Ulnar Nerve Decompression Instruments Instructions Manual

Important general instructions for use Ensure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized specialized technicians. Use this product only with the combinations and with the accessories and spare parts listed in this instruction manual. Use other combinations, accessories and replacement 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 device to sale by or on the order of a physician.

Safety instructions and levels of danger Symbol

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.

GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35--0 Telefax: +49 70 43 35--300 MANUFACTURER [email protected] www.richard--wolf.com

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: +1 84 79 13 11 13 Telefax: +1 84 79 13 14 88 sales&[email protected] www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette 51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a 1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 1405 51 51 45

[email protected]

[email protected] www.richard--wolf.at

[email protected] www.richard--wolf.be Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard--wolf.com

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INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon -- 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard--wolf.com

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Contents 1

Technical description...

1

2

Intended use...

1

3

Indications and field of use...

2

4

Contraindications...

2

5

Combinations...

2

6 6.1

Illustration... Legend and identification...

3 3

7 7.1 7.1.1 7.1.2 7.2 7.2.1 7.2.2

Use... Preparation... Inserting the light guide rod (1.5) into the speculum (1)... Inserting the PANOVIEW telescope (3) / (4) into the optical dissector (2)... Additional notes and instructions for use... Using the speculum with light guide rod... Using the optical dissector (2) with installed PANOVIEW telescope (3) / (4)...

5 5 5 5 6 6 6

8 8.1 8.2

Checks... Visual check... Functional check...

7 7 7

9 9.1 9.2 9.3 9.4 9.5 9.6 9.6.1 9.6.2

Reprocessing and maintenance... Disassembly before cleaning... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Sterilization... Steam sterilization... STERIS and STERRAD sterilization procedures...

8 8 8 8 8 8 8 8 8

10

Technical data and order data...

9

11

Spare parts and accessories...

9

12 12.1

Operating, storage, transport and shipping conditions... 10 Disposal of product, packaging material and accessories... 10

13

Literature... 10

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1

Technical description Instrumentation for decompressing the ulnar nerve (cubital tunnel syndrome), consisting of: Speculum with light connector with a light guide rod adapted to the external contour of the handles. for cleaning, the light guide rod can be disconnected via a positive locking plug--and--socket connection. with speculum tynes. The return movement of the tynes is effected via leaf springs attached to the handle grips. Optical dissector with spatula with distal opening. with graduated access sleeve for holding the PANOVIEW telescope 30°. with ergonomically designed handle, consisting of a finger support and a thumb plate. with automatic ”click” lock for inserting and locking the telescope in place. Telescopes, Ø 4 mm dia. PANOVIEW telescope 30° PANOVIEW 3 wide angle telescope 30° Modular Metzenbaum scissors consisting of: Metzenbaum scissors Ø 3.5 mm dia. Ergonomic handle (modular system) Scissors by Metzenbaum, curved Dressing forceps by Duplay with fluted grasping surfaces on the tynes. with locking mechanism between the handle rings.

2

Intended use This instrumentation is designed for endoscopic operation of the cubital tunnel syndrome via a minimally invasive passage, with the target of decompressing the ulnar nerve in the cubital tunnel (sulcus ulnaris). Speculum with light connector the speculum is used for spreading the incision and tunneling or expanding the operating area. for visualizing the passage. for placing the telescope in conjunction with the optical dissector, and for illuminating the passage via the light rod attached to the speculum. Optical dissector the optical dissector is used for continuous atraumatic dissection and splitting of soft tissue in the cubital tunnel under endoscopic view. The graduation on the access sleeve is used for orientation and visualization of the neurolysis path. for splitting compressed structures near the ulnar nerve. for exposing and transsecting fasciae in conjunction with the nescessary auxiliary instruments. PANOVIEW Telescopes the PANOVIEW Telescopes serve to visualize the inside of the patient. Modular Metzenbaum Scissors / Scissors by Metzenbaum are used for the splitting, preparation and transsection of soft tissue parts and fasciae. Dressing forceps by Duplay for tunneling or extending the operating area by mild spreading of the forceps. This allows further auxiliary instruments to be inserted.

1

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Indications and field of use Compression neuropathy of the ulnar nerve in the areas of the upper and lower extremities in conjunction with endoscopic accessories in the disciplines of Arthroscopy Orthopedics / Hand surgery NOTE ! We recommend reading the relevant literature regarding the planned use. see also section 13 “Literature”

4

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.

5

Combinations The Instrumentation is used in conjunction with: Light sources and fiber light cables Telescopes Cameras and objective lenses Endoscopic accessories CAUTION ! Be careful if products are incorrectly combined ! Injury may result to the patient, user or others, and damage may result to the product. Different products should only be used in combination if their intended uses and relevant technical data (working length, diameter, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product. Endoscopes GA- S 001 Modular Forceps and Scissor System GA- S 021 Fig. 1

1.6

The cold--light connector (1.6) can be unscrewed and replaced by suitable adaptors to connect fiber light cables of other manufacturers. For order data please refer to the latest catalog sheet.

Fig. 1

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2

6

Illustration 1.3

1

1.4

# #

1.2

1.5 1.6

5

1.1

2.4

# #

2.1

2

2.2

2.6

2.3

2.5

#

6

# 7.2 7.1

3/4

7

#

7.3

# Fig. 2 6.1

Legend and identification

3

Item

Designation

Item

Designation

1

Speculum

3

PANOVIEW telescope 30°

1.1

Speculum tynes

4

PANOVIEW 3 wide angle telescope 30°

1.2

Plug--in connection

5

1.3

Locking screw

6

Scissors by Metzenbaum, curved

1.4

Handle grips

7

Dressing forceps by Duplay

1.5

Light guide rod

7.1

Dressing forceps, curved

1.6

Cold--light connector

7.2

Dressing forceps, straight

2

Optical dissector

7.3

Lock

2.1

Spatula

2.2

Passage sleeve

#

Product no.

2.3

Handle

2.4

Thumb plate

2.5

Slider

2.6

Graduation

Modular Metzenbaum scissors Ø 3.5 mm dia. with insulated sheath tube

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Symbols

Designation Attention, consult ACCOMPANYING DOCUMENTS

REF

Order number Lot identification number

SN

Serial number Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product and/or packaging are marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function in category I, are additionally marked with the code number of the notified body (0124).

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7

Use CAUTION ! The products have only limited strength ! Exerting excessive force will cause damage, impair the function and therefore 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.

7.1

Preparation Check assembly: section 9.5 Carry out a check: sections 8 and 8.1

7.1.1

Inserting the light guide rod (1.5) into the speculum (1)

1.6

Fig. 3 Screw on and tighten the cold--light connector (1.6). Position the light guide rod (1.5) between the speculum tynes (1.1) and fix in the plug--in connection (1.2). The two components are firmly locked together.

1.1

1.2

1.5

Fig. 3 7.1.2

Inserting the PANOVIEW telescope (3) / (4) into the optical dissector (2) Fig. 4 Insertion Insert the PANOVIEW telescope (3) / (4) axially into the access sleeve (2.2) until the slider (2.5) engages. The pin (a) engages in the groove (b).

(a) (b)

2.2

2.5

3/4

Fig. 4

Fig. 5 Withdrawal Push down the slider (2.5), hold depressed and remove PANOVIEW telescope (3) / (4). IMPORTANT ! The slider (2.5) cannot be removed.

Fig. 5

5

2.5

3/4

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7.2

Additional notes and instructions for use Connect the fiber light cable via the cold--light connector to a suitable light source. Fig. 6 NOTE ! To obtain optimum light transmission, the diameters of the fiber core of the endoscope and of the fiber light cable must be the same. Possible causes when using a fiber light cable that is too large: the coupling point with the endoscope may become excessively hot is too small: the light output is reduced For a suitable fiber bundle diameter please check the product number of the fiber light cable. the code number on the cold--light connector (1.6) must correspond with the two digits to the right of the decimal point of the product number Exception: The fiber light cable 8061.933 has a fiber bundle diameter of 3.5 mm.

1.6

Fig. 6

CAUTION ! Intense heat due to high light energy ! In the case of unfavorable combinations, using the highly temperature- resistant fiber light cable 8063.353 can cause a temperature increase at the coupling point between the fiber light cable and the endoscope. The user may get burns and the endoscope can become damaged. Reduce the light output, if necessary use fiber light cable with product no. 8061.xxx / 8062.xxx. Perform a functional check: section 8.2

7.2.1

Using the speculum with light guide rod Fig. 7

1.4 1.3

After incision and ensuing subcutaneous tunneling: Insert the speculum with light guide rod under visual control into the distal area of the cubital tunnel. Carefully push together the handle grips (1.4). Lock the spread speculum tynes with lock screw (1.3). Visualize the operating area through the illuminated speculum.

Fig. 7

7.2.2

Using the optical dissector (2) with installed PANOVIEW telescope (3) / (4) Note ! The optical dissector (2) with installed PANOVIEW telescope (3) / (4) is recommended for use in: the decompression of nerves neurolysis under visual control gently pushing away soft tissue around the fascia.

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6

8

Checks CAUTION ! Be careful if products are damaged or incomplete ! Injury may result to the patient, user or others. Run through the checks before and after each use. Do not use products which are damaged or incomplete or have loose parts. Return damaged products together with loose parts for repair. Do not attempt to do any repairs yourself.

8.1

Visual check Check the instruments and accessories for: damage sharp edges loose or missing parts rough surfaces. Any lettering, labeling or identification necessary for the safe intended use must be legible. Missing or illegible lettering, labeling or identification which may lead to wrong handling and reprocessing must be reinstated. Check the cutting edges of cutting instruments for adequate sharpness. Fig. 8 CAUTION ! Caution if the surface is damaged in the hinge area of the forceps ! The hinge pin can loosen. Check for surface changes, such as hairline cracks, around the hinge pin.

Fig. 8

8.2

Functional check Check image quality and light output of the PANOVIEW telescope (3)/(4) and of the light guide rod (1.5). for this, see instruction manual GA--S001. Check the individual components for compatibility. Check that the connections are securely locked. Check that the individual instruments can be assembled and locked together easily. Replace the instruments if the connection although locked is not secure cannot be locked or is difficult to lock. Check the lock of dressing forceps (7.3) for proper functioning. Check the jaw sections / the speculum tynes (1.1) for easy opening and closing.

7

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9

Reprocessing and maintenance IMPORTANT ! Further information on the reprocessing is described in Manual GA--J020 “Reprocessing of RICHARD WOLF Heat Stable Instruments” and these instructions must be followed.

9.1

Disassembly before cleaning Remove all connections between the instrumentation and the system components. Remove the light guide rod (1.5). Remove cold--light connector (1.6). Remove the PANOVIEW PLUS telescope (3) / (4).

9.2

Manual reprocessing Wet preparation at the point of use Disassembly before cleaning: section 9.1 Manual cleaning / disinfection

9.3

Machine reprocessing Dry preparation at the point of use Disassembly before cleaning: section 9.1 Machine cleaning / disinfection

9.4

Checks Perform a visual check: sections 8.1

9.5

Assembly before sterilization NOTE ! Before sterilization screw on the screw connections only loosely to allow adequate flow of the sterilization medium to avoid stress cracks. Tighten all screw connections before use. Screw on the cold--light connector (1.6) 1--2 turns only loosely.

9.6

Sterilization

9.6.1

Steam sterilization Steam sterilization at 134°C (273°F) using the fractional pre--vacuum method.

9.6.2

STERIS and STERRAD sterilization procedures NOTE ! The STERIS  and STERRAD  sterilization procedures have been approved for use on our endoscopes and endoscopic accessories only with regard to material compatibility.

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10

Technical data and order data Item Illustration

Designation, technical data SPECULUM W. REMOVABLE LIGHT ROD WL 55MM consisting

--

891607002

1

8916070021

SPECULUM WL 55MM

1.5

8916070022

LIGHT CARRIER

2

891607001

OPT. DISSECTOR WL 158MM

3

8880.543

TELESCOPE 30° Ø 4MM SL 170MM

4

8885.443

WIDE ANGLE TELESCOPE 30° Ø 4MM SL 170MM

5

8390.0083

METZENBAUM SCISSORS MONO Ø 3.5MM BNDL

--

8390.008

SCISSORS INSERT WITH SHEATH Ø 3.5MM

--

8393.0003

HANDLE PISTOL SHAPED MONO

82240.2618

METZENBAUM SCISSORS TL 180MM

822403300

METZENBAUM SCISSORS

822403301

METZENBAUM SCISSORS

7.1

82330.0220

DRESSING FORCEPS WL 70MM

7.2

823300300

DUPLAY EXCISION FORCEPS

6

11

Product no.

of:

Spare parts and accessories Item Illustration

Product no.

Designation, technical data

1.5

8916070022

LIGHT CARRIER

1.6

8095.00

ADAPTER ENDOSCOPE SIDE

The products can be combined as required provided the relevant technical data and intended uses are observed. For the general overview please refer to the latest catalog sheets and brochures, or contact Richard Wolf or your Richard Wolf representative.

12

Operating, storage, transport and shipping conditions

9

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

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

12.1

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

13

Literature IMPORTANT ! As we cannot provide a comprehensive bibliography we would ask users to keep themselves informed of all new developments in this field. Die Endoskopische Operation des Kubitaltunnelsysndroms und ihre anato-mischen Grundlagen Author: R. Hoffmann, M. Siemionow Georg Thieme Verlag Handchir Mikrochir plast Chir 2005; 37 DOI: 10.1055/s--2005--864871

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