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Related Manuals for Storz FLEX-XC Series
Summary of Contents for Storz FLEX-XC Series
- Page 1 Instruction Manual Flexible Video-Uretero-Renoscope FLEX-XC series 11278 VU/VSU...
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Page 3: 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 mod- ern, high-quality piece of equipment from KARL STORZ. -
Page 4: Table Of Contents
Contents Important information for users of KARL STORZ instruments ___________________________________________________________________ Illustrated description ______________________________________________________________________________________________________________ General information for the safe use of the Flexible Video-Uretero-Renoscope ________________________________________________ Specifications _________________________________________________________________________________________________________________ Operating conditions _________________________________________________________________________________________________________ Equipment classification ______________________________________________________________________________________________________ User qualification _____________________________________________________________________________________________________________ Warnings and cautions _______________________________________________________________________________________________________ Definitions _____________________________________________________________________________________________________________________... - Page 5 Contents Cleaning and sterilization instructions ___________________________________________________________________________________________ General information __________________________________________________________________________________ 19 Water quality requirements _________________________________________________________________________________________________ Cleaning equipment and accessories _____________________________________________________________________________________ Bedside pre-cleaning (at point of use) _____________________________________________________________________________________ Leakage test ________________________________________________________________________________________________________________ Manual cleaning ____________________________________________________________________________________________________________ Detergent cleaning __________________________________________________________________________________ 24 Water rinsing _______________________________________________________________________________________ 25 Drying ____________________________________________________________________________________________ 26 Inspection __________________________________________________________________________________________ 26 Sterilization _________________________________________________________________________________________ 26...
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Page 6: Illustrated Description
Illustrated Description ⑤ ④ ⑦ ③ ⑨ ② Leakage Tester ⑥ ⑧ ⑩ ① Pressure Compen sation Cap... -
Page 7: General Information For The Safe Use Of The Flexible Video-Uretero-Renoscope
General Information for the Safe Use of the Flexible Video-Uretero-Renoscope ① Control Buttons ② Supply Connector ③ Connection for Leakage Tester or Pressure Compensation Cap ④ Distal Tip ⑤ Shaft ⑥ Handpiece ⑦ Working Channel with Luer Lock Connectors ⑧ Deflection Lever ⑨... -
Page 8: User Qualification
This instrument has been tested and complies with the EMC limits as per EN/IEC 60601-1-2: 2007 CISPR 11 Class A. User Qualification The KARL STORZ Flexible Video-Uretero-Renoscopes may only be used by persons with an appropriate medical qualifi- cation and who are acquainted with the technique of uretero-renoscopy. The information given in these instructions only serves to instruct in the correct handling and preparation of the Flexible Video-Uretero-Renoscope. -
Page 9: Device Description
Device Description The KARL STORZ Flexible Video-Uretero-Renoscope has a working length of 675 mm with an outer diameter of 2.9 mm. The shaft consists of a working channel, 1.2 mm in diameter, that can be used for insertion of various flexible instruments. -
Page 10: Warnings And Cautions
CAUTION: The pressure compensation cap must be in place on the vent port for: • plasma sterilization • shipping Warning: Always unplug the Flexible Video-Uretero-Renoscope before carrying out any maintenance and/or cleaning. Warning: The Flexible Video-Uretero-Renoscope may only be repaired by personnel authorized by KARL STORZ. -
Page 11: Unpacking The Device
General Information for the Safe Use of the Flexible Video-Uretero-Renoscope Unauthorized repairs may impair functioning and safety, and are therefore strictly forbidden. KARL STORZ gives no warran- ty for Flexible Video-Uretero-Renoscope that are repaired by unauthorized personnel. Warning: If a malfunction should occur during application on a patient, stop the application immediately. Place the distal tip of the videoscope in the neutral, nondeflected position and remove the video endoscope slowly and carefully from the patient. -
Page 12: Handling Instructions
Handling Instructions Handling Note: Damage to the Flexible Video-Uretero-Renoscope resulting from incorrect operation is not covered by the manufac- turer’s warranty. Operating The following instructions outline the correct operation of the Flexible Video-Uretero-Renoscope and the corresponding accessories. Suitable accessories for your Flexible Video-Uretero-Renoscope, such as biopsy forceps, can be found in the UROLOGY catalog or excerpts from this manual. -
Page 13: Handling The Deflection Mechanism
Handling Instructions Handling the Deflection Mechanism Note: The neutral position of the distal tip is straight, without any deflection. Warning: Accessories must only be inserted into the instrument channel of the Flexible Video-Uretero-Renoscope with the distal tip in the neutral, non-deflected position. The deflection lever must never be operated with force or abruptly to avoid injuring the patient or damaging the device. -
Page 14: Handling The Accessories
Handling Instructions Handling the Accessories CAUTION: Only use flexible accessories (forceps, cleaning brushes etc.) from KARL STORZ. Accessories from other man- ufacturers may damage the Flexible Video-Uretero-Renoscope. CAUTION: Only introduce the instruments into the proximal port of the Flexible Video-Uretero-Renoscope. Warning: When HF electrodes or laser probes are used, it must be ensured that power is not applied until the active parts have emerged from the instrument channel and are in the user’s field of view, and the site of the operation is clearly... -
Page 15: Directions For Use
22201015-104, 22201015-110 or 22201015-112 Warning: The KARL STORZ Flexible Video-Uretero-Renoscope should not be used in combination with Camera Control Units from other manufacturers. The use of non-compatible units may cause injury to the patient or damage to the instru- ment. It must be ensured that parts of the endoscope that are not electrically insulated do not come into contact with con- ductive surfaces or electrically live parts of other units, at any time. -
Page 16: Control Buttons
Directions for Use Install the Camera Control Unit on a firm, level surface. Plug the power cord into the specified power socket. Plug the Flexible Video-Uretero-Renoscope supply cable into the HD socket of the Camera Control Unit. Turn on the CCU to power up the endoscope imager and the integrated light source. IMAGE 1 HD HUB CCU IMAGE 1S Control Buttons... -
Page 17: Inspection Prior To Use
Directions for Use Inspection Prior to Use Warning: Every time the Flexible Video-Uretero-Renoscope is used, it, and any accessories used in combination, must be inspected to ensure that they are in perfect condition. A damaged Flexible Video-Uretero-Renoscope or damaged accesso- ries must not be used. -
Page 18: Checking The Deflection
Directions for Use Inspect the supply cable for damage (cut, dents, scratches, etc.) and the supply connector for loose connections. Checking the Deflection Warning: Actuate the deflection lever gently and carefully as far as the limit stop. The deflection lever must never be oper- ated with force or abruptly, to avoid injuring the patient or damaging the device! Warning: Before use, always check that the deflection lever and the distal tip connected to it function correctly. -
Page 19: Inspecting The Led Function
Directions for Use Inspecting the LED Function Prepare the IMAGE 1 HD CCU or IMAGE 1 S CCU as described above and connect to the Flexible Video-Uretero- Renoscope. Emission of light at the distal end should be recognizable. Light intensity is automatically regulated by the cam- era control unit. -
Page 20: Cleaning And Sterilization Instructions
CAUTION: The Flexible Endoscope must be protected from objects that could cause damage to the device such as wire bristle brushes, sharp objects etc. 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. -
Page 21: Water Quality Requirements
Cleaning and Sterilization Instructions Water Quality Requirements CAUTION: Flexible Endoscopes must never be immersed in normal saline solution, as even brief contact can result in pit- ting 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 22: Cleaning Equipment And Accessories
Cleaning and Sterilization Instructions 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 11276CL2/10) 60 cc Syringe Soft, Lint-Free Cloth Lens Cleaner or Cotton Tip Applicator 70% Isopropyl Alcohol Luer Plug (P/N 29100-BK) -
Page 23: Leakage Test
Endoscopes must not be used in medical procedures as they pose a patient safety risk. If a Flexible Endoscope is leaking, it should be sent to KARL STORZ for repair or replacement (see Flexible Endoscope Return Instructions). The use of unau- thorized repair facilities voids the product warranty and recommended reprocessing methods from KARL STORZ. - Page 24 Observe for a formation of bubbles on the exterior of the Flexible Endoscope or a stream of air bubbles. 10. If the Flexible Endoscope has a leak as determined by a fall in pressure as seen on the KARL STORZ Leakage Tester (P/N 13242XL) or if bubbles are discovered per the steps above, immediately remove the Flexible Endoscope from the water.
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Page 25: 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. ... -
Page 26: Water Rinsing
Cleaning and Sterilization Instructions 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. Repeat steps 5 and 6 with opposite Luer. While immersed, use a soft, lint-free cloth to clean the exterior of the entire Flexible Videoscope. A minimum of one complete wipe of the entire exterior of the Flexible Videoscope should be performed. -
Page 27: Drying
Warning: Follow the cleaning instructions in this manual to thoroughly clean the Flexible Video-Uretero-Renoscope prior to sterilization. KARL STORZ recommends to sterilize the Flexible Video-Uretero-Renoscope via the STERRAD NX and 100NX Sterilization systems, or the STERIS System 1E Liquid Chemical Sterilant Processing System. -
Page 28: Sterrad ® Sterilization
Cleaning and Sterilization Instructions STERRAD Sterilization ® CAUTION: STERRAD Sterilization may cause cosmetic changes to the Flexible Video-Uretero-Renoscope that do not necessarily impact the functionality of the device. CAUTION: Place the Pressure Compensation Cap on the vent port before STERRAD sterilization. CAUTION: The Flexible Video-Uretero-Renoscope must be fully DRIED before loading into the STERRAD sterilizer. -
Page 29: Amsco V-Pro Max Sterilization
Cleaning and Sterilization Instructions Amsco V-PRO maX Sterilization CAUTION: Place the Pressure Compensation Cap on the vent port before Amsco V-PRO maX sterilization. CAUTION: The Flexible Video-Uretero-Renoscope must be fully DRIED before loading into the V-PRO sterilizer. CAUTION: Use only FDA-cleared polypropylene sterilization wraps. Do not use paper pouches or sterilization wraps con- taining wood pulp or cotton. -
Page 30: 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 31: Storage
Storage Storage CAUTION: To prevent biofilm formation within the endoscope channel it is critical that the scope channels be thoroughly dried prior to storage. CAUTION: Care must be taken during handling to prevent contact with other objects and the distal end from swinging freely. -
Page 32: Endoscope Return Instructions
CAUTION: The Pressure Compensation Cap 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 33: Appendix
Possible Reason: Dirty lens. Solution: Disconnect Flexible Video-Uretero-Renoscope and clean distal lens with cotton tip applicator and alcohol. Possible Reason: Lens water-damaged. Solution: Send Flexible Video-Uretero-Renoscope to KARL STORZ for repair. Inadequate Lighting Possible Reason: CCU not connected. Solution: Connect CCU to power. -
Page 34: 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. -
Page 35: Repair Program
Except as otherwise provided herein and/or by the applicable warranty information for a specific product or type of product, all KARL STORZ-branded products are generally warranted to be in good working order at the date of delivery and free from defects in workmanship and materials for one (1) year from date of delivery. However, since some products carry a shorter or a longer warranty period, Customer should check with KSEA’s Customer Support Department or product spe-... -
Page 36: 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. -
Page 37: Software Ownership And Licensing
(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 purchase, lease or other acquisition of products, (iv) KARL STORZ, or the applicable... - Page 40 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...
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Questions and answers
Can the flex xc be sterilized with hydrogen peroxide
Yes, the Storz FLEX-XC Series can be sterilized using hydrogen peroxide in a STERRAD sterilizer. The instructions mention using the ‘FLEX’ or ‘DUO’ cycle for the 100NX system, the “Advanced” cycle for the NX system, and the “Long” cycle with boosters for the 100S system. The process involves double-wrapping the sterilization tray with FDA-cleared polypropylene wrap and ensuring proper placement in the sterilizer.
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