Table of Contents
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Table of Contents
Related Manuals for Storz 11303BNX
Summary of Contents for Storz 11303BNX
- Page 1 Instructions for use Flexible intubation videoendoscopes...
- Page 2 02-2021 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.
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Page 3: Table Of Contents
Table of contents Table of contents 1 General information............................ 5 Read the instructions for use ........................ 5 Read the instructions for use of combinable products................ 5 Scope................................ 5 Description of warning messages...................... 5 2 Normal use.............................. 7 Intended use ............................. 7 Indications.............................. 7 Contraindications............................ 8 Target user populations .......................... 8 Patient groups............................ 8 3 Safety ................................ 9 Serious incidents ............................ 9... - Page 4 Table of contents Electromagnetic Compatibility........................ 24 10 Faults and messages .......................... 25 10.1 Fault correction ............................ 25 11 Subsidiaries.............................. 26 Instructions for use • Flexible intubation videoendoscopes • BMF168_EN_V1.0_02-2021_IFU_CE-MDR...
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Page 5: General Information
Read the instructions for use of the combinable products carefully and follow all the safety notes and warnings. 1.3 Scope This instruction manual is valid for: Product name Article number Flex. intubation videoendoscope 5.5 x 65 11303BNX Flex. intubation videoendoscope 6.5 x 65 11304BCX Flex. intubation videoendoscope 3.0 x 51.5 11301ABX Flex. intubation videoendoscope 5.5 x 65 11301BNX... - Page 6 General information ATTENTION ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • Flexible intubation videoendoscopes • BMF168_EN_V1.0_02-2021_IFU_CE-MDR...
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Page 7: Normal Use
Normal use 2 Normal use 2.1 Intended use Flexible intubation endoscopes Flexible intubation endoscopes without working channel (CMOS) are used for both endotracheal and nasal intubation. Flexible intubation endoscopes without working channel (CMOS) are used for endoscopic visualization and image transmission for diagnosis of the upper and lower respiratory tract. -
Page 8: Contraindications
Normal use 2.3 Contraindications The use of the intubation endoscope is contraindicated if, in the opinion of the responsible physician, the surgical method is contraindicated or the patient is not able to undergo surgery or anesthesia due to his or her general condition. Intubation endoscopes must not be used for interventions in direct contact with the central nervous system (CNS) and central cardiovascular system. -
Page 9: Safety
Safety 3 Safety 3.1 Serious incidents According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that directly or indirectly had, could have had, or could have any of the following consequences (MDR, Art. 2, No. 65 [1]): – Death of a patient, user, or another person –... -
Page 10: Observing Ambient Conditions
Combination of the product with unsuitable instruments and devices can result in uncontrolled behavior and injury to patients, users and third parties. Only make changes to the product if these changes are approved by KARL STORZ. 3.8 Hot components The high level of light intensity may cause the distal end, the light connections for the endoscope and fiber optic light cable, and adjacent components to heat up. -
Page 11: Product Description
Product description 4 Product description 4.1 Product overview Connecting cable Working channel with leaflet valve Function buttons Tube holder Suction valve Sheath Pressure compensation valve Distal tip Connection for suction valve/irrigation Deflection lever adaptor Instructions for use • Flexible intubation videoendoscopes • BMF168_EN_V1.0_02-2021_IFU_CE-MDR... -
Page 12: Possible Combinations
Product description 4.2 Possible combinations The product can be combined with the following components: Product name Article number C-MAC Monitor 8403ZX C-MAC Monitor 8404ZX C-HUB II 20290320 TELE PACK + TP101 Suction valve, reusable 11301CB1 Suction valve for single use 11301CE1 Suction valve 091011-01... - Page 13 Product description Flexible intubation videoendoscope 11301 BNX, 11303 BNX Illumination Integrated LED light source Electrical power consumption 1 W Sensor CMOS technology Weight 400 g Drip-water protection IPX8 Flexible intubation videoendoscope 11302BDX Direction of view 0° Angle of view 100° Deflection up 140°, down 140° Working length 65 cm Outside diameter of distal tip...
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Page 14: Symbols Employed
Product description 4.4 Symbols employed 4.4.1 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no. Serial number Batch code Number of products in the product packaging Unique Device Identifier Consult the printed or electronic instructions for use Unsterile Fragile, handle with care Keep away from sunlight... -
Page 15: Symbols On The Product
Product description Symbol Meaning Do not reuse Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this mark, the manufacturer declares the compliance of the devices with the applicable standards and directives The device must not be modified in any way 4.4.2 Symbols on the product Symbol... -
Page 16: Preparation
Preparation 5 Preparation 5.1 Unpacking the product Carefully remove the product and accessories from the packaging. Check the delivery for missing items and evidence of shipping damage. In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately. -
Page 17: Connecting The C-Mac Monitor
Preparation 5.3 Connecting the C-MAC monitor Insert the connecting cable of the product into the serial port on the back or side of the C-MAC Monitor. To charge the battery, insert the power supply cord into the connection socket on the C- MAC Monitor and plug it into the power supply. -
Page 18: Checking The Functions
Preparation The image focus is adjusted automatically. Manual adjustment is not necessary. 5.5 Checking the functions Slowly move the deflection lever to check the deflection of the distal tip; see chapter Operating the deflection mechanism [p. 19]. Check the suction; see chapter Activating the suction function [p. 21]. Instructions for use •... -
Page 19: Application
Application 6 Application 6.1 Switching on the product Press the On/Off button on the C-MAC Monitor to switch the product on. Press the ON/OFF button again to switch the product off. 6.2 Operating the deflection mechanism WARNING Incorrect handling! Risk of injury! The patient can be injured if the deflection lever is moved with force or abruptly. -
Page 20: Operating The Function Buttons
Application Move the deflection lever downwards using the thumb to angle the distal tip upwards. To place the distal tip in the straight position, move the deflection lever until you hear a click. 6.3 Operating the function buttons The product is equipped with the following function buttons: Start/stop video recording Save a still image White balance... -
Page 21: Using The Working Channel
Unsuitable accessory! Product damage! Make sure that the accessories are of the appropriate length and diameter. Only use accessories from KARL STORZ. If no instrument is inserted in the working channel, seal the proximal end of the working channel with a plug (29100). -
Page 22: Maintenance, Servicing, Repairs, And Disposal
7 Maintenance, servicing, repairs, and disposal 7.1 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). -
Page 23: Accessories And Spare Parts
Accessories and spare parts 8 Accessories and spare parts 8.1 Accessories Item Order no. Sealing cap 29100 Irrigation adapter 11301CD1 Suction valve for single use 11301CE1 Suction valve for single use, sterile 091011-20 Bronchoscope insertion tube, size 4, with in- 10309 tegrated mouthpiece, for single use, sterile, insertion length 85 mm, made from EVA... -
Page 24: Electromagnetic Compatibility
Electromagnetic compatibility 9 Electromagnetic compatibility 9.1 Electromagnetic Compatibility The described product has been tested as a system with the following devices. Relevant electromagnetic compatibility (EMC) information can be found in the "Electromagnetic compatibility (EMC)" section of the instructions for use for the devices. Device Article number C-MAC Monitor... - Page 25 Insufficient illumination Light conducting fibers dam- Send product to aged KARL STORZ for repair Illumination doesn't work Product not connected to the Connect to the power power supply supply Product failed...
- Page 26 KARL STORZ Veterinary Endoscopy-America, Inc. Email: info-be@karlstorz.com 1 South Los Carneros Road, Goleta, CA 93117, USA KARL STORZ Endoscopie France S. A. S. Phone: +1 805 968-7776, Fax: +1 805 685-2588 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Email: info@karlstorzvet.com...
- Page 27 No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. Email: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
- Page 28 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: info@karlstorz.com www.karlstorz.com...
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