KESS-Working Sleeves, Irrigation Attachments and Auxiliary Instruments Instructions Manual

Important general instructions for use Ensure that this product is only used as intended and described in the instruction manual, by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized specialized technicians. Operate this product only in the combinations and with the accessories and spare parts listed in the instruction manual. Use other combinations, accessories and wearing parts only if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repair as required by the instruction manual in order to protect the patient, user or third parties. Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual.

CAUTION -- USA only: Federal law restricts this unit to be used or sold, except under the supervision of a medical doctor.

Safety instructions and levels of danger Symbol

Level of danger WARNING! Failure to observe can result in death or severe 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 surrounding. NOTE! Tips for optimum use and other useful information.

GERMANY RICHARD WOLF GmbH D--75438 Knittlingen Pforzheimerstr. 32 Tel.: (..49)--(0)7043--35--0 Fax:(..49)--(0)7043--35300 MANUFACTURER

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Tel.: (001)--847--913 1113 Fax: (001)--847--913 1489

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: (..44)--(0)181--944--7447 Fax: (..44)--(0)181--944--1311

BELGIUM N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 B--9031 Gent --Drongen Tél.: (..32)--(0)9--2808100 Fax: (..32)--(0)9--2829216

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F--51100 Reims Tél.: (..33)--(0)3--26--870289 Fax: (..33)--(0)3--26--876033

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Lederergasse 32 A--1082 Wien Tel.: (..43)--(0222)1--405 6219 Fax: (..43)--(0222)1--408 7084

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Intended use The working sleeves, irrigation attachments and auxiliary instruments for KESS (Dr.Knight’s endoscopic spinal surgery system) are used to perform endoscopic surgery on the lumbar spine, e.g. for decompression of the intervertebral disks. The intervention is performed via surgically created passages.

1.1

Spinal cannula set is used for local anesthesia and primary definition of the port of access.

1.2

Dilator serves as a guide for the working sleeve and is introduced via the obturator.

1.3

Working sleeve/ irrigation attachment provide the port / channel for the use of the instruments and allow irrgation and suction via the irrigation attachments.

1.4

Trephine serves to create a window in the fibrous ring of the intervertebral disk.

1.5

Elevator / exploring hook / exploring probe/ anulotome / dissector These auxiliary instruments are introduced through the instrument channel of the diskoscope for palpation / preparation and removal of tissue from within the disk.

1.6

Insertion set serves to create a first passage/port.

1.7

Instrument holding forceps is used for holding the PANOVIEW PLUS Diskoscope during an intraoperative X--ray.(see fig. ) Follow the relevant X--ray regulations.

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Indications and field of application For examination, diagnosis and/or therapy with endoscopic accessories in spinal surgery (e.g. arthroscopic microdiskectomy (AMD), spinal endoscopy).

3

Contraindications Contraindications directly related to the product are presently unknown. On the basis of the patient’s general condition the physician/surgeon in charge must decide whether the planned use is possible or not. For further information see the latest medical literature.

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Combinations The ”KESS” instruments are used in connection with endoscopic devices and endoscopic accessories. CAUTION! When different products are combined it is necessary that they are compatible in their intended use and relevant technical data (working length, diameter, etc.). Follow the instruction manuals of the products used in combination with this product.

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Illustration I 1.1

Fig. 1 1.2

1.4

1

Fig. 2 1.3

Fig. 3 2

Fig. 4 4 3

6 5

5.1

Legend Fig.

Item 1

Model/part no. 8793.802 8793.803

1

2 1 3

1.1 1.2 1.3 1.4 2 3

4

2

4 5 6

8793.781 8793.022 8793.025 8793.221 8793.222 89.03

Designation, Technical Data Spinal cannula set, dia. 1.0 mm, WL= 260 mm Spinal cannula set, dia 0.65 mm, WL= 260 mm consisting of: Spinal cannula Inner needle Obturator, blunt/conical tip, 400 mm long Identification for position of bevelled tip. Dilator, dia. 5.3 mm, WL= 225 mm Working sleeve, dia. 6.2 mm, WL= 165 mm Working sleeve with lateral window, dia. 6.2 mm, WL= 165 mm Irrigation attachment, lockable, inner dia. 6.2 mm Irrigation attachment, rotating, inner dia. 6.2 mm Sealing cap, grey

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Illustration II

Fig. 5

7

8 9

Fig. 6

10 11 12

13.1 13.2

Fig. 7

Fig. 8

6.1

14

Legend Item

Fig.

7

5

8 9 10 11 12 13 13.1 13.2 13.3 14

7

13

13.3

6

7

8

Model/part no. 8793.522 8793.521 8793.581 8793.592 8793.597 8793.596 8793.598 8793.531 8793.532 8793.533 8793.534 8793.856

Designation, Technical Data Trephine, dia. 6 mm, WL= 200 mm , cutting window dia. 3 mm Trephine, dia. 6 mm, WL= 200 mm , cutting window dia. 5 mm Anulotome dia. 2 mm, WL= 350 mm Dissector dia. 2 mm, WL= 350 mm Exploring hook, dia. 2 mm, WL= 350 mm Elevator, dia. 2 mm, WL= 350 mm Exploring probe, dia. 2.5 mm, WL= 350 mm Insertion set, consisting of: Insertion trocar sleeve Insertion trocar, blunt Insertion trocar, pyramid--shaped INSTRUMENT HOLDING FORCEPS TL 208MM

Identification 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).

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Use CAUTION ! The instruments have only limited strength. Excessive force can lead to damage and impair the function.

8.1

Preparation Run through the checks. (chapter 9) Connect lockable irrigation attachment (4) to working sleeve (3), fig. 9. Put on sealing cap (6). Clamping lever (4.1) is in position ”I”, fig. 9a. To lock, fig. 9b : insert working sleeve (3) in irrigation attachment (4) and move clamping lever (4.1) to position ”II”. To unlock, fig. 9b: move clamping lever (4.1) to position ”I”.and remove working sleeve (3).

Fig. 9 4.1

I

II

Fig.9a

3

4.1

Fig. 9b 6 4

Connect rotating irrigation attachment (5) to working sleeve (3), fig. 10. Put on sealing cap (6). To lock, fig. 10a: retract and hold working sleeve (5.1). Insert working sleeve (3) in irrigation attachment (5), let go of clamping sleeve (5.1) NOTE! The working sleeve (3) and the irrigation attachment (5) are locked correctly if clamping sleeve (5.1) returns to its home position. Check for correct locking by pulling slightly.

Fig. 10

3

5.1

Fig. 10a

6 5 To unlock: retract and hold clamping sleeve (5.1), then remove working sleeve (3).

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Inserting inner needle (1.2) in spinal cannula (1.1), fig.10 : The pin (a) engages in groove (b).

Fig.11 b 1.1 a 1.2 8.2

Instrument holding forceps with ratchet lock (14) : Closing the forceps: The ratchet mechanism (14.1) engages automatically in steps when the handles are pushed together. Opening the forceps: Push the handles laterally as indicated by the arrow.

Fig.12

14.1

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Checks Check instruments and accessories for damage, sharp edges and rough surfaces. Replace damaged (brittle) sealing caps (6). Check lettering for completeness and easy legibility. Check suction rate of working sleeve (3) with irrigation attachment (4)/(5) attached. NOTE! Do not use instruments once they have become damaged. Send in damaged instruments for repair.

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Reprocessing and maintenance NOTE! Follow the ”General instructions on the reprocessing of R.Wolf endoscopes and accessories”, order no.: GA--J 020, where the following procedures are described in detail.

10.1

Manual reprocessing IMPORTANT ! Flush spinal cannulas immediately after use. Remove any clogging with a guide wire. Do not use spinal cannulas once they have become damaged. Dispose of damaged spinal cannulas. Decontamination by immersion Disassembly before cleaning Remove sealing caps (6). Disconnect working sleeve (3) from irrigation attachment (4)/(5). Manual cleaning / disinfection

10.2

Machine reprocessing Dry preparation/wrapping for reprocessing. Disassembly before cleaning Same procedure as described under ”manual reprocessing” Machine cleaning / disinfection

10.3

Checks see chapter 9.

10.4

Sterilization Steam sterilization at 134°C (272°F) using the fractional method.

10.5

Operating, storage, transport and shipping conditions. Operating conditions

+10°C to +40°C , 30% to 75% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping conditions

-- 20°C to +60°C , 10% to 90% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

NOTE! To prevent damage during transport or shipment of the products we recommend using the original packaging material.

10.6

Disposal of product, packaging material and accessories. For disposal observe the regulations and laws valid in your country. For further information please contact the manufacturer.

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Technical data and Order data see chapter 5 ”Illustration”

11.1

Spare parts and accessories Item 6

6

Order no. 89.03

Designation SEALING CAP CAP 5.1--6.0MM

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