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Mastertitelformat Mastertitelformat bearbeiten bearbeiten Mastertextformat bearbeiten – Zweite Ebene in The Power Dritte Ebene Electrical Safety – Vierte Ebene NEHES – August 17, 2018 Twin State Seminar Isolated Power Systems in Healthcare Facilities Presenter: David Knecht – Bender Inc.

Mastertitelformat Mastertitelformat Agenda bearbeiten bearbeiten Why Electrical Safety in Hospitals Mastertextformat bearbeiten Technical Overview of Isolated Power Systems –&Zweite Codes StandardsEbene Best Practice (Equipment Selection, Design, Installation, Maintenance) Dritte Ebene FAQs – Vierte Ebene - What should I do when the LIM goes into alarm? What preventive & periodic maintenance is required for the LIM? When should the Isolated Power System integrity be tested? What is the maximum conductor length for an Isolated Power Panel? How many circuits (breakers) can I have in an Isolated Power Panel?

Mastertitelformat Mastertitelformat bearbeiten Key types of risk bearbeiten Why Electrical Safety in Healthcare Facilities? Risk due to electric current Mastertextformat bearbeiten Mechanical risk sources Chemical risk sources Thermal risk sources Dritte Ebene Risk due to ionising radiation Risk due to–RFVierte fields Ebene Biological hazards Human failure – Zweite Ebene Risk to life and property Dangerous currents flowing through the body Interruption of power supply Inadequate quality supply voltage Excessive temperatures Arcing Ignition of explosive mixtures Extraneous influences, cumulative effects 10

Why Electrical Safety in Healthcare Facilities? The risks for the patients in hospitals . The patient s natural reactions to hazards are often reduced or switched-off The heart muscle is highly sensitive to electric currents (currents 10 µA) The insertion of catheters and invasive devices bypasses the electrical resistance of the skin Body functions are temporarily or continuously supported by multiple medical electrical devices Fire risks through the use of anaesthetics, disinfectants or cleaning agents BENDER Presentation Theme 12

First (Tolerable) Failure” principle “First (Tolerable) Failure” principle - Failures can occur but they must not lead to a risk Dual protection is provided The First Failure must be detected and eliminated before a second failure occurs Control of the “First Failure” in a reasonable safe system BENDER Presentation Theme 14

Why Electrical Safety BENDER Presentation Theme 15

Isolated Power Systems Overview To provide ungrounded single-phase power to patient care areas deemed as “Wet Procedure Locations”, so as to: Reduce electric shock hazard - Limits magnitude of ground fault current Practically eliminate danger of massive electrical shocks (macro shock) from ground fault Increase operational safety - Increased electric power reliability by not interrupting power on ground fault Eliminate arcing on ground faults BENDER Presentation Theme 16

Isolated Power Systems Grounded vs. Isolated (Ungrounded) System BENDER Presentation Theme 17

Isolated Power Systems Leakage Current All energized electrical components – cables, windings, medical devices – have a distributed capacitance to ground – called leakage capacitance Cable insulation also has distributed conductance to ground - because insulation resistance is not infinite modeled as a parallel impedance to ground Sum of capacitive and resistive current to ground known as Leakage Current Contributing factors resulting in increased Leakage Current - proximity of grounded & ungrounded components length of ungrounded conductors quantity of devices connected to the system devices containing ground filtration circuitry BENDER Presentation Theme 18

Isolated Power Systems Electric Shock Hazard Leakage Current Grounded System A high fault current can flow The fault current is only limited by the body impedance (1kΩ) IF Supply Voltage (𝑍𝐵 𝑍𝐹) 120𝑉 (1𝑘Ω 0Ω) 𝟏𝟐𝟎𝒎𝑨 Leakage Current 120V ZB 1 kΩ ZF 0Ω Isolated Power System (IPS) The IPS is a “small” local network with low leakage capacitances The fault current is limited by: ZB body impedance ZCe impedance of the fault loop ICe Supply Voltage (𝑍𝐵 𝑍𝑐𝑒) BENDER Presentation Theme 120𝑉 (1𝑘Ω 500𝑘Ω) 120V Zce 500 kΩ ZB 1 kΩ 𝟎. 𝟐𝟒𝒎𝑨 24

Isolated Power Systems Operational Safety Fault Grounded System A fault current flows determined by the ground impedance and the fault. IF IK (IK typically 20A) Overcurrent Protection Device does not trip Risk of equipment malfunctions IF I K Overcurrent Protection Device trips Unexpected interruption of power Fault Isolated Power System (IPS) In the event of a fault RF only a very low current ICe flows Overcurrent Protection Device does not trip In the event of single conductor to ground fault, power is not interrupted Alarm indicated by a Line Isolation Monitor BENDER Presentation Theme 25

Isolated Power Systems Line Isolation Monitor (LIM) Line Isolation Monitor (LIM) - test instrument designed to measures how “isolated” the system is from ground by continually measuring impedance to ground of each phase Predicts and displays what the highest ground fault current would be if the line with the highest impedance would be connected to ground This predicted current is called the Total Hazard Current - Total Hazard Current alarm point 5 mA (NFPA 99 & NEC) BENDER Presentation Theme 26

Isolated Power Systems Line Isolation Monitor (LIM) When a ground fault occurs the LIM will: - sense the new lower impedance to ground re-calculate the fault current that would flow if the remaining phase (with the highest impedance to ground) were to become grounded LIM predicts the highest fault current for the next ground fault to occur (definition of hazard current) - display a hazard message and generate an audible alarm LIM issues a hazard alarm when either: - the leakage current becomes excessive a fault occurs between either conductor and ground BENDER Presentation Theme 27

Isolated Power Systems Summary Electrical Shock - Added protection against electrical shock hazards resulting from the system’s high impedance to ground (capacitive/resistive) return path Continuity of Supply - Power will remain during a single fault condition (i.e. L1 or L2 connected to Ground) Advanced Warning of Faulty Equipment - Provides a warning when the insulation integrity of medical devices connected to the Isolated Power System are compromised BENDER Presentation Theme 28

Codes & Standards Overview Applicable Codes - NFPA 99:2012 - Health Care Facilities Code minimum requirements for the performance of various system - NFPA 70:2014 - National Electrical Code, Article 517 minimum requirements for the installation of various electrical system CMS approved into Federal Law in 2016 Plans submitted after 7/5/2016 must comply with NFPA 99:2012 Always check with your local Authority Having Jurisdiction (AHJ). - Local codes such as North Carolina Department of Health and Human Services (NCDHHS) and Agency for Health Care Administration (AHCA) have more stringent requirements for the installation & performance of Isolated Power Systems. BENDER Presentation Theme 36

Codes & Standards NFPA 99 - 2012 Edition Chapter 4 - Fundamentals - 4.1 Building System Categories 4.2 Risk Assessment 4.3 Application Chapter 6 - Electrical Systems - 6.1 Applicability 6.2 Nature of Hazards 6.3 Electrical System 6.4 Essential Electrical System Requirements —Type 1 6.5 Essential Electrical System Requirements —Type 2 6.6 Essential Electrical System Requirements —Type 3 BENDER Presentation Theme 39

46 Codes & Standards Risk Categories - Patient Care Spaces 4.1* Building System Categories Category 1 Critical Care Space Category 2 General Care Space Category 3 Basic Care Space Category 4 Support Space Failure of system or equipment is likely to cause major injury or death to patients or caregivers. Failure of system or equipment is likely to cause minor injury to patients or caregivers. Failure of system or equipment is not likely to cause injury to patients or caregivers, but can cause discomfort. Failure of system or equipment has no impact on patients or caregivers. Examples: Operating rooms Cardio Cath. labs Delivery Rooms Intensive Care Units Post-anesthesia units Trauma rooms Examples: Inpatient bedrooms Dialysis rooms In-vitro rooms Procedural rooms Examples: Examination space Medical & Dental offices Nursing homes Limited care facilities Examples: Anesthesia work rooms Laboratories Morgues Waiting rooms Utility rooms Lounges BENDER Presentation Theme 46

Codes & Standards NFPA 99 - 2012 Edition Chapter 4 - Fundamentals - 4.1 Building System Categories 4.2 Risk Assessment 4.3 Application Chapter 6 - Electrical Systems - 6.1 Applicability 6.2 Nature of Hazards 6.3 Electrical System 6.4 Essential Electrical System Requirements —Type 1 6.5 Essential Electrical System Requirements —Type 2 6.6 Essential Electrical System Requirements —Type 3 BENDER Presentation Theme 48

Codes & Standards Chapter 6 - Electrical Systems 6.3 Electrical System 6.3.1 Sources 6.3.2 Distribution 6.3.2.2* All Patient Care Rooms 6.3.2.2.1 Regular Voltage Wiring Requirements 6.3.2.2.2 Grounding Requirements 6.3.2.2.3* Grounding Interconnects 6.3.2.2.4 Protection Against Ground Faults 6.3.2.2.5 Low-Voltage Wiring 6.3.2.2.6 Receptacles 6.3.2.2.7 Special Grounding 6.3.2.2.8 Wet Procedure Locations 6.3.2.2.9 Isolated Power 6.3.2.2.10 Essential Electrical Systems (EES) 6.3.2.2.11 Battery-Powered Lighting Units 6.3.2.3 Laboratories 6.3.2.4 Other Non-patient Areas 6.3.2.5 Ground-Fault Protection 6.3.2.6 Isolated Power Systems BENDER Presentation Theme 6.3.3 Performance Criteria and Testing 6.3.3.1 Grounding Systems in Patient Care Rooms 6.3.3.1.1* Grounding System Testing 6.3.3.1.2 Reference Point 6.3.3.1.3* Voltage Measurements 6.3.3.1.4* Impedance Measurements 6.3.3.1.5 Test Equipment 6.3.3.1.6 Criteria for Acceptability for New Construction 6.3.3.2 Receptacle Testing in Patient Care Rooms 6.3.3.3 Isolated Power Systems 6.3.3.4 Ground-Fault Protection Testing 6.3.4* Administration of Electrical Systems 6.3.4.1 Maintenance and Testing of Electrical System 6.3.4.2 Record Keeping 6.3.4.2.1* General 6.3.4.2.2 Isolated Power System (Where Installed) 49

Codes & Standards NFPA 99 - Wet Procedure Locations Wet Procedure Locations - area in a patient care room where a procedure is performed normally subject to wet conditions while patients are present including standing fluids on the floor or drenching of the work area either of which condition is intimate to the patient or staff Wet procedure locations shall be provided with special protection against electric shock. - Isolated Power System or Class A GFCI Receptacles GFCI only if loss of power can be tolerated https://hubbellcdn.com/brochure/Premise WLBVM007.pdf Operating rooms shall be considered to be a wet procedure location, unless a risk assessment conducted by the health care governing body determines otherwise. - risk assessment should include all relevant parties clinicians, biomedical engineering staff, and facility safety engineering staff BENDER Presentation Theme 58

Codes & Standards CMS Survey Centers for Medicare and Medicaid Services K-Tags K913 K914 BENDER Presentation Theme 59

Codes & Standards NFPA 99 – Risk Classifications (cont.) Classification Classification of the risk should be made in agreement with: medical staff (clinicians, biomedical engineering, and facility safety engineering) designer of record authority having jurisdiction Governing Body of the facility BENDER Presentation Theme . with medical staff . and circumstance - indicate medical procedures that will be performed in the space - Can procedures be discontinued at any time & repeated? - determine equipment and contact between applied parts and the patient - Can the patient be expected to accept an interruption? - Is the patient’s natural resistance (skin) bypassed? - Are only listed electrical medical devices connected to the supply? 62

Best Practices Equipment Selection Space usage - medical equipment & device list - Load & impedance determinations Recommended to limit 120V systems to 10kVA or less - Supply needs for equipment operating 120V (i.e. portable lasers) Physical location - Panel location - In-room or adjacent to room Install centrally as close to loads as possible Indication must be installed in locations where circuits are supplied from the Isolated Power System Isolated Power Systems supplying 120V circuits can only supply one Operating Room - Wall structure - depth & load bearing capability Most systems 8” deep & 24” wide Can weigh up to 600lbs - Accessibility of system BENDER Presentation Theme 69

Isolated Power Panels – Types IP - Operating Room - most common 3, 5, 7½, 10 kVA 6” or 8” deep 43” tall x 24” wide Up to 16 circuits (SQD, Eaton, GE) recommended not to exceed 12 IP - ICU - Like above except: includes receptacles and/or ground jacks on front panel 48” tall x 24” wide 71

Isolated Power Panels – Types IX – Dual (Duplex) System Panel - Two systems in a common enclosure Requires independent feeder per system 3, 5, 7½, 10 kVA 8” deep 71” tall x 34” wide Up to 16 circuits per system (SQD, Eaton, GE) recommended not to exceed 12

Isolated Power Panels – Types ID – Dual Output Voltage Panel - provides both 120V and 208V (220V, 230V or 240V) power single feeder 10, 15, 20, 25kVA 12” or 14” deep 51” tall x 34” wide - - 56”x34” available includes receptacles and/or ground jacks on front panel Up to 16 circuits (SQD, Eaton, GE) recommended not to exceed 12

Isolated Power Panels – Types IP – Controlled Power Panel - provides multiple ORs with 208V (220V, 230V or 240V) power 15 or 25kVA Up to 12 circuits maximum of 6 circuits simultaneously active recommended not to exceed 4 - PLC limits the number of simultaneously “active” circuits circuit selection is operated via laser receptacle module (door contact) located in OR XRM – Laser Receptacle Module - Receptacle, Remote Indicator, & PLC input (door) contact Optional “IN-USE” indicator

Remote Indicating Devices MK Series LED display for long life Mounts to standard electrical box Includes “Mute” button Optional: - “Push to Test” Button Transformer Overload Indication Numeric THC / Transformer Load Value Easy to clean rugged stainless steel and Lexan front foil design MK2430 MK800

Isolated Power System - Basic

Isolated Power System - Options Mains load monitoring

Isolated Power System - Options Mains load monitoring Branch circuit ground fault location

Isolated Power System - Options Mains load monitoring Branch circuit load monitoring Branch circuit ground fault location

Best Practices Design Overcurrent Protection & Switches - Branch over current protection devices (OCPD) shall be 2-pole, since both conductors are current carrying Hardwired fixed equipment should be connected with 2-pole switches boom brake & motor, film viewers, etc. Isolated Conductors - Dielectric constant of 3.5 or less is recommended (XHHW, XHHW-2) Identification of conductors; insulation shall be: Orange with a distinctive colored stripe other than white, green, or gray Terminated on Receptacle “Neutral” terminal Brown with a distinctive colored stripe other than white, green, or gray Terminated on Receptacle “HOT” terminal - Keep length of conductors to a minimum. Longer runs higher leakage BENDER Presentation Theme 81

Best Practices Design Conduit - Install “as a crow flies” or “beeline” Use nonflexible metal conduit ¾" conduit minimum - not more the 2 circuits (6-conductors) per ¾" conduit. Use 1" conduit with 3 or 4 circuits, but do not use larger than 1”. Devices per Circuit - Recommended to limit circuits to two duplex receptacles (4 outlets) The LIM is looking for a worse case scenario. Adding receptacles to a circuit for additional equipment will result in additional leakage BENDER Presentation Theme 82

Best Practices Design Use “Hospital Grade” devices only - Do not use GFCI, Surge Protection Devices, Relocatable Power Taps with Ground checks, or Isolated Ground devices Any device that has a relationship with an equipment ground to function properly, will not operate properly on an IPS Equipment located outside the patient vicinity not typically connected to IPS - Fixed-mounted, permanently connected therapeutic equipment not likely to become energized with non-moveable elements Field Lighting (overhead ceiling lights) Dedicated receptacle for room cleaning equipment BENDER Presentation Theme 83

Frequently Asked Questions What should I do when the LIM goes into alarm? What preventive & periodic maintenance is required for the LIM? When should the Isolated Power System integrity be tested? What is the recommended maximum conductor length for an Isolated Power Panel? How many circuits (breakers) can I have in an Isolated Power Panel? BENDER Presentation Theme 85

Frequently Asked Questions Operational Questions (Q): What should I do when the LIM goes into alarm? Do NOT endanger the patient by discontinuing the procedure prematurely - The alarm does not mean there is imminent danger Acknowledge the alarm & immediately notify personnel responsible for the equipment’s maintenance If the alarm happened soon after an electrical equipment was connected, disconnect the equipment that was most recently connected - Only disconnect the equipment if it will not endanger the patient. Once the procedure is complete, responsible personnel should investigate & correct the alarm’s root cause. - This process is often tedious and time consuming (if done manually) and requires deenergizing the circuits on the system. Automatic on-line fault location systems (EDS / FLS) are available in the marketplace. BENDER Presentation Theme 86

Frequently Asked Questions Operational Questions (Q): What preventive & periodic maintenance is required for the LIM? LIM Testing - External Fault Impedance / Response Test after installation, and prior to being placed in service and/or any repair or renovation to the electrical distribution system all LIM manufactures recommend minimum of annual testing - Functional - Audible & Visual Alarm Test performed by depressing test button on unit annually for digital LIMs & monthly for analog LIMs BENDER Presentation Theme 87

Frequently Asked Questions Operational Questions (Q): When should the Isolated Power System integrity be tested? IPS system - after installation, and prior to being placed in service and/or any repair or renovation to the electrical distribution system Lug and breaker torque validation (annual) Grounding system integrity (recommended every 1 – 3 years) System impedance & hazard current (recommended every 1 – 3 years) BENDER Presentation Theme 88

Frequently Asked Questions Design Questions (Q): What is the maximum conductor length for an Isolated Power Panel? BENDER Presentation Theme 89

Frequently Asked Questions Design Questions (Q): What is the maximum conductor length for an Isolated Power Panel? BENDER Presentation Theme 90

Frequently Asked Questions Design Questions (Q): What is the maximum conductor length for an Isolated Power Panel? Minimum NFPA acceptance criteria for impedance to ground is 200 kΩ On 120V system, the maximum allowable system hazard current is calculated as follows: - 𝐼 𝑡𝑜𝑡𝑎𝑙 𝑉 𝑍 120 𝑉 200 𝑘Ω 600 𝑢𝐴 Manufacture’s permissible leakage (𝐼𝑚) for the IPS according to UL-1047 (table 30.1 & 30.2): - 𝐼 𝑚 𝐼 𝑖𝑛𝑡𝑒𝑟𝑖𝑜𝑟 𝐼 𝑡𝑟𝑎𝑛𝑠𝑓𝑜𝑟𝑚𝑒𝑟 50 𝑢𝐴 25 𝑢𝐴 75 𝑢𝐴 Leakage current of XLPE cable (𝐼𝑤 ) is 1 μA/ft in metallic conduit, as per IEEE 602-2007 - Recommend conservative value of 1.1 μA/ft. to allow for manufacture variations Therefore, the recommended conductor length (𝑊𝑚𝑎𝑥 ) can be calculated as follows: - 𝑊𝑚𝑎𝑥 𝐼𝑡𝑜𝑡𝑎𝑙 𝐼𝑚 𝐼𝑤 600𝑢𝐴 75𝑢𝐴 1.1𝑢𝐴 480𝑓𝑡 (A): The recommended conductor length of XLPE wire is 480ft. BENDER Presentation Theme 91

Frequently Asked Questions Design Questions (Q): How many circuits (breakers) can I have in an Isolated Power Panel? UL-1047 limits the quantity of branch breakers per system to 16 maximum. Recommended maximum conductor length per system (𝑊𝑚𝑎𝑥 ) is calculated as 480ft Most modern general purpose operating rooms are 600sqft with 10ft ceilings. - Based on standard design practices, the average linear length per circuit (𝑊𝑛), originating from a centrally located IPS is 40-58ft. Thus the recommended number of circuits can be calculated as: - 𝐶𝑚𝑎𝑥 𝑊𝑚𝑎𝑥 𝑊𝑛 480 𝑓𝑡 40 𝑓𝑡 12 - 𝐶𝑚𝑎𝑥 𝑊𝑚𝑎𝑥 𝑊𝑛 480 𝑓𝑡 58 𝑓𝑡 8 (A): The recommended number of breakers is 8 – 12 per system. BENDER Presentation Theme 92

Why Electrical Safety Our families deserve at least the same level of electrical shock protection in critical healthcare environments as is provided for them in residential washbasin locations. BENDER Presentation Theme 93

Operating rooms Cardio Cath. labs Delivery Rooms Intensive Care Units Post-anesthesia units Trauma rooms Category 2 General Care Space Failure of system or equipment is likely to cause minor injury to patients or caregivers. Examples: Inpatient bedrooms Dialysis rooms In-vitro rooms Procedural rooms .

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