Percutaneous Low Pressure Nephroscope Instructions Index : 07-06-1.0

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.

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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]

GA--D 354

Contents 1

Intended use...

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 6.1.2 6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 6.3 6.3.1

Use... Preparation... Inserting obturator (3) into operating sheath (2)... Inserting nephroscope (1) into operating sheath (2)... Additional notes and indications for use... Light... Current... Irrigation fluid... HF application... Laser application... Percutaneous tumor resection in the renal pelvis... Procedure...

3 3 3 3 4 4 4 5 5 5 5 6

7 7.1 7.2 7.2.1

Checks... Visual checks... Functional check... Checking image quality and light output...

7 7 7 7

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... Nephroscope (1)... Operating sheath (2)... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Assembly of nephroscope (1)... Assembly of operating sheath (2)... Sterilization... Steam sterilization... Sterist and Sterradt sterilization procedures...

8 8 8 8 8 8 8 9 9 9 9 9 9

9

Technical data and order data... 10

10

Spare parts and accessories... 10

11 11.1

Operating, storage, transport and shipping conditions... 10 Disposal of product, packaging material and accessories... 10

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1

Intended use Nephroscope with suitable Richard Wolf auxiliary instruments are used e.g. for the disintegration and removal/aspiration of kidney and bladder stones as well as for the removal of tumors via a percutaneous or transuretheral passage in conjunction with intracorporeal lithotripters, e.g. operated pneumatically, by ultrasound, electrohydraulically or by laser under endoscopic control.

2

Indications and field of use For the diagnosis and therapy of diseases such as urolithiasis or stenoses and tumors in conjunction with endoscopic accessories in the upper and lower urogenital tract. The products 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 Z Intracorporeal lithotripsy systems (e.g. ultrasonic, EHL, etc.) Z Suction and irrigation devices Z Light sources and flexible light cables Z Video cameras and objective lenses Z Endoscopic accessories: Grasping forceps, stone extractors, stricture scalpels, transducers, sonotrodes, probes and laser fibers. 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. The cold--light connector (1.2) can be unscrewed and replaced by suitable adaptors to connect flexible light cables of other manufacturers. For the order number please refer to the latest catalog sheet.

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Illustration 1.4

1 1.5 1.2

1.1

1.3

#

1.6

1.1

1.2

1.3 1.4 1.7

1 1.5

#

1.7

1.6 2.1

#

2.2

2

3 2.3

#

2.4 4.1

3.1

4.2 4.3

4 # 5.1

Legend and identification Item 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 #

Designation Nephroscope Sheath tube Cold--light connector Irrigation stopcock Port stopcock (for insertion) Sealing cap Eyepiece with eye cup Colored coding ring red: Direction of view 25_ Product no.

Item 2 2.1 2.2 2.3 2.4 3 3.1 4 4.1 4.2 4.3

Designation Operation sheath Suction holes Drain stopcock Locking lever Screw ring Obturator Central bore for guide wire Internal sheath Distal insulation Irrigation stopcock Locking lever

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 Perform a visual check: section 7 and 7.1 Z Attach sealing cap (1.5).

6.1.1

Inserting obturator (3) into operating sheath (2) Locking: Z The locking lever (2.3) is in position “I” (12 o’clock position) Z Insert the obturator (3) into the operating sheath (2) ' The pin (b) must engage in groove (a) Z Turn the locking lever (2.3) to position “II” (2 o’clock position).

I

2.3

2

a II b

3

Fig. 1 Unlocking: Z Turn the locking lever (2.3) to position “I” (12 o’clock position), remove the obturator (3). 6.1.2

Inserting nephroscope (1) into operating sheath (2) Locking: Z The locking lever (2.3) is in position “I” (12 o’clock position) Z Insert the nephroscope (1) into the operating sheath (2). ' The pin (b) must engage in the groove (a). Z Turn the locking lever (2.3) to position “II” (2 o’clock position)

Fig. 2

2.3

I

a

II

b

2

1 Unlocking: Z Turn the locking lever (2.3) to “I” (12 o’clock position) and remove the nephroscope (1).

3

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Z Connect the supply lines (light, irrigation, drain, video) Z Carry out a function check. Z After the necessary orientation and a view of the objects to be treated, insert the corresponding auxiliary instrument (e.g. lithotripsy probes, grasping forceps, etc.).

6.2

Additional notes and indications for use In the case of percutaneous use, puncture the hollow organ with a conventional puncture set if this hasn’t been done before, and dilate to the corresponding internal diameter (24 Fr. or larger) of the operating sheath (2). Remove the dilators except for the guide wire. Z Place the operating sheath (2) without the obturator (3) over the 24 Fr. telescope dilator or: Z insert the operating sheath (2) with obturator (3) via the guide wire into the hollow organ. L Carry out both procedures under x--ray control.

6.2.1

.

NOTE! If an ”Amplatz” sheath is used, the nephroscope (1) can be used directly, i.e. without operating sheath (2). The water supply flows through the nephroscope. The Amplatz sheath represents the drain.

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IMPORTANT! Use only products with type BF applied parts in conjunction with this endoscope.

Light

CAUTION! Heat accumulation due to high light energy! In the case of unfavorable combinations, the use of high temperature- resistant flexible light cable 8063.35 can cause a temperature increase at the coupling point between the flexible light cable and the endoscope. For the user this may result in burns and the endoscope may become damaged. Reduce the light output, use flexible light cable product no. 8061.xx3 / 8062.xx3, if necessary. WARNING ! Generation of heat due to high light energy ! Danger of inadvertent tissue damage due to insufficient distance between the light exit area and the tissue. Do not touch the light exit area and avoid direct contact with the tissue. WARNING ! Fire hazard ! The high temperatures generated at the light exit area cause excessive heating or even ignition when the endoscope is placed on heat- sensitive flammable surfaces (such as dark drapes etc.). Always lay the endoscope down at a safe place. If you do not use the endoscope for a prolonged period of time, switch off the light source. 6.2.2

Current WARNING ! Danger of electric shock ! Patient leakage currents can add up, if endoscopes are combined with powered endoscopic accessories. You should ensure that the combinations do not exceed the authorized patient leakage currents.

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6.2.3

Irrigation fluid CAUTION ! Caution when using electrically conductive irrigation fluid ! The use of such fluid will lead to inadvertent thermal tissue damage. The user must select a low- conductivity irrigation fluid suitable for the purpose.

2.2

CAUTION ! Carry- over of irrigation fluid into vessels as a result of positive pressure ! Such carry- over will cause severe injury to the patient. To ensure a low- pressure continuous irrigation effect, open drain stopcock (2.2) on operating sheath (2) while irrigation fluid is supplied.

auf

Fig. 3 6.2.4

HF application Make sure you observe the “Instructions and notes on HF applications”, order no.: GA--S 002 as well as the HF device manufacturer’s instructions. WARNING ! Danger of injury if the HF instrument is not visible through the scope ! Inadvertent tissue damage as well as damage to the distal end of the endoscope and parts of the instrument is possible. Activate HF instruments only after the live part conducting HF current has become fully visible in the field of view of the endoscope and touches the intended area to be treated. WARNING! HF arcing! Danger of injury from wrong HF application and insufficient distance between parts conducting HF current and other conductive parts.

Fig. 4

During activation, parts of HF instruments conducting high frequency current must be at a safe distance of at least 10 mm from the distal end of the endoscope (Fig. 4). 6.2.5

Laser application CAUTION! Do not work outside the field of view! Inadvertent tissue damage as well as damage to the distal end of the endoscope and parts of the instrument is possible! Activate the laser only after the tip of the laser fiber has become fully visible in the field of view of the endoscope and touches the intended area to be treated. CAUTION! Accumulation of heat due to highly concentrated laser beam! The heat generated by the laser beam can reduce the strength of instrument parts. Do not aim the laser beam at instrument parts, in particular not at plastic parts. Maintain adequate safety distance. CAUTION! Do not work without filter attachment! Danger of eye injuries! Use a suitable filter attachment on the endoscope eyepiece.

6.3

Percutaneous tumor resection in the renal pelvis

.

5

By percutaneous resection of tumors in the renal pelvis, patients with a single kidney or in poor general condition can be treated saving the organ. The internal sheath (4) is used in conjunction with the operating sheath (2) to guarantee continuous irrigation. IMPORTANT! Preferably, working elements with passive cutting action (spring--assisted cutting) should be used to avoid injuries by projecting electrodes in the relatively narrow renal pelvis.

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6.3.1

Procedure

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IMPORTANT! Follow the instruction manual for the resectoscope instrument set. Z Insert the electrode into the working element in accordance with the resectoscope manual. Z Introduce the telescope into the working element in accordance with the resectoscope manual. Z Introduce the pre--assembled working element into the internal sheath (4). Locking: ' The locking lever (4.3) must be in “I” (12 o’clock position) ' Introduce the working element into the operating sheath (2). ' The pin (b) must engage in groove (a). ' Turn the locking lever (4.3) to “II” (2 o’clock position). Unlocking: ' Turn the clamping lever (4.3) to position “I” (12 o’clock position), then remove the working element.

4.3 I

II a

b

Fig. 5 Z Introduce the complete instrument set into the operating sheath (2) already in situ. ' The locking lever (2.3) must be in position “I” (12 o’clock position) ' Introduce the complete pre--assembled internal sheath (4) into the operating sheath (2). ' The pin (c) must engage in groove (d). ' Turn the locking lever (2.3) to position “II” (2 o’clock position). Unlocking: ' Turn the locking lever (2.3) to position “I” (12 o’clock position), the remove internal sheath (4).

4 d

c

2 2.3 II

I

Fig. 6

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6

7

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 checks Z Check instruments and accessories for -- damage -- sharp edges -- loose or missing parts -- rough surfaces. ' Check the sealing cap (1.5) for damage and replace if necessary. 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 the suction and irrigation flow before each use

7.2.1

Checking image quality and light output Z Any deposits on the glass surface can cause a stained or blurred field of view and may reduce the light transmission considerably. ' Wipe glass surfaces with a swab (wooden swab carrier, not metal or plastic) soaked with alcohol, wipe hard--to--remove deposits with instrument cleaner *.

*For this, also refer to “Notes and instructions on the reprocessing of RICHARD WOLF products, accessories and devices”, order no. GA--J 020.

Fig. 7 Z Hold the distal end of the endoscope towards a light source. ' Broken fibers appear as black dots on the cold--light connector (1.2). The light output is no longer sufficient if approx. 30% of the fibers are broken.

1.2

Fig. 8

7

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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

Nephroscope (1) Z Remove the rubber cap (1.5). Z Unscrew the cold--light connector (1.2).

8.1.2

Operating sheath (2) Z Unscrew the screw ring (2.4) -- LEFT--HAND THREAD -- and remove. Z Remove the irrigation ring (2.5). Z Remove the sealing rings (2.6).

2

2.4

2.5

2.6

Fig. 9 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)

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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

Assembly of nephroscope (1) Z Screw on the cold--light connector (1.2) only loosely.

8.5.2

Assembly of operating sheath (2) Z Install the sealing rings (2.6), moisten with instrument oil 200.532 if necessary. Z Install irrigation ring (2.5) as far as it will go. Z Screw on the screw ring (2.4) only loosely -- LEFT--HAND THREAD

2.6

Fig. 10 8.6

Sterilization

8.6.1

Steam sterilization

2.4

2.5

Z Steam sterilization at 134°C (272°F) using the fractional pre--vacuum method. Sterist t and Sterradt t sterilization procedures

8.6.2

9

.

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.

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Technical data and order data Model/ type no. Designation, Technical data

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8962.433

PANOVIEW operating telescope Direction of view 25_; oval probe channel for 4 mm auxiliary instruments, working length 195 mm.

8972.433

PANOVIEW operating telescope with angled eyepiece Direction of view 25_; oval probe channel for 4 mm auxiliary instruments, working 195 mm

8962.061

Operating sheath consisting of:

8962.065

Operating sheath (2) 27 Fr., working length 175 mm

8962.067

Obturator (3)

8962.122

Internal sheath, insulated distal end.

Spare parts and accessories Illustration

Model/ type no. Designation, Technical data 8962.951

Stricture scalpel, crescent--shaped, 3,5 mm dia.

886.00

Luer lock tube fitting

88.01

Sealing cap (red--organ) (item 1.5)

8095.00

Cold--light connector (item 1.2)

6.03

Cleaning brush Diameter 5 mm, length of brush 50 mm, total length 375 mm

200.532

Instrument oil (10 ml)

-- 15 364.068

Sealing rings (item 2.6) for operating sheath (2)

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

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11.1

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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