background image

3  Safety Instructions

6 / 24

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

EMC and Electrical Safety Information

The SDI® 4c, a connected BIOM® 5 and a microscope constitute a Medical Electrical 
System (ME System) in accordance with DIN EN 60601-1. If you connect any more 
devices, they too become part of the ME System.

Make sure that all devices of the ME System meet the provisions of IEC 60601-1
or of IEC 60950-1

Use the plug-in power supply unit included in the scope of delivery.

Attention

Use of a Multiple Socket Extension Cord

Risk of personal injury or material damage caused by unsafe multiple socket extension 
cord

If you use a multiple socket extension cord to connect the SDI® 4 to the 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 extension cord on the floor.

Do not use more than one multiple socket extension cord.

Plug only the SDI® 4 into this multiple socket extension cord.

If you use a multiple socket extension cord, it must be supplied with power via an 
isolating transformer.

Electromagnetic Compatibility (EMC / Cables)

Risk of personal injury or damage to property due to electromagnetic interference

Portable and mobile HF communications appliances (high frequency) can affect
medical, electric equipment.

Make sure that portable and mobile RF communications equipment do not cause
interference.

Recommendation: Maintain a minimum distance of 4 m. If the distance is shorter,
you must ensure that the SDI® 4 functions correctly.

Содержание SDI 4

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

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Отзывы: