Storz 11301 BNX Series Instruction Manual
Flexible intubation video endoscope
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- Instructions for use manual (28 pages) ,
- Instruction manual (82 pages)
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Summary of Contents for Storz 11301 BNX Series
- Page 1 Instruction Manual Flexible Intubation Video Endoscope Series 11301 BNX, Monitor 8403 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 Controls 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 Controls, Displays, Connectors and their uses Safety instructions Indications for use User qualification Warnings and cautions Safety precautions when using the Flexible Intubation Video Endoscope Handling... - Page 7 Contents Video recording Single image capture Inspecting the image quality Switching off the monitor System reset Monitor bag 8403 YD Cleaning and Sterilization/Disinfection instructions General information Water quality requirements Cleaning equipment and accessories Bedside pre-cleaning (at point of use) Leakage Test Manual cleaning Detergent cleaning Water rinsing...
- Page 8 Contents Important information Disposal Troubleshooting Accessories Electromagnetic compatibility information for KARL STORZ Flexible Intubation Video Endoscope 11301 BNX Monitor 8403 ZX Shipping Return Policy Repair Program Warranty Policy Limitation of liability Software ownership and licensing...
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Page 9: Safety Instructions
KARL STORZ. 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 Warning: Switch off the Flexible Intubation Video Endoscope before putting it down and do not place it in the proximity of the patient (as per IEC 60601-1-1). Warning: Only KARL STORZ devices (monitor 8403 ZX) may be used. Disregarding this warning can endanger the patient and user.
- Page 12 Safety Instructions CAUTION: To avoid damaging the monitor, do not remove the SD card or connecting cord while a video is recording. CAUTION: To avoid damaging the monitor, always switch it off before replacing the SD card.
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Page 13: Handling
Warning: The Flexible Intubation Video Endoscope is delivered unsterilized, 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 and Accessories The set 11301BNX-KT comprises: 11301 BNX Flexible Intubation Video Endoscope 5.5 x 65 mm... -
Page 14: Operating Conditions
Handling Operating Conditions Flexible intubation video endoscope: Ambient temperature: 15° C– 37° C (59° F– 98.6° F) Humidity: 15% – 80% relative humidity Monitor 8403 ZX: Ambient temperature: 15° C– 37° C (59° F– 98.6° F) Humidity: 15% – 80% relative humidity Electromagnetic Compatibility This device has been tested and is found to comply with the EMC limits of EN/IEC 60601-1-2 :2001 CISPR 11 Class B. -
Page 15: Installation And Operating Instructions
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. CAUTION: Do not store or reprocess the Flexible Intubation Video Endoscope together with sharp objects in order to avoid causing damage to the outer casing. -
Page 16: Holding Correctly
Installation and Operating Instructions Holding Correctly Grip the handle of the Flexible Intubation Video Endoscope in your left or right hand, as shown in the picture. With this kind of control grip, the Flexible Intubation Video Endoscope can be operated with one hand. Installing the Suction Valve Place the suction valve (P/N 11301CE1) onto the valve connection and turn it until the lateral projections on the... -
Page 17: Handling The Shaft
Installation and Operating Instructions Handling the Shaft CAUTION: Do not carry the Flexible Intubation Video Endoscope by the shaft. Do not pull, clamp or twist the shaft of the Flexible Intubation Video Endoscope. CAUTION: The shaft of the Flexible Intubation Video Endoscopes must never be kinked or coiled up too tightly. It is best to store the Flexible Intubation Video Endoscope in a suspended position or to keep it sterilized in a tray specifically designed for sterilizing and storage. -
Page 18: 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. An audible click is heard to indicate the distal tip is in neutral position. Warning: The distal tip of the Flexible Intubation Video Endoscope must be straight, not angled, when the Flexible Intubation Video Endoscope is inserted into the patient. -
Page 19: Handling The Working Channel
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: Inspecting The Suction Function
Installation and Operating Instructions Inspecting the Suction Function The suction function can be triggered by pressing the suction valve (P/N 11301CE1) (when the suction pump is connected and switched on). Note: The opening of the instrument channel should be sealed (P/N 29100-BK) to ensure that no secondary air is sucked in. -
Page 23: Inspecting The Surfaces
Installation and Operating Instructions Inspecting the Surfaces 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 sheath and distal tip, is in perfect condition and that there are no sharp edges. -
Page 24: 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 25: 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 26: System Reset
Installation and Operating Instructions System Reset If a system error occurs (unit no longer reacts, although connections and power supply are in order), a system reset has to be implemented. This is the equivalent of rebooting a computer. For this, a thin screwdriver or similar is inserted into the round opening next to the SD card holder and carefully pushed downward in order to activate the reset button... -
Page 27: 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 28: 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 29: 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) 60 cc Syringe Soft, lint-free cloth Lens cleaner or cotton tip applicator 70% Isopropyl alcohol Luer plug (P/N 29100-BK) -
Page 30: Bedside Pre-Cleaning (At Point Of Use)
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 31: Leakage Test
4. Ensure that both the flexible endoscope vent port and KARL STORZ Leakage Tester (P/N 13242XL) are completely dry before conducting the leak test. 5. Attach the KARL STORZ Leakage Tester (P/N 13242XL) or automated leak tester using the adaptor at the end of... - Page 32 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.
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Page 33: 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 34 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 a syringe attached to the rinse tube assembly (P/N 11301CDT).
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Page 35: Water Rinsing
Cleaning and Sterilization/Disinfection Instructions 19. Draw a minimum of 50 mL of cleaning solution into the syringe and flush back through the channel. 20. Keep the Flexible Videoscope immersed for the manufacturer’s recommended contact time (e.g. Enzol) immersion for a minimum of 1 minute). 21. -
Page 36: Drying
Cleaning and Sterilization/Disinfection Instructions 11. Draw air into the 60 cc syringe and attach to rinse tube assembly (P/N 11301CDT). Holding the distal end of the Flexible Videoscope out of the water, flush the 60 cc of air to expel all the water from the channel. 12. -
Page 37: Sterilization
CAUTION: Flexible intubation video endoscopes must not be steam sterilized (autoclaved) under any circumstances. CAUTION: KARL STORZ recommends the use of one cleaning agent and one sterilization method to prevent the unknown rate of material degradation due to material-chemical interactions from various cleaning and sterilization processes. -
Page 38: Sterilization Methods
Cleaning and Sterilization/Disinfection Instructions Sterilization Methods Ethylene Oxide (EtO) Sterilization 1. Remove the cleaning cap (P/N 8401 YZ) on the video connecting cord before sterilization. 2. Place the pressure compensation cap (P/N Z10455) on the vent port before EtO gas sterilization. 3. -
Page 39: Steris System 1E (Ss1E) Liquid Chemical Sterilant Processing System
Cleaning and Sterilization/Disinfection Instructions STERIS System 1E (SS1E) Liquid Chemical Sterilant Processing System CAUTION: Remove the pressure compensation cap (P/N Z11457) from the vent port prior to processing in the SS1E. 1. Place the Flexible Intubation Video Endoscope into the Universal Flexible Processing Tray C1160E / C1140E. 2. -
Page 40: Reference For Cleaning And Sterilization
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 41: 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 42: 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 43: Description Of The Unit
Description of the Unit System Description The Flexible Intubation Video Endoscope from KARL STORZ has a 650 mm pellethane working shaft, 5.4 mm in diameter and an instrument channel with 2.1 mm in diameter. The PEEK (polyetheretherketone) distal tip is 5.5 mm in diameter and houses the CMOS video module. -
Page 44: 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 45: Disposal
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 46: 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... -
Page 47: 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 48 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.
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Page 49: Monitor 8403 Zx
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 11301 BNX in conjunction with monitor 8403 ZX. - Page 50 Electromagnetic Compatibility (EMC) Information for KARL STORZ Flexible Intubation Video Endoscope 11301 BNX Monitor 8403 ZX Table 200 Accessories and cables which have been shown to comply with EN/IEC 60601-1-2: Cable type Shielded Length (m) Ferrite Used for Charger 40 1500 31 Charging the internal ®...
- Page 51 Electromagnetic Compatibility (EMC) Information for KARL STORZ Flexible Intubation Video Endoscope 11301 BNX Monitor 8403 ZX Table 202 Guidance and manufacturer’s declaration–electromagnetic immunity The Flexible Intubation Video Endoscope 11301 BNX in conjunction with monitor 8403 ZX is intended for use in the electromagnetic environment specified below.
- Page 52 Electromagnetic Compatibility (EMC) Information for KARL STORZ Flexible Intubation Video Endoscope 11301 BNX Monitor 8403 ZX Table 204 Guidance and manufacturer’s declaration – electromagnetic immunity – for equipment and systems that are not life-supporting The Flexible Intubation Video Endoscope 11301 BNX in conjunction with monitor 8403 ZX is intended for use in the electromagnetic environment specified below.
- Page 53 Table 206 Recommended separation distances between portable and mobile RF communications equipment and the KARL STORZ Flexible Intubation Video Endoscope 11301 BNX in conjunction with Monitor 8403 ZX The Flexible Intubation Video Endoscope 11301 BNX in conjunction with Monitor 8403 ZX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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Page 54: 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 55: 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 56: 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 57: 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 60 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.,...