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15  Technical Data

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Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

Switching options: SDI® 4e

Switching options: SDI® 4m

Sterilization and disinfection procedures

refer to the 

Conditioning Manual

The unit can be attached to the following microscopes:

Zeiss

Leica

Moeller

Takagi

Topcon

Kaps

Alcon

CE in accordance with directive 93 / 42 / EWG for Medical Devices

The unit is a Class I product.

Conformity assessment: Directive 93/42 / EEC: annex VII

Combination foot switch (electric, plugged into a 5-pole jack at the 
SDI® 4e)

Star knob (manual)

Star knob (manual)

Combination foot switch

Wipe-down disinfection

Rubber cap for star knob

Steam autoclaving

(max. 134° C)

Summary of Contents for SDI 4

Page 1: ...OCULUS SDI 4 INSTRUCTION MANUAL Stereoscopic Diagonal Inverter...

Page 2: ...tructions This operating manual describes the following SDI 4 models SDI 4c SDI 4e SDI 4m Due to ongoing development the diagrams shown in the instruction manual may depict minor changes to the actual...

Page 3: ...he SDI 4 to an Operation Microscope 10 8 Operation 13 8 1 Prior to each Use 13 8 2 Practical Tips for Use 13 9 Care and Maintenance 14 9 1 Removing the Accessories 14 9 2 Cleaning 14 9 3 Sterilization...

Page 4: ...Table of Contents iii iii Instruction Manual SDI 4 G 54320 EN 0220 Rev01...

Page 5: ...DI 4c with two protective dust covers and transportation lock 54320 SDI 4c Leica Version with two protective dust covers and transportation lock 54330 Accessories for each SDI 4 Sterilisable rubber ca...

Page 6: ...I 4 Pictograms on the packaging 1 Company logo manufacturer 8 Power supply 2 CE marking 9 Date of manufacture 3 5 UDI number 10 Serial number of the device 4 Matrix 11 Reference number 6 Disposal in h...

Page 7: ...e Instruction Manual Make sure to keep the instruction manual in a safe place and available to operating personnel at all times Observe the legal regulations with regard to accident prevention 3 1 1 U...

Page 8: ...personnel Transport and storage instructions Refer to the notes in sect 10 page 15 Instructions for setup and connection Only OCULUS an authorized dealer or trained personnel are allowed to setup and...

Page 9: ...ng knob of the SDI 4 must be sterilised before the first and before each subsequent use It is imperative that you heed the cleaning disinfection and sterilisation instructions given in the Conditionin...

Page 10: ...he power supply you must heed the following information Use a multiple socket extension cord that complies with the requirements of DIN EN 60601 1 2005 section 16 Do not place the multiple socket exte...

Page 11: ...ians and operating theatre personnel who due to their training or their knowledge and practical experience can guarantee proper handling of the device Only OCULUS or an authorized dealer is allowed to...

Page 12: ...or lamp 3 Star knob 7 Connection for a foot switch optional 4 SDI 4e 8 Power supply connection Fig 5 1 Unit Components SDI 4e 1 Top dustcover 6 Indicator lamp Transporting lock for star knob 7 Connect...

Page 13: ...ck into position The indicator lights up shortly before the final position is reached For SDI 4c only If you are using the SDI 4c in conjunction with the BIOM 5c the image inversion function is contro...

Page 14: ...you want to transport it or if you have to return it for service or repair this can only be optimally done in the plastic case with special insert and with the transport lock for the star knob Like t...

Page 15: ...g the other microscope components Proceed in the same manner when mounting the beam splitter the binocular eyepiece and other components of the microscope Carefully tighten the hexagon socket set scre...

Page 16: ...3 pole jack 4 After plugging in the plug secure it by turning the screw connectors knurled bushings If you want to connect the SDI 4 to a BIOM 5c Plug the BIOM 5c plug into one of the rotating 4 pole...

Page 17: ...I 4c is supplied and sterile Adjust the binocular tube to as comfortable a position as possible 8 2 Practical Tips for Use To adjust the optical system of the SDI 4 Briefly press the foot switch The o...

Page 18: ...le but pull the respective plug or loosen the screw connectors To do so take hold of the respective plug To disconnect the hand or foot switch Loosen the screw connector of the plug at the connecting...

Page 19: ...t and storage conditions the national regulations and the regulations of your hospital Also see sect 15 page 20 Avoid impacts when moving the SDI 4 to another location since this can have an adverse a...

Page 20: ...stance The image is cropped The SDI 4 or other components are incorrectly mounted at an angle The optics of the SDI 4 are not in operating position locking position Correct the assembly Turn it on or...

Page 21: ...ssumption of Liability for Functions and Damage OCULUS will only accept responsibility for the safety reliability and serviceability of the SDI 4 if the unit is used in compliance with the following t...

Page 22: ...4986 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 info oculussurgical com 13 Disposal of Used Devices Dispose of the SDI 4 in compliance with the...

Page 23: ...version 54310 SDI 4c 54320 SDI 4c Leica version 54330 Accessories Order Number Rubber covering for star knob 5 pack 54335 Footswitch for SDI 4e 54883 Extension cable to SDI 4e foot switch 54885 Plug...

Page 24: ...chnical Data Fig 15 1 Dimensions SDI 4c SDI 4e and SDI 4m dimensions Classification according to IEC 60601 1 Serviceable life expectancy 6 Years Width 96 mm Depth 91 4 mm Height 38 9 mm Type of protec...

Page 25: ...e in potentially explosive atmospheres or in the vicinity of potentially explosive mixtures of anaesthetics or laughing gas and oxygen Ambient conditions Transport conditions Storage conditions Temper...

Page 26: ...the following microscopes Zeiss Leica Moeller Takagi Topcon Kaps Alcon CE in accordance with directive 93 42 EWG for Medical Devices The unit is a Class I product Conformity assessment Directive 93 4...

Page 27: ...I GEM12 24 I GEM12 48 I GEM12 05 I P1J Standard USB Optional GEM12 09 P1J I GEM12 07 P1J I GEM12 12 P1J I GEM12 15 P1J I GEM12 18 P1J I GEM12 24 P1J I GEM12 48 P1J I 2 4A 1 33A 1 6A 1A 0 8A 0 66A 0 5...

Page 28: ...l 49 641 2005 0 Fax 49 641 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 outside of U S...

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