BME-2516

Electronics in Bioelectrical
Applications
Lecture 6 part 1 – Patient safety II

Sari Ahokas
sari.ahokas@tut.fi
Department of Biomedical Engineering
Tampere University of Technology
Spring 2011

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Patient safety

Patient safety is of major concern in medical electronics, must

be considered and certified

SAFETY: freedom of hazards or risks (minimized)

Absolute safety cannot be achieved in medicine

• freedom of non-acceptable risk factors
• risk minimized with respect to the benefits

Total safety = safety of the device and its use + environmental safety
(effect of the environment)

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Physiological effects of electrical current

Electric stimulation of excitable tissue (nerve or

muscle)
Resistive heating of tissue
Electrochemical burns and tissue damage
Involuntary muscle contraction
unconciousness
VF
Secondary effects: falling

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 Let go current vs. frequency

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Components of electrical safety

design according to the safety standards SFS-EN 60601 Safety of electrical

medical devices

electrical medical device = used to study, treat or monitor, connected

electrically or physically to patient or transfers energy to/from patient

safety factors
• protection against excess current and voltage
• leakage voltage, isolation
• Insulation
• minimize the incidence of human errors
• Availability of electric power

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Skin resistance and risk of macroshocks

Potential difference required for current to flow (e.g. unprotected part with
voltage + grounded part)
Skin impedance
• Dependens on current path, voltage, duration, frequency, skin resistance,
area, individuals, …
• Resistance of the skin: Webster: “For 1cm2 of electronic contact with dry,
intact skin, resistance may range from 15k to almost 1M , depending on
the part of the body and the moisture or sweat present.”
• For wet or broken skin resistance down to 1%
• Internal resistance only 100-200
• Electrodes, catheters, electronic thermometers, etc. make patient more
vulnerable to macroshocks

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Electric faults in equipments

Electric faults may be result of insulation

failure, shorted components, mechanical
failure
ungrounded
Power cords and receptacles under
physical stress

Fluids such as blood, urine may cause

short circuits if they enter devices

Electric shocks can occur if sufficient

potential exist between conductive
surfaces (e.g. chassis & GND)

Medical devices often have metal chassis grounded

or cabinet

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Electric faults

In ungrounded devices this may cause danger and macroshock to a person

touching simultaneously the chassis and the ground

Flowing current is voltage divided by the total resistance between two contact
points

Grounding the chassis the resistance through the ground line is much lower
than the skin impedance

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 Leakage currents

Major source of potentially lethal currents in an instrument is the leakage

current which is undesirable current flowing through or over insulator surface,
Webster:

= “small currents that inevitably flow between any adjacent insulated

conductors that are at different potentials”

usually the leakage current flows from the case to the ground through the stray
capacitance.

When the ground connection is broken, the leakage current can become
dangerous to the patient

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Department of Biomedical Engineering
Department of Biomedical Engineering
Department of Biomedical Engineering
Protection against electrical hazards

A. Power distribution

Isolated from all grounded objects and sources of electric current

All conductive surfaces close to patient set to same potential
Grounding with very well conducting elements (<0.15 )

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Protection against electrical hazards

B. Equipment design

Effective grounding
• three-wire receptacles (additional insulated ground for patient care areas)
• In critical care: every exposed conducting areas close to the patient must be grounded
(single ground point)
• Continuity of the ground wire must be regularly tested
• thick grounding cables decrease the resistance
Reduction of leakage current
• in chassis and in patient-leads
• proper insulation between hot wire and chassis
Double-insulated equipment
• normal insulation between energized conductors and the chassis
• secondary insulation between the chassis and outer surface
in case of ground fault the outer surface can not be energized to hazardous potential

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 operation at low voltages
• low voltage is always safer than high voltage battery powered
systems
• macroshock can be avoided but not microshock

electrical isolation
• isolated preamplifier breaks the ohmic contact between the input
and output of the amplifier
• Different supply voltages and GND

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 Medical safety conclusion

Proper design
Good power distribution
Periodic testing
Training programs for medical personnel

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