Medical equipment 02

LECTURE 2:
Calibration and electrical safety of
medical equipment
Calibration and electrical safety of medical
equipment
Topics:
• Electrical safety (when to test?).
• Regulatory requirements of test and calibration service.
• Calibration definition.
• Calibration importance.
• International electrotechnical commission(IEC)
• Classes and types of medical electrical.
• Electrical Shock Hazard
• Electrical Safety Analyzer 601PRO Series- XL-Fluke
 Electrical Safety
Electrical safety (when to test?):
Electrical safety is very important factor that needs to be
tested:
a) On newly acquired equipment prior to being accepted
for use.
b) During routine planned preventative maintenance.
c) After repairs have been carried out on equipment.

Test and measurement performed according to the

International protocols IEC 60601 and IEC 62353 (which is
valid for medical devices)
 Electrical Safety
Hazards medical electrical equipment:
• Medical electrical equipment can present a
rang of hazards to the patient, the user, or to
service personnel.
• Many such hazards are common to many or all
types of medical electrical equipment, whilst
others are strange to particular categories of
equipment.
Regulatory requirements of test and calibration
service
• Written program
• Routine calibration or verification at suitable intervals
• Control of check, 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
 Calibration verification
• 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.
 Biomedical calibration
Biomedical calibration measurement:
• Is the measurement of the accuracy of the
medical device or the medical system by
using the standard measurement system
whose accuracy is known, and is the
determination and the record of the
deviations.
 Calibration importance
Properly calibrated equipment provides confidence that your
Products/Services meet their specifications.
• Calibration:
1. Increases production yields,
2. Optimizes resources,
3. Ensures measurements (and perhaps products) are
compatible with those made elsewhere.
4. By making sure that your measurements are based on
international standards, you stimulate customer
acceptance of your products around the world.
 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 and standards
 AAMI, IEC, UL, NFPA, etc.
• Protect against legal liability

In case of a patient incident

International electrotechnical commission (IEC)
• The International electrotechnical
commission (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”.
Classes of medical electrical equipment
• Equipment Class {I,II,III} method of protection
against electric shock
 Types of medical electrical equipment
• Equipment Types {B,BF, CF} degree of protection
 Applied Part
• Parts that contact PATIENTS
• 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.
 Electrical Shock Hazard
• A common experience due to electric shock associated with
equipment's.
• 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
* Absence of concept/ faulty design
* Relied upon life support devices(pacemaker/respirators)
An Introduction to safety Analyzer
 Electrical Shock Hazard
• Use of medical equipment in conjunction with other
instruments and equipment
• 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 stimulation varies from individual to
individual.
An Introduction to Electric shock Hazard
 Micro-current Shock
• Current passes directly through the
heart wall
• Threshold 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
Physiological Effects of Electricity
 6o1PRO Series XL-
Available electrical safety tests
 Mains voltage Mains on applied part
 Dual lead voltage leakage
 Dual Lead Leakage Patient auxiliary
 Current consumption current
Accessible voltage
 Insulation Resistance
Accessible leakage
 Protective earth resistance Equivalent device
 Earth leakage current leakage
 Patient leakage current Equivalent patient
leakage
References