Nephroscope also for adipose patients Instructions

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 surrounding. NOTE! Tips for optimum use and other useful information.

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.: 847--913 1113 Fax: 847--913 1488

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: 020--8944 7447 Fax: 020--8944 1311

E--mail: [email protected] Internet: www.richard--wolf.com

E--mail: sales&[email protected] Internet: www.richardwolfusa.com

E--mail: [email protected] Internet: www.richardwolf.uk.com

BELGIUM N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 B--9031 Gent --Drongen Tel.: +32 9.280.81.00 Fax: +32 9.282.92.16

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F--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 A--1160 Wien Tel.: +43 1-- 405 51 51 Fax: +43 1-- 405 51 51--45

E--mail: [email protected]

E--mail: [email protected]

E--mail: [email protected] Internet: www.richard--wolf.at

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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 6.3 6.4

Use... Preparation... Insert the obturator in the operating sheath... Insert the nephroscope in the operating sheath... Additional notes and instructions for use... Light... Current... Irrigation fluid... HF application... Laser application...

4 4 4 5 6 6 6 7 7 7

7 7.1 7.2

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

8 8 8

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... Disassembly of nephroscope... Disassembly of operating sheath... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Assembly of nephroscope... Assembly of operating sheath... Sterilization... Steam sterilization... Sterist and Sterradt sterilization procedures...

10 10 10 11 11 11 11 12 12 12 13 13 13

9

Technical data and order data... 14

10

Spare parts and accessories... 14

11

Operating, storage, transport and shipping conditions... 15

12

Disposal of product, packaging material and accessories... 15

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1

Intended use The nephroscope is used with appropriate R. Wolf auxiliary instruments to shatter and remove/suck out kidney and bladder stones. It is also used to remove tumors using a percutaneous or transurethral passage, in combination with intracorporeal lithotriptors, e.g.: pneumatic, ultrasound, electrohydraulic or laser, under endoscopic control.

2

Indications and field of use For diagnosis and therapy of urolithiasis and tumors in combination with endoscopic accessories for the upper and lower urinogenital tract. The longer working length of the nephroscope means it can also be used in adipose patients. The procedures may only be performed by adequately trained and qualified medical personnel.

3

Contraindications Contraindications directly related to the product are presently unknown. The physician/surgeon in charge must decide whether the planned use is possible or not on the basis of the patient’s general condition. For further information see the latest medical literature.

4

Combinations Z Intracorporeal lithotripsy systems (e.g. ultrasound, EHL, etc.) Z Suction and irrigation units Z Light sources and flexible light cables Z Video cameras and lenses Z Endoscopic accessories: Holding forceps, stone extractors, scalpels for stricturotomy, transducers, sonotrodes, laser fibers. CAUTION ! Caution if products are incorrectly combined ! Injury may result to the patient, user or others, and damage may result to the product. Different products should only be used in combination if their intended use and relevant technical data (working length, diameter, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product. The cold--light connector (1.5) can be unscrewed and replaced by suitable adaptors to connect the flexible light cables of other manufacturers. For the order number please refer to the latest catalog sheet.

1.5

1

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5

Illustration 1.5

1.6

#

1.7 1.8

1

1.1

1.4

1.2

1.9

1.3

1.10 1.14

1.12

1 .11

1.13 2.1

2.2 2.3

2

3

2.4

3.1 2.6 2.5

Fig. 1

5.1

#

#

Legend and identification Item 1 1.1

Designation Nephroscope Lens

1.2

Light exit

2

1.3 1.4 1.5

Working channel Sheath Cold--light connector

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 3 3.1 #

16 1.6 1.7 1.8 1.9 1.10 1.11 1.12

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Color ring g orange g Identification of direction of view 12_ Serial no. Eyecup Passage Sealing cap Screw cap Membrane valve

Item 1.13 1.14

Designation Irrigation tap Viewing direction Operating sheath with rotatable irrigation ring Suction openings Slide with color coding brown: 27 Fr. Data in Fr. Automatic locking mechanism Drain stopcock Screw ring Irrigation ring, see fig. 12 (page 11) Sealing ring, see fig. 12 (page 11) Obturator Central hole for guide wire Type no.

2

Symbols

Designation Attention, consult ACCOMPANYING DOCUMENTS

REF

Order number Lot identification number Units, pieces Steam sterilization -- fractional method 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).

3

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6

Use CAUTION ! The products only have 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 Unscrew the screw cap (1.11) and check whether a membrane valve (1.12) has been used (Fig. 2). Z Insert membrane valve as necessary (1.12). Z Tighten screw cap (1.11) again. Z Position sealing cap (1.10).

1.11 1.12 1.11

1.10

Fig. 2 6.1.1

Insert the obturator in the operating sheath. Z Lock in position (Fig. 3a): Introduce the obturator (3) into the operating sheath (2) [pin (b) in groove (a)] and push until the locking mechanism (2.4) automatically engages. . NOTE ! If locking mechanism (2.4) fails to engage, push release button (2.2) as far as it will go and repeat the procedure.

2.2

a

2.2

b

2.4

3

Fig. 3b

Fig. 3a

2

3

Fig. 3 Z Release (Fig. 3b): Press slide (2.2) and remove obturator (3).

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6.1.2

Insert the nephroscope in the operating sheath Z Lock in place (Fig. 4a): Introduce nephroscope (1) into operating sheath (2) [pin (c) in groove (a)] and push together until locking mechanism (2.4) engages automatically.

.

NOTE ! If locking mechanism (2.4) fails to engage, push release button (2.2) as far as it will go and repeat the procedure.

a

2.4

c

1

2.2

Fig. 4a

2

Fig. 4b

1

Fig. 4 Z To release (Fig. 4b): Push release button (2.2) and remove operating sheath (2). Z Connect supply lines (light, irrigation supply and drain, video camera).

Fig. 5 Z Perform a functional check (section 7.2). Z After locating and viewing the object to receive treatment, introduce appropriate auxiliary instrument (e.g. lithotripsy probes, holding forceps, etc.)

5

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6.2

Additional notes and instructions for use In the case of percutaneous application, puncture the hollow organ (only if this has not been done before) with a conventional puncture set and dilate to the required internal diameter (24 Fr.) of the operating sheath. Z Insert operating sheath (2) with obturator (3) in the hollow organ using the guide wire. or: Z Position operating sheath (2) without obturator (3) via a 24 Fr. dilator. L Perform the two procedures under X--ray control.

6.2.1

.

NOTE ! If an ”Amplatz sheath” is used, the nephroscope (1) can be inserted directly without operating sheath (2). Irrigation water is supplied via the nephroscope and drained via the Amplatz sheath. In this case it is left to the user as to whether he/she uses the blue sealing cap (see spare parts and accessories, section 10) or not.

.

NOTE ! To obtain optimum light efficiency, we recommend using a Richard Wolf flexible light cable.

.

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

Light

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

6.2.3

Irrigation fluid

to

2.5 on

Fig. 6

6.3

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. 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 (2.5) on operating sheath (2) while irrigation fluid is supplied. (Fig. 6)

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 !

Fig. 7

Danger of injury from wrong HF application and insufficient distance between parts conducting HF current and other conductive parts. 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. 7).

6.4

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.

7

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7

Checks CAUTION ! Be careful If products are damaged or incomplete ! Injury may result to the patient, user or others. 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

Fig. 8 1.10

1.12

7.2

Z Check instruments and accessories for -- damage -- sharp edges -- loose or missing parts -- rough surfaces. ' Check that sealing cap (1.10) and membrane valve (1.12) are intact, and replace if necessary (Fig. 8). Z Any lettering, labels or identification necessary to ensure usage in accordance with intended purpose must be legible. ' Missing or illegible lettering, labeling or identification which may lead to incorrect handling and reprocessing must be reinstated.

Functional check Z Check suction and irrigation flow before each use. Check image quality and light output: Z Any deposits on the glass surfaces can cause a stained or blurred field of vision and can impair light transmission considerably. ' Wipe the glass surfaces with a swab soaked with alcohol (wooden swab carrier, not metal or plastic), wipe off hard--to--remove deposits with instrument cleaner* (Fig. 9).

*For this see also the “Notes and instructions on the reprocessing of R. Wolf products, accessories and devices”, order no.: GA--J 020.

Fig. 9

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8

Z Hold the distal end of the endoscope towards a light source. ' At the cold--light connector (1.6) broken fibers will appear as black dots. If more than 30% of the fibers are broken, the light transmission properties are no longer sufficient (Fig. 10).

1.5

Fig. 10

9

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8

Reprocessing and maintenance .

IMPORTANT ! Follow the latest version of ”Notes and instructions on the reprocessing of R. 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 R. 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

Disassembly of nephroscope Z Unscrew cold--light connector (1.5) (Fig. 11). Z Remove sealing cap (1.10). Z Unscrew screw cap (1.11). Z Remove membrane valve (1.12). ' For this purpose, use supplied O--ring tool (see “Spare parts and accessories”, section 10).

.

IMPORTANT ! We recommend replacing the membrane valve (1.12) after each use.

1.5

1.12 1.11

1.10

Fig. 11

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10

8.1.2

Disassembly of operating sheath Z Unscrew threaded ring (2.6) -- LEFT--HAND THREAD! -- and remove. Z Remove irrigation ring (2.7). Z Remove O--ring seals (2.8) with the supplied O--ring tool (see “Spare parts and accessories”, section 10). Use recess to prevent damage to O--rings (Fig. 12a)

Fig. 12a

2

2.6

2.7

2.8

Fig. 12 8.2

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

8.3

Machine reprocessing Z Dry decontamination at the point of use Z Disassembly before cleaning: see section 8.1 Z Machine cleaning / disinfection ' Clean screw cap (1.11) and inside thread manually in advance.

.

NOTE ! Unscrew screw cap (1.11) without membrane valve (1.12) to connect to the washer (Fig. 13).

1.12

1.11

Fig. 13 8.4

Checks Z Perform a visual check: section 7.1

11

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8.5

Assembly before sterilization

.

NOTE ! Before sterilization screw on screw connections only loosely

' to allow adequate flow of the sterilization medium ' to avoid stress cracks. Tighten all screw connections before use. 8.5.1

Assembly of nephroscope Z Screw on cold--light connector (1.6) loosely (Fig. 14). Z Place membrane valve (1.12) in screw cap (1.11). Z Unscrew screw cap (1.11) with inserted membrane valve (1.12).

1.5

1.11 1

1.11 1.12 Fig. 14

8.5.2

Assembly of operating sheath Z Attach seals (2.8), lubricate with instrument oil 200.532 if required. Z Attach irrigation ring (2.7) by pushing it on as far as it will go. Z Screw on threaded ring loosely -- LEFT--HAND THREAD !

2.8

Fig. 15

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2.6

2.7

12

8.6

Sterilization

8.6.1

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

8.6.2

13

Sterist and Sterradt 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 restrictions, such as discoloration of plastic materials, as well as further notes see the latest version of ”Notes and instructions on the reprocessing of R. 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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9

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

8966.401

10

PANOVIEW--PLUS--OP endoscope with parallel stereo eyepiece; Viewing angle 85_, viewing direction 12_

Working length

Maximum passage

250 mm

12 Fr. (4 mm)

8966.051

Operating sheath, external diameter 27 Fr. also:

230 mm

24 Fr. (8 mm)

8966.151

Obturator, external diameter 24 Fr.

255 mm

3.5 Fr. (1.2 mm)

Spare parts and accessories Illustration

--

Model/ type no no. Designation, Designation Technical data 8061.253

Flexible light cable

8955.27

Telescopic dilator set

15176.106

Screw cap (item 1.11)

89.00

89.02

Sealing cap for instruments up to 2.4 mm (black) Sealing cap for instruments from 2.4 mm to 3.4 mm (red--orange) Sealing cap for instruments above 3.4 mm (blue)

89.103

Membrane valve (item 1.12) pack of 10 (yellow)

886.00

Luer lock tube

8095.00

Cold--light connector (item 1.5)

15 106.230

O--ring holder

6.09

Cleaning brush

103.00

Pneumatic bulb

200.532

Instrument oil

15 364.264

Sealing ring (item 2.8) for operating sheath 8966.051

89.01

--

--

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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11

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

.

12

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.

15

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