THE HEARTBEAT B E H I N D T H E HEARTBEAT MEDICAL POWER BROCHURE

THE HEARTBEAT B E H I N D T H E HEARTBEAT MEDICAL BROCHURE

A B O U T EOS P O W E R EOS Power has been designing standard, modified and custom medical power solutions for the global medical market for 2 years. We understand and implement unique electrical, quality and safety requirements of medical customers into our broad range of Class I and Class II medically approved power solutions. This focused design effort has resulted in a range of best in class medically approved power solutions which allow medical customers huge flexibility when making critical decisions on their choice of power source. The current EOS medical power range can offer power solutions from 2 to 0 watts with many unique footprints, power densities and specifications. Let EOS power your medical applications! Our best in class support, products and warranties all come as standard.

S T A N D A R D MEDICAL P O W E R S O L U T I O N S The EOS standard medical power supplies are available in industry standard footprints such as 2 x 4 inches, 3 x inches, 4 x 6 inches and the NEW 2 x 3 x 0.7 inches format. EOS Power offers end customers standard specifications such as Class II product options and a BF rating (Body Floating) on higher power products which are not available from many alternate suppliers. Adding these specifications to the standard high efficiency, high power density and full medical approvals ensures that EOS is a leader in providing standard medical power solutions.

MWLC Conduction Rated Arctic Series The EOS MWLC Conduction Rated Arctic Series addresses the growing demand in the market for conduction rated power supplies. The MWLC Arctic Series again sees EOS Power deliver industry leading power densities and specifications in an industry standard 3 x inches footprint: 0 watts of EOS Power in 22. cubic inches which can be used in conduction, convection or forced-air modes of operation. MWLP Low Profile Blue Series with Extended Warranty Option The MWLP Blue Series offers the size conscious customer industry leading watts per cubic inch in height profiles ranging from mm to 2 mm in industry standard footprints. The Blue Series allows customers shrink their applications without compromising on power, quality or functionality. The Blue Series also comes with an extended warranty option: customers can choose their MWLP product with an extended warranty period of seven years. MWLT Economical Green Series The EOS Power Economical Green Series was designed with the value focused customer in mind. The MWLT Green Series offers market leading specifications in industry standard footprints at very competitive price levels. While cost is important to many end users, EOS does not compromise on quality or workmanship which makes the Green Series the perfect choice for the quality and cost conscious customer. MULP Ultra Low Profile Orange Series The EOS Power Ultra Low Profile Orange Series sets new height profile benchmarks in the power supply industry with a maximum height of just 0.7 inches (that s an incredible 19.0 mm). The MULP Orange Series packs up to watts per cubic inch into their small profiles which enables customers miniaturize their applications without compromising on available power levels. While still maintaining the 0.7 inch product height, the Orange Series is also available with Power Good and Power Fail signaling capability.

M O D I F I E D MEDICAL P O W E R S O L U T I O N S EOS Power offers low barrier of access to modification capabilities and value added engineering services. We understand and support that not all end customer requirements will be satisfied by a standard medical product alone. EOS Power specializes in providing end customers a total power solution whether that is changing voltages, adding functionality, mechanical additions or manufacturing solutions. Modifications and value added medical power solutions are an EOS Power specialty. We have supplied non-standard solutions to global medical customers for over two decades. Contact EOS Power for more details of how to get a fast quotation for your value added medical solution.

C U S T O M I Z E D MEDICAL P O W E R S O L U T I O N S EOS Power has dedicated custom power resources which are available to quote unique medical power supply requirements. Our years of experience in medical power supply design and production can help our customers choose the best design solution for their requirements. EOS Power works in parallel with the end customer to agreed timeline and milestone targets and supports the customer throughout the lifetime of the product application. EOS personnel are available to quote medical custom design requirements upon receipt of a full product specification. Contact EOS Power if you require custom medical solutions which are delivered to specification, on time and within budget.

40 60 WATTS PRODUCT FEATURES MODEL NUMBER VOLTAGE EFFICIENCY (%) NO- MULP40 3 x 2 x 0.7 Inches 40 W Temperature PCB Mounting Option EN 60601-1-2:20 MULP40 0 MULP40 1* MULP40 MULP40 13* MULP40 MULP40 13* MULP40 MULP40 13* MULP40 MULP40 13* MULP40 MULP40 13* MULP40 8 8 3.33 3.33 2.67 2.67 1.67 1.67 1.33 1.33 0.83 0.83 0.7 8 8 8 8 MULP40 138* 8 0.7 MWLT40 Single & Triple Output 4 x 2 x 1.2 Inches 40 W No Load Power 0.3 W (Single Output) Dual Fusing LFMWLT40 00 LFMWLT40 01 LFMWLT40 02 LFMWLT40 03 LFMWLT40 04 LFMWLT40 00 LFMWLT40 01 LFMWLT40 02 LFMWLT40 03.1.2,.,.8.2,,.8.2, 14.6, 14.8 3.3,.2,.8 8 3. 2.7 1.7 0.83 6.0, 2.0, 0. 6.0, 1.0, 0. 6.0, 1., 0. 6.0, 3.0, 0. 8 8 EN 60601-1-2:20 MWLT60 Single & Triple Output 4 x 2 x 1.2 Inches 0 to 6 W Convectioncooled No Load Power 0.3 W (Single Output) Dual Fusing LFMWLT60 00 LFMWLT60 01 LFMWLT60 02 LFMWLT60 03 LFMWLT60 04 LFMWLT60 00 LFMWLT60 01 LFMWLT60 02 LFMWLT60 03.1.2,.,.8.2,,.8.2, 14.6, 14.8 3.3,.2,.8.4 4.33 2.7 1.3 8.0, 3.0, 0. 8.0, 1., 0. 8.0, 2., 0. 6.0, 3.0, 0. 8 8 EN 60601-1-2:20

7 0 WATTS PRODUCT FEATURES MODEL NUMBER VOLTAGE EFFICIENCY (%) NO- MWLP7 3 x 2 x 1 Inches 7 W Efficiencies up to % Temperature, Thermal Shutdown Dual Fusing Screw Terminal & Header LFMWLP7 01 LFMWLP7 11* LFMWLP7 02 LFMWLP7 12* LFMWLP7 03 LFMWLP7 13* LFMWLP7 04 LFMWLP7 14* LFMWLP7 0 LFMWLP7 1* LFMWLP7 06 LFMWLP7 16* 8 8 6.2 6.2 3. 3. 1.6 1.6 2.0 2.0 1.29 1.29 Type Connector Options EN 60601-1-2:20 PRODUCT FEATURES MODEL NUMBER VOLTAGE (convection) EFFICIENCY (forced-air) (%) NO- MWLP0 3 x 2 x 1.18 Inches 0 W Forced-air & 0 W Efficiencies up to % Temperature Dual Fusing Screw Terminal & Header LFMWLP0 01 LFMWLP0 11* LFMWLP0 02 LFMWLP0 12* LFMWLP0 03 LFMWLP0 13* LFMWLP0 04 LFMWLP0 14* LFMWLP0 0 LFMWLP0 1* LFMWLP0 06 LFMWLP0 16* 8 8 6.66 6.66 4.16 4.16 2.08 2.08 3.33 3.33 1.72 1.72 8 8 2. 2. 4 4 2.07 2.07 Type Connector Options EN 60601-1-2:20

0 1 WATTS PRODUCT FEATURES MODEL NUMBER VOLTAGE (convection) (forced-air) EFFICIENCY (%) NO- MWLT0 4 x 2 x 1.32 Inches 0 W Forced-air & 0 W Screw Terminal & Header Type Connector Options V Fan Output LFMWLT0 00 LFMWLT0 LFMWLT0 01 LFMWLT0 11 LFMWLT0 02 LFMWLT0 12 LFMWLT0 03 LFMWLT0 13 LFMWLT0 04 LFMWLT0 14 16 16 4.17 4.17 2.08 2.08 20 16.. 6.2 6.2 3.13 3.13 8 8 8 8 EN 60601-1-2:20 MULP1 PGPF 4 x 2. x 0.7 Inches 1 W Forced-air & 0 W Power Good & Power Fail Signal Temperature MTBF > 3 m hours as per Telcordia SR-332 Issue 3 MULP1 00 MULP1 03* MULP1 00 MULP1 03* MULP1 00 MULP1 03* MULP1 00 MULP1 03* MULP1 00 MULP1 03* MULP1 008 MULP1 038* 8 8 8 8 4 4 2. 2. 2.07 2.07 7. 7. 6 6 3.7 3.7 3.1 3.1 V Fan Output EN 60601-1-2:20

1 22 WATTS PRODUCT FEATURES MODEL NUMBER VOLTAGE (convection) (forced-air) EFFICIENCY (%) NO- MULP1 4 x 2 x 0.7 Inches 1 W Forced-air & 0 W Screw Terminal & Header Type Connector Options V Fan Output EN 60601-1-2:20 MULP1 MULP1 13* MULP1 MULP1 13* MULP1 MULP1 13* MULP1 MULP1 13* MULP1 MULP1 13* MULP1 8 MULP1 138* 8 8 8 8 4 4 2. 2. 2.07 2.07 7. 7. 6 6 3.7 3.7 3.1 3.1 MWLT200 Single Ouptut x 3 x 1. Inches 200 W Forced-air & 160 W Leakage current ua Screw Terminal & Header Type Connector Options V Fan Output V Standby Output LFMWLT200 00 LFMWLT200 LFMWLT200 01 LFMWLT200 11 LFMWLT200 02 LFMWLT200 12 LFMWLT200 03 LFMWLT200 13 LFMWLT200 04 LFMWLT200 14 LFMWLT200 0 LFMWLT200 1 13.33 13.33.67.67 3.33 3.33.33.33 3 26 13.33 13.33 4.17 4.17 8 8 8 8 MWLP22 4 x 2 x 1 Inches 22 W Forced-air & 1. W 7 Years Extended Warranty Option Temperature MTBF > 3.37 m hours as per Telcordia SR-332 Issue 3 LFMWLP22 01 LFMWLP22 11* LFMWLP22 02 LFMWLP22 12* LFMWLP22 03 LFMWLP22 13* LFMWLP22 04 LFMWLP22 14* LFMWLP22 0 LFMWLP22 1* LFMWLP22 06 LFMWLP22 16* 8 8 9.37 9.37 7. 7. 4.68 4.68 2.34 2.34 3.7 3.7 1.94 1.94 18.7 18.7 9.37 9.37 4.68 4.68 7. 7. 3. 3. 94 94 94 94 V Fan Output EN 60601-1-2:20

27 WATTS PRODUCT FEATURES MODEL NUMBER VOLTAGE (convection) (forced-air) EFFICIENCY (%) NO- MULP27 PGPF x 3. x 0.7 Inches 27 W Forced-air & 0 W Power Good & Power Fail Signal Temperature MTBF > 3 m hours as per Telcordia SR-332 Issue 3 MULP27 00 MULP27 03* MULP27 00 MULP27 03* MULP27 00 MULP27 03* MULP27 00 MULP27 03* MULP27 00 MULP27 03* MULP27 008 MULP27 038* 8 8.. 6.2 6.2 3. 3. 2.76 2.76 20.83 20.83.41.41.2.2 4.31 4.31 V Fan Output EN 60601-1-2:20 MULP27 x 3 x 0.7 Inches 27 W Forced-air & 0 W Temperature MTBF > 3 m hours as per Telcordia SR-332 Issue 3 V Fan Output MULP27 MULP27 13* MULP27 MULP27 13* MULP27 MULP27 13* MULP27 MULP27 13* MULP27 MULP27 13* MULP27 8 MULP27 138* 8 8.. 6.2 6.2 3. 3. 2.76 2.76 20.83 20.83.41.41.2.2 4.31 4.31 EN 60601-1-2:20

0 30 WATTS PRODUCT FEATURES MODEL NUMBER VOLTAGE (convection) (forced-air) EFFICIENCY (%) NO- MWLT0 3 x x 1. Inches Up to 32 W Forced-air & 200 W LFMWLT0 00 3 LFMWLT0 01 3 LFMWLT0 02 3 LFMWLT0 03 3 LFMWLT0 04 3 LFMWLT0 0 3 28 13.33 4.17 40 2 20 13.4 6.77.83 86 89 89 V Fan Output V Standby Output EN 60601-1-2:20 MWLP30 x 3 x 1 Inches 30 W Forced-air & 200 W 7 Years Extented Warranty Option Temperature Thermal Shutdown MTBF > 2.6 m hours as per Telcordia SR-332 Issue 3 LFMWLP30 01 LFMWLP30 11* LFMWLP30 02 LFMWLP30 12* LFMWLP30 03 LFMWLP30 13* LFMWLP30 04 LFMWLP30 14* LFMWLP30 0 LFMWLP30 1* LFMWLP30 06 LFMWLP30 16* 8 8 4.17 4.17 3.4 3.4 2 18.7 21.67 18 14.6 14.6 7.3 7.3 11.67 11.67 6.04 6.04 94 94 94 94 V Fan Output Screw Terminal & Header Type Connector Options EN 60601-1-2:20 * with Molex Connector ** suffix "-II" at the end of model number is required for the Class II option

40 0 WATTS PRODUCT FEATURES MODEL NUMBER VOLTAGE (convection) (forced-air) EFFICIENCY (%) NO- MWLT40 4 x 6. x 1.6 Inches U-Channel, Top & Side Fan Options OR-ing MOSFET Option Dual Fusing Optional Active Current Sharing V Standby Output Power Good & Power Fail Signal Remote ON/OFF EN 60601-1-2:20 LFMWLT40 00 LFMWLT40 01 LFMWLT40 02 LFMWLT40 03 LFMWLT40 04 LFMWLT40 0 LFMWLT40 00 T LFMWLT40 01 T LFMWLT40 02 T LFMWLT40 03 T LFMWLT40 04 T LFMWLT40 0 T LFMWLT40 00 S LFMWLT40 01 S LFMWLT40 02 S LFMWLT40 03 S LFMWLT40 04 S LFMWLT40 0 S 31 20.83 16.66.3 6.2 31 20.83 16.66.3 6.2 31 20.83 16.66.3 6.2 37. 18.7 9.37 37. 18.7 9.37 37. 18.7 9.37 83 86 83 86 83 86 PRODUCT FEATURES MODEL NUMBER VOLTAGE (convection) (conduction) (forced-air) EFFICIENCY (%) NO- MWLC0 MWLC0 9.17 41.67 < 200 @ 1 < 400 @ 2 < 0.7 x 3 x 1. Inches 0 W Forced-air, 20 W Conduction & 0 W MWLC0 7.33 13.33 33.33 < 200 @ 1 < 400 @ 2 < 0.7 Hybrid Cooling Design MWLC0 6.2.42 22. < 200 @ 1 < 400 @ 2 < 0.7 Temperature V Fan Output Thermal Shutdown MWLC0 1 < 200 @ 1 < 400 @ 2 < 0.7 Multiple Mounting Options MWLC0 3.13.21 11.46 < 200 @ 1 < 400 @ 2 < 0.7 EN 60601-1-2:20 MWLC0 8 8 2.9 4.31 9. < 200 @ 1 < 400 @ 2 < 0.7

Quick Reference Safety Approvals IEC 60601-1:200 (ed.3);am1 Guidance The latest version of 60601-1 is the 3rd edition+am1 which was first published in December 200. The standard has been adapted in the major countries/regions of the world and published as the following versions: EU: EN 60601-1:2006 USA: Isolation & Separation - IEC60601-1:200 Insulation Basic (1 x MOP) Double or Reinforced (2 x MOP) ANSI/AAMI ES 60601-1:200; AMD1:20 Canada: CSA-C22.2 No. 60601-1:08; No. 60601-1:14 Currently equipment are approved to 3rd editions of the standard MOOP Air Creepage Clearance Distance Test Voltage MOPP Air Creepage Clearance Distance Test Voltage 2.0 mm 3.2 mm 00 VAC 2. mm 4.0 mm 00 VAC 4.0 mm 6.4 mm 00 VAC.0 mm 8.0 mm 4000 VAC Insulation test voltages based on 20 VAC working voltage MOP = Means of protection MOOP = Means of operation protection MOPP = Means of patient protection Emission and Immunity Specifications IEC 011/022 IEC 600-3-2 IEC 600-3-3 IEC 600-4-2 IEC 600-4-3 IEC 600-4-4 IEC 600-4- IEC 600-4-6 IEC 600-4-8 IEC 600-4-11 Leakage Currents Earth leakage Enclosure leakage Patient leakage Leakage Current Earth* Enclosure Patient Limits for conducted and radiated emissions Limits for harmonic current emissions Limitation of voltage changes, voltage variations & flicker Electrostatic discharge immunity Radiated immunity Electrical fast transient immunity Electrical surge immunity Conducted disturbance immunity Immunity to power frequency magnetic field Immunity to voltage dips, short interruptions and variations on supply line Current flowing in the earth conductor Current flowing to the earth via the patient from the enclosure Current flowing to the earth via the patient from an applied part NC TYPE B SFC TYPE BF TYPE CF NC SFC NC SFC 000 µa ma 000 µa ma 000 µa ma 0 µa 00 µa 0 µa 00 µa 0 µa 00 µa 0 µa 00 µa 0 µa 00 µa 0 µa 00 µa NC = Normal Conditions SFC = Single Fault Conditions *Typical EOS µa C L A S S I a n d C L A S S I I What are the Classifications for Protection against Electric Shock? There are two classifications that fall under sub-clause 6.2 of the standard: 1) the Power Source and 2) Applied Parts. Power sources can be an external power source and is either classified as a Class I or Class II Medical Equipment or an internal power source, which is classified as Internally Powered Medical Equipment. Power Sources: External Class I, External Class II or Internal: Class I provides its protection against electric shock by having an additional safety ground (known as Protectively Earthed) that is connected to the internal and/or external conductive parts (metal) of the power source. Class II provides its protection against electric shock by having an additional layer of insulation beyond that of Basic Insulation (a single layer of insulation), and is provided either by Double Insulation (two layers of insulation) or by Reinforced Insulation (the same as Double Insulation, but as one insulation system that is twice as thick, typically). An Internal Power Source is typically a battery. I E C 6 0 6 0 1-1 ( e d. 3 ) ; a m 1 The third edition of IEC 60601-1 is filled with new and revised requirements. Particularly manufacturers who had been operating using the second edition of the standard will find the most significant changes in four sections of the revision. These sections are general requirements (clause 4), electrical safety (clause 8), mechanical safety (clauses 9 & ) and thermal and fire safety (clause 11). Clause 4: General Requirements: The most important change in the third edition s general requirements is that manufacturers must apply risk management (in accordance with ISO 14971) to the device being certified to the third edition of 60601-1. This requirement, found in clause 4.2, combines for the first time the need to comply with both, a product and a process standard. Clause 8: Electrical Safety: In the third edition basic and double/reinforced insulations have been replaced by one or two means of (patient and operator) protection. The requirements that the insulation must meet depend on who is being protected. For means of patient protection the third edition sets essentially the same requirements as the second edition. One means of patient protection in the third edition is equal to the second edition s basic insulation. The third edition s two means of patient protection is equal to double/reinforced insulation in the second edition. Clauses 9 and : Mechanical Safety: Mechanical requirements of the third edition contain considerable detail and address a far broader range of specific hazards. One of the most notable additions to the mechanical requirements deals with pinching and shearing caused by moving parts. Third edition also adds new requirements and tests. Clause 11: Thermal and Fire Safety: Range of limits based on the thermal properties of the material and the likely duration of contact. The limit for these parts is a maximum of 86 ºC for materials such as wood, where contact is 1 minute or less, and a minimum of ºC for all materials where contact will be minutes or more. Contact duration must be evaluated and documented in the risk management file. In conclusion for EOS: The third edition of IEC 60601-1 represents a major step forward in medical device standardization. Requiring the use of ISO 14971 for risk management ensures that manufacturers can meet the implied requirement of the second edition to look for hazards beyond those addressed in the standard. It also ensures that this can be done using a consistent process. The same applies for cases in which designers want to address a hazard using techniques that differ from those identified in the standard. In general, the flexibility specifically allowed in most of the requirements in the third edition should help to create new devices efficiently and at a reasonable and competitive cost. However, the standard has changed radically. It is crucial that design teams begin to become familiar with the document and here at EOS we provide this support.

EOS NORTH AMERICA: e-mail: usasales@eospower.com EOS EUROPE: e-mail: emeasales@eospower.com EOS ASIA-PACIFIC: e-mail: asiasales@eospower.com EOS INDIA: e-mail: indiasales@eospower.com www.eospower.com