Manipulator 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 on 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 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!

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

Intended use...

1

2

Indications and field of application...

1

3

Contraindications...

1

4

Combinations...

1

5 5.1

Illustration... Legend and identification...

1 1

6 6.1 6.2 6.3 6.3.1 6.3.2 6.3.3 6.4 6.4.1 6.4.2 6.5 6.5.1 6.5.2

Use... Examples... Preparation... Handle (4) with lock (4.3)... Preparing the lock (4.3)... Working with lock (4.3)... Working without lock (4.3)... Disassembly... Sheath (2) and handle (4)... Insert (1) and sheath (2)... Assembly... Insert (1) in sheath (2)... Sheath (2) and handle (4)...

2 2 2 2 2 3 3 4 4 4 4 4 5

7 7.1 7.2

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

6 6 6

8 8.1 8.2 8.3 8.4 8.5

Reprocessing and maintenance... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Sterilization...

7 7 7 7 7 7

9

Technical data and order data...

8

10

Operating, storage and transport and shipping conditions...

8

11

Disposal of product, packaging material and accessories...

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1

Intended use The manipulator is designed for the dissection, retraction, passing around tissue and organs. The endoscopicly controlled surgical procudures are carried out via surgically generated passages.

2

Indications and field of application For examination, diagnosis and therapy with endoscopic accessories in various medical disciplines such as surgery, urology and gynecology by adequately trained and qualified medical personnel. The eye and the hook are designed to tie a band around tissue or organs, e.g. Oesophagus banding in fundoplicatio. Gastric banding in the case of adiposity.

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.

4

Combinations The instrument is used together with endoscopes 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.). Observe the instruction manuals of the products used in combination with this product.

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Illustration 4.2

4 2

3 4.3

#

1

4.1

*

Fig. 1 5.1

Legend and identification Item

Designation

Designation

1

Inner part

4

Handle, axial

2

Sheath

4.1

Movable handle

3

Knurled locking collar

#

Model/Type no.

*

Lot no.

<60

1

Item

4.2

Fixed handle

4.3

Locking mechanism

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 products have limited strength! Exerting excessive force may lead to damage or impaired function and can endanger the patient. Immediately before and after each use, check the products for damage, loose parts and completeness. Ensure that no instrument parts remain in the patient.

6.1

Examples “Gastric Banding” In endoscopic “Gastric Banding”, the manipulator is used for pulling the gastric band around the fundus of the stomach. Depending on the make/design, the end of the band is either threaded into the corresponding closure or engaged in the hook via a thread.

Fig. 2

6.2

Preparation Perform check (section 7)

6.3

Handle (4) with lock (4.3)

6.3.1

Preparing the lock (4.3) Push locking lever (a) from position “I” to “II” (fig. 3) . Ratchet lock (4.3) engages automatically.

a

Fig. 3

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6.3.2

Working with lock (4.3) Close manipulator. Ratchet lock (4.3) engages automatically. Open manipulator . Push the finger plate (b) or tigger (b) (fig. 4). Ratchet lock (4.3) is disengaged. The manipulator returns to the initial position (home position).

b

Fig. 4 6.3.3

Working without lock (4.3) Push locking lever (a) from position “II” to “I” (fig. 5) . Actuate movable grip (4.1). Manipulator works without lock (4.3) .

a

Fig. 5

3

a

4.3

4.1

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6.4

Disassembly

6.4.1

Sheath (2) and handle (4) NOTE! Always disengage the ratchet lock before disassembly. Push locking lever (a) from position “II” to “I” (see section 6.3.3) Hold manipulator, as shown in fig. 6. The fixed grip (4.2) is in axial position, with the movable grip (4.1) facing upward. Turn knurled locking collar (3) in direction of arrow and pull off sheath (2), (fig. 5).

4.1

2

3

4.2

Fig. 6 6.4.2

Insert (1) and sheath (2) Hold sheath (2) firmly, turning the insert (1) in direction of arrow and remove insert from sheath (2), (fig. 7).

2

1

Fig. 7

6.5

Assembly

6.5.1

Insert (1) in sheath (2) Hold sheath (2) firmly and insert (1) in sheath (2) so that guide keys (c) engage in groove (d), (fig. 8). Turn insert (1) in direction of arrow as far as it will go. Insert (1) is locked in sheath (2), (fig. 8) .

c c 1

d

d

2

Fig. 8 NOTE! If the insert is not locked in the sheath, the sheath cannot be fixed to the handle.

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6.5.2

Sheath (2) and handle (4) NOTE! Deactivate the ratchet lock before assembly. To deactivate the lock, push locking lever (a) from position “II” to “I” (see section 6.3.3) Hold manipulator, as shown in fig. 9. Fixed grip (4.2) is in axial position, with the movable grip (4.1) facing downward.

4.2

4.1

Fig. 9

Hold fixed grip (4.2) firmly. Slide sheath (2) with fastened/fixed insert (1) into handle (4). Turn insert (1) until it audibly clicks into place (fig. 10). This will cause the movable grip (4.1) to move upward. Screw on knurled collar (3) as indicated by the arrow (fig.10) .

4.2

1

2

3

4.1

4

fig. 10 NOTE! The manipulator can be attached in 4 working positions (90 pitch) (Fig. 11) .

Fig. 11 IMPORTANT! Before sterilization To prevent stress cracks and to ensure unimpeded steam access, loosen knurled locking collar (3) at least 1 full turn. Before the surgical procedure Firmly tighten knurled locking collar (3).

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Checks IMPORTANT! Perform the checks before and after every use. IMPORTANT! Do not use products which are damaged, 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. 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 or reprocessing must be replaced.

7.2

Functional check Check functionality of locking mechanism (ratchet lock) on the handle. When working with the ratchet lock, the ratchet must engage automatically in each position. Hold manipulator firmly as shown in Fig.12 and rotate insert (1). If insert (1) can be rotated, the sheath tube (2) must replaced.

2 1 Fig. 12

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8

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

8.1

Manual reprocessing Wet preparation at the point of use Disassembly before cleaning (see chapter 6.4) Manual cleaning / disinfection (fig. 13) Rinse sheath tube (2) and handle (4) with a cleaning gun. Clean the hook and the eye of the insert (1) with suitable cleaning brushes.

2

4 Fig. 13

8.2

1

Machine reprocessing Dry preparation at the point of use Disassembly before cleaning Same procedure as described under ”manual reprocessing” Ultrasound cleaning Machine cleaning / disinfection For automatic cleaning in a washer we recommend using RIWO Clean Racks as universal holders.

8.3

Checks see section 7.

8.4

Assembly before sterilization see section 6.5.

8.5

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

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Technical data and order data Model/type no.

Designation, Technical data

8397.654

BAND MANIPULATOR INSERT Ø 10MM

8397.901

SHEATH TUBE Ø 10MM SL 370MM

8393.941

NEEDLE HOLDER HANDLE AXIAL

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 GmbH or your R.Wolf representative.

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Operating, storage and 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

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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