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Wolf Vertebris Lumbar-Thoracic Endoscopic Instrument - User Manual
Wolf Vertebris Lumbar-Thoracic Endoscopic Instrument - User 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 GERMANY UK
RICHARD WOLF RICHARD WOLF GmbH RICHARD WOLF UK Ltd.
Medical Instruments Corporation 75438 Knittlingen Waterside Way
353 Corporate Woods Parkway Pforzheimerstr. 32 Wimbledon
Vernon Hills, Illinois 60061 Telephone: +49 70 43 35-0 SW17 0HB
Toll Free: 001 (800) 323 - 9653 Telefax: +49 70 43 35-300 Telephone: + 44 20 89 44 74 47
Phone: 001 (847) 913 - 1113 info@richard-wolf.com Telefax: + 44 20 89 44 13 11
Fax: 001 (847) 913 - 1488 www.richard-wolf.com admin@richardwolf.uk.com
MANUFACTURER www.richardwolf.uk.com
sales@richardwolfusa.com
www.richardwolfusa.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
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 Attachable handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.3.6 Trephines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.3.7 Spongiosa pusher and funnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
GA-B 223 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
6 Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
II GA-B 223
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
1.3.3 Dilators
Dilators are used for blunt preparation of the access channel. The cannulated
dilators can be inserted via a guide wire.
1.3.6 Trephines
The trephine is used to create a window in the fibrous ring of the intervertebral
disc.
1 GA-B 223
1.5 Forceps instruments, punches, scissors
1.5.3 Scissors
for the dissection of soft and cartilaginous tissue.
1.6.1 Abrader
Abraders are used for the resection of osseous structures under simultaneous as-
piration of severed tissue chips.
1.8.1 Deflector
The deflector is used for deflecting flexible auxiliary instruments.
3 Contraindications
CJD -- Creutzfeldt--Jakob Disease or
vCJD -- Variant of the Creutzfeldt--Jakob Disease
BSE -- Bovine Spongiform Encephalopathy; the so--called mad cow disease
(e.g. Creutzfeldt--Jakob 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.
GA-B 223 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
The cold--light connector (1.5) can be unscrewed and replaced with suitable
1.5 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.
Fig. 1
3 GA-B 223
5 Illustration
5.1 Endoscopes, endoscopic accessories
5.1.1 Endoscope A
2.1
2
#
1.1 1.2 1.3 #
*
1.1 1 1.5
1.12
1.4
3
1.6
4 5
1.7
1.9
1.10 1.8 6
3
1.11
7
1.10 1.8
1.9
Fig. 2
GA-B 223 4
5.1.2 Endoscope B
180°
1.5
1.2
1.3 8.1 2
1.1
1 1.15
*
35
1.12
3
1.4 1.14 1.6
4 5
8 #
1.11 1.13 1.7
3
6
7
Fig. 3
5 GA-B 223
5.2 Suction- and irrigation instruments
4 5 6
# 5.1 #
3 6.1
5.3 5.2 #
7 9
7.1 3 9.2 3
#
#
7.1 7.2
Fig. 4 9.1
10 11
#
Fig. 5
GA-B 223 6
5.3 Access instruments
12
#
Fig. 6
13
13.1
13.2
13.3
Fig. 7 14
7 GA-B 223
5.3.3 Dilators
15
15.1
#
15.2
15.2.1
* #
Fig. 8
16
* 16.1
* 16.1
##
# ###
16.2
Fig.9 #
GA-B 223 8
5.3.5 Attachable handles
17
#
Fig. 10
5.3.6 Trephines
18
Fig. 11 #
19
#
16
20
# #
Fig. 12
9 GA-B 223
5.4 Hand and auxiliary instruments
21 24
22 25
23 26
#
27
Fig. 13
GA-B 223 10
5.5 Forceps instruments, punches, scissors
28 29 30
# 28.1 30.1
28.2 # 30.2
29.2
29.2 30.3
30.5
30.6 30.4
29.1
32 32.1 31 31.1
33
33.7
33.6 33.5
Fig. 14
For more informations see instruction manuals GA--S 003 and BB--S 003--1 / BB--S 003--2
11 GA-B 223
5.6 Motorized instruments
5.6.1 Abraders
#
34
35
36 #
37
Fig. 15
For more information see instruction manual GA--A 202 and GA--A 238
#
38
39 #
39.
Fig. 16 1
39.2
For more information see instruction manual GA--A 202 and GA--A 238
GA-B 223 12
5.7 HF / RF Instruments
40.1
40.2 40
*
#
41.1 41
41.2
#
41.3
41.4
41.5 *
41.6
# 42
43
Fig. 17
13 GA-B 223
5.7.2 Bipolar Micro Grasping Forceps
47
44 45 46
44
45
46.1 46.2 #
45.1
46 46.3
46.4
Fig. 18
GA-B 223 14
5.8 Accessories
5.8.1 Deflector
48
Fig. 19 #
49.2
49.1 49.3 49
#
50.1 50.2 50.1
# #
50
Fig. 20 * *
15 GA-B 223
5.9 Packaging identification
Symbols Meaning
SN Series number
Manufacturing date
Manufacturer
Units, pieces
Use--by date:
25
Permissible temperature range
15
<60
< 60 %
Keep dry, atmospheric humidity below 60 %
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 marked with the code
number of the notified body (0124).
GA-B 223 16
6 Use
WARNING!
Do not reprocess disposable items!
Products marked ”disposable”, i.e. for single use only, have been designed
for only one use on or in a single patient.
If disposable items are reprocessed to be used again, product quality may
deteriorate, which will endanger the patient, user and others.
In this case the manufacturer can no longer guarantee the product’s safety
and performance.
CAUTION!
The products have only limited strength!
Exerting excessive force will cause damage, impair the function and there-
fore endanger the patient.
Immediately before and after each use, check the products for damage,
loose parts and completeness.
Ensure that no missing instrument parts remain in the patient.
Do not use products which are damaged, incomplete or have loose parts.
6.1 Preparation
Z Perform a visual check: section 7.1
Z Tighten the cold--light connector (1.5) (Fig. 1, page 3).
. NOTE!
The sealing membrane (1.7) amd membrane valve (5.2) should be re-
placed after each use.
Fig. 21 1.7 4 3
. NOTE!
If locking mechanism won’t engage, push release button (6.1) as far as it will go,
then repeat the procedure.
6.1
17 GA-B 223
Stopcock adapter (Fig. 23)
Z Place the sealing membrane (1.7) into the locking collar.
Z Firmly tighten the cone adapter (6).
Z Introduce the stopcock adapter (7) into cone adapter (6) until the locking mech-
anism snaps into place.
. NOTE!
If locking mechanism won’t engage, push release button (6.1) as far as it will go,
then repeat the procedure.
Z Attach the sealing cap (3).
6.1
Fig. 23 1.7 6 3
Endoscope A
For connecting endoscope A to objective lenses with C--mount thread, use the
plug--on eyepiece.
Z Attaching the plug--on eyepiece (2) (Fig. 24):
-- Unscrew the locking screw (2.1) turning in direction of arrow “a” as far as it
2 will go before you attach the eyepiece.
-- Install the plug--on eyepiece (2) and tighten the locking screw (2.1) in direction
2.1
of arrow “b”.
Fig. 24
Fig. 25
Z Install the rubber caps (1.8).
Z Connect the irrigation tubes (A) to the irrigation stopcocks (1.10).
Z Connect the fiber light cable (B) to the cold--light connector (1.5) and to a suit-
able light source.
B
A
1.5
A
1.8
Fig. 25 1.10
GA-B 223 18
Endoscope B (Fig. 26)
. NOTE!
The eyepiece with eyecup of endocope B cannot be removed.
When mounting the irrigation adapter (8) make sure that you overcome the resist-
ance of the 0--rings and keep the irrigation adapter perfectly aligned.
Z Push the irrigation adapter (8) in direction of arrow as far as it will go.
' The irrigation adapter snaps into place.
Z Connect the irrigation tube (A) to the irrigation stopcock (8.1).
Z Connect the fiber light cable (B) to the cold--light connector (1.5) and to a suit-
able light source.
1.5
A
8.1
xxxxx.xxxx
8
Fig. 26
Fig. 27
1.5 . NOTE!
To achieve optimum light transmission the fiber bundle diameters of the en-
doscope and of the fiber light cable must be the same.
Possible consequences when using a fiber light cable with
' excessive diameter:
excessive heating at the coupling point with the endoscope
1.15 ' insufficient diameter:
Fig. 27
reduced light output
The model / type no. of the fiber light cable is an indicator for the suitable
fiber bundle diameter (1.15).
' The code number on the cold light connector (1.5) must be the same as
the last 2 digits to the right of the decimal point of the product number
(type number).
Exception: Fiber light cable 8061.933 has a fiber bundlediameter
of 3.5 mm.
CAUTION!
Intense heat due to high light energy!
Under unfavourable conditions the use of the high temperature resistant
fiber light cable 8063.353 can cause a temperature increase at the coupling
point between the fiber light cable and the endoscope.
Danger of burns for the user and risk of damage to the endoscope.
Reduce the light output, or use fiber light cable product no. 8061.xxx /
8062.xxx if necessary.
Z Carry out a function check: section 7.2
19 GA-B 223
6.1.2 Attaching access instruments
. NOTE!
The working sleeves (16) can be inserted in 4 working positions, i.e. in every 90
position.
Z Install the sealing cap (3) [not with attachable handle (17)] (Fig. 28).
Fig. 28
Fig. 29
Z Retract the locking sleeve (9.2) and hold it in the retracted position.
Z Insert working sleeve (16) in irrigation adapter (9).
Z Let go of the clamping sleeve (9.2).
' The clamping sleeve (9.2) returns to its home position.
Z Pull slightly to check that the connection is securely locked.
Z Connect the irrigation tube (A) to the irrigation stopcock (9.1)
[not with attachable handle (17)].
16 9
9.1
9.2 A
Fig. 29
10 Fig. 30
Z Plug the suction connector (11) under slight rotation into suction tube (10).
Z Connect the suction tube to the suction connector (11).
11 . NOTE!
If on a short--term basis increased aspiration is required, the suction con-
Fig. 30 nector (11) can also be be directly attached to the distal end of the endo-
scope.
GA-B 223 20
6.1.3 Motorized instruments
. NOTE!
In intadiscal use with the nucleus resector we recommend additional irrigation via
the luer connector or working sleeve.
Advantages:
' It improves cutting performance
' It facilitates the removal of tissue fragments
' It minimizes the risk of a possible clogging of the nucleus resectors
A . IMPORTANT!
If the luer connector (37.1) is not required, it should be closed with the luer
Fig. 31a 37.2 lock cap (37.2) to avoid reduced suction power.
Fig. 31b
38
9 Z Install the sealing cap (3) as shown in Fig. 28.
Z Insert working sleeve (16) into irrigation adapter (9) and connect the irrigation
supply tube (A) to the luer connector (9.1) as shown in Fig. 29.
Z With the resector blade (38) connected to the shaver handpiece, insert the
resector blade (38) into the working sleeve (Fig. 31b).
Z Operate the resector blade (38) with irrigation supplied through the working
A sleeve and suction connected to the shaver handpiece.
9.1
Fig. 31b
. IMPORTANT!
Use only products with type BF or CF applied parts in conjunction with the endo-
scope.
WARNING!
Intense heat due to high light energy!
Danger of inadvertent tissue damage
' due to insufficient distance between the light exit area and the tissue
' due to soiling / contamination in the light exit area
' when using high performance light projectors.
Do not touch the light exit area and avoid direct contact with the tissue.
Remove any soiling / contamination.
WARNING!
Fire hazard!
When placing the endoscope onto heat- sensitive flammable surfaces (dark
drapes etc.) the high light energy at the light exit area of the endoscope can
cause high temperatures or even ignition.
Store the endoscope at a safe place.
Switch off the light source if you do not use the endoscope for a prolonged
period of time.
21 GA-B 223
CAUTION!
Danger of burns!
Due to the high energy of the light source the cold light connector will be
hot when disconnecting it from the light source.
Burns may result from unintentional contact with the connector.
Do not touch the light connector, allow it to cool down.
6.2.2 Current
WARNING!
Danger from electric shock!
Patient leakage currents can add up if the endoscope is combined with
powered endoscopic accessories.
Make sure that the combinations do not exceed the permissible patient leak-
age currents.
6.2.3 Image quality
CAUTION!
Increased risk potential if the image is blurred!
Danger of injuring the patient.
Stop the intervention for safety reasons if the image is blurred.
Check the image quality of the endoscope before use (section 7.2).
CAUTION!
Irrigation fluid can be electrically conductive!
Depending on the application, a suitable low- conductivity irrigation fluid
must be selected by the user.
Do not use saline (NaCl) solution for HF applications.
CAUTION!
Determine the irrigation and suction rates!
Due to the differing anatomical conditions the irrigation and suction rates
cannot be quantified. The user must adapt these rates to the patient and to
the situation.
CAUTION!
In the case of motor- driven instruments!
Do not apply any suction during extradiscal application of the instruments!
To prevent inadvertent aspiration of other types of tissue (e.g. nerves),
suction is not permissible when the instruments are applied extradiscally.
GA-B 223 22
6.2.6 HF application
Follow the ”Notes and instructions on HF applications”, order no.: GA--S 002
as well as the HF device manufacturer’s instructions.
WARNING!
Danger of injury if the HF instrument is not visible through the scope!
Inadvertent tissue damage as well as damage to the distal end of the endo-
scope and instrument parts are possible.
Use HF instruments only within the scope of their specifications (voltage
strength, duty factor).
Activate HF instruments only after the part conducting HF current has be-
come fully visible through the scope and contact is made with the desired
area of use.
WARNING!
HF arcing!
Danger of injury due to incorrect HF application and insufficient distance
between parts conducting live HF current and other conductive parts.
Parts of HF instruments that conduct live HF current must maintain a safety
distance of at least 10 mm from the distal end of the endoscope or working
sleeve during activation (Fig. 32)
Fig. 32
CAUTION!
Danger of burns due to leackage currents when using high- frequency current.
Burns on the surgeon’s eye or face may occur.
Use the endoscope only with the eyepiece (2) attached (Fig. 33).
2
Fig. 33
CAUTION!
Careful if HF output power is incorrectly selected!
Injuries to the patient as well as damage to the product are possible.
The power should be set on the basis of the surgeon’s experience / training
regarding the corresponding indication.
. NOTE!
For determining the optimal power setting we recommend starting with a low
power setting.
23 GA-B 223
6.3 Laser application
When applying a laser make sure you follow the laser device manufacturer’s in-
structions as well as the general regulations on the use of lasers.
Wear the required personal protection equipment.
CAUTION!
Do not work outside the scope’s field of view!
Inadvertent tissue damage as well as damage to the distal end of the endo-
scope and to instrument parts are possible.
Activate the laser only after
' the tip of the laser fiber is fully visible through the endoscope and
' the pilot beam makes contact with the intended area to be treated.
CAUTION!
High temperatures due to highly coherent laser beam!
The heat generated by the laser beam reduces the strength of instrument
parts.
Do not direct the laser beam at instrument parts, in particular not at plastic
parts.
Keep a safe distance.
CAUTION!
Highly coherent light beams!
C Danger of eye injuries!
When using the product in conjunction with laser devices make sure you wear
adequate personal safety gear.
When using an ND- YAG laser while working through the endoscope under
direct view, use the additional filter attachment (C) (Fig. 34).
Keep a safe distance.
Fig. 34
. NOTE!
For information about further forceps, punches and scissors, see GA--S003 and
BB--S003--1.
CAUTION!
Danger of injury as well as possible damage to the endoscope when
introducing or withdrawing instruments in open condition!
Inadvertent tissue damage, damage to the distal end of the endoscope as
well as loss of particles from the jaws are possible.
Introduce and withdraw the instrument only in closed condition and under
visual control (Fig. 35).
Fig. 35
GA-B 223 24
CAUTION!
Danger of injury if the intradiscal grasping forceps is not used under visual
control!
Inadvertent manipulations may result in injuries.
Limit the use to the intradiscal space and ensure this by image converter
control if necessary.
30.4
30.6
Fig. 36
. NOTE!
The jaws (29.7) can be rotated through 360 to any position which suits the surgeon.
Z Changing the position of the jaws (Fig. 37):
-- Loosen locking screw (30.5) by turning as indicated by the arrow ”open”.
-- Turn the jaws (33.7) to the required position.
-- Tighten locking screw (30.5) by turning as indicated by the arrow ”close”.
' The jaws are locked in this position.
open close
33.7
Fig. 37 30.5
25 GA-B 223
Z Locking the forceps handle (Fig. 38):
Push the handle grips together and turn the locking mechanism (26.3) in the
direction indicated by the arrow.
' The jaws (33.7) are closed and locked.
30.3
33.7
Fig. 38
. NOTE!
The deflection lever can be mounted on the left or right--hand side.
. IMPORTANT!
Deflection lever (30.4) is only functional if mounted parallel to the sheath.
Z Assembling the deflection lever (Fig. 39):
-- Insert the square section of the deflection lever in the square bore.
-- Push the deflection lever in the square bore as far as it will go.
' The deflection lever (30.4) clicks into place.
30.4
Fig. 39
GA-B 223 26
Z Disassembly of deflection lever (Fig. 40):
-- Push onto the square of the deflection lever (30.4) from the opposite side until it
disengages from the square bore (Fig. 40a).
-- Remove the deflection lever (30.4) (Fig. 40b).
30.4
Fig. 40a Fig. 40b
30.4
Fig. 40
7 Checks
CAUTION!
Be careful if products are damaged or incomplete!
Injuries of the patient, user or others are possible.
Run through the checks before and after each use.
Do not use the products if they are damaged, incomplete or have loose parts.
Return damaged products together with any loose parts for repair.
Do not attempt to do any repairs yourself.
7.1 Visual check
Z Check the instruments, in particular their distal areas, and the accessories for
' damage
' sharp edges
' loose or missing parts
' possible surface changes (e.g. corrosion)
' rough surfaces
' hairline cracks.
Z Replace sealing membrane (1.7) and membrane valve (5.2) after each use.
Z Replace any torn or damaged rubber caps (1.8 / 47), sealing caps (3) and O--
rings.
Z Check the jaws for defective cutting edges and corroded parts. (Fig. 41)
CAUTION!
Danger of injury!
Check for surface changes, such as hairline cracks, around the hinge pin
(Fig. 41).
Caution if surface in the hinge area of the forceps is damaged.
The hinge pin can loosen.
Z Any lettering, labeling or identification necessary for the safe intended use
must be legible.
' Missing or illegible lettering, labeling or identifications leading to incorrect
handling and reprocessing must be reinstated.
Fig. 41
27 GA-B 223
7.2 Functional check
7.2.1 Endoscopes
Z Check image quality and light output in conjunction with the system compo-
nents.
Z Check the glass surfaces for any deposits.
' Deposits on the glass surfaces can cause a spotted or blurred field of view
and thus impair light transmission considerably.
' Wipe the glass surfaces with a swab soaked with alcohol (wood swab car-
rier, not metal or plastic), remove hard--to--remove deposits with instrument
cleaner.
35
Fig. 42
35
Fig. 43
GA-B 223 28
8 Reprocessing and maintenance
WARNING!
Creutzfeldt Jakob Disease!
If the patient is suspected of having the Creutzfeldt Jakob Disease (CJD) or a
variant of the Creutzfeldt Jakob Disease (vCJD) or the latter have been diag-
nosed, adequate measures must be taken to prevent possible transmission
to other patients, users and third parties.
For this purpose apply the country- specific reprocessing guidelines and
regulations.
8.1 Disassembly before cleaning
8.1.1 Endoscopes
Z Unscrew the cold--light connector (1.5) (Fig. 44).
1.5
Fig. 44
. NOTES!
Remove and replace the sealing membrane (1.7) and membrane valve (5.2)
after each use.
1.7 3
Fig. 45
6.1
5.1
29 GA-B 223
Stopcock adapter (Fig. 47)
Z Remove the sealing cap (3).
Z Push the tab (6.1) and remove the stopcock adapter (7).
Z Unscrew the cone adapter (6).
Z Remove the sealing membrane (1.7).
6.1 7
Fig. 47 1.7 6 3
Endoscope A
Z Remove the plug--on eyepiece (2) (Fig. 24, page 18).
Endoscope B
Z Push the locking tab (1.14) and remove the irrigation adapter (8) in direction of
arrow (Fig. 48).
35
1.14
8
Fig. 48
Working sleeve and irrigation adapter or attachable handle (17) (Fig. 49)
Z Separate the working sleeve (16) from the irrigation adapter (9) .
Z Remove the sealing cap [not with attachable handle (17)] (3).
16 9.2 9
Fig. 49
GA-B 223 30
8.1.3 Forceps instruments, punches, scissors
ZUnscrew the luer--lock sealing cap (30.1) (Fig. 50).
30.1 ZRemoving the deflection lever: see Fig. 40
Fig. 50
8.2.1 Endoscopes
Z Wet preparation at the point of use
Z Disassembly before cleaning: see section 8.1
Z Manual cleaning with an approved enzymatic cleaner.
30.2
Fig. 51
37.2
37
Fig. 52
31 GA-B 223
8.3 Machine reprocessing
8.3.1 Endoscopes
Z Dry preparation at the point of use
Z Disassembly before cleaning: see section 8.1
Z Machine cleaning with an approved enzymatic cleaner.
Endoscope B
. IMPORTANT!
Before machine reprocessing, preclean the rotatable irrigation adapter (8) manually.
. IMPORTANT!
Before you place endoscope B into the reprocessing basket, install the rotatable
irrigation adapter (8) (section 6.1.1).
Endoscopes A and B (Fig. 53 / Fig. 54)
Z Screw on the supplied irrigation adapter (C).
' Before, clean the endoscope’s contact surfaces manually.
Z Place the parts used into the small items basket:
-- Rubber caps (1.8)
-- Sealing cap (3)
-- Sealing cap adapter (4)
-- Membrane adapter (5)
-- Cone adapter (6) and
-- New sealing membrane (1.7)
-- Snap--on eyepiece (2), only in the case of endoscope A
Z Place the cold--light connector (1.5) onto the corresponding holder.
Z Pass the irrigation tubes through the meshes, connect all connectors and open
the stopcocks (8.1) / (1.9) / (1.10).
. IMPORTANT!
For machine cleaning do not place the stopcock adapter (7) into the reprocessing
basket but store it securely in the corresponding holders in the rinsing basket.
Endoscope B (Fig. 53)
4 1.7 1.5
38044.411
= rinsing tube 8 B C
Fig. 53
GA-B 223 32
Endoscope A (Fig. 54)
1.5 6 4 2
38044.111
= rinsing tube B C
Fig. 54
8.3.2 Forceps instruments, punches, scissors, nucleus resector with luer connector
Z Dry preparation at the point of use
Z Disassembly before cleaning: see section 8.1
Z Machine cleaning with an approved enzymatic cleaner.
' To prevent damage in the washer/disinfector, place the products in special
holders or in a reprocessing basket.
' Connect forceps / nucleus resector with luer connector (37) via luer connec-
tors (30.2 / 32.2), (37.1) to the washer/disinfector.
Z Oil all movable parts sparingly with instrument oil.
Wipe off/remove any excess oil.
8.4 Checks
Z Perform a visual check: see section 7.1
33 GA-B 223
8.5 Assembly before sterilization
. NOTE!
Before sterilization screw on the threaded connections only loosely:
' to allow a sufficient flow of sterilization medium.
' to prevent stress cracks.
Tighten all threaded connections before use.
. IMPORTANT!
Do not screw on the luer lock caps (30.1 / 32.3), (37.2) to allow a sufficient flow
of sterilization medium.
Screw on the luer lock caps after sterilization and before use.
8.5.1 Endoscopes
Z Attach the cold--light connector (1.5) and screw it home (Fig. 1, page 3).
Z Oil all movable parts sparingly with endoscope oil.
Wipe off/remove any excess oil.
Endoscope B
Z Disassemble the rotatable irrigation adapter (8) (section 8.1.1) and oil the slid-
ing surfaces on the endoscope sparingly with instrument oil. Remove any ex-
cess oil.
Z Attach the rotatable irrigation adapter (8) see section 6.1.1.
Fig. 56
GA-B 223 34
8.6 Sterilization
Endoscopes A and B
Z Before sterilization, assemble endoscope B or A, as described under section
8.5.1.
Z Screw on the sealing cap attachment (4) only loosely.
Endoscope B (Fig. 57)
C 1.5
38044.411
8 B 4
Fig. 57
7 C 1.5
38044.111
Fig. 58 A 4
Z For sterilization wrap the reprocessing basket/tray in compliance with the stan-
dards in your country or use a suitable sterilization container.
35 GA-B 223
8.6.1 Steam sterilization
Z Steam sterilization at 132 C (270 F) using a Pre--Vac cycle at an exposure
time of 4 minutes with a 20 -- 30 minute dry time.
Fig. 59
Steam Sterilization
Z Steam sterilization at 132 C (270 F) using a Pre-Vac cycle at an exposure
time of 4 minutes with a 20 -- 30 minute dry time.
GA-B 223 36
9 Technical data and order data
For additional information on the reprocessing, see Manual GA--J020 “Reproces-
sing of RICHARD WOLF Heat Stable Instruments”.
For technical data, order data and combinations of the following instruments see
”System overview VERTEBRIS lumbar--thoracic”, order no. BB--B 223.
Z Endoscopes, endoscopic accessories
Z Suction and irrigation instruments
Z Access instruments
Z Manual and auxiliary instruments
Z Motorized instruments
' see “Overview of motorized instruments” order no. BB--B 223--1.
For further information see the respective manuals.
37 GA-B 223
Item Illustration Product no. Designation
The products can be combined as required provided their relevant technical data and intended uses are ob-
served. For the general overview please refer to the latest catalog sheets and brochures, or contact Richard
Wolf or your Richard Wolf representative.
. IMPORTANT!
Store sterile products in their original packaging until use.
Incorrect storage may lead to loss of sterility.
. NOTE!
To prevent damage during transport or shipment of the products we recommend
using the original packaging material.
GA-B 223 38
12 Warranty and Customer Service
Richard Wolf guarantees our instruments to be free from any defects in materials and workmanship under
normal use and service for one year. Richard Wolf general terms and conditions may be found on the
back of our invoice.
Parts delivered separately by Richard Wolf are subject to all of the same general terms and conditions for
our products, including the limitations of warranty and liability.
All products should be returned to Richard Wolf for any necessary or desired repair or part replacement.
No product repair or part replacement should be done other than by Richard Wolf unless the care and
instruction manual or other written information indicates that repair or part replacement is authorized. If
authorized, parts must be replaced only by parts supplied or specified by Richard Wolf, and product repair
and part replacement must be done in strict conformance with Richard Wolf specifications and
instructions for repair and part replacement, including post replacement testing and recalibration. Failure
to follow this requirement in any way can be dangerous to you, your personnel and your patients and
voids the warranty for the product repaired or the product in which the part was replaced and if the part
was supplied by Richard Wolf, for that part.
Delivery by Richard Wolf of technical documents such as circuit or other design diagrams does not
constitute authorization for product repair or part replacement. Richard Wolf instruments and other
products should never be modified or altered under any circumstances.
Contact Richard Wolf if you have any question (1) whether replacement of a part or a repair is authorized
by Richard Wolf, or (2) whether you have complete instructions and specifications for part replacement or
repair.
These instructions do not attempt to cover all details or variations in equipment, nor to provide for every
possible contingency to be met in connection with installation, operation, or maintenance. Should further
information be required or should problems arise which are not covered sufficiently for the purchaser’s
purpose, the matter should be referred to Richard Wolf Medical Instruments Corporation.
Our national sales and service offices, as well as our manufacturing facility, are located in Illinois. Trained
manufacturer’s representatives are located throughout the U.S. to serve you. For any questions
regarding these instruments, or to place an order, contact Richard Wolf customer service department at
847--913--1113 or 800--323--WOLF (9653).
INSTRUMENT ORDERING POLICY
Richard Wolf reserves the right to make substitutions, if necessary, without prior notice.
REPAIR POLICY
Defective merchandise will be repaired or replaced at no charge to the customer, provided the customer
delivers such defective merchandise prepaid. Any repairs, maintenance or servicing of Richard Wolf
merchandise by anyone other than a factory authorized representative will render our warranty null and
void.
REPAIR SHIPMENTS
When returning your instrument for repair, we suggest that you prevent shipping damage to the
instrument by reusing the box that it was originally shipped in. Richard Wolf also recommends that the
instrument be insured for an amount to cover the cost of replacement.
IMPORTANT
For general safety and health reasons, Richard Wolf requires that you clean and sterilize all instruments
before returning them for repair. If instruments are received in an unsanitary condition, Richard Wolf will
clean and sterilize each instrument and add a $ 100.00 cleaning charge for each instrument requiring
cleaning.
39 GA-B 223