Specification for
Operating Theatre Insight Solution
(Classic Level)
The Operating Theatre Insight Solution provides protection from
electrical shock and ensures continuity of electric power in for operating rooms,
surgical theatres and other critical care areas.
February 2013
Operating Theatre Insight Solution (Classic) Technical Specification
Page 2
Table of Contents
1.
Overview of solution for isolated panel systems ................................................................. 3
2.
Description of electrical switchgear for each operating theatre ........................................... 3
3.
Display and remote control in operating theatre ................................................................. 4
4.
Setup.................................................................................................................................. 5
5.
Standards compliance ........................................................................................................ 5
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Operating Theatre Insight Solution (Classic) Technical Specification
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1. Overview of solution for isolated panel systems
Electrical power availability and quality are crucial to the safety of patients in the running of an
operating theatre. Operating theatre electrical installations must ensure continuity of care and
provide protection against electric shocks under all circumstances; the solution implemented
must therefore meet the following criteria:

Energy availability: Design that fulfils the IEC 60364-7-710 requirements for Criticality
Level 1. The requirement for “less than 0.5 second outages” is managed using a UPS
and automatic change-over. The 3 hour endurance is managed using an upstream
generator backup system. The supplier shall produce dependability calculations for the
solution in terms of MTBF(mean time between failures) in relation to undesirable events.
The unavailability time of the IT outlets during an operation shall be < 0.04 min/year.

Electrical shock protection: according the IEC 60364-7-710 standard the solution is in
compliance with the Group 2 location through isolation transformers and associated
monitoring system.
The electrical installation shall comply with or exceed the IEC 60364-7-710 international or
local medical standards.
2. Description of electrical switchgear for each operating theatre
The operating theatre electrical switchgear shall be installed in the operating room corridor or in
the vicinity of each room.
According the IEC standard, the switchgear is powered by 2 separate sources:


The main incomer supply comes from the UPS system.
The safety incomer supply comes directly from the other part of
the main low voltage switchgear.
An automatic change-over shall transfer the source of power from the main
incomer supply to the safety incomer supply in less than 30 milliseconds in
the case of an outage.
Utility and generator set power sources should limit any potential outage to a
maximum of 15 seconds before re-energizing the main and safety incomers.
Total breaker selectivity must be managed by circuit breaker protection up-stream from the
isolation panel, with a current rating above 63A and curve D, to limit trips caused by in-rush
current.
To ensure a high level of fault discrimination and to increase power availability, a minimum of 12
circuit breakers shall be used to protect short, separate circuits, especially for the isolated
power outlets (wall outlets or surgical/anesthesia pendants).
According to the IEC standard, each circuit breaker shall protect a maximum of 3 outlets.
All operating room electrical cabinets shall be wired and physically organised in the same way.
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Operating Theatre Insight Solution (Classic) Technical Specification
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The wiring shall be in compliance with the recommendations of IEC 60364-4-4-44, IEC 610006-2 and IEC 61000-6-3.
It shall be possible for the protective devices to be controlled by the maintenance staff, without
requiring direct contact.
The power and communication circuit routing shall be completely separate. Propagation of
electrical fields shall be prevented by physical separation systems (in accordance with IEC
61439-1).
Environmental conditions (in either the operating room or electrical room) must be:





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Indoor location
Altitude of less than 2000 m
30°C maximum ambient temperature
90% maximum relative humidity
465W power dissipation by the switchboard
Maximum sound level of less than 30 dB, measured 1.0 m from the ground
Electrical parameters are:



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
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Operating voltage: 230 V AC
Operating frequency: 50-60 Hz
Operating current: 63 A
Isc: 25 kA
Neutral systems: IT and TNS
Transformer: 6.3kVA, 8kVA or 10 kVA
3. Display and remote control in operating theatre
The display for the remote monitoring system, built using a Vigilohm HRP or equivalent, is
located in the operating room and must include the following functions:




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Insulation fault alarm (orange light)
Electrical fault alarm, in case of isolation transformer
overload or over-heating, or feeder circuit breaker trip
(red light)
A buzzer synchronised with the alarm status
Normal operation (green light)
Push button for insulation test
Push button to mute the buzzer
The system must also provide an option to complete the insulation fault diagnostic through a
feeder location function in front face of the switchgear.
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Operating Theatre Insight Solution (Classic) Technical Specification
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4. Setup
A complete verification of the system shall be carried out once a year by qualified staff who
have been trained on the system. It shall focus, in particular, on the reliability of the electrical
system, the behaviour of the components, the acquisition, measurement and communication
system, as well as on the co-ordination with the upstream installation (electrical and data).
It shall be easy to replace all the solution components, without affecting any other components.
5. Standards compliance
The installation shall comply with the following standards:
5.1. IEC 61439-1 and -2: "Low-voltage switchgear and control gear assemblies - General Rules"
and "Low-voltage switchgear and control gear assemblies - Power switchgear and control
gear assemblies".
5.2. IEC 60364-7-710: "Electrical installations of buildings - Requirements for special
installations or locations - Medical locations".
5.3. IEC 61557-8: "Electrical safety in low-voltage distribution systems up to 1000 V AC and
1500 V DC - Equipment for testing, measuring or monitoring of protective measures - Part
8: Insulation monitoring devices for IT systems".
5.4. 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".
5.5. IEC 60364-4-44: "Low-voltage electrical installations - Protection for safety - Protection
against voltage disturbances and electromagnetic disturbances".
5.6. IEC 61000-6-2: "Electromagnetic compatibility (EMC) – Generic standards – Immunity for
industrial environments".
5.7. IEC 61000-6-3: "Electromagnetic compatibility (EMC) – Generic standards – Emission
standard for residential, commercial and light-industrial environments".
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July 31, 2017