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Summary of Contents for Storz OR1 SmartScreen
- Page 1 Instructions for use OR1 SmartScreen WM200...
- Page 2 04-2021 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 2 – Test levels for proximity fields from HF wireless communications equipment ....... 20 Table 3 – Test levels for radiated and conducted immunity tests ............ 20 Table 4 – Emission class and group ....................... 22 9 Subsidiaries.............................. 23 Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... -
Page 4: General Information
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. NOTICE ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... -
Page 5: Normal Use
2 Normal use 2.1 Intended use The KARL STORZ SMARTSCREEN is designed for use by qualified personnel in practices and operating rooms. The SMARTSCREEN is used for controlling the allocated, compatible KARL STORZ medical devices (such as the KARL STORZ AIDA® WD300) from within an unsterile area and should be positioned under the compatible KARL STORZ equipment. -
Page 6: Safety
Have the device installed and put into service by authorized and trained electricians of KARL STORZ SE & Co. KG or by companies authorized by KARL STORZ. Use either the power cord supplied by KARL STORZ or a power cord which has the same properties and which bears a national mark of conformity. -
Page 7: Damage Due To Ingress Of Liquid In Electrical Components
Do not open the product. Have servicing carried out by KARL STORZ or a company authorized by KARL STORZ. Failure to do so will void the guarantee. Do not touch the output jacks of the product and the patient at the same time during use. - Page 8 If adjacent or stacked use is necessary, the product should be observed to verify normal operation in the configuration in which it will be used. Comply with national and local regulations. Only make changes to the product if these changes are approved by KARL STORZ. Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR...
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Page 9: Product Description
The product can be combined with the following components: Product name Item number Cable set WO10042 Power supply unit WM20001 DisplayPort cable WA1000C USB-A to USB-B cable 20090179 Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... -
Page 10: Technical Data
Potential equalization connection (POAG) Touchscreen Technology PCAP Driver No installation required in Windows Support Windows Linux kernel 3.x.x and 4.x.x Number of points of contact Max. 10 General Dimensions (L x W x H) 305 x 355 x 46 mm Weight 6.6 kg Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... -
Page 11: Symbols Employed
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 Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... -
Page 12: Symbols On The Type Plate
(EU) 2017/745. A code number after the CE mark indicates the responsible notified body. 4.5 Ambient conditions Storage/transport conditions Ambient temperature -20°C ... +60°C Relative humidity Max. 90% Operating conditions Ambient temperature 0°C ... 50°C Relative humidity Max. 80% Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... -
Page 13: Preparation
Ensure adequate air circulation. 5.4 Connecting the product Connect the DisplayPort cable to the video output socket. Connect the USB cable to the USB-B port. Connect the power cord to the direct current input socket. Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... -
Page 14: Connecting The Product To Aida
Connect the other end of the USB cable to the AIDA (WD300) USB-A port. Connect the AIDA (WD300) serial interface to the direct current input socket using the RS232 to DC connector. Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... -
Page 15: Putting The Product Into Operation
Press in the monitor front panel to release the monitor guide. Pull out the monitor. Move the monitor into the required position. Image signals that do not originate from a KARL STORZ device may only be used for information purposes. Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... -
Page 16: Maintenance, Servicing, Repairs, And Disposal
6.3 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 17: Accessories And Spare Parts
Accessories and spare parts 7 Accessories and spare parts 7.1 Accessories Item Order no. Power supply unit WM20001 KARL STORZ OR1 FUSION CONTROL, 19” WO200-02 Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... -
Page 18: 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 • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... - Page 19 (50/60 Hz) should correspond to acc. to IEC the values typically 61000-4-8 found in commercial and hospital environ- ments. is the mains alternating voltage before applying the test levels. Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR...
- Page 20 – guidelines Conducted RF distur- 3 V 3 V Portable and mobile HF bances acc. to IEC communications equip- 150 kHz to 80 MHz 61000-4-6 ment should be used no closer to any part of the Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR...
- Page 21 If abnormal perfor- mance is observed, additional measures may be necessary, such as re-orienting or relocating the device. Over the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3 V/ Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR...
- Page 22 Class A and those directly connected to the acc. to IEC 61000-3-2 public low voltage power supply network that supplies buildings Voltage fluctuations/flicker emis- Complies used for domestic purposes. sions acc. to IEC 61000-3-3 Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR...
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Page 23: 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 • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR... - Page 24 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 25 Subsidiaries Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR...
- Page 26 Subsidiaries Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_IFU_CE-MDR...
- Page 27 Subsidiaries Instructions for use • OR1 SmartScreen • PQJ219_EN_V1.0_04-2021_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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