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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
3 BENDER > Electrical Safety in medically used rooms
Solutions presented by BENDER Group
Complete Solutions
7 BENDER > Electrical Safety in medically used rooms 7
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
Anlagen in medizinisch
genutzten Bereichen
1981:
DIN 57107/VDE
0107/6.81 Errichten und Prüfen
von elektrischen
Anlagen in medizinisch
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
8 BENDER > Electrical Safety in medically used rooms
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
9 BENDER > Electrical Safety in medically used rooms 9
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
10 BENDER > Electrical Safety in medically used rooms 10
Power in electrical safety
Solutions for
electrical safety
according to IEC 60364-7-710
Source: www.trilux.com
11 BENDER > Electrical Safety in medically used rooms 11
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
12 BENDER > Electrical Safety in medically used rooms 12
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
13 BENDER > Electrical Safety in medically used rooms 13
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
14 BENDER > Electrical Safety in medically used rooms 14
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 …..)
15 BENDER > Electrical Safety in medically used rooms
The power in electrical safety
How can the medical IT system
and the power supply of medical
locations perfectly monitored ?
16 BENDER > Electrical Safety in medically used rooms 16
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.
17 BENDER > Electrical Safety in medically used rooms 17
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
19 BENDER > Electrical Safety in medically used rooms
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.
21 BENDER > Electrical Safety in medically used rooms 21
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 !
22 BENDER > Electrical Safety in medically used rooms 22
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
23 BENDER > Electrical Safety in medically used rooms
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.
24 BENDER > Electrical Safety in medically used rooms 24
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
25 BENDER > Electrical Safety in medically used rooms 25
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
26 BENDER > Electrical Safety in medically used rooms
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
27 BENDER > Electrical Safety in medically used rooms 27
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
28 BENDER > Electrical Safety in medically used rooms 28
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.
29 BENDER > Electrical Safety in medically used rooms 29
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
31 BENDER > Electrical Safety in medically used rooms 31
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
32 BENDER > Electrical Safety in medically used rooms 32
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 -
33 BENDER > Electrical Safety in medically used rooms 33
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
34 BENDER > Electrical Safety in medically used rooms 34
…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
36 BENDER > Electrical Safety in medically used rooms
Hospitals using Bender in Brazil, US, UK, China,
Germany (for illustration)
37 BENDER > Electrical Safety in medically used rooms 37
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 …