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OCULUS BIOM 5c Instruction Manual

Binocular indirect ophthalmo-microscope
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OCULUS
BIOM
5
INSTRUCTION MANUAL
Binocular Indirect Ophthalmo-Microscope
Instruction Manual BIOM® 5 (GA/55400/0313/en – YYYY-MM-DD)
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  • Page 1 ® OCULUS BIOM INSTRUCTION MANUAL Binocular Indirect Ophthalmo-Microscope Instruction Manual BIOM® 5 (GA/55400/0313/en – YYYY-MM-DD) 1 / 1...
  • 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 Scope of Delivery ........................1 Graphic Symbols on the Equipment ................... 2 Safety Instructions........................2 About this Manual ...................... 2 3.1.1 Pictograms Used in this Manual............3 Safety Instructions for Use ..................3 3.2.1 Instructions for Use ................
  • Page 4 Table of Contents 16 Order Information, Accessories and Replacement Parts..........36 16.1 Components for the BIOM® 5................36 16.2 Sterilization Components for the BIOM® 5............38 16.3 Stereoscopic Diagonal Inverter Systems for the BIOM® 5.......38 17 Technical Data..........................38 iii / iii Instruction Manual BIOM® 5 (G/55400/0413/en)

  • Page 5: Scope Of Delivery

    1 Scope of Delivery Scope of Delivery ® BIOM Component Order No BIOM® 5c  Version BIOM® 5c 55400 Version BIOM® 5cl  55403 Sterilizable drive belts (10 pcs)  Sterilizable cable duct  BIOM® 5m Version BIOM® 5m 55462 ...

  • Page 6: Graphic Symbols On The Equipment

    2 Graphic Symbols on the Equipment Graphic Symbols on the Equipment Company logo + Manufacturer Country of manufacture CE marking Device number Serial number Device name Fig. 2-1: Graphic Symbols on the Equipment BIOM® 5 Safety Instructions About this Manual ...

  • Page 7: Pictograms Used In This Manual

    3 Safety Instructions 3.1.1 Pictograms Used in this Manual Attention Identifies a potentially dangerous situation which may cause minor injury or material damage. Note Denotes situations which could result in incorrect findings, denotes user in- structions and useful or other important information. Identifies important information about the product and its use, which re- quire special attention.
  • Page 8 OCULUS employee or by a person authorized by OCULUS. Instructions for Operation and Maintenance  Prior to use: Let OCULUS or an authorized dealer train you in the op- eration of the BIOM® 5.  Never put a damaged BIOM® 5 into operation.

  • Page 9: Instructions For Use

    The BIOM® 5 is intended for use with compatible designed surgical micro- scopes in hospitals, clinics or other institutions for human medicine. Use only surgical microscopes named by OCULUS Optikgeräte GmbH as adaptable for the OCULUS. Only operate the device using original accessory parts supplied by us, and when the device is in technically correct working order.

  • Page 10: Device Description

    5 Device Description Device Description ® BIOM 1 Reduction lens (not supplied with the BIOM®) 2 Housing with swivel mechanism 3 Lens receptacle 4 Focus adjustment wheel 5 Control mark 6 Lensholder with safety rod 7 Front lens (not supplied with the BIOM®) 8 Drive module Fig.

  • Page 11: Function Of The Biom® 5

    5 Device Description ® BIOM 1 Reduction lens (not supplied with the BIOM®) 2 Adjuster, housing with swivel mechanism 3 Lens receptacle 4 Focus adjustment wheel 5 Control mark 6 Lens holder with safety rod 7 Front lens (not supplied with the BIOM®) Fig.

  • Page 12: Transport And Storage

    6 Transport and Storage The patient’s eyeball can be moved freely during the surgery. Peripheral fundus portions are thus easy to examine. This combined optical system achieves a fundus view of up to 125° in total. The optical system of the BIOM® 5 consists of the reduction lens and the front lens.

  • Page 13: Connect The Biom® 5C To The Sdi® 3C

    12, page Assembly and instruction in the use of the BIOM® 5 and its accessories will be done by an OCULUS employee or by a dealer authorized by OCULUS. Prior to Start-Up  An adapter is needed for attachment of the BIOM® 5. Check whether it adapted to the respective surgical microscope type.
  • Page 14 8 Initial Operation Check and Mount the Dovetail Connections:  First visually check the connection for correct mounting.  Check this by gently rocking the connection before you begin mount- ing any of the other attachments. Attention Risk of injury to the patient if the BIOM® 5 drops. Loose connections can pose a hazard if you mount the adapter plate incor- rectly.

  • Page 15: Biom® 5 In Use

    9 BIOM® 5 in Use ® BIOM 5 in Use Choose the Appropriate Optics  Use the appropriate reduction lens for the surgical microscope’s objec- tive.  Select the appropriate front lens for the surgery. Lens 53603 Lens 53606 Lens 53604 Lens 53602 Lens 53601 Currently available front lens:...

  • Page 16: Assembly

    9 BIOM® 5 in Use Disposable lens Sets In addition to the re-sterilizable lenses, disposable sterile BIOM® Optic Sets can also be used on the BIOM® 5. Fig. 9-1: Disposable lenses (similar to those shown here) The sets consist of a wide-angle front lens and a reduction lens, which can be used for a microscope length of f=175 mm or f= 200 mm.
  • Page 17 9 BIOM® 5 in Use ® BIOM 5m Components Housing with swivel mechanism 3 Front lens Adapter plate 4 Reduction lens Fig. 9-2: BIOM® 5m Components ® BIOM 5c Components Housing with swivel mechanism 5 Cable duct Adapter plate 6 Reduction lens Drive belt 7 Cable connector Front lens...
  • Page 18 9 BIOM® 5 in Use   Insert the reduction lens. Plug in the adapter plate. You must thereby over- come the detent that secures the connection. Risk of injury to the patient if the BIOM® 5 is inserted incorrectly Attention If you do not insert the BIOM®...
  • Page 19 9 BIOM® 5 in Use ® Additionally for the BIOM You must insert the drive belt and put on a cable duct. The purpose of the cable duct is to keep the connecting cable of the drive unit at the BIOM® 5c (also fits the previous model) away from the unsterile microscope parts.

  • Page 20: Under Sterile Conditions: Test The Safety Functions

    9 BIOM® 5 in Use Under Sterile Conditions: Test the Safety Functions Attention Risk of injury in the event of malfunction  Only use the BIOM® 5 after the following functions have been tested and are in perfect working order. control marking ...

  • Page 21: Connect The Biom® 5 To The Microscope

    9 BIOM® 5 in Use  Prior to each use, check that:  The device is in technically perfect condition. All connections and fasteners that can be loosened are properly  tightened and are in a safe condition. The dovetail mount for the adapter is securely fastened at the ...
  • Page 22 9 BIOM® 5 in Use ® For BIOM 5c only For the BIOM® 5c, you must connect the control cable to the SDI® 4c. Fig. 9-8: Connect the control cable without touching the unsterile microscope parts  Connect the control cable to one of the side couplers of the SDI® 4c. Make sure that the cable does not touch any unsterile parts of the microscope.

  • Page 23: Swivel The Biom® 5 To Its Parked Position

    9 BIOM® 5 in Use  Connect the cable to the SDI®. The connector locks automatically. Recommendation: If surgery is to be done on the left eye, connect the control cable at the left hand side of the SDI®. When doing surgery on a right eye, connect the control cable at the right hand side.

  • Page 24: Instructions For Focusing The Biom® 5M

    9 BIOM® 5 in Use Instructions for Focusing the ® BIOM Focusing on the BIOM® 5m is done manually with the adjusting wheel and can also be done by a sterile assistant, who follows the surgery via a co- observer viewer. Fig.

  • Page 25: Instructions For Visualization Of The Posterior Eye Segment

    9 BIOM® 5 in Use  Make sure that the front lens does not come into contact with the eye.  Do not adjust the working height of the microscope while focusing the BIOM® 5.  Do not use the microscope’s focusing function while focusing the BI- OM®...
  • Page 26 9 BIOM® 5 in Use Only for combination BIOM® 5c / SDI® 4c:   The image reversal is deactivated when the BIOM® 5c is swiveled out of the beam path. The SDI® 4c is automatically activated when the BIOM® 5c is ...

  • Page 27: Practical Information For Use

    9 BIOM® 5 in Use Practical Information for Use Attention Risk of eye injury as a result of uncontrolled head movements of the patient.  Take suitable measures to suppress uncontrolled head movements of the patient during the surgery.  Avoid any contact of the front lens with the cornea.

  • Page 28: End Operation Of The Biom® 5

    9 BIOM® 5 in Use ® 9.9.1 End Operation of the BIOM  Swivel the BIOM® 5 to its parked position.  After completing the surgery in the posterior segment: Slide up the safety rod of the BIOM® 5 by hand and flip the BIOM® aside. ...
  • Page 29 9 BIOM® 5 in Use ® BIOM After completing the surgery:   Pull the plug of the BIOM® 5c out of the coupler at Detach the cable holder from the plug. the SDI® 4c housing. To do this, grip the plug at the sleeve and unlock it.

  • Page 30: Dismantle

    10 Troubleshooting 9.11 Dismantle  Proceed in reverse order from assembly of the BIOM® 5.  Pull the BIOM® 5 off the adapter plate. To do so, swivel the BIOM® 5 out, fig. 9-4, page 14, pict.  Dismount the two optics, fig.
  • Page 31 Clean the BIOM® 5 in an ultra-  sound bath Treat the rod with a suitable,  silicone oil-free lubricant prior to the next sterilization Send the BIOM® 5 to OCULUS  The rod is bent  service department Loose adapter The locking screws are Tighten the locking screws by ...
  • Page 32 10 Troubleshooting Error Possible Cause Help Unfocused image BIOM® 5 is maladjusted Focus the BIOM® 5 in accor-   dance with the instructions given in the manual A reduction lens is not being Use a reduction lens   used The reduction lens is not com- Check the engraving on the re-...

  • Page 33: Change The Drive Module

    11 Change the Drive Module Error Possible Cause Help Malfunction when using the 5-pole plug has been forcibly Plug it in the right way round   combination control unit plugged in the wrong way (pay attention to the lug and round slot of the polarity reversal protection)
  • Page 34  Please heed the separate Conditioning Manual. Note The sterilization tray from the company OCULUS Optikgeräte GmbH (Art. No. 55185) can also be used for cleaning the BIOM® components. Cleaning and Sterilization Instructions The BIOM® 5, the adapter and the optics can be cleaned in a dishwasher with a mild alkaline cleaning agent and can be cleaned and disinfected in the disinfector (refer to the Conditioning Manual).
  • Page 35 12 Cleaning, Sterilization and Maintenance The OCULUS Optikgeräte GmbH company offers a sterilization container with a specially designed insert for keeping the BIOM® 5, optical components and the adapter plate in place for optimum care during and after sterilization ...

  • Page 36: Disposal Of Used Devices

    Clean and Sterilize the Reduction Lens and Ophthalmosco- py lens The optics can either be doubly shrink-wrapped or secured in the steriliza- tion insert from Oculus Optikgeräte GmbH for sterilization in the autoclave.  Dismantle the optical components of the BIOM® 5 before cleaning and sterilizing it.

  • Page 37: Warranty And Service

    This certification must contain the date of performance and statement of the performing company, with signature. If requested, OCULUS will provide the service technician with a list of  spare parts and additional descriptive material for this purpose.

  • Page 38: Manufacturer And Service Address

    14.2 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 Tel.: +49 641 2005-0 Fax: +49 641 2005-295 E-mail: sales@oculus.de...

  • Page 39: Declaration Of Conformity

    15 Declaration of Conformity 15 Declaration of Conformity KONFORMITÄTSERKLÄRUNG / OCULUS Optikgeräte GmbH Münchholzhäuser Str.29 DECLARATION DE CONFORMITE / D-35582 Wetzlar DECLARATION OF CONFORMITY / Tel: ++49 641 / 20 05 – 0 DICLARATIONE DE CONFORMITA / Fax: ++49 641 / 20 05 - 255 DECLARATION DE CONFORMITA OCULUS Optikgeräte GmbH...

  • Page 40: Order Information, Accessories And Replacement Parts

    16 Order Information, Accessories and Replacement Parts 16 Order Information, Accessories and Re- placement Parts ® 16.1 Components for the BIOM Basic Unit Component Order no. BIOM® 5 55400 BIOM® 5 55403 BIOM® 5 55462 BIOM® 5 55463 ® ® Accessories for BIOM 5c / BIOM Component...
  • Page 41 16 Order Information, Accessories and Replacement Parts ® Adaption Components for the BIOM Component Order no. Adapter for Kaps SOM Adapter for Leica M500/M501/M620 55445 Adapter for Leica M650/M690 55446 Adapter for Leica M822 55447 Adapter for Leica M820/ M841/ M844 55448 Adapter for Möller Ophtamic 900/ Hi-R 900/EOS 900/ 55440...

  • Page 42: Sterilization Components For The Biom® 5

    17 Technical Data 16.2 Sterilization Components for the ® BIOM Component Order no. Sterilization container with tray for the BIOM® 5 and its 55180 accessories Insert for sterlization container 55185 55190 Paper filters for sterilization container (100 pcs/box) 16.3 Stereoscopic Diagonal Inverter Systems for the BIOM®...
  • Page 43 17 Technical Data ® ® Dimensions BIOM 5ml and BIOM Dimensions (W x D x H) 63 x 112 x 124-160 mm (2.5 x 4.4 x 4.9-6.2 in) Overall height approx. 137-173 mm (5.4 - 6.8 in) Travel of the safety rod approx.
  • Page 44 17 Technical Data The unit can be attached to the following microscopes: Zeiss:  OPMI 1/6 OPMI CS with Retrolux /CS OPMI CS with Retroskop /CS OPMI MDI/MDO/MDU OPMI VISU 150/ VISU 160 OPMI VISU 200 / VISU 210 OPMI Lumera® OPMI Lumera®...

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