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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

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Summary of Contents for OCULUS BIOM 5c

  • Page 1 ® OCULUS BIOM INSTRUCTION MANUAL Binocular Indirect Ophthalmo-Microscope...
  • 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 BIOM® 5 Symbols........................2 Structure of the Documentation ....................3 Safety Instructions........................4 About this Manual ......................4 4.1.1 Used Graphic Symbols.................4 Safety Instructions for Use ..................5 4.2.1 Instructions for Use..................6 Intended Use..........................7 Device Description ........................8 Mode of Operation of the BIOM®...
  • Page 4 Table of Contents iii / iii Instruction Manual BIOM® 5 (G/55400/1218/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 Sterilisable drive belts (10 of)  Sterilisable cable duct (1 of)  BIOM® 5m Version BIOM® 5m 55462 ...

  • Page 6: Biom® 5 Symbols

    2 BIOM® 5 Symbols BIOM® 5 Symbols Company logo + manufacturer Applied part of the type B (BIOM® 5c and BIOM® 5cl only) CE marking Power supply voltage Heed Instruction Manual Date of manufacture UDI-Nummer Serial number of the device Matrix Reference number Disposal with household waste is prohibited (BIOM®...

  • Page 7: Structure Of The Documentation

    3 Structure of the Documentation Structure of the Documentation The following documents are supplied with the BIOM® 5: Instruction Manual: The design of the unit is described in detail in  this document. You will also find all safety-related information for use of the BIOM®...

  • Page 8: Safety Instructions

    4 Safety Instructions Safety Instructions About this Manual  Carefully read through the instruction manual.  Keep the instruction manual in good condition, near to the device.  Please read the separate operating instructions for the SDI® 4 and accessories. ...

  • Page 9: Safety Instructions For Use

    Only OCULUS or an authorized dealer is allowed to train the personnel. Transport and storage instructions Refer to the notes in sec.

  • Page 10: Instructions For Use

    4 Safety Instructions Operation and maintenance information  Before initial operation: Let OCULUS or an authorized dealer train you in the operation of the BIOM® 5.  Never operate a damaged BIOM® 5.  Only operate the BIOM® 5 using original accessory parts supplied by us, and when the device is in technically perfect working order.

  • Page 11: Intended Use

    The BIOM® 5 is intended for use with compatible surgical microscopes in hospitals, clinics or other institutions for human medicine The surgical microscopes must be declared as adaptable by OCULUS Optikgeräte GmbH Only operate the device using original accessory parts supplied by us, and when the device is in technically perfect working order.

  • Page 12: Device Description

    6 Device Description Device Description ® ® BIOM BIOM Reduction lens (not supplied with the BIOM®) Control mark Housing with swivel mechanism Loupe holder with safety rod Lens receptacle Ophthalmoscopy magnifying loupe (not supplied with the BIOM®) Focus adjustment wheel Drive module (BIOM®...

  • Page 13: Mode Of Operation Of The Biom® 5

    The BIOM® 5 is used in conjunction with an SDI (Stereoscopic Diagonal Inverter) to erect the image for non-contact, wide-angle observation of the fundus and vitreous body. If the matching OCULUS SDI® is used, full compatibility with the BIOM® 5 models is guaranteed.

  • Page 14: Transport And Storage

    Clean, disinfect and sterilise the BIOM® 5 before putting it into use for the first time, sec. 12, page Installation and instruction in the use of the BIOM® 5 and its accessories will be undertaken by an OCULUS employee or by an OCULUS authorized dealer. Before First Use ...

  • Page 15: Use Of The Biom® 5

    9 Use of the BIOM® 5 ® Use of the BIOM Choose the Appropriate Optics  Use the appropriate reduction lens for the surgical microscope’s objective.  Select the appropriate front loupe for the surgery. The following front loupes can be steam-autoclaved: 53603 53602 Wide-field high definition loupe...

  • Page 16: Mounting The Biom® 5

    9 Use of the BIOM® 5 ® Mounting the BIOM  Make sure that all components are present and are sterile. ® Example: Components of the BIOM BIOM® 5cl Ophthalmoscopy magnifying loupe Adaptor plate Cable duct (BIOM® 5c/cl only) Drive belt (BIOM® 5c/cl only) Reduction lens Fig.
  • Page 17 9 Use of the BIOM® 5   Insert the reduction lens. Then turn the reduction Plug in the adaptor plate until it reaches the stop. lens clockwise until it reaches the stop. Attention Risk to the patient if the BIOM® 5 is plugged in incorrectly If you do not plug in the BIOM®...
  • Page 18 9 Use of the BIOM® 5 ® Additionally for BIOM 5c/cl: You must insert the drive belt. You can put on a cable duct. The cable duct is used to keep the connecting cable of the drive unit at the BIOM® 5c/cl away from unsterile parts of the microscope.

  • Page 19: Under Sterile Conditions: Test The Safety Functions

    9 Use of the BIOM® 5 Under Sterile Conditions: Test the Safety Functions Attention Risk of injury due to improper function  Only use the BIOM® 5 when the following functions have been checked and are in proper working order. ...

  • Page 20: Connect The Biom® 5 To The Microscope

    9 Use of the BIOM® 5 ® Connect the BIOM 5 to the Microscope Attention Risk of injury to the patient if mounting is done incorrectly  Never mount the BIOM® 5 over the patient.   Push the sterile cap onto the knurled screw. Push the adaptor plate with the BIOM®...
  • Page 21 9 Use of the BIOM® 5 ® For BIOM 5c/cl only For the BIOM® 5c/cl, you must connect the control cable with the SDI® 4c or BIOM® connecting spacer. Fig. 9-6: BIOM® 5c/cl: Connecting the control cable (example: SDI® 4c) ...

  • Page 22: Swing The Biom® 5 To The Parked Position

    9 Use of the BIOM® 5 ® Swing the BIOM 5 to the Parked Position  During extra-ocular surgery phases, swing the BIOM® 5 out of the beam path into the parked position.  When swinging out the BIOM, push in the safety rod, including the front loupe, with you finger, until the rod reaches the limit stop.

  • Page 23: Instructions For Focussing The Biom® 5M/Ml

    9 Use of the BIOM® 5 ® Instructions for Focussing the BIOM 5m/ml Focussing on the BIOM® 5m is done manually with the adjusting knob, and on the BIOM® 5c/cl, also by means of a foot pedal. Fig. 9-9: Focussing with the adjusting knob Attention Risk of eye injury due to poor visibility conditions The use of intraocular instruments in poor visibility conditions for the...

  • Page 24: During The Surgery

    9 Use of the BIOM® 5 Special Case „Air-filled eye“  During the fluid-air-exchange: Turn the focussing knob of the BIOM® 5 until the front lens reaches the highest position.  Use the microscope’s fine focus to enlarge the image section. ®...
  • Page 25 9 Use of the BIOM® 5 Attention Incorrect detaching is hazardous to the patient  Never detach the BIOM® 5 over the patient.  To dismount the BIOM® 5, swing it to its standby position. BIOM® 5m/ml  Pull the BIOM® 5 off the adaptor plate. ...
  • Page 26 9 Use of the BIOM® 5 Note Risk of damage to the unit if the plug is pulled incorrectly If you pull on the cable, you could damage it and the complete drive module would then have to be exchanged. ...

  • Page 27: Troubleshooting

    (Address: sec. 14.2, page 28).  Never operate a damaged BIOM® 5.  Before returning to OCULUS: Condition the BIOM® 5 and its components in accordance with the conditioning instructions. Troubleshooting guide – BIOM® 5 Fault Possible cause Remedy The safety rod of the BIOM®...
  • Page 28 10 Troubleshooting Fault Possible cause Remedy Unclear image Soiled glass surfaces Clean the glass surfaces    The glass surfaces have been  Change the sterilisation damaged during sterilisation method, replace lenses if necessary  The glass surfaces have been ...
  • Page 29 10 Troubleshooting Fault Possible cause Remedy No function whatsoever when the The combination control unit Establish the connection to   combination control unit is actua- is not connected to the the SDI® 4c or BIOM® SDI® 4c or BIOM® connecting connecting spacer spacer ...

  • Page 30: Change The Drive Module

    11 Change the Drive Module 11 Change the Drive Module  Proceed in the manner described in the assembly instructions for the drive module. 12 Cleaning, Sterilisation and Maintenance Attention Risk of infection due to improper reconditioning  Bring the BIOM® 5 and its components to the conditioning station immediately after the surgery.

  • Page 31: Guarantee And Service

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

  • Page 32: Manufacturer And Service Address

    14 Guarantee and Service 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 35582 Wetzlar Germany Tel.: +49 (0) 641 2005-0 Fax: +49 (0) 641 2005-299 E-mail: support@oculussurgical.de...

  • Page 33: Declaration Of Conformity

    15 Declaration of Conformity 15 Declaration of Conformity Instruction Manual BIOM® 5 (G/55400/1218/en) 29 / 36...

  • Page 34: Order Information, Accessories And Replacement Parts

    16 Order Information, Accessories and Replacement Parts 16 Order Information, Accessories and Replacement Parts ® 16.1 Components for the BIOM Basic unit Component Order no. BIOM® 5c 55400 BIOM® 5cl 55403 BIOM® 5m 55462 BIOM® 5ml 55463 ® ® Spare parts for the BIOM 5c / BIOM Component Order no.
  • Page 35 16 Order Information, Accessories and Replacement Parts ® Adaption components for BIOM Component Order no. For Alcon LuxOR with Q-Vue Adaptor plate 55423  For Alcon LuxOR without Q-Vue Adaptor plate 55423   Dovetail mount 54856 Adaptor plate for Kaps SOM 55423 Adaptor for Leica M500/M501/M620 55445...

  • Page 36: Sterilisation Components

    16 Order Information, Accessories and Replacement Parts Component Order no. Dovetail for Zeiss MDO/Retrolux CS 54538 Spacer Zeiss OPMI MD 54539 Spacer for Möller Ophtamic 900 mit 20°-illumination 54639 unit 16.2 Sterilisation Components Component Order no. Sterilisation container with insert for BIOM5 and accessories 55180 Insert for sterilisation container 55185...

  • Page 37: Technical Data

    17 Technical Data 17 Technical Data ® Dimensions of the BIOM BIOM® 5m and BIOM® 5c BIOM® 5ml and BIOM® 5cl Dimensions (W x D x H) 63 x 112 x 110 –145 mm 63 x 112 x 124–160 mm Total height approx.
  • Page 38 17 Technical Data Sterilization and Disinfection Procedures BIOM® 5 Steam autoclave, 134°C Reduction lens (only the reduction lenses listed in this manual) Steam autoclave, 134°C Ophthalmoscopy loupe (only the loupes listed in this manual) Steam autoclave, 134°C Adaptor Steam autoclave, 134°C Drive belt Steam autoclave, 134°C Cable duct...
  • Page 39 17 Technical Data Instruction Manual BIOM® 5 (G/55400/1218/en) 35 / 36...
  • Page 40 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:

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