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Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 1 AS/NZS 3003:2011 Electrical installations Patient areas Stuart Clifton.

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Presentation on theme: "Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 1 AS/NZS 3003:2011 Electrical installations Patient areas Stuart Clifton."— Presentation transcript:

1 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 1 AS/NZS 3003:2011 Electrical installations Patient areas Stuart Clifton and Lawrie Knuckey February 2012 Seminar

2 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 2 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 new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

3 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 3 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. new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

4 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 4 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. new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

5 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 5 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. new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

6 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 6 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. new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

7 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 7 Clinical engineering framework Safe use of electricity in medicine is maximized by following the safety triangle: new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs SAFE EQUIPMENT AS/NZS 3200-series IEC 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.

8 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 8 Regulatory framework 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. new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs We are consulting engineers – not lawyers. Legal questions may need to be discussed with a state electrical authority or a lawyer.

9 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 9 Regulatory framework Compliance with AS/NZS 3003: – Was not a legal requirement when first published in – 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 – Became a legal requirement throughout Australia in 2007 when it was included as a requirement of AS/NZS Formal inspection/testing of AS/NZS 3003 installation work – by a licensed electrical inspector – became a legal requirement in Victoria in 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 new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

10 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 10 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 – May be a duty of care under occupational health and safety legislation or common law. new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

11 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 11 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. new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

12 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 12 Regulatory framework Energy Safe Victoria guidelines: – Even plug-in appliances are fixed electrical equipment if: a)>18 kg without wheels; or b)fixed in position; or c)recommended to be fixed in position; or d)provided with means for fixing; or e)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. new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

13 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 13 Regulatory framework Energy Safe Victoria guidelines: – Even plug-in appliances are fixed electrical equipment if: a)>18 kg without wheels; or b)fixed in position; or c)recommended to be fixed in position; or** d)provided with means for fixing; or e)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. new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

14 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 14 Regulatory framework Energy Safe Victoria guidelines: – Even plug-in appliances are fixed electrical equipment if: a)>18 kg without wheels; or b)fixed in position; or c)recommended to be fixed in position; or d)provided with means for fixing; or e)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! new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – S t i l l r e q u i r e s p a t i e n t a r e a s t o b e w i r e d a s : B P A s ( b o d y - p r o t e c t e d e l e c t r i c a l a r e a s ), o r C P A s ( c a r d i a c - p r o t e c t e d e l e c t r i c a l a r e a s ) BPAs and CPAs

15 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 15 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. new standard: – Still applies wherever mains powered medical electrical equipmen t is used. – Still requires patient areas to be wired as: BPAs (body- protect ed electric al areas), or CPAs (cardia c- protect ed electric al areas) BPAs and CPAs

16 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 22 Patient areas 2003Locations 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. 2011Locations 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 23 Patient areas 2003Locations 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. 2011Locations 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 24 Patient areas 2003Locations 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. 2011Locations 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 25 Patient areas 2003Locations 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. 2011Locations 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 26 Patient areas 2003Locations … in which it is intended that mains powered medical electrical equipment will be used … 2011Locations 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 27 Patient areas 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. EXAMINATION LIGHT MUST BE PLUGGED IN HERE

28 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 28 Patient areas Within a patient area:

29 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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 readily accessible isolating switches or a dedicated LPD. Permanently wired appliances protected by LPDs that also protect socket- outlets or other appliances must have readily accessible isolating switches.

30 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 31 Extent of the patient area 2003The 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 32 Extent of the patient area 2003Socket-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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia Extent of the patient are a

35 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 35 Extent of the patient area

36 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 36 Extent of the patient area

37 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 37 Extent of the patient area 2011The 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 38 Extent of the patient area 2003Socket-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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 39 Extent of the patient area 2011Socket-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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 40 Extent of the patient area 2011The 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 41 Extent of the patient area 2011The 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 42 Extent of the patient area 2011The 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 43 Socket-outlets near patient areas

44 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 44 Socket-outlets near patient areas STAFF BASE BUSY CORRIDOR BEDROOM < 5m xxxxxxxxxxxx

45 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 45 Socket-outlets near patient areas xxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxx

46 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 46 Socket-outlets near patient areas

47 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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. POWER AVAILABLE NEW SOCKET-OUTLETEXISTING SOCKET-OUTLETS POWER AVAILABLE POWER AVAILABLE

48 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 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 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 49 Classification of patient areas Some locations must only be BPAs (unless intended for cardiac-type procedures): 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!)

50 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 50 ? Classification of patient areas Some locations must only be BPAs: Patient ensuite bathrooms, shower rooms, toilets …

51 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 51 Classification of patient areas BPAs and CPAs still not allowed in the same room.

52 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 52 UPS status indicators UPS status indicator now required in patient areas with: – socket-outlets or permanently wired equipment supplied from a UPS, and – continuous patient observation, … including: – operating theatres, and nursing stations or staff bases in: recovery wards, intensive care units, isolation rooms, and other special care areas.

53 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 53 UPS status indicators UPS status indicator requirements: – Must be marked UPS STATUS. – Must be connected to the UPS electrical supply system. – Loss of supply to the UPS must initiate synchronized, pulsating, audible and visual alarms. – Audible alarm must continue until muted. – Visual alarm must continue until the supply is restored to the UPS or the UPS is exhausted. New standard is not retrospective: – Existing installations do not have to be upgraded, but … – new work (one new socket-outlet) must comply with this requirement.

54 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 54 Socket-outlet protection Socket-outlets requiring LPD protection* clearly specified: * Except socket-outlets mounted on – and forming part of – a medical electrical system.

55 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 55 Socket-outlet protection Intention was to treat 10 amp IEC sockets on endoscopy systems as general purpose outlets. … except for unintended consequence: * Except socket-outlets mounted on – and forming part of – a medical electrical system.

56 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 56 Socket-outlet protection Socket-outlets requiring LPD protection* clearly specified. --- another unintended consequence: xxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxx Special purpose industrial outlet in Pan Room

57 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 57 Magnetic field requirements 7.1 GENERAL Health care facilities must ensure magnetic fields do not exceed safe levels in areas used for sensitive monitoring or recording equipment. Maximum field strength and test methods are specified for locations intended for ECG monitoring and recording. For electrophysiological measurements such as EEG, EMG and ENG: – Substantially more demanding requirements apply. – Maximum field strength and test methods are not specified. – Facility management must ensure magnetic fields are reduced to acceptable levels when specifying the wiring of such locations.

58 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 58 Magnetic field requirements 7.2 REQUIREMENTS The following patient areas where ECG monitoring and recording is expected to be carried out must be arranged so that: – Total magnetic field flux density does not exceed 3 microtesla (μT). – No individual harmonic exceeds 1.6 μT. – Limits apply between 800 and 1200 mm above floor, over the whole area except within 300 mm of the walls. Nominated patient areas: – Accident and emergency departments. – Cardiac catheterisation laboratories. – Coronary care units and intensive care units. – Outpatient departments for diagnostic ECG. – Resuscitation units. – Stress testing units.

59 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 59 Magnetic field requirements Nominated patient areas: – Accident and emergency departments. – Cardiac catheterisation laboratories. – Coronary care units and intensive care units. – Outpatient departments for diagnostic ECG. – Resuscitation units. – Stress testing units. It is unclear why these requirements do not apply in locations such as: -Cardiac ultrasound rooms. -ECG rooms (other than those in outpatient departments). -ECT rooms. -Imaging rooms with ECG monitoring or synchronised imaging. -Operating theatres. -Procedure rooms intended for general anaesthesia.

60 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 60 Magnetic field requirements 7.3 TESTING New building: – Prior to new work: Contractor must confirm with facility management that electrical reticulation has been designed and located to achieve compliance. – After work is finished: Contractor must arrange compliance testing. Existing building: – Prior to new work: Contractor must confirm with facility management that satisfactory testing has been carried out. – After work is finished: Contractor must arrange for compliance testing to be repeated.

61 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 61 Magnetic field requirements 7.3 TESTING Existing building: – Prior to new work: Contractor must confirm with facility management that satisfactory testing has been carried out. – After work is finished: Contractor must arrange for compliance testing to be repeated. Within existing buildings, these requirements apply to: – New patient areas – such as: New cardiac cath lab. New ICU. – Alterations in existing patient areas – such as: New $30 socket-outlet in existing ICU. New $1,000,000 X-ray system in existing cardiac cath lab.

62 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 62 Magnetic field requirements 7.3 TESTING Existing building: – Prior to new work: Contractor must confirm with facility management that satisfactory testing has been carried out. – After work is finished: Contractor must arrange for compliance testing to be repeated. What about a room that has been successfully used for electrocardiography for 20 years?

63 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 63 Magnetic field requirements 7.3 TESTING New building: – Prior to new work: Contractor must confirm with facility management that electrical reticulation has been designed and located to achieve compliance. – After work is finished: Contractor must arrange compliance testing. What about trying out the room with an ECG machine?

64 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 64 Socket-outlets for cleaning purposes Socket-outlet marked for cleaning purposes: Still required in each CPA. Can be outside a BPA if located within 15 m. Not required in MRI rooms. Still required in CPA ensuites. Not required in BPA ensuites if available within 15 m. Must still be protected by an LPD. Must be supplied from a different circuit than other socket-outlets. (This circuit may supply a large number of such socket-outlets.)

65 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 65 Separation of circuits BPAs Circuits supplying socket-outlets* must not supply electrical points in another room (except any ensuite). CPAs Circuits must not supply: – Socket-outlets* in more than one patient location. – Electrical points in another room. *Except socket-outlets for cleaning purposes Socket-outlets for cleaning purposes – Must be supplied by dedicated circuit. – Circuit may supply many patient areas.

66 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia EP earthing system retained But EP terminals no longer required. Looping allowed providing it does not depend on pressure of single screw bearing directly on wiring. Cpa euite SINGLE SCREW TYPE NOT ALLOWED SINGLE SCREW OK AS DOES NOT BEAR DIRECTLY ON WIRE JOINING WIRES UNDER CRIMP THEN INTO SINGLE SCREW CONNECTOR IS ALLOWED

67 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia EP earthing system retained EP junction may have multiple nodes. Nodes must be isolated from structural metal. EP JunctionNODE 0.01 ohm connections between the EPJ and its nodes. 0.1 ohm connections to EP junction or one of its nodes. Distribution Board

68 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia EP earthing system retained RCDs mounted in structurally connected wall boxes

69 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia EP earthing system retained RCDs mounted in non-structurally connected wall boxes

70 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia EP earthing system retained Transformer isolated supply - structurally connected wall boxes

71 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia EP earthing system retained Transformer isolated supply – non-structurally connected wall boxes

72 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia EP earthing system retained But all equipotential conductor now 4mm 2.

73 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia EP earthing system retained Special earthing required for X-ray and imaging systems:

74 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia EP earthing system retained 0.1 EP earthing system still only works for building earth currents < 0.5 A. Building earth currents > 16 A easily encountered in buildings with more than one connection between neutral bars and earth, e.g. old buildings with metal-clad wiring. Test 1 - verify protective earthing of socket-outlets and fixed Class I electrical equipment. Test 2 - verify EP earthing of structurally connected, non-electrical fittings in the patient environment. Test 3 - verify <50 mV between the EP junction and: – All socket-outlets in the CPA. – Fixed electrical equipment in the patient environment. – Structurally connected, non-electrical fittings in the patient environment.

75 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 75 Marking of BPA and CPA wall signs Person and organization that carried out the required certification: Date of certification. Person or organization that carried out the most recent electrical safety testing. Date of test. Report number Date by which the next test is required. Edition of AS/NZS 3003 against which the area was originally commissioned.

76 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 76 Marking of BPA and CPA wall signs Person and organization that carried out the required certification of: -The original installation? -The latest installation work? Date of certification. Person or organization that carried out the most recent electrical safety testing. Date of test. Report number Date by which the next test is required. Edition of AS/NZS 3003 against which the area was originally commissioned.

77 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 77 Marking of BPA and CPA wall signs Person and organization that carried out the required certification. Date of certification. Person or organization that carried out the most recent electrical safety testing. Date of test. Report number Date by which the next test is required. The most recent testing may be just a new socket-outlet, but the new sticker obliterates what is often the only record of the last full routine test. Edition of AS/NZS 3003 against which the area was originally commissioned.

78 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 78 Marking of BPA and CPA wall signs Person and organization that carried out the required certification: Date of certification. Person or organization that carried out the most recent electrical safety testing. Date of test. Report number Date by which the next test is required. Edition of AS/NZS 3003 against which the area was originally commissioned Biomec: Combines these two labels (saved cost and effort). Assumes this sticker relates to certification of the original installation.

79 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 79 Marking of BPA and CPA wall signs

80 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 80 Statement by electrical contractor The contractor must: Certify in writing that the work has been tested to – and complies with – AS/NZS Certify in writing that the work followed a formal specification prepared by the health care institution or practice, or … that the number of socket-outlets has been discussed with medical or nursing personnel and the likely loading on each circuit has been checked. Supply documentary evidence that the isolation transformer, line isolation monitor and overload monitor comply with AS/NZS Supply a certificate of compliance or a manufacturers statement that each ELV supply complies with a suitable standard.

81 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 81 Special patient areas Revised requirements for home haemodialysis: – Room to be wired as BPA with following exceptions. – Dedicated circuit protected by LPD required for socket-outlets used for medical electrical equipment. – Other socket-outlets to be protected by 30 ma RCD. – Socket-outlet for cleaning purpose not required. – Supply available lights not required unless RO unit is in another room. – RCD protected labeling not required. – BPA area sign not required. Questions now emerging from clinicians and clinical engineers about special installation requirements in: – Rental properties. – Holiday locations.

82 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 82 Special patient areas New requirements for home use of other medical electrical equipment – No special wiring requirement if medical electrical equipment is: Internally powered or Class II, and Provided with Type BF or CF applied part. – Similar requirements to those for haemodialysis if: Class I, or Provided with Type B applied part. Questions now emerging from clinicians and clinical engineers about the special installation requirements for the home use of: – Class I medical electrical equipment with Type BF or CF applied parts. – Some Class II medical electrical equipment, even with Type B applied parts.

83 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 83 Special patient areas New requirements for BPAs for self harm patients (e.g. psychiatric and prison wards) – RCDs may be located outside the room. – Amber supply available lights not required on socket-outlets. – BPA area signs may be located outside room entrance.

84 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 84 Alterations, additions and repairs Alterations and additions … from new socket-outlets to new or replacement CT scanners. – All new work must comply with 2011 standard. – Patient area must be upgraded if not already BPA or CPA. – Alteration cannot proceed until routine safety test is up-to-date. – All socket-outlet colours must be upgraded if necessary to 2011 standard if total number is increased by >10%. – Earthing must be upgraded if necessary to the 2011 standard if: the EP junction is inaccessible for making new connections, or new work involves installing fixed equipment rated above 2.0 kW. Repairs – Standard goes close to disallowing repairs to fixed medical electrical equipment in any location not wired as a BPA or a CPA.

85 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 85 Some other outstanding problems plug-in medical electrical equipment CPA required wherever plug-in medical electrical equipment is used for cardiac-type procedure, except X-ray and imaging systems.

86 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 86 Some other outstanding problems such as rooms – not roof spaces! Locations that have to be wired as CPAs

87 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 87 Some other outstanding problems Locations that have to be wired as BPAs BPAs (!) in nursing homes

88 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 88 Some other outstanding problems socket-outlets (!) in Circuits in CPAs

89 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 89 Some other outstanding problems readily accessible (!) Locations that have to be wired as BPAs

90 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 90 Some other outstanding problems Table 2.1 of AS/NZS 3009:1998 Socket-outlet colours (colour coding requirements)

91 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 91 Some other outstanding problems Available: in the hospital? in the particular building of the hospital? at the switch-board supplying the UPS? in the room housing the UPS? Supply to UPS that then supplies socket-outlets

92 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 92 Routine in-service testing Detailed inspection and testing requirements are included in the standard. As routine testing is now a requirement in all patient areas, it has become a legal requirement throughout Australia. Must be up-to-date before starting any alteration or addition. Associated report form is full of errors. Biomec recommends that hospitals and medical practices: – Review procedures or contracts for routine testing of patient areas. – Adopt the new requirements (AS/NZS 3003:2012 Section 9). – Ignore or disallow use of the associated report form (Appendix G). – Disallow test stickers for alterations/additions.

93 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 93 COMMON REQUIREMENTS – BPAs AND CPAs Testing interval – Maximum 12 months. Inspection – All electrical equipment and fittings. – Labelling. Socket-outlets – Colour. – Power-available indicator lights on RCD protected circuits. – Maximum number of protected points. – Toggle marking or on indicator lights. – Double-pole switches on transformer isolated supplies. – LPD protection where required. Routine in-service testing

94 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 94 COMMON REQUIREMENTS – BPAs AND CPAs RCDs used as LPDs – Sensitivity test – one test. – Maximum tripping time – two tests. – Test interval may be increased to 24 months based on risk management relating to the actual RCDs reliability data; but each RCD test button must then be tested each six months. Transformer isolated supplies – Installation prospective hazard current – LIM alarm - resistive and capacitive, balanced and unbalanced faults. – Overload alarm Uninterruptible power supplies (UPSs) – Check that (someone else?) has tested the UPS status indicators. Routine in-service testing

95 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 95 Routine in-service testing ADDITIONAL TESTS – BPAs Protective earthing – Reticulated metal service may be used as a reference in some circumstances. – Verify earthing resistance to: Earth pins of socket-outlets accessible below 2.3 m. Earth pins of socket-outlets used for electrical appliances accessible below 2.3 m. Class I electrical appliances accessible below 2.3 m.

96 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 96 Routine in-service testing ADDITIONAL TESTS – CPAs Earthing – EP junction/node or medical gas/suction outlet may be used as reference in some circumstances. – Use four-wire milliohm meter to verify earthing resistance to: Earth pins of socket-outlets accessible below 2.3 m. Earth pins of socket-outlets used for electrical appliances accessible below 2.3 m. Class I electrical appliances accessible below 2.3 m. Potential difference to EP junction: – At least two socket-outlets in each patient location. – Reticulated plumbing in at least one patient location. – Permanently wired electrical equipment in patient environment.

97 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 97 Thank you

98 Biomedical Engineering Company of Australia Consulting engineers Biomec Australia 98 Thank you


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