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Calibration and Electrical Safety of Medical Equipment

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Electrical Shock Hazard An Introduction to ... measuring and test equipment ... there being no provision for protective earthing or reliance upon installation ... – PowerPoint PPT presentation

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Title: Calibration and Electrical Safety of Medical Equipment


1
Calibration and Electrical Safety of Medical
Equipment
  • Dr Fadhl Al-Akwaa
  • fadlwork_at_gmail.com
  • www.Fadhl-alakwa.weebly.com

2
Why Test Calibration
  • What you cannot measure you cannot control

3
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 the process
of calibration.
4
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
5
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
6
What to TEST for?
Performance Testing Safety Testing
7
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.

8
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.
9
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

10
International Electrotechnical Commission
  • The International Electrotechnical Commission1
    (IEC) is a non-profit, non-governmental
    international standards organization that
    prepares and publishes International Standards
    for all electrical, electronic and related
    technologies collectively known as
    "electrotechnology".

11
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.

12
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 dunités (in
    English, the International System of Units).

13
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.

14
List of IEC standards
  • IEC standards have numbers in the range
    6000079999 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.

15
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
16
List of IEC standards
  • IEC 60601 Medical Electrical Equipment
  • IEC 62304 Medical Device Software - Software Life
    Cycle Processes
  • IEC 62366 Medical devicesApplication of
    usability engineering to medical devices
  • IEC 62464 Magnetic resonance equipment for
    medical imaging

http//en.wikipedia.org/wiki/List_of_IEC_standards
17
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.

18
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

19
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

20
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21
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
22
Classes and types of medical electrical equipment
  • Equipment ClassI,II,III method of protection
    against electric shock
  • Equipment TypeB,BF,CF degree of protection

23
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.

24
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.

25
Class I
26
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

27
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

28
Class II
29
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.

30
  • 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".

31
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.
32
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.

33
Terminology and definitions
  • http//www.601help.com/Disclaimer/glossary.htmlPr
    otectiveEarthTerminal

34
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

35
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

36
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 ? resistor
produces 1 W of heat. A 1 Vrms square wave
applied across a 1 ? 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.
37
Calculate RMS
0.707 Vpk
38
  • 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.

39
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

40
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41
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
42
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

43
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

44
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.

45
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46
EARTH LEAKAGE CURRENT
  • current flowing from the MAINS PART through or
    across the insulation into the PROTECTIVE EARTH
    CONDUCTOR

47
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.

48
EARTH LEAKAGE CURRENT Measurement
49
Measurement of earth leakage current
50
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.

51
Enclosure leakage current/ touch current
52
Measurement of enclosure leakage current
53
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.

54
Patient leakage current
55
Measurement of patient leakage current
56
Measurement of patient leakage current
57
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

58
Patient auxiliary current
59
Measurement of patient auxiliary current.
60
Mains on applied parts
61
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 0.2? at any such
    point. The test is obviously only applicable to
    class I equipment.

62
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 example, functional
    earths.

63
  • Applicable to Class I, all types
  • Limit 0.2?
  • DB9801 recommended? Yes, at 1A or less.
  • HEI 95 recommended? Yes, at 1A or less. Notes
    Ensure probe is on a protectively earthed point

64
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.

65
  • Applicable to Class I, all types
  • Limits Not less than 50M?
  • DB9801 recommended? Yes
  • HEI 95 recommended? Yes
  • Notes Equipment containing mineral insulated
    heaters may give values down to 1M?. Check
    equipment is switched on.

66
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 50M?
    (see figure 10).

67
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.

68
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
69
Limitation of voltage, current or energy(87)
70
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71
Electrical Safety Tests
http//www.ebme.co.uk/arts/safety/part6.htm
  • Available electrical safety tests include
  • 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

72
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
73
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 Safety Analyzer
74
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
75
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
76
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

An Introduction to Electric Shock Hazard
77
Physiological Effects of Electricity
78
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

79
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
80
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
81
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
82
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
83
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
84
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

An Introduction to Electric Shock Hazard
85
Macroshock and Microshock
86
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

87
Automated Electrical Safety Analyzer 601PRO
Series XL Fluke Biomedical
88
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
89
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
90
Standard Features
  • Flags failures, and simulates performance, ECG,
    and arrhythmia, waveforms.
  • Results automatically analyzed and saved in
    non-volatile memory
  • Accepts device information that is input using an
  • External keyboard,
  • Integrated keypad,
  • Barcode keyboard wedge
  • Optional Feature
  • Onboard thermal printing

601PRO Series XL
91
Specifications
Voltage Range 0 to 300 V True RMS (single and dual lead)
Accuracy DC - 100 Hz 1.5 of reading 1 LSD
Insulation Resistance Range 0.5 to 400.0 MO
Accuracy 5 of reading 2 LSD
Current Consumption Range 0 to 15 A ac True RMS
Accuracy 5 of reading 2 LSD
Mains on Applied Part Applied Voltage 110 of mains voltage
Accuracy 2 of reading 6 µA
Protective Earth Resistance Range 0.000 to 2.999 O
Accuracy 5 of reading 4 mO (1 A, 10 A, and 25 A test currents) (Refer to Operators 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
601PRO Series XL
92
Specifications
IEC601-1 and AAMI Leakage Currents 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 Simulation and Performance Testing 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
93
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
94
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
95
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
96
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
97
Setting Up the 601PRO
  1. Using Factory Default Settings
  2. Selecting the Test Standard
  3. Selecting the Printer Output
  4. Selecting the RS232 Baud Rate
  5. Activating the Beeper
  6. Setting the Time and Date

601PRO Series XL
98
Setting Up the 601PRO
  1. Configuring the Enclosure Leakage for the Auto
    mode Sequence
  2. Selecting Language Options
  3. Selecting the DC Option
  4. Selecting the Auto/Step Tests Controlled Power
    Sequences or 601CE Conventional Test
  5. Sequences enabling Stop on Failure
  6. Configuring for Device Records or Templates

601PRO Series XL
99
Manual Mode
  1. Connecting the Device Under Test
  2. The Power-Up Sequence
  3. Selecting the Test Standard
  4. Selecting the Class/Type
  5. Saving Standard, Class, Type and Test Current
  6. Using View Present Settings
  7. Manual Operation

601PRO Series XL
100
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
101
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
102
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
103
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
104
Standards and Principles
  1. Accessing System Setup
  2. Selecting the Test Standard
  3. Referring to Test Limits for the Selected Standard

601PRO Series XL
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