EMO SYSTEMS EMO EN-100C Datasheet

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EMO S ystems GmbH • Rungestr. 19 • 10179 Berlin • Germany • Tel.: +49 . 30 . 4000 475-80 • Fax: +49 . 30 . 4000 475-90 • [email protected] • www.emosystems.de

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 (3rd 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.

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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.

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EN-100

Network Isolators for PCB assembly

Name

Article

number

Special features

Dielectric strength

in kV (AC)

TVS diodes

10/100/1000

Mbit

Return Loss @

100MHz in dB

Insertion Loss @

100MHz in dB

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

4 SUMMARY OF VARIANTS

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5 DRAWINGS

All dimensions in millimetres

5.1 EN-100T

5.1.1 EN-100T MODULE DIMENSIONS

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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.

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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.

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5.2 EN-100L

5.2.1 EN-100L MODULE DIMENSIONS

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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.

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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.

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5.3 EN-100S

5.3.1 EN-100S MODULE DIMENSIONS

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5.3.2 EN-100S FITTING DIMENSIONS

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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.

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5.4 EN-100C

5.4.1 EN-100C MODULE DIMENSIONS

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5.4.2 EN-100C FITTING DIMENSIONS

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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.

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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.

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Category

Standards specifications or test criteria

Characteristic Name

EMOSAFE EN-100 (...)

Designed for

PCB module

Supported network protocols

IEEE802.3

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

IEC 60601-1:2005 (3rd)

UL 60601-1 Protection Class I and Class II devices or

devices with an independent power supply; with applied parts B, BF and CF

Isolation type

Reinforced isolation

Isolation distances which are realised internally

12.5 mm clearance and leakage distances Markings

CE, UL, RoHS compliant, lead(Pb)-free

Category

Standards specifications or test criteria

Characteristic

Housing dimensions

See dimensioned drawings

Weight

approx. 6 g

Category

Standards specifications or test criteria

Characteristic

Maximum operating voltage (maximum mains voltage) of connected devices

IEC 60601-1:2005 (3rd)

UL 60601

≤ 400 V AC / ≤ 450 V DC Dielectric strength (AC/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 VAC / 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

IPP = 1A, tp=8/20µs

12.5 V

IPP = 5A, tp=8/20µs

17.5 V

IPP = 12A, tp=8/20µs

25.0 V

9 SPECIFICATIONS

9.1 GENERAL

9.2 MECHANICAL

9.3 ELECTRICAL

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Category

Criteria

Characteristic

Storage

Temperature Air humidity Air pressure

-25 to +70 °C 10 to 90% (non-condensing) 700 to 1060 hPa

Transportation

Temperature Air humidity Air pressure

-40 to +70 °C 10 to 90% (non-condensing) 500 to 1060 hPa

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

10 to 90% (non- condensing)

Air pressure

500 to 1060 hPa

Max. operating voltage of equipment connected in V AC/V DC

400/565

Achievable protective measures, number and type in accordance with IEC 60601-1:2005

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

9.4 ENVIRONMENTAL CONDITIONS — STORAGE AND TRANSPORTATION

9.5 OPERATING CONDITIONS AND AREA OF APPLICATION

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Required

Actual dimensions

Clearance distance

7 mm

12.5 mm

Leakage distance

12 mm

12.5 mm

A

Ethernet Ethernet

Output

PCB

9.6 ISOLATION DIAGRAM

Valid for all variants

Input

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.

9.7 FREQUENCY RESPONSE

Typical frequency response for the Insertion Loss and the return loss of an EN-100C Network Isolator.

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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).

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EMO Systems GmbH • Rungestr. 19 • 10179 Berlin • Germany • Tel.: +49. 30. 4000 475-80 • Fax: +49. 30. 4000 475-90 • [email protected] • www.emosystems.de

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.

12 PRODUCT MARKINGS

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 (3rd 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.

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Berlin, 2013-11-11

Location, Date

Friedrich Riemeier (Managing Director)

Name (Function)

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 re- striction 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

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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:

[email protected]

19 LEGAL NOTICE

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.