VISION EF-Sensor Cystoscope Instruction Manual

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual and 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 Symbols

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.

. .

0

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 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

GA-D376

Contents 1

Technical description...

1

2

Intended use...

1

3

Indications and field of use...

1

4 4.1 4.2

Contraindications and side effects... Contraindications... Side effects...

2 2 2

5 5.1

Combinations... Compatibility of sensor cystoscopes with camera controller...

2 2

6 6.1 6.2

Illustration... Legend and identification... Symbols...

3 3 4

7 7.1 7.1.1 7.2 7.2.1 7.2.2 7.3 7.4 7.4.1 7.4.2 7.4.3 7.4.4 7.4.5 7.5 7.6 7.7 7.7.1 7.7.2

Operating instruction... Assignment of function keys (15)... Contour enhancement... Preparation... Adapter (8) (option)... Biopsy valve cpl. (9) (option)... Connecting the sensor cystoscope to the camera controller... Notes and instructions for use... Deflecting the instrument tip (4)... Light... Electrical current... Image quality... Irrigation fluid... HF applications... Laser application... Auxiliary instruments and endoscopic accessories... Introducing flexible auxiliary instruments... Inserting the sensor cystoscope via a guide wire...

6 7 7 7 7 8 9 11 12 12 13 13 13 14 15 16 16 17

8 8.1 8.2 8.2.1 8.2.2 8.3 8.3.1

Checks... Visual check... Function check... Adapter (8) (option)... Sensor Cystoscope... Leakage test... Carrying out a manual leakage test...

18 18 18 19 19 19 20

9 9.1 9.1.1 9.1.2 9.1.3 9.1.4

Reprocessing and maintenance... Reprocessing sequence - Sensor cystoscope... Machine reprocessing... Manual reprocessing... Sterilization... Storage...

21 23 25 30 35 36

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9.2 9.2.1 9.2.2 9.2.3 9.2.4 9.3 9.4

Reprocessing sequence - adapter (8), biopsy valve cpl. (9)... Machine reprocessing... Manual reprocessing... Sterilization... Storage... Reprocessing sequence - Leak tester (163.903)... Reprocessing in case of repair...

10

Technical data and order data... 44

11

Spare parts and accessories... 44

12 12.1

Operating, storage, transport and shipping conditions... 46 Disposal of product, packaging material and accessories... 46

II

37 40 41 42 42 43 43

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1

Technical description

Flexible Vision EF Sensor Cystoscopes comprise the following: Z Flexible insertion sheath Z Control housing with control lever Z Fixed proximal supply cable with camera connector Z Deflectable instrument tip +210°/-210° Z Function keys on the handle Z Integrated image sensor in instrument tip Z Integrated LED illumination in instrument tip Z Working channel with biopsy port at 45 with two luer fittings Z Adapter (option) Z Biopsy valve cpl. (option) Z Universal sealing valve 1-6 Fr. (option) (single-use item)

2

Intended use

Flexible sensor cystoscopes are used for visualizing body cavities and organs via natural and surgically created passages. Z Adapter (option) ' is used for inserting auxiliary instruments through the working channel ' is used for connecting suction and irrigation components Z Biopsy valve cpl. (option) ' The biopsy valve seals off when auxiliary instruments of 3-5 Fr. are inserted in the working channel Z Universal sealing valve 1-6 Fr. (option) (single-use item) ' is used for the insertion of 1-6 Fr. auxiliary instruments through the working channel These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.

3

Indications and field of use

For examination, diagnosis and / or therapy in conjunction with endoscopic acces­ sories. The product is used in the following disciplines: Z Urology ' urogenital tract ' cystoscopy ' nephroscopy Z Surgery ' choledochoscopy

CAUTION! Video signal processing may fail! This may delay or stop the operation. There must always be an operable comparable device or a conventional system as a backup so that the user can complete the operation should the video image or LED illumination fail.

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4

Contraindications and side effects

4.1

Contraindications Contraindications directly related to the product are presently unknown. On the basis of the latest medical state of the art and the patient's general condition, the doctor in charge must decide whether the intended application is possible or not. For further notes and instructions please refer to the latest medical literature.

4.2

Side effects

5

Combinations

No side effects are known if the product is used as intended. Sensor cystoscopes are used in conjunction with: Z Flex HD camera controller ENDOCAM 5521101 Z HF surgical devices Z Suction and irrigation devices Z Lasers Z Endoscopic accessories, e.g. ' Flexible forceps ' Flexible HF instruments ' Laser fibers ' etc.

CAUTION! Be careful not to combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. The different products can only be used together if their intended uses and rele­ vant technical data (such as working length, diameter, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in combination with this product. Follow the "Notes and instructions on HF applications", order no.: GA-S002 as well as the HF device manufacturer's instructions.

5.1

Compatibility of sensor cystoscopes with camera controller

.

2

IMPORTANT! The sensor cystoscopes are compatible with Richard Wolf camera controller „Flex HD Camera Controller ENDOCAM 5521101“. Follow the instruction manual GA-A308 of the camera controller "Flex HD camera controller ENDOCAM 5521101".

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Illustration

1 3 8.4

8.4.1 8.4.2

8.4.3

8.4.4

2 3 4

11 8.3

10

8 8.2 7 6

9.3

8.1

6.1 #4

5

9

9.2 9.1

#5

14.1

14.2

#6 #7

12 13

14

15.2

#1

15 13 #3 #2 15.1

Fig. 1

6.1

Legend and identification Item

Designation

Item

Designation

1

Working channel

9

Biopsy valve cpl. (option)

2

Objective lens

9.1

Valve housing

3

Light exit

9.2

Sealing valve

4

Instrument tip, controllable

9.3

Sealing cap

5

Flexible instrument sheath

10

Universal sealing valve 1-6 Fr. (option)

6

Irrigation connector

11

Rubber cap

6.1

Luer sealing cap

12

Connector for leakage test and pressure equalization

7

Luer fitting

13

Control lever

8

Adapter (option)

14

Supply cable

8.1

Locking ring

14.1

Camera plug

8.2

Supply and drain stopcocks

14.2

Plug protection cap

8.3

Instrument port stopcock

15

Function keys

8.4

Stopcock, complete

15.1

Function key 1 (left)

8.4.1

Stopcock plug

15.2

Function key 2 (right)

8.4.2

Stopcock housing

8.4.3

Luer fitting

8.4.4

Indication of capacity on stopcock housing / stopcock plug

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3

Item

Designation

#

Other markings

#1 #2

#3 #4

6.2

Item

Designation

Product no.

#5

Follow the instruction manual

CE 0124

#6

Flexing of instrument tip U = Up distal movement of control lever D = Down proximal movement of control lever

#7

IPX7 (Protected against the effects caused by temporary immersion in water)

Recycle the product separately. Do not dis­ card together with other waste.

Working channel in Fr.

Symbols Symbols

Designation Follow the instruction manual

Observe the instruction manual

REF

Order number

SN

Serial no.

LOT

Lot identification Manufacturer

Manufacturing date

Do not reuse

Do not resterilize Number, amount Expiry date

STERILE EO Sterilized with ethylene oxide Do not use if package is damaged

4

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Symbols

Designation Keep away from sunlight

XX° XX° XX%

Limitation of temperature

Limitation of humidity

XX%

IPX7

Protected against the effects of temporary immersion in water Recycle the product separately. Do not discard together with other waste. Identification in conformity with Medical Product Directive 93/42/EEC, only valid if the product and/or the packaging is marked with this identification. 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 no. of the notified body (0124).

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7

Operating instruction WARNING! Do not reprocess a single-use product! If a single-use product is reprocessed for further use, the product properties can be impaired and/or changed, endangering the patient, user and others. Possible dangers / risk factors: ' Strength problems ' Severe impairment of the function ' Damage to the product ' Substantially increased risk of infection ' Biocompatibility problems This single-use product is only designed for one single-use on one single patient. If a single-use product is reprocessed, the product responsibility lies with the user or with the person reprocessing the product. In this case the manufacturer can no longer guarantee the safety and performance of the product. ' It is not permissible to reprocess a disposable (i.e. single-use) product. ' Discard a single-use product after use in accordance with the country-spe­ cific regulations. 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. WARNING! Do not use a single-use item more than once! If a single-use product is used more than once, the product properties can be im­ paired and/or changed, endangering the patient, user and others. Possible dangers / risk factors: ' Strength problems ' Damage to the product ' Severe impairment of the function This single-use product is only designed for one single-use on one single patient. If a single-use product is reprocessed, the product responsibility lies with the user or with the person reprocessing the product. In this case the manufacturer can no longer guarantee the safety and performance of the product. ' Discard a single-use product after use in accordance with the country-spe­ cific regulations.

6

.

IMPORTANT! The sealing valve (9.2) is delivered in unsterile condition and must be repro­ cessed before use. ' see section 9.2, pages 40, 41

.

NOTE! When connecting the flexible endoscope to the camera controller, in general a white balance adjustment is not necessary. The configuration of illumination and image generation allows a one time white bal­ ance. The latter is stored on the flexible endoscope in the factory.

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7.1

Assignment of function keys (15)

. 7.1.1

NOTE! Function key 1 (left) (15.1) is not assigned.

Contour enhancement Fig. 2

15.2

Contour enhancement facilitates the visibility of fine image structures. It can be selected via the right function key 2 (15.2). ' Stage 1: standard image sharpness ' Stage 2: enhanced image sharpness

15

Z Brief actuation of function key 2 (15.2) (< 1s): ' Switchover between stage 1 and stage 2

15.1 Fig. 2

7.2

Preparation

.

NOTE! The following products can be attached to the luer fitting (7): ' Biopsy valve cpl. (9) (option) ' Adapter (8) (option) ' Universal sealing valve 1-6 Fr. (10) (option) ' Other commercially available disposable (single-use) stopcocks and valves Z Carry out a check: see sections 8 and 8.1

7.2.1

Adapter (8) (option) Installing the adapter (8) 8.4.1

Fig. 3 Z Connect the stopcock plug (8.4.1). Z Plug the rubber cap (11) onto the adapter (8).

. 8

11

NOTE! Instead of the rubber cap (11), optionally the biopsy valve cpl. (9) or the uni­ versal sealing valve 1-6 Fr. (10) can be installed.

Fig. 3

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Fig. 4 Z Pull and hold the locking ring (8.1) as indicated by the arrow as far as it will go. Z Engage the luer fitting (7) in the slot of the locking ring (8.1) and let go of lock­ ing ring (8.1). ' The locking ring (8.1) must return to its home position. Z Close the irrigation connector (6) with a luer sealing cap (6.1).

6.1

7 6

8.1

Fig. 4

Connecting the supply and drain tubes Fig. 5 Z Connect the supply and drain tubes to the supply and drain stopcocks (8.2). Z Open the supply and drain stopcocks (8.2). Z Switch on the suction and irrigation system and check the suction and irrigation function. Z Check the entire system for leak-tightness and free passage (patency).

8.2

Fig. 5 Z Carry out a function check: see section 8.2 7.2.2

Biopsy valve cpl. (9) (option)

9

9.3

6

7

6.1

Assembling the biopsy valve cpl. (9) Fig. 6 Z Check assembly: Section 9.2, page 42. Z Screw on the valve cap (9.3) and tighten. Z Screw the biopsy valve cpl. (9) onto the luer fitting (7). Z Close the irrigation connector (6) with a luer sealing cap (6.1).

. NOTE! Optionally, the universal sealing valve 1-6 Fr. (10) can be installed in­ stead of biopsy valve, cpl. (9). Fig. 6

8

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Connecting the irrigation tube Fig. 7 Z Remove the luer sealing cap (6.1). Z Connect the irrigation tube to the irrigation connector (6). Z Switch on the irrigation system and check the irrigation function. Z Check the entire system for leak-tightness and free passage (patency).

10

6.1

6 Fig. 7 Z Carry out a function check: see section 8.2

7.3

Connecting the sensor cystoscope to the camera controller

.

IMPORTANT! Limited strength of the supply cable. Exerting excessive force or high mechanical loads can damage the supply cable or the wiring, which in turn will lead to image interference or image or illumination fail­ ure. ' Do not pinch, squash or excessively bend the supply cable ' Do not pull on the supply cable

Fig. 8

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Fig. 9 Z Unscrew the plug protection cap (14.2) from the camera plug (14.1).

14.2

14.1

Fig. 9 Fig. 10 Z Switch on the camera controller. Z After the boot procedure of the controller, connect the sensor cystoscope via the camera plug (14.1) to the „Flex HD Camera Controller ENDOCAM 5521101“ cam­ era controller. ' for further information see GA-A308

CAUTION! Danger of dazzling! Danger of impaired sight. Do not look into the light exit area of a flexible endoscope which is connected to the camera controller.

14.1

Fig. 10

10

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7.4

Notes and instructions for use CAUTION! Danger of transmitting microorganisms! To prevent a contamination of the camera plug when disconnecting it from the camera controller during the course of the operation, screw on the plug protection cap immediately after disconnecting the plug. A soiled camera plug requires thorough cleaning, disinfection and rinsing with ster­ ile water and sufficiently dried contacts before installing the plug protection cap. Any residual moisture between the contacts may impair signal transmission (e.g. interruptions, contact problems). The plug protection cap stays in place during the entire reprocessing process. CAUTION! Flexible endoscopes have limited strength! High forces and excessive mechanical loads can cause damage and impair the function. Do not kink the flexible instrument sheath and do not bend in too narrow a radius (minimum diameter 150 mm).

Fig. 11

CAUTION! Do not block the deflectable instrument tip by outer influences (e.g. limited free space)! This may damage the controls. If the instrument tip is blocked, do not forcefully actuate the control lever. Move the instrument tip to a position allowing control without applying any force.

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7.4.1

Deflecting the instrument tip (4)

.

NOTE! A tactile notch on the control lever (13) indicates that the instrument tip (4) is straight (0° position). Fig. 12 Z Actuate the control lever (13). Direction

Deflection

Movement of control lever

up (U)

210

to proximal

down (D)

210_

to distal

up (U)

210

to distal

down (D)

210_

to proximal

Type

73151001

73151006

4 up down

pro­ ximally

distally

13 Fig. 12

7.4.2

Light

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 Do not touch the light exit area and avoid direct contact with the tissue. Remove any soiling. WARNING! Fire hazard! When placing the endoscope onto heat-sensitive flammable surfaces (dark drapes etc.) the high light energy at the light exit area of the endoscope can cause high temperatures or even ignition. Store the endoscope in a safe place.

12

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7.4.3

Electrical current

.

IMPORTANT! Use only products with a type BF applied part in conjunction with the flexible en­ doscope. WARNING! Danger of electric shock! Patient leakage currents can add up if the endoscopes are combined with other energetically operated endoscopic accessories. Make sure that the combinations do not exceed the permissible patient leakage currents.

7.4.4

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 8.2.2). 7.4.5

Irrigation fluid

CAUTION! Take care not to use the wrong irrigation fluid! Caution, do not choose high-conductivity irrigation fluid for monopolar HF appli­ cations! ' Increased risk of patient leakage currents ' No function of the HF instrument The user must choose the irrigation fluid as required by the application. The irri­ gation fluid must have a low electrical conductivity. Do not use saline (NaCl) for monopolar HF applications. CAUTION! Danger of elevated temperatures when working without irrigation fluid! Injuries to the mucous membrane due to excessive temperatures endanger the patient. Activate the electrode only while it is immersed in irrigation fluid and under con­ tinuous irrigation.

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7.5

HF applications

Follow the "Notes and instructions on HF applications", order no. GA-S002 as well as the HF device manufacturer's instructions.

.

NOTE! The flexible endoscope is insulated to prevent large surface burns in the case of an operator's error.

.

NOTE! In the case of HF applications, interferences may occur in the endoscopic image. This is a normal occurence and does not indicate any malfunction. 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 instrument parts is possible. Use HF instruments only within the scope of their specifications (voltage strength, duty factor). Activate HF instruments only after the part carrying high-frequency current has become fully visible through the scope and contact is made with the area to be treated.

Fig. 13

CAUTION! Careful if HF voltage is too high ! Danger of injury due to damaged HF electrode insulation! Exceeding the maximum recurring peak voltage permissible for the HF elec­ trodes in combination with HF surgical devices and/or a wrong choice of the mode of operation can destroy the insulation and cause leakage currents. There is the possibility of thermal tissue damage for the patient, user and others. Use HF electrodes in combination with HF surgical devices only with a maximum recurring peak voltage of 1.5 kV in coagulation mode. A use in the cutting or SPRAY coagulation mode is not permissible. CAUTION! Thermal tissue injuries due to damaged insulation! On frequently reprocessed and on aged HF instruments the insulation can be damaged. A damaged insulation causes leakage currents leading to thermal tissue injuries of the patient, user or others. Check the insulation for damage before use. Do not use HF instruments once the insulation is damaged.

Fig. 14

14

CAUTION! Danger of HF arcing! Insufficient distance between the parts carrying high-frequency current and other conductive parts can lead to unintentional tissue damage and damage to the instrument. When the HF current is activated, parts of HF instruments carrying high-fre­ quency current must have a minimum distance of 10 mm from the distal end of the endoscope. In the case of HF sparking, replace the electrode immediately, check the endo­ scope for damage and send in the endoscope for repair if necessary to avoid consequential damage.

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CAUTION! Careful if HF output power is incorrectly selected! Injuries of the patient as well as damage to the product are possible. The power should be set on the basis of the surgeon's experience and training in view of the corresponding indication.

. 7.6

Laser application

NOTE! We recommend starting at a lower power setting to determine the optimum power setting. In the case of laser applications be sure to also follow the laser device manufac­ turer's notes and instructions 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 flexible en­ doscope and to instrument parts are possible. Activate the laser only after ' the tip of the laser fiber has become fully visible through the flexible scope and ' the pilot beam makes 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 destroying the working channel by the sharp distal end of the laser fiber! The stronger (stiffer) the laser fiber the bigger the danger that the sharp distal end of the laser fiber destroys the working channel. Insert the laser fiber in the instrument channel carefully, and only with straight in­ strument sheath, as well as straight position (0° position) of the instrument tip, and withdraw it in the same way. CAUTION! Danger of destroying the instrument with a fractured laser fiber! If the instrument tip is angled (small bending radius) this increases the danger of a fracture of the laser fiber and even more so with increasing laser fiber diameter. If the laser fiber breaks within the instrument channel while the laser is active, this will immediately destroy the instrument. In the latter case, switch off the laser energy immediately. When using highly flexible laser fibers with a maximum permissible laser fiber diameter of 365 m only a reduced deflection of the instrument tip is possible. CAUTION! Increased danger of laser fiber breakage if there is no protective coating or jacket! We recommend removing only 1 mm of the laser fiber jacket at the distal tip.

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7.7

Auxiliary instruments and endoscopic accessories

7.7.1

Introducing flexible auxiliary instruments

WARNING! Danger of injury if the auxiliary instrument is not visible through the scope! Inadvertent tissue damage as well as damage to the distal end of the flexible en­ doscope and to instrument parts are possible. Insert auxiliary instruments only under visual control. Carry out manipulations only if the auxiliary instruments are fully visible through the flexible scope. Insert and withdraw the auxiliary instrument through the working channel only when the instrument tip is straight. Fig. 15 The insertion port stopcock (8.3), the biopsy valve cpl. (9) or the universal sealing valve 1-6 Fr. (10) allow the insertion of auxiliary instruments, such as flexible biopsy forceps, if required. Z Open the instrument port stopcock (8.3) on adapter (8) and insert the auxiliary instrument.

8.3

10

8 9 Fig. 15

.

16

IMPORTANT! Use only flexible auxiliary instruments with a maximum outer diameter of 5 Fr.

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