11272 VN/VNU Flexible Video-Urethro-Cystoscope Instruction Manual

Important Information for Users of KARL STORZ Instruments Thank you for placing confidence in the KARL STORZ brand name. As with all of our other products, this product is the result of years of experience and great care in manufacture. You and your organization have chosen a modern, high-quality item of equipment from KARL STORZ. These instructions are intended to assist you in the proper handling, cleaning and sterilization of the Flexible VideoUrethro-Cystoscope. Read them carefully. Keep this manual available for ready reference. Warning: KARL STORZ instruments are provided non-sterile, and must be cleaned and sterilized prior to the initial use and before each subsequent use. CAUTION: Do not mix sterilization methods as it will accelerate product deterioration. CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a physician. KARL STORZ is constantly working on the further development of all products. Please appreciate that changes to the scope of supply in form, equipment and technology are possible for this reason. Therefore, no claims may be deduced from the information, figures and descriptions in this manual.

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Contents

Important information for users of KARL STORZ instruments____________________________________________________ 2 Illustrated description______________________________________________________________________________________ 5 Controls, displays, connectors and their uses__________________________________________________________________ 6 Specifications___________________________________________________________________________________________ 6 General information for the safe use of the Flexible Video-Urethro-Cystoscope_____________________________________ 7 User qualification________________________________________________________________________________________ 7 Warnings and cautions___________________________________________________________________________________ 7 Definitions______________________________________________________________________________________________ 7 Device description_______________________________________________________________________________________ 8 Indications for use_______________________________________________________________________________________ 8 Safety precautions when using the Flexible Video-Urethro-Cystoscope__________________________________________ 9 Warnings and cautions___________________________________________________________________________________ 9 Unpacking the device___________________________________________________________________________________ 12 Basic equipment_______________________________________________________________________________________ 12 Operating conditions____________________________________________________________________________________ 12 Electromagnetic compatibility____________________________________________________________________________ 12 Handling instructions_____________________________________________________________________________________ 13 Handling______________________________________________________________________________________________ 13 Operating_____________________________________________________________________________________________ 13 Holding the Flexible Video-Urethro-Cystoscope correctly_____________________________________________________ 13 Handling the shaft______________________________________________________________________________________ 13 Directions for use________________________________________________________________________________________ 14 Handling the deflection mechanism_______________________________________________________________________ 14 Handling the accessories________________________________________________________________________________ 15 Compatible camera control units/light sources______________________________________________________________ 16 Connection to the Tele Pack™___________________________________________________________________________ 17 Connection to the light source___________________________________________________________________________ 18 Connection to the camera control unit TELECAM® DX II/SL II_________________________________________________ 19 Connection to the camera control unit Image 1 and Image 1 HUB_____________________________________________ 20 User button___________________________________________________________________________________________ 20 Inspecting the surfaces_________________________________________________________________________________ 21 Checking the deflection_________________________________________________________________________________ 22 Inspecting the light source_______________________________________________________________________________ 23 Inspecting the camera control unit________________________________________________________________________ 23 Inspecting the instruments and the instrument channel______________________________________________________ 24 Cleaning and sterilization instructions________________________________________________________________________ 25 General information_____________________________________________________________________________________ 25 3

Contents

Water quality requirements_______________________________________________________________________________ 26 Cleaning equipment and accessories______________________________________________________________________ 27 Bedside pre-cleaning___________________________________________________________________________________ 28 Leakage testing__________________________________________________________________________________________ 29 Cleaning and sterilization instructions________________________________________________________________________ 32 Manual cleaning________________________________________________________________________________________ 32 Detergent cleaning_____________________________________________________________________________________ 32 Water rinsing__________________________________________________________________________________________ 34 Drying________________________________________________________________________________________________ 35 Inspection_____________________________________________________________________________________________ 35 Sterilization____________________________________________________________________________________________ 36 Sterilization methods____________________________________________________________________________________ 37 STERIS Amsco V-PRO maX sterilization___________________________________________________________________ 37 References for cleaning and sterilization___________________________________________________________________ 38 Storage_________________________________________________________________________________________________ 39 Endoscope return instructions______________________________________________________________________________ 40 Maintenance____________________________________________________________________________________________ 41 Storage/transport conditions_____________________________________________________________________________ 41 Directive compliance____________________________________________________________________________________ 41 Important information___________________________________________________________________________________ 41 Disposal______________________________________________________________________________________________ 41 Troubleshooting__________________________________________________________________________________________ 42 Accessories_____________________________________________________________________________________________ 43 Shipping________________________________________________________________________________________________ 44 Return policy____________________________________________________________________________________________ 44 Repair program__________________________________________________________________________________________ 45 Warranty policy__________________________________________________________________________________________ 45 Limitation of liability_______________________________________________________________________________________ 46 Software ownership and licensing__________________________________________________________________________ 47

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Illustrated Description

③

④

⑤

②

⑥

⑦

⑨

⑪ Leakage Tester

⑧

①

5

⑩

⑫ Pressure Compensation Cap

Controls, Displays, Connectors and Uses

① ② ③ ④ ⑤ ⑥ ⑦

⑧ ⑨ ⑩ ⑪ ⑫

User buttons Light source connector Video connector Connection for Leakage Tester or pressure compensation cap Protective cap for video connector Distal tip Shaft Handpiece Working channel with Luer lock connectors Deflection lever Leakage tester 13242 XL Pressure compensation cap 11025E

Specifications:

11272 VN/VNU

Direction of view:

0˚

Field of view:

120˚

Depth of field:

3–50 mm

Tip deflection:

210˚ up 140˚ down

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Tip diameter:

5.5 mm

Working shaft diameter:

5.3 mm

Working channel diameter:

2.2 mm

Working shaft length:

370 mm

Total length:

635 mm

General Information for the Safe Use of the Flexible Video-Urethro-Cystoscope

User Qualification The KARL STORZ Flexible Video-Urethro-Cystoscope may only be used by persons with an appropriate medical qualification and who are acquainted with the cystoscopic technique. The information given in these instructions only serves to instruct in the correct handling and preparation of the Flexible Video-Urethro-Cystoscope. It is not intended as an introduction to the technique of cystoscopy. Please read these safety instructions carefully before using the device. Before using the instrument on the patient it is imperative that you be acquainted with how the instrument operates and is controlled.

Warnings and Cautions Please read this manual carefully. It is very important that the user be thoroughly familiar with the operation of the instrument prior to use on a patient. The terms Warning, CAUTION and Note are intended to draw your attention to important parts of the instruction manual. Close attention to all warnings, precautions and notes is necessary for safe and effective operation of the Flexible Video-Urethro-Cystoscope.

Definitions Warning: A warning indicates that the personal safety of the patient or physician may be compromised. Disregarding the warning may result in serious injury to the patient or the physician. CAUTION: A caution indicates that the device may be damaged if the caution is disregarded. Note: A note provides additional information regarding the safe operation of the instrument.

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General Information for the Safe Use of the Flexible Video-Urethro-Cystoscope

Device Description The KARL STORZ Flexible Video-Urethro-Cystoscope has a working shaft, equipped with a distal tip, which houses the CCD video module, and can be deflected up or down. The handle houses the deflection lever and the video control buttons, which can be programmed to perform functions such as white balance, image capture, zoom, and provide access to the set up menu. The Flexible Video-Urethro-Cystoscope also features a working channel with a TLuer fitting, to accommodate the use of small diameter flexible instruments, electrodes and/or laser fibers. The KARL STORZ Flexible Video-Urethro-Cystoscope is connected to the camera control unit and light source via an integrated umbilical cord and a plug. This plug is inserted directly into a KARL STORZ compatible light source. The connection to the camera control unit is made with a detachable connector cord, which allows for compatibility with multiple KARL STORZ camera control units. Opening the equipment or performing any repairs or modifications to the equipment by unauthorized persons shall release KARL STORZ from any liability for its performance. Any such opening, repair, or modification performed during the warranty period shall void all warranties.

Indications for Use The KARL STORZ Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.

Contraindications The KARL STORZ Video-Urethro-Cystoscope is contraindicated for use when, in the opinion of a qualified physician, such use would create a condition that would be dangerous for the patient.

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General Information for the Safe Use of the Flexible Video-Urethro-Cystoscope

Safety Precautions When Using the Flexible Video-Urethro-Cystoscope The Flexible Video-Urethro-Cystoscopes must be used according to the recognized medical rules and procedures of endoscopy. Note: The patient leakage current limit of the CF application part may be exceeded when CF application parts (application on heart) are used in combination with other BF application parts. In this case, the reduction of the patient leakage current should be effected using only CF application parts as far this is possible. Note: The Flexible Video-Urethro-Cystoscope does not offer any electric insulation against high frequency (HF) currents. Protection against high frequency currents should be ensured through the use of correct HF instruments. Please read the instructions for use in the instruction leaflet supplied with the HF application part for more information.

Warnings and Cautions Warning: Read the following safety instructions carefully before using the Flexible Video-Urethro-Cystoscope to avoid putting your patients, personnel or yourself at risk. Warning: Inspect the Flexible Video-Urethro-Cystoscope prior to each surgical procedure to ensure that it functions correctly and that it has been correctly cleaned and sterilized. Warning: Every time the Flexible Video-Urethro-Cystoscope is used, you must first check that it, and any accessories used in combination with it, are in perfect condition. Damaged Flexible Video-Urethro-Cystoscopes or damaged accessories must not be used. Warning: Combinations of medical devices are only assured to be safe if: • they are identified as such in the respective instruction manual or • the intended purpose and the interface specifications of the devices used in combination permit this. Pay careful attention to the instructions and interface specifications of medical products used in combination. Warning: The Flexible Video-Urethro-Cystoscope is delivered non-sterile and must be cleaned and sterilized before the initial use as well as before any further application. Warning: The pressure compensation cap (P/N 11025E) must be removed from the vent port for: • endoscopic interventions • manual/machine preparation 9

General Information for the Safe Use of the Flexible Video-Urethro-Cystoscope Warning: Only use accessories (guide wire, cleaning brushes etc.) that are specifically suited for the intended purpose and can be employed in line with generally accepted technical standards and safety guidelines. Warning: Do not allow any electrically live components or instruments to come into contact with the Flexible Video-Urethro-Cystoscope. Warning: The Flexible Video-Urethro-Cystoscope must not be used during the discharge of a cardiac defibrillator. Remove the Flexible Video-Urethro-Cystoscope from the operation area before discharge takes place. Warning: Danger of explosion if flammable gases are used in the immediate proximity of the Flexible Video-UrethroCystoscope. The Flexible Video-Urethro-Cystoscope must not be used in the presence of flammable or combustible media. Warning: High energy light radiated through Flexible Video-Urethro-Cystoscopes may give rise to high temperatures in front of the light outlet, at the end faces of the light guide and at the tip of the Flexible Video-Urethro-Cystoscope. Prolonged direct contact of light-emitting surfaces on tissue can lead to burns, this must therefore be avoided at all costs. Warning: Even after the proximal connector is removed from the light source, surfaces will remain hot for a period of time (Risk of user being burnt). Warning: The pressure compensation cap (P/N 11025E) must be in place on the vent port for: • plasma sterilization • venting • shipping Warning: The “Cleaning, Sterilization and Care of KARL STORZ Instruments” section of this manual explains procedures for cleaning and sterilization and these instructions must be followed. Warning: The Flexible Video-Urethro-Cystoscope may only be repaired by personnel authorized by KARL STORZ. Unauthorized repairs may impair the function and safety of the device, and are therefore strictly forbidden. KARL STORZ does not warranty Flexible Video-Urethro-Cystoscopes that are repaired by unauthorized personnel. Warning: Damage to the Flexible Video-Urethro-Cystoscope and injury to the patient or user resulting from incorrect operation are not covered by the manufacturer’s warranty. Warning: Always unplug the Flexible Video-Urethro-Cystoscope before carrying out any maintenance and cleaning. Warning: Contaminated Flexible Video-Urethro-Cystoscopes can cause serious or fatal diseases during transportation or at the recipient’s premises. See “Endoscope Return Instructions” for return information.

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General Information for the Safe Use of the Flexible Video-Urethro-Cystoscope CAUTION: Do not expose the Flexible Video-Urethro-Cystoscope to direct sunlight or excessive heat, to avoid damage to the device. CAUTION: Flexible Video-Urethro-Cystoscopes must never be exposed to X-rays, to avoid damage. CAUTION: Do not steam sterilize (autoclave) the Flexible Video-Urethro-Cystoscope. CAUTION: The maximum permissible temperature for decontamination and sterilization is 65° C (149° F). Warning: If a malfunction should occur during a medical procedure, stop immediately. Place the distal tip of the Flexible Video-Urethro-Cystoscope in the non-deflected position and remove the Flexible Video-Urethro-Cystoscope slowly and carefully from the patient. CAUTION: Do not hit the distal tip of the Flexible Video-Urethro-Cystoscope against hard objects, and never use a sharp object to remove dirt. CAUTION: Never lay heavy objects on the Flexible Video-Urethro-Cystoscope. CAUTION: Do not mix sterilization methods as it will accelerate product deterioration.

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General Information for the Safe Use of the Flexible Video-Urethro-Cystoscope

Unpacking the Device Warning: The Flexible Video-Urethro-Cystoscope is delivered non-sterile, so it must be sterilized prior to initial use and before each subsequent reuse. Check for missing items and evidence of shipping damage. File any complaints immediately with KARL STORZ or the supplier.

Basic Equipment Flexible Video-Urethro-Cystoscope 11272 VN/VNU with the following accessories: 1

Carrying case

1

Instruction manual Z18442US

1

Grasping forceps 27023 FE

1

Biopsy forceps 27023 ZE

1

Leakage Tester 13242 XL

1

Flat cleaning brush 27652/3

1

Short cleaning brush 9990/50

1

Long cleaning brush 110910-50

1

Luer plug 29100-BK

1

Pressure compensation cap 11025E

Operating Conditions Ambient temperature: 15°–37° C (59°–98.6° F) Humidity: 15%–80%

Electromagnetic Compatibility CE marked equipment has been tested and is found to comply with the EMC limits of EN/IEC 60601-1-2 :2001 CISPR 11 Class B.

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Handling Instructions

Handling Note: Damage to the Flexible Video-Urethro-Cystoscope resulting from incorrect operation is not covered by the manufacturer’s warranty. Warning: The Flexible Video-Urethro-Cystoscope is delivered non-sterile, so it must be sterilized prior to initial use and before each subsequent reuse.

Operating The following instructions outline the correct operation of the Flexible Video-Urethro-Cystoscope and the corresponding accessories. This is not an introduction to the techniques of cytoscopy. Instructions on endoscopic technique can be found in the relevant medical literature. Suitable accessories for your Flexible Video-Urethro-Cystoscope, such as biopsy forceps, can be found in the UROLOGY catalog or extracts from this catalog.

Holding the Flexible Video-Urethro-Cystoscope Correctly Grip the handle of the Flexible Video-Urethro-Cystoscope in your left or right hand, as shown in the picture. With this kind of control grip, the Flexible Video-Urethro-Cystoscope can be operated with one hand.

Handling the Shaft CAUTION: Do not carry the Flexible Video-Urethro-Cystoscope by the shaft. Do not pull, clamp or twist the shaft of the Flexible Video-Urethro-Cystoscope. CAUTION: The shaft of the Flexible Video-Urethro-Cystoscope must never be kinked or coiled up too tightly. It is best to store the Flexible Video-Urethro-Cystoscope in a suspended position or to keep it in a tray specifically designed for sterilization and storage (39403AS). Warning: Do not apply lubricant to the lens to avoid clouding. Use a suitable, water-soluble lubricant for the distal section of the shaft (For materials recommended and approved by KARL STORZ, please see www.karlstorz.com). Observe the anatomy the entire time during use. If you lose your orientation, pull the deflection mechanism back slightly into the neutral position until vision is restored.

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Directions for Use

If during use the image fails, is disturbed, becomes blurred, or if vision generally is impeded, put the deflection mechanism into the neutral position and slowly pull the shaft of the Flexible Video-Urethro-Cystoscope out of the patient’s body.

Handling the Deflection Mechanism Note: The neutral position is when the scope’s distal tip is straight, without any deflection. Warning: Suitable accessories, such as biopsy forceps, must only be introduced into the instrument channel of the Flexible Video-Urethro-Cystoscope with the distal tip in the neutral, non-deflected position. Once the instrument has been introduced, gently actuate the lever. Warning: The deflection lever must never be operated with force or abruptly to avoid perforation and injury to the patient or irreparable damage to the device. Warning: Before removing the Flexible Video-Urethro-Cystoscope from the patient, the distal tip of the Flexible Video-Urethro-Cystoscope must be put into the neutral position, otherwise injuries to the patient or damage to the instrument may occur. Warning: If the distal tip can no longer be properly controlled (sticking etc.) via the deflection lever, or if the deflection mechanism develops any other fault, the Flexible Video-Urethro-Cystoscope must not be used. Warning: If a functional defect occurs during use on the patient, discontinue use immediately. Put the distal tip of the Flexible Video-Urethro-Cystoscope into the neutral, non-deflected position and remove the Flexible Video-UrethroCystoscope slowly and carefully from the patient. CAUTION: The resistance that can be felt when deflecting the tip using the deflection lever increases as the angle of deflection increases. Actuate the deflection gently and carefully, without any sudden or jerky movements.

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Directions for Use

Handling the Accessories (Forceps, Cleaning Brushes, HF Electrodes etc.) CAUTION: Only use flexible accessories listed in this manual. Accessories from other manufacturers may damage the Flexible Video-Urethro-Cystoscope. CAUTION: Only introduce the instruments from the proximal port of the Flexible Video-Urethro-Cystoscope. Warning: When HF electrodes or laser probes are used, it must be ensured that power is not applied until the active parts are clear of the instrument channel and are in the user’s field of vision, and the site of the operation is clearly recognizable. Activation in the instrument channel may lead to serious injury to the patient and damage to the Flexible Video-Urethro-Cystoscope. Warning: When HF electrodes or laser probes are used, it must be ensured that power is only applied when there are no flammable gases in the operating field or in the proximity of the Flexible Video-Urethro-Cystoscope. CAUTION: When laser probes are used, it must be ensured that the laser beam does not hit the distal tip of the Flexible Video-Urethro-Cystoscope. CAUTION: Do not force accessories, such as biopsy forceps, through the working channel, to avoid damaging the device. The accessory should easily pass, without any hindrance, through the entire channel. CAUTION: When the distal tip is deflected, do not introduce any instrument into the Flexible Video-UrethroCystoscope. Return the distal tip to the neutral position before introducing the instrument and then move the deflection lever gently and carefully. CAUTION: Inserting sharp-tipped accessories into the instrument channel may damage the Flexible Video-Urethro-Cystoscope. CAUTION: Do not attempt to remove foreign bodies through the instrument channel. After the foreign body has been secured within the forceps’ jaws, withdraw the entire Flexible Video-Urethro-Cystoscope and the instrument from the patient. After the foreign body has been removed from the forceps, close the jaws and retract completely through the working channel.

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Directions for Use

Compatible Camera Control Units/Light Sources Camera Control Unit

KARL STORZ TELE PACK® KARL STORZ TELECAM® SL II (as of software version 470212-0209A) KARL STORZ TELECAM® DX II (as of software version 470212-0609A) KARL STORZ IMAGE 1 222000 20-1 (as of software version 470212-0609A) KARL STORZ IMAGE 1 HUB 222010 20-1 (as of software version 470212-0609A)

Light source

KARL STORZ Xenon 175 201321 20-1 / Xenon 300 201331 20-1 / Xenon Nova 175 201315 20 / Xenon Nova 300 201340 20 / Miniature 481-C

Connecting cables for Image 1 HUB NTSC the camera control unit 0.9 m: 22200077, 1.9 m: 22200377, Image 1 / Telepack / Telecam SL II / DX II 20213070 Note: The KARL STORZ Flexible Video-Urethro-Cystoscope should not be used in combination with camera control units and light sources from other manufacturers. The use of non-compatible units can lead to patient injury or unit damage.

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Directions for Use

Connection to the Tele Pack™ CAUTION: The Flexible Video-Urethro-Cystoscope can be used with the Tele Pack™ 200431 20 (NTSC). The video connection is made using the connecting cable 20213070, which must be ordered separately. The instruction manual of the TELE PACK™ must be followed. CAUTION: The Flexible Video-Urethro-Cystoscope must be fully connected to the TELE PACK™ before the TELE PACK™ is switched on. Warning: Ensure that the electrically non-insulated parts of the Flexible Video-Urethro-Cystoscope do not come into contact with conductive surfaces, e.g., voltage-carrying elements of other units, at any time. Unscrew the cap for the video connector and remove it from the supply connector. Insert the video connecting cable 20 213070 into the round port of the supply connector and the square port of the TELE PACK™. If necessary, remove the protection cap of the connector.

Note: Always put the exposure setting of the TELE PACK™, in conjunction with the Flexible Video-UrethroCystoscope, to “Auto Border”. For this, see the TELE PACK™ instruction manual. Power up the Tele Pack™. As an alternative to the Tele Pack™, a light source can be used in combination with the camera control units TELECAM® SL II / TELECAM®DX /Image1™ / Image1™ hub.

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Directions for Use

Connection to the Light Source Note: The Flexible Video-Urethro-Cystoscope can be used with KARL STORZ light sources as listed in the “Compatible Camera Control Units/Light Sources” section. Warning: The instruction manual of the specified light source must be followed. Warning: Reduce the intensity of the light source so that optimal illumination of the operating field is still achieved. The higher the intensity of the light source, the greater the heat emitted at the tip of the Flexible Video-Urethro-Cystoscope.

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1.

Install the light source on a firm, level surface.

2.

Plug the power cord into the specified power socket.

3.

Plug the supply connector into the light source.

Directions for Use

Connection to the Camera Control Unit TELECAM® DX II/ SLII Note: The Flexible Video-Urethro-Cystoscope can be used with the camera control units TELECAM® DX II 202330 20 / TELECAM® SL II 202130 20 specified by KARL STORZ for this purpose. The video connection is made using the connecting cable 20213070, which must be ordered separately. The instruction manual of the camera control unit must be followed. The complete operating instructions for the camera control unit can be found in the instruction manual. Warning: The keyboard of the camera control unit must not come into contact with the patient or be placed in the proximity of the patient.

CAUTION: Take care with the connectors on the Flexible Video-Urethro-Cystoscope! The connectors on the Flexible Video-Urethro-Cystoscope or video connection cable can be damaged if they are incorrectly plugged into the Flexible Video-Urethro-Cystoscope. Make sure that the pins are correctly aligned. Note: Always adjust the exposure setting of the TELECAM® DX II/SL II camera control unit, in conjunction with the Flexible Video-Urethro-Cystoscope to “Brightness Low”.

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1.

Install the camera control unit on a firm, level surface.

2.

Plug the power cord into the specified power socket.

3.

Unscrew and remove the cap for the video cable connector.

4.

Plug the video connection cable into the round port in the supply connector.

5.

Connect the video connection cable to the camera control unit.

Directions for Use

Connection to the Camera Control Unit Image 1 and Image 1 HUB. Note: The Flexible Video-Urethro-Cystoscope can be used with the intended camera control unit from KARL STORZ Image 1 202000 20-1 / Image 1 HUB 22 2010 20-1. The video connection is made using the connecting cable 22200077 NTSC, which must be ordered separately. The instructions for the camera control unit must be followed. The complete operating information for the camera control unit can be found in the relevant instruction manual. Warning: The keyboard of the camera control unit must not come into contact with the patient or be placed in the proximity of the patient. CAUTION: Take care with the connectors on the Flexible Video-Urethro-Cystoscope! The connectors on the Flexible Video-Urethro-Cystoscope or video connecting cable can be damaged if they are incorrectly plugged into the Flexible Video-Urethro-Cystoscope. Make sure that the pins are correctly aligned.

User Button The Flexible Video-Urethro-Cystoscope has three control buttons which can be assigned specific functions in the camera control unit’s device menu. The assignment set is retained after switching off and on again. Instructions on programming the control keys can be found in the instruction manual of the camera control unit.

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