Storz 11272 VN Instruction Manual
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Storz 11272 VN Instruction Manual

Flexible video-urethro-cystoscope
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Instruction
Manual
Flexible Video-Urethro-Cystoscope
11272 VN/VNU

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Summary of Contents for Storz 11272 VN

  • Page 1 Instruction Manual Flexible Video-Urethro-Cystoscope 11272 VN/VNU...

  • Page 2: Important Information For Users Of Karl Storz Instruments

    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.

  • Page 3: Table Of Contents

    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...
  • Page 4 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...

  • Page 5: Illustrated Description

    Illustrated Description ③ ④ ⑤ ⑥ ② ⑦ ⑨ ⑪ Leakage Tester ⑧ ① ⑩ ⑫ Pressure Compensation Cap...

  • Page 6: Controls, Displays, Connectors And Their Uses

    ⑨ Working channel with Luer lock connectors ⑩ Deflection lever ⑪ Leakage tester 13242 XL ⑫ 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˚...

  • Page 7: General Information For The Safe Use Of The Flexible Video-Urethro-Cystoscope

    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.

  • Page 8: Device Description

    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.

  • Page 9: Safety Precautions When Using The Flexible Video-Urethro-Cystoscope

    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 (appli- cation on heart) are used in combination with other BF application parts.
  • Page 10 • venting • shipping Warning: The “Cleaning, Sterilization and Care of KARL STORZ Instruments” section of this manual explains proce- dures 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.
  • Page 11 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 dam- age 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.

  • Page 12: 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:...

  • Page 13: Handling Instructions

    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.

  • Page 14: Directions For Use

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

  • Page 15: Handling The Accessories

    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.

  • Page 16: Compatible Camera Control Units/Light Sources

    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...

  • Page 17: Connection To The Tele Pack

    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.

  • Page 18: Connection To The Light Source

    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.

  • Page 19: Connection To The Camera Control Unit Telecam ® Dx Ii/Sl Ii

    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.

  • Page 20: Connection To The Camera Control Unit Image 1 And Image 1 Hub

    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.

  • Page 21: Inspecting The Surfaces

    Directions for Use Inspecting the Surfaces Warning: The surface of the flexible shaft must be inspected visually and by carefully feeling it, to detect any cracks, cuts, dents, foreign bodies or other forms of damage. CAUTION: Do not squeeze the shaft or the distal tip of the Flexible Video-Urethro-Cystoscope too tightly. Every time the Flexible Video-Urethro-Cystoscope is used, you must first check that its surface, particularly the sur- face of the sheath and distal tip, is in perfect condition and that there are no sharp edges.

  • Page 22: Checking The Deflection

    Directions for Use Checking the Deflection 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! Warning: Before use, always check that the deflection lever and the distal tip move in conjunction with each other.

  • Page 23: Inspecting The Light Source

    Directions for Use Inspecting the Light Source Prepare the light source or Tele Pack and connect to the Flexible Video-Urethro-Cystoscope. Emission of light at ™ the distal end of the Flexible Video-Urethro-Cystoscope should be recognizable. The light intensity can be adjusted manually via the light source.

  • Page 24: Inspecting The Instruments And The Instrument Channel

    Directions for Use Inspecting the Instruments and the Instrument Channel CAUTION: All accessories should easily pass, without any hindrance, through the entire channel. CAUTION: Accessories that are bent or twisted may be difficult to pass and must be replaced. Damaged accesso- ries may cause serious damage to the channel.

  • Page 25: Cleaning And Sterilization Instructions

    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 26: 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 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 27: 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 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 28: Bedside Pre-Cleaning

    Cleaning and Sterilization Instructions Bedside Pre-cleaning (at point-of-use) Water Quality Recommendation: Utility water Prior to pre-cleaning, turn off the light source and detach the flexible endoscope. Wipe the entire exterior of the flexible endoscope with a soft, lint-free, cloth, moistened with water, or a diluted mild/neutral pH enzymatic clean- ing solution (e.g.

  • Page 29: Leakage Testing

    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 30 Attach the KARL STORZ Leakage Tester (P/N 13242 XL) or automated leak tester using the adaptor at the end of the tubing to the flexible endoscope’s vent port using a clockwise push and turn motion until it stops.
  • Page 31 Cleaning and Sterilization Instructions 12. 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.

  • Page 32: Cleaning And Sterilization Instructions

    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 33 Cleaning and Sterilization Instructions While immersed, ensure one Luer is plugged and use a syringe attached to the other Luer to suction up a mini- mum 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.

  • Page 34: Water Rinsing

    Cleaning and Sterilization Instructions 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 35: Drying

    Cleaning and Sterilization Instructions Drying Remove the flexible videoscope from the water and dry the exterior with a fresh soft, lint-free cloth. Discard all disposable cleaning accessories. Inspection Visually inspect the flexible videoscope for cleanliness and dryness. Open the video protective cap and visually inspect the video connector for cleanliness and dryness.

  • Page 36: Sterilization

    • immersing in liquid/cleaning solution. Warning: The pressure compensation cap (P/N 11025E) must be in place on the vent port for: • plasma sterilization • venting • shipping KARL STORZ recommends to sterilize the Flexible Video-Uretero-Cystoscope via STERIS Amsco V-PRO maX Sterilization System.

  • Page 37: Sterilization Methods

    Cleaning and Sterilization Instructions Sterilization Methods STERIS Amsco V-PRO maX Sterilization CAUTION: Place the pressure compensation cap (P/N 11025E) on the vent port before STERIS Amsco V-PRO maX sterilization. CAUTION:The Flexible Video-Urethro-Cystoscope must be fully DRIED before loading into the V-PRO sterilizer. CAUTION: Only use FDA-cleared polypropylene sterilization wraps.

  • Page 38: References For Cleaning And Sterilization

    References for Cleaning and Sterilization References for Cleaning and Sterilization The Difficulty of Reprocessing Reusable Rigid Laparoscopic Forceps and Other Endoscopic Accessories: Are Disposables the Answer? Health Devices, Vol. 23, Nos. 1 – 2, pp. 57– 58, 1994. Descoteaux, J-G, Poulin, E.C., Julein, M. And Guidoin, R. Residual Organic Debris on Processed Surgical Instruments.

  • Page 39: 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 40: Endoscope Return Instructions

    CAUTION: The pressure compensation cap (P/N 11025E) 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 41: Maintenance

    We reserve the right to return contaminated instruments/equipment to the sender. Repairs, changes or expansions which are not carried out by KARL STORZ or by experts authorized by KARL STORZ will invalidate all warranty rights.

  • Page 42: Troubleshooting

    Withdraw Flexible Video-Urethro- Cystoscope and clean distal lens with cotton tip applicator and alcohol. Lens water-damaged Send Flexible Video-Urethro- Cystoscope to KARL STORZ for repair. Inadequate lighting Light not connected Switch on the light and select desired light intensity. Send Flexible Video-Urethro-...

  • Page 43: Accessories

    Accessories Additional Accessories Cat. no. Item Z09219 Carrying case 27023 FE Grasping forceps for small fragments 27023 ZE Biopsy forceps 13242 XL Leak tester 27652/3 Flat cleaning brush 9990/50 Short cleaning brush 110910-50 Long cleaning brush 29100-BK Luer plug 11025E Pressure compensation cap 22200077 Cable, Image 1 video endoscope adaptor, NTSC...

  • Page 44: 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 45: 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 46: 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 47: 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 48 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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