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15 Declaration of Conformity

Instruction Manual BIOM® 5 (G/55400/1218/en)

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15 Declaration of Conformity

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Содержание BIOM 5c

Страница 1: ...OCULUS BIOM 5 INSTRUCTION MANUAL Binocular Indirect Ophthalmo Microscope...

Страница 2: ...instructions This operating manual describes the following BIOM 5 models BIOM 5c and 5cl long version BIOM 5m and 5ml long version Except for the difference in length the respective long version is id...

Страница 3: ...Sterile Conditions Test the Safety Functions 15 9 4 Connect the BIOM 5 to the Microscope 16 9 5 Swing the BIOM 5 to the Parked Position 18 9 6 Make the Basic Settings at the Microscope 18 9 7 Instruc...

Страница 4: ...Table of Contents iii iii Instruction Manual BIOM 5 G 55400 1218 en...

Страница 5: ...o that an orderly handling of the complaint for damages is possible Component Order no BIOM 5c Version BIOM 5c Version BIOM 5cl Sterilisable drive belts 10 of Sterilisable cable duct 1 of 55400 55403...

Страница 6: ...9 Power supply voltage 3 Heed Instruction Manual 10 Date of manufacture 4 UDI Nummer 11 Serial number of the device 5 Matrix 12 Reference number 6 Disposal with household waste is prohibited BIOM 5c a...

Страница 7: ...ted information for use of the BIOM 5 Attention All safety related instructions for use of the BIOM 5 are given in the instruction manual for the unit It is therefore imperative that you read and unde...

Страница 8: ...he SDI 4 and accessories Please read the special packing notice included with the adaptor and accessories 4 1 1 Used Graphic Symbols Attention Denotes a potentially hazardous situation which can easil...

Страница 9: ...device Only OCULUS or an authorized dealer is allowed to train the personnel Transport and storage instructions Refer to the notes in sec 7 page 10 Instructions for setup and connection Comply with th...

Страница 10: ...nd the patient changes When the BIOM 5 is swung into the working position into the beam pa th the following instructions must be followed Do not use the coarse adjustment knob at the microscope stand...

Страница 11: ...0950 1 Make certain that the SDI 4 used for the power supply 5 Intended Use This binocular indirect ophthalmomicroscope BIOM 5 is used for non contact observation of surgeries in the posterior segment...

Страница 12: ...ed with the BIOM 5 Control mark 2 Housing with swivel mechanism 6 Loupe holder with safety rod 3 Lens receptacle 7 Ophthalmoscopy magnifying loupe not supplied with the BIOM 4 Focus adjustment wheel 8...

Страница 13: ...the front loupe The reduction lens provides a virtually constant distance between the patient s eye and the surgical microscope when the BIOM 5 is swung in or swung out The reduction lens reduces the...

Страница 14: ...l See also sec 17 page 33 8 Initial Operation 8 1 Before Initial Operation Remove the BIOM 5 and its accessories from the packaging Clean disinfect and sterilise the BIOM 5 before putting it into use...

Страница 15: ...Loupe Sets The following front loupes can be steam autoclaved 53603 Wide field high definition loupe 53602 Wide field E loupe 53606 Hi res loupe 53601 Wide field loupe for deep set eyes 53604 90D lou...

Страница 16: ...BIOM 5 Make sure that all components are present and are sterile Example Components of the BIOM 5cl 1 BIOM 5cl 4 Ophthalmoscopy magnifying loupe 2 Adaptor plate 5 Cable duct BIOM 5c cl only 3 Drive b...

Страница 17: ...it reaches the stop Plug in the adaptor plate 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 5 correctly you will get a...

Страница 18: ...u 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 Insert the drive belt Fasten the cable duc...

Страница 19: ...ned and are in a safe condition The dovetail mount for the adaptor is securely fastened at the microscope Flip the BIOM 5 towards the adaptor plate Make sure that the housing body can be shifted witho...

Страница 20: ...he 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 5 into the dovetail mount at the mic...

Страница 21: ...OM connecting spacer Plug the control cable into one of the side sockets on the SDI 4c or BIOM connecting spacer Make sure that the cable does not come into contact with any unsterile parts of the mic...

Страница 22: ...ding the front loupe with you finger until the rod reaches the limit stop When swinging into the beam path Lift up safety rod and only release it again when the swung in end position has been reached...

Страница 23: ...When focussing with the BIOM 5 heed the following instructions Before you begin to focus the BIOM 5 check the distance from the ophthalmoscopy magnifying loupe to the patient s eye When focussing the...

Страница 24: ...d the eye is simultaneously monitored It must be ensured that the surgeon can stop the motorized focussing function at any time Attention Risk of eye damage if the working distance between the BIOM 5...

Страница 25: ...off the adaptor plate Loosen the knurled screw fig 9 5 page 16 fig 3 Pull the adaptor plate off the dovetail mount Bring the BIOM 5 and its components to the conditioning station immediately BIOM 5c...

Страница 26: ...it and the complete drive module would then have to be exchanged Always grip the plug of the BIOM 5c cl at the sleeve in order to release the lock Pull the BIOM 5 off the adaptor plate Loosen the knu...

Страница 27: ...ody in safety rod extension channel Safety rod is bent Carefully mechanical cleaning and change to a better demineralised water clean the BIOM 5 ultrasonically Careful mechanical cleaning and removal...

Страница 28: ...he microscope objective Focus the BIOM 5 in accordance with the instructions Use a reduction lens Check the engraving on the reduction lens and exchange the reduction lens if necessary see sec 9 1 pag...

Страница 29: ...or adjusting wheel Activate the sockets in accordance with the instructions for the stand Contact the microscope manufacturer for assistance Malfunction when using the combination control unit 5 pole...

Страница 30: ...to the separate conditioning instructions 13 Disposal of Used Devices Dispose of the BIOM 5 in compliance with the corresponding legal requirements Comply with the hygiene and disposal regulations of...

Страница 31: ...unctions and Damage OCULUS will only accept responsibility for the safety reliability and serviceability of the BIOM 5 if the unit is used in compliance with the following terms Only use the equipment...

Страница 32: ...tives Manufacturer and Service Address Germany OCULUS Optikger te GmbH M nchholzh user Stra e 29 35582 Wetzlar Germany Tel 49 0 641 2005 0 Fax 49 0 641 2005 299 E mail support oculussurgical de www oc...

Страница 33: ...15 Declaration of Conformity Instruction Manual BIOM 5 G 55400 1218 en 29 36 15 Declaration of Conformity...

Страница 34: ...pes Component Order no BIOM 5c 55400 BIOM 5cl 55403 BIOM 5m 55462 BIOM 5ml 55463 Component Order no Drive belts pack of 10 54176 Cable duct pack of 5 54178 Component Order no Reduction lens for f 175...

Страница 35: ...diameterfor BIOM 5 55426 Adaptor for M ller Ophtamic 900 Hi R 900 EOS 900 Allegra 900 55440 Adapter for Takagi OM 19 55417 Adaptor for Takagi OM 8 OM 18 55418 Adapter for Takagi OM 8 OM 9 55419 55419...

Страница 36: ...container with insert for BIOM5 and accessories 55180 Insert for sterilisation container 55185 Paper filters for sterilisation container 100 pcs box 55190 Component Order no Component Order no SDI 4c...

Страница 37: ...3 mm Travel of safety rod approx 29 mm approx 29 mm Product Weight Product Weight BIOM 5m approx 186 g BIOM 5cl approx 260 g BIOM 5ml approx 190 g Reduction lens approx 30 g BIOM 5c approx 250 g Front...

Страница 38: ...of protection against electric shock Protection class 2 Degree of protection against electric shock Type B Degree of protection against harmful penetration of water IPX8 Power supply via SDI 4 power 0...

Страница 39: ...17 Technical Data Instruction Manual BIOM 5 G 55400 1218 en 35 36...

Страница 40: ...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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