Hioki ST5540, ST5541 Instruction Manual
ST5540
ST5541
Instruction Manual
LEAK CURRENT HiTESTER
July 2016 Revised edition 7
ST5540A981-07 16-07H
EN
Contents
Contents
i
1
Measurement Flowchart.................................1
Introduction.....................................................2
Inspection.......................................................2
Checking the contents of the package...........2
Safety Notes...................................................3
Usage Notes...................................................5
Chapter 1 Overview 7
1.1 Instrument Overview ..................7
1.2 Features .....................................8
1.3 What is Leakage Current? .......10
1.4 Leakage Current Measurement
Complying with Standards .......11
1.5 Types of Leakage Current .......12
1.6 Types of Leakage Current
Measurement ...........................13
Connect the terminal ................................. 36
3.4 Turning Power On and OFF .....38
Turning Power On ..................................... 38
Turning Power Off ..................................... 40
3.5 Pre-Test Inspection.................. 41
Checking measurement frequency ............ 43
Connection/VA check screen .................... 44
Chapter 4 Settings 47
4.1 Selecting a Network .................48
4.2 Selecting the Grounding Class of
Equipment Under Test .............49
Registering an Equipment Name/
Control Number........................................ 50
4.3 Selecting a Measurement Mode
(opens the measurement screen)
..................................................51
2
3
4
5
Chapter 2 Instrument Labels
and Screens 23
2.1 Instrument Labels and Functions
................................................. 24
2.2 Screen configuration outline ....27
2.3 About the Touch Panel ............30
Chapter 3 Setting
Preparations 31
3.1 Power switch, breaker ON/OFF 31
3.2 Connecting the Power Cord 3.....2
Connecting the instrument power cord ......32
Connecting the power cord of the
equipment under test ................................33
Making connections to terminals S10, S12
and S13 ....................................................35
3.3 Connecting equipment under
test to the instrument ...............36
4.4 Setting the Measurement Range
(Auto/Hold) ...............................54
4.5 Setting the Filter .......................59
4.6 Setting the Allowable Value .....61
Turning lower limit values on and off for
specific leakage current measurements .. 63
4.7 Selecting the Type of Target
Current .....................................64
4.8 Changing the Measurement
Method (Auto/Manual) ..............67
Setting automatic measurement items ...... 68
Setting the measurement delay
(delay time) .............................................. 70
Setting the measuring time ........................ 73
Chapter 5 Measurement
Preparations 75
5.1 Connecting the Test Lead ........75
Using L2200 Test Lead ............................. 77
Using the 9195 Enclosure Probe
(for measuring enclosure leakage current) 77
ST5540A981-07
ii
Contents
Using Alligator Clips (when using two
or three test leads) .................................................78
Chapter 6 Measurements 79
6.1 Making manual measurements 79
6.2 Making automatic measurements
................................................. 82
6.3 Measurement examples ...........83
Earth leakage current measurement ......... 83
Touch current measurement ..................... 84
Patient leakage current measurement*
(Patient connection - Earth) ..................... 90
Patient leakage current measurement*
(external voltage on a SIP/SOP).............. 93
Patient leakage current measurement*
(external voltage on a specific F-type
applied part) ............................................. 95
Patient leakage current measurement*
(external voltage on metal accessible part
not protectively earthed) .......................... 97
Patient auxiliary current measurement* .... 99
Total patient leakage current measurement*
(Patient connection - Earth)................... 100
Free current measurement
(Enclosure - Enclosure) ......................... 101
6.4 Saving Measurement Data
(As required).......................... 102
Checking Saved Measurement Data ....... 104
Displaying Saved Measurement Data ..... 104
Selecting Saved Measurement Data ...... 105
Deleting Saved Data ............................... 105
6.5 Saving Measurement Conditions
7.2 Panel Load(Loading Saved
Measurement Conditions)...... 120
7.3 Initializing the Instrument .......121
7.4 Setting the Display Language 123
7.5 Checking Fuses(During Earth
leakage current and protective
conductor current measurements)
................................................123
7.6 Self-Test .................................124
7.7 Power On Polarity Switching
(to keep equipment under test
on during polarity switching) .. 126
Connect the isolation transformer............ 126
Setting Power On Polarity Switching ....... 127
Relay check 2 .......................................... 128
7.8 Auto Measure Setting
(set instrument status) ........... 129
7.9 Setting Lower Limit Values (factor)
............................................... 130
7.10 Setting Indication Unit ............131
7.11 Setting Date and Time ...........132
7.12 Interface Setting
(For Communication and Printing)
................................................133
7.13 Setting the Beep Sound .........135
7.14 Setting the Backlight .............. 136
(Panel Save Function)
(as required) ..........................106
6.6 Printing Measurement Data
(as required) ..........................108
Setting up and connecting a printer ......... 108
Chapter 7 Instrument System
Settings 115
System Screen Configuration .................. 116
7.1 Setting the Mode (To use the
instrument as a voltmeter) .....117
Chapter 8 Controlling the
Instrument From a
Computer
(RS-232C,
USB interface) 139
8.1 ST5540/ST5541 Remote Interface
Overview (USB connection) ...140
8.2 Connect and be sure to tighten
the screws on the connector.. 141
Installation and operation procedures ..... 143
Specifications of RS-232C....................... 144
Specifications of USB .......................... ... . 144
iii
Contents
8.3 Setting Communication
Conditions on the HiTESTER 145
8.4 Command Message Description
................................................146
Message Format ......................................146
Output Queue and Input Buffer ................151
Event Registers ... ... .... ... ... ... .... ... ... ... .... ... .152
8.5 Initialization Items ..................153
8.6 Message Reference ...............154
Common Messages .................................154
Messages Specific to the HiTESTER....... 154
8.7 Command Message Description
............................................... 162
Common Messages .................................163
Specific commands ..................................165
8.8 To Transfer All Saved Data to
a Computer ............................243
8.9 Troubleshooting .....................244
Chapter 9 External Control
245
Network Section ...................................... 259
10.5 Other Functions ......................261
10.6 System-related Functions ......263
10.7 User interface .........................264
10.8 EXT I/O ..................................264
10.9 Relay output for medical equipment
(only ST5540) .........................264
10.10 PC Interfaces....................... 265
10.11Printer ...................................265
10.12General Specifications .......... 266
10.13Compliant standards............. 268
10.14Measurement Networks ........269
Network A (for Electrical Appliance
and Material Safety Law) ....................... 269
Network B1 (for JIS T 0601-1:1999) ........270
Network B2 (for IEC 60601-1:2005 3rd) .. 271
Network C (for IEC 60990) ...................... 272
Network D (for UL) .................................. 274
Network E (General-purpose 1) .............. 275
Network F (General-purpose 2) ............... 275
Network G (for IEC61010-1) .................... 276
11
5
6
7
9.1 Description of Signals............ 246
9.2 Connecting to the EXT I/O
Terminal................................. 247
9.3 Electrical Specifications .........249
9.4 Internal Circuit Configuration .250
9.5 Timing Chart ..........................251
Panel load function at EXT I/O start . .... ... .253
9.6 Example of Output Signal
Connection .............................254
Chapter 10 Specifications255
10.1 Basic Functions...................... 255
10.2 Auxiliary measurement functions*
............................................... 256
10.3 Measurement System ............256
Chapter 11 Maintenance
and Service 279
11.1 Cleaning and Storage ............279
11.2 Repair and Servicing...............280
11.3 Replacing Fuses ....................282
11.4 Instrument Disposal ...............283
Appendix A1
Appendix1Terminology.................... A1
Appendix2List of instrument status,
other test condition and special
test condition......................... A4
Appendix3List of default settings..... A7
Appendix4External Dimensions..... A29
8
9
10
Appendix
10.4 Accuracy ................................258
Current Measurement Section .................258
Index
iv
Contents
Index i
Measurement Flowchart
See "6.5 Saving Measurement Conditions (Panel Save Function) (as required)" (p. 106)
See "6.4 Saving Measurement Data (As required)" (p. 102)
See "3.5 Pre-Test Inspection" (p. 41)
See "Chapter 6 Measurements" (p. 79)
Manual : Free-run measurement
(Measurement conditions can be changed during ongoing measurements)
Automatic : Set measurement conditions and measuring time to perform automatic measurements.
See "6.6 Printing Measurement Data (as required)" (p. 108)
See "Connecting the power cord of the equipment under test"
(p. 33)
See "Connecting the instrument power cord" (p. 32)
See "5.1 Connecting the Test Lead" (p. 75)
See "3.1 Power switch, breaker ON/OFF" (p. 31)
See "3.4 Turning Power On and OFF" (p. 38)
See "3.1 Power switch, breaker ON/OFF" (p. 31)
See "3.4 Turning Power On and OFF" (p. 38)
Connect the power cord
Connect test leads
Pre-Operation Inspection
Measurements
After automatic measurement ends
See "Chapter 4 Settings" (p. 47)
Settings depend on measurement method (Manual or Automatic)
Manual measurement : Perform settings from (p. 48) to (p. 67)
Automatic measurement : Perform settings from (p. 48) to (p. 73)
Turn on the circuit breaker
Settings
Connecting equipment under test to the instrument
See "3.3 Connecting equipment under test to the instrument"
(p. 36)
Turn on the power switch of the HiTESTER
The actual connection procedure will vary with the power supply
of the equipment under test.
Disconnect test leads and equipment under test
Turn off breakers and instrument power
Be sure to read "Usage Notes" (p. 5) before measuring.
The flowchart does not show the detailed procedures but the rough workflow.
1
2
2
"ST5540/ST5541 Leak Current HiTester".........1
Power cord (for main instrument)..................... 1
Power cord for equipment under test............... 2
(
for [LINE IN])
Enclosure Probe............ ... ................................ 1
Spare fuse for main instrument........................ 1
(250 V F50 mAL)
L2200 Test Lead...........................................1set
(1 red, 1 black)
Test lead(red)................................................... 1
(only ST5540)
Instruction manual............................................ 1
CD-ROM .......................................................... 1
Confirm that these contents are provided.
Introduction
Thank you for purchasing the HIOKI Model "ST5540/ST5541 Leak Current HiTester". To obtain maximum
performance from the instrument, please read this manual first, and keep it handy for future reference.
Inspection
When you receive the instrument, inspect it carefully to ensure that no damage oc curr ed du rin g shippin g.
In particular, check the accessories and connector s. If damage is evi dent, or if it fails to operate according
to the specifications, contact your dealer or Hioki representative.
• Before using the instrumen t, make sure that the insulation on the test leads is
undamaged and that no bare conductors are improperly exposed. Using the
Model L2200 Test Lead in such conditions could cause an electric shock, so contact your dealer or Hioki representative for replacements.
• Before using th e in stru ment, m ake sur e that the insu lation on the po wer co rd s is
undamaged and that no bare conductors are improperly exposed. Using the
instrument in such conditions could cause an electric shock, so contact your
dealer or Hioki representative for replacements.
• Use the original packing materials when transporting the instrument, if possible.
Checking the contents of the package
Safety Notes
This instrument is designed to comply with IEC 61010 Safety Standards,
and has been thoroughly tested for safety prior t o shipment. However, mishandling during use could result in injury or death, as well as damage to
the instrument. Using the instrument in a way not described in this manual
may negate the provided safety features.
Be certain that you understand the instructions and precautions in the
manual before use. We disclaim any responsibility for accidents or injuries
not resulting directly from instrument defects.
This manual contains information and warnings essential for safe operation of the instrument and for
maintaining it in safe operating condition. Before using it, be sure to carefully read the following safety
precautions.
3
2
Safety Symbols
In the manual, the symbol indicates particularly important information th at the user should read befo re
using the instrument.
The symbol printed on the instrument indicates that the user should refer to a corresponding topic in the
manual (marked with the symbol) before using the relevant function.
Indicates a fuse.
Indicates a grounding terminal.
Indicates AC (Alternating Current).
Indicates the ON side of the power switch.
Indicates the OFF side of the power switch.
Indicates that the product conforms to regulations set out by the EC Directive.
WEEE marking:
This symbol indicates that the electrical and electronic appliance is pu t on the EU market after August 13,
2005, and producers of the Member States are requ ired to display i t on the applia nce u nder Articl e 11 .2 of
Directive 2002/96/EC (WEEE).
The following symbols in this manual indicate the relative importance of cautions and warnings.
Indicates that incorrect operation presents an extreme hazard that could result in serious injury or death
to the user.
Indicates that incorrect operation presents a significant hazard that could result in serious injury or death
to the user.
Indicates that incorrect operation presents a possibility of injury to the user or damage to the instrument.
Indicates advisory items related to performance or correct operation of the instrument.
4
USB
Other Symbols
Indicates a prohibited action.
See Indicates the location of reference information.
*
(Example)
Leakage current
Accuracy
We define measurement tolerances in terms of f.s. (full scale), rdg. (reading) and dgt. (digit) values, with
the following meanings:
Indicates that descriptive information is provided below.
For information on text in italics, refer to "Appendix1 Terminology" (p. A1).
Indicates descriptions relating to the RS-232C only.
Indicates descriptions relating to the USB only.
f.s. (maximum display
value):
rdg. (reading or
displayed value):
dgt. (resolution):
The maximum displayable value. This is usually the name of the currently selected range.
The value currently being measured and indicated on the measuring instrument.
The smallest displayable unit on a digital measuring instrument , i.e., the input value that
causes the digital display to show a "1" as the least-significant digit.
Measurement categories
This instrument complies with CAT II (300 V) safety requirements.
To ensure safe operation of measurement instruments, IEC 61010 establishes safety standards for various electrical environments, categorized as CAT II to CAT IV, and called measurement categories.
CAT II :
CAT III : Prima ry electrical circuits o f heavy equipment (fixed installations) connected directly to th e distrib ution panel,
CAT IV : The circuit from the service drop to the service entrance, and to the power meter and primary overcurrent pro-
Using a measurement instrument in an environment designated with a higher-numbered category than
that for which the instrument is rated could result in a severe accident, and must be carefully avoided.
Use of a measurement instrument that is not CAT-rated in CAT II to CAT IV measurement applications
could result in a severe accident, and must be carefully avoided.
Primary electrical circuits in equipment connected to an AC electrical outlet by a power cord (portable tools,
household appliances, etc.)
CAT II covers directly measurin g ele ctrical outlet recept acles.
and feeders from the distribution panel to outlets.
tection device (distribution panel).
Usage Notes
Follow these precautions to ensure safe operation and to obtain the full benefits of the various functions.
Avoid the following locations that could cause an accident or damage to the instru-
ment.
5
2
Exposed to direct sunlight
Exposed to high temperature
Exposed to water, oil, other
chemicals, or solvents
Exposed to high humidity or
condensation
Exposed to high levels of particulate dust
Subject to vibration
Avoid obstructing the ventilation holes on the sides of the instrument, as it could
overheat and be damaged, or cause a fire.
If the instrument operates abnormally or displays a n abno rma l indication, tur n off
the power switch immediately, and contact your dealer or Hioki representative.
Precautions before measurement
In the presence of corrosive or
explosive gases
Exposed to strong electromagnetic fields
Near electromagnetic radiators
Near induction heating systems
(e.g., high-frequency induction heating systems and IH
cooking utensils)
• Before turning on the instrument, confirm that the voltage of the power
source matches the voltage specification indicated on the instrument's
power connector ([AC IN]). (The voltage specification (100, 120, 220 or
240 V) ordered by the customer is marked with a black dot in the line
voltage column on the rear panel.)
Note that using the power supply with improper voltage may damage the
instrument and result in electrical hazards.
• To avoid electrical accidents and to maintain the safety specifications of
this instrument, connect the power cord provided only to a 3-contact
(two-conductor + ground) outlet.
Do not use excessive force on the touch pane l, and do not use sharp object s that
could damage the touch screen.
6
Do not touch any part of
the test lead beyond the
finger barrier
Fuse
Connection
• Replace the fuse only with one of the specified chara cteristics and
voltage and current ratings. Us ing a non-specified fuse or shorti ng
the fuse holder may cause a life-threatening hazard.
Measurement terminal section : 250 V F50 mAL
• To avoid electric shock, turn off the power switch and disconnect
the power cord and test leads before replacing the fuse.
• Since a blown fuse cannot be repaired or replaced by the customer, contact your dealer or nearest Hioki sales office.
Use the VA check function for power supply fuse and blown fuse
check function for measurement circuit fuse to check for blown
fuses.
Measurement
• Always turn both devices OFF when connecting and disconnecting an interface connector and test lead. Otherwise, an electric shock accident may
occur.
• To avoid damaging the power cord, grasp the plug, not the cord, when
unplugging it from the power outlet.
• To avoid breaking the test lead or enclosure probe, do not bend or pull them.
• When the power is turned off, do not apply voltage or current to the measurement terminals. Doing so may damage the instrument.
• L (Line), N (Neutral) and G (Ground) are indicated on the te rminal bl ock of th e
instrument, and the contacts of the power cord of the device to be measured
are denoted L, N and E (Earth). If the power cord does not include an earth
(E) line, connect only the L and N terminals.
For details regarding the terminal block, refer to "3.3 Connecting equipment
under test to the instrument" (p. 36).
To avoid the risk of electric shock when test leads are connected to
the T1 - T3 terminals, do not touch the part of the test lead that is
beyond the finger barrier.
The terminals output high voltages in some measurement modes.
7
1.1 Instrument Overview
1
Overview Chapter 1
1.1 Instrument Overview
To ensure the safe use of electrical products, it is necessary to conduct electrical safety tests such as
insulation resistance, withstand voltage, ground resistance, and leakage current.
Complying with laws and standards regarding medical electrical equipment as well as non-medical electrical equipment, this instrument can be used to measure leakage current in all types of electrical products from computers to medical equipment. It consists of measu rement networ ks that simulate the human
body and a high-frequency volt meter.
It is also capable of switching power supply polarities and making measurements under simulated singlefault conditions in equipment under test.
To simplify leakage current testing, all test operations can be selected and run from a touch panel on the
display screen.
Applicable lines of business and product applications
Manufacturers of medical electrical equipment Type approval testing, shipment inspection
Dealers of medical electrical equipment Maintenance, inspection
Service technicians for medical electric al equipment
(authorized service technicians)
Clinical engineers, hospitals Maintenance, inspection
Clinical engineering schools For educational purposes
Authorized electricians for operating rooms, ICUs,
and CCUs
Public organizations Type inspection
Manufacturers of general electrical equipment Type inspection , shipment inspection
Users of general electrical equipment Maintenance, inspection
General electrical equipment installers Maintenance, inspection
Service technicians for general electrical equipment Maintenance, inspection
Manufacturers of general electrical equipment pa rts Type inspection, shipment inspection
Manufacturers of power supply equipment Type inspection, shipment inspection
Manufacturers of electrical automobiles Type inspection, shipment inspection
Maintenance, inspection
Isolation transformer inspection
Chapter 1 Overview
8
Wide range of measurement networks in compliance with standards
and laws
1. Network A :For compliance with Electrical
Appliance and MaterialSafety Law
2. Network B1 :For JIS T0601-1:1999
3. Network B2 :IEC 60601-1:2005 3rd
Complies with JIS T 0601-1:2012
4. Network C :For IEC60990
5. Network D :For UL
6. Network E :For general-purpose 1
7. Network F :For general-purpose 2
8. Network G :For IEC 61010-1
Leakage current measurement mode
1. Earth leakage current
2. Touch current (Enclosure - Earth)
3. Touch current (Enclosure - Enclosure)
4. Touch current (Enclosure - Line)
5. Patient auxiliary current
6. Patient leakage current (Patient connection - Earth)
7. Patient leakage current (external voltage on a SIP/SOP
*
)
8. Patient leakage current (external voltage on a specific F-type applied part)
9. Patient leakage current
(external voltage on metal accessible part not protectively earthed)
10. Total patient leakage current (Patient connection - Earth)
11. Total patient leakage current (external voltage on a SIP/SOP
*
)
12. Total patient leakage current (external voltage on a specific F-type applied part)
13. Total patient leakage current
(external voltage on metal accessible part not protectively earthed)
14. Free current (Enclosure - Enclosure)
15. Enclosure - Earth leakage current
16. Enclosure - Enclosure leakage current
17. Enclosure - Line leakage current
18. Patient leakage current I
19. Patient leakage current II
20. Patient leakage current III
*
SIP(Signal Input Part)/SOP(Signal Output Part)
Power on polarity switching function
Rated current 20 A
1.2 Features
1.2 Features
To test electrical equipment for leakage current, it is necessary to use a measurement network that simulates the human body in compliance with applicable standards or laws.
The instrument includes the 8 measurement networks below.
The use of these networks enables instrument compliance with other standards.
Once a measurement network is selected, the instrument displays a leakage current measurement mode
corresponding to the applicable standard or law.
This function makes it possible to contin ue testing without shutting down the equipment under test when
polarities are changed, which shortens the duration of the test.
(Be sure to use an isolation transformer when using power on polarity switching.)
The instrument provides a rated current of 20 A and a rated voltage of 250 V.
9
Function for checking for blown fuses
Ease of operation
Interfaces
Printing (with optional printer)
Monitor function
1.2 Features
The insutrument allows you to check for unintended blown fuses in networks.
Check for blown fuses before and after measurements to enable high-reliability measurements.
All operations are performed using the touch panel. The display shows operable keys and the interactive
system guides you through measurement procedures.
The RS-232C, EXT I/O and USB interfaces are provided as standard equipment to enable the easy
transfer of measurement data with a computer. The EXT I/O connector allows external control.
Connect the optional 9442 Printer to print out measurement data and saved measurement data.
1
Chapter 1 Overview
The instrument is equipped with a function to monitor the power supply voltage and current of equipment
under test.
10
1.3 What is Leakage Current?
1.3 What is Leakage Current?
High voltage is present in an electrical ap plia n ce t ha t uses a commercial power supply as its main power
source. Touching such equipment may expose a person to an electrical shock when current passes
through the body to ground. This electrical shock is the result of "le akage curr ent" or "touch curren t." Normally, electrical equipment is grounded to protect against electrical shocks. Current regularly flows
through the grounding wire, but should an abnormality (due to faulty design or fault) occur in equipment,
the resulting electrical shock may cause serious personal injury and sometimes lead to the death of the
*1
victim. For this reason, leakage current measurements including single-fault conditi ons
lated.
Leakage current measurements perfor med acco rd ing to the applicable standard makes it possible to verify the safety of equipment.
*1
What is a single-fault condition?
This refers to when equipment has a fault in a safety protection measure, or a fault that may result in a
hazardous condition.
Leakage current testing includes the following three single-fault conditions.
are strictly regu-
1. Disconnected grounding wire (not applicable in current tests of leakage current)
2. One wire in the power cord is disconnected (neutral power supply wire)
*2
3. External equipment damage
(patient leakage current II and patient leakage current III)
*2
In JIS T0601-1:1999 classified as a single-fault condition.
Not a single-fault condition, the instrument is capable of switching polarity during measurements and
retaining a recording of the phase with the highest leakage current.
11
1.4 Leakage Current Measurement Complying with Standards
1.4 Leakage Current Measurement
Complying with Standards
Electrical safety standards and laws are enacted for electrical products according to fields of application.
Each standard and law specifies a circuit network for simulating the human body, and prescribes network
performance, as well as measuring locations, type (e.g., AC, DC) of current to be measured, allowable
values, and other characteristics.
Listed below are various standards that requir e leakage current measurement.
Standards requiring leakage current measurement
(Refer to the User's Guide for information on other standards.)
Electrical equipment
IEC 60065:2001 +A1:2005
IEC60335-1:2010
IEC 60950-1:2005 Safety of information technology equipment
IEC 60990:1999
UL2231-1, UL2231-2 Personnel Protection Systems for EV
Electric measuring instruments
IEC 61010-1:2010
Medical electrical equipment
JIS T 0601-1:1999
JIS T 0601-1:2012
IEC 60601-1:2005 3rd
Audio, video, and similar electronic apparatus - Safety
requirements
Safety of household and similar electrical appliances.
- Part 1: General requirements
Methods of measuring touch current and protective conductor current
Safety requirements for electrical equipment used in measurements, control and laboratories
Current measurement circuits for testing in damp co nditions
Medical electrical equipment-Part1:General requirements
for basic safety and essential performace
Medical electrical equipment
Part 1: General requirements for safety
1
Chapter 1 Overview
12
1.5 Types of Leakage Current
1.5 Types of Leakage Current
Leakage current can largely be classified as shown in the table below.
Types of
Leakage Current
Earth leakage
current
Touch current
Enclosure
leakage current
Patient leakage
current
Patient auxiliary
current
Total patient
leakage current
Protective
conductor current
Overview
This refers to electric current that flows through a protective earth conductor to
the ground.
Touch current is electric current that flows through a p erson who touches an
ungrounded enclosed section of equipment. It does not include current that
flows to the human body in contact with an applied part.
Patient leakage current flows through the body of someone connected to the
applied part.
Test items vary based on the type of applied part.
Electric current that flows between applied parts and through a patient during
normal operation of medical equipment that is not intended to have any physiological effect.
When multiple applied parts are attached to a patient, the total leakage current
must be measured.
The sum of patient leakage current of applied part s is tot a l p atient leakage current.
Electric current that flows through a protective earth conductor (grounding
wire) during normal operating conditions
Refer-
ence
Page
P.13
P.14
P.15
P.15
P.19
P.20
13
1.6 Types of Leakage Current Measurement
1.6 Types of Leakage Current Measurement
Earth leakage current measurement
Class-II equipment does not require the measurement of Earth leakage current since it has no protective
earth conductor.
Earth leakage current is measured by inserting a resistance equivalent to the human body in the protec-
tive earth conductor. Using a clamp (Clamp On HiTester) for measuring current does not satisfy the standard.
1
Chapter 1 Overview
14
1.6 Types of Leakage Current Measurement
Touch current measurement
Class-I equipment does not require the measurement of enclosure leakage current since metal enclosures must be grounded for electrical protectio n.
disconnected (single fault), the enclosure is no longer grounded for protection and must be measured.
For Class-II equipment, all enclosures are ungrounded for electrical protection and must be tested.
Ungrounded equipment are often made of plastics and other insulated materials. Since leakage current
flows through the human body, the standard stipulates that a probe is applied to metal foil the size of a
hand pressed against the insulated material. Use the 9195 enclosure probe supplied with the instrument
for measurements involving this instrument.
There are two paths for touch current to flow: "enclosure
human body enclosure." Note that for "enclosure human body enclosure" to occur a person
must touch two electrically isolated (separate) enclosure sections not two sections on the same enclosure.
However, when the protective earth conductor becomes
human body earth" and "enclosure
15
1.6 Types of Leakage Current Measurement
Patient auxiliary current
Patient auxiliary current is current that flows through an "applied part human body applied part" path.
Regardless of the medical equipment class, type of applied parts, and signal input/output selection, all
medical equipment with multiple applied part s must undergo this measurement.
Make both AC and DC measurements for this type of leakage current.
1
Chapter 1 Overview
Patient leakage current measurement (Patient connection - Earth)
This is electric current that flows through an "applied part
Regardless of medical equipment class, type of applied parts and signal input/output section, all medical
equipment with patient connections must undergo this measurement.
Make both AC and DC measurements for this type of leakage current.
human body ground" path.
16
1.6 Types of Leakage Current Measurement
Patient leakage current measurement (external voltage on a SIP/SOP)
This is electric current that flows through an "applied part human body ground" path.
Measure medical instruments with a signal input/output section and applied parts other than F-type. Measure assuming that medical equipm ent with a broken signal input/output section is connected. Instead of
connecting damaged medical equipment to generate a single-fault condition, input a voltage that is 110%
of the rated voltage.
(Use the T3 terminal on the instrument)
IEC 60601-1:2005 3rd Edition stipulates that the connection of damaged medical equipment does not
constitute a single-fault condition, but handles it as a normal condition.
JIS T0601-1:1999 treats patient leakage current II as patient leakage current I plus a
single fault condition.
17
1.6 Types of Leakage Current Measurement
Patient leakage current measurement
(external voltage on a specific F-type applied part)
This is electric current that flows through an "applied part of malfunctioning medical equipment human
body
F-type applied part" path.
The measurement of this leakage current is required only for medical devices with an F-type applied part.
Instead of connecting damaged medical equipment to generate a single-fault condition, input a voltage
that is 110% of the rated voltage.
1
Chapter 1 Overview
18
1.6 Types of Leakage Current Measurement
Patient leakage current measurement
(external voltage on metal accessible part not protectively earthed)
Additions to IEC 60601-1:2005 3rd Edition
Patient leakage current is current that takes the following route: "metal accessible part not protectively
earthed
patient connection of applied parts that are not protectively earthed (B-type or BF-type) and with metal
accessible parts that are not protectively earthed.
Instead of connecting damaged medical equipment to generate a single-fault condition, input a voltage
that is 110% of the rated voltage to metal accessible parts not protectively earthed. (Use the T3 terminal
on the instrument)
This test is not required for CF-type applied parts.
applied part human body Earth." Use this standard to measure medical equipment wit h
19
1.6 Types of Leakage Current Measurement
Total patient leakage current measurement
To tal patient leakage current is the total of all leakage current to or from patient connections of all the
same type of applied parts (B-Type, BF-Type and CF-Type applied parts) simultaneously connected.
When there are two or more patient connections that go to different functions and are not electr ically connected together, the total patient leakage current for B-Type applied parts must be measured.
If required, measure all patient leakage current components (patient connection - earth, external voltage
on an SIP/SOP, external voltage on an F-type applied part, external voltage on a metal accessible part
that is not protectively earthed.)
(The figure shows patient - earth.)
1
Chapter 1 Overview
20
1.6 Types of Leakage Current Measurement
Protective conductor current measurement
A protective conductor current measurement measures the electric current that flows thro ugh a protective
earth conductor (grounding wire) during normal operating cond itions.
Like Earth leakage current, class II equipment does not have a protective earth wire and therefore does
not require measurement of protective conductor current.
To measure the protective conductor current, place a resistor with a resistance so small as to be negligible in the protective earth wire circuit.
Measurement
General electrical equipment
Medical electrical equipment
Touch current
Enclosure - Line
1.6 Types of Leakage Current Measurement
List of Leakage-Current Measurement Items
Normal
condition
Single-
fault
condition
(Description of fault) (Other conditions)
Situation other than touch current
(Enclosure - Line) is applicable
21
1
Chapter 1 Overview
1. One wire in the power
cord is disconnected.
2. protective earth conductor is disconnected
Touch current
•Enclosure - Earth
•Enclosure - Enclosure
Earth leakage current
Patient leakage cur-
rent (Patient connec-
tion - Earth)/
(Patient leakage
current I)
Patient leakage
current
(external voltage on a
SIP/SOP)/
(Patient leakage
current II)
Patient leakage cur-
rent (external voltage
on a specific F-type
applied part)/
(Patient leakage
current III)
Patient leakage cur-
rent (external voltage
on metal accessible
part not protectively
earthed)
Patient auxiliary
current
*
Measurement with a disconnected protective earth conductor is applicable only to Class-I equipment.
1. One wire in the power
cord is disconnected.
1. One wire in the power
cord is disconnected.
2. The protective earth
conductor is disconnected.
1. One wire in the power
cord is disconnected.
2. The protective earth
conductor is disconnected.
1. The protective earth
conductor is disconnected.
1. One wire in the power
cord is disconnected.
2. The protective earth
conductor is disconnected.
1. Functional grounding wire is disconnected
2. Grounding wire for patient connection and power
*
supply circuit for measurement are disconnected
3. A voltage that is 110% of the rated voltage is applied between an isolated signal input/output
section and earth (Not medical equipment)
1. Functional grounding wire is disconnected
(Class I only)
2. Grounding wire for patient connection and power
supply circuit for measurement are disconnected (Class I only)
1 Functional grounding wire is disconnected
2. Grounding wire for patient connection and power
supply circuit for measurement are disconnected
1. Functional grounding wire is disconnected
2. Metal accessible part not protectively earthed
and grounding wire is disconnected
3. A voltage that is 110% of the rated voltage is applied between an isolated signal input/output
section and earth
1. A voltage that is 110% of the rated voltage is applied between an F-applied part and earth.
(Does not qualify as a single fault condition under IEC 60601-1: 2005 3rd Edition.)
2. Metal accessible part not protectively earthed
and grounding wire is disconnected
3. Functional grounding wire is disconnected
1. Applied to metal accessible part not protectively
earthed
2. Functional grounding wire is disconnected
Functional grounding wire is disconnected
22
1.6 Types of Leakage Current Measurement
ST5540/ST5541 List of functions
item ST5540 ST5541
Network A
Network B1
Network B2
Network
Testing leakage current mode
Major functions
Total patient leakage current
Enclosure - Earth leakage current
Enclosure - Enclosure leakage current
Enclosure - Line leakage current
Patient leakage current I
Patient leakage current II
Patient leakage current III
Power on polarity switching function
Function for checking for blown fuses
Frequency band switching
110% voltage output terminal (T3 terminal)
S10, S12, S13, E terminal
Network C
Network D
Network E
Network F
Network G
Earth leakage current
Touch current
Patient auxiliary current
Patient leakage current
Free current
Rated current 20 A
–
–
–
–
–
–
–
–
–
–
–
Instrument Labels
23
and Screens Chapter 2
2
Chapter 2 Instrument Labels and Screens
24
Front Panel
Detects overcurrent in the power line for equipment
under test and activates a protective device.
(Rated current : 20 A)
: ON (for normal measuring operation)
: OFF (idle condition or when overcurrent
protection device has been triggered)
See (p. 31)
Covers the terminal block to prevent electric shock.
Turn the circuit breaker off ( ) before opening the
cover.
See (p. 37)
Outputs voltage based on the power supplied to
[LINE IN] (p. 25).
Also used to connect the power cord of equipment
under test.
See (p. 36)
Five-inch liquid crystal display unit with a touch
panel function.
Also provided with input key functions.
The backlight (p. 136) can be set to turn OFF automatically.
Turns the main instrument ON and OFF.
See (p. 38)
1. Circuit breaker
2. Terminal block cover
3. Terminal block
4. Liquid crystal display unit (LCD)
5. Power switch
Generates a beep sound when a key is pressed, and
activates a warning buzzer.
See (p. 135)
Used to adjust screen contrast.
Turning the dial to the right darkens the display; turning to the left lightens the display.
Use this dial when the display requires adjustment.
Insulates the voltage supplied to [LINE IN] (p. 25)
using the built-in transformer and outputs a 1:1 voltage from terminal T3. Effective only when B1 or B2
network is selected. (only ST5540)
See (p. 75)
Input 110% of the rated voltage to [LINE IN] (p.
25) using the isolation transformer to use the T3
terminal. The T3 terminal will only output a 110% of
the rated voltage when the same voltage is input to
[LINE IN].
Lights when high volltage is generated at the T1 - T3
terminals.
Used to measure leakage current other than Earth
leakage current. The T2 terminal is provided with a
protective fuse.
(fuse rating : 250 V, F50 mAL)
See (p. 75), (p. 282)
6. Buzzer
7. Contrast adjustment dial
8. 110% voltage output terminal (terminal T3)
9. Warning lamp
10. Measuring terminals (terminals T1)
11. Measuring terminals (terminals T2)
1
2
3
4
5
6
7
8
9
11
10
2.1 Instrument Labels and Functions
2.1 Instrument Labels and Functions
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