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UNIMET® 1100ST – The test system which offers safety for the future

UNIMET® 1100ST

Quality management as required by ISO9001 in respectof manufacturers of medical electrical equipmentManufacturers of medical electrical equipment who are certified underISO9001 must provide evidence that the products have been tested andthat they have met the specified requirements. The basis for the testingactivity is also the IEC 60601 or the version applicable in a specific country.

In this context it is especially advantageous that the UNIMET® 1100STitself is manufactured and calibrated under the requirements of ISO9001.

Electrical equipmentThe daily use of electrical equipment makes it easy to quickly forget thedangers which can arise from defective equipment. Even in industry, de-fective equipment items can be the cause of interruptions to productionand the exposure of personnel to danger. Here, too, periodic testing canprovide the remedy.

The basis for this is DIN VDE 0701 “Repair, modification and testing ofmedical electrical equipment.“ DIN VDE 0702 should be used for regularperiodic testing.

UNIMET® 1100ST – a universal test systemThe increasing use of electricalequipment in hospitals and in in-dustry places a high premium ontheir reliable performance.

Any possible equipment faults andfunctional failure involve high levelsof risk to human beings and to as-sociated equipment.

It pays to guard against these risksby testing the electrical safety ofsuch items of electrical equipment

for industrial applications andmedical electrical devices after pro-duction and in daily use. In this way,the safety of the user is ensuredand the availability of the equip-ment is increased, which in the endreduces costs.

The UNIMET® 1100ST is a compact,universal testing system for testingaccording to all appropriate stan-dards.

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Simple handling thanks to the catalogue system

Type catalogueThis catalogue records the classifi-cation features of the devices accor-ding to the type designations, forexample: drilling machine XY, in-fusion pump AFX.When a new de-vice is tested for the first time andits type is already available in themaster device data, all that is neces-sary is to call up the type designa-tion. After it has undergone testing,the DUT is stored under the identi-fication number in the device cata-logue.

This means an enormous amountof time is saved when new pur-chases are made. Another advan-tage: all devices of the same typeare tested under the same condi-tions.

The type and device catalogue which is integrated into the UNIMET® 1100ST system provides a basis for testingthat will save time as well as money.

Device catalogueIn the device catalogue, the data forthe individual devices are storedaccording to the identification num-bers. For periodic tests, all that needto be called up via the keyboard orbarcode is the identification num-ber.

Connect the DUT – perform the test– and that’s all. This means enor-mous savings on time and costsfor repeat tests.This procedure pro-viding a clear “passed / failed” ver-dict enables not only skilled per-sons but also instructed persons tocarry out reliable tests.

ClassificationFor new devices which are not yetentered in the type catalogue, thenecessary test steps and the asso-ciated limit values are quickly andreliably determined thanks to dia-logue between the UNIMET® 1100STand the test engineer.

This classification scheme is thenstored in the type catalogue, so tospeak as a set of test regulationsfor a specified type of device, andit is consequently available to becalled up for all other devices ofthis type.

Startmenue UNIMET® 1100ST

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Easy operation, safe and simple

UNIMET® 1100ST

Mobile and internationalThe compact and robust device isdesigned for mobile use. A choiceof national languages and a long-range mains part make UNIMET®1100ST the ideal testing devicefor international use.

Open system conceptThe multi-interface concept allowssimple control of external add-ondevices, or permits the UNIMET®1100ST itself to be controlled froma PC.This makes the device flexible,for example in final inspection andtesting of devices.

InterfacesThe measurement data can be ex-changed directly between UNIMET®1100ST and a PC via the RS232 in-terface. A standard commercial PCprinter can be connected to theCentronics interface. It is also easyto implement software updatesvia the RS232 interface, for exam-ple when standards are modified.

Data memoryThe integrated data memory allows700 data records to be stored in thetype catalogue and the devicecatalogue.

Socket outletDevices up to amaximum load of3.8 kVA (16 A) can

be connected to the socket outlet.Sufficient enough to test also high-power equipment, such as laserequipment, during operation (alsothree-phase devices with DS601).

Connection to applied partWith ten jacks andautomatic switch-over, for exampleto the patient auxi-liary current and pa-tient leakage cur-rent measurementin conformity withIEC 60601.

Active test probeTest probe with integrated switch-ing contact, which starts the mea-surement.This is particularly bene-ficial for testing large equipment.

Protective conductor testcurrentStandard 10 AOptional 25 A

Function keysOperation is made very simplethanks to the ergonomically arran-ged function keys and the user-friendly graphic display.

TM 1000 keyboard moduleThe keyboard module is integratedinto the front cover for direct entryof ID numbers, type of equipmentand other information.

Note: Country-specific test sockets / connecting cables are available on request.

T1000 carrying bag

T1000 carrying bagFor convenient storage of theUNIMET® 1100ST, the printer, bar-code wand, cables, etc.

Inkjet printer

Inkjet printerFor immediate print-outs of testprotocols in DIN A4 format.

Barcode scanner

Barcode scannerFor rapid identification of the DUT.

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Extensive range of accessories

Accessories (optional):

PK3 test kit

VK701 adaptor

DS601 three-phase adaptor

DS601 three-phase adaptorTo test medical electrical three-phase DUTs in operating condi-tion, according to IEC 60601.

TP16 cable drum

TP16 cable drumFor convenient PE conductor mea-surement on large equipment.

PK3 test kitContains a number of adaptors toconnect medical electrical equip-ment to the UNIMET® 1100ST.

VK701 adaptorFor testing extension cords and power supply cords, CEE connectors andpower supply cords with earthing pins.The automatic test includes check-ing the wiring and the connection between the individual poles of theplug and the socket outlet. In addition, the insulation resistance of theconductors against the PE conductor is measured.

Trolley TW1000

Trolley TW1000For easy transport.

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Two partners which understand one another…

A practical example:Equipment managementin hospitals and industryThe high volume of investment tiedup in extensive stocks of devicescalls for a modern equipment ma-nagement system. This not onlyfulfils the legal requirements, butalso allows weak points to be detec-ted at an early stage and createstransparency of costs and services.As a result, the decisions to betaken about new investments aremade easier.

The data exchange between theUNIMET® 1100ST and high-perfor-mance software packages such asvFM and MTDATA guarantees time-saving transfer of data withoutpaper. The data are then availablein the PC, to be used (for example)as the basis for taking decisionson future procurement of devices.In combination with vFM or MT-DATA, UNIMET® 1100ST thereforerepresents a major contribution to-wards cutting costs.

Practical example:Final inspection andtesting after productionYour own test regulations for finalinspection can be compiled, takingthe individual requirements of thedevice manufacturer into account.In the final inspection department,UNIMET® 1100ST can be remote-controlled by a PC. The measure-ment results can be transferred intoroutine test certificates. In this way,UNIMET® 1100ST assists with therequirement to reduce the timetaken for testing, and to satisfyquality guidelines such as ISO 9001.

UNIMET® 1100ST in use

Modern equipment management aims for high availability of the equip-ment and cost saving, and nowadays this calls for more than simple mea-surement.There is a demand for targeted relief from burdensome routinework, such as documentation. UNIMET® 1100ST offers variable paths to-wards this goal, which can be coordinated with the requirements in eachcase and are consistently adaptable to the practical requirements. A par-ticularly advantageous feature here is the bi-directional transfer of databetween the UNIMET® 1100ST and the PC. Measurement data can betransmitted to the PC and / or to a equipment management program.In the other direction, the equipment which is due for testing can betransmitted back to UNIMET® 1100ST, where it is ready to be called upfrom the device catalogue. This saves an enormous amount of timeand also avoids transmission errors.

Your advantages:• Transparency of costs and services

• Time pressure on test engineers is relieved

• Paper-free test procedures

• Transmission errors are avoided

• Significant reduction of costs for documentation and device stockmaintenance

• Optimised deployment of personnel

DIN VDE 0750 / IEC 60601

Earth leakage currentLeakage current which flows in theprotective conductor of Class I equip-ment.

Patient leakage current 1)

Leakage current which can flow fromthe applied part to earth via a patient.

Enclosure leakage current 1)

Current which flows to earth or to an-other part of the enclosure, when theenclosure or parts thereof are touched.

Patient auxiliary current 1)

Current which flows between the indi-vidual connections of the applied part.

Measurements according to IEC 60601UNIMET® 1100ST satisfies the require-ments of IEC 60601 for the measure-ment to be performed under all normaland single fault conditions.The require-ment that the patient auxiliary currentmust be measured from every singlepatient connection to all other patientconnections that are linked together isaccurately satisfied by the UNIMET®1100ST, thanks to the automatic switch-over between the patient jacks.

Normal conditions• Normal and reversed pole connec-

tions to the supply system

• Functional earth with and withoutearthing of the measuring circuit

• F-type applied part with and withoutearthing of the measuring circuit

Single fault conditions• Interruption of the protective con-

ductor

• Interruption of a system conductor

• Patient leakage current to earth forF-type applied part with 110 % ofthe nominal system voltage

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Measurement carried out accuratelyin compliance with the standards

Protective conductor resistanceThe principle of measurement is inden-tical for IEC 60601,VDE 0751,VDE 0701,VDE 0702.The difference lies in the limitvalues and the test current.

• IEC 60601, test current 25 A, 5 s

• DIN VDE 0751, test current 5…25 A, 5 s

• DIN VDE 0701, test current > 0.2 A

• DIN VDE 0702, test current > 0.2 A

Protective conductor

Substitute device leakage currentMeasurement between short-circuited mainsplugs and earth and / or the enclosure.

Substitute patient leakage currentMeasurement between short-circuited patientconnections and earth, and / or the enclosure.

DIN VDE 0751

1) The DUT shall be set up so that it is insulated from earth. 2) Measurements at Class I and Class II equipment are only to be carriedout at exposed conductive parts which are not connected to the protective conductor.

Note: Only a few measurements are illustrated above, please refer to the UNIMET® 1100ST CD for further measurements.

Device leakage current SK1 –direct measurement

Device leakage current –residual current measurement

2136en / 1104 / 2000 / Wö / WerbedruckRight to modifications reserved !

Insulation resistanceMeasurement according to VDE 0701/VDE 0702. Measuring voltage: DC 500 V.

Substitute device leakage currentMeasurement according to VDE 0701 /VDE 0702. Measuring voltage: AC 230 V.

Protective conductor current(Class I) Touch current (Class II)Measurement according to VDE 0701,VDE 0702, direct measuring procedure.

DIN VDE 0701 / 0702 Technical data:General DataNominal system voltage AC 100…240 VFrequency range 48…62 HzMax. power consumption 100 VA…350 VAMax. load 3.8 kVA (16A)Protection class Class I

Measuring rangesSystem voltage measurement 90 V…264 VLoad current measurement 0,01 A…16 AApparent power measurement 5 VA…3.8 kVALeakage, substitute leakage andauxiliary current 0.001 mA…19.999 mAResidual currents 0.02 mA…19.999 mA

Protective conductor testingAC test (0.3 Ω) > 10 A

optional 25 AMeasuring range 0.001 Ω…29.99 Ω

Substitute leakage currents,test voltage / operating voltageMax. test current 2.5 mA

Insulation resistanceTest voltage DC 500 VMax. test current 2.5 mAMeasuring range 0.04 MΩ…299.99 MΩ Interfaces USB, RS 232, Centronics Dimensions(W x H x D) mm 345 x 410 x 140Weight without printer 8 kg…11 kg

Protective conductor current(Class I) Touch current (Class II)Measurement according to VDE 0701,VDE0702, residual current measuring procedure.

UNIMET®1100STUnico sul mercatoL’unico analizzatore di sicurezza elettrica che esegue la prova del PE con 25A in accordo alle richieste dello standard IEC60601-1.UNIMET®1100ST presenta un assistente alla classifi cazione che consente all’utilizzatore di eseguire le misure in accordo agli standard.

Caratteristiche• Conforme alle normative per un utilizzo universale• Aiuto alla classifi cazione basato sulle normative• Sequenza di prova automatica, semiautomatica o manuale• Sonda con contatto integrato• Memoria per mille record di dati• Sistema di catalogazione consente grande risparmio di tempo• Dieci conduttori paziente da 4 mm• Editor di sequenza del test• Determinazione dei valori limite conforme agli standard• Tastiera per l’inserimento dei dati• Diversi accessori funzionali

Prove standard in accordo a:• IEC60601-1• IEC62353:2007-05• EN 62353:2008-08• UL60601-1• IEC61010-1:2001-02• ANSI/AAMI ESI• DIN VDE 0701-0702:2008-06

Misure standard di:• Resistenza del conduttore di terra• Resistenza di isolamento• Corrente di dispersione di terra• Corrente di dispersione nelle parti applicate• Correnti ausiliarie (nel paziente)• Corrente del PE• Correnti sostitutive• Correnti di contatto

Metodi di misura delle correnti di dispersione• Metodo diretto• Metodo differenziale• Metodo delle correnti alternative

Misure e test aggiuntivi• Tensione• Consumo di corrente• Ispezione a vista• Prova funzionale

Interfacce• Porta RS232• Porta USB e Centronic per stampante

Accessori standard• Borsa di trasporto• TM1000 – tastiera• Sonda attiva• Adattatore DS601 per prova di dispositivi trifase• Cavo di misura con sonda e terminale• Cavo di interfaccia (null-modem)

Servizi• Intervallo di calibrazione 24 mesi• Garanzia 36 mesi• Aggiornamento software• Corsi