Stone Extractors 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 Tel.: (..49)--(0)7043--35--0 Fax:(..49)--(0)7043--35300 MANUFACTURER E--mail: [email protected] Internet: www.richard--wolf.com

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Tel.: ++1 847--913 1113 Fax: ++1 847--913 1488 E--mail: sales&[email protected] Internet: www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: ++ 4420--8944 7447 Fax: ++ 4420--8944 1311 E--mail: [email protected] Internet: www.richardwolf.uk.com

BELGIUM N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent --Drongen Tel.: +32 9.280.81.00 Fax: +32 9.282.92.16 E--mail: [email protected]

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette 51100 Reims Tel.: +33 3.26.87.02.89 Fax: +33 3.26.87.60.33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a 1160 Wien Tel.: +43 1-- 405 51 51 Fax: +43 1-- 405 51 51--45 E--mail: [email protected] Internet: www.richard--wolf.at

UNITED ARAB EMIRATES RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9 th Floor, Room 904 Dubai, U.A.E. Tel.: 00 971 4368 1926 Fax: 00 971 4368 6112 E--mail: [email protected]

INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Gurgaon -- 122 001 National Capitol Region Tel.: 00 91 124 5315 700 Fax: 00 91 124 5315 705 E--mail: [email protected]

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E--mail: [email protected]

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Contents 1

Intended use...

1

2

Indications and fields of use...

1

3

Contraindications...

1

4

Combinations...

1

5 5.1

Illustration... Legend and identification...

2 2

6 6.1 6.2

Use... Preparation... Additional notes and instructions for use...

3 3 3

7 7.1 7.2

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

4 4 4

8 8.1 8.1.1 8.1.2 8.2 8.3 8.4 8.5 8.5.1 8.5.2 8.6 8.6.1 8.6.2

Reprocessing and maintenance... Disassembly before cleaning... Grip with lock screw... Sliding handle... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Grip with lock screw... Sliding handle... Sterilization... Steam sterilization... Sterist and Sterradt sterilization procedures...

5 5 5 5 6 6 6 6 6 6 6 6 6

9

Technical data and order data...

7

10 10.1

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

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I

1

Intended use The stone extractors are used for grasping and immobilizing stones and stone concretions and removing them from the inside of the body under visual control (imaging procedures).

2

Indications and fields of use Uro and cholelithiasis, for example for the removal of ureter stones from the urogenital tract. The product may only be used by adequately qualified and trained medical personnel.

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 stone extractors are used in conjunction with uretero--renoscopes and endoscopic accessories (sonotrodes, probes, stone grasping forceps, etc.) CAUTION ! Caution if products are incorrectly combined ! Possible injury of the patient, user or others as well as possible damage 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.

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Illustration 2 1.1

3.1

1.2

3.2

3.3

3.4

2.1 3A

1.3 3.5 3.6 3B

1.4

1.5

5.1

Legend and identification Item

Designation

Item

Designation

1

Cage variants

3

Grip variants

1.1

Three--arm

3A

Sliding grip

1.2

Four--arm

3.1

Lock screw

1.3

Five--arm

3.2

Sliding element

1.4

Four--arm with filiform tip

3.3

Guide

1.5

Stone gripper, three--arm

3.4

Grip

3B

Grip with lock screw

2

Outer coating

3.5

Knurled nut

2.1

Locking collar

3.6

Lock screw

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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6

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.

6.1

Preparation Z Check assembly: section 8.5 Z Carry out a check: section 7

6.2

Additional notes and instructions for use

.

IMPORTANT ! When inserting the stone extractors into the endoscope, make sure they are retracted or closed. When you see the stone through the scope, carefully push the closed cage past the stone (it may be necessary to look for a gap) and open it behind the stone. Slowly rotate the cage while pulling it back to catch the stone, then close the cage. Repeat the procedure, if necessary. Carefully pull back the endoscope and the stone extractor. Experts recommend pulling the stone as close to the endoscope tip as possible to avoid loosing it and to protect the tubular structures.

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IMPORTANT ! When manipulating the stone gripper, all arms must be visible through the scope to avoid unintentional injuries of the mucous membrane.

CAUTION! op

Close cage

Open cage

3

When using stone extractors in conjunction with flexible endoscopes, the function of the stone extractors is only guaranteed up to an angle of max. 120_. If the endoscope is angled beyond 120_, both the stone extractor and the flexible endoscope can be damaged - in particular if the stone extractor is too large. Therefore, use only stone extractors up to 3 Fr. In the case of flexible uretero renoscopes we recommend using stone extractors up to 2.4 Fr. At angles above 90_, the closed cage must be fully visible through the scope before the scope can be angled beyond 90 degrees. Only then can the cage be opened without any problem.

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Checks CAUTION! Be careful if products are damaged or incomplete! Possible injury of patient, user or third persons. 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 Z Check the instruments and accessories for -- damage -- sharp edges -- loose or missing parts -- rough surfaces Z 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.

7.2

Functional check Z Check that cage (1) and grip (3) are securely fastened. Z Jog the sliding element (3.2) back and forth to check whether the cage (1) can be fully retracted into the outer sheath (2) and fully extended again. Z Check that the sliding handle (3A) can be moved easily.

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8

Reprocessing and maintenance .

IMPORTANT ! Follow the current ”Notes and instructions on the reprocessing of Richard Wolf products, 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 Richard Wolf products. Do not exceed the maximum exposure time specified by the manufacturer of the disinfectants used.

8.1

Disassembly before cleaning

8.1.1

Grip with lock screw Z Release the knurled nut (3.5) and the lock screw (3.6) by turning them in opposite directions. ' Remove cage (1) with outer sleeve (2) and knurled nut (3.5). Z Pull the cage (1) from the distal end of the outer sleeve (2). ' We recommend replacing the cage (1) after each use to guarantee perfect functioning.

2

1

3.5 3.6

8.1.2

Sliding handle Z Release the lock screw (3.1). Z Pull the cage (1) out of the outer sleeve (2). ' We recommend replacing the cage after each use to guarantee perfect functioning. Z Unscrew the locking collar (2.1) and remove from the sliding handle (3A) together with the outer sleeve (2).

1

5

2

2.1

3.1

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8.2

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

8.3

Machine reprocessing Z Dry preparation at the point of use Z Disassembly before cleaning: see section 8.1 Z Machine cleaning / disinfection

8.4

Checks Z Perform a visual check (see section 7.1)

8.5

Assembly before sterilization

.

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

8.5.1

Grip with lock screw Z Insert the proximal end of the cage (1) into the outer sleeve (2) until the end projects from the other side of the outer sleeve (2). Z Install the knurled nut (3.5) on the thread of lock screw (3.6). Z Insert the proximal end of the cage (1) into the lock screw (3.6). Z Turning the lock screw (3.6) and the knurled nut (3.5) in opposite directions locks the proximal end of the cage (1) in this position..

8.5.2

Sliding handle Z Insert the proximal end of the cage (1) in the outer sleeve (2) until the end projects from the other side of the outer sleeve (2). Z Engage the proximal end of the cage (1) into the sliding element (3.2). Z Tighten lock screw (3.1). Z Screw on the locking collar (2.1). ' Check the cage for secure fastening.

8.6

Sterilization

.

8.6.1

IMPORTANT ! Do not retract the cage (1) into the outer sleeve during sterilization not to impair its resilience.

Steam sterilization Z Steam sterilization at 134°C (272°F) using the fractional pre--vacuum method.

8.6.2

Sterist and Sterradt

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sterilization procedures

.

NOTE ! The Sterist and Sterradt sterilization procedures have been approved for use on our endoscopes and endoscopic accessories only with regard to material compatibility. For information about possible limitations, such as discoloration of plastic materials, as well as further notes see the latest version of ”Notes and instructions 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 ! Sterist sterilization procedure: Connect all channels to the system to ensure thorough reprocessing. Follow the manufacturer’s instructions.

6

9

Technical data and order data Illustration

Replacement cage

Outer sleeve

8741.202

8741.203

8137.841

8137.94

Handle/ grip

Working length

Fr.

Product no.

910 mm

2.4

8741.201

640 mm

4

8137.241

four--arm

four--arm

five--arm

8593.605 8137.845

8137.94

640 mm

4

8137.245

8741.031

8741.037

910 mm

3

8741.03

8741.252

8741.037

910 mm

3

8741.33

four--arm

three--armed

8593.606

gripper

Illustration

Working length

Fr.

Product no.

660 mm

4

8137.041

660 mm

4

8137.043

660 mm

4

8137.045

660 mm

4

8137.144

740 mm

3.5

8137.231

four--arm

three--arm

five--arm

four--arm, with a 3 cm filiform tip (3 Fr.)

four--arm

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.

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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

. 10.1

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 observe the regulations and laws valid in your country. ' For further information please contact the manufacturer.

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