SUMMER INTERNSHIP

A report of internship undergone at

Centre for Calibration and Testing of Medical Equipment

NHHID, Chennai -25.

Submitted by

SRIVARSHINI R – 2020116024

in partial fulfilment for the award of the degree of

BACHELOR OF ENGINEERING IN
BIOMEDICAL ENGINEERING

DEPARTMENT OF ELECTRONICS AND COMMUNICATION

ENGINEERING
ANNA UNIVERSITY, CHENNAI

JULY 2022

i
CERTIFICATE COPY

ii
 ACKNOWLEDGEMENT

I owe my sincere gratitude to Dr. M. MEENAKSHI, Professor and Head

(Department of Electronics and Communication Engineering), Dr. M. SASIKALA,
Professor in-charge and Director (Centre for Medical Electronics, Department of
Electronics and Communication Engineering), and all Professors who provided me
with the opportunity to get trained in National Hub for Healthcare Instrumentation
Development (NHHID) - Centre for Calibration and Testing of Medical
Equipment (CCTME), Chennai – 25.

My special thanks to Mr. C. KAUSHIK VIKNESH (Summer Internship

Training Coordinator and Faculty In-charge, Department of Electronics and
Communication Engineering) for taking the responsibility of making all the
arrangements which helped me to complete my summer internship training
successfully.

This training wouldn’t have been successful without the continuous effort and
guidance of Dr. M. SASIKALA, Coordinator, NHHID and Dr. S. MUTTAN
(Quality Manager, CCTME) who considered me as a member of their team and
oriented me as well as guided me in practically realizing the work of a Biomedical
Engineer.

Finally, I would like to thank all the other people in the department and my
colleagues who helped me and made it a worthwhile experience in my career.

R. Srivarshini
2020116024

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 TABLE OF CONTENTS

CHAPTER TITILE PAGE

NO. NO.
List of Tables xii
List of Figures xv
List of Abbreviations xviii
1. Introduction 1
1.1 About Centre for Calibration and Testing of Medical Equipment 1
1.2 Need for testing and calibration of medical equipment 1
1.3 Benefits of calibrating medical devices 2
1.4 Services 2
2. Facilities of Centre 3
2.1 Electrical Safety Analyzer 3
2.1.1 Description 3
2.1.2 Instrumentation Familiarization 4
2.1.3 Technical Specifications 6
2.1.4 SOP 6
2.1.5 Tolerance Range 11
2.2 Vital Sign Simulator 12
2.2.1 Description 12
2.2.2 Instrumentation Familiarization 13
2.2.3 Technical Specifications 14
2.2.4 Equipment Calibrated 14
2.2.4.1 Patient Monitor 14
2.2.4.1.1 Description 14
2.2.4.1.2 SOP 14
2.2.4.1.2.1 Scope 14
2.2.4.1.2.2 Reference 15
Standards
2.2.4.1.2.3 Masters Used 15
2.2.4.1.2.4 Environmental 15
Conditions
2.2.4.1.2.5 Calibration 15
Method
2.2.4.1.2.6 Precautions 15
2.2.4.1.2.7 Methodology 16
2.2.4.1.2.8 Performance 17
Parameters
2.2.4.2 ECG Monitor 21
2.2.4.2.1 Description 21
2.2.4.2.2 SOP 21
2.2.4.2.2.1 Scope 21
2.2.4.2.2.2 Reference 21
Standards
2.2.4.2.2.3 Masters Used 22
2.2.4.2.2.4 Environmental 22

iv
 Conditions
2.2.4.2.2.5 Calibration 22
Method
2.2.4.2.2.6 Precautions 22
2.2.4.2.2.7 Methodology 22
2.2.4.2.2.8 Performance 23
Parameters
2.2.4.3 Pulse Oximeter 25
2.2.4.3.1 Description 25
2.2.4.3.2 SOP 25
2.2.4.3.2.1 Scope 25
2.2.4.3.2.2 Reference 25
Standards
2.2.4.3.2.3 Masters Used 26
2.2.4.3.2.4 Environmental 26
Conditions
2.2.4.3.2.5 Calibration 26
Method
2.2.4.3.2.6 Precautions 26
2.2.4.3.2.7 Methodology 26
2.2.4.3.2.8 Performance 27
Parameters
2.2.4.4 Sphygmomanometer 29
2.2.4.4.1 Description 29
2.2.4.4.2 SOP 29
2.2.4.4.2.1 Scope 29
2.2.4.4.2.2 Reference 29
Standards
2.2.4.4.2.3 Masters Used 30
2.2.4.4.2.4 Environmental 30
Conditions
2.2.4.4.2.5 Calibration 30
Method
2.2.4.4.2.6 Precautions 30
2.2.4.4.2.7 Methodology 30
2.2.4.4.2.8 Performance 31
Parameters
2.2.4.5 Digital BP Apparatus 33
2.2.4.5.1 Description 33
2.2.4.5.2 SOP 33
2.2.4.5.2.1 Scope 33
2.2.4.5.2.2 Reference 33
Standards
2.2.4.5.2.3 Masters Used 34
2.2.4.5.2.4 Environmental 34
Conditions
2.2.4.5.2.5 Calibration 34
Method
2.2.4.5.2.6 Precautions 34
2.2.4.5.2.7 Methodology 34

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 2.2.4.5.2.8 Performance 35
Parameters
2.3 Gas Flow Analyzer 36
2.3.1 Description 36
2.3.2 Instrumentation Familiarization 36
2.3.3 Technical Specifications 38
2.3.4 Equipment Calibrated 39
2.3.4.1 Ventilator 39
2.3.4.1.1 Description 39
2.3.4.1.2 SOP 40
2.3.4.1.2.1 Scope 40
2.3.4.1.2.2 Reference 40
Standards
2.3.4.1.2.3 Masters Used 40
2.3.4.1.2.4 Environmental 40
Conditions
2.3.4.1.2.5 Calibration 41
Method
2.3.4.1.2.6 Precautions 41
2.3.4.1.2.7 Methodology 41
2.3.4.1.2.8 Performance 42
Parameters
2.3.4.2 Boyle’s Apparatus 44
2.3.4.2.1 Description 44
2.3.4.2.2 SOP 44
2.3.4.2.2.1 Scope 44
2.3.4.2.2.2 Masters Used 44
2.3.4.2.2.3 Environmental 44
Conditions
2.3.4.2.2.4 Calibration 44
Method
2.3.4.2.2.5 Precautions 45
2.3.4.2.2.6 Methodology 45
2.3.4.2.2.7 Performance 45
Parameters
2.3.4.3 Anesthesia Workstation 47
2.3.4.3.1 Description 47
2.3.4.3.2 SOP 47
2.3.4.3.2.1 Scope 47
2.3.4.3.2.2 Reference 47
Standards
2.3.4.3.2.3 Masters Used 48
2.3.4.3.2.4 Environmental 48
Conditions
2.3.4.3.2.5 Calibration 48
Method
2.3.4.3.2.6 Precautions 48
2.3.4.3.2.7 Methodology 48
2.3.4.3.2.8 Performance 49
Parameters

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 2.3.4.4 Suction Pump 52
2.3.4.4.1 Description 52
2.3.4.4.2 SOP 52
2.3.4.4.2.1 Scope 52
2.3.4.4.2.2 Reference 52
Standards
2.3.4.4.2.3 Masters Used 53
2.3.4.4.2.4 Environmental 53
Conditions
2.3.4.4.2.5 Calibration 53
Method
2.3.4.4.2.6 Precautions 53
2.3.4.4.2.7 Methodology 53
2.3.4.4.2.8 Performance 54
Parameters
2.3.4.5 Nebulizer 56
2.3.4.5.1 Description 56
2.3.4.5.2 SOP 56
2.3.4.5.2.1 Scope 56
2.3.4.5.2.2 Reference 56
Standards
2.3.4.5.2.3 Masters Used 56
2.3.4.5.2.4 Environmental 57
Conditions
2.3.4.5.2.5 Calibration 57
Method
2.3.4.5.2.6 Precautions 57
2.3.4.5.2.7 Methodology 57
2.3.4.5.2.8 Performance 58
Parameters
2.3.4.6 Gas Flow Meter 59
2.3.4.6.1 Description 59
2.3.4.6.2 SOP 59
2.3.4.6.2.1 Scope 59
2.3.4.6.2.2 Reference 59
Standards
2.3.4.6.2.3 Masters Used 60
2.3.4.6.2.4 Environmental 60
Conditions
2.3.4.6.2.5 Calibration 60
Method
2.3.4.6.2.6 Precautions 60
2.3.4.6.2.7 Methodology 60
2.3.4.6.2.8 Performance 61
Parameters
2.4 Electrosurgical Analyzer 62
2.4.1 Description 62
2.4.2 Instrumentation Familiarization 62
2.4.3 Technical Specifications 63
2.4.4 Equipment Calibrated 64

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 2.4.4.1 Electrosurgical Unit 64
2.4.4.1.1 Description 64
2.4.4.1.2 SOP 66
2.4.4.1.2.1 Scope 66
2.4.4.1.2.2 Reference 66
Standards
2.4.4.1.2.3 Masters Used 67
2.4.4.1.2.4 Environmental 67
Conditions
2.4.4.1.2.5 Calibration 67
Method
2.4.4.1.2.6 Precautions 67
2.4.4.1.2.7 Methodology 68
2.4.4.1.2.8 Performance 69
Parameters
2.5 Defibrillator Analyzer 72
2.5.1 Description 72
2.5.2 Instrumentation Familiarization 72
2.5.3 Technical Specifications 74
2.5.4 Equipment Calibrated 74
2.5.4.1 Defibrillator 74
2.5.4.1.1 Description 75
2.5.4.1.2 SOP 76
2.5.4.1.2.1 Scope 76
2.5.4.1.2.2 Reference 76
Standards
2.5.4.1.2.3 Masters Used 76
2.5.4.1.2.4 Environmental 76
Conditions
2.5.4.1.2.5 Calibration 76
Method
2.5.4.1.2.6 Precautions 77
2.5.4.1.2.7 Methodology 77
2.5.4.1.2.8 Performance 78
Parameters
2.6 Infusion Device Analyzer 82
2.6.1 Description 82
2.6.2 Instrumentation Familiarization 82
2.6.3 Technical Specifications 84
2.6.4 Equipment Calibrated 84
2.6.4.1 Infusion Pump 84
2.6.4.1.1 Description 85
2.6.4.1.2 SOP 85
2.6.4.1.2.1 Scope 85
2.6.4.1.2.2 Reference 85
Standards
2.6.4.1.2.3 Masters Used 85
2.6.4.1.2.4 Environmental 86
Conditions
2.6.4.1.2.5 Calibration 86

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 Method
2.6.4.1.2.6 Precautions 86
2.6.4.1.2.7 Methodology 86
2.6.4.1.2.8 Performance 87
Parameters
2.6.4.2 Syringe Pump 90
2.6.4.2.1 Description 90
2.6.4.2.2 SOP 90
2.6.4.2.2.1 Scope 90
2.6.4.2.2.2 Reference 90
Standards
2.6.4.2.2.3 Masters Used 91
2.6.4.2.2.4 Environmental 91
Conditions
2.6.4.2.2.5 Calibration 91
Method
2.6.4.2.2.6 Precautions 91
2.6.4.2.2.7 Methodology 91
2.6.4.2.2.8 Performance 92
Parameters
2.7 Incubator Analyzer 95
2.7.1 Description 95
2.7.2 Instrumentation Familiarization 95
2.7.3 Technical Specifications 97
2.7.4 Equipment Calibrated 98
2.7.4.1 Infant Incubator 98
2.7.4.1.1 Description 98
2.7.4.1.2 SOP 98
2.7.4.1.2.1 Scope 98
2.7.4.1.2.2 Reference 98
Standards
2.7.4.1.2.3 Masters Used 99
2.7.4.1.2.4 Environmental 99
Conditions
2.7.4.1.2.5 Calibration 99
Method
2.7.4.1.2.6 Precautions 99
2.7.4.1.2.7 Methodology 100
2.7.4.1.2.8 Performance 101
Parameters
2.7.4.2 Radiant Warmer 103
2.7.4.2.1 Description 103
2.7.4.2.2 SOP 103
2.7.4.2.2.1 Scope 103
2.7.4.2.2.2 Reference 103
Standards
2.7.4.2.2.3 Masters Used 104
2.7.4.2.2.4 Environmental 104
Conditions
2.7.4.2.2.5 Calibration 104

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 Method
2.7.4.2.2.6 Precautions 104
2.7.4.2.2.7 Methodology 104
2.7.4.2.2.8 Performance 105
Parameters
2.8 Fetal Simulator 107
2.8.1 Description 107
2.8.2 Instrumentation Familiarization 107
2.8.3 Technical Specifications 108
2.8.4 Equipment Calibrated 109
2.8.4.1 Fetal Monitor 109
2.8.4.1.1 Description 109
2.8.4.1.2 SOP 109
2.8.4.1.2.1 Scope 109
2.8.4.1.2.2 Reference 110
Standards
2.8.4.1.2.3 Masters Used 110
2.8.4.1.2.4 Environmental 110
Conditions
2.8.4.1.2.5 Calibration 110
Method
2.8.4.1.2.6 Precautions 110
2.8.4.1.2.7 Methodology 110
2.8.4.1.2.8 Performance 111
Parameters
2.8.4.2 Fetal Doppler 113
2.8.4.2.1 Description 113
2.8.4.2.2 SOP 113
2.8.4.2.2.1 Scope 113
2.8.4.2.2.2 Reference 113
Standards
2.8.4.2.2.3 Masters Used 114
2.8.4.2.2.4 Environmental 114
Conditions
2.8.4.2.2.5 Calibration 114
Method
2.8.4.2.2.6 Precautions 114
2.8.4.2.2.7 Methodology 114
2.8.4.2.2.8 Performance 115
Parameters
2.9 Standard Weights 117
2.9.1 Description 117
2.9.2 Technical Specifications 117
2.9.3 Equipment Calibrated 117
2.9.3.1 Weighing Scale 117
2.9.3.1.1 Description 118
2.9.3.1.2 SOP 118
2.9.3.1.2.1 Scope 118
2.9.3.1.2.2 Reference 118
Standard

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 2.9.3.1.2.3 Masters Used 118
2.9.3.1.2.4 Environmental 118
Conditions
2.9.3.1.2.5 Calibration 118
Method
2.9.3.1.2.6 Precautions 119
2.9.3.1.2.7 Methodology 119
2.9.3.1.2.8 Performance 119
Parameters
2.10 Analytical Balance 121
2.10.1 Description 121
2.10.2 Instrumentation Familiarization 121
2.10.3 Technical Specifications 122
2.10.4 Equipment Calibrated 122
2.10.4.1 Micropipette 122
2.10.4.1.1 Description 122
2.10.4.1.2 SOP 123
2.10.4.1.2.1 Scope 123
2.10.4.1.2.2 Masters Used 123
2.10.4.1.2.3 Environmental 123
Conditions
2.10.4.1.2.4 Calibration 123
Method
2.10.4.1.2.5 Precautions 123
2.10.4.1.2.6 Methodology 124
2.10.4.1.2.7 Performance 124
Parameters
3. Medicall Expo Visit 126
4. Hospital Visit 128
5. Conclusion 130

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 LIST OF TABLES

Table No. Title Page No.

2.1 ESA Front Panel Control and Connections 4
2.2 ESA Side Panel Control and Connections 5
2.3 ESA Technical Specifications 6
2.4 ESA Tolerance Range 11
2.5 VSS Technical Specifications 14
2.6 PM Reference Standard 15
2.7 Masters’ details for PM 15
2.8 Tolerance Range for PM 17
2.9 Reference Standard for ECG Monitor 21
2.10 Masters’ details for ECG Monitor 22
2.11 Reference Standard for Pulse Oximeter 25
2.12 Masters’ details for Pulse Oximeter 26
2.13 Reference Standard for Sphygmomanometer 29
2.14 Masters’ details for Sphygmomanometer 30
2.15 Reference Standard for Digital BP Apparatus 33
2.16 Masters’ details for Digital BP Apparatus 34
2.17 Gas Flow Analyzer Keypad Functions 37
2.18 Gas Flow Analyzer Technical Specifications 38
2.19 Ventilator Reference Standard 40
2.20 Masters’ details for Ventilator 40
2.21 Tolerance Range for Ventilator 42
2.22 Masters’ details for Boyle’s Apparatus 44
2.23 Tolerance Range for Boyle’s Apparatus 45
2.24 Reference Standard for Anesthesia Workstation 47
2.25 Masters’ details for Anesthesia Workstation 48
2.26 Tolerance Range for Anesthesia Workstation 49
2.27 Reference Standard for Suction Pump 52
2.28 Masters’ details for Suction Pump 53
2.29 Reference Standard for Nebulizer 56
2.30 Masters’ details for Nebulizer 56

xii
2.31 Gas Flow Meter Reference Standard 59
2.32 Masters’ details for Gas Flow Meter 60
2.33 Tolerance Range for Gas Flow Meter 61
2.34 Electrosurgical Analyzer Controls and Connections 63
2.35 Electrosurgical Analyzer Technical Specifications 64
2.36 ESU Reference Standard 66
2.37 Masters’ details for ESU 67
2.38 Defibrillator Analyzer Front Panel Controls and Connections 73
2.39 Defibrillator Analyzer Rear Panel Connections 73
2.40 Defibrillator Analyzer Technical Specifications 74
2.41 Defibrillator Reference Standard 76
2.42 Masters’ details for Defibrillator 76
2.43 Tolerance Range for Defibrillator 78
2.44 IDA Front Panel Controls and Connections 83
2.45 IDA Rear Panel Connections 83
2.46 IDA Technical Specifications 84
2.47 Infusion Pump Reference Standard 85
2.48 Masters’ details for Infusion Pump 85
2.49 Reference Standard for Syringe Pump 90
2.50 Masters’ details for Syringe Pump 91
2.51 Incubator Analyzer Connections 96
2.52 Incubator Analyzer Front Panel Controls 97
2.53 Incubator Analyzer Technical Specifications 97
2.54 Infant Incubator Reference Standard 99
2.55 Masters’ details for Infant Incubator 99
2.56 Reference Standard for Radiant Warmer 103
2.57 Masters’ details for Radiant Warmer 104
2.58 Fetal Simulator Control and Connections 108
2.59 Fetal Simulator Technical Specifications 108
2.60 Fetal Monitor Reference Standard 110
2.61 Masters’ details for Fetal Monitor 110
2.62 Reference Standard for Fetal Doppler 113
2.63 Masters’ details for Fetal Doppler 114

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2.64 Standard Weights Technical Specifications 117
2.65 Weighing Scale Reference Standard 118
2.66 Masters’ details for Weighing Scale 118
2.67 Analytical Balance Controls 122
2.68 Analytical Balance Technical Specifications 122
2.69 Masters’ details for Micropipette 123
4.1 Equipment Calibrated 129

xiv
 LIST OF FIGURES

Figure No. Title Page No.

2.1 Electrical Safety Analyzer 3
2.2 ESA Front Panel Control and Connections 4
2.3 ESA Side Panel Control and Connections 5
2.4 Mains Voltage test menu 6
2.5 Protective Earth Resistance test menu 7
2.6 Insulation Resistance test menu 8
2.7 Earth Leakage Current test menu 8
2.8 Enclosure Leakage Current test menu 9
2.9 Patient Leakage Current test menu 9
2.10 Patient Leakage Current lead selection 10
2.11 Patient Auxiliary Leakage Current test menu 10
2.12 Patient Auxiliary Leakage Current lead selection 10
2.13 Vital Signs Simulator 12
2.14 VSS Front Panel Controls 13
2.15 VSS Rear Panel Connections 13
2.16 Patient Monitor 14
2.17 Patient Simulator Settings 18
2.18 Setting Respiration rate 18
2.19 SpO2 Setup 19
2.20 NIBP Test Settings 20
2.21 ECG Monitor 21
2.22 ECG Heart Rate Settings 24
2.23 Pulse Oximeter 25
2.24 SpO2 Test Settings 28
2.25 Sphygmomanometer 29
2.26 NIBP Test Selection Menu 31
2.27 NIBP Manometer Mode 31
2.28 NIBP Leak Test 32
2.29 Digital BP Apparatus 33
2.30 NIBP Test Menu 35

xv
2.31 Gas Flow Analyzer 36
2.32 Gas Flow Analyzer Interface Module 36
2.33 Back of Interface Module 37
2.34 Oxygen Sensor Kit 37
2.35 High Flow Module 38
2.36 Ventilator 39
2.37 Ventilator Interfacing 43
2.38 Gas Flow Analyzer Parameter Screen 43
2.39 Boyle’s Apparatus 44
2.40 Anesthesia Workstation 47
2.41 Suction Pump 52
2.42 Nebulizer 56
2.43 Gas Flow Meter 59
2.44 Electrosurgical Analyzer 62
2.45 Electrosurgical Analyzer Front Panel Control and 62
Connections
2.46 Electrosurgical Analyzer Rear Panel Connections 62
2.47 Electrosurgical Unit 64
2.48 Defibrillator Analyzer 72
2.49 Defibrillator Analyzer Front Panel Controls and Connections 72
2.50 Defibrillator Analyzer Rear Panel Connections 73
2.51 Defibrillator 74
2.52 Defibrillator Menu 78
2.53 Defibrillator Charge Time 79
2.54 ECG Heart Rate Setting 80
2.55 Amplitude Setting 80
2.56 Defibrillator Synchronization Test 81
2.57 Infusion Device Analyzer 82
2.58 IDA Front Panel Controls and Connections 82
2.59 IDA Rear Panel Connections 83
2.60 Infusion Pump 84
2.61 Priming Screen 88
2.62 Channel Flow Screen 89
2.63 Occlusion Screen 89

xvi
2.64 Syringe Pump 90
2.65 Bolus Screen 93
2.66 Flow rate Screen 94
2.67 Occlusion Pressure Screen 94
2.68 Incubator Analyzer 95
2.69 Incubator Analyzer Connections 95
2.70 Incubator Analyzer Front Panel Controls 96
2.71 Infant Incubator 98
2.72 Temperature Probe Connections 101
2.73 Incubator Test Setup with probes 102
2.74 Radiant Warmer 103
2.75 Temperature Sensor Probe Connections 106
2.76 Fetal Simulator 107
2.77 Fetal Simulator Front Panel Control and Connections 107
2.78 Fetal Monitor 109
2.79 MFH 112
2.80 Fetal Doppler 113
2.81 Mechanical Fetal Heart 116
2.82 Standard Weights 117
2.83 Adult Weighing Scale 117
2.84 Analytical Balance 121
2.85 Analytical Balance Controls 121
2.86 Micropipette 122
2.87 Weighing Result Window 124
3.1 Medicall Expo 126
4.1 DRR Eye Hospital 128

xvii
 LIST OF ABBREVIATIONS

Abbreviations Explanations
NHHID National Hub for Healthcare Instrumentation Development
CCTME Centre for Calibration and Testing of Medical Equipment
NABH National Accreditation Board for Hospital and Healthcare
Providers
AERB Atomic Energy Regulatory Board
ECG Electrocardiogram
IBP Invasive Blood Pressure
NIBP Non-Invasive Blood Pressure
SpO2 Oxygen Saturation
LCD Liquid Crystal Display
AC/DC supply Alternating Current / Direct Current
LED Light Emitting Diode
USB Universal Serial Bus
IEC International Electrotechnical Commission
ESU Electrosurgery Units
HF High Frequency
CE European Conformity
ESA Electrical Safety Analyzer
DUT Device Under Test
DST Department Of Science and Technology
SOP Standard Operating Procedure
PE Protective Earth
AP Applied Part
NC Normal Connection
ON Open Neutral
ON-R Open Neutral – Reverse Polarity
NC-R Normal Connection – Reverse Polarity
OE Open Earth
OE-R Open Earth – Reverse Polarity
VSS Vital Signs Simulator

xviii
BPM Beats Per Minute
BrPM Breaths Per Minute
LPM Litres Per Minute
CPM Cubic Feet Per Minute
PM Patient Monitor
STD Standard
BP Blood Pressure
ISO International Organization for Standardization
AED Automated External Defibrillation
Sync Synchronize
V. Fib Ventricular Fibrillation
IDA Infusion Device Analyzer
LSD Least Significant Digit
IV Intravenous
ESU Electrosurgical Unit
RMS Root Mean Square
MFH Mechanical Fetal Heart
SS Stainless Steel
IS Indian Standard
PIP Peak Inspiratory Pressure
PEEP Positive End Expiratory Pressure
OT Operation Theatre

xix
 CHAPTER 1
INTRODUCTION

1.1 ABOUT CENTRE FOR CALIBRATION AND TESTING OF

MEDICAL EQUIPMENT

National Hub for Healthcare Instrumentation Development (NHHID) was

established in Anna University with DST funding in 2011 for promoting and
accelerating indigenous development of healthcare instrumentation. Centre for
Calibration and Testing of Medical Equipment (CCTME) is a sophisticated
laboratory of NHHID equipped with state-of-the-art calibrating equipment, IEC
standards, operating procedures and trained professionals guided by faculty
experts to perform calibration of medical devices to ensure reliable performance
for quality healthcare. It provides credible traceability certificates along with
calibration reports.

1.2 NEED FOR TESTING AND CALIBRATION OF MEDICAL

EQUIPMENT
 Medical device failures can be disastrous, but they can be quickly
resolved if immediate action to determine the cause of failure.
 In 1999, the Institute of Medicine issued a report finding that anywhere
between 44,000 and 98,000 patients die each year in hospitals as a result
of medical errors, including equipment and operator errors or failures.
 A defective device or improperly programmed infusion pump might
deliver an overdose of a medication that can significantly harm you or a
loved one. Premature babies, the elderly, and patients with chronic
illnesses can be seriously injured by even the smallest of errors.

1
  A malfunctioning heart monitor could miss a dangerous, life threatening,
heart arrhythmia that could lead to a failure to diagnose and treat a
potentially fatal or deadly heart rhythm.
 Testing and calibration of medical equipment ensures accuracy,
effectiveness and long life of equipment.
 Accurate measurements play a vital role at each stage in development and
production of quality medical services.
 The effectiveness of quality control steps depends directly on the
accuracy and confidence with which the test and measuring instruments
can yield test results.
 Periodic checking of test and measuring instruments is very essential for
reliable measurements and diagnosis.

1.3 BENEFITS OF CALIBRATING MEDICAL DEVICES

 Provides greater quality of healthcare

 Boosts patients’ confidence
 Mandate for accreditation process (like NABH)
 Contributes to patients’ safety against electrical hazards
 Lowers risk due to equipment malfunction and increases patients’ safety

1.4 SERVICES

 On-site and In-house testing and calibration of medical devices

 Diagnosis of problems and recommendation for service
 Quality Assurance check for radiological equipment as per AERB
protocols
 Free recalibration (within Chennai)

2
 CHAPTER 2

FACILITIES OF CENTRE

2.1 ELECTRICAL SAFETY ANALYZER

Figure 2.1 – Electrical Safety Analyzer

2.1.1 DESCRIPTION

An electrical safety analyzer is an instrument used to perform various

electrical safety tests, including ground continuity test, insulation test, high
voltage test, and line leakage test, to check that the device under test is in
compliance with electrical safety requirements. Gross shock is experienced by
an accidental contact with the electric supply at any point on the surface of the
body. The micro shock is caused by the leakage current of extremely small
magnitude that can be fatal to a patient when a direct, localized electrical path
exists to the heart. Leakage currents are divided according to the current path
into the enclosure leakage current, earth leakage current, and patient leakage
current. Electrical safety analyzers are widely used to perform field service on
medical equipment throughout their facilities, in clinics, or any place where on-
site service is required.

3
2.1.2 INSTRUMENT FAMILIARIZATION

Figure 2.2 – ESA Front Panel Control and Connections

Table 2.1 – ESA Front Panel Control and Connections

4
Figure 2.3 – ESA Side Panel Control and Connections

Table 2.2 – ESA Side Panel Control and Connections

5
2.1.3 TECHNICAL SPECIFICATIONS

Table 2.3 – ESA Technical Specifications

Voltage
Ranges (Mains voltage) 90.0 V to 132.0 V ac rms
180.0 V to 264.0 V ac rms
Earth Resistance
Range 0.000 Ω to 2.000 Ω
Accuracy ±(2 % of reading + 0.015 Ω)
Equipment Current
Range 0.0 A to 20.0 A ac rms
Accuracy ±(5 % of reading + (2 counts or 0.2 A,
whichever is greater))
Leakage Current
Crest factor ≤3
Range 0.0 μA to 199.9 μA
200 μA to 1999 μA
2.00 mA to 10.00 mA
Accuracy
DC to 1 kHz ±(1 % of reading + (1 μA or 1 LSD,
whichever is greater))
2.1.4 SOP

Switch ON the Electrical Safety Analyzer.

Measure the following parameters using Electrical Safety Analyzer and ensure
if it lies in the permissible range.

1. MAINS VOLTAGE TEST (V)

 To access the Mains Voltage test, push V button.
 Push each function softkey to do each of the three measurements: Live to
neutral, neutral to ground, and live to ground.

Figure 2.4 – Mains Voltage test menu

6
 Note down the observed readings.
 Repeat the procedure thrice.
2. CURRENT TEST (A)
 To measure the current consumed by the DUT, push A button.
 Note down the observed readings.
 Repeat the procedure thrice.
3. PROTECTIVE EARTH RESISTANCE TEST (Ω)
 Make sure the power cord from the DUT is connected into the test
receptacle.
 Push Ω to reveal the resistance function menu.
 Connect one end of a test lead to the V/Ω/A jack.
 Connect the test lead from the V/Ω/A jack to the DUT enclosure or
protective earth connection.

Figure 2.5 – Protective Earth Resistance test menu

 After you make the connections to the DUT, the measured resistance
shows in the display.
 Note down the observed readings.
 Repeat the procedure thrice.

7
4. INSULATION RESISTANCE TEST (MΩ)
 Make sure the power cord from the DUT is connected into the test
receptacle.
 Push MΩ to reveal the resistance function menu.
 Connect one end of a test lead to the V/Ω/A jack.
 Connect the test lead from the V/Ω/A jack to the DUT enclosure or
protective earth connection.

Figure 2.6 – Insulation Resistance test menu

 After you make the connections to the DUT, the measured resistance is
shown in the display for Mains-P.E, A.P-P.E, Mains-A.P.
 Note down the observed readings.
 Repeat the procedure thrice.
5. EARTH LEAKAGE CURRENT TEST (µA)
 Connect a lead between the V/Ω/A jack and the DUT enclosure.
 Push µA.
 Push the Earth Leakage softkey from the Leakage Current Test menu.

Figure 2.7 – Earth Leakage Current test menu

8
 Measure the current shown in the display for the conditions: NC, ON,
ON-R, NC-R.
 Note down the observed readings.
 Repeat the procedure thrice.
6. CHASSIS (ENCLOSURE) LEAKAGE CURRENT TEST (µA)
 Connect a lead between the V/Ω/A jack and the DUT enclosure.
 Push µA.
 Push the Chassis softkey from the Leakage Current Test menu.

Figure 2.8 – Enclosure Leakage Current test menu

 Measure the current shown in the display for the conditions: NC, OE,
ON, OE-R, ON-R, NC-R.
 Note down the observed readings.
 Repeat the procedure thrice.
7. LEAD-TO GROUND (PATIENT) LEAKAGE CURRENT TEST
(µA)
 Push µA.
 Push the More softkey.

Figure 2.9 – Patient Leakage Current test menu

9
 Push the Select softkey.
 Push < or > to advance through each applied part grouping, or the
individual applied parts, to ground.

Figure 2.10 – Patient Leakage Current lead selection

 Measure the current shown in the display for the conditions: NC, OE,
ON, OE-R, ON-R, NC-R.
 Note down the observed readings.
 Repeat the procedure thrice.
8. PATIENT AUXILIARY LEAKAGE CURRENT TEST (µA)
 Push µA.
 Push the Patient Auxiliary softkey.

Figure 2.11 – Patient Auxiliary Leakage Current test menu

 Select any lead for this test.

Figure 2.12 – Patient Auxiliary Leakage Current lead selection

10
  Measure the current shown in the display for the conditions: NC, OE,
ON, OE-R, ON-R, NC-R.
 Note down the observed readings.
 Repeat the procedure thrice.

2.1.5 TOLERANCE RANGE

As per the standard IEC 60601-1, following are the permissible tolerance values
for efficient functioning of DUT.

Table 2.4 – ESA Tolerance Range

Mains 230V±10%
Insulation >2MΩ
Protective Earth <3Ω
Earth Leakage Current
NC <5000µA
SFC <10000µA
Enclosure Leakage Current
NC <100µA
SFC <500µA
Patient Leakage Current
Type B, BF
NC <100µA
SFC <500µA
Type CF
NC <10µA
SFC <50µA
Patient Auxiliary Current
Type B, BF
NC <100µA
SFC <500µA
Type CF
NC <10µA
SFC <50µA

11
2.2 VITAL SIGNS SIMULATOR

Figure 2.13 – Vital Signs Simulator

2.2.1 DESCRIPTION

The vital sign simulator simulates a patient monitor and is intended for
use in medical emergency training simulations. Vital Signs Simulator offers
total patient monitor quality and safety testing from non-invasive blood pressure
(NIBP), static pressure and dynamic pressure tests. It offers secure lead
connections and assures patient monitor quality and safety. It tests ECG,
arrhythmias, respiration, temperature, IBP, NIBP, cardiac output,
catheterization, SpO2 in a single 5-minute patient monitor testing tool.

12
2.2.2 INSTRUMENT FAMILIARIZATION

Figure 2.14 – VSS Front Panel Controls

Figure 2.15 – VSS Rear Panel Connections

13
2.2.3 TECHNICAL SPECIFICATIONS

Table 2.5 – VSS Technical Specifications

ECG 20 to 300 BPM

NIBP 0 to 410 mmHg
IBP 0 to 300mmHg
SpO2 50 to 100%
Respiration 5 to 180 BrPM

2.2.4 EQUIPMENT CALIBRATED

2.2.4.1 PATIENT MONITOR

Figure 2.16 – Patient Monitor

2.2.4.1.1 DESCRIPTION

Patient monitors measure, record, distribute and display combinations of

biometric values such as heart rate, SPO2, blood pressure, temperature and
more. High-capability, multi-function monitors are typically used in hospitals
and clinics to ensure a high level of quality patient care.

2.2.4.1.2 SOP

2.2.4.1.2.1 SCOPE

To test the Patient Monitor using Vital Signs Simulator and ESA.

14
2.2.4.1.2.2 REFERENCE STANDARD

Table 2.6 – PM Reference Standard

IEC 60601-1 General requirements for basic safety

and essential performance

Pulse oximetry standard ISO Basic safety and essential performance

9919:2005. requirements of multifunction patient
NIBP and ECG IEC 60601-2-27, IEC monitoring equipment.
60601-2- 34, IEC 60601-2-49

2.2.4.1.2.3 MASTERS USED

Table 2.7 – Masters’ details for PM

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Vital Signs Simulator Rigel UNISIM LITE

2.2.4.1.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.2.4.1.2.5 CALIBRATION METHOD

Direct Method

2.2.4.1.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.

15
2.2.4.1.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection

 Check the device for contamination and verify its clean

&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Patient Leakage Current
 Patient Auxiliary Leakage Current
 Insulation Resistance Test

16
2.2.4.1.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Table 2.8 – Tolerance Range for PM

Switch ON the Vital Signs Simulator.

Measure the following parameters using Vital Signs Simulator and ensure
if it lies in the permissible range.

1. ECG HEART RATE (BPM)

 Interface the ECG Adapter Module to the DUT and the master.
 Interface the ECG Leads to the ECG Adapter Module with respect
to the colour code.
 Select the Patient test Settings to set the parameters forHeart rate.
Set the STD value to 10%, 50%, 100% of the operating range of
DUT.
 The different options above are available across three individual
screens accessible using the tab button (F2)

17
 Figure 2.17 – Patient Simulator Settings

 Referring to fig 2.17, manually enter the required heart rate.

 Select by pressing the key (F4) and confirm.
 Press the Green Start key to start the simulation or press the home
key to return to the main summary screen.
 Note down the readings obtained for the set Heart Rate values.
 Repeat the same procedure thrice.
2. RESPIRATION RATE (BrPM)
 Interface the ECG Adapter Module to the DUT and the master.
 Interface the ECG Leads to the ECG Adapter Module with respect
to the colour code.
 Use the arrow keys to scroll to the setting and use the “+” and “-”
keys to change the values. Use the increment and decrement soft
keys (F1, F2) to set the parameters for Respiration Rate. Set the
STD value to 10%, 50%, 100% of the operating range of DUT.

Figure 2.18 – Setting Respiration rate

18
 Select by pressing the key (F4) and confirm.
 Press the Green Start key to start the simulation or press the home
key to return to the main summary screen.
 Note down the readings obtained for the set Respiration Rate
values.
 Repeat the same procedure thrice.
3. SpO2 (%)
 Interface the Finger Module to the simulator and DUT.
 Use the SPO2 test settings to set the required parameters for SPO2
simulation: SPO2 value.

Figure 2.19 –SpO2Setup

 Set the Heart Rate to 60BPM.

 Set the SpO2 levels to 80%, 90%, 100%.
 Note down the observed readings.
 Repeat the same procedure thrice.
4. NIBP (SYSTOLIC/DIASTOLIC) (mmHg)
 Interface the Pressure Cuff (wound around stable object) to the
simulator and DUT.

19
 Figure 2.20 – NIBP Test Settings

 Use the NIBP Test Settings to setup a selection of Dynamic

Pressure simulations.
 Set any three ranges of Systolic/Diastolic Pressure.
 Press the NIBP button on the Patient Monitor
 Note down the observed readings.
 Repeat the same procedure thrice.

20
2.2.4.2 ECG MONITOR

Figure 2.21 –ECG Monitor

2.2.4.2.1 DESCRIPTION

An ECG is often used alongside other tests to help diagnose and monitor
conditions affecting the heart. It can be used to investigate symptoms of a
possible heart problem, such as chest pain, palpitations (suddenly noticeable
heartbeats), dizziness and shortness of breath.

2.2.4.4.2 SOP

2.2.4.4.2.1 SCOPE

To test the ECG Monitor using Vital Signs Simulator and Electrical Safety
Analyzer.

2.2.4.4.2.2 REFERENCE STANDARD

Table 2.9 – Reference Standard for ECG Monitor

IEC 60601-1 General requirements for basic safety

and essential performance.
IEC 60601-2-49 Basic safety and essential performance
of electrocardiographs, Parameter like
ECG Simulation needs to be checked
and simulated

21
2.2.4.4.2.3 MASTERS USED

Table 2.10 – Masters’ details for ECG Monitor

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Vital Signs Simulator Rigel UNISIM LITE

2.2.4.4.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.2.4.4.2.5 CALIBRATION METHOD

Direct Method

2.2.4.4.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master

2.2.4.4.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.

22
  Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Patient Leakage Current
 Patient Auxiliary Leakage Current
 Insulation Resistance Test

2.2.4.4.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Switch ON the Vital Signs Simulator.

Measure the following parameters using Vital Signs Simulator and ensure
if it lies in the permissible range.

23
 Interface the ECG Adapter Module to the DUT and the master.
 Interface the ECG Leads to the ECG Adapter Module with respect
to the colour code.
 Select the Patient Test Settings to set the parameters for Heart rate.
Set the STD value to 10%, 50%, 100% of the operating range of
DUT.
 The different options above are available across three individual
screens accessible using the tab button (F2)

Figure 2.22 – ECG Heart Rate Settings

 Referring to fig 2.22, manually enter the required heart rate.
 Select by pressing the key (F4) and confirm.
 Press the Green Start key to start the simulation or press the home
key to return to the main summary screen.
 Note down the readings obtained for the set Heart Rate values.
 Repeat the same procedure thrice.

24
2.2.4.3 PULSE OXIMETER

Figure 2.23 – Pulse Oximeter

2.2.4.3.1 DESCRIPTION

A pulse oximeter is a device that is usually placed on a fingertip. It uses

light beams to estimate the oxygen saturation of the blood and the pulse rate.
Oxygen saturation gives information about the amount of oxygen carried in the
blood. Medical professionals often use them in critical care settings like
emergency rooms or hospitals. Some doctors, such as pulmonologists, may use
them in office settings.

2.2.4.3.2 SOP

2.2.4.3.2.1 SCOPE

To test the Pulse Oximeter using Vital Signs Simulator and Electrical Safety
Analyzer.

2.2.4.3.2.2 REFERENCE STANDARD

Table 2.11 – Reference Standard for Pulse Oximeter

IEC 60601-1 General requirements for basic safety

and essential performance
ISO 9919:2005 Medical electrical Particular requirements for basic safety
equipment - Part 2-61 and essential performance of pulse
oximeter equipment

25
2.2.4.3.2.3 MASTERS USED

Table 2.12 – Masters’ details for Pulse Oximeter

NAME OF THE MASTER MAKE MODEL

Vital Signs Simulator Rigel UNISIM LITE
Electrical Safety Analyzer Fluke ESA615

2.2.4.3.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.2.4.3.2.5 CALIBRATION METHOD

Direct Method

2.2.4.3.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.

2.2.4.3.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean &
decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.

26
  Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Insulation Resistance Test
 Protective Earth Test

2.2.4.3.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Switch ON the Vital Signs Simulator.

 Interface the Finger Module to the simulator and DUT through

Finger Sensor.
 Use the SPO2 test settings to set the required parameters for SPO2
simulation: SPO2 value.

27
 Figure 2.24 –SpO2 Test Settings

 Set the Heart Rate to 60BPM.

 Set the SpO2 levels to 80%, 85%, 90%, 95%, 100%.
 Note down the observed readings.
 Repeat the same procedure thrice.

28
2.2.4.4 SPHYGMOMANOMETER

Figure 2.25 – Sphygmomanometer

2.2.4.4.1 DESCRIPTION

A sphygmomanometer is a device that measures blood pressure. It

composes of an inflatable rubber cuff, which is wrapped around the arm. A
measuring device indicates the cuff's pressure. A bulb inflates the cuff and a
valve releases pressure. Air is pumped into the cuff, enabling the determination
of systolic and diastolic blood pressure by increasing and gradually releasing
the pressure in the cuff.

2.2.4.4.2 SOP

2.2.4.4.2.1 SCOPE

To test the Sphygmomanometer using Vital Signs Simulator.

2.2.4.4.2.2 REFERENCE STANDARD

Table 2.13 – Reference Standard for Sphygmomanometer

Apparatus
IEC 60601- 2-30:2009: Medical Particular requirements for basic
electrical equipment -- Part 2-30 safety and essential performance of
automated non-invasive
sphygmomanometers

29
2.2.4.4.2.3 MASTERS USED

Table 2.14 – Masters’ details for Sphygmomanometer

NAME OF THE MASTER MAKE MODEL

Vital Signs Simulator Rigel UNISIM LITE

2.2.4.4.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.2.4.4.2.5 CALIBRATION METHOD

Direct Method

2.2.4.4.2.6 PRECAUTIONS

 Environmental conditions are ensured to be satisfactory.

 Check the traceability of the master.

2.2.4.4.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.
30
2.2.4.4.2.8 PERFORMANCE PARAMETERS

Switch ON the Vital Signs Simulator.

Measure the following parameters using Vital Signs Simulator and ensure
if it lies in the permissible range.

1. NIBP MANOMETER MODE (mmHg)

 Interface the Pressure Cuff (wound around stable object) to the
simulator and DUT.

Figure 2.26 – NIBP Test Selection Menu

 Select the NIBP Manometer Mode option.

 Set the STD value to 25%, 50%, 75%,100% of the operating range
of DUT with the help of the cuff and ensure the right pressure
levels are set with the help of the graduated scale near the column.

Figure 2.27 – NIBP Manometer Mode

31
 After setting the pressure with the help of the cuff, tighten the
screw near the cuff to avoid any leakage.
 Note down the observed readings in the master.
 Repeat the same procedure thrice.

2. NIBP LEAK TEST (mmHg)

 Interface the Pressure Cuff (wound around stable object) to the
simulator and DUT.
 Select the NIBP Leak Test option.
 Set the Start Pressure and Timer to 60 seconds.

Figure 2.28 – NIBP Leak Test

 Once the system is stabilized at the set pressure, the timer will
count up for the set duration.
 After the completion of the set duration, note down the
observed readings in the master.
 Repeat the same procedure thrice.

32
2.2.4.5 DIGITAL BP APPARATUS

Figure 2.29 – Digital BP Apparatus

2.2.4.5.1 DESCRIPTION

A digital blood pressure monitor is a fully or semi-automated, simple,

lightweight machine used for monitoring blood pressure. It measures blood
pressure and pulse simply and quickly and is easy to use, reliable and portable.
The whole measurement process is automatic apart from placing the cuff around
your arm. The cuff then inflates until it fits tightly around your arm, cutting off
your blood flow, and then the valve opens to deflate it.

2.2.4.5.2 SOP

2.2.4.5.2.1 SCOPE

To test the Digital BP Apparatus using Vital Signs Simulator.

2.2.4.5.2.2 REFERENCE STANDARD

Table 2.15 – Reference Standard for Digital BP Apparatus

IEC 60601-1 General requirements for basic safety

and essential performance
IEC 60601-2-27 Basic safety and essential performance
requirements of multifunction of
digital BP apparatus.

33
2.2.4.5.2.3 MASTERS USED

Table 2.16 – Masters’ details for Digital BP Apparatus

NAME OF THE MASTER MAKE MODEL

Vital Signs Simulator Rigel UNISIM LITE

2.2.4.5.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.2.4.5.2.5 CALIBRATION METHOD

Direct Method

2.2.4.5.2.6 PRECAUTIONS

 Environmental conditions are ensured to be satisfactory.

 Check the traceability of the master.

2.2.4.5.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.
34
2.2.4.5.2.8 PERFORMANCE PARAMETERS

Switch ON the Vital Signs Simulator.

 Interface the Pressure Cuff (wound around stable object) to the

simulator and DUT.

Figure 2.30 –NIBP Test Menu

 Use the NIBP Test Settings to setup a selection of Dynamic

Pressure simulations.
 Set any four ranges of Systolic/Diastolic Pressure.
 Switch ON the DUT after setting the Systolic/Diastolic Pressure on
the master.
 Note down the observed readings.
 Repeat the same procedure thrice.

35
2.3 GAS FLOW ANALYZER

Figure 2.31 – Gas Flow Analyzer

2.3.1 DESCRIPTION

A gas flow analyzer measures pressure, flow, volume, oxygen

concentration and gas temperature. Additionally, they test a variety of medical
gas flow and pressure devices such as endoscopic insufflators, anesthesia
machines, flow meters, pressure gauges and suction devices.

2.3.2 INSTRUMENT FAMILIARIZATION

Figure 2.32 – Gas Flow Analyzer Interface

Module 36
Table 2.17 – Gas Flow Analyzer Keypad Functions

Figure 2.33 – Back of Interface Module

Figure 2.34 – Oxygen Sensor Kit

37
 Figure 2.35 – High Flow Module

2.3.3 TECHNICAL SPECIFICATIONS

Table 2.18 –Gas Flow Analyzer Technical Specifications

Flow
Range -200 to +300.0 SLPM air, oxygen and
nitrogen
-40 to +40 SLPM carbon dioxide
0 to 300 air/oxygen mixture
Accuracy Air and oxygen: ±2% of reading
Nitrogen and carbon dioxide: ±3% of
reading
Air/Oxygen mixture: ±4% of reading
Tidal Inspiratory Volume
Range 0.01 to 10L STP
Accuracy Air and oxygen: ±2% of reading +
0.02L
Air/Oxygen mixture: ±4% of reading
+ 0.02L STP
Tidal Expiratory Volume
Range 0.01 to 10L STP
Accuracy Air and oxygen: ±3% of reading +
0.03L
Air/Oxygen mixture: ±4% of reading
+ 0.04L STP
Minute Volume
Range 0.01 to 100L STP
Accuracy ±3% of reading

38
I:E Ratio
Range 1:100 to 100:1
Accuracy ±4% of reading
Respiratory Rate
Range 1 to 1500 BrPM
Accuracy ±2% of reading
Low Pressure
Range -25.0 to 150.0 cmH2O
Accuracy ±0.5% of reading
Oxygen Concentration
Range 21 to 100%
Accuracy 2% concentration

2.3.4 EQUIPMENT CALIBRATED

2.3.4.1 VENTILATOR

Figure 2.36 – Ventilator

2.3.4.1.1 DESCRIPTION

A ventilator is a machine that supports breathing, and is used mainly in a

hospital or rehabilitation setting. Medical issues or conditions that make it hard
for the patient to breathe necessitate that a ventilator is used to aid the breathing
process. A ventilator helps get oxygen into the lungs of the patient and removes
carbon dioxide (a waste gas that can be toxic). It is used for life support, but

39
does not treat disease or medical conditions. Many conditions, such as
pneumonia, COPD, brain injuries, and strokes require the use of a ventilator.

2.3.4.1.2 SOP

2.3.4.1.2.1 SCOPE

To test the Ventilator using Gas Flow Analyzer and Electrical Safety Analyzer.

2.3.4.1.2.2 REFERENCE STANDARD

Table 2.19 –Ventilator Reference Standard

IEC 60601- 1 General requirements for basic safety

and essential performance
IEC 60601- 2-12: Medical electrical Particular requirements for the safety
equipment -- Part 2-12, IEC60601-2- of lung ventilators - - Critical care
13 ventilators, The Vital Parameters of
Ventilator machine needs to be
analyzed and tested are like
Bidirectional flow (high- and low-flow
ranges), volume, vacuum, pressure,
and oxygen-concentration

2.3.4.1.2.3 MASTERS USED

Table 2.20 – Masters’ details for Ventilator

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Gas Flow Analyzer TSI Certifier FA Plus

2.3.4.1.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

40
2.3.4.1.2.5 CALIBRATION METHOD

Direct Method

2.3.4.1.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.

2.3.4.1.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection

 Check the device for contamination and verify its clean

&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance

41
  Current
 Earth Leakage Current
 Enclosure Leakage Current
 Patient Leakage Current
 Patient Auxiliary Leakage Current
 Insulation Resistance Test

2.3.4.1.2.8 PERFORMANCE PARAMETERS

Table 2.21 –Tolerance Range for Ventilator

PIP < 30 cmH2O

Other set parameters ±5% of the set value
Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Switch ON the Gas Flow Analyzer.

Measure the following parameters using Gas Flow Analyzer and ensure if
it lies in the permissible range.

 Connect the Interface Module to the Flow Module.

 Attach the Oxygen Sensor Kit to the inlet of the Flow Module.
Connect the filter to the Oxygen Sensor Kit.
 Interface the Oxygen Sensor to the Flow Module through the
oxygen sensor connector.
 Connect a tube from the Oxygen Sensor Kit to the ‘+’ Low
Pressure Port in the Flow Module to measure the airway pressure.

42
  Connect the Y-circuit of the DUT to the filter.
 Connect the test lung to the outlet of the Flow Module.

Figure 2.37 – Ventilator Interfacing

 Set values in the DUT for tidal volume, breath rate, flow rate,
oxygen concentration, I:E ratio, PEEP.
 Select the following parameters in the master that are to be
measured.
o Inspiratory Tidal Volume (L)
o Expiratory Tidal Volume (L)
o Breath Rate (BrPM)
o Flow Rate (LPM)
o I:E Ratio
o PEEP (cmH2O)
o PIP (cmH2O)
o O2 Concentration (%)

Figure 2.38 – Gas Flow Analyzer Parameter Screen

 Note down the observed readings.

 Repeat the procedure thrice.

43
2.3.4.2 BOYLE’S APPARATUS

Figure 2.39 – Boyle’s Apparatus

2.3.4.2.1 DESCRIPTION

Boyle's machine is designed to provide an accurate supply of medical

gases mixed with an accurate concentration of anesthetic vapour, and to deliver
this continuously to the patient at a safe pressure and flow.

2.3.4.2.2 SOP

2.3.4.2.2.1 SCOPE

To test the Boyle’s Apparatus using Gas Flow Analyzer.

2.3.4.2.2.2 MASTERS USED

Table 2.22 – Masters’ details for Boyle’s Apparatus

NAME OF THE MASTER MAKE MODEL

Gas Flow Analyzer TSI Certifier FA Plus

2.3.4.2.2.3 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.3.4.2.2.4 CALIBRATION METHOD

Direct Method
44
2.3.4.2.2.5 PRECAUTIONS

 Environmental conditions are ensured to be satisfactory.

 Check the traceability of the master.

2.3.4.2.2.6 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

2.3.4.2.2.7 PERFORMANCE PARAMETERS

Table 2.23 –Tolerance Range for Boyle’s Apparatus

N2O:O2 3:1

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

45
Switch ON the Gas Flow Analyzer.

Measure the following parameters using Gas Flow Analyzer and ensure if
it lies in the permissible range.

1. O2 FLOW RATE (LPM)

 Connect the Interface Module to the Flow Module.
 Connect the DUT to the inlet to the Flow Module with the tubing
through the Adapter.
 Set the flow rate of N2O to zero and increase the flow rate of O2 in
the DUT with the knob.
 Select Flow Rate option in the master to measure flow rate.
 Note down the observed readings.
 Repeat the procedure thrice.
2. N2O:O2 BALANCE
 Connect the Interface Module to the Flow Module.
 Connect the DUT to the inlet to the Flow Module with the tubing
through the Adapter.
 Set the flow rate of O2 to zero and increase the flow rate of N2O in
the DUT with the knob.
 Check whether the O2 knob is rotating automatically to maintain
the 3:1 ratio (N2O:O2).
 Select Flow Rate option in the master to measure flow rate.
 To ensure proper functioning of the DUT, set 3L of N2O to be
delivered and check if the total amount of gas mixture delivered is
approximately 4L (1L of O2 should be automatically delivered).
 Note down the observed readings.
 Repeat the procedure thrice.

46
2.3.4.3 ANESTHESIA WORKSTATION

Figure 2.40 –Anesthesia Workstation

2.3.4.3.1 DESCRIPTION

The anesthesia workstation is designed to be a complete anesthesia and

respiratory gas delivery and monitoring system. It combines advanced
ventilation features, gas delivery and agent vapourizing with patient
monitoring and information management to form an integrated anesthesia
care station. The components of the workstation include gas delivery and
scavenging system, vapourizers, electronic flow meters, ventilator.

2.3.4.3.2 SOP

2.3.4.3.2.1 SCOPE

To test the Anesthesia Workstation using Gas Flow Analyzer and Electrical
Safety Analyzer.

2.3.4.3.2.2 REFERENCE STANDARD

Table 2.24 – Reference Standard for Anesthesia Workstation

IEC 60601- 1/ISO 8835- 2,-3,-4- Electrical Safety Test, Flow/Volume

5/62353 accuracy, Pressure accuracy, Time
accuracy, Oxygen Concentration
accuracy, Alarm functions, Hypoxic
Guard Test.

47
2.3.4.3.2.3 MASTERS USED

Table 2.25 – Masters’ details for Anesthesia Workstation

NAME OF THE MASTER MAKE MODEL

Gas Flow Analyzer TSI Certifier FA Plus
Electrical Safety Analyzer Fluke ESA615

2.3.4.3.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.3.4.3.2.5 CALIBRATION METHOD

Direct Method

2.3.4.3.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.

2.3.4.3.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.

48
  Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Patient Leakage Current
 Patient Auxiliary Leakage Current
 Insulation Resistance Test

2.3.4.3.2.8 PERFORMANCE PARAMETERS

Table 2.26 –Tolerance Range for Anesthesia Workstation

PIP < 30 cmH2O

Other set parameters ±5% of the set value
N2O:O2 3:1
Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

49
Switch ON the Gas Flow Analyzer.

Measure the following parameters using Gas Flow Analyzer and ensure if
it lies in the permissible range.

1. VENTILATOR MODE
 Switch ON the ventilator mode in the DUT.
 Connect the Interface Module to the Flow Module.
 Attach the Oxygen Sensor Kit to the inlet of the Flow Module.
Connect the filter to the Oxygen Sensor Kit.
 Interface the Oxygen Sensor to the Flow Module through the
oxygen sensor connector.
 Connect a tube from the Oxygen Sensor Kit to the ‘+’ Low
Pressure Port in the Flow Module to measure the airway pressure.
 Connect the Y-circuit of the DUT to the filter.
 Connect the test lung to the outlet of the Flow Module
 Set values in the DUT for tidal volume, breath rate, flow rate,
oxygen concentration, I:E ratio, PEEP.
 Select the following parameters in the master that are to be
measured.
o Inspiratory Tidal Volume (L)
o Expiratory Tidal Volume (L)
o Breath Rate (BrPM)
o Flow Rate (LPM)
o I:E Ratio
o PEEP (Bar)
o PIP (cmH2O)
o O2 Concentration (%)
 Note down the observed readings.

50
 Repeat the procedure thrice.

2. ANESTHESIA MODE
 Switch ON the anesthesia mode in the DUT.
a) O2 FLOW RATE (LPM)
 Connect the Interface Module to the Flow Module.
 Connect the DUT to the inlet to the Flow Module with the tubing
through the Adapter.
 Set the flow rate of N2O to zero and increase the flow rate of O2 in
the DUT with the knob.
 Select Flow Rate option in the master to measure flow rate.
 Note down the observed readings.
 Repeat the procedure thrice.
b) N2O:O2 BALANCE
 Connect the Interface Module to the Flow Module.
 Connect the DUT to the inlet to the Flow Module with the tubing
through the Adapter.
 Set the flow rate of O2 to zero and increase the flow rate of N2O in
the DUT with the knob.
 Check whether the O2 knob is rotating automatically to maintain
the 3:1 ratio (N2O:O2).
 Select Flow Rate option in the master to measure flow rate.
 To ensure proper functioning of the DUT, set 3L of N2O to be
delivered and check if the total amount of gas mixture delivered is
approximately 4L (1L of O2 should be automatically delivered).
 Note down the observed readings.
 Repeat the procedure thrice.

51
2.3.4.4 SUCTION PUMP

Figure 2.41 – Suction Pump

2.3.4.4.1 DESCRIPTION

Suction Pump, also known as an aspirator, is used to remove gases or

liquids such as mucus, vomit, serum, blood, saliva, or other secretions from a
patient's body cavity. These cavities could be the lungs, mouth, and even the
skull. Suction pumps work on the principle of negative pressure that creates a
vacuum effect to pull out secretions from a person’s oral cavity. To create this
negative pressure, several components of the suction pump work in conjunction.

2.3.4.4.2 SOP

2.3.4.4.2.1 SCOPE

To test the Suction Pump using Gas Flow Analyzer and Electrical Safety
Analyzer (if electrically operated).

2.3.4.4.2.2 REFERENCE STANDARD

Table 2.27 – Reference Standard for Suction Pump

IEC 60601-1 General requirements for basic safety

and essential performance
ISO 10079- 1. Specifies safety and performance
requirements for electrically powered
medical and surgical suction
equipment

52
2.3.4.4.2.3 MASTERS USED

Table 2.28 – Masters’ details for Suction Pump

NAME OF THE MASTER MAKE MODEL

Gas Flow Analyzer TSI Certifier FA Plus
Electrical Safety Analyzer Fluke ESA615

2.3.4.4.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.3.4.4.2.5 CALIBRATION METHOD

Direct Method

2.3.4.4.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.

2.3.4.4.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.

53
  Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Insulation Resistance Test

2.3.4.4.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Switch ON the Gas Flow Analyzer.

Measure the following parameters using Gas Flow Analyzer and ensure if
it lies in the permissible range.

 Connect the Interface Module to the Flow Module.

54
 Connect the DUT to the high-pressure port of the Flow Module
through the Adapter.
 Set different suction pressure values in the DUT.
 Select PHIGH option in the master to measure the suction pressure.
 Note down the observed readings.
 Repeat the procedure thrice.

55
2.3.4.5 NEBULIZER

Figure 2.42 –Nebulizer

2.3.4.5.1 DESCRIPTION

Nebulizer is a device that turns the liquid medicine into a mist which is
then inhaled through a mouthpiece or a mask. Nebulizers are a helpful way to
deliver medication during palliative care , patients with acute breathing illness,
such as pneumonia and to very young children.

2.3.4.5.2 SOP

2.3.4.5.2.1 SCOPE

To test the Nebulizer using Gas Flow Analyzer and Electrical Safety Analyzer
(if electrically operated).

2.3.4.5.2.2 REFERENCE STANDARD

Table 2.29 – Reference Standard for Nebulizer

IEC 60601-1 General requirements for basic safety

and essential performance

ISO 27427:2013 Anesthetic and respiratory equipment -

- Nebulizing systems and components
2.3.4.5.2.3 MASTERS USED

Table 2.30 – Masters’ details for Nebulizer

NAME OF THE MASTER MAKE MODEL

Gas Flow Analyzer TSI Certifier FA Plus
Electrical Safety Analyzer Fluke ESA615

56
2.3.4.5.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.3.4.5.2.5 CALIBRATION METHOD

Direct Method

2.3.4.5.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.

2.3.4.5.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

57
 Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Insulation Resistance Test

2.3.4.5.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Switch ON the Gas Flow Analyzer.

Measure the following parameters using Gas Flow Analyzer and ensure if
it lies in the permissible range.

 Connect the Interface Module to the Flow Module.

 For Flow Measurement, connect the DUT to the inlet to the Flow
Module with the tubing through the Adapter.
 Select Flow Rate option in the master to measure flow rate.
 For Pressure Measurement, connect the DUT to the high-pressure
port of the Flow Module through the Adapter.
 Select PHIGH option in the master to measure the pressure.
 Note down the observed readings.
 Repeat the procedure thrice.
58
2.3.4.6 GAS FLOW METER

Figure 2.43 – Gas Flow Meter

2.3.4.6.1 DESCRIPTION

The medical gas flow meter is a medical device for oxygen or medical air
inhalation of first-aid and hypoxic patients in the hospital, including oxygen
flow meter, and medical air flow meter. It mainly consists of gas pressure
gauge, pressure reducer, safety valve, flow tube, flow control valve, and
humidification bottle, and other components. Oxygen flow meter is mainly used
to regulate the flow of oxygen, oxygen humidification. Whether its performance
is accurate and reliable will directly affect the patient's personal safety.
2.3.4.6.2 SOP

2.3.4.6.2.1 SCOPE

To test the Gas Flow Meter using Gas Flow Analyzer and Electrical Safety
Analyzer (if electrically operated).

2.3.4.6.2.2 REFERENCE STANDARD

Table 2.31 – Gas Flow Meter Reference Standard

ISO 8185 and ISO 9360- 1/62353 General requirements for Flow Test,
Temperature Test, Electrical Safety
Test (Only if it is electrically
operated)

59
2.3.4.6.2.3 MASTERS USED

Table 2.32 – Masters’ details for Gas Flow Meter

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Gas Flow Analyzer TSI Certifier FA Plus

2.3.4.6.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.3.4.6.2.5 CALIBRATION METHOD

Direct Method

2.3.4.6.2.6 PRECAUTIONS

 Environmental conditions are ensured to be satisfactory.

 Check the traceability of the master.

2.3.4.6.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.

60
  Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Insulation Resistance Test

2.3.4.6.2.8 PERFORMANCE PARAMETERS

Table 2.33 –Tolerance Range for Gas Flow Meter

Flow Rate 2lpm ± 10%

Switch ON the Gas Flow Analyzer.

Measure the following parameters using Gas Flow Analyzer and ensure if
it lies in the permissible range.

 Connect the Interface Module to the Flow Module.

 Connect the DUT to the inlet to the Flow Module with the tubing
through the Adapter.
 Select Flow Rate option in the master to measure flow rate.
 Note down the observed readings.
 Repeat the procedure thrice.

61
 2.4 ELECTROSURGICAL ANALYZER

Figure 2.44 – Electrosurgical Analyzer

2.4.1 DESCRIPTION

Electrosurgical unit (ESU) analyzers automate the testing and inspection

of the output circuits and safety features of ESUs. They perform testing that
would otherwise require several other pieces of equipment, as well as
considerably more time and greater technician expertise. They are used largely
by clinical engineering departments for routine inspection and preventive
maintenance procedures and, less often, for accident investigations and
troubleshooting.

2.4.2 INSTRUMENT FAMILIARIZATION

Figure 2.45 – Electrosurgical Analyzer Front Panel Figure 2.46 – Electrosurgical Analyzer Rear
Control and Connections Panel Connections

62
 Table 2.34 – Electrosurgical Analyzer Controls and Connections

2.4.3 TECHNICAL SPECIFICATIONS

Table 2.35 – Electrosurgical Analyzer Technical Specifications

RMS Bandwidth 30 Hz to 10 MHz (-3 dB) for

instrumentation only; 30 Hz to 2.4
MHz (-3 dB) with loads
Current 20 mA to 2200 mA
Current Accuracy 20 to 2200 mA ±2 % of reading
Load Resistance 10 to 2500 Ω in steps of 25 Ω (at
dc);
2500 to 5200 Ω in steps of 100 Ω
(at dc)
10 Ω at 100 W for 30 seconds, 15
63
 % duty cycle
25 to 50 Ω at 200 W for 30
seconds, 15 % duty cycle
75 to 2975 Ω at 400 W for 30
seconds, 15 % duty cycle
≥3000 Ω at 70 W for 30 seconds,
15 % duty cycle
all load resistances at 500 W for 5
seconds, 10 % duty cycle

Additional Fixed Load 200 Ω, 400 W maximum for 30

seconds, maximum 15 % duty
cycle
Range 1.4 to 16 (V peak voltage / V
RMS)
Peak-to-Peak Voltage 0 to 10 kV (closed load only)
Accuracy ±10 %

2.4.4 EQUIPMENT CALIBRATED

2.4.4.1 ELECTROSURGICAL UNIT

Figure 2.47 – Electrosurgical Unit

2.4.4.1.1 DESCRIPTION

Electrosurgical unit enables surgeons to perform mono and bipolar

surgery simultaneously in a wide range of applications such as: ambulatory
surgery, endoscopy, first aid, gastroenterology, general surgery, Gynecology,
64
neurosurgery, otolaryngology, orthopedics, pediatric surgery, plastic surgery,
Urology and Vascular Surgery.

Bipolar
A bipolar circuit uses two electrodes of equal size to create a dipole
circuit. The bipolar circuit is the classical form of diathermic heating, in that the
loss created in the dielectric is evenly dispersed between the electrodes. In
electrosurgery, a high current density is applied through bipolar forceps,
coagulating the small amount of tissue contained between the tips of the forceps
with minimal effect on surrounding tissue.

Unipolar
In unipolar electrosurgery, a small active electrode relative to the patient
plate is used at the site of surgery. The high current density produced at the
active electrode creates a pronounced diathermic effect, causing tissue
destruction at the operative site. The patient plate's large size lowers the current
density at its placement site, preventing unwanted burns.

Desiccation
Desiccation is produced by low current and relatively higher voltage
applied over a broad area, producing a low current density. In desiccation, the
cells are shrunken and shriveled with elongated nuclei. Cellular detail is
preserved. This effect is produced by the loss of water from the cells, without
extensive coagulation of proteins.

Coagulation
Coagulation occurs at higher current densities than are used in
desiccation, resulting in higher tissue temperatures. The tissue fluids boil away
and the proteins become denatured, forming a white coagulum. There is loss of
cellular definition as all tissue structures fuse into a formless, homogenous mass
with a hyalinized appearance.

65
Fulguration
Fulguration results from the action of electrical arcs striking the tissue at
widely divergent locations, producing a high localized instantaneous current
density, but a low average current density. The characteristics of fulguration are
the superficial nature of the tissue destruction, and the presence of large
amounts of carbonization.

Vaporization
The cutting of tissue by electrical current is due to the vaporization of
cells. As with the other tissue effects, the cutting action of electrical current is a
product of current density. A dampened (coagulating) current can be made to
divide tissue (albeit at the expense of great lateral thermal damage) by
increasing the power or decreasing the electrode size, and an undamped,
sinusoidal current (cutting) will produce coagulation if the current density is
low, and the electrode contacts’ tissue.
2.4.4.1.2 SOP

2.4.4.1.2.1 SCOPE

To test the ESU using Electrosurgical Analyzer and Electrical Safety Analyzer.

2.4.4.1.2.2 REFERENCE STANDARD

Table 2.36 – ESU Reference Standard

IEC 60601-1 General requirements for basic safety

and essential performance

IEC 60601- 2-2: Medical electrical Medical electrical equipment - Part 2-

equipment - Part 2-2: Particular 2: Particular requirements for the
requirements for the basic safety and basic safety and essential
essential performance of high performance of high frequency
frequency surgical equipment and surgical equipment and high
high frequency surgical accessories frequency surgical accessories,

66
 Electrosurgical/Cautery Machine
critical parameters needs to be
measured and checked like with
precise power, current, frequency,
crest factor and load resistance
ranges, Automatic power distribution
measurement, Return electrode
measurement (REM)test including
power, Contact quality Monitor test,
peak-to-peak voltage, and crest factor,
Vessel Sealing Test

2.4.4.1.2.3 MASTERS USED

Table 2.37 – Masters’ details for ESU

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Electrosurgical Analyzer Fluke QA - ESII

2.4.4.1.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.4.4.1.2.5 CALIBRATION METHOD

Direct Method

2.4.4.1.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.

67
2.4.4.1.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Patient Leakage Current
 Patient Auxiliary Leakage Current
 Insulation Resistance Test

68
2.4.4.1.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Check if the alarm is functioning for improper connection of electrodes.

Switch ON the Electrosurgical Simulator and DUT.

Measure the following parameters using Electrosurgical Simulator and

ensure if it lies in the permissible range

1. MONOPOLAR TESTING CUT ACTIVATION

 Connect one monopolar needle electrode to the Monopolar
Instrument Receptacle.
 Connect the black jack to the Black Terminal on the Analyzer and
the other end being clipped to the patient return electrode.
 Connect the red jack to the Red Terminal on the Analyzer and the
other end being clipped to the active electrode.
 Select the power applied by the DUT under Monopolar Cut and set
it to maximum power settings.
 Set the different parameters in the Analyzer with the help of the
knob.
 Select the Mode option and set it to Continuous Operation by
pressing Enter with the help of function softkey (F5).
 Select the load on the Analyzer according to the specified data in
the DUT.

69
 Select the Start option on the Analyzer using function softkey (F3)
and press the Cut button (yellow button) on the electrode.
 Note down the different readings obtained.
 Set different values of power. Set the STD value to 10%, 25%,
50%, 100% of the operating range of DUT and note down the
observed power.
 Repeat the same procedure thrice.
2. MONOPOLAR TESTING COAG ACTIVATION
 Connect one monopolar needle electrode to the Monopolar
Instrument Receptacle.
 Connect the black jack to the Black Terminal on the Analyzer and
the other end being clipped to the patient return electrode.
 Connect the red jack to the Red Terminal on the Analyzer and the
other end being clipped to the active electrode.
 Select the power applied by the DUT under Monopolar Coag and
set it to maximum power settings.
 Set the different parameters in the Analyzer with the help of the
knob.
 Select the Mode option and set it to Continuous Operation by
pressing Enter with the help of function softkey (F5).
 Select the load on the Analyzer according to the specified data in
the DUT.
 Select the Start option on the Analyzer using function softkey (F3)
and press the Coag button (blue button) on the electrode.
 Note down the different readings obtained.
 Set different values of power. Set the STD value to 10%, 25%,
50%, 100% of the operating range of DUT and note down the
observed power.

70
 Repeat the same procedure thrice.
3. BIPOLAR TESTING COAG ACTIVATION
 Connect one bipolar needle electrode to the Bipolar Instrument
Receptacle
 Connect the black jack to the Black Terminal on the Analyzer and
the other end being clipped to the patient return electrode.
 Connect the red jack to the Red Terminal on the Analyzer and the
other end being clipped to the active electrode.
 Select the power applied by the DUT under Bipolar Coag and set it
to maximum power settings.
 Set the different parameters in the Analyzer with the help of the
knob.
 Select the Mode option and set it to Continuous Operation by
pressing Enter with the help of function softkey (F5).
 Select the load on the Analyzer according to the specified data in
the DUT.
 Select the Start option on the Analyzer using function softkey (F3)
and press the Coag button (blue button) on the electrode.
 Note down the different readings obtained.
 Set different values of power. Set the STD value to 10%, 25%,
50%, 100% of the operating range of DUT and note down the
observed power.
 Repeat the same procedure thrice.

71
2.5 DEFIBRILLATOR ANALYZER

Figure 2.48 – Defibrillator Analyzer

2.5.1 DESCRIPTION

Defibrillator analyzers automate the inspection and preventive

maintenance testing of defibrillators. They need to be able to test at least four
basic defibrillator performance characteristics: discharge energy, synchronized-
mode operation, automated external defibrillation, and ECG monitoring.

2.5.2 INSTRUMENT FAMILIARIZATION

Figure 2.49 – Defibrillator Analyzer Front Panel Controls and Connections

72
Table 2.38 – Defibrillator Analyzer Front Panel Controls and Connections

Figure 2.50 – Defibrillator Analyzer Rear Panel Connections

Table 2.39 – Defibrillator Analyzer Rear Panel Connections

73
2.5.3 TECHNICAL SPECIFICATIONS
Table 2.40 – Defibrillator Analyzer Technical Specifications

Auto-ranged Measurement 0.1to 600J

Accuracy
0.1to 360J ±(1% of reading + 0.1J)
360 to 600J ± (1% of reading + 0.1J), typical
Load Resistance
Resistance 50 ohms
Accuracy ±1%, non-inductive
Pulse Width
Range 1 to 50 ms
Accuracy ±(1% of reading + 2V)
Voltage
Range 20 to 5000V
Accuracy ±(1% of reading + 2V)
Current
Range 0.4 to 100.0 A
Accuracy ± (1% of reading + 0.1A)
Charge Time Measurement
Range 0.1 to 100.0 s
Accuracy ± 0.05 s
Synchronization Test
Range -120 to +380ms
Accuracy ± 1ms

2.5.4 EQUIPMENT CALIBRATED

2.5.4.1 DEFIBRILLATOR

– Defibrillator
Figure 2.51 74
2.5.4.1.1 DESCRIPTION

Defibrillators are devices that send an electric pulse or shock to the heart
to restore a normal heartbeat. They are used to prevent or correct an arrhythmia,
an uneven heartbeat that is too slow or too fast. If the heart suddenly stops,
defibrillators can also help it beat again. The defib pads should be placed in
sternum and apex.

AED mode in Defibrillator

When the pads are in place, the AED automatically measures the person's
heart rhythm and determines if a shock is needed. If it is, the machine tells the
user to stand back and push a button to deliver the shock. The AED is
programmed not to deliver a shock if a shock isn't needed.

Sync mode in Defibrillator

To perform synchronized cardioversion, the defibrillator is placed into the

“synchronize” mode by pressing the appropriate button on the machine. This
causes the monitor to track the R wave of each QRS complex that goes by. A
synchronizing marker will appear above each QRS complex, indicating that the
synchronize feature is active.

The appropriate energy level is then selected, and the discharge/shock

button is pressed and held. The defibrillator does not release the shock
immediately. Instead, it waits for the next R-wave to appear and delivers the
shock at the time of the R-wave. This allows the shock to be provided safely
away from the T wave, avoiding the R-on-T phenomenon.

75
2.5.4.1.2 SOP

2.5.4.1.2.1 SCOPE

To test the Defibrillator using Defibrillator Analyzer and Electrical Safety

Analyzer.

2.5.4.1.2.2 REFERENCE STANDARD

Table 2.41 – Defibrillator Reference Standard

IEC 60601-1 General requirements for basic safety

and essential performance

IEC 60601- 2-4 Particular requirements for the safety

of cardiac defibrillator. Defibrillator
unit critical Parameters needs to be
measured like Energy Measurement,
Charge Time, ECG Simulation,
Patient test Load (Resistance),
External Pacer Test etc
2.5.4.1.2.3 MASTERS USED

Table 2.42 – Masters’ details for Defibrillator

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Defibrillator Analyzer Fluke IMPULSE 7000DP

2.5.4.1.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.5.4.1.2.5 CALIBRATION METHOD

Direct Method

76
2.5.4.1.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.

2.5.4.1.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current

77
  Patient Leakage Current
 Patient Auxiliary Leakage Current
 Insulation Resistance Test

2.5.4.1.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Table 2.43 – Tolerance Range for Defibrillator

Energy ±15% of set value

Heart Rate ±5% of set value
Charge Time <15s
Synchronization Time <60ms
ECG Amplitude ±5% of set value

Switch ON the Defibrillator Analyzer.

Measure the following parameters using Defibrillator Analyzer and ensure if it

lies in the permissible range.

1. ENERGY(JOULES)
 Press the softkey labeled Energy to enter the energy test procedure.

Figure 2.52 – Defibrillator Menu

 Place the paddles according to the labels: sternum and apex.

78
 Set the STD value to 10%, 25%, 50%, 75%, 100% of the operating
range of DUT.
 The Energy option in the master is accessible using the function
softkey (F1).
 Charge the defibrillator using one of the energy settings when the
light turns green, and with the defib paddles on the Analyzer’s
input, press the discharge button. The Analyzer senses the
discharge and the energy delivered appears in the display in Joules.
 Note down the readings obtained for Energy.
 Repeat the same procedure thrice
2. CHARGING TIME (s)
 Before starting the charge time test, ensure the defibrillator is not
charged.
 From the Defibrillator main menu, press the softkey labeled
Charge Time.

Figure 2.53 – Defibrillator Charge time

 The MEASURE option above is accessible using the function
softkey (F3).
 Set the energy level to maximum.
 In a few seconds after pressing the softkey labeled Measure, a
Charge Defib in: countdown begins.
 When the countdown reaches zero and sounds the beeper, press the
charge button on the defibrillator.
 The Analyzer begins a Charge Time count up. When the
defibrillator reaches full charge, discharge the defibrillator into the

79
 Analyzer. The Analyzer senses the discharge and the charge time
appears in the display.
 Note down the readings obtained for Charging Time.
 Repeat the same procedure thrice.
3. ECG (HEART RATE) (BPM)
 Interface the ECG Leads to the ECG lead connectors with respect
to the colour code.

Figure 2.54 – ECG Heart Rate Setting

 Select the Rate option to set the parameters for Heart rate. Set the
STD value to 10%, 50%, 100% of the operating range of DUT.
 The Rate option above is accessible using the function softkey (F3)
and the value is then set.
 Note down the readings obtained for Heart Rate.
 Repeat the same procedure thrice.
4. AMPLITUDE (mV)
 Interface the ECG Leads to the ECG lead connectors with respect
to the colour code.

Figure 2.55 – Amplitude Setting

 Select the Amplitude option to set the parameters for Amplitude.

 The Amplitude option above is accessible using the function
softkey (F2) and the STD value is then set to 2mV.

80
 The waveform obtained is observed to note down the Amplitude
readings.
 Repeat the same procedure thrice.
5. SYNCHRONIZATION TEST (ms)
 Interface the ECG Leads to the ECG lead connectors with respect
to the colour code.

Figure 2.56 –Defibrillator Synchronization Test

 From the Defibrillator main menu, press the softkey labeled Sync.
 Set the energy level to maximum.
 Place the defibrillator in this mode as well by pressing the SYNC
button. The defibrillator will now synchronize its discharge pulse
with the ECG heart rate.
 Charge the defibrillator and discharge it into the Analyzer’s
defibrillator inputs. The Analyzer senses the discharge and the
measured delay appears in the display.
 Note down the Synchronization Test readings.
 Repeat the same procedure thrice.

81
2.6 INFUSION DEVICE ANALYZER

Figure 2.57 – Infusion Device Analyzer

2.6.1 DESCRIPTION

Infusion pump analyzers are test devices that aid in determining the
performance of infusion pumps. These devices perform simple flow tests, and in
some instances volume and occlusion pressure tests as well, that otherwise
would be performed using burettes or other calibrated glassware, balances,
timers, and pressure meters or gauges.

2.6.2 INSTRUMENT FAMILIARIZATION

Figure 2.58 – IDA Front Panel Controls and Connections

82
Table 2.44 – IDA Front Panel Controls and Connections

Figure 2.59 – IDA Rear Panel Connections

Table 2.45 – IDA Rear Panel Connections

83
2.6.3 TECHNICAL SPECIFICATIONS

Table 2.46 – IDA Technical Specifications

Flow Rate Measurement

Range 0.1 ml/h to 1500 ml/h
Accuracy 1 % of reading ±1 LSD for flows of
16 to 200 ml/h for volumes over 20
ml, otherwise 2 % of reading ±1 LSD
for volumes over 10 ml under
laboratory conditions.
Volume Measurement
Range 0.06 ml to 9999 ml
Accuracy 1 % of reading ±1 LSD for flow rates
of 16 ml/h to 200 ml/h for volumes
over 20 ml. Otherwise 2 % of reading
±1 LSD for volumes over 10 ml
under laboratory conditions.
Pressure Measurement
Range 0 psi to 45 psi or equivalent in mmHg
Accuracy and kPa
1 % of full scale ±1 LSD under
laboratory conditions.

2.6.4 EQUIPMENT CALIBRATED

2.6.4.1 INFUSION PUMP

Figure 2.60 – Infusion Pump

84
2.6.4.1.1 DESCRIPTION

An infusion pump is a medical device that delivers fluids, such as

nutrients and medications, into a patient's body in controlled amounts. Infusion
pumps are in widespread use in clinical settings such as hospitals, nursing
homes, and in the home. Infusion pumps may be capable of delivering fluids in
large or small amounts, and may be used to deliver nutrients or medications –
such as antibiotics, chemotherapy drugs, and pain relievers.

2.6.4.1.2 SOP

2.6.4.1.2.1 SCOPE

To test the Infusion Pump using IDA and Electrical Safety Analyzer.

2.6.4.1.2.2 REFERENCE STANDARD

Table 2.47 – Infusion Pump Reference Standard

IEC 60601-1 General requirements for basic safety

and essential performance

IEC 60601- 2-24:2012 Medical Particular requirements for the basic

electrical safety and essential performance of
infusion pumps and controllers, For
Syringe Pump critical parameters
needs to be measured /Analyzed like
Flow Rate, Volume Measurement,
Pressure Measurement, etc.
2.6.4.1.2.3 MASTERS USED

Table 2.48 – Masters’ details for Infusion Pump

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Infusion Device Analyzer Fluke IDA 5

85
2.6.4.1.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.6.4.1.2.5 CALIBRATION METHOD

Direct Method

2.6.4.1.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.

2.6.4.1.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

86
 Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Insulation Resistance Test

2.6.4.1.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Check for the proper working of the alarm for the following conditions.

 No operation – If it has been left idle for more than 2 minutes.

 Priming Stuck – If total volume reaches 6ml while priming the
infusion tubing.
 Infusion Ending – 3 minutes before the completion of infusion.
 Battery Low – If the battery capacity is low.
 Key Stuck – If the key is stuck after powered ON.
 Occlusion – If the pump reaches the occlusion pressure level
threshold.

87
Switch ON the Infusion Device Analyzer and DUT.

Measure the following parameters using Infusion Device Analyzer and

ensure if it lies in the permissible range.

1. FLOW RATE (LPM)

 Fit the tubing of the loaded infusion bag in the slot of the DUT and
lock it.
 Connect the tubing to the Fluid Inlet channel of the master and
connect the drainage tube to the Fluid Outlet channel of the master.
 Set the flow rate and volume (in the DUT) of the infusion fluid to
be delivered.
 Select the Priming option in the master and press Enter.
 Press the Priming/Bolus/Purge button on the DUT until the Red bar
shown on the screen of the master turns entirely Blue.

Figure 2.61 – Priming Screen

 After Priming process, start the infusion process by pressing Enter.

 The I.V fluid will flow until the Infusion Ending Alarm is
indicated.
 At that instant, select the Stop option in the master.
 In case of improper alarm functioning, select the Stop option after
the estimated elapse time.
 Note down the observed parameters for the set Flow Rate and
Volume.

88
 Figure 2.62 – Channel Flow Screen

 Repeat the same procedure for different values of Flow Rate and
Volume.
2. OCCLUSION PRESSURE (psi)
 Fit the tubing of the loaded infusion bag in the slot of the DUT and
lock it.
 Connect the tubing to the Fluid Inlet channel of the master and
connect the drainage tube to the Fluid Outlet channel of the master.
 Set the flow rate and volume (in the DUT) of the infusion fluid to
be delivered.
 Set the pressure level in DUT to low/medium/high.
 Start the infusion process by pressing Enter.
 Select the Occlusion option on the master and wait for the
Occlusion Alarm to be indicated.

Figure 2.63 –Occlusion Screen

 Note down the observed Occlusion Pressure.

 Repeat the same procedure thrice.
89
2.6.4.2 SYRINGE PUMP

Figure 2.64 –Syringe Pump

2.6.4.2.1 DESCRIPTION

Syringe pumps are used to deliver a very small amount of medication,

mechanically moving the piston of a syringe to send medication into IV tubing.
A wide range of syringe pumps is available on the market, delivering flow rates
of 0.012–300 mL/min. They infuse solutions at a constant rate. In the case of a
medication which should be slowly pushed in over the course of several
minutes, this device saves staff time and reduces medical errors.

2.6.4.2.2 SOP

2.6.4.2.2.1 SCOPE

To test the Syringe Pump using IDA and Electrical Safety Analyzer.

2.6.4.2.2.2 REFERENCE STANDARD

Table 2.49 – Reference Standard for Syringe Pump

IEC 60601-1 General requirements for basic safety

and essential performance

IEC 60601- 2-24:2012 Medical Particular requirements for the basic

electrical safety and essential performance of
infusion pumps and controllers, For
Syringe Pump critical parameters
needs to be measured /Analyzed like
Flow Rate, Volume Measurement,
Pressure Measurement, etc.

90
2.6.4.2.2.3 MASTERS USED

Table 2.50 – Masters’ details for Syringe Pump

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Infusion Device Analyzer Fluke IDA 5

2.6.4.2.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.6.4.2.2.5 CALIBRATION METHOD

Direct Method

2.6.4.2.2.6 PRECAUTIONS

 Environmental conditions are ensured to be satisfactory.

 Check the traceability of the master.
 Check for the Mains Voltage to be 230V using multimeter.

2.6.4.2.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.

91
  Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Insulation Resistance Test

2.6.4.2.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the

DUT.

Alarm Function

Check for the proper working of the alarm for the following conditions.

 No operation – If it has been left idle for more than 2 minutes.

 Priming Stuck – If total volume reaches 6ml while priming the
infusion tubing.
 Infusion Ending – 3 minutes before the completion of infusion.
 Battery Low – If the battery capacity is low.

92
  Key Stuck – If the key is stuck after powered ON.
 Occlusion – If the pump reaches the occlusion pressure level
threshold.

Switch ON the Infusion Device Analyzer and DUT.

Measure the following parameters using Infusion Device Analyzer and

ensure if it lies in the permissible range.

1. FLOW RATE (LPM)

 Fit the tubing of the loaded syringe in the slot of the DUT and lock
it.
 Connect the tubing to the Fluid Inlet channel of the master and
connect the drainage tube to the Fluid Outlet channel of the master.
 Set the flow rate and volume (in the DUT) of the infusion fluid to
be delivered.
 Select the Priming option in the master and press Enter.
 Press the Priming/Bolus/Purge button on the DUT until the Red bar
shown on the screen of the master turns entirely Blue.

Figure 2.65 – Bolus Screen

 After Priming process, start the infusion process by pressing Enter.
 The I.V fluid will flow until the Infusion Ending Alarm is
indicated.
 At that instant, select the Stop option in the master.
 In case of improper alarm functioning, select the Stop option after
the estimated elapse time.

93
 Note down the observed parameters for the set Flow Rate and
Volume.

Figure 2.66 –Flow rate Screen

 Repeat the same procedure for different values of Flow Rate and
Volume.
2. OCCLUSION PRESSURE (psi)
 Fit the tubing of the loaded syringe in the slot of the DUT and lock
it.
 Connect the tubing to the Fluid Inlet channel of the master and
connect the drainage tube to the Fluid Outlet channel of the master.
 Set the flow rate and volume (in the DUT) of the infusion fluid to
be delivered.
 Set the pressure level in DUT to low/medium/high.
 Start the infusion process by pressing Enter.
 Select the Occlusion option on the master and wait for the
Occlusion Alarm to be indicated.

Figure 2.67 – Occlusion Pressure Screen

 Note down the observed Occlusion Pressure.
 Repeat the same procedure thrice.

94
2.7 INCUBATOR ANALYZER

Figure 2.68 – Incubator Analyzer

2.7.1 DESCRIPTION

The Incubator Analyzer is designed to test and perform preventative

maintenance on infant incubators and radiant warmers while simultaneously
measuring airflow, relative humidity, sound, and four independent temperatures.
It is compatible with closed, forced-convection incubators, and open infant
warmers, including transportable, air-controlled, and baby-controlled units.

2.7.2 INSTRUMENT FAMILIARIZATION

Figure 2.69 – Incubator Analyzer Connections

95
 Table 2.51 – Incubator Analyzer Connections

Item Description
 Temperature sensor connections (T1
through T4)
 Temperature sensor connection (T5)
 Temperature probe connection for K-
Type Thermocouple
 Power connection
 Sound probe connection
 Humidity probe connection
 Airflow probe connection
 Skin Temperature connection
 USB port
 Tripod spacers

Figure 2.70 – Incubator Analyzer Front Panel Controls

96
 Table 2.52 – Incubator Analyzer Front Panel Controls

2.7.3 TECHNICAL SPECIFICATIONS

Table 2.53 – Incubator Analyzer Technical Specifications

Air Convection Temperature for Incubator

Accuracy ± 0.05 °C
Range 0 °C to 50 °C
Air Convection Temperature for Radiant
Warmers ± 0.2 °C
Accuracy 0 °C to 50 °C
Range
Relative Humidity
Accuracy ±3 % RH (0 % to 100 %,
noncondensing)
Range 0 % to 100 %
Air Flow
Accuracy ±0.1 m/sec
Range 0.2 m/sec to 2.0 m/sec at 35
°C, 50 % RH
Sound Pressure
Accuracy ±5 dB(A)
Range 30 dB(A) to 100 dB(A)
Surface Temperature
Accuracy ±0.5 °C
Range -5 °C to 60 °C

97
2.7.4 EQUIPMENT CALIBRATED

2.7.4.1 INFANT INCUBATOR

Figure 2.71 – Infant Incubator

2.7.4.1.1 DESCRIPTION

Baby incubators provide the ideal environment for your baby to thrive.
Newborns, particularly those born prematurely, can have trouble regulating their
body temperature. This, and the fact that they don't have much fat, makes them
prone to hypothermia. Hypothermia is when your body loses heat faster than it can
produce it. This can cause complications like low tissue oxygen, breathing
difficulty, and slowed growth. Incubators prevent hypothermia by helping your
baby maintain an optimal temperature. Another feature of baby incubators is that
they help block out noise.

2.7.4.1.2 SOP

2.7.4.1.2.1 SCOPE

To test the Infant Incubator using Incubator Analyzer and Electrical Safety
Analyzer.
c

98
2.7.4.1.2.2 REFERENCE STANDARD

Table 2.54 – Infant Incubator Reference Standard

IEC 60601/62353 Relevant standards: Electrical Safety Test, Also Incubator

IEC 60601-2- 20 Critical parameters needs to be Tested
and measured like
 Airflow
 Sound
 Humidity
 Air and surface temperature in 6
independent points
Optional skin temperature

2.7.4.1.2.3 MASTERS USED

Table 2.55 – Masters’ details for Infant Incubator

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Incubator Analyzer Fluke INCU II

2.7.4.1.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.7.4.1.2.5 CALIBRATION METHOD

Direct Method

2.7.4.1.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.
99
2.7.4.1.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Patient Leakage Current
 Patient Auxiliary Leakage Current
 Insulation Resistance Test

100
2.7.4.1.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Switch ON the Incubator Analyzer.

Measure the following parameters using Incubator Analyzer and ensure if

it lies in the permissible range.

 Select Infant Incubator option as device under calibration in the

master.
 Place the master and the temperature sensors (T1 – T5) as per the
location specified on the mat.

Figure 2.72 – Temperature Probe Connections

 Connect the sensors (T1 – T5), Relative humidity probe, Air flow
probe and Sound probe to the respective connectors in the master.
 Place the Skin temperature sensor of the DUT close to the K-type
thermocouple.

101
 Set 35ºC on the DUT and select the following parameters like:
o Air Temperature (ºC)
o Skin Temperature (ºC)
o Relative Humidity (%RH)
o Air Flow (CPM)
o Sound (dB)
 On the master and press the Test button.

Figure 2.73 – Incubator Test Setup with probes

 Note down the observed readings.

 Activate the alarm and note down the sound observed inside the
DUT.
 Repeat the same procedure thrice.

102
2.7.4.2 RADIANT WARMER

Figure 2.74 –Radiant Warmer

2.7.4.2.1 DESCRIPTION

Radiant Warmer, is a body warming device to provide heat to the body.

This device helps to maintain the body temperature of the baby and limit the
metabolism rate. Radiant warmers increase convective and evaporative heat loss
and insensible water loss but eliminate radiant heat loss or change it to net gain.

2.7.4.2.2 SOP

2.7.4.2.2.1 SCOPE

To test the Radiant Warmer using Incubator Analyzer and ESA.

2.7.4.2.2.2 REFERENCE STANDARD

Table 2.56 – Reference Standard for Radiant Warmer

IEC 60601- 1 General requirements for basic safety

and essential performance
IEC 60601- 2-21:2009 &IEC60601-1- Particular requirements for the basic
19 Medical electrical equipment - Part safety and essential performance of
2-21 &2- 19 infant radiant warmers, Radiant
Warmer machines critical parameters
needs to be checked and tested like
 Air and surface temperature in 6
independent points
Optional skin temperature

103
2.7.4.2.2.3 MASTERS USED

Table 2.57 – Masters’ details for Radiant Warmer

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Incubator Analyzer Fluke INCU II

2.7.4.2.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.7.4.2.2.5 CALIBRATION METHOD

Direct Method

2.7.4.2.2.6 PRECAUTIONS

 Environmental conditions are ensured to be satisfactory.

 Check the traceability of the master.
 Check for the Mains Voltage to be 230V using multimeter.

2.7.4.2.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection

 Check the device for contamination and verify its clean

&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.

104
  Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Patient Leakage Current
 Patient Auxiliary Leakage Current
 Insulation Resistance Test

2.7.4.2.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Switch ON the Incubator Analyzer.

Measure the following parameters using Incubator Analyzer and ensure if

it lies in the permissible range.

105
 Select Radiant Warmer option as device under calibration in the
master.
 Place the master and the temperature sensors (T1 – T5) as per the
location specified on the mat.

Figure 2.75 – Temperature Sensor Probe Connections

 Connect the sensors (T1 – T5) to the respective connectors in the

master.
 Place the Skin temperature sensor of the DUT close to the K-type
thermocouple.
 Set 35ºC on the DUT and select the following parameters like:
o Air Temperature (ºC)
o Skin Temperature (ºC)

On the master and press the Test button.

 Note down the observed readings.

 Repeat the same procedure thrice.

106
2.8 FETAL SIMULATOR

Figure 2.76 – Fetal Simulator

2.8.1 DESCRIPTION

Fetal simulator mimics fetal and maternal heartbeats (ECG), along with
uterine activity during labor to accurately test and troubleshoot fetal electronic
monitors. It can simulate several fetal parameters including twins, via such
monitor modes such as ultrasound.

2.8.2 INSTRUMENT FAMILIARIZATION

Figure 2.77 –Fetal Simulator Control and Connections

107
 Table 2.58 –Fetal Simulator Control and Connections

2.8.3 TECHNICAL SPECIFICATIONS

Table 2.59 –Fetal Simulator Technical Specifications

Fetal ECG
Fetal ECG static rates 30, 60, 90, 120, 150, 180, 210, 240
BPM Fetal ECG sensitivity 50 μV, 100 μV, 200 μV, 500 μV, 1
(amplitude) mV, 2 Mv

108
US-1 Tracks the primary direct fetal activity
US-2 Secondary fetal cardiac activity for
either independent “normal” or
“twins” simulation.
Maternal ECG
Maternal ECG static rates 60, 80, 100, 120, 140, 160 BPM
Maternal ECG sensitivity (amplitude) 0.5 mV, 1 mV, and 2 mV
2.8.4 EQUIPMENT CALIBRATED

2.8.4.1 FETAL MONITOR

Figure 2.78 – Fetal Monitor

2.6.4.1.1 DESCRIPTION

Fetal heart rate monitoring measures the heart rate and rhythm of fetus.
Continuous electronic fetal heart monitoring may be used during labor and
birth. An ultrasound transducer placed on the mother's abdomen conducts the
sounds of the fetal heart to a computer. It helps to detect changes in the normal
heart rate pattern during labor. If certain changes are detected, steps can be
taken to help treat the underlying problem. Fetal heart rate monitoring also can
help prevent treatments that are not needed.

2.8.4.1.2 SOP

2.8.4.1.2.1 SCOPE

To test the Fetal Monitor using Fetal Simulator and Electrical Safety Analyzer.

109
2.8.4.1.2.2 REFERENCE STANDARD

Table 2.60 – Fetal Monitor Reference Standard

IEC 60601/62353 Electrical Safety test, Fetal Heart rate

accuracy, Maternal Heart rate
accuracy, Intrauterine pressure
accuracy, Alarm function
2.8.4.1.2.3 MASTERS USED

Table 2.61 – Masters’ details for Fetal Monitor

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Fetal Simulator Fluke PS320
2.8.4.1.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.8.4.1.2.5 CALIBRATION METHOD

Direct Method

2.8.4.1.2.6 PRECAUTIONS

 Check for the Mains Voltage to be 230V using multimeter.

 Environmental conditions are ensured to be satisfactory.
 Check the traceability of the master.

2.8.4.1.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

110
 Visual Inspection

 Check the device for contamination and verify its clean

&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Patient Leakage Current
 Patient Auxiliary Leakage Current
 Insulation Resistance Test

2.8.4.1.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

111
Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Switch ON the Fetal Simulator.

Measure the following parameters using Fetal Simulator and ensure if it

lies in the permissible range.

1. FETAL HEART RATE (BPM)

 Connect the Mechanical Fetal Heart to the port on the master.

Figure 2.79 – MFH

 Place the DUT ultrasound transducer face-up on sensing part and

coat it with an appropriate ultrasound conductive gel.
 Set the fetal heart rate in the master to 10%, 50%, 100% of
operating range of DUT.
 Note down the observed readings displayed on the DUT.
 Repeat the procedure thrice.
2. MATERNAL HEART RATE (BPM)
 Connect the ECG leads to the connectors on the master.
 Set the maternal heart rate in the master to 10%, 50%, 100% of
operating range of DUT.
 Note down the observed readings displayed on the DUT.
 Repeat the procedure thrice.
112
2.8.4.2 FETAL DOPPLER

Figure 2.80 – Fetal Doppler

2.8.4.2.1 DESCRIPTION

A fetal doppler is a test that uses sound waves to check fetal heartbeat. It's
a type of ultrasound that uses a handheld device to detect changes in movement
that are translated as sound. It uses the Doppler effect to provide an audible
simulation of the heartbeat. The average fetal heart rate is between 110 and 160
beats per minute. It can vary by 5 to 25 beats per minute. An abnormal fetal
heart rate may mean that the fetus is not getting enough oxygen or that there are
other problems.

2.8.4.2.2 SOP

2.8.4.2.2.1 SCOPE

To test the Fetal Doppler using Fetal Simulator and Electrical Safety Analyzer.

2.8.4.2.2.2 REFERENCE STANDARD

Table 2.62 – Reference Standard for Fetal Doppler

IEC 60601/62353 Electrical Safety test, Fetal Heart rate

accuracy, Maternal Heart rate
accuracy, Intrauterine pressure
accuracy, Alarm function

113
2.8.4.2.2.3 MASTERS USED

Table 2.63 – Masters’ details for Fetal Doppler

NAME OF THE MASTER MAKE MODEL

Electrical Safety Analyzer Fluke ESA615
Fetal Simulator Fluke PS320

2.8.4.2.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.8.4.2.2.5 CALIBRATION METHOD

Direct Method

2.8.4.2.2.6 PRECAUTIONS

 Environmental conditions are ensured to be satisfactory.

 Check the traceability of the master.
 Check for the Mains Voltage to be 230V using multimeter.

2.8.4.2.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.

114
  Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.
 Ensure if all the necessary Accessories are available.

ELECTRICAL SAFETY TEST

Measure the following parameters using Electrical Safety Analyzer and

ensure if it lies in the permissible range.

Carry out the tests with the DUT Screen in the OFF condition.

 Voltage
 Protective Earth Resistance
 Current
 Earth Leakage Current
 Enclosure Leakage Current
 Insulation Resistance Test

2.8.4.2.2.8 PERFORMANCE PARAMETERS

Battery Operating Status

Remove the AC Supply and ensure if the battery is operational in the DUT.

Alarm Function

Set values above and below the upper and lower limit for the alarm range of
DUT and check for the proper working of the alarm.

Switch ON the Fetal Simulator.

Measure the following parameters using Fetal Simulator and ensure if it

lies in the permissible range.

115
1. FETAL HEART RATE (BPM)

 Connect the Mechanical Fetal Heart to the port on the master.


Figure 2.81 – Mechanical Fetal Heart

 Place the DUT ultrasound transducer face-up on sensing part and

coat it with an
appropriate ultrasound conductive gel.
 Set the fetal heart rate in the master to 10%, 50%, 100% of
operating range of DUT.
 Note down the observed readings displayed on the DUT.
 Repeat the procedure thrice.

116
2.9 STANDARD WEIGHTS

Figure 2.82 – Standard Weights

2.9.1 DESCRIPTION

Standard weights are used primarily to test commercial weighing devices

for compliance with commercial requirements. Use of these field standards at
all appropriate levels of manufacture, distribution, and Weights and Measures
inspection will help promote accuracy and uniformity in commerce.

2.9.2 TECHNICAL SPECIFICATIONS

Table 2.64 –Standard Weights Technical Specifications

Weights
Range 1mg to 200g (Weight Box)
Up to 20Kg in Loose Box

2.9.3 EQUIPMENT CALIBRATED

2.9.3.1 WEIGHING SCALE

Figure 2.83 – Adult Weighing Scale

117
2.9.3.1.1 DESCRIPTION

An adult weighing scale is a device for measuring weight, often of a

person. They are versatile because they may perform calculations on the
measurement and transmit it to other digital devices. On a digital scale, the force
of the weight causes a spring to deform, and the amount of deformation is
measured by one or more transducers called strain gauges.

2.9.3.1.2 SOP

2.9.3.1.2.1 SCOPE

To test the Adult Weighing Scale using Standard Weights.

2.9.3.1.2.2 REFERENCE STANDARD

Table 2.65 –Weighing Scale Reference Standard

IS 2489 (1963) Weights Test

2.9.3.1.2.3 MASTERS USED

Table 2.66 – Masters’ details for Weighing Scale

NAME OF THE MASTER MAKE MODEL

Weights Set Sensortron M1 Class SS

2.9.3.1.2.4 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.9.3.1.2.5 CALIBRATION METHOD

Direct Method

118
2.9.4.1.2.6 PRECAUTIONS

 Environmental conditions are ensured to be satisfactory.

 Check the traceability of the master.

2.9.4.1.2.7 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection
 Check the device for contamination and verify its clean
&decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.

2.9.4.1.2.8 PERFORMANCE PARAMETERS

1. REPEATABILITY TEST
 Switch ON the weighing scale.
 Place the standard weights which are 50% and 100% of the full-
scale value on the center of the weighing scale.
 Note down the observed weight.
 Repeat the same procedure 10 times.
 Find the accuracy of the weighing scale with the help of the
readings obtained.
2. LINEARITY TEST
 Switch ON the weighing scale.
 Place the standard weight on the center of the weighing scale.

119
 Note down the observed weight.
 Repeat the same procedure 10 times with increasing the weights in
a linear manner.
 Find the accuracy of the weighing scale with the help of the
readings obtained.
3. POSITION TEST
 Switch ON the weighing scale.
 Place the standard weight on different positions of the weighing
scale as mentioned in the observation sheet.
 Note down the observed weight.
 Repeat the same procedure twice.
 Find the accuracy of the weighing scale with the help of the
readings obtained.

120
2.10 ANALYTICAL BALANCE

Figure 2.84 – Analytical Balance

2.10.1 DESCRIPTION

Analytical balances are highly sensitive lab instruments designed to

accurately measure mass. Analytical balances have a draft shield or weighing
chamber to prevent the very small samples from being affected by air currents.
They're meant to detect very fine increments, so the slightest vibrations or
breeze can impact the results. As such, analytical balances should be used in a
dedicated room with as few disturbances as possible. Analytical balances need
to be monitored carefully and calibrated frequently.

2.10.2 INSTRUMENT FAMILIARIZATION

Figure 2.85–Analytical Balance Controls

121
 Table 2.67 –Analytical Balance Controls

2.10.3 TECHNICAL SPECIFICATIONS

Table 2.68 –Analytical Balance Technical Specifications

Maximum Capacity 82 / 220 g

Minimum load 1 mg
Readability [d] 0.1 / 0.1 mg
Linearity ± 0.06 / 0.2 mg

2.10.4 EQUIPMENT CALIBRATED

2.10.4.1 MICROPIPETTE

Figure 2.86 – Micropipette

2.10.4.1.1 DESCRIPTION

Micropipettes are utilized in the laboratory to transfer small quantities of

liquid, usually down to 0.1 µL. Micropipettes are of two types, the Fixed
122
micropipettes, and the Variable Micropipettes. The Fixed micropipettes are
designed to transfer the fixed amount of volume of the liquid. The fixed
micropipettes cannot be adjusted to withdraw more or less of the volume. On
the other hand, the Variable pipettes come with a wide range of adjustments,
can be adjusted to withdraw the desired volume within the range of
micropipettes, say 10 µl – 100 µl micropipette which can be adjusted to any
number in between 10 µl – 100 µl.

2.10.4.1.2 SOP

2.10.4.1.2.1 SCOPE

To test the Micropipette using Analytical Balance.

2.10.4.1.2.2 MASTERS USED

Table 2.69 – Masters’ details for Micropipette

NAME OF THE MASTER MAKE MODEL

Analytical Balance RADWAG XA 82/220.4Y PLUS

2.10.4.1.2.3 ENVIRONMENTAL CONDITIONS

Temperature 25ºC ± 2ºC

Relative Humidity 50 ± 5 %RH

2.10.4.1.2.4 CALIBRATION METHOD

Indirect Method

2.10.4.1.2.5 PRECAUTIONS

 Environmental conditions are ensured to be satisfactory.

 The master should be placed away from external disturbance like air
circulation, AC on a vibration-resistant table.

123
  Check the traceability of the master.

2.10.4.1.2.6 METHODOLOGY

Note down the Calibration site, calibration frequency (as per customer
request), date of calibration and the details of the DUT (Name, Make, Model,
Serial Number, Location, Range, Least Count, Accuracy, Calibration Range).

Visual Inspection

 Check the device for contamination and verify its clean &
decontamination status.
 Observe the device for any physical damage.
 Check the device for proper alignment of switches & control units.
 Ensure the right Display Intensity & Visualization.
 Check if the Labelling & Safety Alert Symbols are present.

2.10.4.1.2.7 PERFORMANCE PARAMETERS

 Switch ON the analytical balance.

 Place the clean, empty beaker on the center of the weighing scale
and close the lid.
 Press the Tray button to bring the weight to zero reference.

Figure 2.87 – Weighing Result Window

124
 Set different volumes in the micropipette and fill it with water
maintained at 22ºC with a density of 1g/ml.
 After filling, discharge it into the clean, empty beaker.
 Place the beaker and note down the observed weight on the
analytical balance.
 Convert the observed weight into volume based on the density of
water.
 Repeat the same procedure 10 times.
 Find the repeatability & accuracy of the micropipette.

125
 CHAPTER 3

MEDICALL EXPO VISIT

Figure 3.1 –Medicall Expo

3.1 DESCRIPTION

Medicall, is India’s largest B2B Medical Equipment Exhibition is organized

by Medexpert Business Consultants Pvt Ltd. Professionals who are tasked with
purchasing and procurement responsibilities like hospital owners, medical
director, purchase managers, biomedical engineers, key decision makers,
owners of diagnostic & other healthcare centers and key policy makers from the
governmental sectors use Medicall as a platform of starting each year
efficiently.

126
 Using the show as an opportunity to get ahead of the upcoming years
product needs, they scope the full variety of options available and then have
detailed discussions with attending key influencers from manufacturing
companies to secure the best deals. Medicall provides a beneficial experience
for all dealers, distributors, importers and exporters who are looking to connect
with key industry players, sales and business development professionals who
are tasked with expanding their product portfolios and entrepreneurs hoping to
source the next big product to supply in their country.

It was conducted at Chennai Trade Centre on 28th, 29th and 30th of July
2022. Medicall is the largest gathering of healthcare and Trade professionals in
India welcoming over 30,000 attendees from 20+ countries. Many companies
exhibited their medical devices which helped visitors to gain technical
knowledge and awareness about latest advancements in the medical field.

Some of the prominent companies that took part in the exhibition are:

1. Gossen Metrawatt GmbH

2. Fluke Technologies Pvt. Ltd.

3. Rigel India Pvt. Ltd.

4. Nice Neotech Medical Systems Pvt. Ltd.

5. Serwell Medi Equip Pvt. Ltd.

6. Schiller Healthcare India Pvt. Ltd.

7. Nihon Kohden India Pvt. Ltd.

8. Wipro GE Healthcare Pvt. Ltd.

9. Lub Dub Medical Technologies Pvt. Ltd.

127
 CHAPTER 4

HOSPITAL VISIT

Figure 4.1 –DRR Eye Hospital

4.1 DESCRIPTION

DRR Eye Hospital, Poonamallee provides global standards of eye care at

an affordable cost. It is NABH accredited tertiary eye care hospital with
international standards. The annual calibration of medical instruments in this
hospital was done on behalf of NHHID, Anna University, Chennai on 6 th
August, 2022.

4.2 MASTERS USED

 Electrical Safety Analyzer

 Vital Signs Simulator

 Defibrillator Analyzer

 Infusion Device Analyzer

 Gas Flow Analyzer

128
  Electrosurgery Analyzer

 Lux Meter

 Temperature Sensor

4.3 EQUIPMENT CALIBRATED

Table 4.1 – Equipment Calibrated

DUT LOCATION QUANTITY

Defibrillator Blood Sample Collection Area 1
Pulse Oximeter OT 2
Suction Pump OT 2
OT light OT 1
Electronic Microscope OT 3
Digital BP apparatus Blood Sample Collection Area 2
Sphygmomanometer Recovery Room 1
Syringe Pump OT 1
Autoclave OT 2
ESU OT 1
Nebulizer Recovery Room 1
ECG Monitor Blood Sample Collection Area 1
TOTAL 18

4.4 INFERENCE

The significance of calibration of medical devices was understood. A

total of eighteen medical instruments in the hospital were tested and verified for
proper functioning. Practical knowledge and hands-on experience were gained
through this visit. The role and responsibility of calibration engineers to make
adjustments to machines, instruments and components using measuring and
diagnostic software to ensure precision settings are in line with standards were
realized.

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 CHAPTER 5

CONCLUSION

I am truly grateful to be a part of this informative internship offered by

the NHHID, Anna University. It was an enlightening experience to work with
calibration engineers and learn about the principles and importance of
calibration. Calibrating a device ensures that the instrument will properly
measure within the desired range for an application. This is important because a
properly calibrated measurement device will help the user to maintain the
system. It improves the accuracy and precision of the measuring device.

The visit to Medicall Expo exposed me to several reputed companies

across the globe with their customized equipment and advanced medical
technologies used in healthcare and treatment. It helped to realize and
appreciate the scope of this booming industry and its humongous potential for
development in the future.

The hospital visit provided me with immense practice-oriented

knowledge while working with several medical instruments. I inferred that the
traceability of medical devices is interlinked with the accuracy of the diagnostic
and therapeutic results. Un-calibrated medical devices may lead to imprecise
measurements. These measurements will have a significant negative impact on
the quality of the healthcare provided to patients.

I also had an opportunity to interact with Dr.S.Muttan, Quality Manager,

NHHID, who guided me to view things from a different perspective. I am
thankful to the calibration engineers at NHHID, who trained me throughout the
time period and imparted pivotal knowledge about the importance of medical
devices’ calibration and its impact on the quality of healthcare services provided
to the patients.

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