Medical/ICT/ITE/Household use Power Supply

GTM91099-60VV-T2 Image
Model ImageGTM91099-60VV-T2, Medical/ICT/ITE/Household use Power Supply,  60601-1-4th Ed. , Wall Plug-in+Desktop Combination, Regulated Switchmode AC-DC Power Supply AC Adaptor, , Input Rating: 100-240V~, 50-60 Hz, IEC 60320/C8 AC Inlet connector, Output Rating: 60 Watts, Power rating with convection cooling (W) , 5-48V in 0.1V increments, Approvals: ETL; Korea (16V, 18V, 19V, 20V, 24V Only; UKCA; India BIS  5V, 12V, 13.8V, 15V, 18V, 19V, 20V, 24V, 36V, 48V; Korea (9.1V,10V,11V,12V, 13V,13.8V,14V,15V Only); CB 62368; cETLus 62368-1; ETL 62368 (pending); South Africa; CE; Ukraine; Level V; China RoHS;WEEE; CE; EC; RoHS; VCCI; IEC 60335; Fuse 60335; LPS 60950; Book 60601; Double Insulation; CB 60601-1 2MOPP; RCM; CE; CCC; cRUus; cULus; CB 60950; CB EN/IEC 60335-1; Peru; IRAM; Taiwan BSMI (16V only); SGS (Brazil); Singapore (16V only); Malaysia; Colombia; NOM (16V only); IEC/EN60601-1; NEMKO EN/IEC 60335-1; CE; EAC; S-Mark IEC/EN 60601-1 60950; ETL; CB 61158; South Africa; South Africa; PSE; PSE; PSE; FCC; IP42; 2MOPP; CB 60601-1; GTM91099-60VV-T2, Medical/ICT/ITE/Household use Power Supply,  60601-1-4th Ed. , Wall Plug-in+Desktop Combination, Regulated Switchmode AC-DC Power Supply AC Adaptor, , Input Rating: 100-240V~, 50-60 Hz, IEC 60320/C8 AC Inlet connector, Output Rating: 60 Watts, Power rating with convection cooling (W) , 5-48V in 0.1V increments, Approvals: ETL; Korea (16V, 18V, 19V, 20V, 24V Only; UKCA; India BIS  5V, 12V, 13.8V, 15V, 18V, 19V, 20V, 24V, 36V, 48V; Korea (9.1V,10V,11V,12V, 13V,13.8V,14V,15V Only); CB 62368; cETLus 62368-1; ETL 62368 (pending); South Africa; CE; Ukraine; Level V; China RoHS;WEEE; CE; EC; RoHS; VCCI; IEC 60335; Fuse 60335; LPS 60950; Book 60601; Double Insulation; CB 60601-1 2MOPP; RCM; CE; CCC; cRUus; cULus; CB 60950; CB EN/IEC 60335-1; Peru; IRAM; Taiwan BSMI (16V only); SGS (Brazil); Singapore (16V only); Malaysia; Colombia; NOM (16V only); IEC/EN60601-1; NEMKO EN/IEC 60335-1; CE; EAC; S-Mark IEC/EN 60601-1 60950; ETL; CB 61158; South Africa; South Africa; PSE; PSE; PSE; FCC; IP42; 2MOPP; CB 60601-1;
Information
Model NumberGTM91099-60VV-T2
DescriptionGTM91099-60VV-T2, Medical/ICT/ITE/Household use Power Supply, 60601-1-4th Ed. , Wall Plug-in+Desktop Combination, Regulated Switchmode AC-DC Power Supply AC Adaptor, , Input Rating: 100-240V~, 50-60 Hz, IEC 60320/C8 AC Inlet connector, Output Rating: 60 Watts, Power rating with convection cooling (W) , 5-48V in 0.1V increments, Approvals: ETL; Korea (16V, 18V, 19V, 20V, 24V Only; UKCA; India BIS 5V, 12V, 13.8V, 15V, 18V, 19V, 20V, 24V, 36V, 48V; Korea (9.1V,10V,11V,12V, 13V,13.8V,14V,15V Only); CB 62368; cETLus 62368-1; ETL 62368 (pending); South Africa; CE; Ukraine; Level V; China RoHS;WEEE; CE; EC; RoHS; VCCI; IEC 60335; Fuse 60335; LPS 60950; Book 60601; Double Insulation; CB 60601-1 2MOPP; RCM; CE; CCC; cRUus; cULus; CB 60950; CB EN/IEC 60335-1; Peru; IRAM; Taiwan BSMI (16V only); SGS (Brazil); Singapore (16V only); Malaysia; Colombia; NOM (16V only); IEC/EN60601-1; NEMKO EN/IEC 60335-1; CE; EAC; S-Mark IEC/EN 60601-1 60950; ETL; CB 61158; South Africa; South Africa; PSE; PSE; PSE; FCC; IP42; 2MOPP; CB 60601-1; GTM91099-60VV-T2, Medical/ICT/ITE/Household use Power Supply, 60601-1-4th Ed. , Wall Plug-in+Desktop Combination, Regulated Switchmode AC-DC Power Supply AC Adaptor, , Input Rating: 100-240V~, 50-60 Hz, IEC 60320/C8 AC Inlet connector, Output Rating: 60 Watts, Power rating with convection cooling (W) , 5-48V in 0.1V increments, Approvals: ETL; Korea (16V, 18V, 19V, 20V, 24V Only; UKCA; India BIS 5V, 12V, 13.8V, 15V, 18V, 19V, 20V, 24V, 36V, 48V; Korea (9.1V,10V,11V,12V, 13V,13.8V,14V,15V Only); CB 62368; cETLus 62368-1; ETL 62368 (pending); South Africa; CE; Ukraine; Level V; China RoHS;WEEE; CE; EC; RoHS; VCCI; IEC 60335; Fuse 60335; LPS 60950; Book 60601; Double Insulation; CB 60601-1 2MOPP; RCM; CE; CCC; cRUus; cULus; CB 60950; CB EN/IEC 60335-1; Peru; IRAM; Taiwan BSMI (16V only); SGS (Brazil); Singapore (16V only); Malaysia; Colombia; NOM (16V only); IEC/EN60601-1; NEMKO EN/IEC 60335-1; CE; EAC; S-Mark IEC/EN 60601-1 60950; ETL; CB 61158; South Africa; South Africa; PSE; PSE; PSE; FCC; IP42; 2MOPP; CB 60601-1;
Agency Documentshttp://www.globtek.info/certs/GTM91099/
CE EC-Declaration for Medicalhttps://globtek.secure.force.com/models/ec_declaration?id=a0O30000007P7ZeEAK
CE EC-Declaration for Industrial/Commercial/ITEhttps://globtek.secure.force.com/models/ec_declaration?id=a0O30000007P7ZeEAK
CE EC-Declaration for Householdhttps://globtek.secure.force.com/models/ec_declaration?id=a0O30000007P7ZeEAK
UKCA-Declaration for Medicalhttps://globtek.secure.force.com/models/ukca_declaration?id=a0O30000007P7ZeEAK
UKCA-Declaration for Industrial/Commercial/ITEhttps://globtek.secure.force.com/models/ukca_declaration?id=a0O30000007P7ZeEAK
UKCA-Declaration for Householdhttps://globtek.secure.force.com/models/ukca_declaration?id=a0O30000007P7ZeEAK
Morocco SDoC Declarationhttps://globtek.secure.force.com/models/Morocco_SDoC_Declaration?id=a0O30000007P7ZeEAK
RoHS/RoHS3 Declarationhttps://www.globtek.com/pdf/rohs_cert/a0O30000007P7ZeEAK
Prop 65 Statementhttps://en.globtek.com/prop-65-statement.pdf
REACH Declarationhttps://www.globtek.com/pdf/iso_certificates/REACH.pdf
Conflict Minerals Declarationhttps://www.globtek.com/pdf/conflict-minerals.pdf
Model Parameters
TypeWall Plug-in+Desktop Combination / Combinato per collegamento a presa elettrica e tipo computer
TechnologyRegulated Switchmode AC-DC Power Supply AC Adaptor / Alimentatore AC-DC di tipo switching
CategoryMedical/ICT/ITE/Household use Power Supply / Medical/ICT/ITE/Household use Power Supply
Input Voltage Range (V)100-240V~, 50-60 Hz
Max Input Current (A)1.5 A
Max Output Power Rating (W)60
Output Voltage Range (V)5-48
EfficiencyV
Ingress ProtectionIP42
Size (mm)117.53*53.47*36.6
EnclosureUser-added image
                         Units shipped without an installed input plug have a "desktop insert" installed.

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Rating Table
Model Number (Final ordering #/Part No to be defined)VoltageAmps (A)Watts (W)RFQ
GTM91099-2509-4.0-T2*5525
GTM91099-3009-4.0-T2*5630
GTM91099-3009-4.0-T2*5630
GTM91099-3009-3.0-T2*6530
GTM91099-3009-2.5-T2*6.54.629.9
GTM91099-3009-1.0-T2*83.7530
GTM91099-4509-T2*9545
GTM91099-4509-T2*9545
GTM91099-6015-3.0-T2*12560
GTM91099-6015-3.0-T2*12560
GTM91099-6515-2.4-T2*12.65.1564.89
GTM91099-6015-1.2-T2*13.84.3459.89
GTM91099-6015-T2*15460
GTM91099-6015-T2*15460
GTM91099-6024-8.0-T2*163.7560
GTM91099-6024-6.0-T2*183.3359.94
GTM91099-6019-T2*193.1559.85
GTM91099-6024-4.0-T2*20360
GTM91099-3024-4.0-T2*201.530
GTM91099-6024-T2*242.560
GTM91099-6024-T2*242.560
GTM91099-6036-T2*361.6659.76
GTM91099-6048-18.0-T2*361.6659.76
GTM91099-6048-12.0-T2*361.6659.76
GTM91099-6048-T2*481.2560
GTM91099-6048-T2*481.2560
GTM91099-4048-T2*480.83339.98
* (Final ordering #/Part No to be defined)
Specifications
A) ELECTRICAL SPECIFICATIONS:
01. Input Voltage: Specified 90-264 Vac, Nameplate rated: 100-240Vac
02. Input Frequency: Specified 47-63 Hz, Nameplate rated 50-60Hz
03. Output Regulation: +/- 5% nominal output voltage measured at the output connector at nominal line
04. Line Voltage Regulation: +/- 2% max at full load
05. Output Ripple (Vp-p): +/-1% or 150mV whichever is greather at nominal output voltage. Measured at 20 MHz bandwidth with 0.1 uf ceramic capacitor in parallel with 10 uf electrolytic capacitor connected at the end of the output connector.
06. Turn-ON/OFF Overshoot: 5% max, 500uS max recovery time for 25% to 50% step load
07. Turn-ON Delay: 2 Seconds, maximum @ full load, nominal line
08. Hold-Up Time: 8 mS at nominal input and full load
09. Inrush Current: 40A max at cold start 120 VAC, 60A max cold start 230VAC
10. Switching Frequency: 100 KHz typical

B) PROTECTION
1. Over-Voltage: Protected, Hiccup with auto recovery
2. Short Circuit: Protected, Hiccup with auto recovery
3. Over-load: Protected, Hiccup with auto recovery
4. Input Protection: Input line and neutral fusing
5. Means of Patient Protection: (2 x MOPP)

C) SAFETY
01. Dielectric Withstand Voltage: 5656Vdc from primary to secondary
02. Touch Current: Maximum allowed values: 100uA NC(Normal condition) 500uA SFC(single fault condition)
03. Means of Protection: 2 x MOPP
04. Primary to Secondary Bridging Capacitor: (2) * Y1 type capacitors in series

D) OTHER:
1. MTBF: 200,000 Hours @ 25°C ambient temperature
2. Operating Temperature: 0°C to 40°C ambient temperature
3. Humidity: 0% to 90% relative humidity
4. Storage Temperature: -10°C to 80°C
5. Cooling: Convection

E) ENCLOSURE
1. Housing: High impact plastic, 94V0 polycarbonate, non-vented
2. Size: 117.53*53.47*36.6 mm +/- 1.0
3. Markings: Label and/or Pad Printed and/or Molded into Case
4. LED: Standard Green color to indicate power on
Derating CurveUser-added image
      Note:
       @ 15W UL certified to +70C for GTM91099-3009-4.0 only
Qty (ea.)/Carton60
Individual Box/Gift Box Size (mm)142*62*60
Individual Box/Gift Box ColorWhite
Master Carton Size (mm)442 x 330 x 275
Gross Weight (kg)15.2
Label Width (mm)44.5
Label Height (mm)49.5
Input Configuration
DescriptionIEC 60320/C8 AC Inlet connectorBlade Insertion Instructions
R-Blade Style Instruction Video

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Mates with IEC 60320/C8 Plug

This series of Interchangeable Blade products may be used with Proprietary Interchangeable Blades as described below or with standard international power cords.
 
Optional INPUT BLADES: R-Socket: below are available blades configurations which are "not included" (unless stated above); may be purchased separately, packaged with power supply, or as a separate "R-KIT" if specified 
1. Class II model NEMA 1-15P AC power plug with 2 prongs, R-NA-2(R) 
2. Australian AS 3112 configuration: SAA 2 pins Class II, R-SAA-2(R) 
3. UK BS 1363 configuration: UK 2 pins (dummy Ground) Class II, R-UK-2(R) 
4. European CEE 7/16 configuration: Europlug 2 PINS, Class II, R-EU-2(R) 
5. China GB 2099 configuration: 2 blades, Class II; CN P/N:R-CN-2(R)
6. Desktop Insert
Kits
05. R-KIT-2(R): 1,2,3,4 above
06. R-KIT-2-INTL(R): 2,3,4 above

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Standard Cordsets
Below are standard cordsets which are "not included" (unless stated above); these may be purchased separately or packaged with the power supply. Contact your Sales Engineer if the style required is not shown below. Many more available in different lengths, colors or cable material.

Standard International IEC 320/C7 Cordsets
  
Part NumberCountryPlugConnectorLength (mm)Length (feet)
2094112M703(R)Argentina (Type I)IRAM 2063IEC 320/C720007
5014112M703A(R)Australian (Type I)AS 3112IEC 320/C720007
207B4111M8703(R)Brazil (Type N)NBR14136IEC 320/C718006
4533501M8703(R)China (Type A)GB 2099.1IEC 320/C718306
2074112M703A(R)European (Type C)CEE 7/16IEC 320/C720007
2084111M8703(R)South Africa (Type M)BS 546IEC 320/C718006
2084111M8703B(R)India (Type D)ISI:1293IEC 320/C718006
2714111M8703A(R)India (Type C)ISI:1293IEC 320/C718006
451J3401M8703(R)Japan (Type A)JIS 8303IEC 320/C718306
2044112M703A(R)Korea (Type C)KS C8305IEC 320/C720007
4511116F703A(R)N. American (Type A)NEMA 1-15PIEC 320/C718306
4033401M8703A(R)Taiwan (Type A)CNS690IEC 320/C718306
6104112M703A(R)UK, Hong Kong, Singapore, Gulf States (Type G)BS1363IEC 320/C720007
Output Configuration
Common output connector options:
Click to add to your request.
L Type (Coaxial 5.5x2.5mm plug)
C Type (Coaxial 5.5x2.1mm plug)
K Type (Coaxial 3.5x1.3mm plug)
LL Type (5.5x2.5mm Locking 760k type)
CL Type (5.5x2.1mm Locking S761k type)
Magnetic Connector
L Type (Coaxial 5.5x2.5mm plug)C Type (Coaxial 5.5x2.1mm plug)K Type (Coaxial 3.5x1.3mm plug)LL Type (5.5x2.5mm Locking 760k type)CL Type (5.5x2.1mm Locking S761k type)Magnetic Connector
YL3 Type (KPPX-3P)
YL4 Type (KPPX-4P)
EJ1/2/3/4/5 (EIAJ RC-5320A type connectors)
MSB Type (Micro USB)
Custom design
YL3 Type (KPPX-3P)YL4 Type (KPPX-4P)EJ1/2/3/4/5 (EIAJ RC-5320A type connectors)MSB Type (Micro USB)Inquire for custom design

For a comprehensive list of options, click here

Contact GlobTek for your specific requirements or custom solutions.

Approvals

Below follows a link to the latest regulatory certifications and marks for this specific product. National standards as well as certification schemes are constantly changing and so is the set of certification marks and symbols applicable to this product. Various standards, marks and symbols, and certificates are subject to change at any time without notice.

Additional standards or unique country certifications are available upon request. Please contact Globtek to request a quotation.

LogoDescription
Medical 4th Ed.EN/IEC 60601-1-2, 4th Edition (Please visit EMC reports for further info)
2MOPP2 x MOPP (Means of Patient Protection) marked with 2MOPP near model name
User-added imageBook 60335 up to 36 Volts
User-added image60601-1 3rd Operating Instructions
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 R32282
RoHS (Pb)
 
BSMI Taiwan GTM91099-6024-8.0-T2 (16V only); CNS143361-1 (99) CNS13438 (95) http://www.bsmi.gov.tw/wSite/ct?xItem=4072&ctNode=816&mp=2
No Logo ApplicableIEC 60601-1: 2005 + C1 + C2 + A1
No Logo ApplicableCB report IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) and or EN 60601-1:2006 3rd Edition 2xMOPP
No Logo CB Certificate IEC 60950-1:2005 (2nd Edition), Am 1: 2009, CB report IEC 60950-1:2005 (2nd Edition), Am 1: 2009 and EN 60950-1:2006 + Am 1:2010 + Am 11:2009 + Am 12:2011

No Logo Applicable

IEC 61558-1:2005+A1, IEC 61558-2-16:2009+A1

No Logo Applicable

CB for IEC 62368-1:2014 (Second Edition)

No Logo Applicable

CB to 60335-1 5th Edition (Safety of Household and Similar Electrical Appliances, Part 1: General Requirements) CB Report/ Certificate IEC 60335-1:2010 Up to 36 volts only
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CCC to GB4943.1-2011 GB9254-2008 GB17625.1-2012
User-added image  CE Certification Class II CE Mark: tested to comply with EN55022:2006/A1:2007 Class B, EN610003-2, EN610003-3 including EN61000-4-2, EN61000-4-3, EN61000-4-4, EN61000-4-5, EN61000-4-6N EN61000-4-11; EMI: Complies with EN55011 CLASS B and FCC Part 15 B
User-added image  CE Certification CE Mark: tested to comply with EN 55032.2012+AC.2013 EN 61000-3-2.2014 EN 61000-3-3.2013 EN 60601-1-2.2015 EN 55024.2010
User-added image  CE Mark: tested to comply with Additional EN610006-1:2007, EN610006-2:2005 EN61000-6-3:2007+A1:2011 EN61000-6-4:2007+A1:2011
User-added image  CE Mark: tested to comply with EN 60601-1-2:2015 Medical electrical equipment Part 1-2: - Mark is on the label or Molded in the case
User-added imageAudio/Video, Information And Communication Technology Equipment - Part 1: Safety Requirements [UL 62368-1:2014 Ed.2] Audio/Video, Information And Communication Technology Equipment - Part 1: Safety Requirements [CSA C22.2#62368-1:2014 Ed.2] (pending)
User-added imageCHINA SJ/T 11364-2014, China RoHS Chart: http://en.globtek.com/globtek-rohs.php
No Logo Colombia GTM91099-T2 No logo
Conforms to UL STD. 62368-1
Certified to CSA STD C22.2 NO.62368-1
Conforms to UL STD. 62368-1 Certified to CSA STD C22.2 NO.62368-1
User-added imagecRUus UL Recognized Component E172861 3rd Edition w-RM ANSI-AAMI ES60601-1 (2005 + C1:09 + A2:10) and CAN-CSA-C22.2 No. 60601-1 (2008)
User-added imageUL 60950-1, 2nd Edition, 2011-12-19 (Information Technology Equipment - Safety - Part 1: General Requirements) CSA C22.2 No. 60950-1-07, 2nd Edition, 2011-12 (Information Technology Equipment - Safety - Part 1: General Requirements)
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User-added image  Certification # TC RU AR46.B.75423 Custom Union of Russia, Belarus and Kazakhstan
No LogoEC-Conformity Declaration: http://www.globtek.com/html/iso_certificates/EC-DECLARATION.pdf, REACH 144 SVHC: http://www.globtek.com/html/iso_certificates/Reach144.pdf
User-added imageMedical Electrical Equipment – Part 1: General Requirement for Basic safety Essential Performance (AAMI ES60601-1:2005+A1) Medical Electrical Equipment – Part 1: General Requirement for Basic safety Essential Performance (CSA C22 2#60601-1:2014 Ed.3)
User-added imageInformation Technology Equipment Safety Part 1: General Requirements (UL 60950-1 Issued: 2007/03/27 Ed: 2 Rev: 2014/10/14)
User-added imageFCC PART 15B Report STR14078169E-3
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IEC/EN60335-1 Up to 36 volts
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IEC/EN60601-1
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INDIA BIS (GTM91099-T2) 5V, 12V, 13.8V, 15V, 18V, 19V, 20V, 24V, 36V, 48V only
User-added imageIndoor Use Only - Mark is on the label or Molded in the case
IP42Ingress Protection: ?IP42 to IEC60529:2001 Protection against granular foreign bodies - Protected against direct sprays up to 15o from the vertical Optional
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PRECAUCION: PARA USO EN EQUIPOS ELECTRONICOS SOLAMENTE
 
IRAM certificate DC-E-G71-001.7 to IEC 60950 + A1:2009
User-added imageJAPAN TUV R-PSE, Cert. No. JD 50313287, to J60950-1(H26) , J55022(H22),J3000(H25)[DC15?30V]. Please reference the following website for guidelines on PSE regulations: http://en.globtek.com/importing-ite-and-medical-power-supplies-ac-adaptors-to-japan/
User-added imageJAPAN TUV R-PSE, Cert. No. JD 50313287, to J60950-1(H26) , J55022(H22),J3000(H25)[DC30?60V]. Please reference the following website for guidelines on PSE regulations: http://en.globtek.com/importing-ite-and-medical-power-supplies-ac-adaptors-to-japan/
User-added imageJAPAN TUV R-PSE, Cert. No. JD 50469658, to J62368-1(H30) , J55032(H29),J3000(H25)[15V or less]. Please reference the following website for guidelines on PSE regulations: http://en.globtek.com/importing-ite-and-medical-power-supplies-ac-adaptors-to-japan/
User-added imageKorea HU10499-18034A GTM91099-6024-8.0-T2 (16V, 18V, 19V, 20V, 24V Only)
User-added imageKorea HU10499-21045A GTM91099-6015-T2(A) (9.1V,10V,11V,12V, 13V,13.8V,14V,15V)
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Efficiency: complies to section 301 of Energy Independence and Security Act (EISA) complies with Energy Star tier 2 (North America), ECP tier 2 (China), MEPS tier 2 (Australia), Code of Conduct (Europe)
LPSLimited Power Source 60950
No Logo Malaysia ST Release Letter GTM91099T2 -T3A IEC60950-1(Ed.2): 2005 + A1:2009 No logo
User-added imageNEMKO IEC/EN 60335-1 (Safety of Household and Similar Electrical Appliances, Part 1: General Requirements) up to 36 Volts
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NOM (Mexico) to NOM-001-SCFI-1993 GTM91099-6024-8.0-T2 for 16V only
No Logo Peru MTC GTM91099-T2 No logo
User-added imageRCM N136; Australia and New Zealand Regulatory Compliance, Mark (http://rcm.standards.org.au/rcmfaq/rcmfaq.htm
RoHSSpecifications of directive 2011/65/EU Annex VI (ROHS-2) with amendment 2015/863-EU (ROHS-3) http://www.ce-mark.com/Rohs%20final.pdf
User-added imageSemko S-Mark-Cert-EN60601-1 and EN60950-1
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Serial Number Information
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FONTE DE ALIMENTAÇÃO DE ITE
SGS (Brazil) to IEC 60950-1_2005 + A1_2009 +A2_2013 (5 - 48 Volts)
User-added imageSingapore GTM91099-6024-8.0-T2 ICE 60950-1:2005 + 2009 +A2:2013 (16V only)
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Cos’è un alimentatore per applicazioni medicali conforme IEC 60601-1?

 

Si tratta di un convertitore che permette di alimentare, tipicamente in DC, un sistema o un componente in ambito elettromedicale, prelevando tensione AC dalla rete. Tipicamente, il case è in materiale plastico e la spina può essere a 2 o 3 poli. Esistono anche versioni open frame da alloggiare all’interno di apparecchiature medicali. La progettazione è eseguita secondo gli standard internazionali e alcuni requisiti sono specifici e particolari in confronto alle più comuni applicazioni per informatica e telecomunicazioni. Che differenze ci sono per quanto attiene la certificazione allo standard IEC 60601-1 Quarta Edizione rispetto alla vecchia IEC 60601-1 Terza Edizione?

Di fatto, le certificazioni in materia di sicurezza fissate dalla Terza Edizione continuano a valere mentre per quanto attiene gli aspetti EMI/EMC si fa riferimento alla Quarta.

Qual è la differenza fra un alimentatore per usi medicali certificato IEC 60950-1 rispetto ad uno certificato IEC 60601-1 ?

 

Sia la IEC 60950-1 che la IEC 60601-1-2 si riferiscono ad alimentatori AC/DC per uso interno o esterno ma con diversi requisiti relativi alle specifiche del sistema da alimentare. Le funzionalità di base sono ovviamente le stesse, ci si riferisce per esempio a tensione di uscita e caratteristiche meccaniche ma, per il resto, ci sono diverse differenze. I dispositivi IEC 60601, in confronto all’altra tipologia, devono essere in grado di sopportare tensioni elevate e avere basse correnti di dispersione. Inoltre, con riferimento al carico, occorre distinguere fra sistemi MOOP e MOPP. Le apparecchiature medicali devono includere uno o più sistemi di protezione ovvero Means of Protection (MOPs) per isolare i pazienti e gli operatori dal rischio di elettrocuzione. Si tratta di isolamento di sicurezza, terra di protezione, distanze di isolamento in aria o altri sistemi contro il contatto diretto. Tutti questi sistemi sono spesso utilizzati in combinazione fra loro. La norma IEC 60601-1 Terza Edizione fissa delle differenze relativamente ai rischi per i pazienti e per gli operatori. Pertanto, un sistema MOP può quindi essere classificato come MOPP (Means of Patient Protection) oppure come MOOP (Means of Operator Protection). La principale differenza sta nelle distanze limite di isolamento. Per esempio, per ottenere la rispondenza ai requisiti 2 x MOPP il livello di isolamento da garantire durante i test che prevedono l’applicazione di 4000 Vac con una distanza di di 8 mm è il doppio rispetto al caso MOPP.

Cos’è un alimentatore per usi medicali IEC 60601-1-2 e qual è la differenza fra la tipologia BF e CF?

Tali sigle si riferiscono alle tipologie B ovvero “body”, BF ovvero “body floating type” e CF ovvero “cardiac floating type. Ci si riferisce in pratica alle modalità di applicazione del dispositivo medicale al corpo del paziente con requisiti tecnici che riguardano tensione di isolamento, correnti disperse, ecc. La parola floating si riferisce all’assenza di collegamento di terra. Si tratta in questo caso di dispositivi in Classe II con isolamento doppio o rinforzato. La tipologia B si riferisce a dispositivi che operano nelle vicinanze del paziente così come definito dalla norma IEC 60601-1 ovvero senza contatto elettrico diretto e con collegamento a terra. Si tratta, per esempio, di sistemi di illuminazione, sistemi di automazione per letti, distributori automatici di medicine, macchinari a raggi x, ecc. Nel caso dei sistemi BF, invece, vi è una stretta prossimità fra paziente e apparecchiatura, si tratta per esempio di endoscopi, sistemi di monitoraggio dei parametri vitali, ecc. Nel caso CF, il collegamento è invece diretto come avviene per defibrillatori, pacemaker, elettrodi ECG intracardiaci, ecc. Per ovvie ragioni, in questo ultimo caso, è richiesto un elevatissimo livello di protezione contro l’elettrocuzione.

Cos’è un alimentatore AC-DC di tipo ibrido plug-in/desktop ?

Anche noti come adattatori AC o convertitori AC-DC, si tratta di una tipologia di alimentatori per uso da esterno. Sono dispositivi ibridi perché possono essere utilizzati come un alimentatore desktop standard mediante l’utilizzo di un cavo IEC 60320 o del sistema di spine fornite dal produttore che ne rendono possibile il collegamento alla rete in maniera diretta o con presa. Alcune apparecchiature elettriche necessitano di alimentazione di potenza ma non dispongono di una circuiteria interna per poter gestire un collegamento diretto alla rete. In casi del genere, un alimentatore AC viene utilizzato per convertire la tensione AC di rete in tensione DC adatta per l’alimentazione dell’apparecchiatura in questione.

Come funziona un adattatore AC-DC?

L’adattatore AC-DC è un convertitore da esterno integrato all’interno di un piccolo case costruito attorno ad una spina AC per collegamento alla rete, da cui derivano anche i vari termini plug, wall plug in, plug-in o plugtop. Una volta collegato alla rete elettrica AC, la tensione viene convertita in DC per l’alimentazione del carico attraverso il cavo di uscita.

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