VERTEBRIS Lumbar-Thoracic Full-Endoscopic Spine Instruments Instructions for Use

Richard Wolf reserves all rights in this document, in particular relating to reproduction, distribution, public communication and public dissemination. This document may not be modified, and texts and images must not be reproduced or translated without the express prior permission of Richard Wolf GmbH.

Copyright © RICHARD WOLF GmbH

Subject to technical changes! Due to ongoing development, the product descriptions, figures, and technical data may deviate slightly from the current state. For further information about our products, please contact Richard Wolf GmbH or a local representative.

Manufacturer RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen GERMANY Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300

www.richard-wolf.com

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Contents 1

General safety instructions and guidance for use ...

6

2

Safety instructions and levels of danger...

7

3

Intended use...

8

3.1

Endoscopes, endoscope accessories ...

8

3.2 3.2.1 3.2.2

Suction and irrigation instruments ... Irrigation adapters, other adapters ... Suction connector, suction device ...

8 8 8

3.3 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7

Access Instruments ... Positioning rod... Spinal cannula set ... Dilatators ... Working sleeves ... Handle adapters ... Trephines ... Spongiosa pusher / funnel...

8 8 8 8 8 8 8 8

3.4 3.4.1

Manual and auxiliary instruments ... Rasp / trocar / spoon / anulotome / dissector / curette / face miller ...

9 9

3.5 3.5.1 3.5.2 3.5.3 3.5.4

Forceps, punches, scissors ... Forceps, micro-rongeurs ... Micro-punches ... Scissors ... Tube sheath punches, bone punches ...

9 9 9 9 9

3.6 3.6.1 3.6.2

Motorized instruments ... Burrs ... Rotary blades, nucleus resector ...

9 9 9

3.7

HF / RF instruments ...

9

3.8 3.8.1 3.8.2

Accessories ... Deflector ... X-tractor extraction instrument ...

9 9 9

4

Indications and field of use ... 10

5

Contraindications... 10

6

Combinations ... 11

7

Illustration ... 12

7.1 7.1.1 7.1.2

Endoscopes, endoscope accessories ... 12 Endoscope A ... 12 Endoscope B ... 13

7.2 7.2.1 7.2.2

Suction and irrigation instruments ... 14 Valve adapters, irrigation adapters, other adapters ... 14 Suction connector, suction device ... 15

7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7

Access Instruments ... 15 Positioning rod... 15 Spinal cannula set for single use... 16 Dilatators ... 16 Working sleeves ... 17 Handle adapters ... 17 Trephines ... 18 Spongiosa pusher and funnel... 18

7.4

Manual and auxiliary instruments ... 19

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7.4.1

Anulotome / dissector / curette / spoon / rasp / trocar / face miller ... 19

7.5

Forceps, punches, scissors ... 20

7.6 7.6.1 7.6.2

Motorized instruments ... 21 Burrs ... 21 Rotary blades ... 22

7.7 7.7.1 7.7.2

HF / RF instruments ... 23 Bipolar coagulation instruments and bipolar electrodes ... 23 Bipolar micro grasping forceps ... 24

7.8 7.8.1 7.8.2

Accessories ... 25 Deflector ... 25 X-tractor extraction instrument ... 25

7.9

Labeling on packaging ... 26

8

Application ... 27

8.1 8.1.1 8.1.2 8.1.3

Preparation ... 27 Mounting endoscopes ... 27 Installing the access instruments ... 30 Motorized instruments ... 32

8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.2.5 8.2.6 8.2.7 8.2.8

General notes and instructions for use... 32 Light... 32 Power ... 33 Image quality ... 33 Irrigation fluid ... 33 Irrigation and suction power ... 34 HF application ... 34 Laser application ... 35 Forceps, punches, scissors ... 37

9

Checks... 41

9.1

Visual checks ... 41

9.2 9.2.1 9.2.2 9.2.3

Function check ... 42 Endoscopes... 42 Suction and irrigation instruments ... 43 Forceps, punches, scissors ... 43

10

Reprocessing and maintenance ... 43

10.1 10.1.1 10.1.2 10.1.3 10.1.4

Disassembly before cleaning ... 43 Endoscopes... 43 Access Instruments ... 45 Forceps, punches, scissors ... 45 Motorized instruments ... 45

10.2 10.2.1 10.2.2 10.2.3

Manual reprocessing ... 46 Endoscopes... 46 Forceps, punches, scissors ... 46 Motorized instruments ... 46

10.3 10.3.1 10.3.2

Machine reprocessing ... 47 Endoscopes... 47 Forceps instruments, punches, scissors, nucleus resector with Luer connector ... 48

10.4

Checks... 48

10.5 10.5.1

Assembly before sterilization... 49 Endoscopes... 49

10.6 10.6.1

Sterilization ... 50 Steam sterilization ... 50

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Technical data and ordering information ... 51

11.1

Spare parts and accessories ... 51

12

Operating, storage, and transport conditions ... 52

13

Disposal of the product, packaging material, and accessories ... 52

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1

General safety instructions and guidance for use The product must only be used as intended following the instruction manual by adequately trained and qualified medical personnel. Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned application and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the products in accordance with the manual before every use and before return shipment to protect the patient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately on receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Any severe incident occurring in conjunction with this product must be reported to the manufacturer and the competent authority of the country where the user and/ or patient resides.

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Safety instructions and levels of danger WARNING This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in death or extremely serious injuries.

CAUTION This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in minor or moderate injury.

ATTENTION This signal word without warning sign is used to indicate a potential danger of material damage.

NOTE This signal word indicates additional useful information for the reader, such as hints for easier operation as well as cross references.

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3

Intended use The instruments and endoscopes enable surgical access, visualization of the surgical area and manipulation, preparation and dissection of tissue in spinal surgery that is performed or supported endoscopically. The instruments are described individually below:

3.1

Endoscopes, endoscope accessories For visualizing the surgical area and the working instruments. The working instruments are inserted through the working channel or instrument port. The irrigation process is completed through a separate irrigation channel or the working channel.

3.2

Suction and irrigation instruments

3.2.1

Irrigation adapters, other adapters For connecting the endoscopes or working sleeves with the suction and irrigation environment.

3.2.2

Suction connector, suction device Make it possible to aspirate more irrigation fluid, blood or ablated matter. If necessary, the suction connector can be connected directly to the distal end of the endoscope.

3.3

Access Instruments

3.3.1

Positioning rod For defining the optimal entry point when opening up access while monitoring the image converter.

3.3.2

Spinal cannula set For primary access and for injecting local anesthetic, as well as for administering the contrast material in discography.

3.3.3

Dilatators For blunt preparation of the access channel. The cannulated dilatators can be inserted via the guide wire.

3.3.4

Working sleeves To secure access during the procedure. They are inserted via a suitable dilatator.

3.3.5

Handle adapters For intraoperative manipulation of working sleeves, with no suction or irrigation function.

3.3.6

Trephines For making a window in the fibrous ring of the intervertebral disc.

3.3.7

Spongiosa pusher / funnel For implantation of spongiosa.

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3.4

Manual and auxiliary instruments

3.4.1

Rasp / trocar / spoon / anulotome / dissector / curette / face miller For palpation, preparation and dissection of soft tissue.

3.5

Forceps, punches, scissors

3.5.1

Forceps, micro-rongeurs For manipulation and removal of soft tissue and cartilage.

3.5.2

Micro-punches For dissection of soft tissue and cartilage.

3.5.3

Scissors For dissection of soft tissue and cartilage.

3.5.4

Tube sheath punches, bone punches For dissection of strong ligaments, cartilage and osseous structures.

3.6

Motorized instruments

3.6.1

Burrs For resection of osseous structures with simultaneous suction of separated tissue parts.

3.6.2

Rotary blades, nucleus resector For resection of the inner core of the intervertebral disc (nucleus pulposus) with simultaneous suction of separated tissue parts.

3.7

HF / RF instruments For tissue coagulation, vascular coagulation, hemostasis, and tissue reduction with endoscopic imaging. When using suction devices, additional irrigation or suction can be applied.

3.8

Accessories

3.8.1

Deflector For deflecting flexible auxiliary instruments.

3.8.2

X-tractor extraction instrument For manipulating cylindrical access instruments.

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4

Indications and field of use For use in spinal operations performed or supported endoscopically. Primarily for removing tissue (prolapse material, bones, cartilage, etc.) in order to decompress neural structures.

5

Contraindications CJD – Creutzfeldt-Jakob Disease or vCJD – Variant of Creutzfeldt-Jakob Disease BSE – Bovine Spongiform Encephalopathy; so-called mad cow disease (e.g., Creutzfeldt-Jakob disease) TSE – Transmissible Spongiform Encephalopathy Contraindications directly related to the product are presently unknown. On the basis of the patient’s general condition, the attending physician must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature. The country-specific laws and regulations must be complied with.

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Combinations The instruments are used in conjunction with: n n n n n n n

Light sources and fiber light cables Cameras and lenses Pumps for irrigation and suction HF surgical devices Lasers Motorized systems / motor handpieces Accessories for endoscopic use

CAUTION Be careful not to combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. n The products must only be used jointly if the intended use and the relevant technical data such as working length, diameter, etc. are the same. n Also follow the instruction manuals of the products used in conjunction with this product. ⊳ System overview VERTEBRIS lumbar-thoracic BB-B223 ⊳ Overview of motorized instruments BB-B223-1 ⊳ POWER CONTROL 2303 GA-A202 ⊳ POWER DRIVE ART1 2304 GA-A238 The cold light connection part (1.5) can be unscrewed and removed to allow the connection of fiber light cables from different manufacturers, using appropriate connection parts. ⊳ The same applies to endoscope A. ⊳ Ordering information can be found on the current catalog pages.

Fig. 1

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7

Illustration

7.1

Endoscopes, endoscope accessories

7.1.1

Endoscope A

Fig. 2 Legend and labeling Item

Designation

Item

Designation

1

Endoscope

1.9

Instrument port

1.1

Irrigation channel

01:10

irrigation valve

1.2

RIWO

2

Plug-on eyecup

1.3

Light outlet

2.1

Locking screw

1.4

Working channel

3

Sealing cap for instrument guide channel

1.5

Cold light connection part

4

Adapter for sealing cap

1.6

Locking collar

5

Membrane adapter

1.7

Sealing membrane

6

Conical adapter

1.8

Rubber cap, red

7

Valve adapter

#

Model no.

*

Serial no.

Item

Designation

Color

Meaning

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01:11

Viewing direction indication

01:12

Color ring

7.1.2

red blue

Direction of view 20° Direction of view 0°

Endoscope B

Fig. 3 Legend and labeling Item

Designation

Item

Designation

1

Endoscope

2

Eyecup

1.1

Irrigation channel

3

Sealing cap for instrument guide channel

1.2

RIWO

4

Adapter for sealing cap

1.3

Light outlet

5

Membrane adapter

1.4

Working channel

6

Conical adapter

1.5

Cold light connection part

7

Valve adapter

1.6

Locking collar

8

Irrigation adapter, rotatable

1.7

Sealing membrane

8.1

irrigation valve

01:14

Locking knob

#

Model no.

01:15

Fiber bundle diameter marking

*

Serial no.

Item

Designation

Color

Meaning

01:11

Viewing direction indication

01:12

Color ring

red

Direction of view 25°

01:13

Maximum capacity in mm

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7.2

Suction and irrigation instruments

7.2.1

Valve adapters, irrigation adapters, other adapters

Fig. 4 Legend and labeling Item

Designation

Item

Designation

3

Sealing cap for instrument guide channel

7

Valve adapter

4

Adapter for sealing cap

7.1

Instrument port

5

Membrane adapter

7.2

irrigation valve

5.1

Sealing insert

9

Irrigation adapter for working sleeves

5.2

Membrane valve

9.1

irrigation valve

5.3

Adapter

9.2

Clamping sleeve

6

Conical adapter

6.1

Tab

#

Model no.

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7.2.2

Suction connector, suction device

Fig. 5 Legend and labeling Item

Designation

Item

Designation

10

Suction device

11

Suction connector

#

Model no.

7.3

Access Instruments

7.3.1

Positioning rod

Fig. 6 Legend and labeling Item

Designation

Item

Designation

12

Positioning rod

#

Model no.

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15

7.3.2

Spinal cannula set for single use

Fig. 7 Legend and labeling Item

Designation

Item

Designation

13

Spinal cannula set for single use

14

Guide wire

13.1

Protection sleeve

13.2

Spinal cannula

13.3

Inner needle See GA-B 175 for more information

7.3.3

Dilatators

Fig. 8 Legend and labeling Item

Designation

Item

Designation

15

Dilatators

#

Model no.

15.1

Dilatator, single-channel

*

Scaling, graduation in mm

15.2

Dilatator, twin-channel

15.2.1 Eccentric hole for guide wire

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7.3.4

Working sleeves

Fig. 9 Legend and labeling Item

Designation

Item

Designation

16

Working sleeves

#

Model no.

16.1

Window position indicator

*

Scaling, graduation in mm

16.2

Extension sleeve

##

Outer diameter in mm

###

Length in mm

7.3.5

Handle adapters

Fig. 10 Legend and labeling Item

Designation

Item

Designation

17

Handle adapter

#

Model no.

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7.3.6

Trephines

Fig. 11 Legend and labeling Item

Designation

Item

Designation

18

Trephines

#

Model no.

Item

Designation

#

Model no.

7.3.7

Spongiosa pusher and funnel

Fig. 12 Legend and labeling Item

Designation

19

spongiosa pusher

20

spongiosa funnel

18

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7.4

Manual and auxiliary instruments

7.4.1

Anulotome / dissector / curette / spoon / rasp / trocar / face miller

Fig. 13 Legend and labeling Item

Designation

Item

Designation

21

Spoon

25

Dissector

22

Curette

26

Anulotome

23

Trocar

27

Face miller

24

rasp

#

Model no.

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7.5

Forceps, punches, scissors

Fig. 14 Legend and labeling Item

Designation

Item

Designation

28–32 Handle types 28

Suction forceps handle

30.5

Set screw

28.1

Adjustment wheel

30.6

Pressure plate

28.2

Suction connector

31

Bone punch

29

Ring handle with/without finger support

31.1

Jaw insert

29.1

Finger support

31.2

Sheath tube

29.2

Handle arm

31.3

Knurled nut

30

Intradiscal grasping forceps, angled

32

Forceps handle with strain relief

30.1

LUER-LOCK sealing cap

32.1

Strain relief

30.2

Luer connector

32.2

Luer connector

30.3

Locking mechanism

32.3

LUER-LOCK sealing cap

30.4

Deflection lever

#

Model no.

20

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