Flexible CMOS Video-Cysto-Urethroscope Instruction Manual

Important Information for Users of KARL STORZ Instruments Thank you for your expression of confidence in the KARL STORZ brand name. Like all of our other products, this product is the result of years of experience and great care in manufacture. You and your organization have decided in favor of a modern, high-quality item of equipment from KARL STORZ. This instruction manual is intended to serve as an aid in the proper handling, cleaning and, where required, sterilization of the Flexible CMOS Video-Cysto-Urethroscope. All essential details of the equipment and all actions required on your part are clearly presented and explained. We thus ask that you read this manual carefully before proceeding to work with the instrument. 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. 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. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

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Symbol Description

Symbol Description Follow the instruction manual

White balance



Single image capture



Video recording

This device has been marked in accordance with the European Directive 2012/19/EU on waste electrical and electronic equipment (WEEE) Device type BF

Electronic information product pollution control (China RoHS)

Manufacturer

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Illustrated Description

⑦

⑨ ④

⑧

11025 E Pressure Compensation Cap 13242 XL Leakage Tester ③

⑭

⑤

②

⑮

⑯

⑰

① ⑩ ⑥

㉒

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㉓

②

㉑

㉔

⑱ ⑳

⑲

⑬

⑫

⑪

Controls, Displays, Connectors and Their Uses ① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩ ⑪ ⑫ ⑬ ⑭ ⑮ ⑯ ⑰ ⑱ ⑲ ⑳ ㉑ ㉒ ㉓ ㉔

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Connecting cord Connection for leakage tester or pressure compensation cap (vent port) Instrument channel/Luer port (the 11272 VA/VUA (11272 V/VU) Flexible CMOS Video-Cysto-Urethroscope is equipped with a T-Luer) Shaft Handle Deflection lever Distal tip Leakage tester (P/N 13242 XL) Pressure compensation cap (P/N 11025 E) Monitor Power supply connection Video output for connecting an external monitor CMOS Video-Cysto-Urethroscope connection Reset button Holder for SD memory card Function symbols Soft keys Charge state Pilot lamp (orange) charging process Power button Pilot lamp (green) power button Video recording White balance Single image capture

Contents

Important Information for Users of KARL STORZ Instruments________________________________________________ 2 Symbol Description____________________________________________________________________________________ 3 Illustrated Description__________________________________________________________________________________ 4 Controls, Displays, Connectors and Their Uses____________________________________________________________ 5 Safety Instructions_____________________________________________________________________________________ 9 Indications for Use___________________________________________________________________________________ 9 User Qualification____________________________________________________________________________________ 9 Warnings and Cautions______________________________________________________________________________ 10 Safety Precautions__________________________________________________________________________________ 10 Installation and Operating Instructions___________________________________________________________________ 13 Unpacking the Device_______________________________________________________________________________ 13 Basic Equipment____________________________________________________________________________________ 13 Operating Conditions________________________________________________________________________________ 14 Electromagnetic Compatibility________________________________________________________________________ 14 External System Components________________________________________________________________________ 14 Handling___________________________________________________________________________________________ 15 Operating__________________________________________________________________________________________ 15 Holding Correctly___________________________________________________________________________________ 15 Handling the Shaft__________________________________________________________________________________ 15 Handling the Deflection Mechanism___________________________________________________________________ 16 Handling the Working Channel________________________________________________________________________ 17 Handling the Accessories (Forceps, Cleaning Brushes, etc.)______________________________________________ 18 Inspecting the Surfaces______________________________________________________________________________ 19 Checking the Deflection______________________________________________________________________________ 19 Connection to the Monitor 8402 ZX___________________________________________________________________ 20 Using the Video Output______________________________________________________________________________ 21 Focus_____________________________________________________________________________________________ 23 Function Buttons of the Endoscope___________________________________________________________________ 23 Function Keys for the Monitor_________________________________________________________________________ 23 Main Menu_________________________________________________________________________________________ 24 Second Level Functions Play Back Menu_______________________________________________________________ 25 Level 2a: Selecting the Recorded Videos_______________________________________________________________ 25 6

Contents

Level 2aa: Playing Back and Deleting a Recorded Video Stream___________________________________________ 26 Level 2b: Selecting the Saved Images__________________________________________________________________ 26 Level 2bb: Viewing and Deleting a Saved Image_________________________________________________________ 27 Third Level Functions________________________________________________________________________________ 27 Fourth Level Functions_______________________________________________________________________________ 28 Fifth Level Functions_________________________________________________________________________________ 28 Sixth Level Functions________________________________________________________________________________ 29 Switching the Flexible CMOS Video-Cysto-Urethroscope On/Off__________________________________________ 30 Video Recording____________________________________________________________________________________ 30 Single Image Capture________________________________________________________________________________ 30 Inspecting the Image Quality_________________________________________________________________________ 31 Switching off the Monitor_____________________________________________________________________________ 31 Energy Management________________________________________________________________________________ 32 Attaching the Monitor to a Stand______________________________________________________________________ 33 System Reset______________________________________________________________________________________ 33 Cleaning, Sterilization and Care_________________________________________________________________________ 34 General Information_________________________________________________________________________________ 34 Water Quality Requirements__________________________________________________________________________ 35 Cleaning Equipment and Accessories__________________________________________________________________ 36 Bedside Pre-cleaning (at point of use)_________________________________________________________________ 37 Leakage Test_______________________________________________________________________________________ 38 Manual Cleaning____________________________________________________________________________________ 40 Detergent Cleaning__________________________________________________________________________________ 40 Water Rinsing______________________________________________________________________________________ 42 Drying_____________________________________________________________________________________________ 43 Inspection_________________________________________________________________________________________ 43 Sterilization_________________________________________________________________________________________ 43 Sterilization Methods________________________________________________________________________________ 44 STERIS V-PRO maX Sterilization______________________________________________________________________ 44 STERRAD Systems Sterilization_______________________________________________________________________ 44 Reference for Cleaning and Sterilization________________________________________________________________ 46 Storage______________________________________________________________________________________________ 47 7

Contents

Endoscope Return Instructions_________________________________________________________________________ 48 System Description___________________________________________________________________________________ 49 Technical Data________________________________________________________________________________________ 49 Maintenance_________________________________________________________________________________________ 51 Servicing and Repair________________________________________________________________________________ 51 Maintenance_______________________________________________________________________________________ 51 Directive Compliance________________________________________________________________________________ 52 Important Information________________________________________________________________________________ 52 Disposal___________________________________________________________________________________________ 52 Troubleshooting_____________________________________________________________________________________ 53 Accessories__________________________________________________________________________________________ 54 Electromagnetic Compatibility (EMC) Information for KARL STORZ NPU System_______________________________ 55 Shipping_____________________________________________________________________________________________ 60 Return Policy_________________________________________________________________________________________ 60 Repair Program_______________________________________________________________________________________ 61 Warranty Policy_______________________________________________________________________________________ 61 Limitation of Liability___________________________________________________________________________________ 62 Software Ownership and Licensing______________________________________________________________________ 63

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Safety Instructions

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.

Indications for Use The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra. Contraindications: There are no known contraindications relating directly to the product. The Flexible CMOS Video-Cysto-Urethroscope must not be used if, in the opinion of a qualified physician, such an application would endanger the patient, e.g. due to the patient’s general condition, or if the endoscopic method as such is contraindicated.

User Qualification The KARL STORZ Flexible CMOS Video-Cysto-Urethroscope may only be used by persons with an appropriate medical qualification and who are acquainted with the cystoscopy technique. The information given in these instructions only serves to instruct in the correct handling and preparation of the Flexible CMOS Video-Cysto-Urethroscope. It is not intended as an introduction to the technique of cystoscopy.

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Safety Instructions

Warnings and Cautions Please read this manual carefully and follow the instructions exactly. The words Warning, Caution and Note convey special meanings. Wherever they are used in this manual, they should be carefully reviewed to ensure the safe and effective operation of this product. To further emphasize the words Warning, CAUTION and Note, they are preceded by a pictogram. Warning: A warning indicates that the personal safety of the patient or physician may be involved. Disregarding a warning could result in injury to the patient or physician. CAUTION: A caution indicates that particular service procedures or safety precautions must be followed to avoid any damage to the product.

 Note: A note indicates special information about operating the product, or clarifies important information. Safety Precautions The Flexible CMOS Video-Cysto-Urethroscope must be used according to the recognized medical rules and procedures of endoscopy. Warning: Every time the Flexible CMOS Video-Cysto-Urethroscope is used, you must first check that it, and any accessories used in combination with it, is in perfect condition. Damaged Flexible CMOS Video-Cysto-Urethroscopes or damaged accessories must not be used. Warning: Combinations of medical devices are only then 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 CMOS Video-Cysto-Urethroscope is delivered non-sterile and must be cleaned and sterilized before initial and subsequent use. Warning: The pressure compensation cap (P/N 11025 E) ⑨ must be removed from the vent port ② for: • endoscopic interventions • immersing in liquid. Warning: Not intended for use with electro surgical instruments. Use of the Flexible CMOS Video-CystoUrethroscope with HF electrodes may cause interference with the image.

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Safety Instructions

Warning: The pressure compensation cap (P/N 11025 E) ⑨ must be in place on the vent port ② for: • plasma sterilization • shipping Warning: Do not point the light beam of the Flexible CMOS Video-Cysto-Urethroscope into the patient's and/or other healthcare provider's eyes. Looking into the light beam may cause eye damage. Warning: Danger of explosion if flammable gases are used in the immediate proximity of the Flexible CMOS VideoCysto-Urethroscope. The Flexible CMOS Video-Cysto-Urethroscope must not be used in the presence of flammable or combustible media. Warning: The Flexible CMOS Video-Cysto-Urethroscope may only be repaired by personnel authorized by KARL STORZ. Unauthorized repairs may impair functioning and safety, and are therefore strictly forbidden. KARL STORZ gives no warranty for Flexible CMOS Video-Cysto-Urethroscopes that are repaired by unauthorized personnel. Warning: Always unplug the Flexible CMOS Video-Cysto-Urethroscope before carrying out any maintenance and cleaning work on it. Warning: The Flexible CMOS Video-Cysto-Urethroscope must not be used during the discharge of a cardiac defibrillator. Remove the Flexible CMOS Video-Cysto-Urethroscope from the operation area before discharge takes place. Warning: When in operation, the integrated LED light source heats up the Flexible CMOS Video-CystoUrethroscope. Switch off the CMOS Video-Cysto-Urethroscope before putting it down and do not place it in the proximity of the patient (as per IEC 60601-1-1). Warning: Only KARL STORZ devices (monitor 8402 ZX) may be used. Disregarding this warning can endanger the patient and user. Warning: If the Flexible CMOS Video-Cysto-Urethroscope should malfunction during application on a patient, stop the application immediately. Place the distal tip of the Flexible CMOS Video-Cysto-Urethroscope in the neutral, nondeflected position and remove the Flexible CMOS Video-Cysto-Urethroscope. CAUTION: Do not steam sterilize (autoclave) the Flexible CMOS Video-Cysto-Urethroscope under any conditions. CAUTION: Do not allow any electrically live components or instruments to come into contact with the Flexible CMOS Video-Cysto-Urethroscope. CAUTION: Do not expose the Flexible CMOS Video-Cysto-Urethroscope to direct sunlight or excessive heat, to avoid damage to the device.

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Safety Instructions

CAUTION: Flexible CMOS Video-Cysto-Urethroscopes must never be exposed to X-rays, to avoid damage. CAUTION: Do not hit the distal tip of the Flexible CMOS Video-Cysto-Urethroscope against hard objects, and never use a sharp object to remove dirt. CAUTION: Never lay heavy objects on the Flexible CMOS Video-Cysto-Urethroscope. CAUTION: To avoid damaging the monitor, do not remove the SD card or connecting cord while a video is recording. CAUTION: To avoid damaging the monitor, always switch it off before replacing the SD card.

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Installation and Operating Instructions

Unpacking the Device Check for missing items and evidence of shipping damage. File any complaints immediately with KARL STORZ or the supplier.

Basic Equipment The following accessories are provided with the Flexible CMOS Video-Cysto-Urethroscope 11272 VA/VUA (11272 V/VU): 1 Carrying case 27677 FV 1 Instruction manual Z18446US 1 Leakage tester 13242 XL 1 Pressure compensation cap 11025 E 1 Flat cleaning brush 27652/3 1 Short cleaning brush 9990/50 1 Long cleaning brush 110910/50 1 Luer plug 29100-BK The following accessories are provided with the Monitor 8402 ZX: 1 Cleaning cap 8403 YZ 1 VESA 75 Quick clip 8401 YCA 1 Ultra II SD card 2 GB 8401 YSD 1 Power supply and charging unit 40150031

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Installation and Operating Instructions

Operating Conditions Flexible CMOS Video-Cysto-Urethroscope: Ambient temperature:

15° - 37° C (59° - 98.6° F)

Humidity:

15% - 80%

Monitor 8402 ZX: Ambient temperature:

0° - 40° C (32° - 104° F)

Humidity:

30% - 70% relative humidity

Electromagnetic Compatibility This device has been tested and is found to comply with the EMC limits of EN/IEC 60601-1-2 :2007 CISPR 11 Class B.

㉖

External System Components Charger Using the medically approved charger (ANR 40150031), the Li-Ion battery of the monitor can be recharged extremely quickly. Moreover, this charger enables the monitor to be operated with a discharged Li-Ion battery. The charger has a green LED display ㉖, which indicates that the output voltage is correct. Country specific configuration The charger features interchangeable primary adapters ㉗, ㉘, ㉙, which allow the system to be adapted to the country-specific power supply outlets.

Primary adapter for Europe: 1530290 Primary adapter for UK: 1530390 Primary adapter for US/Japan: 1530490 ㉗

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㉘

㉙

Primary adapter for Australia: 1530690

Installation and Operating Instructions

Handling CAUTION: In order to avoid damage to the exterior, do not store the CMOS Video-Cysto-Urethroscope together with sharp objects.

Operating The following instructions outline the correct operation of the Flexible CMOS Video-Cysto-Urethroscope and the corresponding accessories. This is not an introduction to the techniques of cystoscopy. Instructions on the endoscopic technique can be found in the relevant medical literature.

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

Handling the Shaft CAUTION: Do not carry the Flexible CMOS Video-Cysto-Urethroscope by the shaft. Do not pull, clamp or twist the shaft of the Flexible CMOS Video-Cysto-Urethroscope. CAUTION: The shaft of the Flexible CMOS Video-Cysto-Urethroscope must never be kinked or coiled up too tightly. Warning: Do not apply lubricant to the lens, to avoid clouding the image and thus posing a risk to the patient! Use a suitable water-soluble lubricant (e.g. Surgilube) for the distal section of the insertion shaft.

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Installation and Operating Instructions

Handling the Deflection Mechanism

 Note: The neutral position of the distal tip is straight, without any deflection whatsoever. Warning: When introducing the CMOS Video-Cysto-Urethroscope into the patient, the distal tip must be in a straight, nondeflected position. Warning: The deflection lever must never be operated with force or abruptly to avoid perforation and injury to the patient or damaging the device irreparably. Warning: Before removing the Flexible CMOS Video-Cysto-Urethroscope from the patient, the distal tip must be put into the neutral position, as 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 CMOS Video-Cysto-Urethroscope must not be used. Warning: If a functional defect occurs with the Flexible CMOS Video-Cysto-Urethroscope during use on the patient, discontinue use immediately. Put the distal tip of the Flexible CMOS Video-Cysto-Urethroscope into the neutral, nondeflected position and remove the Flexible CMOS Video-Cysto-Urethroscope 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, as far as the limit stop. The distal tip is deflected by actuating the deflection lever slowly. The distal end will deflect in accordance with the direction of actuation (forward or backward).

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Installation and Operating Instructions

Handling the Working Channel Do not use force when guiding the instruments and cleaning brushes through the channels. This can cause damage to the interior, particularly if the tip of the instrument is deflected. When a rubber channel sealing cap is first used, the instrument is subjected to increased resistance. This  Note: resistance will decrease the more often the sealing cap is used. • When introducing an instrument into the instrument channel the flexible CMOS Video-Cysto-Urethroscope must be in a straight, non-deflected position. CAUTION: Only introduce the instruments from the proximal port of the flexible CMOS Video-Cysto-Urethroscope. CAUTION: The resistance felt upon inserting the instrument increases with the degree of deflection. If the instruments are introduced using force, this can result in damage to the Flexible CMOS Video-Cysto-Urethroscope or the instrument channel. CAUTION: If the resistance is too great upon inserting an instrument then the instrument must not be inserted with force. Pull the instrument out and apply a water soluble lubricant to the tip thereof, then insert again. Before removing the instrument from the patient, the distal tip must be in a straight position. Forceps, scissors and other accessories whose jaws can be opened or closed must always be inserted into the instrument channel with closed jaws. The jaws may only be opened when the distal tip of the instrument is completely clear of the channel. Opening the jaws in the instrument channel can cause damage to the Flexible CMOS Video-Cysto-Urethroscope.

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Installation and Operating Instructions

Handling the Accessories (Forceps, Cleaning Brushes, etc.) CAUTION: Only use flexible accessories (forceps, cleaning brushes etc.) approved by KARL STORZ. Accessories from other manufacturers may damage the flexible CMOS Video-Cysto-Urethroscope. CAUTION: Inserting sharp-tipped accessories into the instrument channel may damage the flexible CMOS Video-Cysto-Urethroscope. CAUTION: Foreign bodies or parts to be extracted must not be removed through the instrument channel using instruments. Instead, the entire flexible CMOS Video-Cysto-Urethroscope must be removed from the patient and the foreign body extracted.

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Installation and Operating Instructions

Inspecting the Surfaces CAUTION: Do not squeeze the distal tip of the Flexible CMOS Video-Cysto-Urethroscope too tightly. Every time the flexible CMOS Video-Cysto-Urethroscope is used, you must first check that its surface, and above all the surface of the sheath and distal tip, is in perfect condition and that there are no sharp edges. To prevent serious injuries to the patient or the user, CMOS Video-Cysto-Urethroscopes with sharp edges must not be used. Inspect the connecting cable for damage (such as breaks, cracks, twisted or squashed sections) and the connector for loose connections. Inspect the shaft for cuffing. The scope should not be used if cuffing is observed.

Checking the Deflection Warning: Before use, always check that the deflection lever and the distal tip connected to it function correctly. Defective Flexible CMOS Video-Cysto-Urethroscopes must not be used. Warning: Actuate the deflection lever gently and carefully as far as the limit stop. The deflection lever must never be operated with force or abruptly, to avoid injuring the patient or damaging the device! Move the deflection lever smoothly and slowly! The distal end will deflect in accordance with the direction of actuation (forward or backward). If the distal end does not deflect properly, contact KARL STORZ for repairs.

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Installation and Operating Instructions ⑬

⑫ ⑪

Connection to the Monitor 8402 ZX The Flexible CMOS Video-Cysto-Urethroscope can be used together with the KARL STORZ Monitor 8402 ZX. Insert the connecting cord ① of the Flexible CMOS Video-Cysto-Urethroscope into the connection socket ⑬ on the monitor. Insert the cable from the power supply into the connection socket ⑪ of the monitor and connect the power supply to the mains. The battery is charged automatically as soon as the monitor is connected to the power supply. This will be displayed by the lighting up of the orange colored LEDs. If required, an external monitor can be connected to the video output ⑫.

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