Storz 11302 BDX Instruction Manual Download Page 3

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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)

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Summary of Contents for 11302 BDX

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

Page 2: ...sented and explained We thus ask that you read this manual carefully before proceeding to work with the instrument Keep this manual available for ready reference Warning KARL STORZ instruments are pro...

Page 3: ...e 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...

Page 4: ...Illustrated Description 4 13242 XL Leakage Tester 8401 YZ Z11457 Pressure Compensation Cap l 2 2 2 g f a 2 2 d s h j k 2 o i u w e t y r q 2 2 2...

Page 5: ...Leakage Tester P N 13242XL a Monitor CCU s Connection 2 d Connection 1 f Mains connection g Reset button h Holder for SD memory card j Status bar k Pilot lamp l On Off switch Pilot lamp charging oran...

Page 6: ...tic compatibility 14 External system components 14 Handling 16 Operating 16 Holding correctly 16 Installing the suction valve 17 Installing the tube holder 17 Handling the shaft 17 Handling the deflec...

Page 7: ...Manual cleaning 34 Detergent cleaning 34 Water rinsing 36 Drying 37 Inspection 37 Sterilization 38 Sterilization methods 39 Ethylene oxide EtO sterilization 39 STERRAD Systems sterilization 40 Amsco...

Page 8: ...ion 48 Disposal 48 Troubleshooting 49 Accessories 50 Electromagnetic compatibility EMC information 52 Shipping 57 Return Policy 57 Repair program 58 Warranty policy 58 Limitation of liability 59 Softw...

Page 9: ...ation of a patient s upper airway and for aiding placement of a tracheal tube User Qualification The KARL STORZ Flexible Intubation Video Endoscope may only be used by persons with an appropriate medi...

Page 10: ...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 application on heart a...

Page 11: ...Video Endoscope before carrying out any maintenance and cleaning work on it Warning The Flexible Intubation Video Endoscope must not be used during the discharge of a cardiac defibrillator Remove the...

Page 12: ...become very hot Do not expose it to direct sunlight or excessive heat CAUTION Flexible Intubation Video Endoscopes must never be exposed to X rays CAUTION Do not hit the distal tip of the Flexible In...

Page 13: ...1 11302 BDX Flexible Intubation Video Endoscope 1 Carrying case 27677 FV 1 Instruction manual Z17844US 1 Leakage Tester 13242XL 1 Pressure compensation cap Z11457 1 Suction valve insert for single use...

Page 14: ...d extremely quickly Moreover this charger enables the monitor to be operated with a discharged Li Ion battery The charger has a green LED display which indicates that the output voltage is correct Cou...

Page 15: ...ptor 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: ...ideo Endoscope and the corresponding accessories This is not an introduction to the techniques of laryngoscopy Instructions on the endoscopic technique can be found in the relevant medical literature...

Page 17: ...ull clamp or twist the shaft of the Flexible Intubation Video Endoscope The shaft of the Flexible Intubation Video Endoscopes must never be kinked or coiled up too tightly It is best to store the Flex...

Page 18: ...r be properly controlled via the deflection lever or if the deflection mechanism develops any other fault the Flexible Intubation Video Endoscope must not be used Warning If a functional defect occurs...

Page 19: ...ert 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 t...

Page 20: ...e power supply with the mains socket The power cord can be fixed to the connection using the union nut The battery is charged automatically as soon as the monitor is connected to the power supply This...

Page 21: ...ption 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 re...

Page 22: ...following functions are available Video recording 2 Starts or stops the recording of a video stream on the SD memory card inserted in the receptacle h White balance 2 Enables the user to carry out a...

Page 23: ...uction pump is connected and switched on Note The opening of the working channel should be sealed P N 29100 BK to ensure that no secondary air is sucked in Inspecting the Insufflation Connect the O2 t...

Page 24: ...ges must not be used Inspect the connecting cord and connector for damage such as breaks cracks twisted or squashed sections or loose connections Checking the Deflection Warning Actuate the deflection...

Page 25: ...down and do not place it in the proximity of the patient Note The function keys on the monitor are used for switching the unit on off The Flexible Intubation Video Endoscope itself does not have an on...

Page 26: ...iefly pressing the power button l will set the monitor to standby operation mode In the case of brief interruptions this enables the monitor to be ready for operation again quickly The standby mode is...

Page 27: ...and or to rails with a cross section of less than 25 mm 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 impleme...

Page 28: ...in contact with intact mucous membranes or non intact skin CAUTION The maximum permitted temperature is 65 C 149 F for decontamination and sterilization CAUTION Personal Protective Equipment PPE is r...

Page 29: ...nic and organic material are removed from the water a final submicron filtration could also be part of the treatment process This water is mainly used for the final rinse Type of Water Utility Water C...

Page 30: ...10 50 Long Cleaning brush P N 11276 CL2 10 60 cc Syringe Soft lint free cloth Lens cleaner or cotton tip applicator 70 Isopropyl alcohol Luer plug P N 29100 BK Cleaning adaptor P N 11301 CD1 Sterile s...

Page 31: ...inimum of 100 mL 3 4 oz of water or a diluted mild neutral pH enzymatic cleaning solution e g Enzol 3 Disconnect the flexible endoscope from the monitor 4 Inspect the vent port and the video pin conne...

Page 32: ...propyl alcohol wipe CAUTION The pressure compensation cap P N Z11457 must be removed from the vent port if present before immersion in any liquids Note In lieu of the KARL STORZ Leakage Tester P N 132...

Page 33: ...t Draw at least 10 mL of water using a syringe Attach the filled syringe to the rinse tube assembly P N 11301CDT and flush the water 9 Keep the flexible endoscope submerged for 1 minute while fully de...

Page 34: ...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 clean...

Page 35: ...9990 50 Insert the brush and rotate 360 three times 13 Insert the long cleaning brush P N 110910 50 into the suction port and slowly push the brush into the channel until resistance is felt Pull the b...

Page 36: ...h the 60 cc of air to expel all the cleaning solution from the channel 24 Remove the Flexible Videoscope from the cleaning solution 25 Discard all disposable cleaning accessories and use new accessori...

Page 37: ...r 2 Remove the cleaning adaptor P N 11301CD1 and cleaning cap P N 8401 YZ 3 Discard all disposable cleaning accessories 4 Dry the exterior with a fresh soft lint free cloth Inspection 1 Visually inspe...

Page 38: ...ic material blood and cleaning solution be completely removed CAUTION Flexible Intubation Video Endoscopes must not be steam sterilized autoclaved under any circumstances Warning The pressure compensa...

Page 39: ...of FDA cleared polypropylene EtO gas compatible sterilization wrap using a sequential double wrapping technique 5 Process in 100 Ethylene Oxide Sterilizer under the following parameters CONDITIONING P...

Page 40: ...AD indicator strip in the tray 3 Double wrap the sterilization tray with two single layers of FDA cleared polypropylene wrap using a sequential double wrapping technique 4 Load the STERRAD sterilizer...

Page 41: ...STERIS System 1 is not a legally marketed device in the United States It may only be used outside of the U S CAUTION Remove the pressure compensation cap P N Z11457 from the vent port prior to SS1E p...

Page 42: ...container b CIDEX OPA No activation is necessary Use CIDEX OPA Solution Test Strips to verify the solution is above the minimum recommended concentration MRC Test the solution prior to each use Recor...

Page 43: ...with hookup DSD 110 HU0101 along with cleaning adaptor 11301CD1 Reprocessor Model CER 1 MV 1 and CER 2 MV 2 are used with hookup CLM 110 HU0080 and CLM 110 HU0137 along with cleaning adaptor 11301CD1...

Page 44: ...using forced air 5 psi must be performed for at least 10 minutes prior to storage 1 When handling the flexible endoscope make certain the shaft is loosely coiled to avoid possible damage 2 Support th...

Page 45: ...ected or sterilized and should never be used on a patient If the leak is detected and found on the exterior of the flexible endoscope and can be sealed with waterproof tape do so and submit the flexib...

Page 46: ...ply cable If an SD memory card is inserted in the monitor 8403 ZX images and videos can be saved using the function buttons on the videoscope and monitor assigned to the video and image registration f...

Page 47: ...useful operating life Maintenance services can be obtained from your local KARL STORZ representative Regardless of the accident prevention regulations or testing intervals for medical instruments pre...

Page 48: ...anty rights KARL STORZ gives no warranty on the correct functioning of equipment or instruments which have been repaired by unauthorized third parties Disposal This unit has been marked in accordance...

Page 49: ...Power cord connector is not properly connected to power Push power cord connector firmly into the power cord cord receptacle receptacle System error Carry out reset see page 24 No image TFT screen is...

Page 50: ...VESA 75 standard holder 8401 YB Suitable for securing rods with a max diameter of 24 mm US 9700 CLP and rails with a max height of 25 mm Cleaning cap to protect contacts during reprocessing 8401 YZ Th...

Page 51: ...aster diameter 100 mm Trolley is delivered unassembled Wire Basket for accessories for mounting to equipment rail 29005 AK 29003 GS Dimensions w x h x d 300 x 200 x 100 mm For usage with equipment car...

Page 52: ...of use and in managing the electromagnetic environment of use to permit the equipment or system to perform its intended use without disturbing other equipment and systems or non medical electrical equ...

Page 53: ...tic environment guidance RF emissions Complies The Flexible Intubation Video Endoscope 11302 BDX in conjunction with monitor 8403 ZX uses RF energy only for its CISPR 11 Class 1 internal function Ther...

Page 54: ...ns power quality should be that of IEC 61000 4 5 2 kV common mode 1 kV differential mode a typical commercial or hospital 2 kV common mode environment Voltage dips short 5 UT Complies Mains power qual...

Page 55: ...manufacturer and d is the recommended separation in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in eac...

Page 56: ...quipment Separation distance d m according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Rated maximum output power of d 3 5 3 P d 3 5 3 P d 7 3 P transmitter W 0...

Page 57: ...ddress and the RMA number When returning products Customer should include a copy of the original invoice or packing slip to ensure prompt issuing of credit Full credit will only be issued for products...

Page 58: ...eriod Any such product s with a defect occurring during the applicable warranty period will be promptly replaced or at the sole discretion of KSEA repaired at no charge to Customer THIS WARRANTY IS IN...

Page 59: ...ts are designed and are otherwise intended to be used and 2 any special incidental consequential punitive exemplary or indirect damages including but not limited to alleged damages for delayed shipmen...

Page 60: ...e 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...

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Page 64: ...enue 7171 Millcreek Drive 815 N W 57th Ave Telegramm Endoskopie El Segundo CA 90245 Mississauga Ontario CANADA L5N3R3 Ste No 480 Telefon 07461 70 80 Telephone 424 218 8100 Telephone 905 816 4500 Miami...

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