Storz VITOM II Instruction Manual Download | Manualshive

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Product description

Instructions for use • VITOM II telescopes 0°/ 90° • TLQ518_EN_V1.0_02-2021_IFU_CE-MDR

11

Symbol

Meaning

Consult the printed or electronic instructions for use

US Federal law (21 CFR 801.109) restricts this device to sale to or on the
order of a licensed physician

CE marking
With this mark, the manufacturer declares the compliance of the devices
with the applicable standards and directives
The device must not be modified in any way

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Summary of Contents for VITOM II

Page 1: ...Instructions for use VITOM II telescopes 0 90 en...

Page 2: ...illustrations product descriptions and texts are the intellectual property of KARL STORZ SE Co KG Their use and reproduction by third parties require the express approval of KARL STORZ SE Co KG All ri...

Page 3: ...6 3 1 Serious incidents 6 3 2 Unsterile product 6 3 3 Correct handling 6 3 4 Damaged products 6 3 5 Working in the field of vision 6 3 6 Hot components 7 3 7 High light intensity 7 3 8 Patient leakage...

Page 4: ...ts carefully and follow all the safety notes and warnings 1 3 Scope These instructions for use are valid for the following products Art no Description 20916025AA VITOM II telescope 20916025AGA VITOM N...

Page 5: ...isualization or documentation of the surgical procedure makes sense in the opinion of the responsible physician 2 3 Contraindications VITOM VITOM 3D systems are not used in contact with the patient s...

Page 6: ...use 3 3 Correct handling If the product is not handled correctly patients users and third parties may be injured Only persons with the necessary medical qualification and who are acquainted with the...

Page 7: ...of light intensity produced by the light source may lead to permanent eye damage or blindness and may cause tissue and items facing the light output to heat up Do not look into the light output Set t...

Page 8: ...oduct overview 1 3 10 2 VITOM II telescope 90 20916025DA 1 Direction of view 2 Screw base for KARL STORZ fiber optic light cable Olympus Winter and Ibe OR Plug in base 9 mm diameter for Wolf fiber opt...

Page 9: ...68 79 g 172 04 g 172 04 g 172 01 g Working length AR length to the irrigation bottle 104 8 mm 104 8 mm 104 8 mm 115 8 mm 115 8 mm Angle of im age field 12 12 12 12 12 Direction of view 0 0 0 90 90 Flu...

Page 10: ...humidity non condensing 10 95 Air pressure 700 1 060 hPa Operating conditions Temperature 10 C 40 C Relative humidity non condensing 30 75 Air pressure 700 1 060 hPa 4 4 Symbols on the packaging Symbo...

Page 11: ...lt the printed or electronic instructions for use US Federal law 21 CFR 801 109 restricts this device to sale to or on the order of a licensed physician CE marking With this mark the manufacturer decl...

Page 12: ...ope cameras the VITOM endoscopes support an adjustable working distance range of approx 20 75 cm Applications with high magnification and overview recordings cannot be realized For fluorescence applic...

Page 13: ...isassembly Instructions for use VITOM II telescopes 0 90 TLQ518_EN_V1 0_02 2021_IFU_CE MDR 13 6 Disassembly 6 1 Disassembling the product Dismount the adapter from the light connection for reprocessin...

Page 14: ...uction manual are exempt from this rule Please contact your local KARL STORZ subsidiary or authorized dealer see the list of subsidiaries Contaminated devices may not be shipped To prevent contact inf...

Page 15: ...n diameter 4 8 mm length 300 cm 495TIP Fiber optic light cable with 90 deflection to the instrument very narrow radius of curvature diameter 4 8 mm length 300 cm 495NVC Wire tray for cleaning steriliz...

Page 16: ...L STORZ Endoscopy Suomi OY Taivaltie 5 01610 Vantaa Finland Phone 358 0 96824774 Fax 358 0 968247755 Email asiakaspalvelu karlstorz fi KARL STORZ SE Co KG Representation Office K stu io st 59 Lenktoji...

Page 17: ...Building B 18F Beijing IFC No 8 Jianguomenwai Street Chaoyang District 100022 Beijing People s Republic of China Phone 86 10 5638188 Fax 86 10 5638199 Email info karlstorz com cn KARL STORZ Endoscopy...

Page 18: ...Subsidiaries Instructions for use VITOM II telescopes 0 90 TLQ518_EN_V1 0_02 2021_IFU_CE MDR 18...

Page 19: ...Subsidiaries Instructions for use VITOM II telescopes 0 90 TLQ518_EN_V1 0_02 2021_IFU_CE MDR 19...

Page 20: ...RZ SE Co KG Dr Karl Storz Stra e 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone 49 7461 708 0 Fax 49 7461 708 105 E mail info karlstorz com www karlstorz com TLQ518 EN V1 0 02 2021 IF...

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