Unitest Telaris 0751, 9095 Instruction Manual
1
UNITEST
®
Instruction Manual
Cat. No. 9095
®
TELARIS 0751
Content ............................................................................................Page
1.0 Introduction ....................................................................................4
1.1 Model and Type Designation/Identification ......................................4
1.2 Product Description ........................................................................4
1.3 Scope of Supply ..............................................................................5
1.4 Optional Accessories ......................................................................5
2.0 Transport and Storage......................................................................6
3.0 Safety Measures ..............................................................................6
3.1 Appropriate Usage ..........................................................................7
4.0 Operation Elements and Display ......................................................8
4.1 Front Panel ......................................................................................8
4.2 LC Display........................................................................................10
5.0 General Information to Perform Measurements ..............................10
5.1 Explanations of Terms......................................................................11
5.2 Performing the Tests ......................................................................14
5.3 Performing Tests in compliance with ..............................................15
DIN VDE 0701, Part 1 (issue 2000-09) ............................................15
5.4 Performing tests in compliance with ..............................................16
DIN VDE 0702, Part 1 (issue 1995-11) ............................................16
5.5 Durchführung von Prüfungen nach DIN VDE 0751,
Teil 1 (Ausgabe 2001-10) ................................................................17
6.0 Performing Individual Tests ............................................................20
6.1 Measuring the PE Resistance (Earth Bond) ......................................20
6.2 Measuring the Insulation Resistance................................................25
6.3 Measuring the Substitute Leakage Current ......................................28
6.4 Measuring the Touch Current ..........................................................31
6.5 Measuring the Protection Level of
Overvoltage Protection Devices (varistors) ....................................34
2
Content
6.6 Measuring the PE earth leakage current
(PE current) and the Differential Current
with Schuko Measurement Adapter (Option) ..................................36
6.7 Function Test, Measurement of the Load Current with
Schuko Measurement Adapter (Option) ..........................................40
6.8 Current Measurement using external
Current Clamp Adapters, with Current Clamp Adapter (Option)........42
6.9 UUTs equipped with Three-phase Connection ..................................44
6.10 Messung des Ersatz-Geräteableitstromes ........................................45
6.11 Messung des Ersatz- Patientenableitstromes ..................................47
7.0 Storing, Printing, and Data Transfer ................................................50
7.1 Entering the UUT Number ..............................................................50
7.2 Saving Measurement Data ..............................................................50
7.3 Viewing Measurement Data ............................................................51
7.4 Printing Measurement Data ............................................................51
7.5 Deleting Saved Measurement
Data/View the Memory Location Number ........................................52
7.6 Infrared Interface, send Measurement Data ....................................53
8.0 Maintenance ....................................................................................53
8.1 Cleaning ..........................................................................................53
9.0 Internal fuses ..................................................................................54
9.1 Display after Fuse Blown ..................................................................54
9.2 Description of the built-in Fuses ......................................................54
10.0 Calibration Interval ..........................................................................54
11.0 Technical Data..................................................................................55
24 month Warranty ..........................................................................61
3
Content
References marked on appliance or in
instruction manual:
Warning of a potential danger, comply with instruction manual.
Reference. Please use utmost attention.
Caution! Dangerous voltage. Danger of electrical shock.
Continuous double or reinforced insulation
complies with Class II according IEC 61140.
Symbol for the marking of electrical and electronic equipment (WEEE Directive
2002/96/EC).
Conformity symbol, the appliance complies
with the valid directives. It complies with the
EMC Directive (89/336/EEC). It also complies
with the Low Voltage Directive (73/23/EEC).
The instruction manual contains information
and references necessary for safe operation
and maintenance of the appliance. Prior to
using the appliance (commissioning / assembly) the user is kindly requested to thoroughly
read the instruction manual and comply with it
in all sections.
Failure to read the instruction manual or to
comply with the warnings and references contained herein can result in serious bodily injury
or appliance damage.
1.0 Introduction
You have acquired a sophisticated appliance by Ch.
BEHA GmbH allowing the operator to perform reproducible measurements over a very long time period. The company Ch. BEHA GmbH is a member of
the worldwide operating BEHA group. The headquarters are located in Glottertal/Black Forest. The
technological centre is also situated in Glottertal.
The BEHA-Group is one of the leading companies
for test and measurement appliances.
1.1 Model and Type Designation/Identification
The serial number label and the order number are
located on the appliance bottom. If you have any
questions, you are kindly asked to always indicate
the product designation, the order number and the
serial number.
1.2 Product Description
The UNITEST TELARIS 0751 is a multi-function test
instrument for regular monitoring and control of
electrical equipment in compliance with BGV A 2
(VBG 4), DIN VDE 0701, DIN VDE 0702, and DIN
VDE 0751.
The measurements required to determine the electrical safety in compliance with DIN VDE 0701 and
DIN VDE 0702 can be performed.
Furthermore, the auxiliary instrument leakage current and the auxiliary patient leakage current for medical instruments can be performed in compliance
with DIN VDE 0751.
An additional external Schuko Measurement
Adapter may be connected to the TELARIS 0751 to
measure PE resistance currents, differential currents, and load currents. Optionally you may also
connect a current clamp adapter to measure PE resistance currents.
The appliance UNITEST TELARIS 0751 is characterised by the following features:
• PE resistance measurement
• Insulation resistance measurement
• Substitute leakage curren
4
Introduction/Product Description
• Touch current measurement
• Substitute housing leakage current
• Substitute patient leakage current
• Response voltage of excess voltage protection
devices (varistors)
• Connection facility for external "Schuko Mea-
surement Adapter to measure PE resistance currents, differential currents, and load currents.
• Connection facility for external current clamp
adapter to measure PE resistance currents, also
for three-phase UUTs
1.3 Scope of Supply
1pc TELARIS 0751
1pc Test lead equipped with test probe
(appliance mounted)
2pcs Test leads
2pcs Test probes
2pcs crocodile clamps
1pc Bag with sample labels
1pc Quick reference guide
1pc Instruction manual
1.4 Optional Accessories
(not included in the scope of supply)
Schuko Measurement Adapter Cat. No. 1296
Current clamp adapter Cat. No. 1245
Adapter for current clamp adapter Cat. No. 1277
Software es control 0751 Cat. No. 1255
es control complete package Cat. No. 1250
Protocol printer Cat. No. 1196
Interface adapter Cat. No. 1157
Measurement adapter (to test appliances equipped
with a three-phase connection):
CEE 5 pole, 16 A Cat. No. 1240
CEE 5 pole, 32 A Cat. No. 1241
Measurement adapter
(to measure the PE resistance current together with
the current clamp adapter):
"Schuko”-"Schuko” Cat. No. 1233
CEE 3 pole, 16 A Cat. No. 1234
CEE 5 pole, 16 A Cat. No. 1235
CEE 5 pole, 32 A Cat. No. 1236
5
Scope of Supply
2.0 Transport and Storage
Please keep the original packaging for later transport, e.g. for calibration. Any transport damage due
to faulty packaging will be excluded from warranty
claims.
In order to avoid appliance damage, we recommend
that accumulators are removed when not using the
appliance over a certain period of time. However,
should the appliance be contaminated by leaking
battery cells, you are kindly requested to return it to
the factory for cleaning and inspection.
Appliances must be stored in dry and closed areas.
In the case of an appliance transported in extreme
temperatures, a recovery time of at least 2 hours is
required prior to appliance operation.
3.0 Safety Measures
The UNITEST TELARIS 0701/0702 has been designed and checked in accordance with the safety
regulations for Electronic test and Measurement
Appliances EN 61010 and IEC 61010, and left our
factory in a safe and perfect condition. The instruction manual contains information and references
necessary for safe operation and maintenance of the
appliance.
In order to avoid electrical shock, the valid safety and VDE regulations regarding excessive
touch voltages must receive the utmost attention when working with voltages exceeding
120V (60V) DC or 50V (25V)rms AC. The values in brackets are valid for limited areas (as
for example medicine and agriculture).
Measurements in dangerous proximity of electrical installations are only to be executed when
instructed by a responsible electrical specialist, and never alone.
Prior to usage, inspect the appliance and test
leads for external damage. Prior to any operation, ensure that connecting leads used and appliances are in perfect condition. The appliance
may no longer be used if one or several functions fail or if the appliance does not appear to
be ready to function.
Only touch test leads and test probes at handle
surface provided. Never directly touch test
probes.
If the operator’s safety is no longer guaranteed,
the appliance is to be put out of service and protected against use. The safety can no longer be
guaranteed if the appliance (or leads):
• shows obvious damage
• does not carry out the desired measurements
• has been stored for too long under unfavourable conditions
• has been subjected to mechanical stress during transport.
The appliance may only be used within the operating ranges as specified in the technical data
section.
Avoid any heating up of the appliance by direct
sunlight to ensure perfect functioning and long
appliance life.
6
Transport and Storage/Safety Measures
3.1 Appropriate Usage
The appliance may only be used under those
conditions and for those purposes for which it
was built.
The appliance may not be used for measurements in electrical distribution systems!
The appliance may only be connected to correctly wired and protected mains sockets, protected with maximum 16 A!
When modifying or changing the appliance, the
operational safety is no longer guaranteed.
Any maintenance and calibration tasks may
only be carried out by our repair service staff.
If the appliance is subjected to an extremely
high electro-magnetic field, its functioning
ability may be impaired.
7
Appropriate Usage
4.0 Operation Elements and Display
4.1 Front Panel
Explanation of the individual operation and
display elements
Figure 4.1: Appliance view
8
Operation Elements and Display
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
18
16
17
1. Mains connection plug, to connect the test appliance to the power supply 230 V +10%/-15%,
50 Hz. The test appliance may only be connected to a mains plug protected with a fuse of
maximum 16 A!
2. Probe, fixed test lead with test probe. Test connection for PE resistance test and touch current. The test probe is used for connecting the
test appliance and the UUT casing or the touchable conductive casing parts.
3. Test socket, in compliance with DIN VDE
0701/0702. To connect UUTs equipped with
earthed mains sockets for the following measurement functions: PE resistance, insulation
resistance, and substitute leakage current.
Connections L and N are short-circuited
within the test socket.
4. Socket ‘L/N’ (red), parallel connection to the
test socket L/N, to connect UUTs not equipped
with a earthed mains plug.
5. Socket ‘PE’ (blue), parallel connection to the
test socket PE, to connect UUTs not equipped
with a earthed mains plug.
6. Digital LCD, to display measurement values,
pre-set limit values, stored data.
7. Key”LIMIT”, to set limit values within the
different measurement functions.
8. Key “NEW TEST”, to connect a new UUT to
which the subsequent measurements are
assigned.
9. Key “Start”, to start a measurement.
10. Key “Store”, to save a measurement.
11. Key “Send”, for data transfer of stored data to
the PC via interface adapter (optional).
12. RS-232 interface (infrared).
13. Key “Clear/Recall”, to delete or view the stored
measurement data and created UUTs.
14. Key “Print”, to print stored data via protocol
printer (optional).
15. Rotary switch "Measurement function” , to select the desired measurement function. This
switch directly activates the selected measurement function.
16. Key “COMP”. To compensate test lead resistance.
17. Key ”Display”, to select the different measurement values within the function RPE and
VProt.level.
18. Measurement adapter connector, to connect
the external Schuko Measurement Adapter
(1196) or the external current clamp adapter
(1245).
9
Operation Elements and Display
4.2 LC-Display
Figure 4.2: Display
19. Attention warning symbol.
20. External voltage present.
21. "Limit” symbol for limit exceeding.
22. Reference: "Turn mains plug at UUT”.
23. Unit display.
24. Unit display for the small result field.
25. Measurement value display, small result field.
26. Limit value display, small result field.
27. Symbol for compensated test lead resistance.
28. Symbol for memory entry.
29. True RMS measurement (TRMS).
30. Display for AC voltage / DC voltage.
31. Over temperature, overheating of the appliance.
5.0 General Information to Perform
Measurements
The test appliance may not be used for measurements in electrical distribution systems!
The maximum admissible mains input voltage
amounts to 230 V +10%/-15%, 50 Hz.
The test appliance and the Schuko Measurement Adapter may only be operated on a correctly wired and earthed mains socket, protected with maximum 16 A!
The test socket, the measurement connectors
in parallel to the test socket, and the PE test
connector may not be connected to external
voltage to avoid test appliance damage.
The probe for connecting the touch current
may not be connected to an external voltage
> 230 V AC/DC to avoid test appliance damage.
You may use only the original test leads supplied or the pertaining safety measurement accessories!
At differential or PE current measurement an external magnetic field can affect the measurement.
Please take care to use the Schuko-Measurement
Adapter as most as possible away from appliances
with high magnetic fields (i.e monitors with CRT,
UUT with big tranformers, welding machines, currents tracks).
At measurements with faulty appliances or appliances with high leakage currents a preceding RCD (Residual Current Device) could trip.
Prior to any use, check the test appliance and
the test leads for perfect function.
The test leads and test probes may only be held
at the handles provided. Imperatively avoid
touching the test probes.
The measurements for checking the electrical
safety must be performed in compliance with
the respectively valid standards or regulations.
10
LC-Display/General Information to Perform Measurements
19 20 21 22
23
2425262728
29
30
31
The measurements used to check the electrical safety must be performed in compliance
with the respectively valid standards and regulations.
5.1 Explanations of Terms
Leakage Current:
The leakage current describes the current which
flows via the insulation of a UUT. This happens either via the casing or via touchable, conducitve
parts, via the PE, or via additional earth connections
(e.g. antenna, water supply) of a UUT.
Contact surfaces:
A part of the instrument, when used appropriately:
• must come in physical (corporal) contact with the
patient, if required, so that the instrument can fulfill its function, or
• can be brought in contact with the patient, or
• must be touched by the patient.
Contact surface of type B:
A contact surface ensuring a protection against
electrical shock, in compliance with the requirements stipulated within VDE 0750/IEC 60601-1, in
particular when observing the admissible leakage
current. It is characterised by the symbol .
NOTE: Contact surfaces of type B are not appropriate for direct applications to the heart.
Contact surface of type BF:
A contact surface of type F allowing a superior protection against electrical shock in compliance with
the requirements stipulated in DIN VDE 0750/IEC
60601-1 than contact surfaces of type B and characterised by the symbol
NOTE: Contact surfaces of type BF are not appropriate for direct application to the heart.
Touch Current:
Here, a current measurement towards earth at
touchable, conductive parts of a UUT is performed.
The limit value in compliance with DIN VDE
0701/0702 amounts to 0.5 mA. The measurement
may be performed either directly or applying the differential current procedure. The touch current
measurement will be performed for appliances of
protection class II, containing touchable, conductive parts or for appliances of protection class I,
which are equipped with touchable parts not connected with the PE. The measurement must be performed for both positions of mains plug.
The appliance UNITEST TELARIS 0701/0702
easy and the appliance UNITEST TELARIS
0701/0702 use the direct measurement procedure for touch current measurement
11
Explanations of Terms
Differential Current:
In compliance with DIN VDE 0701/0702, this is a
measurement procedure to determine the PE current or the touch current, performing a summation
current measurement for all active conductors (L N) of an UUT. Thus, the total leakage current for a
UUT can be determined.
The measurement must be applied if the UUT is
equipped with additional earth connections or if an
insulated UUT installation is not possible.
The Schuko Measurement Adapter (Option) of
the appliance UNITEST TELARIS 0701/0702 allows to perform the measurement using with
the differential current procedure.
Electrical Safety:
Condition of instruments for which the repercussions of electrical current on patients, users, or third
parties are limited, in compliance with DIN EN
60601-1 (VDE 0750 Part 1).
Earth leakage current:
Current flowing from the power supply through or
via the insulation to the protective earth.
Substitute Leakage Current:
In compliance with DIN VDE 0701, this is an alternative measurement procedure to determine the PE
resistance current or the touch current.
In compliance with DIN VDE 0702, this measurement is a substitute measurement for the insulation
measurement which can be performed if appliances
equipped with heating of protection class I do not
match the required insulation values.
This measurement procedure determines without
mains voltage the leakage current conducted via the
PE resistance, or a touchable part.
Auxiliary instrument leakage current:
Current flowing when connecting the instrument in
compliance with Figure 6.21 or Figure 6.22 and
using the measurement circuit MD (in compliance
with DIN VDE 0750 Part 1, En 60601-1) at which the
nominal value or mains voltage and the nominal
value of the mains frequency are present.
Auxiliary patient leakage current:
Current flowing when connecting the instrument in
compliance with Figure 6.25 or Figure 6.26 using a
measurement circuit MD in compliance with Figure
C.1 at which the nominal value of mains voltage and
the nomimal value of the mains frequency are present.
Fixed instruments:
Instrument connected to the mains by means of
fixed connections which can only be removed using
tools.
Casing leakage current:
Current flowing from the casing or casing parts, excluding contact surfaces, which can be touched by
the patients during appropriate usage, whereby it is
deviated via another external conductible connection than the protective earth to the ground or to another part of the casing.
Instrument leakage current:
Current flowing from the power supply via the insulation of the casing and/or the contact surface to
the protective earth (PE), if a conductible connection is realised between the contact surfaces and the
casing.
Insulation Measurement:
A measurement of the insulation resistance is performed between the active parts (L1-L2-L3-N) and
the protection earth conductor (PE) within a system,
an appliance, or a machine. For this purpose, a test
voltage of 500 V DC is used, in compliance with DIN
VDE 0701/0702.
Medical, electrical instrument
Electrical instrument equipped with only one connector for a certain supply network destined for diagnosis, treatment, or patient observation under
medical supervision and being in corporal or electrical contact with the patient and/or transmits energy to or from the patient and/or indicates such a
transfer of energy to or from the patient.
12
Explanations of Terms
Medical, electrical system:
Combination of several instruments of which at
least one instrument is a medical, electrical instrument and which are inter-connected via functional
connection or portable multiple sockets.
Patient leakage current:
Current flowing from the contact surface via the patient to the ground, or current which is generated at
the patient by an unforeseeable external voltage and
which is flowing to the ground either via the patient
or a contact surface of type F.
Patient connection:
Every individual part of the contact surface via
which current may flow either in normal condition
or in condition of the first occuring error between
the patient and the instrument.
Test to make sure that the system is not live:
Also called "Leakage current during operation”. This
leakage current is determined by current measurement on touchable, conductible part of a UUT towards ground, in compliance with DIN VDE 0701,
Part 240. According to DIN VDE 0701, Part 240, the
limit value is 0.25 mA. This measurement is similar
to the contact voltage measurement.
Protection Class I :
appliances of protection class I are UUTs provided
with a basic insulation between active (live) parts
and the casing. The metal casing or metal casing
parts must be appropriately connected to the protection earth conductor. The mains plug of appliances of protection class I are equipped with an
earth connector.
Protection Class II :
Appliances of protection class II are equipped with
a continuously reinforced or supplementary insulation between the active (live) parts and the casing.
Such appliances may, however, have touchable,
metal parts. The mains plug of UUTs to protection
class II are not equipped with an earth connector.
Protection Class III :
Appliances of protection class III are made either for
connection to safety extra low voltage (SELV) current circuits or are only supplied with SELV via an
internal power supply.
Earth leakage current (PE current):
This is a part of the UUT leakage current, flowing in
the PE (protection earth conductor). According to
DIN VDE 0701/0702, the limit value amounts to 3.5
mA. The protection earth conductor current is either
determined by direct current measurement within
the UUT PE or by applying the differential current
measurement. The direct measurement is performed if the UUT is not equipped with an additional earth connection or if the insulation of the UUT
against earth is possible. The measurement has to
be performed in both positions of the mains plug.
In compliance with DIN VDE 0701:2000-09, the PE
current measurement represents an additional
measurement to determine the insulation capacitance for appliances of protection class I.
In compliance with DIN VDE 0702, this measurement is a substitute for the insulation measurement
for appliances of protection class I and for which the
insulation measurement cannot or may not be performed.
The Schuko Measurement Adapter (option) of
the appliance UNITEST TELARIS 0701/0702
allows the PE resistance current measurement
in compliance with the direct measurement
procedure and the differential current procedure.
13
Explanations of Terms
PE resistance (earth bond):
We are dealing with the PE resistance of the mains
connection point (earth connector of the mains
plug) to all touchable, metal UUT casing parts which
have to be connected to the PE resistance. During
PE or resistance measurement, the connecting lead
has to be moved over the total lengths in sections.
This measurement can only be performed for appliances of protection class I.
Visual Check:
Here, you must make sure that the appliance parts
contributing to the electrical safety are undamaged
and appropriate. The following must be checked:
• Casing, protection covers
• Connecting leads and plugs
• Condition of insulations
• Strain relief, antikink protection, and arrange-
ment of wiring
• Signs for overload or inappropriate use
• Forbidden interventions or modifications
• Fuse holders and fuses, accessible for the user
• Cooling openings and air filters
• Protection covers
• Overpressure valves
• Fixtures
• Contamination or corrosion which might impair
the safety
• Safety labelling
5.2 Performing the Tests
The accident prevention prescriptions (German
Unvallverhütungsvorschrift BGV A 2 for "Electrical
Systems and Equipment", issued by the professional associations (German Berufsgenossenschaft) defines the conditions for testing electrical
appliances:
• Prior to first commissioning and after any mod-
ification, after repair, prior to repeated commissioning, as well as in regular TIME INTERVALS.
• For portable appliances, these TIME INTER-
VALS generally amount to 6 months (for use on
building sites reduced to 3 months).
Depending on the use, this interval is flexible,
provided the appliance safety is ensured. The
test interval can be extended to maximum 12
months for building sites and to maximum 24
months for the use in offices.
The DIN VDE regulations of the series DIN VDE
0701 and DIN VDE 0702 define the test procedure and the limit values.
14
Explanations of Terms / Performing the Tests
5.3 Performing Tests in compliance with
DIN VDE 0701, Part 1 (issue 2000-09)
DIN VDE 0701 defines the requirements regarding
the electrical safety for electrical appliances. It contains the tests and limit values for repaired or modified appliances. After repair or modification, it must
be ensured that there will be no risk of danger for
the user if the appliance is used appropriately.
The test order is as follows:
1.) Visual Check
2.) Test of PE resistance (for appliances of protection class I)
The limit value amounts to:
0.3 Ωfor appliances equipped with mains leads
up to 5 m, plus 0.1 Ω for every further 7.5 m,
however, maximum 1.0 Ω.
3.) Insulation resistance measurement (if applicable) The limit value amounts to:
1 MΩ for appliances of protection class I
2 MΩ for appliances of protection class II* Remark 1
0.25 MΩ for appliances of protection class III
0.3 MΩ for appliances of protection class I with
switched on heating elements * Remark 2
Remark 1: This is also applicable for conductive
parts of class I appliances which are NOT connected to PE.
Remark 2: For appliances of class I (with heating elements) at which the required limit values for insulation resistance is not fulfilled, the appliance test
could be considered as passed, if the PE current is
within the limits.
4a.) Measurement of PE resistance Current
(for appliances of protection class I)
The limit value amounts to 3.5 mA.
-at appliances with heating elements and a
rated power of > 3.5 kW the PE current may not
exceed 1 mA/1 kW.
-for ovens/cooking facilities, etc. up to 6 kW 7
mA, more than 6 kW 15 mA.
The PE resistance current may be measured either
directly via the substitute leakage current method or
via the differential current method
4b.) Measurement of the touch current (for appli-
ances of protection class II)
The limit value amounts to 0.5 mA
The touch current may be measured directly
either via the substitute leakage current
method or via the differential current method.
These measurements must also be carried out
for appliances of protection class I equipped
with touchable, conductive parts.
5.) Functional Test
6.) Test of Markings
15
Performing Tests in compliance with DIN VDE 0701
5.4 Performing tests in compliance with
DIN VDE 0702, Part 1 (issue 1995-11)
DIN VDE 0702 defines the test procedures and limit
values for repeat tests. A repeat test is defined as a
test performed in regular time intervals used as
proof for the electrical safety on electrical appliances. It must be ensured that the protection is effective against direct and indirect touch. DIN VDE
0702 is valid for all electrical appliances which can
be disconnected from an electrical system by
means of a plug-in system.
The test order is as follows:
1.) Inspection, visual check
2.) Measuring the PE resistance ( for appliances of
protection class I)
The limit value amounts to:
0.3 Ωfor appliances equipped with mains leads
up to 5 m, plus 0.1 Ω for every further 7.5 m.
3.) Insulation resistance measurement
The limit value amounts to:
0.5 MΩ for appliances of protection class I
2 MΩ for appliances of protection class II
0.25 MΩ for appliances of protection class III.
If the insulation measurement does not test all
active UUT parts, a PE resistance current or
touch current may be performed as a substitute measurement. These measurements may
also be carried out as substitute measurements
for appliances for which the performance of an
insulation measurement gives reasons to
reservations.
4.) Measurement of substitute leakage current
The limit value amounts to:
7 mA for appliances of protection class I with a
heating capacity of < 6 kW,
15 mA for appliances of protection class I with
a heating capacity of > 6 kW
A substitute leakage current measurement
must be performed for appliances of protection
class I equipped with heating elements and for
which the requested insulation resistance is
not obtained,
5.) Measurement of the PE resistance current (for
appliances of protection class I)
The limit value amounts to 3.5 mA.
This is a substitute measurement to the insulation measurement for appliances of protection
class I.
6.) Touch current measurement (for appliances of
protection class II)
The limit value amounts to 0.5 mA.
This is a substitute measurement to the insulation measurement for appliances of protection
class II or for appliances of protection class I
equipped with touchable, conductive parts.
16
Performing Tests in compliance with DIN VDE 0702
5.5 Performing Tests in compliance with
DIN VDE 0751, Part 1 (Edition 2001-10)
DIN VDE 0751 stipulates the requirements for the
electrical safety on medical, electrical instruments
or systems. Mention is made here regarding tests
and limit value for tests prior to commissioning, during repair, changes, modifications, or repetition
tests on medical instruments.
When performing measurements prior to commissioning, the first measured values must be determined and documented whilst indicating the measurement procedure. This documentation will be
used as reference for future measurements (source: translated from DIN VDE 0751, Part 1:2001-10,
Section 4.2).
When performing measurements for repetition
tests, the measured values must be documented
whilst indicating the measurement procedure. The
values must then be evaluated. If the leakage current measurement values exceed factor 0.9 of the
admissible values, the first measurement values are
to be taken as reference for evaluation (please refer
to DIN VDE 0751, Part 1:2001-10, Section 4.3).
The test sequence is as follows:
1.) Inspection
- fuse insert parts, accessible from outside, for current values and characteristics
- inscriptions
- does the mechanical condition allow further and
safe use
- no safety-impairing damages or pollutions
- also check and assess accessories used (e.g.
mains cable) or one-off parts (patient cable, tubes)
- required documentation availabe and complete
2.) - Measurement of protective earth conductor
resistance (for instruments pertaining to protection class I)
The limit value is:
- 0.3 Ω for instruments with fixed mains connection (or for instruments with removable
mains connection cable at the instrument, together with the mains connection cable)
- 0.2 Ω for instruments with removable mains
connection cable (between the protective earth
contact of the instrument plug and the conductible and touchable parts).
- 0,1 Ω only for the removable mains connection cable.
3) - Measurement of leakage currents
The leakage current measurement for instruments pertaining to protection class I, may
only be performed once the protective earth
conductor test has been successful.
Measurement has to be made of instrument and patient leakage currents, whereby the following measurement procedures may be used:
- Measurement of the auxiliary leakage current
- Direct measurement of the leakage current
- Measurement of the leakage current in complian-
ce with the differential current procedure
3a.) Measurement of the auxiliary instrument lea-
kage current in compliance with Figure 6.21
and Figure 6.22 (or Figure C4 of DIN VDE
0751).
3b.) Measurement of the auxiliary patient leakage
current in compliance with Figure 6.25 and Figure 6.26 (or Figure C7, C8, and C9 of DIN VDE
0751).
3c.) Measurement of the instrument leakage cur-
rent during instrument operation (measurement in compliance with Figure C5, C6 of DIN
VDE 0751).
3d.) Measurement of the patient leakage current du-
ring instrument operation (measurement in
compliance with Figure C8, C10 of DIN VDE
0751).
17
Performing Tests in compliance with DIN VDE 0751
Table 1: Limit values for leakage currents
18
Performing Tests in compliance with DIN VDE 0751
Source: Table F.1 off DIN VDE 0751 TPart 1:2001-10
Leakage current in mA in mA
Contact surface TYP B TYP BF
Instrument leakage current, in general 0.5 0.5
Instrument leakage current for instruments in compliance
with remarks 1 and 3 2.5 2,5
Instrument leakage current for instruments in compliance with remark 2 5.0 5,0
Instrument leakage current for instruments 0.1 0.1
pertaining to protection class II and for instruments with conductible,
touchable parts which are not connected to the protective earth
conductor, pertaining to protection class I
Auxiliary instrument leakage current
- within protective earth conductor or parts connected to the
protective earth 1.0 1,0
- Instruments with mineral insulation and instruments in compliance
with remark 1 5,0 5,0
- in compliance with remark 2 10.0 10-0
Mobile X-ray instruments with 5.0 5.0
additional protective earth
Mobile X-ray instruments without additional protective earth 2.0 2.0
Patient leakage current
DC current 0.01 0.01
AC current 0.1 0.1
Auxiliary patient leakage current - 5.0
Mains voltage on contact surface
Auxiliary patient leakage current - 5.0
REMARK 1: instrument systems which are not equipped with the touchable parts that are not connected with
the protective earth conductor and which are in compliance with the requirements for instrument leakage current, and, if applicable, for the patient leakage current.
Example: Electronic data processing devices with shielded power supply.
REMARK 2: Instruments destined for fixed connection and which are equipped with a protective earth conductor being connected in such a way or being mechanically secured in a certain place that it can only be removed using tools.
Examples for such instruments are:
- the main components of an x-ray system such as the x-ray generator, the table for medical examination.
- Instruments equipped with mineral-insulated heating elements.
- Instruments showing superior ground leakage current values than the admissible values in
"Ground Leakage Current, in general" due to the requirement to meet radio protection conditions.
REMARK 3: Mobile x-ray instruments and mobile instruments with mineral insulation.
4.) Measurement of the insulation resistance
Only for old generation medical devices, please refer to DIN VDE 0751 Part 1, Appendix E.
In case of doubt regarding the perfect condition of
the quality of the instrument insulation, an insulation resistance measurement can be performed.
The limit value is:
2 MΩ for instruments pertaining to protection
class I
7 MΩ for instruments pertaining to protection
class II.
5.) Function test
Afterwards, a specialised person in electrotechnics
and medical device technology with particular
knowledge in the respective instrument must perform a safety evaluation.
The tests must be documented.
6 ) –Evaluation of the Documentation and Tests
6.1) Evaluation
The safety evaluation of INSTRUMENTS/SYSTEMS
must be performed by a specialised person in electrotechnics and medical device technology with
particular knowledge in the respective instrumnet..
If the safety of the INSTRUMENT/SYSTEM is not
guaranteed, e.g. by failing the acceptance test in
compliance with section 5, the INSTRUMENT/SYSTEM must be marked accordingly and the USER
must be informed in writing about the DANGERS
emanating from the INSTRUMENT/SYSTEM.
6.2) Documentation
The tests are to be documented. The documentation must fulfill the following minimum requirements:
a) –Designation of the executing site (e.g. company, department);
b) Name of tester and evaluating person;
c) Designation of the INSTRUMENT/SYSTEM (e.g.
type, manufacture number, inventory number)
and the respective accessories in compliance
with section 4.1. The assignment of test documentation to the INSTRUMENT/SYSTEM must
be unambigous.
d) –Tests and measurements:
- Date, type scope, and results of the visual inspections.
- Measurement (measurement procedure, measurement equipment, measurement values),
- Function checks.
e) Total evaluation.
f) Date and signature of the evaluating person,
when using data processing, indicate the personal coding.
19
Performing Tests in compliance with DIN VDE 0751
6.0 Performing Individual Tests
6.1 Measuring the PE Resistance (Earth Bond)
6.1.1 General Information regarding the PE
resistance Measurement
Before any PE resistance measurement it must
be ensured that the UUT is not connected to live
voltages.
During the measurement, the mains lead must
be moved across the total length in sections,
whereby no measurement result fluctuation
must occur. A fluctuating measurement result
indicates an error.
For appliances equipped with additional metal
connections, such as e.g.
• water connection (e.g. washing machine)
• gas connection (e.g. warm water heating unit)
or
• antenna connection (e.g. SAT-Receiver) the
measurement result might be falsified due to
the additional connection to the PE resistance.
The PE resistance connection via an additional
connection must be removed when performing
the measurement.
For the appliance UNITEST TELARIS 0751 the
test current is an AC current. The key ”Display”
(17) is used to display the measurement values for both polarities during active measurement. Measurement results showing high differences for the two polarities indicate an
insufficient PE connection. Thus, corroded
connections to the PE resistance can be determined.
In compliance with DIN VDE 0701, Part 1 and
DIN VDE 0702, Part 1, the minimum test current is 200 mA.
For appliances equipped with mains lines of up
to 5 m, the limit value amounts to 0.3 Ω in compliance with DIN VDE 0701/0702 0,3 Ω, i.e. for
active limit value display ‘LIMIT 0.3 Ω’ the symbols and ‘LIMIT’ may not be displayed!
When dealing with longer connection cables,
the limit value is to be defined in accordance
with the standard applied.
According to DIN VDE 0751 the limit value is
0,3 Ω, i.e., if the limit value indicator is switched on ‘LIMIT 0,3 Ω’ the symbols and ‘LIMIT’
must not appear! If the connection lines are of
a certain length, the limit value must be defined
in accordance with the respective standard
applied.
20
Measuring the PE Resistance
Loading...