Cystoscope Instruction Manual

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, Maintenance and repair must be carried out by authorized experts. 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 appli­ cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the pa­ tient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately on receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly.

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!

User tips for optimum device use and other useful information.

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GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [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 [email protected] www.richard-wolf.be

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

[email protected]

[email protected] www.richard-wolf.com

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

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

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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 6.2 6.2.1 6.2.2 6.2.3 6.3 6.4 6.4.1 6.4.2 6.5 6.6

Use... Preparation... Assembling the irrigation and probing adapter... Additional notes and instructions for use... Light... Current... Irrigation fluid... Auxiliary instruments... Lithotripsy applications... Additional notes and instructions on electrohydraulic lithotripsy (EHL)... Additional notes and instructions on laser lithotripsy... HF applications... Laser application...

3 3 3 4 4 5 5 5 5 6 6 7 7

7 7.1 7.2

Checks... Visual check... Function check...

7 7 8

8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.8.1 8.8.2 8.8.3

Reprocessing and maintenance... Disassembly before cleaning... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Sterilization... Steamsterilization... Low-temperature sterilization... Hydrogen peroxide plasma... Gas... Peracetic acid...

9 9 10 10 10 10 10 10 10 10 10 10

9

Technical data and order data... 11

10

Spare parts and accessories... 11

11 11.1

Operating, storage, transport and shipping conditions... 11 Disposal of product, packaging material and accessories... 11

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I

1

Intended use

2

Indications and field of use

3

Contraindications

4

Combinations

The Operating Cysto-Urethroscope is used to visualize the lower urinary tract (urethra/bladder) by natural or surgically created passages. For examination, diagnosis and therapy in conjunction with endoscopic acces­ sories for the following use: Transurethral extractions or lithotripsy of bladder stones Tumor diagnostics Removal of foreign bodies Incontinence and reflux therapy This product may only be used by adequately qualified and trained medical per­ sonnel. 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. Intracorporeal lithotripsy systems (e.g. EHL, laser, etc.) Suction and irrigation device Light source and flexible light cable Video camera and objective lens Endoscopic accessories: Grasping forceps, stone extractors, probes, laser fibers, syringes.

CAUTION ! Be careful if products are incorrectly combined ! Injury may result to the patient, user or others, and damage may result to the prod­ uct. 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 prod­ uct.

The cold-light connector (1.6) can be unscrewed and replaced by suitable adapters to connect flexible light cables of other manufacturers. (Fig. 1). For order numbers, please refer to the latest catalog sheet.

1.6

Fig. 1

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1

5

Illustration

1.9 1.2 1.1 1.6 1.7 1.8 1.10

1.5

2.3

2

1 1.3 1.4 AUTOCLAVE

1.11 1.12

2.1

2.2

Fig. 2 5.1

Legend and identification Item

Designation

Item

Designation

1 1.1

Operating cystourethroscope Objective lens

1.9 1.10

Eyepiece with eye cup Locking lever

1.2

Light exit

1.11

Locking mechanism

1.3

Working channel

1.12

Labeling: direction of view

1.4

Endoscope tip

1.5

Sheath tube

2

Irrigation and probing adapter

1.6

Cold-light connector

2.1

Irrigation and drain stopcocks

1.7

Red ring: marks steam sterilizability

2.2

Insertion stopcock (port)

2.3

Rubber cap

1.8

Colored ring, green: Identification of direction of view 5

#

Type No.

Symbols

Meaning Attention, consult ACCOMPANYING DOCUMENTS

REF

Order number Lot identification number

SN

Series number 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).

2

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6

Use CAUTION! The products have only limited strength! Exerting excessive force will cause damage, impair the function and therefore en­ danger 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

6.1.1

Assembling the irrigation and probing adapter

Perform a visual check: section 7.1

Install the rubber cap (2.3) (Fig. 1).

Fig. 3

2.3 The locking lever (1.10) should be in position I. Locking (Fig. 2): Insert the irrigation and probing adapter (2) axially into the operating CystoUrethroscope (1). The pin (a) engages in the groove (b). Turn the locking lever (1.10) to position II . Both components are locked together.

1

1.10

I

II a b

2

Fig. 4

Unlocking: Turn the locking lever (1.10) to position I (see Fig. 8). The locking mechanism (1.11) is unlocked.

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Connect the irrigation and drain tubes (A) to the irrigation and drain stopcocks (2.1). (Fig. 3) Connect the flexible light cable (B) to the cold-light connector (1.6).(Fig. 3)

NOTE! For optimum light transmission, the fiber bundle diameters of the endoscope and of the light cable should be the same. If you select a flexible light cable with an excessively large cross-section the cou­ pling point on the endoscope may become extremely hot. If a flexible light cable with an excessively small cross-section is used, the light output is reduced. CAUTION! Heat may be generated due to high light energy! If the high-temperature-resistant flexible light cable 8063.353 is used, under unfa­ vorable conditions, a temperature increase may occur at the coupling point be­ tween the flexible light cable and the endoscope. Burns may result to the user and damage may result to the endoscope. Reduce the light output, use flexible light cable model number8061.xx3 / 8062.xx3, if necessary.

B

1.6

Fig. 5

A

2.1

Carry out a function check (Section 7.2)

6.2

Additional notes and instructions for use IMPORTANT! An x-ray device should be available for this intervention to allow a radioscopy check when required.

6.2.1

Light

IMPORTANT! Use only products with Types BF applied parts in conjunction with this endo­ scope. WARNING! Heat may be generated due to high light energy! Danger of unintentional tissue damage due to insufficient distance between the light exit area and tissue. Do not touch the light exit area and avoid direct contact with the tissue.

4

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WARNING ! Fire hazard! Do not place the light exit area against heat-sensitive flammable surfaces (dark drapes, etc.) as this can lead to excessively high temperatures or even ignition. Lay down the endoscope in a safe place. Switch off the light source if the endoscope is not to be used for a period of time. 6.2.2

Current

WARNING! Danger of electrical shock! Patient leakage currents can add up if endoscopes are combined with electrically powered endoscopic accessories. Check the combination before use. 6.2.3

Irrigation fluid

CAUTION! Irrigation fluid can be electrically conductive! The user must choose a low-conductivity irrigation fluid suitable for the applica­ tion. Do not use NaCl (saline) for HF applications!

6.3

Auxiliary instruments CAUTION! Danger of injury if the auxiliary instrument is not visible through the scope! Unintentional tissue damage as well as damage to the distal end of the endo­ scope are possible! Insert the auxiliary instrument only under visual control. Carry out manipulations only after the auxiliary instrument is fully visible through the endoscope. Select the auxiliary instruments to be used in conjunction with this product in accordance with the passage size and working length requirements (see Tech­ nical Data and Order Information, Section 9).

6.4

Lithotripsy applications IMPORTANT! Follow the sonotrode manufacturer's instructions. CAUTION! Discard kinked probes and probes with damaged insulation immediately. Interrupt the operation if necessary and replace the probe. Carefully check the probes before each use. CAUTION! Danger of injury when inserting the probes. If you insert the probes too quickly and improperly, the probes may cause perfo­ rations or injuries when exiting the endoscope. Introduce the probes carefully and under visual control. CAUTION! Do not work outside the scope's field of view. Danger of perforation! Keep the probe controlled via the scope at all times to prevent mechanical perfo­ ration.

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6.4.1

Additional notes and instructions on electrohydraulic lithotripsy (EHL). EHL probes can be used for the disintegration of ureteroliths. This however re­ quires continuous irrigation water supply and direct contact between the probe tip and the stone as well as a clear view of the concretion.

NOTE! Sorbite-mannite irrigation solutions are not suitable for electrohydraulic lithotripsy. Jammed stones can be disintegrated directly using an EHL probe and the debris then extracted using a stone extractor or a grasping forceps.

CAUTION! Danger of injuries of the mucous membrane! With the EHL probe activated, direct contact with the mucous membrane can cause perforations and/or haematomas. Guide the EHL probe under endoscopic view to the concretion and activate only if the probe tip is free and in contact with the stone.Trigger the electrohydraulic shock wave only at a minimum distance of 10 mm from unprotected tissue. If the distance is shorter the tissue must be screened off by a concretion. The above must be followed to efficiently disintegrate stones. CAUTION! The endoscope tip may become damaged during the procedure! To avoid damage to the endoscope tip (1.4) from electrohydraulic shock waves, the EHL probe, while activated, must have a safety clearance of at least 10 mm from the distal end of the sheath (Fig. 4).

Fig. 6 6.4.2

Additional notes and instructions on laser lithotripsy For laser applications, follow the notes and instructions of the laser device manu­ facturer and the general guidelines for laser applications. Wear the required personal protection gear.

CAUTION! Do not work outside the field of view of the scope! Inadvertent tissue damage as well as damage to the distal end of the endoscope and instrument parts can occur! Activate the laser only after the tip of the laser fiber has become fully visible through the endoscope and is in contact with the area to be treated 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! Danger of eye injuries when using the laser without filter attachment! Use a suitable filter attachment on the endoscope eyepiece.

6

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6.5

HF applications

Make sure you observe the “Notes and Instructions 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 the instrument parts is possible. Activate HF instruments only if the live high-frequency part is fully visible through the endoscope and in contact with the area to be treated.

10mm Fig. 7 6.6

Laser application

7

Checks

WARNING! HF arcing! Danger of injury due to incorrect HF application and insufficient distance between live HF instruments and other conductive parts. Live high-frequency parts of HF instruments must be kept at a safe distance of at least 10 mm from the distal end of the endoscope when they are activated.(Fig. 5). Here, the same regulations as under 6.4.2 Notes and Instructions on Laser Lithotripsy apply.

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

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Check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces. Check the rubber cap (2.3) for damage and replace, if necessary. 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

7.2

Function check

Check the Cysto-Urethroscope in assembled condition for proper operation. Check the suction and irrigation flow before each use. Check image quality and light output: Deposits on the glass surfaces can result in a stained or blurred field of view and can considerably impair light transmission. Wipe glass surfaces with a swab (wooden swab carrier, not metal or plastic) soaked with alcohol, hard-to-remove deposits with instrument cleaner* (Fig. 6). *For this purpose, see also “Notes and Instructions on the “Reprocessing of RICHARD WOLF Heat-stable Instruments“ , order no.: GA-J 020.

Fig. 8

Hold the distal end of the endoscope towards a light source. Broken fibers appear as black dots in the cold-light connector (1.6). If 30% of the fibers are broken, the light output is no longer sufficient (Fig. 7).

1.6

Fig. 9

8

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Reprocessing and maintenance IMPORTANT! Follow the current “Reprocessing of RICHARD WOLF Heat-stable Instruments“ , 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 prod­ ucts. Do not exceed the maximum exposure time specified by the manufacturer of the disinfectants used. Disassemblable stopcock plugs! Follow BB-J 020 "Reprocessing of Disassemblable Stopcocks".

8.1

Disassembly before cleaning

Disconnecting the irrigation and probing adapter (2) from the operating CystoUrethroscope (1). (Fig. 8) Turn the locking lever (1.10) to position I. The locking mechanism (1.11) is unlocked. Remove the irrigation and probing adapter (2) from the operating Cysto-Ure­ throscope (1).

1 I

1.10

2

Fig. 10 Unscrew the cold-light connector (1.6). (Fig. 9)

1.6

Fig. 11 Remove the rubber cap (2.3). (Fig. 10)

2.3 Fig. 12

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8.2

Manual reprocessing

8.3

Machine reprocessing

8.4

Checks

8.5

Assembly before sterilization

Wet preparation at the point of use Disassembly before cleaning: see section 8.1 Manual cleaning / disinfection Dry preparation at the point of use Disassembly before cleaning: see section 8.1 Machine cleaning / disinfection Perform a visual check (see section 7.1)

NOTE!

1.6

Before sterilization, only screw on screw connections loosely to allow sufficient flow of the sterilization medium. Tighten all screw connections before use.

Screw on the cold-light connector (1.6) only loosely (Fig. 11).

Fig. 13 8.6

Sterilization

8.7

Steamsterilization

8.8

Low-temperature sterilization

Sterilization of products using the fractional pre-vacuum method (ISO13060/ISO17665) taking into account the corresponding national require­ ments. Temperature exposure time: 4 min at 134°C +4°C (273°F +7°F) 132°C +4°C (270°F +7°F) Evacuation: 3x Drying time: 10 - 20 min Maximum sterilization temperature: 138°C

IMPORTANT! The low-temperature procedures using hydrogen peroxide and peracetic acid are approved for endoscopes and endoscopic accessories with regard to their mater­ ial compatibility. By no means must these low-temperature methods be used alternately. Possible interaction between these sterilization processes can cause damage to the instruments. 8.8.1

Hydrogen peroxide plasma STERRAD 50 / 100S / 200 / NX PLASMASTER 40 / 80 / 140(9) Hydrogen peroxide (V-PRO™1)

8.8.2

and 100 NX

Gas Ethylene oxide gas (EO) Formaldehyde gas (FA)

8.8.3

Peracetic acid STERIS SYSTEM 1 / STERIS SYSTEM 1E

10

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9

Technical data and order data

10

Type no.

Endoscope tip / Sheath tube

Viewing direction of the eyepiece

Direction of view

Working length

Working channel

8626.431

9.5/11.5Fr

lateral

5°

116mm

1 x 5 Fr

Spare parts and accessories Illustration

Model/ type no.

Designation, Technical data

8625.315

ADAPTER FOR CYSTOSCOPE

8626.65

RIGID GRASP. FORCEPS 5FR WL 340MM

823.05

COAG ELECTRODE MONO 5FR WL 400MM

886.00

LUER LOCK CONNECTOR

8095.00

ADAPTER ENDOSCOPE SIDE (item 1.6) RUBBER CAP CAP 0.5MM

88.005

RIWO red (item 2.3) with 0.5 mm bore for instruments up to 5 Fr. RUBBER CAP CAP 0.8MM

88.01

RIWO red (item 2.3) with 0.8 mm bore for instruments up to 7 Fr.

103.00

BELLOWS PUMP

The products can be combined as required provided the relevant technical data and intended uses are ob­ served. 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

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

11.1

Disposal of product, packaging material and accessories

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

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