Gossen MetraWatt SECULIFE ST, SECULIFE STHV Operating Instructions Manual
Operating Instructions
SECULIFEST and SECULIFEST HV
Test Instruments for Portable Appliance Testing according to Health and Safety Policy
and in Accordance with the Medical Product Law as well as for Routine Testing
3-349-448-03
16/11.11
45678910
!
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23
22
21
25
22
26
27
20
19
Probe connection
Insert the double plug of the probe into sockets 4 and
5 such that the plug with the white ring contacts
socket 5 (vertical bar).
Note: Contact problems with exposed conductive parts
when using the standard probe with test tip
In order to assure good contact, surface coatings must be
removed from devices under test with special tools at a suitable location so that the surface has a metallic shine. The tip
of the test probe is not suitable for scratching away paint, because this may impair its coating and/or mechanical
strength. The brush probe (Z745G) may be more suitable
than the test probe in certain individual cases.
Measurements at jacks 1 – 2 – 3
Always start with the measurement before contacting
the measuring point. Between jacks 1 and 2, a maxi-
11
12
13
RS232
IOIOI
PROBE
54
SONDE
Setup
3
2
1
HV
Function
Test
V
Aux
Applied Parts
AC E G I
BDFHK
!
Iso
I leakage
/
PE
Auto
L
3
max. 253 V
N
2
max. 10 V
SL
1
mum of 10 V may be applied. Between jacks 2 and 3,
14 15 1816 17
up to 253 V may be applied.
Attention: Jacks (2) and (3) are short-circuited
during all measurements at the test socket!
(Exception: see chapter 12.2)
Standard equipment
1
Test instrument with 10 + 2 connectors for application parts
1 Probe cable with test probe
1 Clip-on alligator clip for test probes
3 Clip-on quick-clamp terminals
10 conductor patient connection cable 2 mm
10 Clip-on alligator clip 2 mm
1 Calibration certificate per DKD
1 Operating instructions
1Carrying strap
Up-to-date PC software (free start-up programs or
demo software for data management, report and list
generation) is available on our website for download.
These operating instructions describe an
instrument with firmware version 7.24.
2 GMC-I Messtechnik GmbH
1 Jack for protective conductor at device under test
Note
i
!
2 Jack for neutral conductor at device under test
3 Jack for phase conductor at device under test
4 Jack for connecting the probe
5 Jack for connecting the probe
6 Function selector switch
– Function Test: Function test
– Auto: Automatic test sequence according to selected standard
– PE: Protective conductor test
– Iso/HV: Insulation test / high-voltage test
– I leakage: Leakage current measurement
– V : Multimeter functions
– Aux: Auxiliary multimeter functions
– Setup: Device configuration
7 scroll key for menu and parameter selection
8 scroll key for menu and parameter selection
9 LCD window
10 Socket connector interface RS232 for (P)SI module SECUTEST PSI/SI+, storage
adapter
SECUSTORE
, barcode or RFID scanner
11 Signal lamp for mains connection error
12 key for entry and for starting test sequences and finger contact
13 help key (context sensitive)
14 Key next to the symbol for switching test voltage to
the test socket (only possible if symbol LED is blinking)
15 Signal lamp for the functions test
16 Functional earth (equipotential bonding)
17 Operational earth
18 Connector jacks for application parts
19 Push-buttons (left and right) for releasing the handle from its snap-in position
20 Earthing contact socket for service purposes (Feature B01),
e.g. for connecting a notebook or an A4 format printer, Terminal Data see page 63
21 Standard outlet socket (test socket) for connecting the device under test
22 Push-buttons (left and right) for releasing the lid
23 Lid
24 Compartment for probe and accessories
25 Cover or (P)SI module (accessory
SECUTEST PS I or SECUTEST SI+)
26 Carrying handle and tilt stand
27 Test probe (accessory probe with coil-cable SK2W (Z745N))
Overview of Available Probe Types
Probe Type Application Special Features
Standard probe (test probe with
coil-cable and alligator clip)
1)
SK2
1)
SK2W
Feature KD01 with probe SK5 Restriction with
Brush probe
Can be plugged onto all above
listed probes and test probes
1)
1)
Accessory
Max. test current: 25 A Probe with cable
Max. test current: 25 A Probe with cable (no coil-cable),
Max. test current: 25 A Probe with cable (coil-cable),
Feature G01 (I
short-circuit current < 25 A
Leakage current,
protective conductor resistance
>25A):
K
(no coil-cable)
2 meters long
2 meters long
Special probe in combination with
“automatic recognition of measuring point change” function (see
chapter 17)
For contacting devices under test
with rotating, vibrating, exposed
conductive parts
when using other probes than those specified above
The cables plugged into the sockets (4 and 5) must be short
circuited for testing with the probe, i.e. by plugging the ends of
the cable together, or via a conductive surface at the device
under test (4-wire measurement).
Remove any corrosion from the device under test.
Data Security
Measurement data, report data and user entries are stored to RAM at the
(P)SI module (accessory), as long as the respective battery supplies the
required amount of voltage.
Save your data to a PC on a regular basis in order to prevent any loss of data
at the (P)SI module. We assume no liability for data loss. We recommend the
following PC programs for data processing and data management:
• PS3 (transmission of measurement data to a PC, documentation,
management, report generating and deadline follow-up)
• PC.doc-WORD/EXCEL (report and list generation
• PC.doc-ACCESS (test data management)
• ELEKTROmanager/PROTOKOLLmanager for SECUTEST...
• patManager (Report and list generation)
GMC-I Messtechnik GmbH 3
Contents Page Contents Page
1 Applications ...................................................................................6
8 Configuring Device Parameters ...................................................18
1.1 Table: Types of DUTs – Tests – Regulations .............................................. 6
1.2 Table: Individual Measurements and Regulations .....................................7
1.3 Table: Leakage Current Types ...................................................................7
1.4 List of Possible Options and Standard Types .............................................. 8
9 Measuring Protective Conductor Resistance ...............................19
9.1 Maximum Allowable Limit Values for Protective Conductor Resistance
for Connector Cables with a Length of up to 5 m ..................................... 20
2 Safety Features and Precautions ...................................................9
2.1 Notes Regarding the High-Voltage Test
(only Feature F02 or SECULIFE ST
HV) .......................................................10
3 Initial Start-Up ..............................................................................11
3.1 Connection to the Mains (115 V / 230 V, 50 Hz / 60 Hz) ............................11
3.2 Automatic Recognition of Mains Connection Errors ..................................12
4 General Notes ..............................................................................12
4.1 Online Instructions ....................................................................................12
4.1.1 Changing the User Interface Language .........................................................12
4.1.2 Automatic Safety Class Selection ..................................................................13
4.1.3 Manual or Automatic Operating Sequences ...................................................13
4.2 Online Help ................................................................................................13
4.3 Adjusting Contrast .....................................................................................13
4.4 Configuring Device Parameters, Setting Date and Time ...........................14
4.5 Configuring Measurement and Sequence Parameters .............................14
4.6 Setting Limit Values ..................................................................................14
4.7 Saving the Settings ...................................................................................14
5 Classification of Devices Under Test ............................................15
5.1 Safety Classes ...........................................................................................15
5.2 Application Parts (electrical medical devices) ..........................................15
6 Abbreviations ...............................................................................16
7 Connecting the Device Under Test ...............................................17
10 Insulation Measurement .............................................................. 20
10.1 Insulation Resistance R
10.2 Equivalent Leakage Current ..................................................................... 22
10.3 High-Voltage Test (Feature F02 or SECULIFE ST
. ....................................................................... 20
INS
HV) ................................. 24
11 Leakage Current Measurement ...................................................26
11.1 Earth Leakage Current IPE (Feature KA01) ................................................ 26
11.2 Housing Leakage Current I
11.3 Patient Leakage Current I
11.4 Patient Auxiliary Current IPA (Feature KA01) ............................................. 27
11.5 Residual Current I
RC .......................................................................................................27
(probe current, contact current) ................. 26
HL
PL ......................................................................................... 27
11.6 Device Leakage Current ILC per IEC 62353 (VDE 0751-1) ......................... 27
12 Multimeter Functions ...................................................................30
12.1 Probe Voltage U
12.2 Alternating / Direct Voltage U
12.3 Resistance R ............................................................................................. 31
– Max. 300 V ........................................................... 30
probe
– Max. 253 V .....................................30
AC/DC
13 Measurements with Accessories .................................................32
13.1 Alternating Current IC with Clip-On Converter ..........................................32
13.2 Protective Conductor Resistance R
13.3 Temperature T with Pt100/1000 Sensor ................................................... 33
via Clip-On Meter ..........................32
PE
14 Function Test ...............................................................................34
4 GMC-I Messtechnik GmbH
Contents Page Contents Page
15 Measurements in Accordance with National and
International Standards with Selector Switch in Auto Position ... 36
15.1 Test Sequences .........................................................................................36
15.2 Setting Up Test Sequences .......................................................................37
15.3 Configuring Measuring Parameters ..........................................................39
15.4 Testing Devices in Accordance with DIN VDE 0701, Part 1 .......................40
15.5 Testing Devices in Accordance with DIN VDE 0701, part 240 ...................42
15.6 Testing Devices in Accordance with DIN VDE 0701-0702:2008 ................44
15.7 Testing Extension Cables for VDE 0701-0702 (VDE 0701 Part 1)
(optional EL1 adapter) ...............................................................................46
15.8 Testing Multiple Outlets for VDE 0701-0702 (optional EL1 adapter) .........47
15.9 Testing in Accordance with DIN EN 60 950 ...............................................48
15.10 Testing Devices in Accordance with EN 61010 ........................................50
15.11 Testing Devices in Accordance with EN 60335 ........................................52
15.12 Testing in Accordance with IEC 62353/VDE 0751 .....................................54
15.13 Testing in Accordance with EN 60601 (Feature KA01) .............................56
16 Storing in (P)SI Module (Accessory) and Database Operations
(Feature KB01) ............................................................................. 58
16.1 Storing Measurement Data in the (P)SI Module ........................................58
16.2 Database Operations .................................................................................58
16.2.1 Storing Test Results to the Test Instrument ...................................................58
16.2.2 Uploading Report Templates into Test Instrument, Reading Out From the Test
Instrument, Editing at the PC and Re-Saving to the Test Instrument ................58
16.2.3 Reading Out and Saving Test Results / Test Data from the (P)SI Module ..........58
20 RS 232 Interface .......................................................................... 64
20.1 Transmission of Measurement Results to the (P)SI module .....................64
20.2 PC Connection ...........................................................................................64
20.2.1 Software Evaluation of Measurement Results ................................................64
20.2.2 Instrument Control via Interface Commands ..................................................64
20.3 Interface Definition and Protocol ..............................................................64
21 Appendix ..................................................................................... 65
21.1 Evaluation of Measured Values for Individual Measurements
as well as for Calculated Quantities .........................................................65
21.2 Evaluation of Measured Values during Equivalent Leakage Current
Measurement (Automatic Test Sequence According to Standard) ........... 65
21.3 Index ......................................................................................................... 66
22 Maintenance - Recalibration ....................................................... 68
22.1 Housing Maintenance ...............................................................................68
22.2 Recalibration ............................................................................................. 68
22.3 Safety Checks ...........................................................................................68
22.4 Device Return and Environmentally Compatible Disposal ........................69
23 Repair and Replacement Parts Service
Calibration Center and Rental Instrument Service ...................... 69
24 Product Support .......................................................................... 70
17 Recognition of Probe to Protective Conductor
(Feature KD01) ............................................................................. 58
18 Storing Test Results and Printing in Report Form ....................... 59
19 Characteristic Values ...................................................................60
GMC-I Messtechnik GmbH 5
1 Applications
Attention!
!
1.1 Table: Types of DUTs – Tests – Regulations
Start-up and
Modifications
Devices under test
to be tested in
accordance with the
following regulations
EC 62353 :2007
I
Laboratory instruments
Measuring and control instruments
Voltage generation devices
Electric tools
Electric heating devices
Electric motor devices
Lamps
Devices for entertainment
electronics, information and
communications technology
Cable reel, extension and
connection leads
Data processing and office
equipment
Electrical medical devices,
application parts
Testing after
Repairs
-0702:2008
DIN VDE 0701
DIN EN 62353:2008
(VDE 0751-1)
Periodic
Tes t in g
-0702:2008
1
EC 62353 :2007
I
DIN VDE 070
DIN EN 62353:2008
Routine Testing
EC 62353 :2007
I
DIN EN 62353:2008
DIN EN 60950/50 116
DINEN61010
DIN EN 60335/50 106
IEC 60601/DIN EN 60601
The test instrument may not be used for measurements
within electrical systems!
Applicable Standards
German National European International
DIN EN 61010 EN 61010 IEC 61010
DIN EN 60601 EN 60601 IEC 60601
DIN EN 60335-1 EN 60335-1 IEC 60335-1
DIN EN 60950 EN 60950 IEC 60950
IEC 62353 :2007
DIN EN 62353:2008
EN 62353 IEC 62353
(VDE 0751-1)
6 GMC-I Messtechnik GmbH
1.2 Table: Individual Measurements and Regulations
Individual Measurements
per Regulation
Tes t Cur re nt [ A]
DIN VDE 0701-0702
DIN VDE 0701
DIN VDE 0701
DIN VDE 0701
DINEN60950
DINEN61010
DINEN60335
IEC 62353
0.2
Protective Conductor
Resistance
Insulation Resistance
Equivalent Leakage Current
High-Voltage Test
Equivalent (Device) Leakage
Current
Equivalent Patient Leakage Current
Residual Current
Contact Current
Absence of Voltage
(exposed conductive parts)
Housing Leakage Current
Earth Leakage Current
Patient Leakage Current
Total Patient Leakage Current
Patient Auxiliary Current
Device Leakage Current
Single Fault Conditions N
PE
Mains at Application Part
10
25
AC AC
Key
Standards printed in grey half-tone will be superseded by the new
DIN VDE 0701-0702:2008 standard.
Required test
IEC 601/EN 60 601 2nd
IEC 601/EN 60 601 3rd
1.3 Table: Leakage Current Types
DIN VDE
0701-0702
Equivalent
Leakage Current
Contact Current/
Measurement for
Absence of
Volta ge
Protective
Conductor
Current with
Residual
Current
Measurement
IEC 62353
(VDE 0751-1)
Equivalent
Device Leakage
Current
Equivalent
Patient Leakage
Current
Housing Leakage
Patient Leakage
Current
NC
Device Leakage
Current during
Operation, Direct
Measurement
Device Leakage
Current during
Operation,
with residual
Current
Measurement
DIN EN 60601-1 The following is
IEL interrupted
from N
Current
NC
Patient Leakage
Current
NC
Patient Auxiliary
Current
NC
Earth Leakage
Current
NC
Key
NC = normal condition
PAP = patient application part
PE = Potential earthing
PC = Protective conductor of the DUT
, system protective conductor
measured:
PROBE
(connected to
protective
conductor)
to L & N
PROBE
(connected to
protective
conductor)
to L & N
L & N & PE to
Patient Jacks
Probe to PE
Patient Jack to PE
Patient Jack to
Patient Jack
Protective
Conductor to PE
Protective
Conductor
Interrupted, Probe
+ PAP to PE
See chapter 11.5
GMC-I Messtechnik GmbH 7
1.4 List of Possible Options and Standard Types
Features 00 01 02 03 04 05 06 07 08 09 10 11 XX
Mains Connection for
Respective Country
User Interface Language C DUKF I ECZENL
High Voltage Testing
HV-DC F without
AC Test Current 50/60 Hz
for Protective Conductor
Measurement
Test Sequence
for IEC 60601
Data Memory
for up to 125 Tests
Recognition of
Probe to Protective Conductor
Direct Printing after each
Measurement for Automatic
Test Sequences
Read-Out via RS232
1)
Each measured value is documented in this case, as opposed to the results of a
test sequence for which only the poorest value for each given test is displayed.
(via the PSI module, the SECUSTORE storage adapter or a PC)
5)
1)
B D
G 10 A 25 A
KA without with
KB without with
KD without with
KE without with
D + ser-
vice socket
4)
UK
max.
6.126 kV DC
( 4KVAC)
F/CZE DK
2)
Adapter set for international use (comes with Feature B01)
4)
if adapter (feature B11) is applied: HV-DC max. 1.5 kV DC
5)
without function test values and without comments on DUT
4)
China/AUS
4)
CH
adapter
set 2)
4)
Designation Type
Test instrument with test current
200 mA DC and 10 A AC
Sequences for IEC 61010, IEC 60 335,
IEC 60950 and IEC 60601,
data memory for up to 125 tests
SECULIFE ST M693A
Same instrument as M693A, however,
suited to international use with adapter
set for mains connection in the respective
user country and English user interface
language SECULIFE ST M693B
8 GMC-I Messtechnik GmbH
Article Number
Designation Type
Same instrument as M693A, however, with
test current 200 mA DC and 25 A AC,
additionally with high-voltage test max.
6.126 kV DC ( 4 KV AC) SECULIFE ST
Same instrument as M693C, however,
suited to international use with adapter
set (application of adapter: high-voltage
test max. 1.5 kV DC) for mains connection
in the respective user country and English
user interface language SECULIFE ST
Article Number
HV M693C
HV M693D
2 Safety Features and Precautions
Note
Attention!
!
This instrument fulfills the requirements of the applicable European and national EC guidelines. We confirm this with the CE marking. The relevant declaration of conformity can be obtained from GMC-I Messtechnik GmbH.
The test instrument has been manufactured and tested in accordance
with the following safety regulations:
IEC 61010-1 / DIN EN 61010-1 / VDE 0411-1, DIN VDE 0404, DIN VDE
0413 Part 2 and 4 and DIN VDE 0104 (Feature F02 or
Only when used for its intended purpose, the safety of the user, the test
instrument and the device under test (electrical equipment or electrical
medical devices) is assured.
Read the operating instructions carefully and completely before placing your test
instrument into service, and follow all instructions contained therein. Make sure
that the operating instructions are available to all users of the instrument.
Tests may only be performed by a qualified electrician or under the supervision of
a qualified electrician. The user must be instructed by a qualified electrician
concerning performance and evaluation of the test.
Manufacturers and importers of electrical medical devices must
provide documentation for the performance of maintenance by
trained personnel.
Observe the following safety precautions:
• The instrument may only be connected to electrical systems with a
maximum of 230 V +10% which are protected with a fuse or circuit
breaker with a maximum rating of 16 A.
• Measurements within electrical systems are prohibited.
• Be prepared for the occurrence of unexpected voltages at devices
under test (for example, capacitors can be dangerously charged).
• Make certain that the measurement cables are in flawless condition,
e.g. no damage to insulation, no interruptions in cables or plugs etc.
• When using a probe with coil cable (SK2W): Grip the test probe firmly,
for example after insertion into a jack socket. Tensioning at the coil
cord may otherwise cause the test probe to snap back resulting in
possible injury.
• Measurement of Insulation Resistance and Equivalent Leakage Current
This test is performed with a maximum voltage of 500 V, with a current
SECULIFE STHV)
limit having been set (I < 3.5 mA). However, contacting the terminals
(3 or 2) causes an electric shock which, in turn, may result in accidents.
• Leakage Current Measurement
During leakage current measurement it is imperative to ensure that the device under test is operated at line voltage. Exposed conductive parts may
be charged with hazardous contact voltage during the test and may consequently not be touched under any circumstances. (There is a power
shutdown as soon as the leakage current is higher than approx. 10 mA).
The function test may only be performed after the DUT has
successfully passed the safety test!
Switching loads on and off
When switching the DUT on or off under load it is imperative that you adhere to the order indicated below. This helps to prevent excessive wear
and tear of the mains relays at the test instrument.
Before the measurement:
1) DUT: Switch the DUT off at the proprietary switch.
2) SECULIFE ST or SECULIFE ST
3) DUT: Switch on the DUT at the proprietary switch.
After the measurement:
4) DUT: Switch the DUT off at the proprietary switch.
5) SECULIFE ST or SECULIFE ST
The measuring and test instrument may not be used:
• If it demonstrates visible damage
• With damaged connector cables, measuring cables or patient ports
• If it no longer functions properly
• After extraordinary stresses due to transport
In such cases, the instrument must be removed from operation and
secured against unintentional use.
HV:
Apply line voltage to the test socket .
HV:
Disconnect the test socket from the line .
GMC-I Messtechnik GmbH 9
Meanings of Symbols on the Instrument
Attention!
!
!
The symbols on the instrument have the following meanings:
Warning regarding dangerous electrical voltage
Warning concerning a point of danger
(Attention: observe documentation!)
Test socket
Mark of approval from VDE test authority
Indicates EC conformity
This device may not be disposed of with the trash. For further
details on the WEEE marking, please refer to our website
www.gossenmetrawatt.com and enter search term ’WEEE’.
2.1 Notes Regarding the High-Voltage Test
(only Feature F02 or SECULIFE ST
The KS13 cable set, or similar cable sets, may not be used for the high-voltage
test. The high-voltage test may only be performed directly via the test socket!
Do not hold the device under test in your hand during testing,
especially when testing safety class II devices.
Make sure that the device under test does not make contact
with any equipment or persons during testing.
Liability Exclusion
In the event of sparkover, PCs operated in proximity to the test instrument may
“crash” resulting in data loss. All data and programs should be suitably backed up
before high-voltage testing is performed, and computers should be shut down if
necessary. A crash may occur even if no RS 232 connection has been established.
The manufacturer of the test instrument assumes no liability for direct or
consequential damage to computers, peripherals or data which occurs
during high-voltage testing.
The manufacturer assumes no liability for defects at the device under test
which result from high-voltage testing. As a rule, defects can only occur at
devices under test which are not in compliance with applicable standards,
which were previously damaged or which have been improperly repaired,
because high-voltage testing is required for type and routine testing by
IEC 61010-1/EN 61010-1 / VDE 0411, part 1, as well as EN 60 335,
EN 60601 and EN 60950.
HV)
10 GMC-I Messtechnik GmbH
3 Initial Start-Up
Attention!
!
L1
N
green-yellow
green-yellow
PE
L1
L2
L3
N
PE
L1
L2
L3
N
green-yellow
U
L–N
= 115 V / 230 V
Connection to the Mains
3.1 Connection to the Mains (115 V / 230 V, 50 Hz / 60 Hz)
õ Connect the mains plug at the test instrument to the mains power out-
let. The function selector switch can be set to any position.
If a mains outlet (earthing contact outlet) is not available, or if only a
3-phase outlet is available, the adapter socket can be used to connect
the phase conductor, the neutral conductor and the protective conductor. The adapter socket has three permanently attached cables
and is included with the KS13 cable set.
If connection is not possible via an earthing contact outlet: Shut
down mains power first.
Then connect the cables from the coupling socket to the mains
using pick-off clips in accordance with the diagram.
Disconnection from mains power is only possible with the mains
plug.
GMC-I Messtechnik GmbH 11
3.2 Automatic Recognition of Mains Connection Errors
Attention!
!
Note
Attention!
!
!
!
The test instrument automatically recognizes mains connection errors,
if the conditions in the following table have been fulfilled. The user is
informed of the type of error, and all measuring functions are disabled
in the event of danger.
Typ e of Ma ins
Connection Error
Voltage at protective
conductor PE to finger
contact
(key)
Protective conductor PE
and phase conductor L
reversed and/or
neutral conductor N
interrupted
Contact voltage at
protective conductor PE
to neutral conductor N
or phase conductor L
Mains voltage
too low lamp
1)
In SETUP – test sequence – IT system
In either of the first two cases listed in the table above,
immediately disconnect the test instrument from the mains
and eliminate the error!
Message Condition Measurements
Text appears at
LCD
lamp
lights up
Text appears at
LCD
lights up
Press
key
U 40 V
Voltage at PE
>65V
U 25 V
U
< 90/180 V
L-N
disabled
impossible
(no supply power)
disabled, although
disabling can be
deactivated
possible
under certain
circumstances
4 General Notes
4.1 Online Instructions
Integrated online instructions inform the operator regarding all required
connections, necessary work steps, operator errors, measurement results
and more in all measuring modes.
Information and test results appear at the dot matrix LCD in clear text.
4.1.1 Changing the User Interface Language
If you require a different language for the user interface of the test instrument, you can load it into your test instrument by means of the update
and options installation program „SECU-Up“. The program is available for
download from our website www.gossenmetrawatt.com (Products >
Software > Software for Testers > SECU-Up).
Upon installation on your PC and starting the program, you proceed by
selecting the „Update“ menu and choosing a language from the following
list:
Deutsch, English, Français, Italiano, .
Only one language at a time can be installed on the test instrument, the
one previously installed is overwritten in the process.
1)
During data transmission, the test instrument and PC may not
be disconnected from the mains power supply under any circumstances.
No other programs under WINDOWS may be activated during
the update.
Voltage at the electrical system’s protective conductor PE may
result in distorted measurement values during testing for the
absence of voltage, or during leakage voltage measurements.
12 GMC-I Messtechnik GmbH
4.1.2 Automatic Safety Class Selection
Note
Auto
Depending upon the type of mains plug or the connection configuration
for the device under test, the test instrument recognizes the respective
safety class and recommends its use for the measurement to be performed.
4.1.3 Manual or Automatic Operating Sequences
Depending upon selections made in the setup menu (selector switch in
the Auto position), the next measurement is started automatically after the
current measurement has been completed, or can only be started after
manual acknowledgement. The integrated online instructions are adequate for most tests and measurements. However, the contents of these
operating instructions should nevertheless be read and observed.
4.2 Online Help
Online help can be queried and displayed at the LCD for all measuring
and test functions, and for almost all settings. Schematic diagrams which
illustrate proper connection of devices under test to the test instrument
can be displayed as well.
õ Press the following key in order to query online help:
4.3 Adjusting Contrast
Set the selector switch to Auto.
Select the “Setup” menu, “return” is highlighted.
Activate contrast adjustment.
Press and hold the ENTER key.
õ Press the same key again in order to exit online help.
Adjust contrast.
Online help can be queried during measurement by pressing
and holding the help key.
Return to the menu.
Store the contrast setting to permanent memory with the save function in
the setup menu.
GMC-I Messtechnik GmbH 13
4.4 Configuring Device Parameters, Setting Date and Time
Device parameters and functions which are valid for all selector switch
positions can be activated or deactivated with the selector switch in the
Setup position (see chapter 8 on page 18).
4.5 Configuring Measurement and Sequence Parameters
Measurement and sequence parameters, as well as functions, can be
activated or deactivated in the setup menu (selector switch in the Auto
position) for the respective test regulation. Refer to chapter 15.3 on page
39 for the significance of the various parameters.
4.6 Setting Limit Values
Upon delivery, the limit values set forth (at the point in time of issue) in applicable national and international standards are stored to the test instrument. Limit values for each of the respective standards can be queried
and changed if required with the setup menu (selector switch in the Auto
position), but changes can only be made which result in even stricter testing than is required by the respective standard.
Newly entered limit values become effective immediately. However, these
are only stored to memory permanently after activating the store function
in the setup menu.
If the limit values set forth in the standards for certain safety classes need
to be restored despite individualized settings, the menu function all values
per standard in the limit values sub-menu must be selected and acknowledged with the key.
If the limit values set forth in the standards are changed, the instrument’s
device software can be updated via the RS 232 interface.
4.7 Saving the Settings
All of the settings and changes which have been entered to the configure,
limit values (selector switch in the Auto position) and zero point (temperature
measurement) (selector switch in the Aux position) menus, as well as the se-
lected contrast setting are retained until the selector switch is turned, or
the test instrument is disconnected from mains power. If settings and
changes should be retained even after mains power has been interrupted,
they must be saved in the setup menu for the respective test regulation or
selector switch position.
14 GMC-I Messtechnik GmbH
5 Classification of Devices Under Test
5.1 Safety Classes
Devices assigned to all of the following safety classes are equipped with
basic insulation, and provide for protection against electrical shock by
means of various additional precautions as well.
Safety Class I Devices
Exposed, conductive parts are connected to the protective conductor so
that they are not charged with voltage if the basic insulation should fail.
5.2 Application Parts (electrical medical devices)
Type B Application Parts (body)
Devices of this type are suitable for both internal and external patient
applications, except for use in direct proximity to the heart.
These devices provide for adequate protection against shock especially
as regards:
• Reliable leakage current
• Reliable protective conductor connection if utilized
Devices of the following safety classes are allowable:
I, II, III or devices with internal electrical power supply.
Safety Class II Devices
These devices are equipped with double insulation or reinforced insulation.
Safety Class III Devices
and Devices with Internal Power Supply
These devices are powered with Safety Extra Low Voltage (SELV). Beyond
this, no voltages are generated which exceed SELV. These devices may
not be connected to the mains. They may only be connected to the test
instrument at jacks 1 through 3.
Type BF Application Parts (body float)
Same as type B, but with type F insulated application parts.
Type CF Application Parts (cardiac float)
Devices of this type are suitable for use directly at the heart. The application part may not be grounded.
Devices of the following safety classes are allowable:
I, II or devices with internal electrical power supply.
Note: The DUT may only be connected to jacks 1 to 3 at the test instrument. It is only possible to perform a visual inspection, a measurement of
the insulation resistance or the supply voltage, see parameter “SC II I U
on page 39.
”
V
Classification Parameter (in the Sequence ... menu)
The test instrument always performs testing in accordance with the strictest limit values of the respectively selected safety class. The test is failed if
this limit value is exceeded.
However, higher limit values are allowed for certain devices under test.
If the classification parameter has been activated (= x), the user is asked if
higher limit values are allowable for these devices. If the user responds
with “Yes”, the DUT is reevaluated and the test may be passed.
Devices with Internal Power Supply
Devices with internal power supply are tested like permanently connected
Safety Class II or II I devices.
GMC-I Messtechnik GmbH 15
6 Abbreviations
AE Error condition: application part grounded
AP Apparent power (during function test)
B, BF, CF Classifications for application parts
DEFI Defibrillator
I Residual current, fault current (during function test)
I
max
RC
wc
HE Error condition: housing grounded
I
CLIP
I-EHC
SCII
I-EHL
A1/A2
I-EHL
FRPE
IEL, I-EL Equivalent leakage current
, I-EDL
I
EDL
I
, I-EPL Equivalent patient leakage current
EPL
, IHL, I-HL Leakage current (differential, probe or contact current)
I
L
(Ia) (Maximum) load current (during function test)
I
L(max)
I
LC
I
PA
I
PE
I
PL
I
PMAP
IRC, (IRe) Residual current (current at protective conductor during
, I-HL Contact current (housing leakage current)
I
C, IHL
IT-system The IT system makes no direct contact between active
L Phase conductor connection of DUT
MedGV German medical device ordinance
Maximum residual current (during function test)
Residual current worst case
Current at clip-on meter
Equivalent device leakage current for devices with
additional safety class II components
Equivalent device leakage current with note A1/A2
(cross-reference within the standard)
Equivalent device leakage current for portable x-ray devices
+PE: with additional protective conductor
–PE: without additional protective conductor
Equivalent device leakage current (current at protective conductor)
Device leakage current
Patient auxiliary current
Earth leakage current (current at protective conductor)
Patient leakage current
Mains to application part (patient leakage current measurement)
automatic test sequence)
conductors and grounded parts: bodies within the electrical system are grounded.
MSELV Medical safety extra-low voltage
N Neutral conductor connection of DUT
NC Normal condition
OE Operational earth
P Active power (during function test)
PA Functional earth (equipotential bonding)
PE Protective conductor connection of DUT
PF Power factor (during function test)
RResistance
, R-INS Insulation resistance
R
INS
R-INS AP-PE Insulation resistance: application part to PE
R-INS
INT. KARD.
Insulation resistance: intercardiac
(application in proximity to the heart)
R-INS NL-PE Insulation resistance: neutral/phase conductor to PE
, R-PE Protective conductor resistance
R
PE
R-PEmains Protective conductor resistance limit value for
+mains: device under test with mains cable
–mains: device under test without mains cable
(protective conductor resistance limit value for mains
cable only = 0.1
SELV Safety extra-low voltage
SFC Single-fault condition
t On-time (during function test)
T, Temp Te mper a tur e
U
AC/DC
U
REF
, U-HV High-voltage
U
HV
, U-INS Test voltage for insulation measurement
U
INS
, U-LN Line voltage
U
LN
U
MEAS
U
Probe
AC/DC voltage
Reference voltage: voltage to which leakage current is
related (as a rule nominal line voltage)
Voltage at which testing was executed.
Displayed for all leakage current measurements.
Probe voltage
W Electrical energy (during function test)
ZVEH General Association of German Electricians
MLV manufacturer’s limit value
MPG German medical product law
16 GMC-I Messtechnik GmbH
7 Connecting the Device Under Test
Note
Note
Attention!
!
Attention!
!
Attention!
!
õ Connect the DUT in accordance with the schematic diagrams included
in the online help function.
Connection of the DUT to the test instrument depends upon:
• The type of device under test:
electrical equipment or not, with or without application parts
• The type of connector included with the DUT:
– With plug (“to test socket” parameter), applies to EL1 adapter as well
– Without plug, single or multi-phase connection (“to jacks” parameter)
– No connection to tester (“permanent connection” parameter),
see also chapter 3.1
Whether or not an adapter is used:
– Adapter to socket (customer specific adapter)
– AT3-II S to socket, adapter for devices which are equipped with
5-pole, 16 A CEE plugs
– AT3-III E to socket, adapter for devices which are equipped with
5-pole, 32 A CEE plugs, see AT3-III operating instructions for test
sequence.
• The DUT’s safety class (I, II or III)
The DUT must be switched on for all tests. Switches, relays,
temperature regulators etc. must all be taken into consideration.
The test instrument automatically recognizes whether or not the DUT is
connected to jacks 1 through 3. The instrument also recognizes whether
or not the DUT has been connected to the test socket. As a default setting, the program sequence assumes that the plug from the DUT has
been connected to the test socket.
õ Position the cursor at the third line in the start menu for the test se-
quence.
õ A selection of possible connection setups can be displayed by
activating the key.
õ Select the desired connection setup with the cursor and
acknowledge with the key.
For omitting the protective conducter test in the case of fully insulated devices see
page 65.
Protective Conductor and Insulation Resistance Measurements for Permanently
Installed Devices Under Test
Deactivate the electrical system which supplies power to the
device under test before connecting the test instrument!
õ Remove the mains fuses from the device under test and disconnect
the neutral conductor N inside the device under test.
Measuring Contact Current (absence of voltage)
Make sure that the contacted parts are not grounded.
High-Voltage Test (Feature F02 or SECULIFE ST
The KS13 cable set, or similar cable sets, may not be used
for the high-voltage test. The high-voltage test may only be
performed directly via the test socket!
HV)
Safety Class II Devices with Safety Class I Mains Plugs
If the device under test is equipped with a safety class I plug
although it complies with safety class II, safety class I is recognized by the test instrument. If this is the case, switch from safety
class I to safety class II in the initial menu.
If the test instrument is unable to automatically recognize how the DUT
has been connected, the recommended connection setup should be
double checked and determined manually if necessary.
GMC-I Messtechnik GmbH 17
õ Connect the device under test to the test socket.
õ Safety class II only: Connect the probe to jacks 4 and 5.
Make sure that the application parts are not connected during
the high-voltage test!
8 Configuring Device Parameters
Setup
duration selected in seconds under “Mains pause”
has elapsed.
Automode x: for fully automatic test sequences the messeges
are mainly suppressed
Test Sequence ...
General device parameters can be
configured and saved with the selector
switch in the Setup position.
Settings x / – = function activated / deactivated
Single-fault
If the single-fault condition has been activated, the test
is interrupted as a failure as soon as an error occurs.
Auto Class PSI Test results (passed or failed) for the various selector
switch positions are automatically assigned to the 8
statistics channels.
inc. Service Error Measurement results are compensated by taking
Select a menu and acknowledge.
IT Network Testing in IT systems can be performed by suppress-
service error into consideration (measuring error).
ing tests for U
whether or not voltage is present at PE.
PE-N
. The U
test determines
PE-N
(Leakage current measurement results may other-
Select parameter and acknowledge, change setting and acknowledge.
Limit values ...
Settings x / – = function activated / deactivated
Illumination Background illumination for the LCD. One of three
different conditions can be selected with the up and
down scroll keys: x: continuously on, –: off
Acst Sig, Seq
Acst Sig, Meas Acoustic signal is generated for: Measured value
Auto meas. point Prerequisite: Feature KD01. An acoustic signal indi-
numbers 1 through 9: duration in minutes after which
illumination is automatically deactivated.
Test time Duration of a single test (0 255 s)
Reference voltage: Voltage to which leakage current makes reference
(as a rule nominal line voltage)
Earth fault: During the short-circuit test, testing is also performed
to determine whether or not a connection exists
Direct Print-Out
Reports Reports which have been saved to memory can be
between L/N and PE (short-circuit to exposed conductive part). We assume that a short-circuit to an
exposed conductive part exists in the event of leakage current greater than 15 mA from L/N to PE. This
value should be increased for some DUTs (in particu-
Select template a report template can be selected for print-out from
Service – Time and date settings
lar high-current consumers), because greater leakage currents are present.
Mains wait Line voltage is first applied to the test socket.
18 GMC-I Messtechnik GmbH
However, testing does not begin until after the
wise be distorted.)
Acoustic signal is generated for: Incorrect connection of the
DUT, error in the electrical supply system, next test step.
fluctuations, test current polarity reversal
cates whether or not the probe is connected to the
protective conductor. The test sequence is run automatically.
Rapid signal frequency: probe connected to PE
Slow signal frequency: next measuring point
Prerequisite: Feature KE01, see chapter 18 on page 59.
selected from a list with an ID number and displayed
(see chapter 18 on page 59).
of 5 different templates.
(if a (P)SI module is used, the same time and date
must also be entered to the (P)SI menu)
– Service functions (password required)
9 Measuring Protective Conductor Resistance
Note
PE
Connecting Safety Class I Devices to the Test Socket
When the DUT is connected, resistance is measured between the protective conductor terminal at the test socket or at the PE jack and the probe
connection at the DUT (contact with conductive parts of the housing).
õ In order to measure protective conductor resistance, contact a
conductive part of the housing with the probe, which is connected to
the protective conductor.
During measurement, the connector cable must only be moved in as far as
it is accessible during repair, modification or testing.
If a change in resistance occurs during the manual test step of the continuity test, it must be assumed that the protective conductor is damaged,
or that one of the connector contacts is no longer in flawless condition.
Definition
Protective conductor resistance
Testing Extension Cables
See test sequence in chapter 15.7 on page 46.
is the sum of the following
resistances:
• Connector cable or device
connector cable resistance
• Contact resistance at plug
and terminal connections
“Connection of the DUT: SC I/II” is not displayed when the test is
performed individually, but rather only during the automatic test
sequence.
• Extension cable resistance if
utilized
Resistance is measured:
• Between each conductive
part of the housing and the earthing contacts at the mains and the de-
vice plug (if a removable mains connector cable is used), or the protec-
Selecting Test Current and Polarity
Test current amperage (200 mA DC or 10 A AC (Feature G00 or SECULIFE ST) or
200 mA DC, 25 A AC (Feature G01 or SECULIFE ST
HV)) as well as polarity can
both be changed by pressing the or the key.
tive conductor terminal for permanently installed devices.
• as 4-pole measurement
• Between the earthing contacts at the mains plug and the earthing
contacts at the device plug for device connector cables
• Between the earthing contacts at the mains plug and the earthing
contacts at the coupling socket for extension cables
Testing with 10 A Test Current (Feature G00 or SECULIFE ST)
or 25 A (Feature G01 or SECULIFE ST
HV)
The test has a maximum duration of 30 s (fixed value) if 10 A or 25 A test
current is used. After this time period has elapsed, the last measured
value is frozen and “data hold, measurement stopped” appears at the display. If the test instrument becomes excessively warm, testing cannot be
repeated until after a waiting period of 1 minute. When testing with 10 A or
GMC-I Messtechnik GmbH 19
25 A, the last measurement can be repeated if the test results in failure.
Combined Testing – Differential Protective Conductor Resistance
Iso / HV
f
o
r
S
C
I
I
Zero balancing is also possible for protective conductor measurement. With
zero balancing, all subsequent measurements are adjusted with an offset
such that 0 is displayed for a selected reference point which is connected to the protective conductor. When test points are contacted with
the probe which are electrically connected to this reference point, differential resistance R
point is displayed. The mains release key must be activated during
measurement in order to perform zero balancing. Press key
between the reference point and the contacted test
PE
„Store
value“ in order to save the reference and/or correction value. The meassage „Zero point corrected“ concerning the reference value is displayed
during all future measurements.
Attention: It is absolutely essential to delete the reference value after the
reference value has been stored and the test has been performed as it is
taken into account in all future tests. To delete the value, the procedure is
the same as for storage, press key
„Delete value“.
9.1 Maximum Allowable Limit Values for Protective Conductor Resistance for Connector Cables with a Length of up to 5 m
R
PE
Housing –
Device Plug
0.2 0.3
0.2 0.2
3)
Open-Circuit
Voltage
< 24 V
4 V < U
L
Tes t Sta nd ard Te st C urre nt
VDE 07010702:2008
IEC 62353
(VDE 0751-1)
EN 61010
EN 60335
EN 60950
EN 60601 0.1 0.2
1)
This value may not exceed 1 for permanently connected data processing
systems (DIN VDE 0701-702, DIN VDE 0701, part 240).
2)
Permanently connected cable
3)
Feature G00 = 10 A (SECULIFE ST) / G01 = 25 A (SECULIFE ST HV)
> 200 mA
10 A
~/25 A
to test socket
only
R
PE
Housing –
Mains Plug
1)
0.3
2)
+ 0.1
additional 7.5 m
2)
10 Insulation Measurement
10.1 Insulation Resistance R
Definition
Safety Class I
Insulation resistance is
measured between shortcircuited mains terminals and
the protective conductor.
Safety Classes II and I II
Insulation resistance is
measured between shortcircuited mains terminals and
external conductive parts
which can be contacted with
the probe.
INS
.
20 GMC-I Messtechnik GmbH
Exception for Permanently Installed Safety Class I Devices
Attention!
!
Attention!
!
Note
Note
Deactivate the electrical system which supplies power to the
device under test before connecting the test instrument!
õ Remove the mains fuses from the device under test and disconnect
the neutral conductor N inside the device under test.
õ Connect the probe to phase conductor L at the device under test in
order to measure insulation resistance.
Sequence
Measurement of Insulation Resistance (equivalent leakage current)
This test is performed with a maximum voltage of 500 V, with a
current limit having been set (I < 3.5 mA). However, contacting
the terminals (3 or 2) causes an electric shock which, in turn,
may result in accidents.
All switches at the device under test must be set to the ON
position during measurement of insulation resistance. This also
applies to temperature controlled switches and temperature
regulators.
Measurement must be performed in all program stages for
devices equipped with program controllers.
R-INS
Start measurement.
Nominal voltage is 500 V DC in this
case.
Nominal voltage can be adjusted within
a range of 50 V to 550 V DC.
When insulation is first started from the menu, nominal voltage is
always set to 500 V. Open-circuit voltage is always greater than
nominal voltage.
Minimum Allowable Limit Values for Insulation Resistance
R
Tes t St anda rd Tes t Vo lta ge
VDE 07010702:2008
IEC 62353
(VDE 0751-1)
500 V
SCI SCII SCIII Heat
1M 2M 0,25 M 0.3 M
2M 7M
INS
70 M 70 M
* for Safety Class I devices with activated heating elements
Notes
All exposed, conductive parts of safety class II and III devices, as well as
of battery-powered devices must be scanned with the probe and insulation resistance and/or leakage current must be measured.
Batteries must be disconnected from their terminals during testing of battery powered devices.
*
GMC-I Messtechnik GmbH 21
10.2 Equivalent Leakage Current
~
DUT
Probe
mA
PE
L
N
Probe
PAT
DUT
~
mA
L
N
PE
mA
Probe
PAT
DUT
L
N
~
PE
Equivalent Patient Leakage Current I
(IEC 62353 (VDE 0751-1))
EPL
Test S etu p
General
The equivalent leakage current measurement is a method for measuring
protective conductor current (DIN VDE 0701-0702) and/or device leakage
current (IEC 62353 (VDE 0751)).
A high-impedance power supply is connected between the short-circuited mains terminals and all exposed metal parts of the housing (which
are connected to one another).
Measurement of Equivalent Leakage Current I
per DIN VDE 0701-0702
EL
A high-impedance power supply
is connected between each patient port and all exposed metal
parts of the housing (which are
connected to one another). The
mains terminals are short-circuited, and connected to the
same point on the housing.
Measurement
The current which flows over the
insulation at the device under test is measured separately for each application part.
Measurement is always performed with an AC power supply with current
limiting. Varying line voltages are taken into account.
Maximum Allowable Limit Values for Equivalent Leakage Current in mA
Test Standard I
VDE 07010702:2008
Measurement of Equivalent Device Leakage Current I
(VDE 0751-1))
(per IEC 62353
EDL
IEC 62353
(VDE 0751-1)
The patient ports are linked with
each other and are connected to
the same point on the housing.
22 GMC-I Messtechnik GmbH
IELEquivalent leakage current
I
Equivalent device leakage current
EDL
I
Equivalent patient leakage current
EPL
PE Protective conductor
1)
for devices with heating power of 3.5 kW
2)
with and without line voltage applied to the application part
EL
SC I: 3.5
1 mA/kW
SC II: 0.5
1)
SC I (parts within or connected to PE)
Permanently connected devices with PE 10
Portable x-ray devices with additional PE 5
Portable x-ray devices without additional PE 2
I
EDL
SC II 0.2 Type BF 5
Devices with mineral insulation 5
1 Type CF 0.05
I
EPL
2)
2)
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