Rigid Biopsy Forceps, Grasping Forceps, Scissors 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.

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IMPORTANT!

Failure to observe can result in damage to the product or surroundings.

NOTE!

User tips for optimum device use and other useful information. 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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Intended Use

1.1

Biopsy forceps

1.2

Scissors

1.3

Grasping forceps

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Indications

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Contraindications

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Combinations

The biopsy forceps are used for soft tissue (connective tissue) biopsies. The biopsy forceps with severing jaws are used for the removal of small parts of soft tissue. The scissors are used for the severing of small parts of soft tissue, e. g. cordlike adhesions and synechia. The grasping forceps is used for the removal of foreign bodies and severed soft tissue. The instruments are used in hysteroscopy and cystoscopy. Contraindications for the patient resulting from the general findings and described in the relevant literature must be observed.

Z Hysteroscopy ' Hysteroscope 20° Ø 5mm NL 217mm (8986.401) PANOVIEW PLUS ' Sheath combination: inner sheath 8974.161 - outer sheath 8974.251 Z Cystoscopy ' Cystoscope 25° 14FR WL 218mm (8642.403) PANOVIEW PLUS ' Cystoscope 12° 8,0/9,8FR WL 150mm (8626.431) E-Line

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NOTE! For additional application related instructions please refer to the manual on the instrument set. If you don't have it, please contact the manufacturer.

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Illustration

Jaw illustrations are rotated 90° 8642.65 8642.60

xxxxxx = Lot number 8642.631 8642.681

Identification in conformity with EEC directive 93/42/EEC on medical products, is only valid if the pro­ duct and/or its packaging is provided with this identification. 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 no. of the notified body (0124).

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Checks Z Check instruments and accessories for damage, hygienic condition and com­ pleteness. Z The joints and hinges must open and close easily. Z The cutting edges of the jaw sections must be sharp and undamaged. ' Do not use instruments which have a damaged cutting edge. Replace dam­ aged instruments.

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Application CAUTION! The instrument could become kinked! When working with these instruments, excessive load may cause them to brake near the handle. Guide the distal instrument tip only via the hysteroscope or cystoscope sheath.

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8.1

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NOTE! Excessive force may cause the instruments to brake. As a result of the necessary small dimensions, the distal sections of the instru­ ments have only limited stability. Do not use these instruments for grasping and removing of large pieces of tissue.

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IMPORTANT! The forceps/Scissors cannot be disassembled.

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NOTE! No shipping damage! The slightly curved distal sheath of the forceps facilitates insertion of the instru­ ments in the working channel.

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IMPORTANT! Further notes and instructions on reprocessing are described in manual GA-J020 "Reprocessing of RICHARD WOLF Heat-stable Instruments" and must be followed.

Reprocessing

Manual reprocessing Z Predisinfection Z Ultrasound cleaning Z Manual cleaning Z Function check

8.2

Machine reprocessing Z Dry preparation for reprocessing Z Ultrasound cleaning Z Machine cleaning Z Function check

8.3

Sterilization Z Steam sterilization using the fractional method at 134C (273F).

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Technical data and order data Product no.

Designation, Techical data

8642.60

RIGID BIOPSY FORCEPS 5FR WL 340MM

8642.65

RIGID GRASP. FORCEPS 5FR WL 430MM

8642.631

RIGID BIOPSY FORCEPS 5FR WL 355MM

8642.681

SCISSORS, RIGID 5FR WL 355MM

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

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Operating, storage, transport and shipping Operating conditions

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

Storage, transport and shipping conditions

-20ºC to +60ºC, 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.

Disposal of product, packaging material and accessories For the disposal follow the laws and regulations valid in your country. ' Further information is available from the manufacturer on request.

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