Punching Sleeve Set ACL / OCP Instruction Manual

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel. Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned appli­ cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the pa­ tient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly.

Safety instructions and levels of danger Symbol

Level of danger

WARNING!

Failure to observe can result in death or extremely serious injuries.

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!

User tips for optimum device use and other useful information.

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GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [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 [email protected] www.richard-wolf.be

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-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 A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.com

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

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 1.1 1.1.1 1.1.2 1.1.3 1.1.4 1.2 1.2.1

Intended use... ACL Punching Sleeve Set... Punching sleeve / Punching cylinder (ACL)... Grip (ACL and OCP)... Ejector (ACL and OCP)... Obturator (ACL and OCP)... OCP Punching Sleeve Set... Punching sleeve (OCP)...

1 1 1 1 1 1 1 1

2

Indications and field of use...

1

3

Contraindications...

1

4

Combinations...

1

5 5.1

Illustration... Legend and identification...

2 2

6 6.1 6.1.1 6.2 6.2.1

Use... Preparation... Connecting the punching sleeve / punching cylinder to the grip... Additional notes and instructions for use:... Labeling/inscriptions...

3 3 3 3 4

7 7.1 7.2

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

4 4 4

8 8.1 8.2 8.3 8.4 8.5 8.6 8.6.1 8.6.2 8.6.3

Reprocessing and maintenance... Disassembly before cleaning... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Sterilization... Steam sterilization... Steris and Sterrad ... Sterilization processes...

5 5 5 5 5 5 6 6 6 6

9 9.1 9.2 9.3

Technical data and order data... ACL Instrument Set... ACL Revision Set... OCP Instrument Set...

7 7 7 8

10

Spare parts and accessories...

9

11 11.1

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

9 9

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I

1

Intended use

1.1

ACL Punching Sleeve Set

Paessler's ACL Punching Sleeve Set (ACL= Anterior Cruciate Ligament) is used for harvesting and transplanting the graft in arthroscopic plastic surgery of the anterior cruciate ligament. As grafts autologous materials are used for example. Paessler's ACL Revision Set is used for harvesting large (autologous) bone plugs from the patient's iliac crest to repair the bone defect in plastic surgery of the an­ terior cruciate ligament.

1.1.1

Punching sleeve / Punching cylinder (ACL) The punching sleeve / punching cylinder serves to create the femoral and tibial tunnels, and to harvest autologous tissue from the iliac crest.

1.1.2

Grip (ACL and OCP)

1.1.3

Ejector (ACL and OCP)

1.1.4

Obturator (ACL and OCP)

1.2

OCP Punching Sleeve Set

1.2.1

Punching sleeve (OCP)

2

Indications and field of use

3

Contraindications

4

Combinations

The grip is attached to the punching sleeve / punching cylinder to facilitate work.

The ejector serves to remove the harvested bone plug or cartilaginous tissue from the punching sleeve or punching cylinder and, if possible, to transplant the plug or tissue during this procedure..

For atraumatic insertion of the punching sleeves.

Paessler's OCP Punching Sleeve Set (OCP=Osteo Chondral cobblestone Plasty) is used in arthroscopic chondroplasty. The defective cartilaginous tissue is punched out and replaced by healthy carti­ laginous tissue.

The punching sleeve serves to punch out the defective cartilaginous tissue and the graft. Paessler's ACL/OCP Punching Sleeve Set, in conjunction with endoscopic acces­ sories, is used for therapy in orthopedics and surgery. The products may only be used by adequately qualified and trained medical per­ sonnel. 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.

CAUTION ! Caution if products are incorrectly combined ! Possible injury of the patient, user or others as well as possible damage to the prod­ uct. Different products should only be used in combination if their intended use and relevant technical data (working length, diameter, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this prod­ uct.

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Illustration

2

X.X

20

10

10

20

# X.X

#

1a

3

1.2 #

**

X.X

1.1

3.1 3.2 30

5

X.X

4 1.5

1.4 1.3 **

2.1

xxxx.xxx

2.2 4.1 #

**

2

1.3

#

2.1

10

20

60

70

50

30

40

20

3 xxxx.xxx

1.5

5.1

1.2 #

#

1b

30

1.1

3.2

Legend and identification Item

Designation

Item

Designation

1a

Punching sleeve

2

Grip

1b

Punching cylinder

2.1

Locking mechanism

1.1

Cutting edge

2.2

Sealing lid

1.2

Coupling element

3

Ejector

1.3

Internal diameter

3.1

Diameter

1.4

External diameter

3.2

Scale defining the size of the bone plug

1.5

Depth scale

4

Obturator

**

Color coding: Identification of matching sizes

4.1

Diameter

#

Product no.

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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2

6

Use CAUTION ! The products have only limited strength ! Exerting excessive force will cause damage, impair the function and thus endan­ ger 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. IMPORTANT ! We recommend replacing the punching sleeves after 10 uses because the cutting edges will become blunt. When using punching sleeves / punching cylinders with blunt cutting edges the mechanical load will be big enough to cause the punching sleeves / punching cylinders to break, and will cause increased stress for the patient as well as pos­ sible damage to the graft.

6.1

Preparation

Check assembly (section 8.5) Perform a visual check (section 7 and 7.1) Screw on the sealing lid (2.2) until you feel the first resistance.

IMPORTANT ! If you screw on the sealing lid (2.2) as far as it will go it might get seized by ham­ mering during use and will require hight forces to be removed. The sealing lid (2.2) can be damaged while hammering the punching sleeve home. Replace the sealing lid (2.2) if it is damaged. 6.1.1

Connecting the punching sleeve / punching cylinder to the grip

open close

1 Fig. 1 6.2

1.2 2.1

2

Illustration 1 Turn the locking mechanism (2.1) counterclockwise. The locking mechanism (2.1) is open. Insert the coupling element (1.2) of the punching sleeve / punching cyinder in the grip. Turn the punching sleeve / punching cyinder (1) into the grip (2). The internal pin of the grip must engage in the groove of the punching sleeve / punching cyinder. Turn the locking mechanism (2.1) clockwise. The two components should be locked together. Perform a functional check (section 7.2)

Additional notes and instructions for use:

The punching sleeves have different diameters than the punching cylinders: Punching sleeves: Internal dia. 3.5 mm to 8.5 mm Punching cylinders: Internal dia. 10 mm to 13 mm

The punching sleeves are used in conjunction with the small grip 8866.601 which has a removable sealing lid (2.2). The punching cylinders are used in conjunction with the large grip 8851.601 which does not have a sealing lid. For hammering in the punching sleeves / punching cylinders we recommend us­ ing the ACL Hammer 8866.956.

3

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6.2.1

Labeling/inscriptions

4.5 3.5

Illustration 2

1.4 1.3

To create the femoral tunnel make sure you observe the external diameter (1.4) of the punching sleeves and punching cylinders: The external diameter (1.4) must correspond to the internal diameter (1.3) of the punching sleeve used for generating the bone plug to be transplanted.

Fig. 2 7

Checks CAUTION! If products are damaged or incomplete. Possible injury of patient, user or third person. 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.

7.1

Visual check Check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces. Check punching sleeves/ punching cylinders for possible cracks and dam­ aged cutting edges (fig. 3) Check sealing lid (2.2) for damage such as burrs. 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 restored.

Fig. 3 7.2

Functional check

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Check that all components can be assembled easily. Check the locking mechanisms of the individual components.

4

8

Reprocessing and maintenance IMPORTANT ! Follow the current "Notes and instructions on the reprocessing of R.Wolf prod­ ucts, accessories and devices", order no.: GA-J 020. Do not use disinfectants containing peracetic acid without corrosion protection agents, phenols or chlorine components for the reprocessing of R. Wolf products. Do not exceed the maximum exposure time specified by the manufacturer of the disinfectants used.

8.1

Disassembly before cleaning 2.3 2.2

NOTE : The large grip does not have a mebrane valve and cannot be disassembled.

Small grip (figure 4) : Unscrew the sealing lid (2.2) from the grip by turning counterclockwise. The membrane valve (2.3) is seated in the sealing lid (2.2). Remove and discard the membrane valve (2.3).

Fig. 4

NOTE : We recommend replacing the membrane valve (2.3) after each use.

8.2

Manual reprocessing

8.3

Machine reprocessing

8.4

Checks

8.5

Assembly before sterilization

5

Dry preparation at the point of use Disassembly before cleaning: see section 8.1 Machine cleaning / disinfection Perform a visual check (see section 7.1)

2.2

Fig. 5

Wet preparation at the point of use Disassembly before cleaning: see section 8.1 Manual cleaning / disinfection

2.3

Figure 5 Place a new membrane valve (2.3) in the sealing lid (2.2). Screw the sealing lid (2.2) into the grip by turning clockwise.

NOTE : Before sterilization apply the screw connections only loosely to allow a sufficient flow of sterilization medium. Tighten all screw connections before use.

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8.6

Sterilization

8.6.1

Steam sterilization

8.6.2

Steris

8.6.3

Sterilization processes

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

and Sterrad

NOTE : The Steris and Sterrad sterilization procedures have been approved for use on our endoscopes and endoscopic accessories only with regard to material com­ patibility. For information about possible limitations, such as discoloration of plas­ tic materials, as well as further notes see the latest version of "Notes and instruc­ tions on the reprocessing of Richard Wolf products, accessories and devices", order no. GA-J 020. Efficacy has been certified by the sterilizer manufacturers in microbiological tests. Follow the manufacturer's instructions. NOTE! Steris sterilization procedure: Connect all channels to the system to ensure thorough reprocessing. Follow the manufacturer's instructions.

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6

9

Technical data and order data

9.1

ACL Instrument Set

Illustration

-

X.X

X.X

20

10

Tubular chisel

10

20

X.X

30

Ejector

-

9.2

Internal / External diameter [mm]

Product no.

Designation

8866.302

ACL--TUBULAR--CHISEL-SET BNDL consisting of: Tubular chisel, Ejector, Handle attachement, Tray

--/--

Spare part no.: 8866.560 8866.261 8866.565 8866.265 8866.570 8866.271 8866.575 8866.275 8866.580 8866.281 8866.585 8866.285

TUBULAR CHISEL EJECTOR TUBULAR CHISEL EJECTOR TUBULAR CHISEL EJECTOR TUBULAR CHISEL EJECTOR TUBULAR CHISEL EJECTOR TUBULAR CHISEL EJECTOR

6.0 / 7.0 --/ 6.0 6.5 / 7.5 -- / 6.5 7.0 / 8.0 -- / 7.0 7.5 / 8.5 -- / 7.5 8.0 / 9.0 -- / 8.0 8.5 / 9.5 -- / 8.5

8866.601

HANDLE ATTACHMENT

--/--

8866.984

TRAY W 412MM H 66.5MM D 293MM

--/--

ACL Revision Set Illustration

7

10

20

30

70

60

50

40

30

20

-

Product no.

Designation

Internal / External diameter [mm]

8851.100 8851.110 8851.120 8851.130

ACL--REVISION BNDL consisting of: Punch cylinder, Ejector, Handle attachement PUNCH CYLINDER PUNCH CYLINDER PUNCH CYLINDER PUNCH CYLINDER

10 / 12 11 / 13 12 / 14 13 / 15

8851.201

EJECTOR

-- / 9.0

8851.601

HANDLE ATTACHMENT

--/--

8851.302

--/--

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OCP Instrument Set Illustration

-

Product no.

8866.322

Designation OCP-- INSTRUMENT--SET BNDL consisting of: Tubular chisel, Obturator Ejector, Handle attachement, Tray

External / Internal / diameter [mm]

--/--

Spare part no.:

X.X

20

X.X

Tubular chisel 10

10

X.X

20

30

Ejector Obturator X.X

9.3

-

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8866.535 8866.235 8866.135 8866.540 8866.241 8866.141 8866.545 8866.245 8866.145 8866.550 8866.251 8866.151 8866.555 8866.255 8866.155 8866.560 8866.261 8866.161 8866.565 8866.265 8866.165 8866.570 8866.271 8866.171 8866.575 8866.275 8866.175 8866.580 8866.281 8866.181 8866.585 8866.285 8866.185

TUBULAR CHISEL EJECTOR OBTURATOR TUBULAR CHISEL EJECTOR OBTURATOR TUBULAR CHISEL EJECTOR OBTURATOR TUBULAR CHISEL EJECTOR OBTURATOR TUBULAR CHISEL EJECTOR OBTURATOR TUBULAR CHISEL EJECTOR OBTURATOR TUBULAR CHISEL EJECTOR OBTURATOR TUBULAR CHISEL EJECTOR OBTURATOR TUBULAR CHISEL EJECTOR OBTURATOR TUBULAR CHISEL EJECTOR OBTURATOR TUBULAR CHISEL EJECTOR OBTURATOR

4.5 / 3.5 3.5/-3.5/-5.0 / 4.0 4.0 /-4.0 /-5.5 / 4.5 4.5 /-4.5 /-6.0 / 5.0 5.0 /-5.0 /-6.5 / 5.5 5.5 /-5.5 /-7.0 / 6.0 6.0 /-6.0 /-7.5 / 6.5 6.5 /-6.5 /-8.0 / 7.0 7.0 /-7.0 /-8.5 / 7.5 7.5 /-7.5 /-9.0 / 8.0 8.0 /-8.0 /-9.5 / 8.5 8.5 /-8.5 /--

8866.601

HANDLE ATTACHMENT

--/--

8866.984

TRAY W 412MM H 66.5MM D 293MM

--/--

8

10

Spare parts and accessories Illustration

Product no. 89.103 15 252.069

Designation SEALING MEMBRANE Ø 17MM Sealing lid for grip

The products can be combined as required provided the 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.

11

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.

11.1

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.

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