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The Power in

Electrical Safety Electrical Safety in medically used rooms according

IEC 60364-7-710:2002-11

Amin Shabou

2 BENDER > Electrical Safety in medically used rooms

opportunities with integrated solutions (Systems)

Past only components trend/future market: systems

http://www.bender-de.com/de/produkte/c/power-quality-and-energy-measurement/power-quality-and-energy-measurement/linetraxxR-pem555.html


Solutions presented by BENDER Group

Complete Solutions

4 BENDER > Electrical Safety in medically used rooms 4

Electrical safety


Why electrical safety?


History of the Standards

2018 2010 2000 1990 1980 1970 1960

1962:

VDE 0107/12.62 Bestimmungen für das

Errichten und Instand-

setzen elektrischer

Anlagen in medizinisch

genutzten Bereichen

1968:

VDE 0107/03.68 Bestimmungen für das

Errichten elektrischer


genutzten Bereichen

1981:

DIN 57107/VDE

0107/6.81 Errichten und Prüfen

von elektrischen


genutzten Räumen

1989:

DIN VDE

0107:1989-11 Starkstromanlagen in

Krankenhäusern und

medizinisch genutzten

Räumen außerhalb von

Krankenhäusern

1994: DIN VDE

107

(VDE 0107):1994-10 Starkstromanlagen in

Krankenhäusern und

medizinisch genutzten

Räumen außerhalb

von Krankenhäusern

2002: DIN VDE 0710

(VDE 0710):2002-11 Errichten von Nieder-

spannungsanlagen –

Anforderung für

Betriebsstätten, Räume und

Anlagen besonderer Art – Teil

710: Medizinisch genutzte

Bereiche

2002:

IEC 60364-7-

710:2002-11 Electrical Installations of

buildings – Part 7-710;

Requirements for special

installations or locations –

Medical locations

2012:

HD 60364-7-

710:2012 Low-voltage electrical

installation - Part 7-710:

Requirements for special

installlations or locations

– Medical locations


What does the standard say?

IEC 60364-7-710:2001-11 Electrical installations of buildings –

Part 7-710: Requirements for special installations or locations – Medical locations

This standard is applicable for:

Hospitals

Private Clinics

Medical and dental practices

Health care centres

Dedicated Medical Rooms in the work place

This IEC 60364-7-710 is a part of the IEC 60364-…. Series. This means, the other parts

of the IEC 60364-… series must be taken into account as far as necessary

How can I identify which other parts of the standard must be taken into account

Example 1

710.41 Protection against electric shock

corresponding chapters of IEC 60364-4-41 are to be taken into account

Example 2

710.556 Safety Services

corresponding chapters of IEC 60364-5-56 are to be taken into account


Standards which requires a medical IT system

Hospital standard worldwide

International

IEC 60364-7-710

UK

BS 7671 GN7 / HTM2007

Ireland

ETCI 10.1

Germany

DIN VDE 0100-710

Norway

64/747/FDIS

Netherlands

NEN 3134

Austria

ÖVE / ÖNORM E 8007

Spain

UNEE 2 0-615-80

Slovakia

STN 33 2140

France

NFC 15-211

Belgium

T 013

South-Africa

SANS 10142-1

Italy

CEI 64-4

Finland

SFS6000

Russia

GOST P 50571

Brazil

NBR 13543

Hungary

MSZ 2040

China

GB16895/GB5033-2002

NFPA99 Solutions are also available


Power in electrical safety

Solutions for

electrical safety

according to IEC 60364-7-710

Source: www.trilux.com


Classification of medical locations

710.3.5 Group 0 710.3.6 Group 1 710.3.7 Group 2

Applied

part

Medical location where

no Applied parts are

intended to be used

Medical location where applied

parts are intended to be used as

follows:

Externally

Invasively to any part of the

body, except where 710.3.7

applies

Medical location where applied parts

are intended to be used in applications

such as intra-cardiac procedures,

operating theatres and vital treatment.

Power

supply

Discontinuity cannot

cause danger of life

Discontinuity of electrical supply does

not represent a threat to safety of the

patient

Discontinuity (failure) of the supply can

cause danger of life

Example Massage room

Office

Bedroom

Haemodialysis room

Physiotherapy room

Operating theatre

Intensive care room

Premature baby room


Danger related to the electrical current

Impact of the electrical current on the human body

A human being is in danger already when, after the occasional touch of a powered piece of

metal, a current of more than 30mA is flowing through parts of the body.

Cardiac Arrest

Irreversible Defects

Contraction of the muscles

Paralysition

Apnoea

Cardiac Arrhythmia

Irreversible Defects of the Heart

Reversible Defects

Shock


Danger related to the electrical current

Impact of the electrical current on the human body

Inside an ICU, an OR, a premature baby room or a dialysis room and while insertion of pipes and tubes …

the critical limit is reduced down to about 10µA !!

Cardiac Arrest

Irreversible Defects

Contraction of the muscles

Paralysition

Apnoea

Cardiac Arrhythmia

Irreversible Defects of the Heart

Reversible Defects

Shock

0,01 mA


In the medical sector there is also

the special situation of the patient …

The risks for the patients in hospitals ...

The patient`s natural reactions to hazards

are reduced or switched-off

The heart muscle is highly sensitive to

electric currents (currents > 10 µA)

Simultaneous application of similar ME on the patient

The insertion of catheters and the like into the body may

reduce the electrical resistance of the skin

Body functions are temporarily or continuously supported or substituted

by medical electrical devices

Fire and explosion risks through the use of

anaesthetics, disinfectants or cleaning

Additional risks by secondary effects

(Downfall, Burn …..)


The power in electrical safety

How can the medical IT system

and the power supply of medical

locations perfectly monitored ?


Transformers for medical IT systems (710.512.1.1)

Requirements for the transformer

Transformers shall be

installed in close proximity to, inside or outside, the

medical location

placed in cabinets or enclosures to prevent unintentional

contact with live parts.

Rated voltage Un on the secondary side of transformers ≤ 250 VAC

Transformers according IEC 61558-2-15, with additional requirements:

The leakage current of the output winding to earth and the leakage current of the enclosure, when

measured in no-load condition and the transformer supplied at rated voltage and rated frequency, ≤ 0.5

mA.

Rated output of the transformers 0.5 kVA … 10 kVA.

For three-phase loads with an IT system a separate three-phase transformer shall be provided for this

purpose with output line-to-line voltage not exceeding 250 V.


Transformers for medical IT systems

Requirements for the transformer

IEC 61558-2-15

Safety of power transformers,

power supply units and similar

Part 2-15: Particular requirements for isolating

transformers for the supply of medical locations:

short circuit voltage ≤ 3%

no-load input current ≤ 3%

inrush current ≤ 12 x rated input current

Single phase transformers

ES0710 series

acc. to IEC 61558-2-15

1…10 kVA

Vertical or horizontal version,

or installed in an enclosure


18

Transformers for medical IT systems


Monitoring of medical IT system

What does the standard say ?

710.413.1.5 Medical IT system

For each group of rooms serving the same function, at least one separate medical IT system is necessary

The medical IT system shall be equipped with an insulation monitoring device in accordance with IEC 61557-8

with the following specific requirements:

the a.c. internal impedance shall be at least 100 kΩ;

the test voltage shall not be greater than 25 V d.c.;

the injected current, even under fault conditions, shall not be greater

than 1 mA peak;

indication shall take place at the latest when the insulation resistance

has decreased to 50 kΩ. A test device shall be provided;

NOTE 2

In Germany, an indication is required if the earth or wiring connection is lost.

Monitoring of overload and high temperature for the

medical IT transformer is required.


IEC 61557-8 Annex A


Load- and temperature monitoring

1st advantage – monitoring of load current IL

Measurement of the load current using a

measuring current transformer

If the transformer power is exceeded

(load current) there is immediate signalling on

plugging in ME equipment

Shut down of unnecessary equipment

2nd advantage – monitoring of temperature

Measurement using a PTC resistor in the

transformer winding

A slow increase in the temperature

of the winding core is detected

Fire risk and damage

due to overheating are prevented

Note:

In the main feeder of the

IT system transformer over-current

protective devices are only used for

protection against short-circuits, so that an

overload does not lead to a power failure !


Medical Insulation Monitoring Device (Med-IMD)

isoMED427P

Application Medical IT systems in medical locations

of group 2 according to IEC 60364-7-710:2002 Medical IMD for monitoring of Insulation resistance Load current Transformer temperature

+ additional features Indication, if earth connection or

connection to system be monitored is lost Integrated test puls generator for insulation

fault location in combination with EDS 151 Fullfills Annex A IEC 61557-8:2007 medical IMD Password protected setup

Clear Textdisplay

Sealable Cover Clear indication

by bright LEDs

Test- and

Resetbutton

intern./extern

Two separate

response

values for pre-

warning/alarm

Setup keys

Communication

Interface for

indication and

operation panels

Space saving

enclosure,

only 35 mm

Technical features

Bender Standard

Nominal voltage AC 70…264 V -

Response value 50…500 kΩ 50 kΩ

Response time ≤ 1 s -

Measuring voltage Um ≤ 12 V DC ≤ 25 V

Internal impedance ≥ 240 kΩ ≥ 100 kΩ

Measuring current ≤ 50 µA ≤ 1mA

Load current 5…50 A -

Transformer temperature 4kΩ (PTC acc. DIN 44081)

Test / Reset button Int. / ext.

Interface BMS (2…90)

2 separate

Output Relays


Why Insulation fault location system?

In intensive care locations several socket-outlets are

arranged at every patient place, sometimes up to 24 socket

outlets and more

In an intensive care unit with 4 beds, for example, these are

more than 90 socket outlets

In intensive care units usually no technical experts are

present, but medical personnel

If a defective device causes an insulation fault,

it will be very difficult to locate the associated

socket outlet

In order to guarantee the patient's safety,

the insulation fault must be found as

quick as possible.


Where is the insulation fault?

IEC 60364-7-710: 413.1.5.4

It is recommended that the first fault be eliminated with the shortest practicable time

But how ?

The solution

Earth fault detection system

EDS151


Insulation fault locator (IFLS) EDS151

with 6 integrated measuring transformers

Technical data

Supply voltage AC 17…24 V

DC 14…28 V

Response value 0,5 mA

Response time ≤ 8 s

Scanning time for all channels approx. 72 s

No. of measuring channels 6 / 528

Interface RS-485 / BMS

Application

Medical locations of group 2 according to IEC 60364-7-

710:2002, e.g. ICU

Up to 528 measuring channels

Scanning time for all channesls approx. 72 s

in combination with Isometer iso427PG

Cyclical self test

+ Additional features

Space-saving construction

Easy installation inside distribution boards

Wide assembling opening for cables and wires

IFLS according IEC 61557-9:2007

Alarm LED

per channel

CT

openings

10 mm

On/Com LED

and bus activity

Setup for

BMS

address

Plugable

Connector


Requirements from IEC 60364-7-710

710.413.1.5

Alarm system

at a suitable

place

Permanently

monitored by medical

staff

IEC 60364-4-41

Protection against

electric shock

413.1.5.4

Its recommended that the

first fault be eliminated with

the shortest practicable time

Intensive care units based on IEC 60364-7-710


Complete Solution

ICU according IEC 60364-7-710

IEC 60364-4-41

Protection against

electric shock

413.1.5.4

Its recommended that

the first fault be

eliminated with the

shortest practicable

time

IFLS system acc.

IEC 61557-9

710.413.1.5

Alarm system at

a suitable place

Permanently

monitored by

medical staff


How do you inform your staff?

Requirements for Remote alarm indications

For each medical IT system, an acoustic and visual alarm system

shall be arranged at a suitable place so that it can be permanently

monitored by the medical staff:

A green signal lamp to indicate normal operation

A yellow signal lamp which lights when the minimum value

set for the insulation resistance is reached. It shall not be

possible for this light to be cancelled or disconnected

An audible alarm which sounds when the minimum value

set for the insulation resistance is reached. This audible

alarm may be silenced.

The yellow signal shall go out on removal of the fault and

when the normal condition is restored

Note: Additionally overload and overtemperature of the IT

system transformer must be indicated.


Indication and control panel MK2430

Application Display of status and alarm messages

in medical locations of group 2

according to IEC 60364-7-710:2002

Straightforward setup of information networks

due to bus connection

Straightforward commissioning due to

pre-defined message texts

+ Additional features

For flush and surface mounting

Standard texts in 20 languages

Preparation of custom message texts

Simple IMD function test

Data logging with time stamp (250 events)

Digital inputs for transfer of other messages

Technical data

Supply voltage AC/DC 24 V

Display Four-line, 4 x20 characters

Programmable text

messages 200

History buffer 250 messages

Alarm relay 1 change-over contact

(type -11)

Digital inputs 12 (type -11)

Interface RS485 / BMS

Address range 1…150

Master support Yes

Information

assessment

by coloured

LED green,

yellow, red

20

languages

Freely progr.

message

texts

Large

buttons

Illuminated

text display

4x20

characters

Test button

12 digital

inputs

History buffer

250 entries

Easy-to-

clean

front foil

Acknowledge

button


Communcation structure


BMS Ethernet Gateway COM460IP

Application Modular, expandable gateway between

BMS bus and TCP/IP Gateway between BMS bus and Ethernet Remote access via LAN, WAN or Internet Display of BMS data via a standard web browser with

Silverlight Range of functions customisable through options

Technical data

Supply voltage AC/DC 76…276 V

Baud rate / BMS 9,6 kbit / s / 57,6 bits/s

Ethernet connection 2 x RJ45

Data rate 10/100 Mbit/s, autodetect

Protocols

(depending on the options

selected)

TCP/IP, ModBus/TCP,

DHCP, SMTP, NTP

Additional features

Commissioning and diagnostic functions for BMS systems

Output of system-specific text codes for devices and metering points Logging and display of alarms with a time stamp (history memory)

Comprehensive data logger functions

E-mail/SMS notifications to various use groups in event of alarms and system faults

Report function (file export)

Info button:

to call up

standard

information

Bright

LEDs

Micro SC

card

slot

LC

Display


The complete solutions

Isolating

transformer

Insulation monitoring

Devices (IMD)

Indication and Control panel Change-

over

Typ ES710 DS0107 IR427 107TD isoMED427P MK7 MK2430 MK2007 Touch ATICS

System

1ph X - X - X - - - - X

3ph - X - LSD470 - - - - - X

Monitoring

Insulation - - X X X X X X X X

Overload - - X X X X X X X X

Temperature - - X X X X X X X X

Fault location - - - - EDS151 - X - X EDS151

Change-over - - - - - - X - X X

Indication

LED - - X X X X X X - X

Text display - - - Dot

matrix

- - Grafik - Grafik X

7-Segment - - X - X - - X - -

Data logging - - - - - - X - X X

Individual text - - - - - - X - X -


Three levels of value propositions

Bender offer Device Basic Standard Complete

Ensure patient safety

and service continuity

IMD Type IR427 n

IMD Type

isoMED427P - n -

ATICS module - n n

Improving efficiency

of operating room

personnel Indication and

operation panels

MK7 MK2430 Touch panel

Improving efficiency

of maintenance personnel - MK2430 Touch panel

COM460IP

Improve efficiency

of suppervisory personnel - - Touch panel

COM460IP

Events tracebility

Hospital BMS COM460IP

Touch panel - -

Touch panel

COM460IP


…to summarize

Summarize

Ungrounded Power Systems

acc. to IEC60364-7-710 offer

and guarantee a higher protection for

patients and staff !

Fault location systems offer precise and fast

localisation of defective electrical equipment

offer and guarantee a higher protection for patients

and staff !

modern and sophisticated indication panels and

visualization possibilities offer precise and fast

information to medical and technical staff

BENDER offers solutions for the power supply

of hospitals according IEC 60364-7-710

Source: www.trilux.com


References


Hospitals using Bender in Brazil, US, UK, China,

Germany (for illustration)


Former and actual Projects

Österreich - Zentralklinikum St. Pölten

Belgien – Universitätsklinik Brüssel

Norwegen – Aker Sykehus Oslo

Deutschland – Charité Berlin

Deutschland – Universitätsklinik Hamburg

England – Kings College Hospital London

Luxemburg – Universitätsklinik Luxemburg

Irland – Königin Victoria Krankenhaus Belfast

Qatar – Al Wakrah Hospital Doha

Prince Hamza Hospital, Amman, JO (IEC)

SIDRA-Hospital, Doha, QA (IEC)

Al-Mansoura-Hospital, Tanta, EG (IEC)

King Fahd Medical City, Riyadh, KSA (NFPA)

and many more for IEC and NFPA …


Thank You!

Dipl. Ing. Amin Shabou Bender GmbH & Co. KG Londorfer Strasse 65 35305 Gruenberg – Germany www.bender.de

phone: +49 6401 807-280 Fax: +49 6401 807-259 E-mail: [email protected]

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