ENGLISH EMOSAFE EN-100 Product Data Sheet Network Isolators for PCB assembly November 2013 1 GENERAL DESCRIPTION The EMOSAFE EN-100 Network Isolator interrupts all galvanically conducting connections (conductors and shielding) between the Ethernet input socket and the Ethernet circuit of the device being protected. They prevent potential equalisation currents and protect devices and their users from transient excess voltages which have been coupled directly or inductively into the Ethernet network line through errors in installation, lightning strikes, switching operations, electrostatic discharges and so on. EMOSAFE EN-100 Network Isolators are meant to be integrated into the PCB of the device being protected. There are models available for plug-in assembly with socket strips and models that can be permanently soldered. Their extremely compact design also allows them to be used in situations where there is very limited space. A summary of the available variants can be found in Section 4 SUMMARY OF VARIANTS All EN-100 models provide especially effective device protection thanks to the implementation of additional TVS diode circuitry. Voltage spikes on single conductors cannot be suppressed using conventional network isolators However, even these are eliminated when using the EN-100. Devices in the EN-100 series meet the requirements of IEC 60601-1 (3 rd Edition) and IEC 60601-1-2 and as such are suitable for providing the galvanic separation of Ethernet interfaces for devices used in the field of medicine. EMOSAFE Network Isolators transmit high-frequency AC voltages using the principle of electromagnetic induction in the frequency range used for data transmission. Due to this transmission principle, they do not require their own power supply. The installation of drivers is not required. Low-frequency signal components are strongly attenuated, so that connected devices may, for example, be protected against ground loops. PD 1056-V20 Page 1/23 2013 EMO Systems GmbH EMO Systems GmbH Rungestr. 19 10179 Berlin Germany Tel.: +49. 30. 4000 475-80 Fax: +49. 30. 4000 475-90 info@emosystems.de www.emosystems.de
2 FEATURES AND ADVANTAGES For PCB assembly, pluggable or solderable Ultracompact Gigabit Ethernet 4.6 kv AC dielectric strength 8.5 kv DC dielectric strength Suitable for devices with a supply voltage of up to 400 V AC Limitation of transient excess voltages on signal lines with use of TVS diodes Extremely low Insertion Loss Conforms to IEC 60601-1 (3 rd Edition) Reinforced insulation in accordance with IEC 60601-1 CE marking UL Recognized Component 3 APPLICATIONS 3.1 PATIENT PROTECTION Galvanic separation of Ethernet interfaces from medical electrical devices/systems where patients must be protected from dangerous leakage currents in conformity with applicable standards. 3.2 EQUIPMENT PROTECTION Protection of particularly valuable devices from ripple voltages and excess voltages from the periphery of the network. 3.3 MEASUREMENT TECHNOLOGY Protection of electrical measuring and monitoring equipment from external and interference voltages arising from the Ethernet cabling. 3.4 AUDIO Reduction of low-frequency AC voltages (mains hum) which are caused by the mains connection to an imperceptible degree. PD 1056-V20 Page 2/23 2013 EMO Systems GmbH
Dielectric strength in kv (AC) TVS diodes 10/100/1000 Mbit Return Loss @ 100MHz in db Insertion Loss @ 100MHz in db 4 SUMMARY OF VARIANTS EN-100 Network Isolators for PCB assembly Name Article number Special features Configuration Pluggable EN-100T A10049 Especially short; downwardspointing pin connectors to be plugged or soldered; THT transformer 4.6 >14 <1 Pluggable EN-100L A10050 Especially short; upwardspointing pin connectors to be plugged or soldered; THT transformer 4.6 >14 <1 Solderable EN-100S A10048 Especially short; edge soldering points for manual soldering to the solder pads; THT transformer 4.6 >14 <1 Solderable EN-100C A10051 Edge soldering points for manual soldering to the solder pads; SMD transformer; no milling of the carrier PCB necessary 4.6 >14 <1 PD 1056-V20 Page 3/23 2013 EMO Systems GmbH
5 DRAWINGS All dimensions in millimetres 5.1 EN-100T 5.1.1 EN-100T MODULE DIMENSIONS PD 1056-V20 Page 4/23 2013 EMO Systems GmbH
5.1.2 EN-100T FITTING DIMENSIONS The pin connectors can be soldered directly into the PCB or, as illustrated, be plugged into a socket strip. This dimensioned drawing illustrates a socket strip with a height of 4.2 mm. The assembly height is reduced by this amount if a socket strip is not used. PD 1056-V20 Page 5/23 2013 EMO Systems GmbH
5.1.3 EN-100T PCB LAYOUT No conducting paths should be placed in the shaded area as this would reduce the leakage distance to inadmissible values. The dimensions given for the shaded area refer to the requirements for the provision of two protective measures for patient protection for devices with a voltage rating of 250 V(400 V). However, the actual requirements for the clearance and leakage distance vary, and have to be determined and checked depending on the device. The assembly of the Network Isolators in a manner that satisfies requirements and the relevant standards is the responsibility of the device manufacturer. PD 1056-V20 Page 6/23 2013 EMO Systems GmbH
5.2 EN-100L 5.2.1 EN-100L MODULE DIMENSIONS PD 1056-V20 Page 7/23 2013 EMO Systems GmbH
5.2.2 EN-100L FITTING DIMENSIONS The pin connectors can be soldered directly into the PCB or, as illustrated, be plugged into a socket strip. This dimensioned drawing illustrates a socket strip with a height of 4.2 mm. The assembly height is changed by this amount if a socket strip is not used. PD 1056-V20 Page 8/23 2013 EMO Systems GmbH
5.2.3 EN-100L PCB LAYOUT No conducting paths should be placed in the shaded area as this would reduce the leakage distance to inadmissible values. The dimensions given for the shaded area refer to the requirements for the provision of two protective measures for patient protection for devices with a voltage rating of 250 V (400 V). However, the actual requirements for the clearance and leakage distance vary, and have to be determined and checked depending on the device. The assembly of the Network Isolators in a manner that satisfies requirements and the relevant standards is the responsibility of the device manufacturer. PD 1056-V20 Page 9/23 2013 EMO Systems GmbH
5.3 EN-100S 5.3.1 EN-100S MODULE DIMENSIONS PD 1056-V20 Page 10/23 2013 EMO Systems GmbH
5.3.2 EN-100S FITTING DIMENSIONS PD 1056-V20 Page 11/23 2013 EMO Systems GmbH
5.3.3 EN-100S PCB LAYOUT No conductors should be placed in the shaded area as this reduces the leakage distance to inadmissible values. The dimensions given for the shaded area refer to the requirements for the provision of two protective measures for patient protection for devices with a voltage rating of 250 V (400 V). However, the actual requirements for the clearance and leakage distance vary, and have to be determined and checked depending on the device. The assembly of the Network Isolators in a manner that satisfies requirements and the relevant standards is the responsibility of the device manufacturer. PD 1056-V20 Page 12/23 2013 EMO Systems GmbH
5.4 EN-100C 5.4.1 EN-100C MODULE DIMENSIONS PD 1056-V20 Page 13/23 2013 EMO Systems GmbH
5.4.2 EN-100C FITTING DIMENSIONS PD 1056-V20 Page 14/23 2013 EMO Systems GmbH
5.4.3 EN-100C PCB LAYOUT No conductors should be placed in the shaded area as this reduces the leakage distance to inadmissible values. The dimensions given for the shaded area refer to the requirements for the provision of two protective measures for patient protection for devices with a voltage rating of 250 V (400 V). However, the actual requirements for the clearance and leakage distance vary, and have to be determined and checked depending on the device. The assembly of the Network Isolators in a manner that satisfies requirements and the relevant standards is the responsibility of the device manufacturer. 6 HANDLING NOTES The EN-100 model Network Isolators are for manual soldering. Procedures using a reflow oven or using wave soldering are not allowed as this may cause thermal damage to the potting material within the transformer component. Avoid temperatures of more than 85 C to prevent thermal stress to the transformer component. PD 1056-V20 Page 15/23 2013 EMO Systems GmbH
7 INSTRUCTIONS FOR USE The EN-100 Network Isolator has been designed for data transmission in the frequency range of 0.3 to 100 MHz. Lower frequencies are strongly attenuated. For this reason, it is generally not possible to transmit the signals from nurse call systems, telephone systems or analogue audio or video signals over a Network Isolator. The EN-100 Network Isolator can be used in a Power over Ethernet (PoE) network without restriction (however PoE devices downstream of the galvanic separation cannot be supplied with power). 8 SAFETY NOTICE 8.1 SAFETY INSPECTIONS The test interval, as well as the requirements to be met for both regular safety inspections and post-repair inspections will then be specified for the interface to be protected by the organisation responsible based upon the applicable standards for this system. 8.2 CLEARANCE AND LEAKAGE DISTANCES The PCB layout and device design of devices that use the EN-100 are to be done such that the applicable standards (e.g. IEC60601-1) for the required clearance and leakage distances are maintained. PD 1056-V20 Page 16/23 2013 EMO Systems GmbH
9 SPECIFICATIONS 9.1 GENERAL Category Standards specifications or test criteria Characteristic Name EMOSAFE EN-100 (...) Designed for Supported network protocols IEEE802.3 PCB module 10BaseT (Cl.14), 100BaseTx (Cl.25), 1000BaseT (Cl.40) Insertion Loss 1 MHz < f < 100 MHz <1 db Return Loss 1 MHz < f < 100 MHz >14 db Suitable for the protection of Ethernet interfaces in ME (medical electrical) devices Isolation type Isolation distances which are realised internally Markings 9.2 MECHANICAL Category Housing dimensions Weight 9.3 ELECTRICAL Category Maximum operating voltage (maximum mains voltage) of connected devices Dielectric strength (AC/DC) IEC 60601-1:2005 (3 rd ) UL 60601-1 Standards specifications or test criteria Standards specifications or test criteria IEC 60601-1:2005 (3 rd ) UL 60601 Protection Class I and Class II devices or devices with an independent power supply; with applied parts B, BF and CF Reinforced isolation 12.5 mm clearance and leakage distances CE, UL, RoHS compliant, lead(pb)-free Characteristic See dimensioned drawings approx. 6 g Characteristic 400 V AC / 450 V DC AC: 4600 V / 50 Hz / 60s DC: 8500 V / 60s Total leakage current 275 V AC / 50 Hz 12.5 µa ± 25% Coupling capacitance 275 V AC / 50 Hz 37.5 pf / channel ±25 % (150 pf total) Protection against momentary transient voltages Line to line TVS diode circuitry Maximum pulse power P pk / tp=8/20 µs 300 W Reverse blocking voltage V RWM 5 V Terminal voltages I PP = 1A, tp=8/20µs I PP = 5A, tp=8/20µs I PP = 12A, tp=8/20µs 12.5 V 17.5 V 25.0 V PD 1056-V20 Page 17/23 2013 EMO Systems GmbH
9.4 ENVIRONMENTAL CONDITIONS STORAGE AND TRANSPORTATION Category Criteria Characteristic Storage Transportation Temperature Air humidity Air pressure Temperature Air humidity Air pressure -25 to +70 C 10 to 90% (non-condensing) 700 to 1060 hpa -40 to +70 C 10 to 90% (non-condensing) 500 to 1060 hpa 9.5 OPERATING CONDITIONS AND AREA OF APPLICATION Category Characteristic Explanatory notes Degree of contamination 2 Contamination only arises through nonconductive materials. Occasional conductivity caused by condensation can be expected Excess voltage category III Environments with up to three-phase wiring Maximum altitude above sea level 3200 m Temperature -10 to +70 C Air humidity Air pressure Max. operating voltage of equipment connected in V AC/V DC Achievable protective measures, number and type in accordance with IEC 60601-1:2005 10 to 90% (noncondensing) 500 to 1060 hpa 400/565 2 MOPP MOOP: Means of Operator Protection MOPP: Means of Patient Protection Insulating material group (CTI value) IIIb (100-175) Insulating Material Group I CTI > 600 Insulating Material Group II 400 < CTI < 600 Insulating Material Group IIIa 175 < CTI < 400 Insulating Material Group IIIb 100 < CTI < 175 PD 1056-V20 Page 18/23 2013 EMO Systems GmbH
9.6 ISOLATION DIAGRAM Valid for all variants Ethernet Input Ethernet Output A PCB The required clearance and leakage distances in Area A of the isolation diagram result, according to IEC 60601-1, in each case from the most unfavourable permitted operational conditions; also see 9.5 OPER- ATING CONDITIONS AND AREA OF APPLICATION. Type Required Actual dimensions Clearance distance 7 mm 12.5 mm Leakage distance 12 mm 12.5 mm 9.7 FREQUENCY RESPONSE Typical frequency response for the Insertion Loss and the return loss of an EN-100C Network Isolator. PD 1056-V20 Page 19/23 2013 EMO Systems GmbH
10 CIRCUIT DIAGRAM Circuit diagram for all EN-100 variants 11 PACKAGING Packaging contents: EN-100 Network Isolator A packaging label is affixed to the packaging. This label contains the following information: Article description Quantity Order Code (OC) Date of Manufacture Serial number The serial number is printed as a 1D- (Code 128) and 2D barcode (Data Matrix). PD 1056-V20 Page 20/23 2013 EMO Systems GmbH
12 PRODUCT MARKINGS This mark certifies conformity of the product with all applicable EU Directives. Designates the product as a UL "Recognised Component"; File no. E249126 The product may not be disposed of with domestic waste. This product contains no substances containing lead and is manufactured using leadfree solder. This product meets the requirements of EC Directive 2002/95/EC concerning the limitation of the use of certain hazardous substances in electrical and electronic equipment. 13 MAINTENANCE When used as directed, EMOSAFE Network Isolators are maintenance-free. 14 ENVIRONMENTAL PROTECTION INFORMATION This device contains electronic components. At the end of its service life, it is to be returned to the manufacturer for disposal. 15 QUALITY EMO Systems maintains a certified quality management system for development and manufacturing according to ISO 9001 and ISO 13485. Before dispatch, each Network Isolator is subjected to a comprehensive quality inspection. Among other things, an examination takes place to see whether the values achieved for leakage current, dielectric strength, Insertion Loss, Return Loss and near-end crosstalk (NEXT) meet the specified requirements. 16 CERTIFICATES All Network Isolators from EMO Systems GmbH are also registered by UL International as "Recognized Components" under the file numbers E249126 and E362969. They are therefore suitable for use in American and Canadian markets. Furthermore, the compliance of our Network Isolators with the standards specifications IEC 60601-1:2005 (3 rd Ed.), UL 60601 and CSA 22.2 no. 601.1-M90 has been confirmed by an independent, accredited laboratory. To view a copy of these certificates, please visit the UL Online Directory or contact us directly. The conformity of our products with the requirements of the IEC 60601-1-2 is also attested to by an external laboratory. The test report is available upon request. PD 1056-V20 Page 21/23 2013 EMO Systems GmbH
17 DECLARATION OF CONFORMITY The company EMO Systems GmbH Rungestraße 19 10179 Berlin Germany hereby declares on its sole authority that the products EMOSAFE Network Isolators EN-100T EN-100L EN-100C EN-100S meet the requirements of the applicable Directives 2006/95/EEC (Electrical equipment designed for use within certain voltage limits), 2004/108/EEC (electromagnetic compatibility) and 2011/65/EU (on the restriction of the use of certain hazardous substances in electrical and electronic equipment). Applied harmonised standards specifications, national standards specifications and other standards documents: IEC 60601-1:1988, A1:1991 and A2:1995 IEC 60601-1: 2005 (3rd Edition) IEC 60601-1-2:2007 This document is valid from 11 November 2013 Berlin, 2013-11-11 Location, Date Friedrich Riemeier (Managing Director) Name (Function) PD 1056-V20 Page 22/23 2013 EMO Systems GmbH
18 CONTACT AND SUPPORT Our latest contact details can be found on our website: http://www.emosystems.de/en/kontakt. Alternatively, you may send an e-mail to the following address: 19 LEGAL NOTICE support@emosystems.de The information provided has been compiled with all due care, and is believed to be accurate and reliable. However, we cannot guarantee that the information is completely free from error. The end user is responsible and liable for the proper use of this product; we assume no liability. We reserve the right to make changes to this data sheet without prior notice. PD 1056-V20 Page 23/23 2013 EMO Systems GmbH