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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 Grnberg Germany www.bender-de.com Fxxx / 06.2002

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 >10A). ! 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 Grnberg Germany

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Power in electrical safety

Classification of medical locations


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

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
Disconnection in case of the first fault a) Patients at risk b) Can the examination or treatment be repeated or interrupted ? Failure of the normal power supply a) Patients at risk b) Can the examination or treatment be repeated or interrupted ? Use of applied parts
a) Externally or invasively, but not for intracardiac application and where power failure can cause danger to life. b) For intracardiac procedures in operating theatres and for vital treatment where discontinuity of the supply can cause danger to life.
Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grnberg Germany

0
no yes

1
no yes

2
yes no

no yes

no yes

yes no

no

yes

yes

no
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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


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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
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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.

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Transformers for medical IT systems (710.512.1.1) IEC 61558-2-15 Safety of power transformers, power supply units and similarPart 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 ! 110 kVA ! Vertical or horizontal version, or installed in an enclosure ! Three-phase transformer ! DS0107 series ! acc. to IEC 61558-2-15 ! 110kVA ! 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 >500k I = 20%

Feature Internal impedance Measuring voltage Measuring current Alarm Interruption system/earth connection

710.413.1.5 > 100 kOhm < DC 25 V max. 1 mA < 50 kOhm -

107TD47 > 240 kOhm < DC12 V < 50 uA 50...500 kOhm Indication

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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 patients 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


! illuminated LC display ! Time and cost-saving installation via a twowire connection (RS485) ! Easy-to-clean lexan front foil ! Simple parallel indication through two-wire interface ! Green Power On LED ! Yellow alarm LED
key, buzzer, acknowledge menu ESC Alarm LED

Power On LED illuminated two-line LC display key, additional text scroll menu key, TEST ISOMETER scroll menu

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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


RS485

medical gas

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


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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.
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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 patients 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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48

Power in electrical safety

The safety power supply in medical locations


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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

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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 predetermined 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 lifesupporting devices, independently from the utility supply and the emergency generator. ! Switchover time <0.5s with a battery capacity for 3 hours.

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

UFC107E65-12-B16
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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 ! In addition one high-capacity load - Total: - IT system transformer

2400 W for 4 beds 2000 W 4400 W for 4 beds 5 kVA

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

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UMC107E - Switchover module and IT system monitoring

Wiring area Connection terminals

Switching elements Voltage relay Control device Mains part supplying Insulation, load and temperature monitoring
Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grnberg Germany

remote alarm indicator


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UMC107E - Switchover module and IT system monitoring

Wiring area Connection terminals

Switching elements Voltage relay Control device Mains part supplying Insulation, load and temperature monitoring
Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grnberg Germany

remote alarm indicator


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Who knows where the insulation fault is ?

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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

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Design of an insulation fault location system

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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.

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

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

Indicating device Insulation, load current, and temperature monitoring device Mains part for MK2418 Fuse
Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grnberg Germany

Measuring current transformer Insulation fault location system

Two-pole circuit breaker for 24 subcircuits

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Electrical safety in hospitals Rsum

! 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 Grnberg Germany

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AKT MHENDSL AKTF MHENDSLK

Contact us
Sat : satis@aktifmuhendislik.com.tr

Proje : proje@aktifmuhendislik.com.tr

Servis : servis@aktifmuhendislik.com.tr
Mehmet Afkan Sokak No:79 34718 Kouyolu / STANBUL Tel : 0 216 327 93 20 Fax : 0 216 327 93 21
Dipl.-Ing. W. BENDER GmbH&Co.KG 35305 Grnberg Germany www.bender-de.com Fxxx / 06.2002

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