Nucleoplasty 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

2

Manufacturer

Distributor

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

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

www.richard-wolf.com

www.riwospine.com

GA-B263

Contents 1

General notes and instructions for use...

5

1.1

Safety instructions and levels of danger...

5

2

Technical description...

6

2.1

Telescope, featuring ...

6

2.2

Access instruments ...

6

2.3

Hand instruments ...

6

2.4

Accessories ...

6

3

Intended use...

7

3.1

Telescope ...

7

3.2

Access instruments ...

7

3.3

Hand instruments ...

7

3.4

Accessories ...

7

4

Indications and field of use ...

8

5

Contraindications and side effects ...

8

5.1

Contraindications...

8

5.2

Side effects...

8

6

Combinations ...

8

7

Illustration ...

9

7.1

Endoscope ...

9

7.2 7.2.1 7.2.2 7.2.3 7.2.4

Access instruments ... 9 Puncture cannula set... 9 Dilator ... 10 Working sleeve ... 10 Irrigation adapter ... 11

7.3 7.3.1 7.3.2 7.3.3

Hand instruments ... 11 Punch, Rongeur ... 11 RF instrument ... 12 Dissector... 13

7.4 7.4.1 7.4.2

Accessories ... 13 Hammer... 13 Sterilization basket ... 14

7.5

Symbols... 15

8

Operating instruction ... 16

8.1 8.1.1

Preparation ... 16 Inserting the working sleeve in the irrigation adapter ... 16

8.2

Application example: Nucleoplasty... 18

8.3

Application example: Access to the facet joint and sacroiliac joint... 21

9

Checks... 23

9.1

Visual check ... 23

9.2 9.2.1 9.2.2 9.2.3

Function check ... 23 Suction and irrigation flow ... 23 Continuous flow sheath ... 24 Irrigation adapter ... 24

10

Reprocessing and maintenance ... 25

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10.1

Reprocessing procedure ... 25

10.2

Reprocessing sequence ... 25

11

Technical data and order data... 33

12

Spare parts and accessories ... 33

13

Operating, storage, transport and shipping conditions ... 34

13.1

Disposal of product, packaging material and accessories ... 34

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

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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2

Technical description The instrument set consists of access instruments, hand instruments and accessories. The individual instruments are described below:

2.1

Telescope, featuring a sheath tube, integrated light guide, optical system. a locking cone a cold-light connector an adapter (unscrewable) a color coding ring indicating the direction of view

2.2

Access instruments Puncture cannula - With proximal luer connector. - With cannulation for guide wire Guide wire Wire with rounded ends. Dilator Cannulation for guide wire, conical blunt with atraumatic ends on both sides. Working sleeve Tube in tube system for continuous irrigation and suction via luer connector. with lateral beveled opening on one end and proximal handle with interface for irrigation adapter. Irrigation adapter with removable irrigation stopcock and quick fastener acting as interface for the working sleeve.

2.3

Hand instruments Punch, Rongeur Comprising: handle with overload protection, sheath with luer connector, jaw section located at the distal end of the sheath tube. RF instrument Comprising: bipolar handle, sheath, sterile electrode. Dissector Single-piece hand instrument with knurled handle and a working element at the distal end.

2.4

Accessories Hammer Hammer with replaceable plastic faces.

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Intended use The reusable surgically invasive instruments intended for temporary application are used for endoscopic or endoscopically assisted therapy or interventional pain therapy on the spine. This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained personnel.

3.1

Telescope Rigid endoscopes are used for visualizing the patient's inside via natural and surgically created passages.

3.2

Access instruments Puncture cannula is used for creating a primary passage and for injecting local anesthetics. Guide wire serves to secure surgically created passages. guides cannulated instruments. Dilator is used for blunt preparation of an access channel. Working sleeves serve to establish and maintain endoscopic access. Irrigation adapter serves to connect the working sleeves to the suction and irrigation environment.

3.3

Hand instruments Forceps and punches Rigid forceps and punches are used for endoscopically controlled grasping and manipulating as well as for the dissection of soft tissue parts and organs. RF instrument is used for tissue / vessel coagulation (hemostasis), for tissue reduction and tissue ablation by means of radio frequency current. Dissector is used for palpation, preparation and dissection of soft tissue.

3.4

Accessories Hammer is used for driving in or out hand instruments in bones (also in conjunction with modular handles) such as n Needle sheath n Bone needles

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4

Indications and field of use The products are used mainly for removing tissue parts (prolaps material, bone, cartilage, etc.) for the decompression of neural structures and the preparation of the disk space.

NOTE We recommend reading relevant literature for the planned application.

5

Contraindications and side effects

5.1

Contraindications CJD

Creutzfeldt-Jakob Disease or a

vCJD

Variant of the Creutzfeldt-Jakob Disease

BSE

Bovine Spongiform Enzephalopathy; so-called mad cow disease (e.g. Creutzfeldt-Jakob Disease)

TSE

Transmissible Spongiform Enzephalopathy

On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. The laws and regulations valid in your country must be complied with. For further notes and instructions please refer to the latest medical literature. Contraindications directly related to the product are presently unknown.

5.2

Side effects No side effects are known if the system is used as intended.

6

Combinations CAUTION Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. n The different 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.

NOTE In addition, follow the following instructions for use: n System overview of VERTEBRIS lumbar-thoracic: Instruction manual GA-B223 n Instrument set for foraminotomy / foraminoplasty Instructions for use GA-B223-01

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Illustration

7.1

Endoscope

1

NOTE For this, follow instructions for use GA-S001

7.2

Access instruments

7.2.1

Puncture cannula set

2

NOTE For this, follow instruction manual GA-B175

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7.2.2

Dilator

3

7.2.3

Working sleeve

4

4.5

4.4 4.3

4.1

4.2

*

Item

Designation

Item

Designation

4.1

Outer sleeve

4.4

Interface to irrigation adapter

4.2

Knurled collar

4.5

Luer connector

4.3

Handle

*

Scale, graduation in mm

10

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7.2.4

Irrigation adapter

5

5.1

5.2 5.3.3 5.3.2

5.3.1

7.3 Item

Designation

Item

Designation

5.1

Quick fastener

5.3

Irrigation stopcock, with removable plug

5.2

Sealing cap,

5.3.1

Stopcock housing

5.3.2

Stopcock plug

5.3.3

Identification of passage (capacity) on stopcock plugs 3 dots = diameter

7.3

Hand instruments

7.3.1

Punch, Rongeur

6

NOTE For this, follow instructions for use GA-S003

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7.3.2

RF instrument

7

NOTE For this, follow instructions for use GA-B210

Sterile

7.1

NOTE For this, follow instructions for use BB-A291-1

12

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7.3.3

Dissector

8

7.4

Accessories

7.4.1

Hammer

9 9.1

Item

Designation

Item

Designation

9

Hammer

9.1

Hammer faces (inserts)

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7.4.2

Sterilization basket

10.1

10.2

10.3

Item

Designation

Item

Designation

10.1

Basket lid

10.2

Instrument carrier

10.3

Basket base

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7.5

Symbols Symbols

Designation Follow instructions for use Product number Lot code Serial Number Manufacturer Identification in conformity with medical devices directive 93/42/ EEC only valid if the product and/or packaging is marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally identified with the code no. of the notified body (0124).

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8

Operating instruction WARNING The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. n Immediately before an after use, check the products for damage, loose parts and completeness. Make sure that no missing instrument parts remain in the patient. n Do not use products which are damaged or incomplete or have loose parts.

CAUTION Product failure during therapeutic applications. Interruptions in therapeutic applications. n

8.1

In therapeutic applications a second product with the same features should be available as a backup.

Preparation NOTE In the case of products provided with a protection cap, the latter serves only as a transport protection. Remove the protection cap before use. ¯ Carry out a visual check ð see section Visual check

8.1.1

Inserting the working sleeve in the irrigation adapter Install the sealing cap (5.2)

5.2

16

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Locking the connection 1. Pull back and hold the quick fastener (5.1). 2. Insert the working sleeve (4) in the irrigation adapter (5). 3. Let go of the quick fastener (5.1). ð The connection is locked. 4. Pull slightly to check that the connection is secure.

4

5.1

5

Unlocking the connection ¯ Pull back and hold the quick fastener (5.1), then remove the working sleeve (6).

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8.2

Application example: Nucleoplasty ¯ Position the puncture cannula (2) in the spinal disk under X-ray control.

2 Remove the inner needle and insert the guide wire.

Remove the puncture cannula and insert the dilator (3) via the guide wire in the intervertebral disk, drive into the disk with the hammer if necessary.

3

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Insert the working sleeve (4) via the dilator (3), drive into the intervertebral disk with the hammer if necessary, and connect the irrigation tube to the luer connector (4.5).

4 4.5

3

A

Remove the guide wire and dilator (3) and insert the working instruments (6) (7) (7.1).

4 3

6

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7.1

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