilisation insert, OCULUS Art. No. 55185 for the BIOM® 5 and its accessories. Fig. 5–4: Components of the BIOM® 5 on the sterilisation insert Dimensions of the OCULUS sterilisation insert...

  • Page 17: Manual Cleaning/Disinfection

    5 Cleaning and Disinfection Manual Cleaning/Disinfection The method described below has been validated for manual cleaning/ disinfection: If you clean and disinfect your equipment manually, you must verify your procedure independently and validate it specific to the product and the method.

  • Page 18: Cleaning In An Ultrasonic Bath (Optional)

    5 Cleaning and Disinfection Cleaning in an Ultrasonic Bath (Optional) Note If the fluid in the ultrasonic bath is too dirty, the cleaning effectiveness will be impaired and there is a risk of corrosion. The criterion is a visibly dirty fluid. ...

  • Page 19: Steam Sterilisation

    6 Steam Sterilisation Steam Sterilisation Prior to Steam Sterilisation Attention Improper cleaning/disinfection is a health risk.  After cleaning/disinfecting the components, check whether they are macroscopically clean, i.e. free from visible soiling, corrosion or damage.  If impurities are found: Clean/disinfect the components again. ...
  • Page 20 6 Steam Sterilisation  Pay particular attention to the following:  Smooth movement of the articulated joint Function of the safety rod of the front loupe   Function of the focussing knob Control mark   Flip the BIOM® 5 towards the adaptor plate. Make Slide the safety rod of the loupe holder up and sure that the housing body can be shifted without down several times to check that it runs smoothly.
  • Page 21 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, disinfect and sterilise the components. Comply with hospital regulations and all applicable national regulations and laws.

  • Page 22: Lubrication

    6 Steam Sterilisation 6.1.2 Lubrication If necessary, you can lubricate the moving parts of the BIOM® 5 prior to steam sterilisation to guarantee their function. Materials needed Lint-free cloth   Silicone-free maintenance substance which is suitable for the steam sterilisation Notes Risk of malfunctions and surface damage if oils containing silicone or...

  • Page 23: Packaging

    Make sure that only cleaned and disinfected components are sterilised. The optics can be either be double shrink-wrapped or secured in the sterilisation insert from OCULUS Optikgeräte GmbH for autoclaving.  Use one of the following sterilisation processes: Fractionated Pre-Vacuum Process ...

  • Page 24: Storage

    7 Storage If, for technical reasons, you use other sterilisation processes, shorter sterilisation times and lower temperatures, you must validate these. Storage  Comply with hospital regulations and the applicable national regulations and laws for storage of the conditioned products. Disposal Prior to disposal: ...

  • Page 25: Manufacturer And Service Address

    9 Guarantee and Service Manufacturer and Service Address Supplemental information is available from our Service Department or from our authorized representatives. Manufacturer and Service Address: Germany: OCULUS Optikgeräte GmbH Münchholzhäuser Straße 29 D 35582 Wetzlar Germany Tel.: + 49 (0) 641 2005-0 Fax: +49 (0) 641 2005 - 295 E-mail: sales@oculus.de...

  • Page 26: Overview: Permitted Sterilisation Method - List Of Articles

    10 Overview: Permitted Sterilisation Method – List of Articles 10 Overview: Permitted Sterilisation Method – List of Articles Approved Sterilisation Processes Steam STATIM Plasma/ Plasma/ V-Pro® Low 5000S/G4 STERRAD® STERRAD® Temperature Article Name Article Cleaning Autoclave 100S SHORT 100NX® Sterilization Method cycle Standard...
  • Page 27 10 Overview: Permitted Sterilisation Method – List of Articles Approved Sterilisation Processes Steam STATIM Plasma/ Plasma/ V-Pro® Low 5000S/G4 STERRAD® STERRAD® Temperature Article Name Article Cleaning Autoclave 100S SHORT 100NX® Sterilization Method cycle Standard System cycle 134° C 132° C 134°...
  • Page 28 10 Overview: Permitted Sterilisation Method – List of Articles Approved Sterilisation Processes Steam STATIM Plasma/ Plasma/ V-Pro® Low 5000S/G4 STERRAD® STERRAD® Temperature Article Name Article Cleaning Autoclave 100S SHORT 100NX® Sterilization Method cycle Standard System cycle 134° C 132° C 134°...

  • Page 29: Consumables And Sterilisable Accessories

    Möller microscope Attention Personal injury caused by contaminated BIOM® and components  Before returning the product to OCULUS: Prepare the BIOM® and sterilisable components according to this treatment instructions.  Send only visibly prepared OCULUS products back to OCULUS 12 Appendix Conditioning Instruction BIOM®...
  • Page 32 Manufacturer and Service Address Deutschland: USA: OCULUS Optikgeräte GmbH OCULUS Surgical, Inc. Münchholzhäuser Straße 29 562 NW Mercantile Place, Ste. 104 D 35582 Wetzlar Port St. Lucie, FL 34986, USA Tel.: +49 (0) 641/2005-0 Tel.: +1 772-236-2622 (outside of U.S.) Fax: +49 (0) 641/2005-299 Tel.: +1 855-SDIBIOM (Toll free in U.S.)

This manual is also suitable for:

Biom 5cBiom 5clBiom 5mBiom 5ml

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