Storz 11302 BDX Instruction Manual
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Storz 11302 BDX Instruction Manual

Flexible intubation video endoscope, monitor
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Instruction
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Flexible Intubation Video Endoscope 11302 BDX
Monitor 8403 ZX

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Summary of Contents for Storz 11302 BDX

  • Page 1 Instruction Manual Flexible Intubation Video Endoscope 11302 BDX Monitor 8403 ZX...

  • 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 2002/96/EC on waste electrical and electronic equipment (WEEE). Device type BF Electronic information product pollution control (China RoHS) Manufacturer...

  • Page 4: Illustrated Description

    Illustrated Description 13242 XL Leakage Tester & Z11457 Pressure Compensation Cap 8401 YZ...

  • Page 5: Controls, Displays, Connectors And Their Uses

    Controls, Displays, Connectors And Their Uses Connecting cord and cable connector Suction valve 11301 CE1/11301 CD1 Connection for Leakage Tester (P/N 13242XL) or pressure compensation cap (vent port) Instrument channel port Shaft Handle Deflection lever Distal tip Leakage Tester (P/N 13242XL) Monitor/CCU Connection 2 Connection 1...

  • Page 6: Table Of Contents

    Contents Important information for users of KARL STORZ instruments Symbol description Illustrated description Controls, displays, connectors and their uses Safety instructions Indications for use User qualification Warnings and cautions Safety precautions when using the Flexible Intubation Video Endoscopes Installation and operating instructions...
  • Page 7 Contents Video recording Single image capture Inspecting the image quality Switching off the monitor Attaching the monitor to a holder System reset Monitor bag 8403 YD Cleaning and Sterilization/Disinfection Instructions General information Water quality requirements Cleaning equipment and accessories Bedside pre-cleaning Leakage test Manual cleaning Detergent cleaning...
  • Page 8 Contents Directive compliance Important information Disposal Troubleshooting Accessories Electromagnetic compatibility (EMC) information Shipping Return Policy Repair program Warranty policy Limitation of liability Software ownership and licensing...

  • Page 9: Safety Instructions

    User Qualification The KARL STORZ Flexible Intubation Video Endoscope may only be used by persons with an appropriate medical qualification and who are acquainted with the laryngoscopic technique. The information given in these instructions only serves to instruct in the correct handling and preparation of the Flexible Intubation Video Endoscope.

  • 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 Switch off the Intubation Videoscope before putting it down and do not place it in the proximity of the patient. Warning: Only KARL STORZ devices (monitor 8403 ZX) may be used. Disregarding this warning can endanger the patient and user.
  • Page 12 Safety Instructions • gas sterilization • shipping CAUTION: The cleaning cap 8401 YZ must be in place on the connecting cord and cable connector for: • Immersing in liquid, e.g. disinfectant solution CAUTION: Do not allow any electrically live components or instruments to come into contact with the Flexible Intubation Video Endoscope.

  • Page 13: Installation And Operating Instructions

    Warning: The Flexible Intubation Video Endoscope is delivered non-sterile, so it has to be disinfected/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 The set 11302 BDX comprises:...

  • Page 14: Operating Conditions

    Installation and Operating Instructions Operating Conditions Flexible Intubation Video Endoscope: Ambient temperature: 15° C–37° C (59° F–98.6° F) Humidity: 15%– 80% Monitor 8403 ZX: Ambient temperature: 0° C–37° C (32° F–98.6° 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 CISPR 11 Class B. External System Components Charger Using the medically approved charger (P/N 40150031), the Li-Ion battery of the monitor can be recharged extremely...
  • Page 15 Installation and Operating Instructions Press the button on the power supply unit to change the adaptor (figure 1). This releases the adaptor which can then be lifted out. When inserting a new adaptor, this must be placed in the guide (fig. 2) and pushed toward the cable until there is an audible click (fig.

  • Page 16: Handling

    Installation and Operating Instructions Handling The Flexible Intubation Video Endoscope must be used according to the medical rules and procedures recognized for the laryngoscopic methods. Note: Damage to the Flexible Intubation Video Endoscope resulting from incorrect operation is not covered by the manufacturer’s warranty.

  • Page 17: Installing The Suction Valve

    Installation and Operating Instructions Installing the suction valve (P/N 11301CE1) Place the suction valve insert onto the valve connection and turn it until the lateral projections on the insert are located above the recesses on the connection. Installing the Tube holder Push the tube holder onto the Flexible Intubation Video Endoscope starting at the distal end until it clicks into place.

  • Page 18: Handling The Deflection Mechanism

    Installation and Operating Instructions Handling the Deflection Mechanism Note: The neutral position of the distal end is straight. Warning:: The distal end of the Flexible Intubation Video Endoscope must be in the neutral position when inserted into the patient. 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.

  • Page 19: Handling The Working Channel

    Do not insert brushes through the channel when the distal end is in the neutral position. When connecting and operating light sources and suction/irrigation devices, pay attention to the instruction manuals for the particular devices. The irrigation devices recommended by KARL STORZ are set to a maximum pressure of 54 kPa (400 mmHg/0.54 bar/7.8 psi).

  • Page 20: Connection To The Monitor 8403 Zx

    Instructions Connection to the Monitor 8403 ZX The Flexible Intubation Video Endoscope can be used together with the KARL STORZ MONITOR 8403 ZX. Warning: It must be ensured that the electrically non-insulated parts of the Flexible Intubation Video Endoscope do not come into contact with conductive surfaces, or voltage-carrying elements of other units, at any time.

  • Page 21: Functions Of The Monitor 8403 Zx

    Installation and Operating Instructions Functions of the Monitor 8403 ZX ® A more detailed description of the functions can be found in the instruction manual for the monitor “C-MAC Monitor 8403 ZX” (P/N 96076008D). Focus The image focus is fixed. Manual adjustment is not necessary. The system is now ready for use.

  • Page 22: Function Buttons Of The Flexible Intubation Video Endoscope

    Installation and Operating Instructions Function Buttons of the Flexible Intubation Video Endoscope The Flexible Intubation Video Endoscope is equipped with 3 keys, which are used to activate the functions displayed as symbols on the Flexible Intubation Video Endoscope. The following functions are available: Video recording : Starts or stops the recording of a video stream on the SD memory card inserted in the receptacle...

  • Page 23: Preparation Prior To Use

    Installation and Operating Instructions Preparation Prior to Use Warning: Every time the Flexible Intubation Video Endoscope is used, you must first check that it, and any accessories used in combination with it, are in perfect condition. Damaged Flexible Intubation Video Endoscopes or damaged accessories must not be used.

  • Page 24: Inspecting The Surfaces

    Installation and Operating Instructions Inspecting the Surfaces Warning: The surface of the flexible sheath 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 distal tip of the Flexible Intubation Video Endoscope too tightly. Every time the Flexible Intubation Video Endoscope is used, you must first check that its surface, and above all the surface of the shaft and distal tip, is in perfect condition and that there are no sharp edges.

  • Page 25: Switching The Flexible Intubation Video Endoscope On/Off

    Installation and Operating Instructions Switching the Flexible Intubation Video Endoscope On/Off Switching on/off: The Flexible Intubation Video Endoscope with the integrated LED light source is switched on by pressing the power button on the monitor. Pressing the key a second time switches the unit off. Warning: Danger of glare: Do not look directly into the light beam emitted from distal tip of the Flexible Intubation Video Endoscope.

  • Page 26: Inspecting The Image Quality

    Installation and Operating Instructions Inspecting the Image Quality Check the image quality before using the Flexible Intubation Video Endoscope. 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 Intubation Video Endoscope from the patient’s body gently and carefully.

  • Page 27: Attaching The Monitor To A Holder

    Installation and Operating Instructions Attaching the Monitor to a Holder Press the holder together to allow the stand bar to be pushed through the openings. Release the holder in the desired position. The selected position is fixed by the holder’s basic tension. The optionally available clamp 8401 YB (see accessories) can similarly be secured to the VESA 75 holder and is used to attach the electronic module to rods with a diameter of less than 25 mm and/or to rails with a cross section of less than 25 mm.

  • Page 28: Cleaning And Sterilization/Disinfection 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 29: Water Quality Requirements

    Cleaning and Sterilization/Disinfection 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 30: Cleaning Equipment And Accessories

    Cleaning and Sterilization/Disinfection 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) Long Cleaning brush (P/N 11276 CL2/10) 60 cc Syringe Soft, lint-free cloth Lens cleaner or cotton tip applicator...

  • Page 31: Bedside Pre-Cleaning

    Cleaning and Sterilization/Disinfection Instructions Bedside Pre-cleaning (at point of use) Water Quality Recommendation: Utility water 1. 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 32: Leakage Test

    CAUTION: Check the KARL STORZ Leakage Tester (P/N 13242XL) for any damage prior to use. Damaged KARL STORZ Leakage Testers (P/N 13242XL) should not be used and should be returned to KARL STORZ for repair or replacement.
  • Page 33 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 13242XL) or if bubbles are discovered per the steps above, immediately remove the flexible endoscope from the water.

  • Page 34: 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 35 Cleaning and Sterilization/Disinfection Instructions 5. Plug the instrument port with the Luer plug (P/N 29100-BK). 6. Completely immerse the scope in the enzymatic cleaning solution. 7. While immersed, suction a minimum of 100 mL of cleaning solution through the channel using the 60 cc syringe attached to the rinse tube assembly (P/N 11301CDT).

  • Page 36: Water Rinsing

    Cleaning and Sterilization/Disinfection Instructions 16. Attach rinse tube assembly (P/N 11301CDT) to the cleaning adaptor (P/N 11301CD1) and attach the cleaning adaptor (P/N 11301CD1) to the suction port. Then, attach a 60 cc syringe to the rinse tube assembly (P/N 11301CDT).

  • Page 37: Drying

    Cleaning and Sterilization/Disinfection Instructions 6. Plug the instrument port with the Luer plug (P/N 29100-BK). 7. Draw a minimum of 50 mL of water into the syringe and flush back through the channel. 8. Remove the Luer plug (P/N 29100-BK) and attach a 60 cc syringe to the instrument port. 9.

  • Page 38: Sterilization

    Cleaning and Sterilization/Disinfection Instructions Sterilization Warning:: Before sterilization, the Flexible Intubation Video Endoscope must be thoroughly cleaned and all visible organic material, blood, and cleaning solution be completely removed. CAUTION: Flexible Intubation Video Endoscopes must not be steam sterilized (autoclaved) under any circumstances.

  • Page 39: Sterilization Methods

    Cleaning and Sterilization/Disinfection Instructions Sterilization Methods Ethylene Oxide (EtO) Sterilization 1. Remove the cleaning cap 8401 YZ on the video connecting cord before sterilization. 2. Place the red pressure compensation cap (P/N Z11457) on the vent port before EtO gas sterilization. 3.

  • Page 40: Sterrad Systems Sterilization

    Cleaning and Sterilization/Disinfection Instructions STERRAD Systems Sterilization CAUTION: STERRAD Sterilization may cause cosmetic changes to the Flexible Intubation Video Endoscope that do not necessarily impact the functionality of the device. CAUTION: Place the pressure compensation cap (P/N Z11457) on the vent port before STERRAD sterilization. CAUTION: The Flexible Intubation Video Endoscope must be fully DRIED before loading into the STERRAD sterilizer.

  • Page 41: Amsco V-Pro-Max Sterilization

    Cleaning and Sterilization/Disinfection Instructions Amsco V-PRO maX Sterilization CAUTION:: Place the pressure compensation cap (P/N Z11457) on the vent port before Amsco V-PRO maX sterilization. CAUTION: The Flexible Intubation Video Endoscope must be fully DRIED before loading into the V-PRO sterilizer. CAUTION: Only use FDA-cleared polypropylene sterilization wraps.

  • Page 42: Manual High-Level Disinfection

    Fill all working channels with the disinfection solution using a syringe. 3. Use the following KARL STORZ validated conditions to achieve high-level disinfection: a. CIDEX: Immerse for 45 minutes at 25° C (77° F) b.

  • Page 43: Automated High-Level Disinfection

    (<5 psi). Automated High-Level Disinfection KARL STORZ and Medivators have completed a validation of the flow properties of the Medivators Reprocessing Systems with the Flexible Intubation Video Endoscope. The scope is compatible with the following Medivators units...

  • Page 44: Storage

    5. For storage of endoscopes post manual or automated HLD or post-SS1E, a channel-purge storage cabinet is preferred. If a channel-purge storage cabinet is not available, hang the endoscope suspended in the appropriate KARL STORZ wall rack. Ensure it is absolutely dry before placing in storage (see Note above).

  • Page 45: Endoscope Return Instructions

    CAUTION: The pressure compensation cap (P/N Z11457) 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 46: System Description

    Technical Data System Description The Flexible Intubation Video Endoscope from KARL STORZ has a 650 mm pellethane working shaft, 4.1 mm in diameter and an instrument channel 1.5 mm in diameter. The PEEK (polyetheretherketone) distal tip is 4.00 mm in diameter and houses the CMOS video module.

  • Page 47: Maintenance

    Maintenance services can be obtained from your local KARL STORZ representative. Regardless of the accident prevention regulations or testing intervals for medical instruments prescribed in different countries, we recommend a functional or safety test of the unit at least once a year.

  • Page 48: Important Information

    STORZ GmbH & Co. KG, a KARL STORZ subsidiary or your specialist dealer for information about your local collection point. Within the scope of application of this directive, KARL STORZ GmbH & Co. KG is responsible for the proper disposal of this device.

  • Page 49: Troubleshooting

    Dirty lens. Withdraw Flexible Intubation Video Endoscope and clean distal lens with cotton tip applicator and alcohol. Lens water-damaged. Send Flexible Intubation Video Endoscope to KARL STORZ Inadequate lighting for repair. Light conducting fibers damaged. Send Flexible Intubation Video Endoscope to KARL STORZ Light does not function for repair.

  • Page 50: Accessories

    Accessories Stand, height 120 cm, star-foot roller stand with antistatic castors, 8401 YA crossbar 25 cm x diameter 25 mm for positioning the monitor, (US 9700GCX) 8401 YAA including storage tray for laryngoscopes, measurements (w x d x h): 30 x 20 x 10 cm Crossbar, for stands 8401 YA, 50 cm x diameter 25 mm, 8401 YAA for positioning the monitor 8403 ZX...
  • Page 51 Accessories Airway TROLL-E, rides on 4 antistatic dual wheels, 2 equipped 200220 85 with locking brakes, for mounting monitors with VESA 75/100 connection,integrated cable conduit in vertical beam and cable manager, load capacity for monitor: maximum 15kg. Dimensions mobile stand: 670 x 1660 x 670 mm (w x h x d), Caster diameter: 100 mm Trolley is delivered unassembled.

  • Page 52: Electromagnetic Compatibility (Emc) Information

    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 Intubation Video Endoscope 11302 BDX in conjunction with monitor 8403 ZX.
  • Page 53 Guidance and manufacturer’s declaration – electromagnetic emissions The Flexible Intubation Video Endoscope 11302 BDX in conjunction with monitor 8403 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 54 Guidance and manufacturer’s declaration–electromagnetic immunity The Flexible Intubation Video Endoscope 11302 BDX in conjunction with monitor 8403 ZX is intended for use in the electromagnetic environment speci fied below. The customer or user of the system should ensure that it is used in such an environment.
  • Page 55 Electromagnetic Compatibility (EMC) Information Table 204 /Table 4 Guidance and manufacturer’s declaration – electromagnetic immunity – for equipment and systems that are not life-supporting The Flexible Intubation Video Endoscope 11302 BNX in conjunction with monitor 8403 ZX is intended for use in the electromagnetic environment speci fied below.
  • Page 56 KARL STORZ Flexible Intubation Video Endoscope 11302 BDX in conjunction with monitor 8403 ZX The Flexible Intubation Video Endoscope 11302 BDX in conjunction with monitor 8403 ZX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 57: 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 58: 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 59: 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 60: 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...
  • Page 64 KARL STORZ GmbH & Co., KG KARL STORZ KARL STORZ KARL STORZ Mittlestraße 8, D-78532 Tuttlingen, Germany Endoscopy-America, Inc. Canada, Ltd. Endoscopia Latino America Postfach 230, D78503 Tuttlingen, Germany 2151 East Grand Avenue 7171 Millcreek Drive 815 N.W. 57th Ave.,...

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