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Summary of Contents for Storz E-BOX
- Page 1 Instructions for use E-BOX TP012...
- 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 3 – Test levels for radiated and conducted immunity tests ............ 17 Table 4 – Emission class and group ....................... 18 Table 5 – Recommended separation distances between portable and mobile HF communications equipment and the product ........................ 18 9 Subsidiaries.............................. 20 Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 4: General Information
Read the instructions for use of the combinable products carefully and follow all the safety notes and warnings. 1.3 Scope These instructions for use are valid for the following products: E-BOX TP012 1.4 Initial commissioning This product must be reprocessed before being used for the first time. Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 5: Normal Use
Normal use 2 Normal use 2.1 Intended use The E-BOX is used for processing and transferring data from an endoscope to KARL STORZ camera control units. The E-BOX has no direct contact with the human body. 2.2 Indications The indication is defined by the device that is controlled using the additional operating elements or for which the additional accessories are used. -
Page 6: Safety
3.3 Damaged products Damaged products can result in injury to patients, users, or third parties. Before each use, check all components of the product for damage. Do not use damaged products. Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 7: Product Description
Socket for flexible single-use videoendoscope Indicator light C-MAC monitor Connecting cable for CCU 4.2 Possible combinations The E-BOX TP012 is only suitable for use with the following KARL STORZ products: Instruments Camera control units ® E-BOX KARL STORZ single-use videoen-... -
Page 8: Technical Data
Ambient temperature - 10° ... + 60°C Relative humidity 5% ... 95% Atmospheric pressure 700 ... 1080 hPa Application Ambient temperature 0° ... 40°C Relative humidity 30% ... 70% Atmospheric pressure 700 ... 1080 hPa Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 9: Symbols On The Packaging
CE conformity mark With this mark, the manufacturer declares the compliance of the prod- ucts with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body. Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 10: Preparation
Connect the connecting cable for the flexible single-use videoendoscope to the E-BOX for X-LINK socket. Connect the connecting cable for the E-BOX for X-LINK to the corresponding port on the camera control unit (CCU). Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR... - Page 11 ð The LED indicator light on the E-BOX lights up green. ð The E-BOX is ready for operation. A live image appears on the monitor. If the LED indicator light does not light up green, this indicates a defect. Should this occur, contact KARL STORZ Service.
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Page 12: Disassembly
Disassembly 6 Disassembly 6.1 Disassembling the product Unplug the E-BOX connector from the C-MAC monitor port or from the port on the C- HUB II. Disconnect the connecting cable for the flexible single-use videoendoscope from the E- BOX socket. To remove the cable from the C-MAC monitor and the E-BOX, firstly gently push in the plug so that it can then be easily removed. -
Page 13: 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 14: Electromagnetic Compatibility
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. Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR... - Page 15 Immunity test acc. 3 V/m 80 MHz to 3 V/m 80 MHz to to IEC 61000-4–3 2.7 GHz 2.7 GHz for radiated, ra- * Refer to Table 2 for wireless proximity RF field test levels Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 16 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 – 5,800 WLAN 802.11 Pulse modula- tion 5,500 217 Hz 5,785 Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 17 = 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: Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 18 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. Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 19 Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range ap- plies. Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorptions and reflections of buildings, objects, and people. Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR...
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Page 20: Subsidiaries
Phone: +358 (0)96824774, Fax: +358 (0)968247755 Email: asiakaspalvelu@karlstorz.fi KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 Email: info-gr@karlstorz.com *Repair & Service Subsidiary Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR... - Page 21 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 22 Subsidiaries Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 23 Subsidiaries Instructions for use • E-BOX • OYD476_EN_V1.0_03-2021_IFU_CE-MDR...
- 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...