PANOVIEW Nephroscope Instructions Manual

Important general notes and instructions for use Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, and that maintenance and repair is only car­ ried out by authorized specialized technicians. 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 application and if the performance characteristics and safety requirements are met. Reprocess the products before every application and before returning them for repairs 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.

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.

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NOTE! Tips for optimum use and other useful information.

GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: +1 84 79 13 11 13 Telefax: +1 84 79 13 14 88 sales&[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

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette 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 1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.at

[email protected] www.richard-wolf.be 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

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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

GA-D 332

Contents 1

Technical description...

1

2

Intended use...

1

3

Indications and field of use...

1

4

Contraindications...

1

5

Combinations...

1

6 6.1

Illustration... Legend and identification...

2 2

7 7.1 7.1.1 7.1.2 7.2 7.2.1 7.2.2 7.2.3 7.2.4 7.3

Use... Preparation... Inserting obturator (3) in operating sheath (2)... Inserting Miniature Nephroscope (1) in operating sheath... Additional notes and instructions for use... Light... Current... Image quality... Irrigation fluid... Laser application...

4 4 4 5 6 6 7 7 7 8

8 8.1 8.2 8.2.1

Checks... Visual check... Function check... PANOVIEW Surgical Telescope...

8 8 8 9

9 9.1 9.1.1 9.1.2 9.2 9.3 9.4 9.5 9.5.1 9.5.2 9.6 9.6.1

Reprocessing and maintenance... Disassembly before cleaning... Disassembly of Miniature Nephroscope (1)... Disassembly of operating sheath (2)... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Assembly of Miniature Nephroscope... Assembly of operating sheath... Sterilization... Steam sterilization...

10 10 10 10 11 11 11 12 12 12 12 12

10

Technical data and order data... 13

11

Spare parts and accessories... 13

12 12.1

Operating, storage, transport and shipping conditions... 14 Disposal of product, packaging material and accessories... 14

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I

1

Technical description

The Miniature Nephroscope consists of: Z PANOVIEW Surgical Telescope ' with laterally offset viewfinder, direction of view 12 ' with working channel Z Operating sheath 15 Fr. / 18 Fr. ' with rotatable irrigation ring Z Obturator 12 Fr. / 15 Fr.

2

Intended use

3

Indications and field of use

4

Contraindications

5

Combinations

The Miniature Nephroscope with auxiliary instruments is used for disintegrating and removing / aspirating kidney and bladder stones, as well as for removing tumors via a percutaneous or transurethral passage. Diagnosis and therapy of urolithiasis and tumors in conjunction with endoscopic accessories in the upper and lower urinogenital tract. Contraindications directly related to the product are currently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature.

CAUTION! Do not combine products incorrectly! Injuries to the patient, user or others as well as damage to the product are possible. Joint application of different products is only permissible if the purpose and the relevant technical data coincide (working length, diameter, etc.). Follow the instruction manuals of the products used in combination with this product. The miniature nephroscope is used in conjunction with: Z light sources and fiber light guides Z video cameras and objective lenses Z suction and irrigation devices Z intracorporeal lithotripsy systems, e.g. ' Pneumatic ' Ultrasound ' Electrohydraulic EHL ' Lasers Z Endoscopic accessories ' Grasping forceps, stone extractors, stricture scalpels ' Transducers, sonotrodes ' Probes, laser fibers Fig. 1

1.6

Z The cold-light connector (1.6) can be unscrewed and replaced by suitable ad­ apters to connect fiber light cables made by other manufacturers. ' For order data please refer to the latest catalogue sheets.

Fig. 1

1

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6

Illustration 1.9 1.7

1.1 1.6

#

1.2 1.4

1.3

1.8

1.5

1.13

1.12

25

4

6

1.10

1 1.16

1.11

1.15 1.14

2.2 2.3

2.1

2.4 3.1

3

2 2.6

#

# 2.5

Fig. 2 6.1

Legend and identification Item

Designation

Item

Designation

1

Miniature Nephroscope

1.14

Irrigation stopcock

1.1

Objective lens

1.15

Indication of internal diameter / passage

1.2

Light exit

1.16

Indication of direction of view

1.3

Working channel

2

Operating sheath with rotating irrigation ring

1.4

Sheath

2.1

Suction holes

1.5

Size specification of fiber light guide

1.6

Cold-light connector

2.2

Tab with color coding white: 15 Fr.; yellow: 18 Fr.

1.7

Colored ring, orange identification for direction of view 12_

2.3

Fr. indication

2.4

Automatic locking mechanism

1.8

Serial no.

2.5

Drain stopcock

1.9

Eyepiece

2.6

Threaded ring

1.10

Rubber cap (red)

2.7

Irrigation ring

1.11

Automatic valve, consisting of:

2.8

Sealing ring

1.12

Valve holder

3

Obturator

1.13

Membrane valve (yellow)

3.1

Central hole for guide wire

#

Product no.

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2

Symbol

Designation Attention, Caution! Follow the instructions for use

REF

Order no.

SN

Serial no. 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 class IIa and above as well as sterile products or products with measuring function of class I are additionally identified with the code no. of the notified body (0124).

3

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7

Use CAUTION! The products have only limited strength! 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. Make sure that no missing parts remain in the patient. Do not use the products if they are damaged or incomplete or have loose parts.

7.1

Preparation

Z Check assembly: see section 9.5 Fig. 3 Z Screw home (1.12) valve holder. ' Before doing so, check that a membrane valve (1.13) is installed. Z Install the rubber cap (1.10).

1.13 1.12 1.10

Fig. 3

Z Carry out a visual check: see sections 8 and 8.1 7.1.1

Inserting obturator (3) in operating sheath (2) Fig. 4 Locking: Z Insert obturator (3) in operating sheath (2) in such a way that groove (a) and pin (b) are aligned, push together until locking mechanism (2.4) engages automatically (Fig. 4a).

.

NOTE! If locking mechanism (2.4) won’t engage, push release button (2.2) as far as it will go and repeat the procedure (Fig. 4b).

a

2.4

2

b

2.2

3 Fig. 4a

Fig. 4b

Fig. 4 Unlocking: Z Push the tab (2.2) and remove the obturator (3).

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4

7.1.2

Inserting Miniature Nephroscope (1) in operating sheath Fig. 5 Locking: Z Insert Miniature Nephroscope (1) in the operating sheath (2) in such a way that groove (a) and pin (c) are aligned, push together until locking mechanism (2.4) engages automatically (Fig. 5a).

c

2.2

Fig. 5a

Fig. 5b

a

2

Fig. 5

.

2.4

1

NOTE! If locking mechanism (2.4) won’t engage, push release button (2.2) and repeat the procedure (Fig. 5b). Unlocking: Z Push release button (2.2) and remove operating sheath (2). Z Connect supply lines (light, irrigation supply, and drain, video camera) Z Carry out a function check: see section 8.2 Z After appropriate orientation and visualization of the object to be treated, insert appropriate auxiliary instrument (e.g. lithotripsy probe, grasping forceps, etc.).

5

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7.2

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 (12 or 15 Fr.) of the operating sheath. Z Insert the operating sheath (2) with obturator (3) in the hollow organ using the guide wire. or: Z Position the operating sheath (2) without obturator (3) using the 12 or 15 Fr. dilator. Perform the two procedures under X-ray control.

.

7.2.1

NOTE! If an "Amplatz sheath " is used (see spare parts and accessories: section 11) the Miniature Nephroscope (1) can be inserted directly without operating sheath (2). The Amplatz sheath can be positioned using a “One-Step" dilator (15 Fr.) or using a telescope dilator (15 Fr.). Irrigation water is supplied via the Miniature Nephroscope and drained via the Amplatz sheath. In this case, it is left to the user as to whether he uses the blue sealing cap (see spare parts and accessories: section 11) or not.

Light

Fig. 6

1.6

.

1.5

25

25

Fig. 6

NOTE! To achieve optimum light transmission the fiber bundle diameters of the endoscope and of the fiber light cable must be the same. Possible consequences when using a fiber light cable with ' excessive diameter: excessive heating at the coupling point with the endoscope ' insufficient diameter: reduced light output The model / type no. of the fiber light cable is an indicator for suitable fiber bundle diameters (1.5). ' The code number on the cold-light connector (1.6) must be the same as the last 2 digits to the right of the decimal point of the product number (type number). Exception: Fiber light cable 8061.933 has a fiber bundle diameter of 3.5 mm.

CAUTION! Intense heat due to high light energy! Under unfavorable conditions the use of the high temperature resistant fiber light cable 8063.353 can cause a temperature increase at the coupling point between the fiber light cable and the endoscope. Danger of burns for the user and risk of damage to the endoscope! Reduce the light output, or use fiber light cable no. 8061.xxx / 8062.xxx if ne­ cessary.

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6

.

IMPORTANT! Use only products with type BF or CF applied parts in conjunction with the endoscope. WARNING! Intense heat due to high light energy! Danger of inadvertent tissue damage ' due to insufficient distance between the light exit area and the tissue ' due to soiling / contamination in the light exit area ' when using high performance light projectors. Do not touch the light exit area and avoid direct contact with the tissue. Remove any soiling or contamination. WARNING! Fire hazard! The extreme heat at the light exit area causes high temperatures or even ignition if the endoscope is placed onto heat-sensitive flammable surfaces (dark drapes, etc.). Store the endoscope at a safe place. Switch off the light source if you do not use the endoscope for a prolonged period of time. CAUTION! Danger of burns! Due to the high energy of the light source the cold-light connector will be hot when disconnecting it from the light source. Burns may result from unintentional contact with the connector. Do not touch the light connector, allow it to cool down.

7.2.2

Current

WARNING! Danger from electric shock! Patient leakage currents can add up if the endoscopes are combined with other powered endoscopic accessories. Make sure that the combinations do not exceed the permissible patient leakage currents. 7.2.3

Image quality

CAUTION! Increased risk potential if the image is blurred! Danger of injuring the patient. Stop the intervention for safety reasons if the image is blurred. Check the image quality of the endoscope before use (section 8.2.1). 7.2.4

Irrigation fluid

CAUTION! Caution when using electrically conductive irrigation fluid! The use of such fluid will lead to unintentional thermal tissue damage. Depending on the application, a suitable low-conductivity irrigation fluid must be selected by the user.

Fig. 7 2.5

closed

open

Fig. 7

7

CAUTION! Liquid may be washed into the patient's body as a result of overpressure! This 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. 7).

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7.3

Laser application

When applying a laser make sure you follow the laser device manufacturer's in­ structions as well as the general regulations on the use of lasers. Wear the required personal protection equipment.

CAUTION! Do not work outside the scope's field of view! Inadvertent tissue damage as well as damage to the distal end of the endoscope and instrument parts are possible. Activate the laser only after ' the tip of the laser fiber is fully visible through the scope. ' contact is made with the intended treatment area by means of the pilot beam. CAUTION! High temperatures due to highly coherent laser beam! The heat generated by the laser beam reduces the strength of instrument parts. Do not direct the laser beam at instrument parts, in particular not at plastic parts. Keep a safe distance. CAUTION! There is a risk of eye injuries when working without filter attachment! Use a suitable filter attachment on the eyepiece of the scope.

8

Checks CAUTION! Be careful if products are damaged or incomplete! Injuries to the patient, user or third parties are possible. 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 any loose parts for repair. Do not attempt to do any repairs yourself.

8.1

Visual check

8.2

Function check

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Z Check the instruments and accessories for the following: ' 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 leading to wrong handling and reprocessing must be reinstated. Z Check rubber cap (1.10), membrane valve (1.13) and the sealing cap of the Amplatz sheath for damage and replace if necessary. Z Check the individual components for compatibility. Z Check for secure connections. Z Check the individual instrument for easy assembly and proper functioning of the locking mechanism(s). Replace the instruments if the connection ' although locked is not secure. ' cannot be locked or is difficult to lock. Z Check the suction and irrigation flow prior to each use.

8

8.2.1

PANOVIEW Surgical Telescope Z Check image quality and light output in conjunction with the system components. Z Check the glass surfaces for any deposits. ' Deposits on the glass surfaces can cause a spotted or blurred field of view and thus impair light transmission considerably. ' Wipe the glass surfaces with a swab soaked with alcohol (wood, not metal or plastic), remove hard-to-remove deposits with instrument cleaner*(Fig. 8).

*see instruction manual GA-J020 "Reprocessing of RICHARD WOLF heat-stable instruments".

Fig. 8 Z Check the light output without the system components. Z Hold the distal end of the endoscope towards a light source. ' Broken fibers will appear as black dots at the cold-light connector (1.6). If approx. 30% of the fibers are broken, the light output is no longer sufficient (Fig. 9).

1.6

Fig. 9

9

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9

Reprocessing and maintenance

.

IMPORTANT! Further notes and instructions on reprocessing are described in manual GA-J020 "Reprocessing of RICHARD WOLF Heat-Stable Instruments", and these must be followed. Removable stopcock plugs! ' Make sure your read BB-J020 “Reprocessing of stopcocks with removable levers”.

9.1

Disassembly before cleaning

9.1.1

Disassembly of Miniature Nephroscope (1) Fig. 10 Z Unscrew the cold-light connector (1.6). Z Remove rubber cap (1.10). Z Unscrew valve holder (1.12). Z Remove membrane valve (1.13). ' For this purpose use supplied O-ring tool (see Spare parts and accessories: section 11).

.

IMPORTANT! We recommend replacing the membrane valve (1.13) after each use.

1.6

1.13 1.12

1.10

Fig. 10 9.1.2

Disassembly of operating sheath (2) Fig. 11 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 11).

2.8

2

Fig. 11

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2.6 2.7

10

9.2

Manual reprocessing

9.3

Machine reprocessing

.

Z Wet preparation at the point of use Z Disassembly before cleaning: see section 9.1 Z Manual cleaning / disinfection

NOTE! To avoid damage during reprocessing we recommend using a suitable reproces­ sing basket (see Spare parts and accessories: section 11). Fig. 12 Z Dry preparation at the point of use Z Disassembly before cleaning: see section 9.1 Z Machine cleaning / disinfection ' Manually clean valve holder (12.2) and internal valve beforehand.

.

NOTE! If you connect the instrument to a washer/disinfector, screw on valve holder (1.12) without membrane valve (1.13).

1.13 1.12

Fig. 12 9.4

11

Checks

Z Carry out a visual check: see section 8.1

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9.5

Assembly before sterilization

.

9.5.1

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

Assembly of Miniature Nephroscope Fig. 13 Z Screw on cold-light connector (1.6) loosely Z Place membrane valve (1.13) in valve holder (1.12). Z Loosely screw valve holder (1.12) with membrane valve (1.13) in place.

1.6 1.13

1.12

Fig. 13

9.5.2

Assembly of operating sheath Assemble operating sheath (2) in reverse order as shown in Fig. 11: Z Attach seals (2.8), lubricate with instrument oil 200.532. 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!

9.6

Sterilization

9.6.1

Steam sterilization

GA-D 332

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

12

10

Technical data and order data Maximum passage

Product no. Designation, technical data

11

8968.421

NEPHROSCOPE 12° 12FR WL 225MM

8968.001

SHEATH FOR NEPHROSCOPE 15FR for this:

8968.101

OBTURATOR FOR NEPHROSCOPE 15FR

8968.011

SHEATH FOR NEPHROSCOPE 18FR for this:

8968.111

OBTURATOR FOR NEPHROSCOPE 18FR

6 Fr. (2 mm) 12 Fr. (4 mm) 3.5 Fr. (1.2 mm) 15 Fr. (5 mm) 3.5 Fr. (1.2 mm)

Spare parts and accessories Item

Illustration

Product no.

Designation, technical data

-

8968.6802

GRASPING FORCEPS BNDL dia. Ø 2 mm / working length = 410 mm

-

8968.601

RIGID GRASP. FORCEPS 6FR WL 365MM

-

8968.671

RIGID GRASP. FORCEPS 6FR WL 365MM for this:

-

8968.675

GRASP. FORCEPS INSERT 6FR

-

-

8742.043

LITHOCLAST PROBE Ø 1.6MM WL 380MM

-

-

8962.519

SONOTRODE Ø 1.9MM WL 361MM

8061.253

FIBER LIGHT CABLE Ø 2.5MM TL 2.3M

8955.185

TELESCOPE DILATOR 9-18FR

8955.27

TELESCOPE DILATOR 9-27FR

-

8968.012

DILATOR 12FR

-

8968.015

DILATOR 15FR

-

8968.041

SHEATH FOR NEPHROSCOPE 18FR

-

89.02

1.12

15 256.393

1.13

89.101

-

13

-

SEALING CAP CAP 3.4-5.1MM (blue) for SHEATH FOR NEPHROSCOPE 18FR 8968.041 PU = 10 / pkg. Valve holder SEAL Ø 7.5MM (yellow) PU = 10 / pkg.

GA-D 332

Item

Illustration

Product no.

Designation, technical data

-

886.00

LUER LOCK CONNECTOR

1.6

8095.00

ADAPTER ENDOSCOPE SIDE

-

15 106.230

O-ring tool

BL -

6.061

CLEANING BRUSH Ø 1.8MM TL 610MM

-

86.90

CLEANING BRUSH

-

103.00

BELLOWS PUMP

1.10

88.01

RUBBER CAP CAP 0.8MM (red) PU = 10 / pkg.

-

200.532

INSTRUMENT OIL

D

TL

2.8

-

15 364.264

Sealing ring for SHEATH FOR NEPHROSCOPE 8968.001/.011

-

-

38045.111

REPROCESS BASKET

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, brochures or contact Richard Wolf or your 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

.

NOTE! To prevent damage during transport or shipment of the products we recommend using the original packaging material.

12.1

Disposal of product, packaging material and accessories

GA-D 332

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

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