ILLKO MDtest Manuale utente

USER’S

MANUAL

MDtest

(100-140 V)

MDtest (100-140 V) - User’s Manual Contents

Contents

1 Introduction 5

1.1 Safety ................................... 5

1.2 PerformanceMDtest ........................... 6

1.3 Appliedstandards............................. 6

1.4 Termsanddeﬁnitions........................... 7

2 Description of the instrument 8

2.1 Generaldescription............................ 8

2.2 Terminals ................................. 9

2.3 Keyboard ................................. 11

2.4 Additionalfunctions ........................... 11

2.5 Display of information . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2.6 GraphicOLEDdisplay.......................... 12

2.7 Selection of the items in Menu or List . . . . . . . . . . . . . . . . . . 12

2.8 Users interface symbols . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2.9 Abbreviations............................... 14

2.10Includedintheset ............................ 15

2.11Optionalaccessories............................ 15

3 Putting into operation 16

3.1 Connecting to mains outlet . . . . . . . . . . . . . . . . . . . . . . . . 16

3.2 Self-test .................................. 17

3.3 Helpscreens................................ 17

4 Measurements 18

4.1 Selection of the function . . . . . . . . . . . . . . . . . . . . . . . . . 18

4.2 Measurement mode control . . . . . . . . . . . . . . . . . . . . . . . . 18

4.2.1 Measurement mode . . . . . . . . . . . . . . . . . . . . . . . . 18

4.2.2 HOLDfunction.......................... 19

4.2.3 Measurement of apparent power consumption . . . . . . . . . 19

4.3 Earthbond-Rpe............................. 20

4.3.1 Test lead resistance compensation . . . . . . . . . . . . . . . . 21

4.3.2 Protective earth resistance . . . . . . . . . . . . . . . . . . . . 21

4.4 Insulation resistance - Riso . . . . . . . . . . . . . . . . . . . . . . . . 22

4.5 Enclosure leakage current according to EN 62353 . . . . . . . . . . . 25

4.5.1 Alternative method - IaltEq . . . . . . . . . . . . . . . . . . . 25

4.5.2 PE current during operation - IdirEq . . . . . . . . . . . . . . 26

4.5.3 Diﬀerential leakage current - IdifEq . . . . . . . . . . . . . . . 28

4.6 Leakage current from the Application parts according to EN 62353 . 30

4.6.1 Alternative method - IaltPat . . . . . . . . . . . . . . . . . . . 30

4.6.2 Direct method - IdirPat . . . . . . . . . . . . . . . . . . . . . 31

4.6.3 Direct method, DUT with an internal electrical power source

-IdirPatB............................. 33

4.7 Leakage currents according to IEC EN 60601-1 . . . . . . . . . . . . 34

4.7.1 Earth leakage current - I60601Earth . . . . . . . . . . . . . . 35

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MDtest (100-140 V) - User’s Manual Contents

4.7.2 Enclosure (chassis) leakage current - I60601Touch . . . . . . . 36

4.7.3 Lead to ground (application part) leakage current - I60601Pat 37

4.7.4 Lead isolation – Mains on Applied Parts leakage current -

I60601MAP ............................ 38

4.8 Other leakage currents . . . . . . . . . . . . . . . . . . . . . . . . . . 39

4.8.1 Alternative method - IaltEq . . . . . . . . . . . . . . . . . . . 39

4.8.2 PE current during operation – IdirEq / diﬀerential leakage

current-IdifEq.......................... 39

4.8.3 Enclosure leakage current - IdirTouch / IdifTouch . . . . . . . 41

4.9 Apparent power, mains voltage and current consumption - Power . . 43

4.9.1 Power, mains voltage and current consumption in test socket . 43

4.9.2 Measuring of power and current consumption by means of

currentclamp........................... 44

5 Database operations 45

5.1 Storing measurement data . . . . . . . . . . . . . . . . . . . . . . . . 45

5.2 The structure of the data memory . . . . . . . . . . . . . . . . . . . . 45

5.3 Enteringcharacters............................ 46

5.4 Identiﬁcation number of device under test (ID) . . . . . . . . . . . . . 46

5.5 Working with test results . . . . . . . . . . . . . . . . . . . . . . . . . 47

5.5.1 Viewing a list of tested DUTs . . . . . . . . . . . . . . . . . . 47

5.5.2 Searching for stored DUTs . . . . . . . . . . . . . . . . . . . . 48

5.5.3 Creating a new DUT ﬁle . . . . . . . . . . . . . . . . . . . . . 48

5.5.4 Deleting a DUT from the main memory . . . . . . . . . . . . 48

5.5.5 Modiﬁcation of the ID number . . . . . . . . . . . . . . . . . . 49

5.5.6 Viewing measured values and evaluation . . . . . . . . . . . . 49

5.5.7 Modiﬁcation of measured values and evaluation . . . . . . . . 50

5.6 Testsequences............................... 50

5.6.1 Description of the test sequence . . . . . . . . . . . . . . . . . 50

5.6.2 Creating a test sequence . . . . . . . . . . . . . . . . . . . . . 50

5.6.3 Assigning a test sequence to appliance . . . . . . . . . . . . . 51

5.6.4 Using the test sequence . . . . . . . . . . . . . . . . . . . . . . 51

6 Instrument main menu 52

6.1 Mainmenustructure........................... 52

6.2 Menu-DUTproperties.......................... 52

6.2.1 Menu - Measured values . . . . . . . . . . . . . . . . . . . . . 52

6.2.2 Menu - Visual inspection result . . . . . . . . . . . . . . . . . 52

6.2.3 Menu - Functional test result . . . . . . . . . . . . . . . . . . 52

6.2.4 Menu - Measurement result . . . . . . . . . . . . . . . . . . . 53

6.3 Menu - Test sequences . . . . . . . . . . . . . . . . . . . . . . . . . . 53

6.4 Menu-Emptyﬁle............................. 53

6.5 Menu-Setup ............................... 53

6.5.1 Menu - System info . . . . . . . . . . . . . . . . . . . . . . . . 53

6.5.2 Menu - Measure DC values . . . . . . . . . . . . . . . . . . . . 53

6.5.3 Menu-Self-test.......................... 54

6.5.4 Menu - Date of next calibration . . . . . . . . . . . . . . . . . 54

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MDtest (100-140 V) - User’s Manual Contents

6.5.5 Menu - Erase database . . . . . . . . . . . . . . . . . . . . . . 54

6.5.6 Menu - Measurement locking . . . . . . . . . . . . . . . . . . . 54

6.5.7 Menu - Save last method . . . . . . . . . . . . . . . . . . . . . 55

6.5.8 Menu - Date and Time . . . . . . . . . . . . . . . . . . . . . . 55

6.5.9 Menu-Keysbeep......................... 55

6.5.10 Menu-Volume .......................... 55

6.5.11 Menu-Language......................... 55

6.5.12 Menu - Nominal voltage . . . . . . . . . . . . . . . . . . . . . 55

7 Additional informations 56

7.1 Communication – data transfer . . . . . . . . . . . . . . . . . . . . . 56

7.2 Messages on the display . . . . . . . . . . . . . . . . . . . . . . . . . 56

7.2.1 Warningmessages......................... 56

7.2.2 Operational information . . . . . . . . . . . . . . . . . . . . . 62

7.2.3 Setting information . . . . . . . . . . . . . . . . . . . . . . . . 64

7.2.4 Database information . . . . . . . . . . . . . . . . . . . . . . . 65

7.3 Reset of the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . 65

7.4 Utilization of other external adapters . . . . . . . . . . . . . . . . . . 66

7.4.1 Adapter for testing extension power supply cords (P 8030) . . 66

7.4.2 Three-phase adapter (P 8015-8018) . . . . . . . . . . . . . . . 66

7.5 Maintenance................................ 66

7.6 Recurrent tests and testing after repair . . . . . . . . . . . . . . . . . 67

7.7 Calibration and service . . . . . . . . . . . . . . . . . . . . . . . . . . 68

7.8 Ecology .................................. 68

8 Technical speciﬁcation 69

8.1 Generaldata ............................... 69

8.2 Functions ................................. 69

8.2.1 Earthbond ............................ 69

8.2.2 Insulation resistance . . . . . . . . . . . . . . . . . . . . . . . 70

8.2.3 Alternative leakage current . . . . . . . . . . . . . . . . . . . . 70

8.2.4 Direct leakage current (TRMS AC+DC value) . . . . . . . . . 71

8.2.5 Direct leakage current (DC component) . . . . . . . . . . . . . 71

8.2.6 Diﬀerential leakage current . . . . . . . . . . . . . . . . . . . . 71

8.2.7 Leakage current by means of three-phase adapter . . . . . . . 72

8.2.8 Apparentpower.......................... 72

8.2.9 Mains voltage UL-N ........................ 72

8.2.10 Current consumption . . . . . . . . . . . . . . . . . . . . . . . 72

8.2.11 Current consumption by means of current clamp . . . . . . . . 72

8.2.12 Apparent power by means of current clamp . . . . . . . . . . 72

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MDtest (100-140 V) - User’s Manual 1 Introduction

1 Introduction

1.1 Safety

WARNING

Read this User’s Manual carefully and completely and follow

all instructions contained therein. If not, the use of the in-

strument may be dangerous for the operator, devices under

test or for the instrument!

If there is reason to believe that safe operation has become impossible,

put the instrument out of operation and secure it against any unin-

tended operation. Safe operation must be presumed to be no longer

possible, if:

•The instrument does not operate properly any longer.

•The instrument, cables, connectors, plugs or accessories exhibits

visible damages.

•The instrument was stored in unfavourable conditions for a long

period.

•The instrument was exposed to extraordinary stress caused by

transport.

WARNING

•Make sure that the instrument, measuring cables and all other

accessories are in ﬂawless condition, e.g. no damaged insulation,

no broken cables or plugs etc.

•Make sure that the AC outlet is easily accessible. If some trou-

ble or malfunction occurs, immediately disconnect the MDtest

adaptor from the outlet.

•If the equipment is used in a manner not speciﬁed by the manu-

facturer, the device’s protection may be compromised.

•The instrument may only be powered from a 100÷140 V / 50 or

60 Hz grounded mains outlet, which is protected with a fuse or

circuit breaker with a maximum rating of 16 A.

•Voltage 127 V / 50/60 Hz will be used in this manual hereinafter.

•In order to check the proper PE connection to a mains outlet,

MDtest generates a continuous current of ca. 1.5 mA / 50 or

60 Hz to the PE conductor. This test current can activate the

insulation monitoring device in IT systems.

•Only a trained, skilled person, who is familiar with hazardous

voltage operations, can handle the MDtest. Unexpected haz-

ardous voltages can occur on devices under test (dangerously

charged capacitors, etc.).

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MDtest (100-140 V) - User’s Manual 1 Introduction

WARNING

•It is necessary to respect all safety regulations applicable to the

particular measurement.

•Test Socket 1of the MDtest must not be used for continuously

powering the appliance. It is intended for test purposes only;

max. test duration is 25 min @ ≤12 A and 60 s @ 12÷16 A.

•The functional test may only be performed after the DUT has

successfully passed the safety test.

•Dangerous voltage or mains voltage may be present on Test

Socket 1during some tests.

•Devices under test which are connected to Test Socket 1of the

MDtest can be powered by mains voltage during some tests. The

appliance can thus be activated.

•The PE terminal is connected to the PE terminal of Test Socket

1. When using the MDtest, do not connect any voltage to the

terminal PE. If connected, there is a danger of electric shock or

damage to the MDtest.

•Use only standard or optional accessories supplied with the

MDtest by your distributor.

The ﬁgures in this manual are only illustrative and may vary slightly

from the actual state or the version on your instrument.

1.2 Performance MDtest

The MDtest is a professional, compact, portable analyzer, designed to verify the

electrical safety of medical devices. The MDtest has an extraordinary wide scope

of use thanks to a lot of optional accessories, which enable testing practically any

portable or hard-wired, one-phase or three-phase medical device.

1.3 Applied standards

•EMC ..............................................EN 55011:2009+A1:2010

EN 61326-1:2013

EN 61000-4-2:2009

EN 61000-4-3:2006+A1:2007+A2:2010

EN 61000-4-4:2004+A1:2010

EN 61000-4-5:2006

EN 61000-4-6:2009

EN 61000-4-11:2004

•LVD ........................................................EN 61010:2010

EN 61010-2-030:2010

EN 61557-16:2014

EN 62353:2014

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MDtest (100-140 V) - User’s Manual 1 Introduction

The MDtest is designed to perform electrical safety testing based on:

•IEC 62353:2014

•IEC 60601-1 (only some tests)

1.4 Terms and deﬁnitions

Accessible conductive part

The part of the ME equipment (other than the applied part), which is accessible to

the patient, to the operator in contact with the patient or can come in contact with

the patient.

Applied part

The part of the ME equipment that (in normal use) necessarily comes into physical

contact with the patient for ME equipment or an ME system to perform its function.

Mains part

The part of electrical equipment forming a circuit that is intended to be connected

to the supply mains.

Another terms and deﬁnitions – see IEC 62353:2014

ID number (ID)

Unique ID number for the DUT.

Hazardous voltage.

Warning concerning a point of danger! Read User’s Manual and

observe all precautions!

Hint, notice.

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MDtest (100-140 V) - User’s Manual 2 Description of the instrument

2 Description of the instrument

2.1 General description

The MDtest instrument is designed to verify the safety of electrical appliances and

medical devices in general. All AC measurements are measured by the method

TRMS (true rms), and for some measurements the DC component value can be

displayed. Measured circuits meet the requirements of EN 60601 and EN 62353

(requirements for measuring circuits), including the required input characteristics.

The MDtest performs the following tests:

•Earth bond test >1 A AC

•Insulation resistance test 250 V DC

•Alternative (substitute) equipment and applied part leakage current

•Direct equipment and applied part leakage current

•Diﬀerential leakage current

•Ground (Earth) leakage current

•Chassis (Enclosure) leakage current

•Lead to Ground (Patient) leakage current

•Lead isolation (Mains on applied parts leakage current)

•PE current during operation and diﬀerential leakage current

•Apparent power, mains voltage and current consumption

With additional equipment can be measured:

•measurement of PE current during operation and diﬀerential leakage current

of three-phase portable appliance by means of optional adapters

•measurement of apparent power and current consumption by means of current

clamp

The MDtest has furthermore additional features, which improve the safety of both

the operator and the DUT. These include:

•check for dangerous contact voltage on the PE of power outlet (before the

start of the measurement)

•check if the PE of the power outlet is grounded (before the start of the mea-

surement)

•automatic check for leakage current amplitude of the device under test

•check of the appliance’s current with automatic switch oﬀ the Test Socket 1:

0÷12 A . . . . . . . . . . . . . . . . . . . . max. 25 min

12 ÷16 A . . . . . . . . . . . . . . . . . . . max. 60 sec

•manual self-test

•nominal voltage 127 V or 120 V can be selected

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MDtest (100-140 V) - User’s Manual 2 Description of the instrument

Features and highlights:

•test results can be saved under an ID number which is unequivocally assigned

to the respective DUT (barcode, RFID chip)

•the test structures created at the PC software can be loaded into the MDtest

•measurement data saved to the test instrument can be imported to PC software

via the USB port and reports can be generated

•user-deﬁned test sequences created at the PC software

•user-deﬁned report templates created at the PC software

2.2 Terminals

1. Test Socket for connection of tested appliance’s power supply cord

2. PE – terminal for connecting the exposed conductive part of the tested appli-

ance (the terminal is connected to the PE terminal of Test Socket 1)

3. ITOUCH 2kΩ– touch leakage current test terminal

4. RISO /IALT – insulation resistance / alternative leakage current test terminal

5. PAT – terminal for connecting the patient parts of tested appliance

6. RPE – earth bond test terminal

7. PEMAINS – terminal connected with PE of mains

8. USB - socket type A for connection USB 2.0 Full Speed HID (Human Interface

Device), e.g. barcode scanner

9. USB – socket type B, PC connection

10. EXT input - current clamp / three-phase adapter / other adapters connector

11. Power supply cord

WARNING

•Do not connect any external voltage to any terminal or connector.

The only exception is the power supply cord 11 which is intended

for powering the MDtest from the 127 V / 50 or 60 Hz mains

outlet.

•Max. load on Test Socket 1is 16 A (limited in time).

•Use original accessories only.

•Do not connect any external voltage between RPE terminal and

the PE in Test Socket 1or PE terminal.

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MDtest (100-140 V) - User’s Manual 2 Description of the instrument

Figure 1: Front panel and rear panel

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