AS/NZS 3003:2011 Electrical installations  Patient areas

1. AS/NZS 3003:2011Electrical installations Patient areas February 2012 Seminar Stuart Clifton and Lawrie Knuckey

2. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Clinical engineering framework • Physiological effects of electric current on living tissue: • Nerve and muscle stimulation • Heating • Deposition of metal ions (current with any d.c. component) • Pathological effects of electric current on living tissue: • Cardiac arrest • Respiratory arrest • Burning • Denervation • Ulceration (d.c. burns) • Risk of death/severity of injury – major factors: • Magnitude of the current • Duration of current flow • Current path

3. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Clinical engineering framework • Macroshock • Current passing through the body other than via direct cardiac contact. • Microshock • Current passing through the body via direct electrical contact with the heart.

4. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Clinical engineering framework • Macroshock • Often apparent from patient reaction ranging from sensory stimulation to violent muscular contraction. • Burning, denervation and possibly ventricular fibrillation may occur depending on the magnitude and path of the current. (Cardiac standstill and massive burning may occur in high voltage shocks e.g. contact with 12 kV conductor; lightning strike.) • The possibility of macroelectrocution is exacerbated with the application of medical electrical equipment when: • the skin resistance is reduced or bypassed by electrodes, electrode paste or gel, or invasive conductors, or • the subject is strapped to the equipment, restrained or unconscious, thus inhibiting escape through voluntary or involuntary action.

5. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Clinical engineering framework • Microelectrocution • Risk exists when an electrical conductor is placed into direct contact with a ventricular heart muscle. • Ventricular fibrillation may be induced by current as low as 100 μa (below the threshold for feeling or visible muscle stimulation). • May occur when an electrode wire, electrolyte-filled catheter or transducer is introduced into direct contact with ventricular heart muscle. • Such procedures include: • cardiac catheterization, • intracardiac ECG, • cardiac pacing, • Swan Ganz procedure. • These are referred to in AS/NZS 2500 as cardiac-type procedures.

6. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Clinical engineering framework • Micro-electrocution • Patient must not be exposed to: • Voltages >50 mV --- need EP earthing. • Current sources >50 μA --- need intact earth wires. • Safe equipment design needed: • Medical electrical equipment/systems must comply with standards. • Safe installation needed: • Patient area must be wired as CPA. • Safe equipment application needed: • Flexible protective earthing conductors must be intact. • Hospital must control leakage currents when assembling trolley-mounted medical electrical systems.

7. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Clinical engineering framework • SAFE EQUIPMENT • AS/NZS 3200-series • IEC 60601-series • SAFE INSTALLATION • AS/NZS 3000 and 3003 (wiring) • X-ray protection installation codes • Surgical laser installation codes • SAFE USE • AS/NZS 2500 and AS/NZS 3551 • Preventive maintenance. • Software upgrades. • Safety testing. • Performance verification. • User education. Safe use of electricity in medicine is maximized by following the safety triangle:

8. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Regulatory framework We are consulting engineers – not lawyers. Legal questions may need to be discussed with a state electrical authority or a lawyer. • Throughout Australia, state legislation requires: • Compliance with AS/NZS 3000 (the “Wiring Rules”). • Electrical installation work must be carried out by licensed electrical workers. • Electrical installation work includes: • Wiring a building. • Installing fixed electrical equipment.

9. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Regulatory framework • Compliance with AS/NZS 3003: • Was not a legal requirement when first published in 1974. • Became a requirement of hospital building contracts. • Became a requirement of medical and allied health professional bodies (e.g. ACHS). • Became a legal requirement in Victoria in 1999. • Became a legal requirement throughout Australia in 2007 when it was included as a requirement of AS/NZS 3000. • Formal inspection/testing of AS/NZS 3003 installation work – by a licensed electrical inspector – became a legal requirement in Victoria in 1999. • Formal inspection/testing of AS/NZS 3003 installation work – by anyone acceptable to the hospital – became a legal requirement throughout Australia in 2011 when it was included as a requirement of AS/NZS 3003.

10. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Regulatory framework • The law does not in itself require electrical installations to be upgraded to comply with changes in AS/NZS 3003, but … • New electrical installation work must comply with current standards. • Alterations* to existing electrical installations are deemed to be new electrical installations. • Alterations* to locations used for medical electrical equipment can only be carried out if the location is a BPA or a CPA. *Alterations from new socket-outlets to a new or replacement CT scanner. • AS/NZS 3003:2011 also requires some upgrading of patient areas when certain alterations are carried out. • Upgrading old facilities: • Is a requirement of AS/NZS 2500. • May be a duty of care under occupational health and safety legislation or common law.

11. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Regulatory framework • Implementation of AS/NZS 3003: • AS/NZS 3003 is ignored in significant parts of the medical and allied health sectors. • Broad acceptance of legal requirements is inhibited by: • Excessive requirements in the 2011 edition of the standard. • Lack of action by state electrical authorities.

12. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Regulatory framework • Energy Safe Victoria guidelines: • Even plug-in appliances are “fixed” electrical equipment if: • >18 kg without wheels; or • fixed in position; or • recommended to be fixed in position; or • provided with means for fixing; or • part of a number of discrete components that function as a group. • Fixed means secured, attached or connected by conduit, metal pipe-work, duct, bolt, screw, clip, other fastening device or fixed wiring.

13. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Regulatory framework • Energy Safe Victoria guidelines: • Even plug-in appliances are “fixed” electrical equipment if: • >18 kg without wheels; or • fixed in position; or • recommended to be fixed in position; or ** • provided with means for fixing; or • part of a number of discrete components that function as a group. • Fixed means secured, attached or connected by conduit, metal pipe-work, duct, bolt, screw, clip, other fastening device or fixed wiring. **Includes plug-in medical electrical equipment such as: Dental chairs. Mammography units. Wall-mounted X-ray viewing boxes.

14. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs Regulatory framework • Energy Safe Victoria guidelines: • Even plug-in appliances are “fixed” electrical equipment if: • >18 kg without wheels; or • fixed in position; or • recommended to be fixed in position; or • provided with means for fixing; or • part of a number of discrete components that function as a group.** • Fixed means secured, attached or connected by conduit, metal pipe-work, duct, bolt, screw, clip, other fastening device or fixed wiring. **Seems to include multi-bed patient monitoring systems!

15. new standard: • Still applies wherever mains powered medical electrical equipment is used. • Still requires patient areas to be wired as: • BPAs (body-protected electrical areas), or • CPAs (cardiac-protected electrical areas) • BPAs and CPAs New edition of AS/NZS 3003 • New standard still applies in patient areas: (Wherever mains powered medical electrical equipment is used.) • Patient areas must still be wired as: BPAs (body-protected electrical areas), or CPAs (cardiac-protected electrical areas) • LPDs (leakage protective devices) still required for: • Most socket-outlets. • Some high risk medical electrical equipment. • LPDs are still: • Type 1 RCDs (residual current devices), or • Isolation transformers with line isolation/overload monitors. • Socket-outlet colours unchanged except for some generator-backed circuits. • Requirements for EP (equipotential) earth wiring in CPAs similar to 2013 edition – but with better drawings.

16. Summary of major changes • Each requirement is followed by a compliance test. • New definition of essential supply. • Certain patient areas must only be BPAs. • Certain patient areas must be CPAs. • LPD protection and EP earthing of socket-outlets outside patient areas: • Has been extended from 2 m to 5 m from each entry. • Is now required with or without a door. • Final sub-circuits may only supply one BPA and its ensuite. • Final sub-circuits may no longer supply socket-outlets for cleaning purposes and other socket-outlets. • Socket-outlets requiring LPD protection clearly specified:

17. Summary of major changes • UPS status indicator now required in some patient areas. • RCDs must now be: • readily accessible, • not installed under benches, and • not positioned near some light switches. • Inaccessible socket-outlets must now have readily accessible isolating switches. • Socket-outlets for cleaning purposes now only required near BPAs. • EP terminals no longer required in CPAs. • The EPJ (equipotential junction) in a CPA may now have conveniently located nodes.

18. Summary of major changes • New commissioning and certification requirements. • New requirements for special patient areas: • Home installations for haemodialysis. • Home installations for other medical electrical equipment. • Self harm areas (e.g. psychiatric and prison wards). • New requirements for alterations, additions and repairs to electrical installations in patient areas:

19. Summary of major changes • New limitations on magnetic fields: • Maximum field strength specified for some (not all) patient areas intended for ECG monitoring and recording. • Requirements apply prior to commencing work, and on completion of work. • Requirements apply to new patient areas and to alterations. • New marking requirements for BPA and CPA area signs. • Full technical requirements for routine inspection and testing.

20. New title • Contention about the institutions covered by previous editions: • Hospital. • Dental surgery. • Day surgery. • Imaging practice. • Physiotherapy practice. • Doctors’ room. • Nursing home. • Other aged care facilities. • AS/NZS 3003 should apply in patient areas of any institution.  ?

21. New title 1976 Electrical installations in electromedical treatment areas 1985 Electrical installations — Patient treatment areas of hospitals and medical and dental practices 1999 Electrical installations — Patient treatment areas of hospitals and medical and dental practices 2003 Electrical installations — Patient areas of hospitals, medical and dental practices and dialyzing locations 2011 Electrical installations — Patient areas

22. Patient areas 2003 Locations in hospitals and medical and dental practices in which it is intended that mains powered medical electrical equipment will be used. Locations in patients’ homes and other facilities intended for dialysis are also included. 2011 Locations where it is intended that mains powered medical electrical equipment will be used on a patient. This does not include areas such as corridors and lifts where medical equipment is only used in an emergency or for transporting patients.

23. Patient areas 2003 Locations in hospitals and medical and dental practices in which it is intended that mains powered medical electrical equipment will be used. Locations in patients’ homes and other facilities intended for dialysis are also included. 2011 Locations where it is intended that mains powered medical electrical equipment will be used on a patient. This does not include areas such as corridors and lifts where medical equipment is only used in an emergency or for transporting patients. The standards applies wherever mains powered medical electrical equipment is used.

24. Patient areas 2003 Locations in hospitals and medical and dental practices in which it is intended that mains powered medical electrical equipment will be used. Locations in patients’ homes and other facilities intended for dialysis are also included. 2011 Locations where it is intended that mains powered medical electrical equipment will be used on a patient. This does not include areas such as corridors and lifts where medical equipment is only used in an emergency or for transporting patients. Discourages application of the standard in areas used just for charging/storing medical electrical equipment (e.g. beds).

25. Patient areas 2003 Locations in hospitals and medical and dental practices in which it is intended that mains powered medical electrical equipment will be used. Locations in patients’ homes and other facilities intended for dialysis are also included. 2011 Locations where it is intended that mains powered medical electrical equipment will be used on a patient. This does not include areas such as corridors and lifts where medical equipment is only used in an emergency or for transporting patients. The standard only applies in areas intended for the regular use of medical electrical equipment.

26. Patient areas 2003 Locations … in which it is intended that mains powered medical electrical equipment will be used … 2011 Locations where it is intended that mains powered medical electrical equipment will be used … • Under either standard: • Where a room is intended for medical electrical equipment that will be connected to a patient in another room, both rooms are patient areas. For example: A&E/ICU/CCU/ward/ staff base with patient monitor. Cardiac cath lab recording room with physiological recorder. Sleep lab recording room. CT control room with injector control unit.

27. Patient areas EXAMINATION LIGHT MUST BE PLUGGED IN HERE • Electrical equipment supplied by socket-outlets outside patient areas: • LPD protection required: Socket-outlets outside BPAs or CPAs used to supply medical electrical equipment in the patient area. • EP earthing required: Socket-outlets outside CPAs used to supply: • medical electrical equipment in the CPA, or • any electrical equipment accessible in the patient environment.

28. Patient areas Within a patient area:

29. “Accessible” & “readily accessible” • Readily accessible now means: • Capable of being reached quickly and without climbing over or removing obstructions, standing on a chair or using a ladder, and • Not more than 2 m above the ground, floor or platform. • RCDs must now be readily accessible and not mounted under benches, in cupboards or cabinets, or behind heavy equipment. • Socket-outlets require LPD protection if they are accessible – not just readily accessible – without a tool. • Socket-outlets that are not readily accessible must have readilyaccessible isolating switches or a dedicated LPD. • Permanently wired appliances protected by LPDs that also protect socket-outlets or other appliances must have readilyaccessible isolating switches.

30. “Group” of socket-outlets • Group of socket-outlets now means: One or more socket-outlets contained within one surround. • No longer a group:

31. Extent of the patient area • 2003 The boundary of the cardiac-protected electrical area extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. entryway without a door) to the boundary formed if such walls or projections were extended.

32. Extent of the patient area • 2003 Socket-outlets that are: • located within 2 m of a patient area, and • in free communication with the patient area (i.e. no door), • … must be: • protected by an LPD, and • connected to thearthing system (if CPA).

33. Extent of the patient area First public draft: Where the walls of a BPA are incomplete (e.g. entryway without a door) and the opening is greater than 2 m, the adjacent area is part of the BPA.

34. 0 1 2 Extent of the patient area

35. Extent of the patient area

36. Extent of the patient area

37. Extent of the patient area 2011 The boundary of the cardiac-protected electrical area extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. an entryway without a door) to the boundary formed if such walls or projections were extended. In this context, the following are not considered walls or boundaries: partitions, dividers, screens, benches, moveable walls or curtains.

38. Extent of the patient area • 2003 Socket-outlets that are: • located within 2 m of a patient area, and • in free communication with the patient area (i.e. no door), • … must be: • Protected by an LPD, and • Connected to the EP earthing system (if CPA).

39. Extent of the patient area • 2011 Socket-outlets that are: • located within 5 m of a patient area (door or no door), • in any room, corridor, etc, opening directly off the patient area, • … must be: • Protected by an LPD, and • Connected to the EP earthing system (if CPA).

40. Extent of the patient area 2011 The boundary of the cardiac-protected electrical area extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. an entryway without a door) to the boundary formed if such walls or projections were extended. In this context, the following are not considered walls or boundaries: partitions, dividers, screens, benches, moveable walls or curtains.

41. Extent of the patient area 2011 The boundary of the cardiac-protected electrical area extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. an entryway without a door) to the boundary formed if such walls or projections were extended. In this context, the following are not considered walls or boundaries: partitions, dividers, screens, benches, moveable walls or curtains, and entryways wider than 10% of the perimeter of the patient area. (Proposed ESV ruling.)

42. Extent of the patient area 2011 The boundary of the cardiac-protected electrical area extends to the walls enclosing the patient location(s) or, if such walls are incomplete (e.g. an entryway without a door) to the boundary formed if such walls or projections were extended. In this context, the following are not considered walls or boundaries: partitions, dividers, screens, benches, moveable walls or curtains, and entryways wider than 10% of the perimeter of the patient area. (Proposed ESV ruling.)

43. Socket-outlets near patient areas

44.  BUSY CORRIDOR STAFF BASE xxxxxxxxxxxx BEDROOM < 5m Socket-outlets near patient areas

45.     xxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxx Socket-outlets near patient areas

46. Socket-outlets near patient areas

47. New essential supply definition • Generator-backed circuits that are subject to load shedding are no longer considered as essential supplies. • Many generator-backed outlets are no longer on essential supplies • ESV has issued exemptions allowing additional red socket-outlets on circuits subject to load shedding under programmable load shedding. NEW SOCKET-OUTLET EXISTING SOCKET-OUTLETS POWER AVAILABLE POWER AVAILABLE POWER AVAILABLE

48. Classification of patient areas Some locations must now be CPAs: • Cardiac catheter laboratories and control rooms. • Cardiac ICU. • CCU. • ICU with regular thermodilution Swann-Ganz monitoring. • Neo natal ICU (Level 3). • Operating theatres for cardiac and thoracic surgery. • Other locations intended for regular or routine cardiac-type procedures. (No mention of wards)

49. Classification of patient areas • Accident and emergency wards. • Blood collection areas. • Chiropractic and physiotherapy rooms. • CT rooms. • Day procedure theatres. • Delivery suites. • Dental surgeries. • Endoscopy theatres and procedure rooms. • General medical and surgical wards. • High dependency wards. • MRI rooms. • Nurseries. • Operating theatres for non-cardiac surgery • Patient ensuites • Patient examination rooms in outpatients. • Plasmapherisis areas. • Plaster rooms. • Recovery areas or wards associated with operating theatres and imaging rooms. • Respiratory function laboratories. • Resuscitation bays. • Stress test rooms. • Treatment rooms. • Ultrasound rooms. • X-ray rooms (Except cardiac cath labs!) • Doctors consulting room. • Nursing homes. (Patient areas only!) Some locations must only be BPAs (unless intended for cardiac-type procedures):

50. Classification of patient areas ? Some locations must only be BPAs: Patient ensuite bathrooms, shower rooms, toilets …