Related Manuals for Storz 11272 VA
Summary of Contents for Storz 11272 VA
- Page 1 Instruction Manual Flexible CMOS Video-Cysto-Urethroscope Models 11272 VA/VUA, 11272 V/VU Monitor 8402 ZX...
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Page 2: Important Information For Users Of Karl Storz Instruments
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. -
Page 3: Symbol Description
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... -
Page 4: Illustrated Description
Illustrated Description ⑦ ⑨ ④ ⑧ 11025 E Pressure Compensation Cap 13242 XL Leakage Tester ③ ⑭ ⑮ ⑯ ⑰ ⑤ ② ① ⑩ ⑥ ⑱ ㉑ ⑳ ⑲ ⑬ ⑫ ⑪ ② ㉓ ㉒ ㉔... -
Page 5: Controls, Displays, Connectors And Their Uses
Their Uses ① Connecting cord ② Connection for leakage tester or pressure compensation cap (vent port) ③ Instrument channel/Luer port (the 11272 VA/VUA (11272 V/VU) Flexible CMOS Video-Cysto-Urethroscope is equipped with a T-Luer) ④ Shaft ⑤ Handle ⑥ Deflection lever ⑦... -
Page 6: Table Of Contents
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... - Page 7 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...
- Page 8 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...
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Page 9: Safety Instructions
User Qualification The KARL STORZ Flexible CMOS Video-Cysto-Urethroscope may only be used by persons with an appropriate medi- cal 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. -
Page 10: Warnings And Cautions
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. - Page 11 Urethroscope. Switch off the CMOS Video-Cysto-Urethroscope before putting it down and do not place it in the prox- imity 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.
- Page 12 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.
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Page 13: Installation And Operating Instructions
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):... -
Page 14: Operating Conditions
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. -
Page 15: Handling
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 cor- responding accessories. -
Page 16: Handling The Deflection Mechanism
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. -
Page 17: Handling The Working Channel
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. Note: When a rubber channel sealing cap is first used, the instrument is subjected to increased resistance. This resistance will decrease the more often the sealing cap is used. -
Page 18: Handling The Accessories (Forceps, Cleaning Brushes, Etc.)
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. -
Page 19: Inspecting The Surfaces
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. -
Page 20: Connection To The Monitor 8402 Zx
Connection to the Monitor 8402 ZX ⑬ ⑫ ⑪ 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. -
Page 21: Using The Video Output
Installation and Operating Instructions Using the Video Output The RCA connection on the rear of the monitor delivers a composite video signal. An RCA cable can be used to send this signal to an external monitor. Note: BNC cables can be used in conjunction with a BNC adapter. Fig. - Page 22 Installation and Operating Instructions Turn the monitor on using the power switch ⑳ (pilot lamp ㉑ lights up). Should single images or a video stream be saved, then an SD memory card must be inserted into the card holder ⑮. ⑮...
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Page 23: Focus
Installation and Operating Instructions Focus The image focus is preset. Manual adjustment is not possible/necessary. The system is now ready for use. Function Buttons of the Endoscope The endoscope is equipped with 3 buttons, which are used to activate the functions displayed as symbols on the ㉒... -
Page 24: Main Menu
Installation and Operating Instructions The following functions are available to you: Main Menu Video recording: Starts or stops the recording of a video stream on the SD memory card which has been inserted into the slot ⑮. Stop video recording: Stops the recording of a video stream. Video recording not possible: No SD card inserted, loading is in process, or the SD card is full. -
Page 25: Second Level Functions Play Back Menu
Installation and Operating Instructions Second Level Functions Play Back Menu Playing back video recordings: Plays back and deletes recorded video streams on the SD memory card which has been inserted into the slot h. Viewing recorded images: Views and deletes recorded single images on the SD memory card which has been inserted into the slot h. -
Page 26: Level 2Aa: Playing Back And Deleting A Recorded Video Stream
Installation and Operating Instructions Level 2aa: Playing Back and Deleting a Recorded Video Stream Video play back menu Delete: Pressing the button for an extended period deletes the video. After deletion, the list of video recordings is shown. Play: Plays back the video recording. Pause: Pauses the video. -
Page 27: Level 2Bb: Viewing And Deleting A Saved Image
Installation and Operating Instructions Level 2bb: Viewing and Deleting a Saved Image Photo play back menu Scrolling up through list: Scrolls upward through the list to select the saved images. Scrolling down through list: Scrolls downward through the list to select the saved images. Delete: Pressing the button for an extended period deletes the image. -
Page 28: Fourth Level Functions
Installation and Operating Instructions Fourth Level Functions Image parameter menu 2 Color saturation: Pressing the softkey displays the +/- keys with which the color saturation of the monitor screen can be adjusted. Hue: Pressing the softkey displays the +/- keys on the monitor with which the color saturation of the hue can be adjusted. -
Page 29: Sixth Level Functions
Installation and Operating Instructions Sixth Level Functions Date: Allows entering or correcting the date. Enter the date in international format – dd.mm.yyyy. Pressing the softkey displays +/- keys to enter the day, then confirm using the arrow key. Enter month and year accordingly. Clock: Allows entering or correcting the clock time. -
Page 30: Switching The Flexible Cmos Video-Cysto-Urethroscope On/Off
Installation and Operating Instructions Switching the Flexible CMOS Video-Cysto-Urethroscope On/Off The Flexible CMOS Video-Cysto-Urethroscope with the integrated LED light source is switched on by pressing the power button ⑳ on the monitor. Pressing the key a second time switches the unit off. ⑳... -
Page 31: Inspecting The Image Quality
Installation and Operating Instructions Inspecting the Image Quality Check the image quality before using the Flexible CMOS Video-Cysto-Urethroscope. Do not use the scope if the image is missing, or unclear/blurry. Warning: If the image fails or there is interference during use in the patient, put the distal tip into the neutral position and remove the Flexible CMOS Video-Cysto-Urethroscope from the patient’s body gently and carefully. -
Page 32: Energy Management
Installation and Operating Instructions Energy Management The charge state of the battery will be displayed on the monitor by the charge state ⑱. The lithium-ion battery can be used for approximately 1 hour when fully charged. The discharged battery is fully charged after 5 hours (when the unit is switched off). While charging, the orange-col- ored LED ⑲... -
Page 33: Attaching The Monitor To A Stand
Installation and Operating Instructions Attaching the Monitor to a Stand Attach the holder onto the back of the monitor using 4 screws. The VESA 75 holder 8401 YC is suitable for securing rods with a diameter of 25 mm. Press the holder together to allow the stand bar to be pushed through the openings. Release the holder in the desired position. -
Page 34: Cleaning, Sterilization And Care
Soft, lint-free cloths and/or sponges along with ONLY the correct KARL STORZ cleaning brush(es) should be used to clean the flexible endoscope. CAUTION: To prevent biofilm formation it is critical that flexible endoscopes be thoroughly dried prior to storage. -
Page 35: Water Quality Requirements
Cleaning, Sterilization and Care Water Quality Requirements CAUTION: Flexible endoscopes must never be immersed in normal saline solution, as even brief contact can result in pitting and corrosion. Definitions Utility Water: Water as it comes from the tap that meets the specifications as defined per the table below. This water is mainly used for flushing, washing and rinsing. -
Page 36: Cleaning Equipment And Accessories
Cleaning, Sterilization and Care Cleaning Equipment and Accessories Mild/neutral pH enzymatic cleaning solution (e.g. Enzol) Cleaning basin or sink Flat cleaning brush (P/N 27652/3) Short cleaning brush (P/N 9990/50) Long cleaning brush (P/N 110910-50) 60 cc syringe Soft, lint-free cloth Lens cleaner or cotton tip applicator 70% Isopropyl alcohol Luer plug (P/N 29100-BK) -
Page 37: Bedside Pre-Cleaning (At Point Of Use)
Cleaning, Sterilization and Care Bedside Pre-cleaning (at point of use) Water Quality Recommendation: Utility water Wipe the entire exterior of the flexible endoscope with a soft, lint-free cloth, moistened with water, or a diluted mild/neutral pH enzymatic cleaning solution (e.g. Enzol). This step is to remove gross debris from the exterior of the flexible endoscope. -
Page 38: Leakage Test
CAUTION: Check the KARL STORZ Leakage Tester (P/N 13242 XL) for any damage prior to use. Damaged KARL STORZ Leakage Testers (P/N 13242 XL) should not be used and should be returned to KARL STORZ for repair or replacement. - Page 39 10. Observe for a formation of bubbles on the exterior of the flexible endoscope or a stream of air bubbles. 11. If the flexible endoscope has a leak as determined by a fall in pressure as seen on the KARL STORZ Leakage Tester (P/N 13242 XL) or if bubbles are discovered per the steps above, immediately remove the flexible endo- scope from the water.
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Page 40: Manual Cleaning
CAUTION: Inserting a brush of incorrect size or forceful insertion can damage the flexible endoscope / instrument channel. CAUTION: Only use cleaning accessories from or approved by KARL STORZ. Note: Complete cleaning of the patient-used endoscope should be started within two hours of the bedside pre- cleaning. - Page 41 Cleaning, Sterilization and Care While immersed, ensure one Luer is plugged and use a 60 cc syringe attached to the other Luer to suction up a minimum of 100 mL of cleaning solution through the instrument channel. Discard the solution drawn through the channel in a separate container. CAUTION: DO NOT discard in the basin the flexible videoscope is being cleaned in.
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Page 42: Water Rinsing
Cleaning, Sterilization and Care Water Rinsing Water Quality Recommendation: Utility or critical water Disinfect a new sink or basin to be used for rinsing following your healthcare facility’s recommended method. After disinfecting, be sure to thoroughly rinse the sink or basin with water to remove all of the disinfectant chemicals. -
Page 43: Drying
Warning: Follow the cleaning instructions in this manual to thoroughly clean the Flexible CMOS Video-Cysto- Urethroscope prior to sterilization. KARL STORZ recommends to sterilize the Flexible CMOS Video-Cysto-Urethroscope via STERRAD NX/100NX Sterilization Systems, or STERIS V-PRO maX Sterilization System. For outside U.S. the CMOS Video-Cysto-Urethroscope can also be sterilized via STERRAD 100S Sterilization System. -
Page 44: Sterilization Methods
Cleaning, Sterilization and Care Sterilization Methods STERIS V-PRO maX Sterilization Equipment and Accessories V-PRO Sterilization Tray FDA-cleared polypropylene wrap CAUTION: Place the pressure compensation cap (P/N 11025 E) on the vent port before V-PRO maX sterilization. CAUTION: The CMOS Flexible Video-Cysto-Urethroscope must be fully DRIED before loading into the V-PRO sterilizer. CAUTION: Only use FDA-cleared polypropylene sterilization wraps. - Page 45 Cleaning, Sterilization and Care Place the Flexible CMOS Video-Cysto-Urethroscope in a STERRAD compatible instrument tray. Place a STERRAD indicator strip in the tray. Double wrap the sterilization tray with two single layers of FDA-cleared polypropylene wrap, using a sequential double wrapping technique. Load the STERRAD sterilizer, arranging the items such that the hydrogen peroxide plasma can surround them.
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Page 46: Reference For Cleaning And Sterilization
Reference for Cleaning and Sterilization Reference for Cleaning and Sterilization American National Standards Institute/Association for the Advancement of Medical Instrumentation: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities: ANSI/AAMI ST91:2015. -
Page 47: Storage
Storage Storage CAUTION: To prevent biofilm formation within the endoscope channel it is critical that the scope channels be thor- oughly dried prior to storage. CAUTION: Care must be taken during handling to prevent contact with other objects and the distal end from swing- ing freely. -
Page 48: Endoscope Return Instructions
CAUTION: The pressure compensation cap (P/N 11025 E) must be in place on the vent port during shipment. Contact KARL STORZ Customer Support team at 800-421-0837 to obtain a Return Material Authorization (RMA). Returns will not be accepted by KARL STORZ without issuance of an RMA. -
Page 49: System Description
Technical Data System Description The Flexible CMOS Video-Cysto-Urethroscope from KARL STORZ has a 370 mm pellethane working shaft, 5.3 mm. in diameter and an instrument channel with 2.2 mm in diameter. The PEEK (polyetheretherketone) distal tip is 5.5 mm in diameter and houses the CMOS video module. The distal tip of the Flexible CMOS Video-Cysto-Urethroscope can be deflected 210°... - Page 50 Technical Data Power Supply 40150031 Line voltage: 100 – 240 VAC, 50/60 Hz Power consumption: 18 VA Output voltage: Power cord: Power cord adaptor for EU/UK/USA/AUS Water protection: IP41 Cable length: LED status display: Green: ready for use, line voltage available Dimensions AC adaptor: approx.
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Page 51: Maintenance
Maintenance Flexible CMOS Video-Cysto-Urethroscope 11272 VA/VUA (11272 V/VU) Direction of view: 0° Angle of view: 120° Deflection: up 210°, down 140° Working length: 37 cm Outside diameter: 5.3 mm Working channel: 2.2 mm Illumination: Integrated LED light source Electrical power consumption: 1 W... -
Page 52: Directive Compliance
KARL STORZ SE & Co. KG, a KARL STORZ subsidiary or your specialist dealer for information about your local col- lection point. Within the scope of application of this directive, KARL STORZ SE & Co. KG is responsible for the proper... -
Page 53: Troubleshooting
TFT screen is dark Defective camera electronics Send Flexible CMOS Video-Cysto-Urethroscope to KARL STORZ for repair TFT screen defective Send TFT screen to KARL STORZ for repair Color distortions White balance not carried out correctly Carry out new white balance TFT screen defective... -
Page 54: Accessories
Accessories 8401 YA, height 120 cm, star-foot roller stand with antistatic castors, crossbar 25 cm x diameter 25 mm for position- ing the monitor, including storage tray for laryngoscopes, measurements (w x d x h): 30 x 20 x 10 cm Crossbar 8401 YAB, for stands 8401 YA, 70 cm x diameter 25 mm, for positioning the monitor 8402 ZX Multifunctional clamp 8401 YB, with VESA 75 standard holder. -
Page 55: Electromagnetic Compatibility (Emc) Information For Karl Storz Npu System
Warning: The use of portable and mobile RF equipment may have an impact on this and other pieces of medical equipment. Warning: The use of accessories other than those specified in the KARL STORZ instruction manual may result in increased emissions or decreased immunity of the Flexible CMOS Video-Cysto-Urethroscope 11272 VA/VUA (11272 V/VU) in conjunction with monitor 8402 ZX. - Page 56 Table 201/Table 1 Guidance and manufacturer’s declaration—electromagnetic emissions The Flexible CMOS Video-Cysto-Urethroscope 11272 VA/VUA (11272 V/VU) in conjunction with monitor 8402 ZX is intended for use in the electromagnetic environment specified below. The customer or user of the system should ensure that it is used in such an environment.
- Page 57 Table 202/Table 2 Guidance and manufacturer’s declaration—electromagnetic immunity The Flexible CMOS Video-Cysto-Urethroscope 11272 VA/VUA (11272 V/VU) in conjunction with monitor 8402 ZX is intended for use in the electromagnetic environment specified below. The customer or user of the system should ensure that it is used in such an environment.
- Page 58 The Flexible CMOS Video-Cysto-Urethroscope 11272 VA/VUA (11272 V/VU) in conjunction with monitor 8402 ZX is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment.
- Page 59 Recommended separation distances between portable and mobile RF communications equipment and the Flexible CMOS Video-Cysto-Urethroscope 11272 VA/VUA (11272 V/VU) The Flexible CMOS Video-Cysto-Urethroscope 11272 VA/VUA (11272 V/VU) in conjunction with monitor 8402 ZX is intended for use in an electromagnetic environment specified below. The customer or user of the system should ensure that it is used in such an environment.
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Page 60: Shipping
(1) Customer name and number, as it appears on the invoice; (2) the telephone number and the person to contact; (3) the applicable P.O. number; (4) the KARL STORZ catalog number and, if applicable, the serial number for each product; and, (5) the reason for the return. KSEA reserves the right to refuse or return any products sent back to KSEA without prior authorization of its Customer Support Department. -
Page 61: Repair Program
Repairs, modifications or alterations of KARL STORZ products, performed by any person or entity, other than by KSEA or an authorized repair facility of KSEA, nullifies and otherwise voids all applicable KARL STORZ warranties. Repair or replacement of a KARL STORZ product shall not extend the term of any applicable warranty. -
Page 62: Limitation Of Liability
(lost profits), or from any other cause, whatsoever, in connection with or arising from the purchase, sale, lease, rental, installation or use of such KARL STORZ products, even if Customer has been advised of the possibility of such damages. SOME JURISDICTIONS DO NOT ALLOW EXCLUSIONS AND DISCLAIMERS OF CERTAIN WARRANTIES OR LIMITATIONS OF LIABILITY, SO THE LIMITATIONS AND/OR EXCLUSIONS, SET FORTH IN THESE TERMS AND CONDITIONS, MAY NOT APPLY. -
Page 63: Software Ownership And Licensing
(i) the purchase, lease or other acquisition of products does not constitute a transfer of the Software, (ii) the Software is the property of KARL STORZ or the applicable third party, (iii) Customer neither owns nor acquires any interest in any copyright, patent or other intellectual property right in or to the Software as a result of such pur-... - Page 64 Distributed by: KARL STORZ SE & Co. KG KARL STORZ KARL STORZ KARL STORZ Dr.-KARL-STORZ-Straße 34 Endoscopy-America, Inc. Canada, Ltd. Endoscopia Latino America 78532 Tuttlingen/Germany 2151 East Grand Avenue 7171 Millcreek Drive 815 N.W. 57th Avenue Postfach 230, 78503 Tuttlingen/Germany...