VERTEBRIS stenosis-dilation spinal canal Instrument set 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 information ...

5

1.1

Safety instructions and levels of danger...

5

1.2

Symbols...

6

2

General safety instructions and guidance for use ...

7

3

Product description...

8

4

Intended purpose ...

8

5

Indications ... 10

6

Contraindications and side effects ... 10

6.1

Contraindications... 10

6.2

Side effects... 10

7

Combinations ... 11

7.1

Overview of permissible combinations and requirements ... 12

8

Illustration ... 13

8.1

Telescope, endoscope accessories ... 13

8.2 8.2.1 8.2.2

Access Instruments ... 15 Working sleeve, dilatator (cannulated), step dilatator set... 15 Irrigation adapter for working sleeve, support arm adapter ... 16

8.3 8.3.1 8.3.2

Working instruments... 17 Tube sheath punches and Kerrison punches ... 17 Bipolar hollow sphere electrodes with electrode handles... 18

8.4

Motorized working instruments... 19

9

Checks... 20

9.1

Visual check ... 20

9.2 9.2.1 9.2.2 9.2.3

Function check ... 21 Discoscope (1)... 21 Working sleeve (5), irrigation adapter (8) ... 22 Tube sheath punch (10), Kerrison punch (11)... 22

9.3

Service life ... 22

10

Use ... 23

10.1 10.1.1 10.1.2 10.1.3 10.1.4 10.1.5 10.1.6 10.1.7 10.1.8 10.1.9 10.1.10

Preparation / Commissioning ... 23 Installing the discoscope (1) ... 24 Connecting the discoscope (1) to the irrigation system... 24 Connecting the discoscope (1) to the system components ... 25 Inserting the endoscope adapter (4) ... 26 Installing the access instruments ... 27 Pre-adjusting the discoscope (1) in the preassembled working sleeve... 27 Optional use of a support arm system... 28 Assembly / locking of working instruments... 29 Locking the Kerrison punch (11) ... 30 Motorized instruments ... 30

10.2 10.2.1 10.2.2 10.2.3 10.2.4 10.2.5

General notes and instructions for use... 30 Light... 31 Power ... 32 Image quality ... 32 Irrigation fluid ... 32 Irrigation / suction ... 32

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10.2.6

HF application ... 33

11

Reprocessing and maintenance ... 35

11.1

Reprocessing sequence – dilatators ... 38

11.2

Reprocessing sequence – discoscope ... 43

11.3

Reprocessing sequence – Kerrison punch ... 51

11.4

Reprocessing sequence – Punches ... 55

12

Technical description... 60

12.1

Technical data ... 60

12.2

Usage, storage, transport, and shipping conditions ... 61

13

Spare parts ... 62

13.1 13.1.1

Spare parts ... 62 Replacing spare parts ... 63

13.2

Consumables ... 63

14

Disposal of product, packaging material and accessories ... 63

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General information

1.1

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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1.2

Symbols

Symbols

Designation Follow the manual Medical device Product number Serial Number Lot code Manufacturer Manufacturing date Number, amount

Data Matrix Code

Capacity in millimeters [mm] CE identification with code number of the competent authority in conformity with Directive 93/42/ EEC on medical products or EU regulation 2017/745 on medical products. Only valid if the product and/or the packaging is marked with this identification. Products where a notified body is not involved in the conformity assessment procedure are marked with the CE-identification without the code number of the notified body. The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveal identical products are described, to the Richard Wolf product with the highest classification. The CE identification of the other Richard Wolf products and, if applicable, of products made by other manufacturers, described in these instructions for use results exclusively from the identification on the product and/or packaging.

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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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3

Product description The product system is suitable for endoscopic spinal surgery. The typical area of application of this system is spinal stenosis. Bone is usually removed during this endoscopic procedure on the spine.

Fig. 1

4

Intended purpose Spine – working sleeve 892209010

WORKING SLEEVE ID 9.5 MM OD 10.5 MM

The product is used to create and secure endoscopic access – if necessary, in combination with adaptable handles or adapters – during endoscopic procedures. Use on the central circulatory system or nervous system is excluded. Spine – rigid telescope 892109205

DISCOSCOPE 20° Ø 9.3 MM SL 177 MM

The product is used to display the inside of the body. Use on the central circulatory system or nervous system is excluded. Punches 892409035

PUNCH Ø 5.4 MM WL 340 MM

892409020

PUNCH Ø 5.4 MM WL 340 MM

892409445

KERRISON PUNCH 5.5X4.5 MM WL 380 MM

892409945

KERRISON PUNCH 5.5X4.5 MM WL 380 MM

The products are used to remove soft tissue, cartilage, or osseous tissue. They must not be used in the central circulatory system or the central nervous system.

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Spine – dilatators 892209505

DILATATOR ID 1.1 MM OD 3.9 MM

892209510

DILATATOR ID 1.1 MM OD 9.4 MM

892209507

DILATATOR ID 4 MM OD 5.9 MM

892209508

DILATATOR ID 6 MM OD 6.9 MM

892209515

DILATATOR ID 7 MM OD 9.4 MM

The products are used for dilating and widening surgically created access points and for blunt preparation of an access channel. Use on the central circulatory system or nervous system is excluded. Spine – endoscope adapter 892009000

ENDOSCOPE ADAPTER

The products are used for positioning the telescope in the working sleeve and for adjusting the distance from the telescope to the working sleeve. Use on the central circulatory system or nervous system is excluded. Adapter for articulated arms 892009070

SUPPORT ARM ADAPTER

The products are used for supporting and securing working sleeves or endoscopes in connection with an articulated arm.

User The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.

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5

Indications The products are used for endoscopic spinal surgery in the lumbar-thoracic area.

Patient population The intended patient population is not restricted to ethnics, age, gender, body height and weight. Before use the attending physician must ensure that the product can be safely used in terms of its dimensions or settings.

6

Contraindications and side effects

6.1

Contraindications There are currently no known contraindications directly related to the product in spinal surgery. Medical contraindications for the aforementioned indications exclude the use of the products concerned. For further information, please refer to the most recent medical literature.

6.2

Side effects No side effects directly related to the product are known if the system is used as intended.

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Combinations CAUTION Incorrect product combinations! Injuries to the patient, user, or others as well as damage to the product are possible. Different products may only be combined if the intended use and the relevant technical data (working length, diameter, peak voltage, etc.) are the same. The instruction manuals of the products used in combination with this product must be observed. ⊳ POWER DRIVE ART1 2304 GA-A 238 ⊳ FLUID CONTROL Arthro 2204 GA-A 268

NOTE Combinations with different auxiliary instruments up to a maximum of Ø 5.5 mm and a working length of at least 290 mm are possible. With the VERTEBRIS fully endoscopic spine instrument set, the following instruments can be used in combination: ⊳ Positioning rod ⊳ Forceps, micro-rongeurs ⊳ Micro-punches ⊳ Scissors ⊳ Button electrode, bipolar ⊳ Bipolar hollow sphere electrodes with electrode handles Observe the corresponding instruction manual: ⊳ VERTEBRIS lumbar-thoracic fully endoscopic spine instrument set GA-B223 ⊳ System overview VERTEBRIS lumbar-thoracic BB-B223 ⊳ VERTEBRIS lumbar-thoracic / stenosis overview – motorized instruments BB-B 223-1 ⊳ Bipolar hollow sphere electrodes with electrode handles GA-B 259

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7.1

Overview of permissible combinations and requirements The products are used with: ⊳ Endoscopic devices ⊳ Endoscopic instruments and accessories ⊳ Surgical instruments and accessories The endoscope-side adapter (1.11) can be unscrewed and removed to allow the connection to fiber light cables from different manufacturers, using appropriate adapters. ⊳ Ordering information can be found on the current catalog pages.

Fig. 2

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Illustration

8.1

Telescope, endoscope accessories

Fig. 3 Item

Designation

Item

Designation

1

Discoscope

1.13

Color ring red, marker for viewing direction indication 20°

1.1

Irrigation cannula

1.14

Sealing membrane

1.2

Lens

1.15

Locking collar

1.3

Light outlet

1.16

Maximum capacity in [mm]

1.4

Working channel

1.17

Viewing direction indication, numerical

1.5

Irrigation adapter, rotatable

2

Sealing cap for instrument guide channel

1.5.1

Stopcock housing

3

Adapter for sealing cap

1.5.2

Luer connector

4

Endoscope adapter

1.5.3

Stopcock insert

4.1

Positioning notches 8 x 45°

1.5.4

Capacity indicator on – Stopcock housing – Stopcock insert

4.2

Adjusting nut

1.6

Sheath tube

4.3

Lock body bundle

1.7

O-rings

4.3.1

Automatic locking mechanism

1.8

Locking knob

4.3.2

Tab with color coding

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1.9

Code, numerical Marker for fiber bundle diameter

1.10

Color ring orange, marker for fiber bundle diameter

1.11 1.12

14

4.4

Adapter

Endoscope-side adapter

#

Model no.

Eyecup

*

Serial no.

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8.2

Access Instruments

8.2.1

Working sleeve, dilatator (cannulated), step dilatator set

Fig. 4 Item

Designation

Item

Designation

5

Working sleeve

7

Step dilatator set consisting of:

5.1

Window 30°

7.1

Grip surfaces

5.2

Scaling, graduation in [mm]

7.2

Scaling, graduation in [mm]

5.3

Window position indicator

7.3

Step dilatator, Ø = 3.9 mm, cannulated

5.4

Ring groove

7.4

Step dilatator, Ø = 5.9 mm

5.5

Positioning notches

7.5

Step dilatator, Ø = 6.9 mm

6

Dilatator, Ø = 9.4 mm, cannulated

7.6

Step dilatator, Ø = 9.4 mm

6.1

Grip surfaces

6.2

Scaling, graduation in [mm]

#

Model no.

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8.2.2

Irrigation adapter for working sleeve, support arm adapter

Fig. 5 Item

Designation

Item

Designation

8

Irrigation adapter for working sleeve

9

Support arm adapter

8.1

O-ring, internal

9.1

Clamp

8.2

Irrigation valve, see item 1.5.1–1.5.4, Fig. 3

9.2

Clamping screw

8.3

Positioning pin

9.3

Clamping plate

8.4

Sliding sleeve

8.5

Groove for support arm adapter

#

Model no.

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8.3

Working instruments

8.3.1

Tube sheath punches and Kerrison punches

Fig. 6 Item

Designation

Item

Designation

10

Tube sheath punch

11

Kerrison punch 60° / 90°

10.1

Jaw section

11.1

Movable rail

10.2

Sheath tube

11.2

Lever

10.3

Knurled nut

11.3

Pin

10.4

Set screw

11.4

Rigid handle section with rigid rail

10.5

Rigid handle section

11.5

Spring

10.6

Spring

11.6

Movable handle section

10.7

Movable handle section

10.8

"Dot marker" # Same number of dots = components belong together

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Model no.

17

8.3.2

Bipolar hollow sphere electrodes with electrode handles

Fig. 7 Item

Designation

Item

Designation

12

Bipolar hollow sphere electrode

13

Electrode handle, bipolar

12.1

Distal head part / active electrodes

13.1

Hexagonal socket

12.2

Neutral electrode

13.2

Handle

12.3

Sheath, insulated

13.3

Cleaning connection

12.4

Hexagonal stop sleeve

13.4

Cable

12.5

Contact part

13.5

Device plug

13.5.1

2-pin international device plug

13.5.2

2-pin US device plug

*

Lot no.

#

Product no. See GA-B 259 for more information

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8.4

Motorized working instruments

Fig. 8 Item

Designation

Item

Designation

14

Oval burr, Ø = 5.5 mm, with lateral protection

16

Ball burr, Ø = 5.5 mm

15

Eccentric oval burr, Ø = 5.5 mm, with lateral protection

17

Diamond ball burr, Ø = 5.5 mm

#

Model no.

See GA-A238 and BB-B223-1 for more information

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9

Checks WARNING Injuries by damaged or incomplete products! Injuries of the patient, user and others are possible. n Do not use the products if they are damaged, incomplete or have loose parts. n Run through the checks before and after each use.

ATTENTION Send in damaged or incomplete products together with any loose parts for repair. Repair only by authorized experts.

9.1

Visual check 1. Check instruments, in particular in the distal region, and accessories for: ð Damage ð Sharp edges ð Loose or missing parts ð Surface changes (e.g., corrosion) ð Rough surfaces ð Fine cracks 2. Any inscription, lettering, or labeling necessary for the safe and intended use must be legible. 3. Replace damaged (brittle) sealing cap (2), sealing membranes (1.14), and Orings (1.7). 4. Check jaw parts for defective cut surfaces and corroded parts.

Fig. 9

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