Continuous--Irrigation Bladderstone Lithotripsy Instrument Set Instructions Manual

1.1 1.5

1.4

1.2 1.3

1.6 1.7 1.9

1.8 1.10

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AUTOCLAVE

1

20x

1.11 1.12

2.1 2.2

2

2.3

2.4 Abb. (fig.) 3 3

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2.1 Abb. (fig.) 5

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2.1 I

II b

a

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2.1 Abb. (fig.) 6

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1

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1

Intended use The instrument set for continuous--irrigation lithotripsy and the auxiliary instruments serve to disintegrate and remove/ aspirate stones from the urogenital tract via the natural passage or percutaneous access via intracorporeal lithotriptors, e.g. ultrasonic, pneumatic, electrohydraulic, lasers or mechanical, under endoscopic control.

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Indications and field of application For diagnosis and therapy of urinary calculi of the upper and lower urogenital tract in the medical disciplines of urology and surgery.

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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 please refer to the current medical literature.

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Combinations The instrument set is used in combination with light sources and flexible light cables, video cameras and objective lenses, suction and irrigation devices , as well as endoscopic accessories (e.g. forceps, intracorporeal lithotripsy probes, punch lithotriptors, etc.). CAUTION! When the various products are used in combination it is absolutely necessary that they are compatible in their intended use and relevant technical data (working length, diameter, peak voltage etc.). Observe the instruction manuals of the products used in combination with this product. For HF applications please also observe GA- S 002 ”Notes on HF Application”. The PANOVIEW PLUS operating endoscope (1) can be combined with the Richard WOLF standard resectoscope sheaths of Fr. 24 and more. This allows combined use of bladder stone lithotripsy and TURP without changing the sheath. In connection with suitable cannula systems, the PANOVIEW PLUS operating endoscope (1) and the operating sheath (2) can be used for transurethral incontinence therapy. Ultrasound, electrohydraulic or pneumatic lithotripsy: PANOVIEW PLUS operating endoscope (1) 8643.401 Operating sheath (2) 8643.011 Obturator (3) 8654.17 mechanical lithotripsy: Operating sheath (2) 8643.011 Obturator (3) 8654.17 R.WOLF PANOVIEW PLUS endoscope 0° or 5° of the 8650.xxx series Punch lithotriptor 8654.90 IMPORTANT ! The punch lithotriptor does not allow for lithotripsy under continuous--irrigation Stone extraction PANOVIEW PLUS operating endoscope (1) 8643.401 Operating sheath (2) 8643.011 Obturator (3) 8654.17 Lithotomy forceps (4) 8962.60/.61/.602 NOTE! The cold light connector (1.6) can be unscrewed and replaced with suitable adapters for the connection of flexible light cables of other manufacturers.

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Caption and identification Item 1 1.1 1.2

Fig. 1

Designation Item PANOVIEW PLUS operating endoscope Objective lens 1.8 Light exit 1.9

1.3 1.4 1.5

Working channel Sheath * red ring

1.10 1.11 1.12

1.6 1.7

Cold light connector red ring Indication that viewing direction is 20°

1.13

2 2.1

2

3 3.1

3

Operating sheath Clamping lever with color code yellow = Fr. 24 Obturator Color code yellow = Fr. 24

Fig.

Series no. Insertion stop cock for auxiliary instruments Rubber cap Supply stop cock *Indication that instruments can be autoclaved Indication of viewing direction * Possibility of steam sterilization at 134°C (272°F) using the fractional method

2.2 2.3 2.4 4

Designation

Clamping mechanism Drain stop cock Suction hose 4

Lithotomy forceps

Symbol in conformity with Medical Devices Directive 93/42/EC. Only valid if the product and/or the packaging is identified with this symbol. Products of category IIa and above are additionally identified with the code no. of the notified body (0124).

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Application

6.1 Preparation Place rubber cap (1.10) on insertion stop cock (1.9). Perform a check (chapter 7) Introducing obturator (3) in operating sheath (2) (fig. 5): Locking: The clamping lever (2.1) is in position ”I”. Introduce obturator (3) in operating sheath (2) in such a way that nose (a) engages in groove (b). Turn clamping lever (2.1) to position ”II” as indicated by the arrow. Unlocking: Turn clamping lever (2.1) to position ”I”. Remove obturator (3). Insert operating endoscope (1) in operating sheath (2). (fig. 6): Same procedure as under ”inserting obturator (3) in operating sheath (2)”.

6.2 Additional instructions for use CAUTION! The instruments have only limited strength. Excessive force can lead to damage and will impair their function.

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IMPORTANT! Use only products with applied parts having BF classification in connection with the continuous--irrigation bladder stone instrument set. For maximum light efficiency the glass fiber cross section of the flexible light cable and the endoscope must be the same. Connect flexible light cable. (fig. 7) Connect irrigation/drain tube. (fig. 7) IMPORTANT! To achieve a permanent low pressure continuous--irrigation effect ensure a level difference between 60 cm and 100 cm in the irrigation water supply. The drain stop cock (2.3) must always be open. IMPORTANT! Depending on the application a low conductivity irrigation fluid must be selected by the user. Use NaCl solution only if no HF application is to follow. CAUTION! The operating sheath (2) can only be introduced atraumatically with the obturator in place. WARNING! Danger from heat due to high light energy. Small distances between light exit area (1.2) and tissue can destroy the tissue. Do not touch the light exit area (1.2) and avoid direct contact with tissue. Fire hazard! Do not place the light exit area (1.2) against heat sensitive, flammable surfaces (dark drapes, etc.) as this can lead to inadmissibly high temperatures or ignition. Switch off the light source if the endoscope is not used for some time. WARNING! Leakage currents! Patient leakage currents can ad up if electrically powered endoscopic accessories or other electrically operated products are connected to the endoscope. Danger of electrical shock! Measure and check the combination before use. CAUTION! During activation the lithotripsy probes (electrohydraulic) must have a safety distance of at least 10 mm from the distal end of the sheath to avoid damage to the sensitive endoscope tip.

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Checks Check instruments and accessories for damage, sharp edges and rough surfaces. Replace rubber caps (1.10) that have become damaged or brittle. Check suction and irrigation performance. NOTE! Do not use instruments once they have become damaged. Return damaged instruments for repair.

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Reprocessing and maintenance IMPORTANT! Follow the ”General Instructions on the Reprocessing of Rigid Richard Wolf Endoscopes and Accessories ”, ordering no: GA--J 020, where the following procedures are described in detail. Manual reprocessing Decontamination by immersion

Machine reprocessing Dry preparation for reprocessing

Disassembly Remove rubber cap (1.10). Remove cold light connector (1.6). Manual cleaning

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Machine cleaning / disinfection Assembly before sterilization Screw on cold light connector (1.6). Checking (see chapter 7) Steam sterilization at 134°C (272°F) using the fractional method.

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.

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

11 Technical data Item

Model/ type no

Designation, technical data

1

8643.401

PANOVIEW PLUS operating endoscope 20°, working length 224 mm, passage Fr. 10.5

2

8643.011

Operating sheath, Fr. 24

3

8654.17

OBTURATOR RESECTOSCOPE 24FR

4

8962.602

RIGID GRASP. FORCEPS 9FR WL 355MM

4

8962.60

RIGID GRASP. FORCEPS 7.5FR WL 350MM

4

8962.61

RIGID GRASP. FORCEPS 10.5FR WL 350MM

12 Spare parts

1.10 1.10

Model/ type no 88.01 88.02

1.6

8095.00

Item

RUBBER CAP CAP 0.8MM RUBBER CAP CAP 1.4MM

Model/ type no 886.00 103.00

ADAPTER ENDOSCOPE SIDE

6.03

Designation, technical data

Designation LUER LOCK CONNECTOR BELLOWS PUMP CLEANING BRUSH Ø 5MM TL 240MM

13 Ordering information The instruments can be combined as required provided their relevant technical data and intended uses correspond. For a general overview please refer to the latest catalogue sheets, brochures or contact Richard Wolf GmbH or your Wolf representative.

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GERMANY RICHARD WOLF GmbH D--75438 Knittlingen Pforzheimerstr. 32 Tel.: (..49)--(0)7043--35--0 Fax: (..49)--(0)7043--35300 MANUFACTURER

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Tel.: (001)--847--913 1113 Fax: (001)--847--913 1489

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: (..44)--(0)181--944--7447 Fax: (..44)--(0)181--944--1311

BELGIUM N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 B--9031 Gent --Drongen Tél.: (..32)--(0)9--2808100 Fax: (..32)--(0)9--2829216

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F--51100 Reims Tél.: (..33)--(0)3--26--870289 Fax: (..33)--(0)3--26--876033

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Lederergasse 32 A--1082 Wien Tel.: (..43)--(0222)1--405 6219 Fax: (..43)--(0222)1--408 7084