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Power in electrical safety

Electrical Safety for

• hospitals
• private clinics
• medical and dental practices
• health care centres

according to
IEC 60364-7-710:2002-11
© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 1
Seminar topics

Why electrical safety in hospitals?


International standard for medical locations: IEC 60364-7-710
Classification of medical locations
Power supplies of main distribution
IT-system in group 2 rooms
Redundant power supply with change over system
Insulation fault location in IT-systems

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Why is a maximum of electrical safety required ?

! The patient`s ability to react


normally on possible hazards is
reduced or eliminated.
! The electrical resistance of the
skin may be reduced through the
insertion of catheters and the like
into natural or artificial orifices.
! The heart muscle is highly
sensitive to electric currents
(currents >10μA).
! Body functions are temporarily or
continuously supported or
substituted by medical electrical
devices.
! Fire and explosion hazards
through anesthetics, disinfection or
cleaning agents may occur.

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Why is a maximum of electrical safety required?

! Electric and magnetic interferences,


e.g. from the power system,
may expose patients to hazards
or may influence the function
of medical electrical devices.
! Surgeries cannot be interrupted
or repeated.
! Intensive care requires simultaneous
application of several medical
electrical devices.
! Permitted leakage currents may
add to critical values.
! Long term recordings of patient
data get lost in case of power
failures.

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The safety concept in healthcare facilities

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A new standard since November 2002

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General scope of IEC 60364-7-710

! IEC 60364-7-710 apply to electrical installations


in medical locations so as to
ensure safety of patients and medical staff.

! NOTE 1
It may be necessary to modify the existing electrical installation
when a change of utilization of the location occurs.
Special care should be taken where intracardiac procedures are
performed in existing installations.

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 7


Power in electrical safety

Classification
of
medical
locations
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Classification of medical locations
710.30

! Classification of a medical location shall be made in agreement with


! the medical staff
! health organization concerned or
! body responsible for the safety of workers in accordance with
national regulations.

! It is necessary that the medical staff indicate which medical procedures


will take place within the location. Based on the intended use, the
appropriate classification for the location shall be determined.

! NOTE 1
Classification of a medical location should be related to the type of contact
between applied parts and the patient, as well as the purpose for which the
location is used.

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Classification of medical locations
(710.3.5-7)

Classification of groups 0 1 2
Disconnection in case of the first fault
a) Patients at risk no no yes
b) Can the examination or treatment be yes yes no
repeated or interrupted ?
Failure of the normal power supply
a) Patients at risk no no yes
b) Can the examination or treatment be yes yes no
repeated or interrupted ?
Use of applied parts
a) Externally or invasively, but not for intracardiac
application and where power failure can cause no yes yes
danger to life.
b) For intracardiac procedures in operating theatres
and for vital treatment where discontinuity of
the supply can cause danger to life. no no yes

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Rooms of group 0 (710.3.5)
! Features
! Disconnection
• In the event of a first short circuit to
exposed conductive parts or earth
fault.
• Failure of the normal power supply
! Examination and treatment
• Interruption/repitition can be tolerated
Examination and treatment can be
interrupted and repeated.
! No use of applied parts

! Examples
Consultation rooms, general wards
! Protective measures
! According to IEC 60364-4-410
! Additional protection
! By equipotential bonding
! Safety power supply source
! Safety lighting SV

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Rooms of group 1 (710.3.6)

! Features
! Disconnection
• In the event of a single short circuit
to exposed conductive parts or
earth fault.
• Failure of the normal power supply
! Examination and treatment
• Interruption/repitition can be tolerated
! Applied parts
• used externally
• Invasively to any part of the body (except
where 710.3.7 applies ->cardiac zone)

! Examples
! Rooms for physiotherapy or hydrotherapy
! Dialysis rooms

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Rooms of group 1 (710.3.6)

! Protective measures
! Double insulation
! Safety extra-low voltage SELV
! Functional extra-low voltage PELV, FELV
! RCD in TN-S systems
! IT system with insulation monitoring

! Supplementary protection
! by equipotential bonding

! Safety power supply


! Safety lighting
with safety power supply source

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Rooms of group 2 (710.3.7)

! Features
! No disconnection
• In the event of a first short circuit to
exposed conductive parts or earth fault
• Failure of the normal power supply
! Examination and treatment
• No interruption or repetition
! Use of applied parts
• for intracardiac procedures
• for vital treatment

! Examples
! Operating theatres
(preparation, major surgery, post-operative treatment)
! Intensive care rooms
! Cardiac catheter rooms

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Rooms of group 2 (710.3.7)
! Protective measures
! Double insulation
! Safety extra-low voltage SELV
! Functional extra-low voltage PELV, FELV
! RCD (not for feeding life-supporting
equipment)
! IT system with insulation monitoring
for circuits feeding life-supporting
equipment

! Supplementary protection
! by equipotential bonding

! Safety power supply


! Safety lighting and safety power supply for
socket-outlets, devices, motors and the like.
! Special safety power supply source for
luminaires of operating theatre tables
and for life-supporting equipment, if required
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List of examples for allocation of medical locations

Annex B
Table B.1

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Power in electrical safety

Power supplies
in
medical
locations
© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 17
Which power supply system is required by the
IEC 60364-4-410 standard ?
1st letter: earthing of the current source
T = direct earthing one point of the current
source
I = isolation of all active parts from earth

2nd letter: earthing conditions of the body of the


electrical installation
T = the exposed conductive parts are earthed,
independently of the earthing of any point of the
current source which might exist
N =the exposed conductive parts are directly
connected with the earthing point of the current
source in AC systems, the earthed point is
generally the neutral point

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The use of earthed systems in hospitals

! Chapter 710.312.2:
The TN-C system is not allowed
in medical locations and medical
buildings downstream of the main
distribution board.

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The TN-S system in medical locations
(710.413.1.3)

! In final circuits of group 1 rated up to 32 A, RCDs ≤ 30 mA shall be


used (additional protection).

! Care shall be taken to ensure that simultaneous use of many items


of such equipment connected to the same circuit cannot cause
unwanted tripping of the residual current protective device (RCD).

! In medical locations of group 1 and group 2, where RCDs are required,


only type A or type B shall be selected, depending on the possible
fault-current arising.

! NOTE:
It is recommended that TN-S systems are monitored to
ensure the insulation level of all live conductors.

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Power in electrical safety

Fault current monitoring in the


TN-S system of the main
distribution board

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RCMS system - features

! The RCMS470 system monitors


! fault/residual currents
! operating currents

! Modular system – up to 720 subcircuits


Response value 1mA ... 2250A

! Use in medically used locations


! Socket-outlet circuits which should not
fail
! Alarm systems, safety devices
! Air conditioning systems, EDP systems
! Cold storage equipment with valuable
frozen goods
! Canteen kitchens
! Monitoring TN-S systems for stray
currents, loading of N-conductors

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 22


Power in electrical safety

The electrical installation


of group 2 rooms

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TN-S system in medical locations of group 2
(710.413.1.3)

! In medical locations of group 2, protection


by automatic disconnection of supply
by means of RCD ≤ 30 mA shall
only be used on the following circuits:

! circuits for the supply of operating


tables
! circuits for X-ray units
! circuits for large equipment with a
rated power ≥ 5 kVA
! circuits for non-critical electrical
equipment
(non life support)

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The medical IT-System (710.413.1.5)

! In group 2 medical locations, the


medical IT system shall be used for
circuits supplying

! medical electrical equipment


! systems intended for life support
! surgical applications
! other electrical equipment located
in the "patient environment",
! excluded equipment listed in
713.413.1.3.

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Why isolated power ? – Increased operational safety

In IT systems
! In the event of an insulation fault RF
only a very low capacitive current Ice flows

! Fuse does not trip


! In the event of a single-pole earth fault,
the power supply is guaranteed
! No interruption of operation
! Alarm indicated by an A-ISOMETER®

In TN systems
! A fault current flows determined by the earth
resistance and the insulation fault.

! IF<Ia Fuse does not trip -


• Risk of malfunctions
• No alarm
! IF >Ia Fuse trips -
• Unexpected interruption of operation
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Why isolated power ? – Low leakage currents

In TN systems
! A high fault current can flow
! The fault current is only limited by
the body impedance

In IT systems
! The IT system is a small local
network with low leakage
capacitances.
! The fault current is limited by the
body impedance, the earthing
resistance and the high impedance
of the fault loop.
! Hazards to persons and equipment
arising from high fault currents are
reduced.

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Why isolated power ? – High degree of fire safety

In TN systems
! When the fault current IF ≤ Ia
! Fuse does not trip
! The electrical energy of the
fault current is transformed
into thermal energy
! Fire risk at
P ≥ 60 W = 260mA/230V).

In IT systems
! A small current flows limited by
the high impedance of the fault loop.
! Considerable less fire risk
! Increased protection for persons
and equipment

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Design of an IT system

! The IT system is supplied by an independent power source, e.g.

! Distribution / isolation transformer


! Control-power transformer
! Generating set
! Battery
! Inverter of an UPS

! The IT system has no direct


connection between live conductors
and earth.

! All exposed conductive parts of the


electrical installation are earthed.

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Transformers for medical IT systems
(710.512.1.1)

! 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.

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 30


Transformers for medical IT systems
(710.512.1.1)

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

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Transformers for medical IT systems

! Single phase transformers


! ES0107 series
! acc. to IEC 61558-2-15
! 1…10 kVA
! Vertical or horizontal
version, or installed in an
enclosure

! Three-phase transformer
! DS0107 series
! acc. to IEC 61558-2-15
! 1…10kVA
! Vertical or horizontal
version, or installed in an
enclosure

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The insulation monitoring device (IMD)
(710.413.1.5)

! 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:

! a.c. internal impedance > 100 kOhm


! the test voltage ≤ 25 V d.c.
! injected current ≤ 1 mA peak, even under fault conditions
! indication when insulation resistance ≤ 50kOhm
! a test device shall be provided

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Measuring principle of an IMD

! The insulation monitoring device is


connected between live conductors
and earth.
! The measuring voltage Um
generated by G is superimposed
onto the system via the coupling Ri,
the measuring resistance Rm and a
low pass filter.
! An insulation fault RF between
system and earth closes the
measuring circuit.
! Im causes a voltage drop Um
proportional to the insulation fault RF
across the measuring resistance Rm.

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A-ISOMETER 107TD47

****IT system ****


R >500kΩ I = 20%

Feature 710.413.1.5 107TD47


Internal impedance > 100 kOhm > 240 kOhm
Measuring voltage < DC 25 V < DC12 V
Measuring current max. 1 mA < 50 uA
Alarm < 50 kOhm 50...500 kOhm

Interruption - Indication
system/earth
connection
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Protection of the IT system
(710.413.1.5, 710.53.1, 710.55.3)

! Overload and overcurrent protection is not allowed


upstream and downstream in the feeder circuit of
the medical IT system transformer (risk: unexpected
tripping)

! Fuses may be used for short circuit protection

! Monitoring of overload and high temperature for the


medical IT transformer is required

! Socket outlet circuits in group 2 rooms:


at each patient‘s place of treatment
! Min. two separate circuits or
! each socket- outlet shall be protected individually
against overcurrent

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Load, temperature and insulation monitoring
with 107TD47

Temperature

Load
Insulation

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Remote alarm indications in rooms of
group 2 (710.413.1.5)

! 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.

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Remote alarm indicator MK2007CBM

! Clear digital seven-segment display


for the indication of the insulation
resistance (3 digits) and the load
current (2 digits)
! Time and cost-saving installation
via a two-wire connection (RS485).
! Easy-to-clean lexan front foil
! Simple parallel indication through
two-wire interface
! Power On LED => green
! Alarm LEDs (insulation fault,
overtemperature, overload)
=> yellow

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Remote alarm indicator MK2418

Alarm LED
! illuminated LC display

! Time and cost-saving


installation via a two- Power On LED
wire connection
(RS485) illuminated two-line
LC display
! Easy-to-clean lexan
front foil key, additional text
scroll menu
! Simple parallel
indication through
two-wire interface key, TEST ISOMETER
scroll menu
! Green Power On LED
key, buzzer,
! Yellow alarm LED acknowledge
menu ESC

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Remote alarm indicator for one or more IMD :
MK2418

107TD47 107TD47

• Text display for information


• Two wire RS485 connection
• Alarms of several insulation monitors can
be displayed
• Parallel indication possible

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Remote alarm indicator MK2418C for additional
information from inputs, e.g. medical gases

MK 2418C-11
8 digital inputs, e.g.
O2
CO2
107TD47 Aircon
medical
RS485
gas

The data can be transferred to other MK2418C-12 installed in parallel.


© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 42
TM operator panels

• Large, backlit text display indicates


user-programmable alarm text
messages and additional
information.
• Three LEDs provide normal
(green), warning (yellow), and
alarm (yellow) indication.
• Different output/input options
provide easy connection to other
systems
• Installation of other technical
equipment,e.g. operating theatre
table control, paging systems,
lighting, etc.
© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 43
TM operator panels

! Alarm/warning messages are


automatically stored with date
and time stamp.
! 650 text messages can be
stored in memory.
! Easy programming of text
messages via serial interface
RS232 and PC software.
! Flush and surface mounted
enclosures are available.

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Power in electrical safety

Notes for the electrical


installation
of group 2 rooms

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Supplementary equipotential bonding
(710.413.1.6)

! In each medical location of group 1 and group 2, supplementary


equipotential bonding conductors shall be installed and connected to
the equipotential bonding bus bar for the purpose of equalizing
potential differences between the following parts, located in the
"patient environment":
! protective conductors
! extraneous-conductive-parts
! screening against electrical interference fields, if installed
! connection to conductive floor grids, if installed
! metal screen of the isolating transformer, if any

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Equipotential bonding in group 2 rooms

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Installations in group 2 rooms

! At each patient’s place of treatment, e.g. bedheads, the configuration


of socket-outlets shall be as follows:

! either a minimum of two separate circuits feeding


socket-outlets shall be installed or
! each socket-outlet shall be individually protected against
overcurrent.

! Where circuits are supplied from other systems (TN-S systems) in the
same medical location, socket-outlets connected to the medical IT
system shall either:
! be of such construction that prevents their use in other systems or
! be clearly and permanently marked.

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Power in electrical safety

The safety
power supply
in medical locations
© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 49
General power supply in hospitals
(710.313.1 )
! In medical locations the distribution system should be designed
and installed to facilitate the automatic change-over from the main
distribution network to the electrical safety source feeding essential
loads

! AV = Normal power supply source


! SV = Safety power supply source
! HV = Main distribution board

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 50


Safety services power supply sources
(710.556.5.2)

! General requirements for safety power supply sources


of group 1 and group 2

! In medical locations, a power supply for safety services is


required which, in case of a failure of the normal power supply
source, shall be energized to feed the equipment stated in
710.556.5.2.2.1, 710.556.5.2.2.2 and 710.556.5.2.2.3 with
electrical energy for a defined period of time and within a pre-
determined changeover period.

! If the voltage at the main distribution board drops in one or


several line conductors by more than 10 % of the nominal voltage,
a safety power supply source shall assume the supply
automatically.

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Equipment for changeover period > 15 s

! Equipment which is required for the maintenance of hospital services, may be


connected either automatically or manually to a safety power supply source
capable of maintaining it for a minimum period of 24 h. This equipment may
include, for example:

! sterilization equipment
! technical building installations, in particular air conditioning,
heating and ventilation systems, building services and
waste disposal systems
! cooling equipment
! cooking equipment
! storage battery chargers

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Equipment for changeover period ≤ 15 s

! selected lifts for firemen


! ventilating systems for smoke extraction;
! paging systems
! medical electrical equipment used in group 2 medical
locations which serves for surgical or other measures of vital
importance. Such equipment will be defined by responsible
staff
! electrical equipment of medical gas supply including compressed
air, vacuum supply and narcosis (anaesthetics) exhaustion as well
as their monitoring devices
! fire detection, fire alarms and fire extinguishing systems

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Equipment for changeover period ≤ 15 s

! Escape routes
! Lighting of exit signs
! Locations for switchgear and controlgear for emergency
generation sets.
! Distribution boards of the normal power supply and for power
supply for safety services.
! Rooms in which essential services are intended. In each room at
least one luminaire shall be supplied from the power source for
safety services.
! Rooms of group 1 medical locations. In each room at least one
luminaire shall be supplied from the power supply source for
safety services.
! Rooms of group 2 medical locations. A minimum of 50 % of the
lighting shall be supplied from the power source for safety
services.

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Changeover period for power supplies

! Changeover period less than or equal to 0.5 s (710.556.5.2.2.1)

! In the event of a voltage failure of one or more line


conductors at the distribution board, a special safety power supply
source shall maintain

! luminaires of operating theatre tables and other essential


luminaires, e.g. endoscopes, for a minimum period of 3 h.
! It shall restore the supply within a changeover period not
exceeding 0.5 s.

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Power supply with one power line

! Power failures of the utility supply


or damages of the supply cable
should not have an impact on the
continuity of the supply to the IT
system:

! One supply cable with the risk of


a complete loss of power supply

ZSV = Special safety power supply source

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Power supply with two supply lines

! Two supply cables –


main distribution: In case one
cable fails, an automatic
changeover unit initiates
automatically a transfer to a
second supply line

! changeover time <15s


(time to start the generator)

ZSV = Special safety power supply source

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Power supply with two supply lines and a special
safety power supply source

! Two supply lines with a safety


power source
! operating theatre
! The second supply line is
supplied via an UPS system.
This ensures the supply of life-
supporting devices,
independently from the utility
supply and the emergency
generator.

! Switchover time <0.5s


with a battery capacity for 3 hours.

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 58


Installation example for an intensive care unit
IT system for 4 beds

UFC107E65-12-B16

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 59


Application example "Intensive care unit"
IT system for 4 patient places

! Requirements of 710.413.1.5
! For each group of rooms at least one separate IT system
! Example 4 patient places

! Capacity balance
! Capacity per bed 600 W 2400 W for 4 beds
! In addition one high-capacity load 2000 W

- Total: 4400 W for 4 beds


- IT system transformer 5 kVA

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 60


Installation example for an operating theatre with a
changeover period of t<15s (operating luminaire t<0.5s)

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 61


UMC107E - Switchover module and
IT system monitoring

Wiring area
Connection terminals

Switching
elements

Voltage relay

Control device

Mains part supplying


Insulation, load and remote alarm indicator
temperature monitoring
© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 62
UMC107E - Switchover module and
IT system monitoring

Wiring area
Connection terminals

Switching
elements

Voltage relay

Control device

Mains part supplying


Insulation, load and remote alarm indicator
temperature monitoring
© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 63
Who knows where the insulation fault is ?

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 64


Who knows where the insulation fault is ?

! The problem
! 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 an insulation fault occurs, due to a defective device, for example,
nobody knows to which socket outlet the defective device is connected
! In order to guarantee the patient's safety, the insulation fault must be
found as quick as possible.
! But how ?

! The solution
! Insulation fault location system EDS474

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 65


Design of an insulation fault location system

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 66


Basic function insulation fault location

! PGH... generates a test


current, limited to
harmless values, for a
defined period of time.
! The test current is
detected and evaluated
by the insulation fault
evaluator.
! This current flows via the
insulation fault location
and is sensed by the
CTs lying within the test
current path.

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 67


UFC107E switchover module, IT system monitoring
and insulation fault location system

Connection terminals
Insulation fault location system
Insulation fault
location system
Switching elements

Voltage monitoring Measuring current


transformer
Insulation fault location
Indicating device system

Insulation, load current,


and temperature monitoring Two-pole
device circuit breaker
for 24 subcircuits
Mains part for MK2418

Fuse

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 68


Electrical safety in hospitals Résumé

! Classification of medical locations


! IT-systems in group 2 rooms
! insulation, load, temperature monitoring
! remote alarm indicators
! Redundant power supply with change over system
! Insulation fault location in IT-systems

! Solutions for these requirements

© Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grünberg Germany www.bender-de.com Fxxx / 06.2002 69


AKTİ
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MÜHENDİ
HENDİSLİ
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Contact us
Satış : satis@aktifmuhendislik.com.tr

Proje : proje@aktifmuhendislik.com.tr

Servis : servis@aktifmuhendislik.com.tr

Mehmet Afkan Sokak No:79 34718 Koşuyolu / İSTANBUL


Tel : 0 216 327 93 20 Fax : 0 216 327 93 21

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