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Transcript
Calibration and Electrical Safety
of Medical Equipment
Dr Fadhl Al-Akwaa
[email protected]
www.Fadhl-alakwa.weebly.com
Please contact Dr Fadhl to use this material
Why Test & Calibration
What you cannot measure
you cannot control
Please contact Dr Fadhl to use this material
As components age and equipment undergoes
changes in temperature or humidity or sustains
mechanical stress, performance gradually
degrades.
This is called drift.
When this happens your test results become
unreliable and both design and performance quality
suffer.
While drift cannot be eliminated, it can be detected
and either corrected or compensated for through
Please
Dr Fadhl to useof
this material
thecontact
process
calibration.
Definitions
• Calibration: process of comparing an unknown against
a reference standard within defined limits, accuracies
and Uncertainties
• Verification: process of comparing an unknown against
a reference standard at usually one data point
Please contact Dr Fadhl to use this material
Requirements of Test & Calibration service
– Written Program
– Routine calibration or verification at suitable intervals
– Control of inspection, measuring and test equipment.
– Calibration procedures including specific directions and limits for
accuracy and precision
– Deviation or discrepancies should be investigated
– Traceable Calibration Standards
– Calibration records
– Visible Calibration status
Please contact Dr Fadhl to use this material
What to TEST for?
• Performance Testing
• Safety Testing
Please contact Dr Fadhl to use this material
When to test
• On newly acquired equipment prior to being
accepted for use
• During routine planned preventative
maintenance.
• After repairs have been carried out on
equipment.
Need for Medical Equipment Testing
• Medical device incidents resulting in patient
injury and death
• Ensure that the equipment is performing to the
expected standards of accuracy, reliability, free of
hysteresis and linear (as designed).
• Safe and effective devices need to be available for
patient care
– Downtime costs money
• Regulations, accreditation requirements and
standards.
Please contact Dr Fadhl to use this material
Why do we do electrical safety?
• Ensure patient safety
– Protect against macroshock
– Protect against microshock
• Test for electrical internal breakdown /
damage to power cord, AC mains feed, etc.
• Meet codes & standards
– AAMI, IEC, UL, NFPA, etc.
• Protect against legal liability
– In case of a patient incident
International Electrotechnical Commission
• The International Electrotechnical
Commission[1] (IEC) is a non-profit, nongovernmental international standards
organization that prepares and publishes
International Standards for all electrical,
electronic and related technologies –
collectively known as "electrotechnology".
International Electrotechnical Commission
• IEC standards cover a vast range of
technologies from power generation,
transmission and distribution to home
appliances and office equipment,
semiconductors, fibre optics, batteries, solar
energy, nanotechnology and marine energy as
well as many others.
• The IEC also manages three global conformity
assessment systems that certify whether
equipment, system or components conform to
its International Standards.
International Electrotechnical Commission
• Today, the IEC is the world's leading
international organization in its field, and its
standards are adopted as national standards
by its members. The work is done by some 10
000 electrical and electronics experts from
industry, government, academia, test labs and
others with an interest in the subject.
• They also first proposed a system of
standards, the Giorgi System, which ultimately
became the SI, or Système International
d’unités (in English, the International System
of Units).
IEC, ISO, ITU, IEEE
• The IEC cooperates closely with the
International Organization for Standardization
(ISO) and the International
Telecommunication Union (ITU). In addition, it
works with several major standards
development organizations, including the IEEE
with which it signed a cooperation agreement
in 2002, which was amended in 2008 to
include joint development work.
• Other standards developed in cooperation
between IEC and ISO are assigned numbers in
the 80000 series, such as IEC 82045-1.
List of IEC standards
• IEC standards have numbers in the range
60000–79999 and their titles take a form such
as IEC 60417: Graphical symbols for use on
equipment. The numbers of older IEC
standards were converted in 1997 by adding
60000, for example IEC 27 became IEC 60027.
List of IEC standards
•
•
•
•
•
•
•
•
IEC 60027 Letter symbols to be used in electrical technology...
IEC 60034 Rotating electrical machinery
IEC 60038 IEC Standard Voltages
IEC 60044 Instrument transformers
IEC 60050 International Electrotechnical Vocabulary
IEC 60062 Marking codes for resistors and capacitors
IEC 60063 Preferred number series for resistors and capacitors
IEC 60065 Audio, video and similar electronic apparatus - Safety
requirements
• IEC 60068 Environmental Testing
• IEC 60071 Insulation Co-ordination
• IEC 60073 Basic Safety principles for man-machine interface, marking and
identification
http://en.wikipedia.org/wiki/List_of_IEC_standards
List of IEC standards
• IEC 60601 Medical Electrical Equipment
• IEC 62304 Medical Device Software Software Life Cycle Processes
• IEC 62366 Medical devices—Application of
usability engineering to medical devices
• IEC 62464 Magnetic resonance equipment
for medical imaging
http://en.wikipedia.org/wiki/List_of_IEC_standards
IEC 60601-x-xx
• – the IEC 60601-1-xx series of collateral
standards for MEDICAL ELECTRICAL
EQUIPMENT;
• – the IEC 60601-2-xx series of particular
standards for particular types of MEDICAL
• ELECTRICAL EQUIPMENT; and
• – the IEC 60601-3-xx series of performance
standards for particular types of MEDICAL
ELECTRICAL EQUIPMENT.
IEC 60601-x-xx
• IEC 60601-1-2, Medical electrical equipment –
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic
compatibility – Requirements and tests
• IEC 60601-1-3, Medical electrical equipment –
Part 1: General requirements for safety – 3.
Collateral standard: General requirements for
radiation protection in diagnostic X-ray
equipment
IEC 60601-x-xx
• IEC 60601-1-6, Medical electrical equipment –
Part 1-6: General requirements for safety
Collateral standard: Usability
• IEC 60601-1-8, Medical electrical equipment –
Part 1-8: General requirements for safety
Collateral standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
Physiological Effects of Electricity
The human body can easily detect macroshock and violent
reactions occur to high current flow level in the body…
Below 1 ma (1,000 µa), it is often much more difficult to detect
the presence of a shock hazard from simple perception…
Classes and types of medical electrical
equipment
• Equipment Class{I,II,III} method of protection
against electric shock
• Equipment Type{B,BF,CF} degree of protection
Classes and types of medical electrical
equipment
• All electrical equipment is categorised into
classes according to the method of protection
against electric shock that is used. For mains
powered electrical equipment there are
usually two levels of protection used, called
"basic" and "supplementary" protection. The
supplementary protection is intended to come
into play in the event of failure of the basic
protection.
Class I
• Class I equipment has a protective earth. The basic
means of protection is the insulation between live
parts and exposed conductive parts such as the
metal enclosure.
• In the event of a fault that would otherwise cause an
exposed conductive part to become live, the
supplementary protection (i.e. the protective earth)
comes into effect. A large fault current flows from
the mains part to earth via the protective earth
conductor, which causes a protective device (usually
a fuse) in the mains circuit to disconnect the
equipment from the supply.
Class I
Class I
• term referring to electrical equipment in
which protection against electric shock does
not rely on BASIC INSULATION only, but which
includes an additional safety precaution in
that means are provided for ACCESSIBLE
PARTS of metal or internal parts of metal to be
PROTECTIVELY EARTHED
CLASS II
• term referring to electrical equipment in
which protection against electric shock does
not rely on BASIC INSULATION only, but in
which additional safety precautions such as
DOUBLE INSULATION or REINFORCED
INSULATION are provided, there being no
provision for protective earthing or reliance
upon installation conditions
Class II
Class III equipment
• Class III equipment is defined in some
equipment standards as that in which
protection against electric shock relies on the
fact that no voltages higher than safety extra
low voltage (SELV) are present. SELV is defined
in turn in the relevant standard as a voltage
not exceeding 25V ac or 60V dc. In practice
such equipment is either battery operated or
supplied by a SELV transformer.
• If battery operated equipment is capable of being
operated when connected to the mains (for example,
for battery charging) then it must be safety tested as
either class I or class II equipment. Similarly,
equipment powered from a SELV transformer should
be tested in conjunction with the transformer as
class I or class II equipment as appropriate.
• It is interesting to note that the current IEC standards
relating to safety of medical electrical equipment do
not recognise Class III equipment since limitation of
voltage is not deemed sufficient to ensure safety of
the patient. All medical electrical equipment that is
capable of mains connection must be classified as
class I or class II. Medical electrical equipment having
no mains connection is simply referred to as
"internally powered".
Equipments Type
different pieces of medical electrical equipment {APPLIED PARTS}
have different areas of application and therefore different electrical safety
requirements. For example, it would not be necessary to make a
particular piece medical electrical equipment safe enough for direct
cardiac connection if there is no possibility of this situation arising.
Normative Reference Page 371
• Current density and electrically induced
ventricular fibrillation. Medical
Instrumentation, January-February 1973, Vol.
7, No. 1.
• WATSON, AB. and WRIGHT, JS., Electrical
thresholds for ventricular fibrillation in man.
Medical Journal of Australia, June 16, 1973.
Terminology and definitions
• http://www.601help.com/Disclaimer/glossary.
html#ProtectiveEarthTerminal
Terminology and definitions
•
•
•
•
•
•
•
•
L1 Hot
L2 Neutral
Earth Ground
Mains Line Voltage
Applied Parts Patient Leads
Enclosure/Case Chassis
Protective Earth Ground Wire
Earth Leakage Current Leakage in Ground
Wire
Terminology and definitions
• Enclosure Leakage Chassis Leakage
• Patient Leakage Lead Leakage
• Patient Auxiliary
Leakage between Patient
Leads
• Mains on Applied Parts Lead Isolation
• Insulation Resistance Dielectric Strength or
Insulation Resistance between Hot and
Neutral to Ground
• Earth Resistance Ground Wire Resistance
R.M.S and Peak to Peak
Vrms is the value indicated by the vast majority of AC voltmeters.
The RMS value of an alternating voltage or current is the same as
the level of direct voltage or current that would be needed to produce
the same effect in an equal load.
For example, 1 V applied across a 1 Ω resistor produces 1 W of
heat. A 1 Vrms square wave applied across a 1 Ω resistor also
produces 1 W of heat. That 1 Vrms square wave has a peak voltage
of 1 V, and a peak-to-peak voltage of 2 V.
Calculate RMS
≈ 0.707 Vpk
• RMS is a sort of average and peak is the top
level
• A peak is an instant reading - RMS is an
"average" reading.
RMS means to take the root of the mean and
square it.
• RMS value is the DC equivalent value to an AC
stream.
• The RMS value of an alternating voltage or
current is the same as the level of direct
voltage or current that would be needed to
produce the same effect in an equal load.
Crest Factor
• The Crest Factor is equal to the peak
amplitude of a waveform divided by the RMS
value.
• Electrical engineering — for describing the
quality of an AC power waveform
Applied Part
No applied part
table
Parts that contact PATIENTS
Applied Part
A part of the equipment which in normal use:
necessarily comes into physical contact with the patient for the
equipment to perform its function; or can be brought into contact with the
patient; or needs to be touched by the patient
Accessible Part
• Part of equipment which can be touched
without the use of a tool.
• EXAMPLE 1 Illuminated push-buttons
• EXAMPLE 2 Indicator lamps
• EXAMPLE 3 Recorder pens
• EXAMPLE 4 Parts of plug-in modules
• EXAMPLE 5 Batteries
•
Leakage currents
• Current that is not functional.
• several different leakage currents are defined
according to the paths that the currents take.
• Earth Leakage Current
• Enclosure Leakage Current
• Patient Leakage Current
• Patient auxiliary current
Causes of Leakage currents
• If any conductor is raised to a potential above
that of earth, some current is bound to flow
from that conductor to earth.
• The amount of current that flows depends on:
1- the voltage on the conductor.
2- the capacitive reactance between the
conductor and earth.
3-the resistance between the conductor and
earth.
EARTH LEAKAGE CURRENT
• current flowing from
the MAINS PART
through or across the
insulation into the
PROTECTIVE EARTH
CONDUCTOR
EARTH LEAKAGE CURRENT
• Under normal conditions, a person who is in contact
with the earthed metal enclosure of the equipment
and with another earthed object would suffer no
adverse effects even if a fairly large earth leakage
current were to flow. This is because the impedance
to earth from the enclosure is much lower through
the protective earth conductor than it is through the
person. However, if the protective earth conductor
becomes open circuited, then the situation changes.
Now, if the impedance between the transformer
primary and the enclosure is of the same order of
magnitude as the impedance between the enclosure
and earth through the person, a shock hazard exists.
EARTH LEAKAGE CURRENT
Measurement
Measurement of earth leakage
current
Enclosure leakage current /
touch current
• LEAKAGE CURRENT
flowing from the
ENCLOSURE to earth or
to another part of the
ENCLOSURE through a
conductor other than
the protective earth
conductor.
Enclosure leakage current/
touch current
Measurement of enclosure leakage
current
Patient leakage current
• Patient leakage current
is the leakage current
that flows through a
patient connected to an
applied part or parts.
• It can either flow from
the applied parts via the
patient to earth or from
an external source of
high potential via the
patient and the applied
parts to earth.
Patient leakage current
Measurement of patient leakage
current
Measurement of patient leakage
current
Patient auxiliary current
• The patient auxiliary
current is defined as the
current that normally
flows between parts of
the applied part
through the patient,
which is not intended to
produce a physiological
effect
Patient auxiliary current
Measurement of patient auxiliary
current.
Mains on applied parts
Protective Earth Continuity
• The resistance of the
protective earth conductor
is measured between the
earth pin on the mains plug
and a protectively earthed
point on the equipment
enclosure (see figure 6). The
reading should not normally
exceed 0.2Ω at any such
point. The test is obviously
only applicable to class I
equipment.
Protective Earth Continuity
• In IEC60601, the test is
conducted using a 50Hz
current between 10A and
25A for a period of at least 5
seconds. Although this is a
type test, some medical
equipment safety testers
mimic this method. Damage
to equipment can occur if
high currents are passed to
points that are not
protectively earthed, for
•
•
•
•
Applicable to Class I, all types
Limit: 0.2Ω
DB9801 recommended?: Yes, at 1A or less.
HEI 95 recommended?: Yes, at 1A or less.
Notes: Ensure probe is on a protectively
earthed point
Insulation Tests Class I
• HEI 95 and DB9801
recommended that for class
I equipment the insulation
resistance be measured at
the mains plug between the
live and neutral pins
connected together and the
earth pin. Whereas HEI 95
recommended using a 500V
DC insulation tester, DB
9801 recommended the use
of 350V DC as the test
voltage.
•
•
•
•
•
Applicable to Class I, all types
Limits: Not less than 50MΩ
DB9801 recommended?: Yes
HEI 95 recommended?: Yes
Notes: Equipment containing mineral
insulated heaters may give values down to
1MΩ. Check equipment is switched on.
Insulation Tests Class II
• HEI 95 further
recommended for class
II equipment that the
insulation resistance be
measured between all
applied parts connected
together and any
accessible conductive
parts of the equipment.
The value should not
normally be less than
50MΩ (see figure 10).
Leakage current summary
• The following table summarises the leakage
current limits (in mA) specified by IEC60601-1
(second edition) for the most commonly
performed tests. Most equipment currently in
use in hospitals today is likely to have been
designed to conform to this standard, but
note that the allowable values of earth
leakage current have been increased in the
third edition of the standard as discussed
above.
Leakage current summary
• The following table summarises the leakage
current limits (in mA) specified by IEC60601-1
(second edition)
http://www.ebme.co.uk/arts/safety/part6.htm
Limitation of voltage, current or energy(87)
Electrical Safety Tests
•
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•
•
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•
•
Available electrical safety tests include:
Mains Voltage
Dual Lead Voltage
Dual Lead Leakage
Current Consumption
Insulation Resistance
http://www.ebme.co.uk/arts/safety/part6.htm
Protective Earth Resistance
Earth Leakage Current
Enclosure Leakage Current
Patient Leakage Current
Mains on Applied Part Leakage
Patient Auxiliary Current
Accessible Voltage
Accessible Leakage
Equivalent Device Leakage
Equivalent Patient Leakage
How to measure resistance?
Proper grounding is the best defense against
macroshock & microshock!
The 2-terminal method is less
accurate due to the effects of test
lead resistance, especially with long
leads and low resistance value
measurements. The much preferred
4-terminal “Kelvin” technique
negates the effects of test lead
resistance and gives more accurate
readings…
An Introduction to Safety Analyzer
Electrical Shock Hazard
• A common experience due to electric shock
• Associated with equipments
• Electric current can flow through the human
body either
– Accidentally or Intentionally
• Other reasons of electric shock include
– Careless use of electricity
– Usage of faulty cords and appliances
– Lack of concept/Faulty design
– Relied upon life support devices (Pace maker/
respirators)
An Introduction to Electric Shock Hazard
Electrical Shock Hazard
• Use of medical equipments in
conjunction
with
other
instruments and equipments
• Environmental conditions
• Patient/Operator not realizing
potential hazards
• 2 situations account hazards
from electric shock
– Gross shock
– Micro - current shock
An Introduction to Electric Shock Hazard
Gross shock
• Experienced by the subject
by an accidental contact with
electric wiring at any point
on the surface of the body
• Current flows through the
body of the subject (ex. from
arm to arm)
• Body acts as a volume
conductor at the mains
frequency
• Degree of simulation varies
from individual to individual
An Introduction to Electric Shock Hazard
Micro - current shock
• Current passes directly through
the heart wall
• Thresholds of sensation of
electric currents differ widely
• Greater % of current may flow
via the arterial system directly
through the heart
• Requires much less currents to
produce ventricular fibrillation
– EX. Catheter laboratory or
operating room where patient
connected to catheter in the
heart
• Here patients have very little
resistance to electric currents
Physiological Effects of Electricity
Tissue Resistance
• Skin - 5000 ohms/cm2
• Blood - 100 ohms/cm2
• Muscle - 200-400 ohms/cm2
• Fat - 2000-3000 ohms/cm2
• Bone - 3000+ ohms/cm2
Current goes to the path of least resistance
An Introduction to Electric Shock Hazard
Leakage Current
• Inherent flow of non functional
current from live electric parts of
instrument to accessible metal parts
• Usually flow through 3rd wire
connection to ground
• Magnitude of leakage current is
determined by the value of the
capacitance present
• Originates due to capacitive coupling
from the power transformer primary
to other parts of the transformer (or
instruments)
An Introduction to Electric Shock Hazard
Types of Leakage Current
• Enclosure leakage current: Current flows in
normal condition from the enclosure (or part of
enclosure) through a person in contact with an
accessible part of enclosure to earth (or
another part of the enclosure)
• Earth leakage current: Current flows in normal
condition to earth from main parts of
apparatus via earth conductor
• Patient leakage current: Current flows through
patient from or to applied parts of the patient
circuits
An Introduction to Electric Shock Hazard
Effects of Electric Current on Human Body
• Threshold of perception of
electric shock is about 1mA
• Tingling sensation is felt when
contacted with electrified
object through intact of skin
• As magnitude of alternating
current is increased
– Tingling sensation leads to
contraction of muscles
– Muscular contraction increases
– Finally value of current is
reached where grip of current
cannot be released
An Introduction to Electric Shock Hazard
Effects of Electric Current on Human Body
• Let -go- current: the max. current at which the subject is
still capable of releasing a conductor by using muscles
– Here individual can withstand with no serious effects
– Average let go current for males- 16mA, females-10.5mA, approx.
9-6 mA for both.
• Hold-on-type: A current level higher than let go current,
the subject looses ability to control his own muscle action
and unable to release grip on the conductor
– Such currents are very painful and hard to bear
– Physical injury is caused b currents in range of 20-100mA
• A very high currents (6 amperes and above) lead to
– Temporary respiratory paralysis
– Serious burns
An Introduction to Electric Shock Hazard
Recommendations of IEC
• International
Electrotechnical
Commission (IEC)
• Continuous medical equipment
current should not exceed 100
uA
• Should be with in a frequency
range of 0 to 1kHz
• In
abnormal
situations
recommended max. current is
500 uA
• Should be in a frequency upto 1
kHz
• Above 1 kHz max increases is
proportionally with frequency
An Introduction to Electric Shock Hazard
Precautions
• Use apparatus or appliances with
three wire power cord
• Provide isolated input circuits on
monitoring equipment
• Have periodic checks of ground
wire continuity
• No other equipment to be
connected when patient monitoring
equipment is connected
• Clearly mark functional controls
• Take care of adapter plugs that do
not ensure proper grounding circuit
• Direct operating instructions to the
operators
• Maintaining voltage differences
Macroshock and Microshock
History
• The expansion of technology was unregulated, and
unexplained deaths in hospitals were attributed by
some to electrical shocks
• Studies showed that electrical shock risks were the
greatest when the patient had conductors internal to
the body
• If a conductive catheter is placed in the heart, 100
micro amps at 60 Hz can cause fibrillation of heart
and death
Automated Electrical Safety Analyzer
601PRO Series XL – Fluke Biomedical
601PRO Series XL
Standard Features
• The most advanced Electrical Safety Analyzer
on the market
• EN60601-1, EN601010-1, and AAMI & ESI
test loads (user selectable) into one device
• The One-Touch-Testing user interface
• Allows user to perform rapid tests on various
medical devices
• Multiple enclosure-leakage points
• Multiple patient-applied-part types
601PRO Series XL
Standard Features
•
•
•
•
Power ON/OFF delay
DC only for patient- and auxiliary-leakage tests
User-programmable test sequences
Offers manual, auto, step, and computer-control
mode operations
• ASCII data transfer
• Memory for up to 1000 device-information
records
• Conducts electrical safety testing in accordance
with IEC 601-1, VDE 751, VDE 701, HEI 95, IEC
1010, AAMI, and AS/NZS 3551 requirements
601PRO Series XL
Standard Features
• Flags failures, and simulates
performance,
ECG,
and
arrhythmia, waveforms.
• Results
automatically
analyzed and saved in nonvolatile memory
• Accepts device information
that is input using an
– External keyboard,
– Integrated keypad,
– Barcode keyboard wedge
Optional Feature
• Onboard thermal printing
Specifications
601PRO Series XL
Voltage
Insulation
Resistance
Current
Consumption
Mains on
Applied Part
Protective Earth
Resistance
Range:
0 to 300 V True RMS (single and dual lead)
Accuracy:
DC - 100 Hz ± 1.5 % of reading ± 1 LSD
Range:
0.5 to 400.0 MΩ
Accuracy:
± 5 % of reading ± 2 LSD
Range:
0 to 15 A ac True RMS
Accuracy:
± 5 % of reading ± 2 LSD
Applied Voltage: ≥ 110 % of mains voltage
Accuracy:
± 2 % of reading ± 6 µA
Range:
0.000 to 2.999 Ω
Accuracy:
± 5 % of reading ± 4 mΩ (1 A, 10 A, and 25 A test currents) (Refer to
Operator’s Manual for additional specs qualifying the effects on
accuracy of variations in load inductance and phase angle.)
Supply Voltage
90 to 265 Vac, auto switching
Specifications
601PRO Series XL
IEC601-1 and AAMI
Leakage Currents
ECG Simulation and
Performance Testing
Range:
0 to 8000 µA True RMS
Accuracy:
(per IEC601-1 or AAMI filter),
-DC - 1 kHz ± 1 % of -reading ± 1 µA
-1 to 100 kHz ± 2 % of reading ± 1 µA
- 100 kHz to 1 MHz ± 5 % of reading ± 1 µA
DC-Only Frequency
Response:
DC - 5 Hz (approx)
ECG Complex:
30, 60, 120, 180, 240 BPM
Performance
Pulse:
30, 60 BPM, 63 ms pulse width
600 to 700 µs rise and fall
time
Sine Waves:
10, 40, 50, 60, 100 Hz
Square Wave:
0.125, 2.000 Hz (50 % duty cycle)
Triangle Wave:
2 Hz, 2 mV
Dimensions
16.62 in L x 11.75 in W x 5.56 in H
Weight
17lb / 7.7kg
601PRO Series XL
Available electrical safety tests
 Mains Voltage
 Dual Lead Voltage
 Dual Lead Leakage
 Current Consumption
 Insulation Resistance
 Protective Earth
Resistance
 Earth Leakage Current
 Enclosure Leakage
Current
 Patient Leakage
Current
 Mains on Applied Part
Leakage
 Patient Auxiliary
Current
 Accessible Voltage
 Accessible Leakage
 Equivalent Device
Leakage
 Equivalent Patient
Leakage
601PRO Series XL
Accessories
•
•
•
•
•
•
•
•
Probe/Safety Lead, Red - 1
Probe/Safety Lead, Black - 1
Adapter, Banana/Alligator - 5
Operators Manual - 1
Large Clamp, Red - 1
Warranty Card - 1
Printer Paper Roll (original) - 1
Printer Paper Roll (new style) - 1
601PRO Series XL
Optional Accessories
•
•
•
•
•
•
•
•
•
•
Carry Case
RS232 Cable (9M-9F)
Printer Cable
Barcode, Keyboard, Wedge
Adapter, Banana, ECG
Keyboard English
Powercord Set Australian
Powercord Set Schuko
Powercord Set US 120 V
Powercord Set UK
601PRO Series XL
System Characteristics
• Keys grouped by color and functionality
• Red keys -used to access menu options
– Include previous key, the four SOFT KEYS,
and the enter key
• Black keys -gain access to additional
functions
– Include the esc/stop key, the view present
settings key, the print header key, and the
print data key.
601PRO Series XL
Setting Up the 601PRO
1.
2.
3.
4.
5.
6.
Using Factory Default Settings
Selecting the Test Standard
Selecting the Printer Output
Selecting the RS232 Baud Rate
Activating the Beeper
Setting the Time and Date
601PRO Series XL
Setting Up the 601PRO
7. Configuring the Enclosure Leakage for the
Auto mode Sequence
8. Selecting Language Options
9. Selecting the DC Option
10.Selecting the Auto/Step Tests: Controlled
Power Sequences or 601CE Conventional
Test
11.Sequences enabling Stop on Failure
12.Configuring for Device Records or
Templates
601PRO Series XL
Manual Mode
1.
2.
3.
4.
5.
Connecting the Device Under Test
The Power-Up Sequence
Selecting the Test Standard
Selecting the Class/Type
Saving Standard, Class, Type and Test
Current
6. Using View Present Settings
7. Manual Operation
601PRO Series XL
Auto/Step Modes
1. Selecting Auto or Step Mode Testing
2. Executing Auto and Step Mode Tests
3. Creating/Editing a Device Record or
Template
601PRO Series XL
Test Records
1. Sending Test Results from the 601PRO to
the Host
2. Computer
3. Test Data Record: Serial Output
4. Printing Test Records
5. Deleting Test Records
601PRO Series XL
Device Records and Templates
1. Connecting the 601PRO and the Host
Computer
2. Sending Device Information Records from
the 601PRO to the Host Computer
3. Receiving Device Information Records from
the Host computer
4. Device Information Record: Definition of
Fields
5. Device Information Record Format
6. Deleting Device Records and Templates
601PRO Series XL
Testing Devices
1. Permanently Wired Devices
2. Portable Devices
3. Portable Devices in Isolated Power
Systems
4. Testing Three-Phase Portable Devices
5. Testing Conductive Surfaces
6. Detachable Power Supply Cable
7. Battery-Powered Equipment
601PRO Series XL
Standards and Principles
1. Accessing System Setup
2. Selecting the Test Standard
3. Referring to Test Limits for the
Selected Standard