Wolf Vertebris Lumbar-Thoracic User manual

Instruction Manual

VERTEBRIS lumbar-thoracic

Full endoscopic spinal instrument set

GA-B 223 / USA / 2012-10 V5.0 / ECO 2012-0519

(RW: 07-09-7.0

/ PDZ 09-3602)

Important general notes and instructions for use

Make sure that this product is used only as intended and described in this instruction manual, by
adequately trained and qualified medical personnel, and that maintenance and repair are only car
ried 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 ship
ment to protect the patient, user and third parties.

Immediately upon receipt, check the product and its accessories for completeness and possible
damage. Should the shipment give right to complaints, please inform the manufacturer or supplier
immediately.

Subject to technical changes!
Due to ongoing developments, the illustrations and technical data may deviate slightly.

CAUTION :
Federal law restricts this device to sale by or on the order of a physician.

Safety instructions and levels of danger

Symbols Level of danger

WARNING!
Failure to observe can result in death or serious injury.

CAUTION!
Failure to observe can result in slight injury or damage to the product.

.

.

IMPORTANT!
Failure to observe can result in damage to the product or surroundings.

NOTE!
Tips for optimum use and other useful information.

USA
RICHARD WOLF
Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Toll Free: 001 (800) 323 - 9653
Phone: [phone] - 1113
Fax: [phone] - 1488
MANUFACTURER

[e-mail]
www.richardwolfusa.com

BELGIUM / NETHERLANDS
N.V. Endoscopie
RICHARD WOLF Belgium S.A.
Industriezone Drongen
Landegemstraat 6
9031 Gent Drongen
Telephone: [phone]
Telefax: [phone]

[e-mail]
www.richard-wolf.be

Marketing Office
U.A.E
RICHARD WOLF Middle East
P.O. Box 500283
AL Thuraya Tower 1

th

Floor,

9
Room 904, Dubai
Telephone: + 9 71 43 68 19 20
Telefax: + 9 71 43 68 61 12

[e-mail]
www.richard-wolf.com

GERMANY
RICHARD WOLF GmbH
75438 Knittlingen
Pforzheimerstr. 32
Telephone: [phone]
Telefax: [phone]
[e-mail]
www.richard-wolf.com

FRANCE
RICHARD WOLF France S.A.R.L.
Rue Daniel Berger
Z.A.C. La Neuvillette
F-51100 Reims
Telephone: [phone]
Telefax: [phone]

[e-mail]

INDIA
RICHARD WOLF India Private Ltd.
JMD Pacific Square
No. 211 A, Second Floor
Behind 32
Gurgaon - 122 001
National Capitol Region
Telephone: + 91 12 44 31 57 00
Telefax: [phone]

[e-mail]
www.richard-wolf.com

nd

Milestone

UK
RICHARD WOLF UK Ltd.
Waterside Way
Wimbledon
SW17 0HB
Telephone: + 44 20 89 44 74 47
Telefax: [phone]

[e-mail]
www.richardwolf.uk.com

AUSTRIA
RICHARD WOLF Austria
Ges.m.b.H.
Wilhelminenstraße 93 a
A-1160 Vienna
Telephone: [phone]
Telefax: [phone]

[e-mail]
www.richard-wolf.com

0

GA-B 223

Contents

1 Intended use 1..............................................................

1.1 Endoscopes, endoscope accessories 1.........................................

1.2 Suction- and Irrigation instruments 1............................................

1.2.1 Irrigation adapters, adapter 1..................................................

1.2.2 Suction connector, suction tube 1..............................................

1.3 Access instruments 1.........................................................

1.3.1 Positioning rod 1.............................................................

1.3.2 Spinal Cannula Set 1.........................................................

1.3.3 Dilators 1...................................................................

1.3.4 Working sleeves 1...........................................................

1.3.5 Attachable handles 1.........................................................

1.3.6 Trephines 1.................................................................

1.3.7 Spongiosa pusher / funnel 1...................................................

1.4 Hand and auxiliary instruments 1...............................................

1.4.1 Rasp / Trocar / Spoon / Anulotome / Dissector / Curette / Face cutter 1.............

1.5 Forceps instruments, punches, scissors 2.......................................

1.5.1 Punches, micro rongeurs 2....................................................

1.5.2 Micro punches 2.............................................................

1.5.3 Scissors 2..................................................................

1.5.4 Tubular sheath punches, bone punches 2.......................................

1.6 Motorized instruments 2......................................................

1.6.1 Abrader 2...................................................................

1.6.2 Rotary blades / Nucleus resector 2.............................................

1.7 HF / RF instruments 2........................................................

1.8 Accessories 2...............................................................

1.8.1 Deflector 2..................................................................

1.8.2 Extractor instrument ”X-tractor” 2...............................................

2 Indications and field of use 2..................................................

3 Contraindications 2...........................................................

4 Combinations 3..............................................................

5 Illustration 4.................................................................

5.1 Endoscopes, endoscopic accessories 4.........................................

5.1.1 Endoscope A 4..............................................................

5.1.2 Endoscope B 5..............................................................

5.2 Suction‐ and irrigation instruments 6............................................

5.2.1 Stopcock‐, irrigation connectors, adapters 6.....................................

5.2.2 Suction tube, suction connector 6..............................................

5.3 Access instruments 7.........................................................

5.3.1 Positioning rod 7.............................................................

5.3.2 Disposable Spinal Cannula Set 7...............................................

5.3.3 Dilators 8...............................................................

5.3.4 Working sleeve 8............................................................

5.3.5

5.3.6 Trephines 9.................................................................

5.3.7 Spongiosa pusher and funnel 9................................................

Attachable handles ......................................................... 9

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I

5.4 Hand and auxiliary instruments 10...............................................

5.4.1 Anulotome / Dissector / Curette / Spoon / Rasp / Trocar / Face cutter 10.............

5.5 Forceps instruments, punches, scissors 11.......................................

5.6 Motorized instruments 12......................................................

5.6.1 Abraders 12..................................................................

5.6.2 Rotary blades 12..............................................................

5.7 HF / RF Instruments 13........................................................

5.7.1 Bipolar coagulations instruments and bipolar electrodes 13.........................

5.7.2 Bipolar Micro Grasping Forceps 14..............................................

5.8 Accessories 15...............................................................

5.8.1 Deflector 15..................................................................

5.8.2 Extractor instrument ”X-tractor” 15...............................................

5.9 Packaging identification 16.....................................................

6Use 17......................................................................

6.1 Preparation 17................................................................

6.1.1 Assembling the endoscopes 17.................................................

6.1.2 Attaching access instruments 20................................................

6.1.3 Motorized instruments 21......................................................

6.2 Additional notes and instructions for use 21.......................................

6.2.1 Light 21......................................................................

6.2.2 Current 22...................................................................

6.2.3 Image quality 22..............................................................

6.2.4 Irrigation fluid 22..............................................................

6.2.5 Irrigation and suction power 22..................................................

6.2.6 HF application 23.............................................................

6.3 Laser application 24...........................................................

6.3.1 Forceps instruments, punches, scissors 24.......................................

7 Checks 27...................................................................

7.1 Visual check 27...............................................................

7.2 Functional check 28...........................................................

7.2.1 Endoscopes 28...............................................................

7.2.2 Suction- and irrigation instruments 28............................................

7.2.3 Forceps instruments, punches, scissors 28.......................................

8 Reprocessing and maintenance 29..............................................

8.1 Disassembly before cleaning 29.................................................

8.1.1 Endoscopes 29...............................................................

8.1.2 Access instruments 30.........................................................

8.1.3 Forceps instruments, punches, scissors 31.......................................

8.1.4 Motorized instruments 31......................................................

8.2 Manual reprocessing 31........................................................

8.2.1 Endoscopes

8.2.2 Forceps instruments, punches, scissors 31.......................................

8.2.3 Motorized instruments 31......................................................

8.3 Machine reprocessing 32.......................................................

8.3.1 Endoscopes 32...............................................................

8.3.2 Forceps instruments, punches, scissors, nucleus resector with luer connector 33......

8.4 Checks 33...................................................................

31...............................................................

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Contents

8.5 Assembly before sterilization 34.................................................

8.5.1 Endoscopes 34...............................................................

8.6 Sterilization 35................................................................

8.6.1 Steam sterilization 36..........................................................

8.6.2 Gas sterilization 36............................................................

8.6.3 Alternate sterilization methods 36...............................................

8.6.4 Short Endoscope Tray, Item # 88090.0007 36....................................

9 Technical data and order data 37................................................

9.1 Spare parts and accessories 37.................................................

10 Operating, storage, transport and shipping conditions. 38...........................

11 Disposal of product, packaging material and accessories. 38........................

12 Warranty and Customer Service 39..............................................

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III

1 Intended use

The instruments and endoscopes serve to create the surgical passages, visualize
the operating area, manipulate and dissect tissue in endoscopic or endoscopically
supported spinal surgery.

For this purpose the instruments described in the following are used:

1.1 Endoscopes, endoscope accessories

For visualizing the operating area and the surgical instruments. The surgical instru­ments are introduced through the working channel or insertion port with stopcock.
Irrigation is carried out via a separate irrigation channel or the working channel.

1.2 Suction-- and Irrigation instruments

1.2.1 Irrigation adapters, adapter

For connecting the endoscopes or working sleeves to the suction and irrigation
environment.

1.2.2 Suction connector, suction tube

They allow additional or inproved aspiration of irrigation fluid, blood or ablated
particles. If necessary the suction connector can also be attached directly to the
distal end of the endoscope.

1.3 Access instruments

1.3.1 Positioning rod

The positioning rod is used to define the optimum entry point when establishing
access under image converter control.

1.3.2 Spinal Cannula Set

The spinal cannula set is used for creating primary access and injecting local
anesthetic, as well as for applying discography media.

1.3.3 Dilators

Dilators are used for blunt preparation of the access channel. The cannulated
dilators can be inserted via a guide wire.

1.3.4 Working sleeves

The working sleeves are used to secure the passage during the operation. Work­ing sleeves are inserted via a suitable dilator.

1.3.5 Attachable handles

For intraoperative manipulation of working sleeves, without suction or irrigation
function.

1.3.6 Trephines

The trephine is used to create a window in the fibrous ring of the intervertebral
disc.

1.3.7 Spongiosa pusher / funnel

This instrument is used for implanting spongiosa.

1.4 Hand and auxiliary instruments

1.4.1 Rasp / Trocar / Spoon / Anulotome / Dissector / Curette / Face cutter

For palpating, exposing and dissecting soft tissue.

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1.5 Forceps instruments, punches, scissors

1.5.1 Punches, micro rongeurs

are used for manipulating and withdrawing soft and cartilaginous tissue.

1.5.2 Micro punches

are used for dissecting soft and cartilaginous tissue.

1.5.3 Scissors

for the dissection of soft and cartilaginous tissue.

1.5.4 Tubular sheath punches, bone punches

are used for dissecting strong ligaments, cartilaginous tissue and osseous struc­tures.

1.6 Motorized instruments

1.6.1 Abrader

Abraders are used for the resection of osseous structures under simultaneous as­piration of severed tissue chips.

1.6.2 Rotary blades / Nucleus resector

Resect disc core material (nucleus pulposus) under simultaneous aspiration of sev­ered tissue chips.

They serve to palpate, expose and dissect tissue.

1.7 HF / RF instruments

For tissue coagulation, vessel coagulation, hemostasis and tissue reduction under
endoscopic view. The use of suction applicators allows additional irrigation or suc­tion.

1.8 Accessories

1.8.1 Deflector

The deflector is used for deflecting flexible auxiliary instruments.

1.8.2 Extractor instrument ”X--tractor”

The ”X--tractor” serves to manipulate cylindrical access instruments.

2 Indications and field of use

For use in endoscopic or endoscopically supported operations of the spine.
Mainly for removing tissue, (such as prolapse material, bones, cartilage, etc.) in
order to decompress neural structures.

3 Contraindications

CJD -- Creutzfeldt--Jakob Disease or
vCJD -- Variant of the Creutzfeldt--Jakob Disease
BSE -- Bovine Spongiform Encephalopathy; the so--called mad cow disease

TSE -- Transmissible spongiform Encephalopathy

On the basis of the patient’s general condition the physician / surgeon in charge
must decide whether the planned use is possible or not.

The regulations and laws valid in your country must be adhered to.
For further information see the latest medical literature.
Contraindications directly related to the product are presently unknown.

(e.g. Creutzfeldt--Jakob disease)

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2

4 Combinations

The instrument set is used in conjunction with:

Z Light sources and fiber light cables
Z Cameras and objective lenses
Z Pumps for irrigation and suction
Z HF surgical devices
Z Laser
Z Motor systems / Motorized handles
Z Endoscopic accessories

CAUTION!
Do not combine products incorrectly!
Injuries of the patient, user or third parties as well as damage to the product

are possible.
The different products can only be combined and used together if the in-

tended use and the relevant technical data (working length, diameter, peak
voltage etc.) are the same.

Follow the instruction manuals of the products used in combination with
this product.

' System Overview VERTEBRIS lumbar -thoracic BB -B 223
' Overview of motorized instruments BB- B 223- 1
' POWER CONTROLE 2303 GA- A 202
' POWER DRIVE ART1 2304 GA- A 238

Fig. 1

1.5

The cold--light connector (1.5) can be unscrewed and replaced with suitable
adapters to connect fiber light cables made by other manufacturers (Fig. 1).

' The same applies to endoscope A.
' For order information please refer to the current catalog sheets.

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5 Illustration

5.1 Endoscopes, endoscopic accessories

5.1.1 Endoscope A

1.1 1.2

1.3

1.1

1

1.4

2.1
2

#

#

*

1.5

1.12

3

1.6

Fig. 2

4

1.7

1.9

1.10

1.11

1.10

1.8

1.8

6

7

1.9

Legend and identification

Item Designation Item Designation

1 Endoscope 1.9 Insertion stopcock / port

1.1 Irrigation channel 1.10 Irrigation stopcock

1.2 Objective lens 2 Snap--on eyepiece with eyecup

1.3 Light exit 2.1 Locking screw

1.4 Working channel 3 Sealing cap

1.5 Cold--light adapter 4 Sealing cap adapter

1.6 Locking collar 5 Membrane adapter

1.7 Sealing membrane 6 Cone adapter

1.8 Rubber cap, red 7 Stopcock adapter

# Product no. * Serial no.

Item Designation Colour Meaning

1.1 1 Indication of viewing direction

1.12 Colored ring

red

blue

Viewing direction 20
Viewing direction 0

5

3

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4

5.1.2 Endoscope B

1.3

1.4

Fig. 3

180°

1.5

1.2

1.1
1

1.14

8.1

1.15

*

35

1.12

1.6

4

8

1.11 1.13

#

1.7

6

Legend and identification

Item Designation Item Designation

1 Endoscope 2 Eyepiece with eyecup

1.1 Irrigation channel 3 Sealing cap

1.2 Objektive lens 4 Sealing cap adapter

1.3 Light exit 5 Membrane adapter

1.4 Working channel 6 Cone adapter

1.5 Cold--light adapter 7 Stopcock adapter

1.6 Locking collar 8 Irrigation adapter, rotatable

1.7 Sealing membrane 8.1 Irrigation stopcock

1.14 Locking tab # Product no.

1.15 Size of fiber core diameter * Serial no.

Item Designation Color Meaning

1.1 1 Indication of viewing direction

1.12 Colored ring red Viewing direction 25

1.13 Maximum capacity (lumen) in mm

2

3

5

3

7

5

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5.2 Suction- and irrigation instruments

5.2.1 Stopcock-, irrigation connectors, adapters

4 56

#

5.1

#

Fig. 4

3

7

7.1

3

#

5.25.3

#

9

9.2

3

6.1

#

7.27.1

9.1

Legend and identification

Item Designation Item Designation

3 Sealing cap 7 Stopcock adapter

4 Sealing cap adapter 7.1 Insertion stop cock

5 Membrane adapter 7.2 Irrigation stopcock

5.1 Sealing insert 9 Irrigation adapter for workling sleeves

5.2 Membrane valve 9.1 Irrigation stopcock

5.3 Adapter 9.2 Locking sleeve

6 Cone adapter

6.1 Tab # Product no.

5.2.2 Suction tube, suction connector

Fig. 5

Legend and identification

Item Designation Item Designation

10 Suction tube 11 Suction connector

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10

11

#

# Product no.

6

5.3 Access instruments

5.3.1 Positioning rod

Fig. 6

Legend and identification

Item Designation Item Designation

12 Positioning rod # Product no.

5.3.2 Disposable Spinal Cannula Set

12

#

13

13.1

Fig. 7

Legend and identification

Item Designation Item Designation

13 Disposable Spinal Cannula Set 14 Guide wire

13.1 Protection sleeve

13.2 Spinal cannula

13.3 Internal needle

For more information see instruction manual GA--B 175

13.2

13.3

14

7

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5.3.3 Dilators

15

15.1

#

15.2

15.2.1

Fig. 8

Legend and identification

Item Designation Item Designation

15 Dilators # Product no.

15.1 Dilator, single--channel * Scale, graduation in mm

15.2 Dilator, dual--channel

15.2.1 Eccentric bore for second channel

5.3.4 Working sleeve

*

#

16

*

*

16.1

16.1

Fig.9

Legend and identification

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##

#

###

#

Item Designation Item Designation

16 Working sleeves # Product no.

16.1 Identification of window position * Scale, graduation in mm

16.2 Extension sleeve ## External diameter in mm

### Length in mm

16.2

8

5.3.5

Fig. 10

5.3.6 Trephines

Attachable handles

Legend and identification

Item Designation Item Designation

17 Attachable handle # Product no.

17

#

18

#

Fig. 11

Legend and identification

Item Designation Item Designation

18 Trephines # Product no.

5.3.7 Spongiosa pusher and funnel

Fig. 12

#

19

#

16

20

#

#

Legend and identification

Item Designation Item Designation

19 Spongiosa pusher

20 Spongiosa funnel # Product no.

9

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