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Summary of Contents for Storz C-MAC S USB IMAGER
- Page 1 Instructions for use C-MAC S USB IMAGER 8403XSB...
- Page 2 07-2022 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 ..........................1.1 Read the instructions for use ..................... 1.2 Read the instructions for use of compatible products ............... 1.3 Scope ............................1.4 General signs and symbols ......................1.5 Description of warning messages ....................2 Normal use ............................2.1 Intended use ... - Page 4 Table of contents 11.4 Table 4 – Emission class and group ..................23 11.5 Table 5 – Recommended separation distances between portable and mobile HF communications equipment and the product ................24 12 Subsidiaries ............................25 Instructions for use • C-MAC S USB IMAGER • IOW228_EN_V2.0_07-2022_IFU_CE-MDR...
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Page 5: General Information
1.3 Scope This instruction manual is valid for: Product name Item number C-MAC S USB Imager 8403XSB The products listed here may not yet be available in all countries due to differences in approval requirements. 1.4 General signs and symbols... -
Page 6: Description Of Warning Messages
General information Lists Numbered list – Unnumbered list, 1st level – Unnumbered list, 2nd level 1.5 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 warnings use the following levels of danger: WARNING WARNING Designates a possible imminent risk. -
Page 7: 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 8: Safety And Warning
Safety and warning 3 Safety and warning WARNING Danger due to non-observance of warnings and safety notes This chapter contains warnings and safety notes structured according to hazards and risks. 1. Carefully read and observe all warnings and safety notes. 2. -
Page 9: National Guidelines On Airway Management
Safety and warning 3.5 National guidelines on airway management Failure to observe the national guidelines on airway management may put the patient at risk. National guidelines on airway management must be observed in addition to the documentation accompanying the product. Instructions for use •... -
Page 10: 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 sin- gle use Extraction mechanism Video connecting cable USB plug Mount for the C-MAC S USB IMAGER 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 11: Possible Combinations
Product description 4.2 Possible combinations The C-MAC S USB IMAGER requires additional accessories for normal use: – C-MAC S video laryngoscope blade – Tempus Pro patient monitor C-MAC S video laryngoscope Monitor blade 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... -
Page 12: Technical Data
Product description 4.4 Technical data Designation Value Classification IEC CLASS N/A Line frequency Voltage 5 V Power input 2 VA Immersion protection IPX8 Camera technology CMOS Resolution 640 x 480 pixels Weight 205 g 4.5 Ambient conditions Storage/transport conditions There are no special transport and storage conditions for these products. Operating conditions Temperature 0°C ... 40°C (32°F ... 104°F) -
Page 13: 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 14 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 15: 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 16: 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 17: 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 18: Accessories And Spare Parts
Accessories and spare parts 9 Accessories and spare parts 9.1 Accessories Item Order no. Forceps acc. to MAGILL, modified acc. to BOEDEKER, 25 cm 809125 Instructions for use • C-MAC S USB IMAGER • IOW228_EN_V2.0_07-2022_IFU_CE-MDR... -
Page 19: Errors And Messages
Send the C-MAC S USB defective. IMAGER to KARL STORZ for repair. – Screen defective. Color distortions – C-MAC S USB IMAGER – Send the C-MAC S USB defective. IMAGER to KARL STORZ for repair. Instructions for use • C-MAC S USB IMAGER • IOW228_EN_V2.0_07-2022_IFU_CE-MDR... -
Page 20: 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 level Compliance level Electromagnetic envi-... - Page 21 Electromagnetic compatibility Interference im- EN/IEC 60601 test level Compliance level Electromagnetic envi- munity tests ronment – guidelines Magnetic field at 30 A/m at 50 Hz / 60 Hz 30 A/m at 50 Hz / 60 Hz If image distortion occurs, the power fre- it may be necessary to in- quency (50/60 Hz) stall the product further acc.
- Page 22 Electromagnetic compatibility Test frequency Frequency Radio service Modulation Immunity Compliance 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 23 Electromagnetic compatibility Interference immunity EN/IEC 60601 test Compliance Electromagnetic environ- tests level level ment – guidelines d = 2.3 √P 800 MHz to 2.5 GHz Interferences may occur in the vicinity of equipment marked with the following symbol: Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations.
- Page 24 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.
- Page 25 E-mail: pisarna@karlstorz.si Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 E-mail: info@karlstorz.com.ar KARL STORZ Polska Sp. z o.o. ul. Bojkowska 47, 44-100 Gliwice, Poland KARL STORZ Endoskopi Norge AS Phone: +48 32 706 13 00, Fax: +48 32 706 13 07 Stamveien1, 1483 Hagan, Norway E-mail: info-pl@karlstorz.com...
- Page 26 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. E-mail: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut, Lebanon...
- Page 27 Subsidiaries Instructions for use • C-MAC S USB IMAGER • IOW228_EN_V2.0_07-2022_IFU_CE-MDR...
- 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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