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Related Manuals for Storz 8403XSB
Summary of Contents for Storz 8403XSB
- Page 1 Instructions for use C-MAC S USB IMAGER 8403XSB...
- Page 2 03-2021 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............................ 4 Read the instructions for use ........................ 4 Read the instructions for use of combinable products................ 4 Scope................................ 4 Description of warning messages...................... 4 2 Normal use.............................. 5 Intended use ............................. 5 Indications for use............................. 5 Contraindications............................ 5 Target user populations .......................... 5 Patient population............................. 5 3 Safety ................................ 6 Serious incidents ............................ 6... -
Page 4: General Information
® – C-MAC S USB IMAGER 8403XSB 1.4 Description of warning messages To prevent any injury to persons or damage to property, the warnings and safety notes in the instructions for use must be observed. The warning messages describe the following levels of danger. -
Page 5: Normal Use
Normal use 2 Normal use 2.1 Intended use C-MAC S IMAGERs are used in conjunction with C-MAC S video laryngoscopes for single use and a monitor to visualize the respiratory tracts and the vocal cords during endotracheal intubation and to inspect and examine the upper respiratory tract. C-MAC S IMAGERs are designed for transient use in invasive procedures through a body orifice and can be reused if reprocessed properly. -
Page 6: 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 7: Product Description
Product description 4 Product description 4.1 Product overview Telescope C-MAC S USB IMAGER for use with the video laryngoscope blades for single use Extraction mechanism Video connecting cable USB plug Mount for the C-MAC S USB IM- AGER C-MAC S video laryngoscope blade for single use (not included in the scope of supply of C-MAC S USB IMAGER) Instructions for use •... -
Page 8: Possible Combinations
C-MAC S USB IMAGER 051113-01, 051113-10 Tempus Pro patient monitor from Philips RDT 8403XSB 051114-01, 051114-10 051116-01, 051116-10 4.3 Technical data C-MAC S USB IMAGER 8403XSB Classification IEC class n/a Line frequency Voltage 5 V Power input 2 VA Immersion protection... -
Page 9: Symbols On The Packaging
Product description 4.5 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Unique Device Identifier Article no. Number of products in the product packaging Serial number Consult the printed or electronic instructions for use Not MR safe Federal (USA) law restricts this device to sale by or on the order of a physician. -
Page 10: 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 11 Preparation Additional devices connected to electrical medical equipment must comply with the relevant IEC or ISO standards (e.g., IEC 60950 for data processing equipment). Furthermore, all configurations must comply with the requirements for medical electrical systems (see Clause 16 of IEC 60601-1). Anybody connecting additional equipment to medical electrical equipment is a system configurator and is therefore responsible for the system’s compliance with the standard requirements for systems.
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Page 12: Application
Application 6 Application 6.1 Using the C-MAC S USB IMAGER The C-MAC S USB IMAGER is used in combination with the Tempus Pro patient monitor from Philips RDT. The instructions for use of the Tempus Pro patient monitor must be observed. The high-intensity light emitted by the C-MAC S USB IMAGER can result in increased temperatures at the light outlet. -
Page 13: Disassembly
Disassembly 7 Disassembly 7.1 Disassembling the product Unplug the USB plug of the video connecting cable from the socket of the Tempus Pro patient monitor. ð The C-MAC S USB IMAGER is switched off. Place a finger in the ring of the extraction mechanism. Pull the C-MAC S USB IMAGER out of the video laryngoscope blade. -
Page 14: Maintenance, Servicing, Repairs, And Disposal
8 Maintenance, servicing, repairs, and disposal 8.1 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 15: Accessories And Spare Parts
Accessories and spare parts 9 Accessories and spare parts 9.1 Accessories Item Order num- MAGILL forceps, modified by B OEDEKER, length 25 cm, suitable for the endo- 809125 scopic removal of foreign bodies, for use with video laryngoscopes of sizes 2–4 Instructions for use •... -
Page 16: Faults And Messages
70% isopropyl alcohol. No picture, screen dark – Defective camera – Send the C-MAC S USB electronics. IMAGER to KARL STORZ for repair. – Screen defective. Color distortions – C-MAC S USB IMAGER – Send the C-MAC S USB defective. -
Page 17: Electromagnetic Compatibility
Electromagnetic compatibility 11 Electromagnetic compatibility 11.1 Table 1 – Compliance level for immunity tests Guidelines and manufacturer’s declaration – electromagnetic immunity The product is intended for use in the electromagnetic environment specified below. The user of the product should make sure that it is used in such an environment. Interference im- EN/IEC 60601 test Compliance level... - Page 18 Electromagnetic compatibility Interference im- EN/IEC 60601 test Compliance level Electromagnetic envi- munity tests level ronment – guidelines Magnetic field at 30 A/m at 50 Hz / 30 A/m at 50 Hz / If image distortion oc- the power fre- 60 Hz 60 Hz curs, it may be neces- quency (50/60 Hz) sary to install the prod- acc.
- Page 19 Electromagnetic compatibility Test fre- Frequency Radio service Modulation Immunity Compliance quency band test level level 1,970 LTE band 1, 3, 4, 25, UMTS 2,450 2,400 – 2,570 Bluetooth, Pulse modula- WLAN 802.11 tion b/g/n, 217 Hz RFID 2450, LTE band 7 5,240 5,100 –...
- Page 20 Electromagnetic compatibility Interference immunity EN/IEC 60601 test Compliance Electromagnetic envi- tests level level ronment – guidelines be less than the compli- ance level in each fre- quency range d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz Interferences may occur in the vicinity of equipment marked with the following symbol:...
- Page 21 Electromagnetic compatibility 11.5 Table 5 – Recommended separation distances between portable and mobile HF communications equipment and the product The product is intended for use in an electromagnetic environment in which HF disturbances are controlled. The customer or user of the product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF communications equipment (transmitters) and the product as recommended below, according to the output energy of the communications equipment.
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Page 22: Subsidiaries
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 23 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 24 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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