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Related Manuals for Storz 11272 VH-TL
Summary of Contents for Storz 11272 VH-TL
- Page 1 Instruction Manual Flexible HD Cysto-Urethroscope 11272 VH-TL/VHU-TL...
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Page 2: Important Information For Users Of Karl Storz Instruments
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. -
Page 3: Table Of Contents
Contents Important information for users of KARL STORZ instruments________________________________________________ 2 Illustrated description __________________________________________________________________________________ 5 General information for the safe use of the Flexible HD Cysto-Urethroscope___________________________________ 6 Specifications ________________________________________________________________________________________ 6 Operating conditions __________________________________________________________________________________ 7 Equipment classification _______________________________________________________________________________ 7 User qualification _____________________________________________________________________________________ 8... - Page 4 Contents Inspecting the instruments and the working channel ______________________________________________________ 19 Cleaning and sterilization instructions ___________________________________________________________________ 20 General information __________________________________________________________________________________ 20 Water quality requirements ____________________________________________________________________________ 21 Cleaning equipment and accessories ___________________________________________________________________ 22 Bedside pre-cleaning (at point of use) ___________________________________________________________________ 22 Leakage testing ______________________________________________________________________________________ 23 Manual cleaning _____________________________________________________________________________________ 25 Detergent cleaning ___________________________________________________________________________________ 25 Water rinsing ________________________________________________________________________________________ 27...
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Page 5: Illustrated Description
Illustrated Description ① ② ② ④ ③ ③ ⑦ ⑨ ⑤ ⑧ ⑩ ⑥ ⑫ ⑪ 13242 XL leakage tester 11025 E pressure compensation cap... -
Page 6: General Information For The Safe Use Of The Flexible Hd Cysto-Urethroscope
Default setting = Zoom ⑩ Select button Default setting = Menu ⑪ Leakage tester ⑫ Pressure compensation cap Specifications: 11272 VH-TL/VHU-TL Direction of view: 0° Field of view: 100° Depth of field: 3–50 mm Tip deflection: 210° up 140° down Working shaft diameter: 5.5 mm... -
Page 7: Operating Conditions
General Information for the Safe Use of the Flexible HD Cysto-Urethroscope Operating Conditions Ambient temperature: 15° — 30° C (59° — 86° F) Humidity: 15% — 80% Equipment Classification Type of protection against moisture: Ordinary Degree of protection against electric shocks: CF-type Mode of operation: Continuous Equipment test certificates: Equipment is certified and manufactured in accordance with IEC 60601-1 (3rd Edition), IEC 60601-2-18 (2nd Edition),... -
Page 8: User Qualification
General Information for the Safe Use of the Flexible HD Cysto-Urethroscope User Qualification The KARL STORZ Flexible HD Cysto-Urethroscope may only be used by persons with an appropriate medical quali- fication and who are acquainted with the technique of flexible cystoscopy. The information given in these instructions only serves to instruct in the correct handling and preparation of the Flexible HD Cysto-Urethroscope. -
Page 9: Device Description
Device Description The KARL STORZ Flexible HD Cysto-Urethroscope has a working length of 37 cm with an outer diameter of 5.5 mm. The shaft consists of a working channel 2.33 mm in diameter that can be used for insertion of various flexible instru- ments. -
Page 10: Safety Precautions When Using The Flexible Hd Cysto-Urethroscope
General Information for the Safe Use of the Flexible HD Cysto-Urethroscope Safety Precautions When Using the Flexible HD Cysto-Urethroscope The Flexible HD Cysto-Urethroscope must be used according to the recognized medical rules and procedures of endoscopy. Note: The patient leakage current limit of the CF-applied parts may be exceeded if CF-applied parts (application on heart) are used in combination with other BF-applied parts. - Page 11 Warning: The Flexible HD 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 HD Cysto-Urethroscope that are repaired by unauthorized personnel.
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Page 12: Unpacking The Device
CAUTION: Never lay heavy objects on the Flexible HD Cysto-Urethroscope. Unpacking the Device Check for missing items and evidence of shipping damage. File any complaints immediately with KARL STORZ or the supplier. Basic Equipment Flexible HD Cysto-Urethroscope 11272 VH-TL/VHU-TL with the following accessories:... -
Page 13: Handling Instructions
Handling Instructions Handling Note: Damage to the Flexible HD Cysto-Urethroscope resulting from incorrect operation is not covered by the manu- facturer’s warranty. Operating The following instructions outline the correct operation of the Flexible HD Cysto-Urethroscope and the corresponding accessories. Suitable accessories for your Flexible HD Cysto-Urethroscope, such as biopsy forceps, can be found in the general surgery catalog or extracts from this catalog. -
Page 14: Directions For Use
Before use, the user must always have full control over the deflection and must develop a sure feel for the deflection mechanism and in particular for the neutral position. Deflection functions as follows with the type 11272 VH-TL endoscope: • If the lever is pushed upwards, the tip is lowered. -
Page 15: Handling The Accessories
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 HD Cysto-Urethroscope. CAUTION: Only use flexible accessories (forceps, cleaning brushes, etc.) from KARL STORZ. Accessories from other manufacturers may damage the Flexible HD Cysto-Urethroscope. -
Page 16: Compatible Camera Control Units
Integrated LED in the Flexible HD Cysto-Urethroscope Warning: The KARL STORZ Flexible HD Cysto-Urethroscope should not be used in combination with CCUs from other manufacturers. The use of non-compatible units may cause injury to the patient or damage to the instrument. -
Page 17: Control Buttons
Directions for Use Install the CCU on a firm, level surface. Plug the power cord into the specified power socket. Plug the Flexible HD Cysto-Urethroscope supply cable into the HD socket of the CCU. Turn on the CCU to power up the endoscope imager and the integrated light source. Control Buttons ⑨... -
Page 18: Inspection Prior To Use
Directions for Use Inspection Prior to Use Warning: Every time the Flexible HD Cysto-Urethroscope is used, it, and any accessories used in combination, must be inspected to ensure that they are in perfect condition. A damaged Flexible HD Cysto-Urethroscope or damaged accessories must not be used. -
Page 19: Inspecting The Led Function
Directions for Use Inspecting the LED Function CAUTION: The CCU must be switched off before connecting the Flexible HD Cysto-Urethroscope. Prepare the IMAGE1 S CCU as described above and connect to the Flexible HD Cysto-Urethroscope. Emission of light at the distal end should be recognizable. Light intensity is automatically regulated by the CCU. Verify that the scope will focus on objects at 3 mm and 50 mm away by pointing the Flexible HD Cysto-Urethroscope at a nearby object (3 mm from the distal tip) and verify that the image on the monitor is a clear, high-quality image. -
Page 20: Cleaning And Sterilization Instructions
Soft, lint-free cloths and/or sponges along with ONLY the correct KARL STORZ cleaning brushes should be used to clean the flexible endoscope. CAUTION: To prevent biofilm formation, it is critical that the flexible endoscope be thoroughly dried prior to storage. -
Page 21: Water Quality Requirements
Cleaning and Sterilization Instructions Water Quality Requirements CAUTION: A flexible endoscope 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 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 Syringe Lint-free cloth Luer plug (e.g. 29100) Pressure compensation cap 11025 E Leakage tester 13242 XL Flat cleaning brush 27652/3 Short cleaning brush 9990/50 Long cleaning brush for working channel 110910-50 Lens cleaner or cotton tip applicator 70% Isopropyl alcohol... -
Page 23: Leakage Testing
KARL STORZ Leakage Testers should not be used and should be returned to KARL STORZ for repair or replacement. CAUTION: The KARL STORZ Leakage Tester should be disinfected prior to use by wiping it down with a 70% isopro- pyl alcohol wipe. - Page 24 Cleaning and Sterilization Instructions Warning: If the pressure cannot be maintained at 160 mmHg, do not continue with reprocessing. Refer to “Endoscope Return Instructions” for return instructions. Warning: Do not perform a wet leak test in water containing detergent as bubble observation is difficult to perform with detergent present.
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Page 25: Manual Cleaning
CAUTION: Inserting a brush of incorrect size or forceful insertion can damage the flexible endoscope and/or working channel. CAUTION: Only use cleaning accessories from or approved by KARL STORZ. Note: Complete cleaning of the patient-used flexible endoscope should be started within two hours of the bedside pre-cleaning. - Page 26 Cleaning and Sterilization Instructions CAUTION: Do not discard in the basin the flexible endoscope is being cleaned in. Repeat with the opposite luer port. While immersed, use a soft, lint-free cloth to clean the exterior of the entire flexible endoscope. A minimum of one complete wipe of the entire exterior of the flexible endoscope should be performed.
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Page 27: Water Rinsing
Cleaning and Sterilization Instructions Water Rinsing Note: A total of three rinses are required. Water Quality Recommendation: Utility or critical water Fill a sink or basin with enough water to completely immerse the flexible endoscope and luer plug (P/N 29100). Completely immerse the flexible endoscope and luer plug (P/N 29100) in the water. -
Page 28: Inspection
(e.g. EN 868 Parts 2-10, EN ISO 11607 Parts 1 + 2, DIN 58953, AAMI ST77) and is compatible with your sterilization systems. Warning: Use one of the KARL STORZ recommended and validated sterilization methods below. For complete instructions on the proper use of the sterilizer, consult the sterilizer’s manufacturer’s instructions. -
Page 29: Sterrad ® Sterilization
Cleaning and Sterilization Instructions STERRAD Sterilization ® CAUTION: STERRAD ® sterilization may cause cosmetic changes to the flexible endoscope that do not necessarily impact the functionality of the device. CAUTION: Place the pressure compensation cap on the vent port before STERRAD sterilization. -
Page 30: V-Pro ® Max/60 Sterilization
Cleaning and Sterilization Instructions V-PRO maX/60 Sterilization ® CAUTION: Place the pressure compensation cap on the vent port before V-PRO ® sterilization. CAUTION: The flexible endoscope must be fully dried before loading into the V-PRO sterilizer. ® CAUTION: Only use FDA-cleared polypropylene sterilization wraps. Do not use sterilization wraps containing wood pulp or cotton. -
Page 31: Storage
Storage Storage CAUTION: To prevent biofilm formation within the flexible endoscope channel, it is critical that the flexible endoscope 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 swing- ing freely. -
Page 32: Endoscope Return Instructions
CAUTION: The pressure compensation cap must be in place on the vent port during shipment for service. 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: Troubleshooting
Solution: Press any head button to return to normal operation. Possible Reason: LED in the distal tip of the Flexible HD Cysto-Urethroscope or supply cable is damaged. Solution: Send the Flexible HD Cysto-Urethroscope to KARL STORZ for repair. Light Does Not Function Possible Reason: CCU is not connected 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; (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 35: 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 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 the customer has been advised of the pos- sibility 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 37: 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) the customer neither owns nor acquires any interest in any copyright, patent or other intellectual property right in or to the Software as a... -
Page 38: Electromagnetic Compatibility
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external anten- nas) should be used no closer than 30 cm (12 inches) to any part of the flexible cystoscope HD VIEW 11272 VH-TL/ VHU-TL together with the IMAGE1 S ™... - Page 39 Electromagnetic Compatibility Table 1 Guidelines and manufacturer’s declaration – electromagnetic immunity The flexible cystoscope HD VIEW 11272VH-TL/VHU-TL together with the IMAGE1S™ is intended for use in an electromagnetic environment specified below. Theuser of the flexible cystoscope HD VIEW 11272VH-TL/VHU-TL together with the IMAGE1 S™ should make sure that it is used in such an environment.
- Page 40 Electromagnetic Compatibility Table 2 Test levels for Proximity fields from RF wireless communications equipment Immunity Compliance level Test Frequency Band Service Modulation Test Level V/m 380 – 390 TETRA 400 Pulse modulation 18 Hz GMRS 460 FM ± 5 kHz deviation 430 –...
- Page 41 Electromagnetic Compatibility Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity – for equipment and systems that are not life-supporting The flexible cystoscope HD VIEW 11272VH-TL/VHU-TL together with the IMAGE1S™ is designed for operation in an electromagnetic environment as defined below. The user of the device should make sure that it is used in such an environment. Interference immunity EN/IEC 60601 test Conformity level...
- Page 42 Electromagnetic Compatibility Table 4 Guidelines and manufacturer’s declaration – electromagnetic emissions The flexible cystoscope HD VIEW 11272VH-TL/VHU-TL together with the IMAGE1 S™ is intended for use in the electromagnetic environment specified below. The customer or user of the flexible cystoscope HD VIEW 11272VH-TL/VHU-TL together with the IMAGE1 S™ should ensure that it is used in such an environment.
- Page 44 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...