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 ...
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Table of contents 8.3 Table 1 – Compliance level for immunity tests ................21 8.4 Table 2 – Test levels for near fields from HF wireless communications equipment ....23 8.5 Table 3 – Test levels for radiated and conducted immunity tests ..........24 8.6 Table 4 –...
General information 1 General information 1.1 Read the instructions for use If the instructions for use are not followed, patients, users, and third parties may be injured or the product may be damaged. Read the instructions for use carefully and follow all the safety notes and warnings. Read the reprocessing instructions carefully and follow all the safety notes and warnings.
General information Step 1 ð Interim result of an action Step 2 ð Result of a completed action Actions in safety notes or in the case of a single step: Step 1 Lists Numbered list – Unnumbered list, 1st level –...
2.1 Intended use OR1 NEO audio/video system The KARL STORZ OR1 NEO audio/video system is a permanently installed (in-wall, on-wall, rack- mounted) system for use in hospitals ("special environment") and professional healthcare settings, and is designed to be used via touchscreen/mouse/keyboard (inside and outside of sterile area with or without sterile drape) via pre-programmed source-to-destination configurations to switch audio and/or video information from source(s) to destination(s).
Normal use 2.6 Target user populations The medical device may only be used by doctors and medical assistants with a relevant specialist qualification. 2.7 Patient population There are no restrictions in terms of patient groups for this product. Instructions for use • OR1 NEO IP encoder/decoder • NKM310_EN_V2.0_09-2023_IFU_CE-MDR...
The installation may only be carried out by authorized and trained personnel of KARL STORZ SE & Co. KG or a company authorized by KARL STORZ. Contact a KARL STORZ branch or specialized dealer (see list of branches). 3.5 Failure of products The product may fail during use. In this case, image transmission will be interrupted. The patient may be injured.
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Safety and warning In case of a failure or malfunction, cease work immediately and switch to a backup system. Prior to each operation, make sure that the personnel are familiar with the procedure for switching over to the backup system. Instructions for use •...
LED lights up green when data is being LED lights up green when data is being transmitted. received. The Reset and Configuration buttons may only be used by personnel authorized by KARL STORZ or KARL STORZ employees. Instructions for use • OR1 NEO IP encoder/decoder • NKM310_EN_V2.0_09-2023_IFU_CE-MDR...
Product description 4.2.2 Back of device OR1 NEO IP HDMI Decoder, single channel, WO10266 1 Potential connection 2 Signal output (HDMI 1.4 or 2.0) 3 Connection for NEO IP 10G network 4 Network connection (RJ-45) 5 Serial interface (RS-232) 6 Power connection (+12 VDC) OR1 NEO IP DisplayPort Encoder, WO10267 1 Signal input (DisplayPort 1.2) 2 Potential connection...
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Product description OR1 NEO IP HDMI Encoder, single channel, WO10265 1 Potential connection 2 Signal input (HDMI 1.4 or 2.0) 3 Connection for NEO IP 10G network 4 Network connection (RJ-45) 5 Serial interface (RS-232) 6 Power connection (+12 VDC) OR1 NEO IP VGA Encoder, single channel, WO10268 1 Signal input (VGA) 2 Potential connection 3 VGA/YPbPr: Switch between RGB and com-...
The product can be used with electrical devices within the OR. Configuration may only be carried out by KARL STORZ or a company authorized by KARL STORZ. The product can be combined with AV system NEO, ab Software Version Rel. 54 and following releases.
Product description When connecting the product with other devices, comply with the instructions under “ME Systems” in IEC 60601-1. 4.4 Technical data Description Value Power + 12 VDC Max. power input 27.5 W Dimensions (L x H x W) 136 x 40 x 112 mm Max. weight 0.6 kg El. protection class IP degree of protection IPx0 4.5 Symbols employed 4.5.1 Symbols on the packaging...
EU directives. A code number after the CE mark indicates the responsible notified body. The EU directives relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ. 4.5.2 Symbols on the type plate Symbol...
Product description 4.6 Ambient conditions Storage/transport conditions Temperature 0 °C ... 70 °C Relative humidity 0 – 95 % (non-condensing) Air pressure 700–1,060 hPa Operating conditions Temperature 0 °C ... 40 °C Relative humidity 0 – 95 % (non-condensing) Air pressure 700–1,060 hPa Max. operating altitude 3,000 m Instructions for use • OR1 NEO IP encoder/decoder • NKM310_EN_V2.0_09-2023_IFU_CE-MDR...
Install the product out of reach of patients. Ensure that there is sufficient air circulation. 5.3 Connecting the product The product may only be connected to other components by KARL STORZ service personnel or personnel authorized by KARL STORZ. Instructions for use • OR1 NEO IP encoder/decoder • NKM310_EN_V2.0_09-2023_IFU_CE-MDR...
6.2 Repairing products If not described further, repairs may only be performed by KARL STORZ or by a company authorized by KARL STORZ. Contact a KARL STORZ branch or specialized dealer (see list of branches). 6.3 Disposing of the product The product meets the requirements of the Directive on Waste Electrical and Electronic Equipment (WEEE).
Accessories and spare parts 7 Accessories and spare parts 7.1 Accessories Item Order no. OR1 4N1 Power Supply Unit for WO10202 WO10203 OR1 10G SFP Module f. WO10265 to WO10270 WO10271 Instructions for use • OR1 NEO IP encoder/decoder • NKM310_EN_V2.0_09-2023_IFU_CE-MDR...
WARNING Reduced immunity! Risk of injury! The use of accessories or cables other than those specified in the KARL STORZ instructions for use may result in increased emissions or decreased immunity of the product. The cables listed have been shown to comply with the requirements of IEC 60601-1-2.
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Electromagnetic compatibility Immunity tests EN/IEC 60601 test level Compliance level Electromagnetic envi- ronment – guidelines Electrostatic dis- ± 8 kV contact discharge ± 8 kV contact discharge Floors should be made of charge (ESD) acc. wood, concrete, or cov- ± 15 kV air discharge ± 15 kV air discharge to IEC 61000-4-2 ered with ceramic tiles.
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Electromagnetic compatibility Immunity tests EN/IEC 60601 test level Compliance level Electromagnetic envi- ronment – guidelines * Refer to Table 2 for wireless proximity RF field test levels Immunity to con- 3 V on 150 kHz to 3 V on 150 kHz to ducted distur- 80 MHz 80 MHz bances, induced by 1 kHz 80% AM modula-...
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Electromagnetic compatibility 8.5 Table 3 – Test levels for radiated and conducted 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. Immunity tests EN/IEC 60601-1-2 test Compliance...
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Electromagnetic compatibility Immunity tests EN/IEC 60601-1-2 test Compliance Electromagnetic environ- level level ment – guidelines fixed transmitters, an electromagnetic site survey should be considered. If the measured field strength at the location where the device is used exceeds the above compliance levels, the device should be monitored to ensure proper function.
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Electromagnetic compatibility Rated power of the Separation distance d [m] according to the transmitter frequency transmitter [W] 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2 √P d = 1.2 √P d = 2.3 √P 0.01 0.12 0.12 0.23 0.38 0.38 0.73 For transmitters whose maximum rated power is not listed in the table above, the recommended...
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KARL STORZ Endoscopy-America, Inc. E-Mail: info-be@karlstorz.com 2151 East Grand Avenue, El Segundo, CA 90245-5017, USA KARL STORZ Endoscopie France S. A. S. Phone: +1 424 218-8100, Fax: +1 424 218-8525 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Toll free phone: 800 421-0837 (USA only) Téléphone: +33 1 30484200, Fax: +33 1 30484201...
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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...
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Subsidiaries Instructions for use • OR1 NEO IP encoder/decoder • NKM310_EN_V2.0_09-2023_IFU_CE-MDR...
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Subsidiaries Instructions for use • OR1 NEO IP encoder/decoder • NKM310_EN_V2.0_09-2023_IFU_CE-MDR...
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Subsidiaries Instructions for use • OR1 NEO IP encoder/decoder • NKM310_EN_V2.0_09-2023_IFU_CE-MDR...
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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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