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General information

Instructions for use • Clamping Jaws with a Dovetail Connection • TYA258_EN_V1.0_02-2021_IFU_CE-MDR

1 General information

1.1 Read the instructions for use

If the instructions for use are not followed, patients, users, and third parties may be injured or
the product may be damaged.

Read the instructions for use carefully and follow all the safety notes and warnings.

Keep the instructions for use clearly visible next to the product.

1.2 Read the instructions for use of combinable products

If the instructions for use of combinable products are not followed, patients, users, and third
parties may be injured or the product may be damaged.

Read the instructions for use of the combinable products carefully and follow all the safety
notes and warnings.

1.3 Scope

This instruction manual is valid for:

Product name

Item number

Clamping jaw for POINT SETTER

, large

28272PSG

Clamping jaw for POINT SETTER

, small

28272PSK

VITOM

3D clamping jaw for POINT SETTER

28272VTP

1.4 Description of warning messages

To prevent any injury to persons or damage to property, the warnings and safety notes in the
instructions for use must be observed. The warning messages describe the following levels of
danger.

WARNING

Designates a possible imminent risk. If this is not avoided, it could lead to death or serious
injuries.

CAUTION

Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.

NOTICE

ATTENTION

Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

Содержание 28272PSG

Страница 1: ...Instructions for use Clamping Jaws with a Dovetail Connection en ...

Страница 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 rights reserved 02 2021 ...

Страница 3: ...d products 6 3 4 Unsterile product 6 3 5 Creutzfeldt Jakob disease 6 4 Product description 8 4 1 Product overview 8 4 2 Possible combinations 8 4 3 Symbols on the packaging 8 4 4 Ambient conditions 9 5 Preparation 10 5 1 Unpacking the product 10 5 2 Testing the product 10 5 3 Installing the clamping jaw 10 5 4 Installing the VITOM 3D in the clamping jaw 28272VTP 10 5 5 Inserting the instrument or ...

Страница 4: ...ctions for use of the combinable products carefully and follow all the safety notes and warnings 1 3 Scope This instruction manual is valid for Product name Item number Clamping jaw for POINT SETTER large 28272PSG Clamping jaw for POINT SETTER small 28272PSK VITOM 3D clamping jaw for POINT SETTER 28272VTP 1 4 Description of warning messages To prevent any injury to persons or damage to property th...

Страница 5: ...systems to the POINT SETTER holding system during microsurgical or open procedures 2 3 Contraindications No contraindications relating directly to the product are currently known Use of the instrument is contraindicated if in the opinion of the responsible physician the patient s health is endangered through its use 2 4 Target user populations The medical device may only be used by doctors and med...

Страница 6: ...se Check the product for the following points before and after every use Completeness Good working order Rough surfaces left inadvertently Sharp corners Burred edges Correct assembly of the components Functionality Do not leave broken off components inside the patient Do not overload the product with mechanical stress Do not bend bent products back to their original position 3 3 Damaged products D...

Страница 7: ...Safety Instructions for use Clamping Jaws with a Dovetail Connection TYA258_EN_V1 0_02 2021_IFU_CE MDR 7 Dispose of the product properly and do not continue to use it ...

Страница 8: ...72VTP for POINT SETTER 2 Rotary knob 5 Unlock buttons 3 Clamping jaw 28272PSK for POINT SETTER small 6 Dovetail 4 2 Possible combinations Clamping jaw Holding system Telescopes instruments 28272PSG POINT SETTER 28172P Telescopes 28272PSK Instruments Telescope sheaths 28272VTP VITOM 3D TH200 4 3 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no Batch...

Страница 9: ... instructions for use for important cau tionary information such as warnings and precautions Unsterile Federal USA law restricts this device to sale by or on the order of a 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 4 4 Ambient conditions There are no special tra...

Страница 10: ...e manufacturer or supplier immediately 4 Keep packaging for further transport 5 2 Testing the product 1 Inspect the product for visible contamination Do not use if contaminated 2 Inspect the product for the following characteristics Good working order Functionality Correct assembly of the components Completeness 5 3 Installing the clamping jaw 1 Insert the dovetail on the clamping jaw into its cou...

Страница 11: ...ssing on the unlock buttons 2 Insert the VITOM 3D exoscope into the clamping jaw ð The sheath groove and the bar on the clamping jaw are interlocking 3 Close the clamping jaw Make sure that the clamping jaw is securely locked in place This is the case when both unlock buttons are fully visible Incorrect Right unlock button not fully visible ...

Страница 12: ...e optical block The clamping jaw 28272PSK is suitable for fixing telescope sheaths 1 Select a suitable clamping jaw for the instrument or telescope 2 Place the instrument or the telescope in the clamping jaw 3 To close the clamping jaw turn the rotary knob 4 When using the clamping jaw 28272PSG it is absolutely essential to ensure that the telescope is correctly clamped 5 With large telescope head...

Страница 13: ...ion Instructions for use Clamping Jaws with a Dovetail Connection TYA258_EN_V1 0_02 2021_IFU_CE MDR 13 6 The following figure shows how the telescope sheath is correctly positioned in the clamping jaw 28272PSK ...

Страница 14: ... the clamping jaws 3 Remove the instrument or the telescope 4 Close the clamping jaw 5 Undo the fixation screw on the POINT SETTER and remove the clamping jaw 6 2 Disassembling the VITOM 3D in the clamping jaw 28272VTP 1 Hold onto the VITOM 3D in order to prevent it from falling down 2 Press the unlock buttons and open the clamping jaw 3 Remove the instrument or the telescope 4 Close the clamping ...

Страница 15: ...RL STORZ Please contact your local KARL STORZ subsidiary or authorized dealer see the list of subsidiaries Contaminated devices may not be shipped To prevent contact infections and airborne infections products must first be decontaminated KARL STORZ reserves the right to send back contaminated products 7 2 Disposing of the product For disposal the following measures are necessary 1 Decontaminate t...

Страница 16: ...orz se KARL 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 Kęstučio st 59 Lenktoji st 27 08124 Vilnius Lithuania Phone 370 5 272 0448 Mobile 370 685 67 000 Email info lt lv karlstorz com KARL STORZ Endoskopi Danmark A S Skovlytoften 33 2840 Holte Denmark Phone 45 45162600...

Страница 17: ...1805 1807 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 Shanghai Ltd Shanghai Branch Room 701A Building 5 Room 501 Building 7 No 3000 Longdong Avenue Pilot Free Trade Zone 201203 Shanghai People s Republic of China Phone 86 21 60339888 Fax 86 21 ...

Страница 18: ...Subsidiaries Instructions for use Clamping Jaws with a Dovetail Connection TYA258_EN_V1 0_02 2021_IFU_CE MDR 18 ...

Страница 19: ...Subsidiaries Instructions for use Clamping Jaws with a Dovetail Connection TYA258_EN_V1 0_02 2021_IFU_CE MDR 19 ...

Страница 20: ...ORZ SE Co KG Dr Karl Storz Straße 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 TYA258 EN V1 0 02 2021 IFU CE MDR ...

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