NATIONAL HUB FOR HEALTHCARE INSTRUMENTATION DEVELOPMENT

CENTRE FOR CALIBRATION ANDTESTING OF MEDICAL EQUIPMENT

Department of Science & TechnologyGovt. of India

It may not be the disease... It may not be the doctor's fault... It may not be the medication...

Have you calibrated your medical equipment recently???IT’S WORTH SOMEONE’S LIFE!!!

BUT THE FAULTY MEDICAL EQUIPMENT THAT KILLS!!!

Calibration Team (For Technical Queries)Contact : Project Scientist

Mob : 98408 62782PH : 044 - 2235 7942 Email ID : nhhidcalib@gmail.com / yahoo.com

Business Liaison Team (For Business Queries)Contact : Business Liason Officer /

Business Liason ExecutivePH : 044 - 2235 7941 / 7938 Email : au.nhhid@gmail.com / nhhid.bio@yahoo.com

THE COORDINATORNHHID

2nd Floor, Kalanjiyam Building, Opp. to Mining Engineering, CEG Campus,

Anna University, Chennai - 600025 Phone: 044-2235 7938 / 7941 / 7942

Email : nhhidcalib@gmail.com / yahoo.com Website : www.nhhid.org

nhhidcalib@gmail.com GO INDIGENOUS SERVE MANKINDwww.nhhid.org

Dr. S. PoonguzhaliTechnical Manager, CCTME

Associate ProfessorDept. of ECE, Anna University

About the CentreNational 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. We provide credible traceability certificates along with calibration reports.

What is Calibration?Calibration is the act of checking or comparing accuracy of measuring equipment with a Standard under specified conditions.

Why Calibrate Medical equipment?Calibrating equipment periodically ensures;

• Accuracy• Efficiency• Safety• Reliability• Longer life of equipment• Uniform Performance of multiple units

Benefits of calibrating medical devices Superior quality of healthcare Enhance patients confidence Mandate for accreditation process (like NABH) Provides patients safety against electrical hazards Reduces risk due to equipment malfunction and increases

patients safety

OUR TECHNICAL MANAGEMENT TEAM

Dr. S. Muttan HOD

Dept of ECE, Anna University

Dr. M. SasikalaDeputy Coordinator, NHHID

Quality Manager CCTMEDirector of Medical Electronics

Professor, Centre for Medical Electronics, Anna University

Dr. Prof. S. MeenakshisundaramCo-Coordinator, NHHIDDean, ACTECH Campus

Dr. Bharanidharan GaneshanAssociate Professor

Radiation Safety Officer, Medical Physics, Anna University

Our expert group is trained & certified in ISO 17025 LQMS & Measurement Uncertainty.

1GO INDIGENOUS SERVE MANKIND

Our 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)

Advantages of our services Brand value Authenticity Constant updates Training

Standards followedISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories.IEC 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.IEC 62353:2014 - Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment.IEC 60601-2-12 - Medical electrical equipment - Part 2: Particular requirements for the safety of lung ventilators for medical use.IEC 60601-2-4 - Medical electrical equipment -Part 2: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillators monitors.IEC 60601-2-49 - Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment.IEC 60601-2-2 - Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.IEC 60601-2-24 - Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers.And other standards.

nhhidcalib@gmail.com2 www.nhhid.org

CALIBRATION FACILITY AND CAPABILITY

FOR

FOR

SUCTION PUMP

BOYLES APPARATUS

ANESTHESIA WORKSTATION

PULSE OXIMETERVITAL SIGNS SIMULATOR

GAS FLOW ANALYZER

ECG MACHINE

BP APPARATUS

PATIENT MONITORING

SYSTEM

VENTILATOR

BIPAP

FLOW METER

3GO INDIGENOUS SERVE MANKIND

FOR

FOR

DEFIBRILLATOR

PACEMAKER

DIATHERMY / CAUTERY

DEFIBRILLATOR ANALYZER

ELECTROSURGICAL ANALYZER

nhhidcalib@gmail.com4 www.nhhid.org

FOR

FOR

INFUSION PUMP ANALYZER

ELECTRICAL SAFETY ANALYZER

SYRINGE PUMP

INFUSION PUMP

APPLICABLE FOR ALL MEDICAL DEVICES

CALIBRATION FACILITY AND CAPABILITY

5GO INDIGENOUS SERVE MANKIND

FOR

FOR

INCUBATOR ANALYZER

DIGITAL LUX METER

INFANT INCUBATOR

BABY WARMER

OT LIGHT

nhhidcalib@gmail.com6 www.nhhid.org

FOR

FOR

FETAL SIMULATOR

DIALYSIS ANALYZER

FETAL DOPPLER

FETAL MONITOR

DIALYSIS MACHINE

CALIBRATION FACILITY AND CAPABILITY

7GO INDIGENOUS SERVE MANKIND

FOR

FOR

PHOTOTHERAPY RADIOMETER

DIGITAL TACHOMETER

PHOTOTHERAPY UNIT

TMT MACHINE

CENTRIFUGE

nhhidcalib@gmail.com8 www.nhhid.org

Analytical Balance

FOR

FOR

PIPETTE

AUTOCLAVE

HOT AIR OVEN / INCUBATOR

9GO INDIGENOUS SERVE MANKIND

INDOOR AIR QUALITY TESTING

PRESSURE CALIBRATOR AND GAUGE

OPERATION THEATRE /OTHER COOLING UNITS

SUCTION APP & ALL GAUGES (+ & - VE)

FOR

FOR

nhhidcalib@gmail.com10 www.nhhid.org

F1 CLASS WEIGHTS

PH MEASURING INSTRUMENT

PH METER

BABY AND ADULT WEIGHING MACHINE

FOR

FOR

11GO INDIGENOUS SERVE MANKIND

SOUND LEVEL METER

SMART DIFFERENTIAL PRESSURE GAUGE

ICU NOISE TESTING

AIR VENT PRESSURE

FOR

FOR

nhhidcalib@gmail.com12 www.nhhid.org

FOR

X-RAY DOSIMETER

CTIQ PHANTOM

MAMMOGRAPHY PHANTOM

HEAD AND BODY

PHANTOM

TOR IQ II PHANTOM

RADIOLOGICAL ANALYZERS

13GO INDIGENOUS SERVE MANKIND

SURVEY METER

RADIATION SURVEY

FOR

X-ray (Mobile, Fixed, Portable) CT Mammography Fluoroscopy C-arm Interventional Radiography Linear Accelerator Dental X-ray (OPG & IOP) DEXA Scan (BMD)

nhhidcalib@gmail.com14 www.nhhid.org

NATIONAL HUB FOR HEALTHCARE INSTRUMENTATION DEVELOPMENT CENTRE FOR CALIBRATION

Anna University, Chennai

Test Report Number : NHHID-AU/2015-Customer Name and Address

Description Make / Model/ Type Serial Number Calibrated at Condition of the equipment Date of calibration Recommended due date for next calibrationPartial / Full Calibration

ENVIRONMENTAL CONDITIONS OF MEASUREMENT Temperature Relative Humidity

DETAILS OF MASTER INSTRUMENTS USED FOR CALIBRATION

Description Make

1. Vital Signs Simulator Fluke/ProSim8

1. The Standards used are traceable to National / International Standards.2. This report refers only to the item calibrated and shall not be reproduced in fu

the issuing laboratory. 3. This report is not valid unless it is signed by the authorized signatory.4. Any error in this report should be brought to 5. The result reported is valid at the time of and under the stated conditions of measurement.6. This is a test report not a certificate.

Procedure used for Calibration *DUT - Device Under Test N/A-Limits of performance not applicable

CALIBRATED BY

HUB FOR HEALTHCARE INSTRUMENTATION DEVELOPMENT CALIBRATION AND TESTING OF MEDICAL EQUIPMENT

Anna University, Chennai - 25 TEST REPORT

-02/001 DATE: 23/02/15 M/S. Health center CEG Campus, Anna university, Guindy, Chennai-600025

DETAILS OF THE DUT* ECG Machine Schiller / AT 2 /CF 12525452 On-Site Good 23/02/15

Recommended due date for next calibration 22/02/16 Partial

ENVIRONMENTAL CONDITIONS OF MEASUREMENT 25.0°C - 29.0°C 62% RH - 65% RH

DETAILS OF MASTER INSTRUMENTS USED FOR CALIBRATION

Make / Model Sl. No Traceability

Fluke/ProSim8 200624 TEKTRONIX

CONDITIONS OF ISSUE OF REPORT 1. The Standards used are traceable to National / International Standards.

refers only to the item calibrated and shall not be reproduced in full without the written approval

is not valid unless it is signed by the authorized signatory. rror in this report should be brought to our knowledge within 15 days from the date of this report.esult reported is valid at the time of and under the stated conditions of measurement.

NHHID-AU/STP/06

Limits of performance not applicable VERIFIED BY AUTHORISED SIGNATORY

HUB FOR HEALTHCARE INSTRUMENTATION DEVELOPMENT – NHHID MEDICAL EQUIPMENT

Page 01 of 02

DETAILS OF MASTER INSTRUMENTS USED FOR CALIBRATION

Traceability Calibration Validity

TEKTRONIX 13/06/2018

ll without the written approval of

our knowledge within 15 days from the date of this report. esult reported is valid at the time of and under the stated conditions of measurement.

AUTHORISED SIGNATORY

M/S. Health CentreCEG Campus,Anna University,Guindy, Chennai-600025

Calibration EngineeringTechnical ManagerCalibration Engineer

15GO INDIGENOUS SERVE MANKIND

NATIONAL HUB FOR HEALTHCARE INSTRUMENTATION DEVELOPMENT CENTRE FOR CALIBRATION

Anna University, Chennai

Test Report Number : NHHID-AU/2015- 1.0 VISUAL INSPECTION OF DUT 1.1 Device clean & decontaminated 1.2 No physical damage to case, display,1.3 Switches & Controls operable are correctly aligned1.4 Display Intensity adequate for daytime1.5 Control number, labeling and warnings present are legible1.6 Inlets & hoses 1.7 Power Cord, Accessory cables and charges1.8 Filters & vents clean

2.0 PERFORMANCE TEST 2.1 Heart Rate

Sl. No Standard Value - Master (bpm)

1 80 2 100 3 120 4 130 5 140

2.2 Amplitude

Sl. No Standard Value - Master (mV)

1 1 2 2.5

Conclusion / Remarks: 1. The measured values are within the specified limits

CALIBRATED BY

HUB FOR HEALTHCARE INSTRUMENTATION DEVELOPMENT CALIBRATION AND TESTING OF MEDICAL EQUIPMENT

Anna University, Chennai - 25 TEST REPORT

-02/001 DATE: 23/02/15

PASS √

display, mounts, or connectors √ Switches & Controls operable are correctly aligned √

time use √ Control number, labeling and warnings present are legible √

1.7 Power Cord, Accessory cables and charges √

Indicated Value-DUT (bpm)

Error/ Deviation

(±bpm) 80 0

100 0 120 0 130 0 140 0

Indicated Value-DUT (mV)

Error/ Deviation

(±mV) 1 0

2.4 0.1

specified limits of standard.

VERIFIED BY AUTHORISED SIGNATORY

HUB FOR HEALTHCARE INSTRUMENTATION DEVELOPMENT – NHHID MEDICAL EQUIPMENT

23/02/15 Page 02 of 02

FAIL N/A √ √

Allowable Tolerance

(bpm) Remarks

±5%

√ √ √ √ √

Allowable Tolerance

(mV) Remarks

±5% √ √

AUTHORISED SIGNATORY

Calibration Engineering Technical ManagerTechnical ManagerCalibration Engineer

nhhidcalib@gmail.com16 www.nhhid.org

Critical care equipmentsCALIBRATION CHARGES

S. No. EQUIPMENT TESTING PARAMETER Calibration

Charges

1. BP Apparatus, Torniquet, Insufflator Pressure Test, Leak Test 200

2. ECG Machine/TMT ECG Waveform Simulation, Amplitude* Electrical Safety Test* 600

3. Pulse Oximeter O2 Saturation, Heart Rate 400

4. Patient Monitor System ECG Simulation, NIBP, SpO2,Electrical Safety Test* 1200

5. Ventilator, Anesthesia Workstation

Full Breath Test, Pressure/Leakage Test, Continuous Flow Test, Electrical Safety Test*

1200

6. Defibrillator Energy, Charge Time, Electrical Safety Test* 800

7. Infusion Pump/Syringe Pump Flow Test, Occlusion Test, Dual Flow Rate Test*, PCA Test* 600

8. Surgical Diathermy Power Distribution Test, Output Test, ESA* 800

9. Flow Meter, Fumigation Flow Rate 20010. Boyles Apparatus O2 Flow, N2O balance O2 880

11. BIPAP/CPAPFull Breath Test, Pressure/Leakage Test Continuous Flow Test

880

12. Fetal/ Maternal/CTG Monitor Fetal Heart Rate, Electrical Safety Test* 600

13. Baby Warmer/ Infant IncubatorElectrical Safety Test*, Temperature Test, Relative Humidity, Sound & Air Flow

1200

14. Infant Phototherapy Irradiance 40015. Dialysis Conductivity, Flow, Temperature 160016. Pressure Gauge Pressure 600

17. OT Light, Focus light, camera console, spot light Luminance Test 400

18. Suction Pump/ Vacuum Jar Pressure 200

17GO INDIGENOUS SERVE MANKIND

19. Autoclave/Hot Air Oven Temperature, Pressure*, ESA* 800

20. Incubator/B.O.D Incubator/Hot plate Temperature, ESA* 800

21. Interferential Therapy Electrical Safety 32022. Short wave Diathermy Electrical Safety, Scope* 32023. Nerve Stimulator Electrical Safety, Scope* 32024. Traction Unit, OT table Electrical Safety 32025. TENS Electrical Safety, Scope* 32026. Physiotherapy Equipments Electrical Safety, Scope* 32027. Nebulizer Flow, Pressure 200

28. Tube sealer, ELISA Reader, ELISA Washer, EEG Machine Electrical Safety 320

29.

Hydrometer, PH meter, Calorimeter, Photometer, USG Machine, Ultra sonic cleaner, Electrophoresis apparatus

Electrical Safety 320

30. Water bath, Wax Bath, Paraffin bath Temperature, ESA* 800

31. Platelet Agitator with Incubator Temperature, Agitation* 80032. VDRL Rotator Speed, ESA*, Cycles 200

33. Centrifuge, shaker, Power Drill Speed, ESA* 200

34. Refrigerated Centrifuge Temperature, Speed, timer, Imbalance, ESA* 1000

35. Refrigerator, Deep freezer, Plasma Freezer, thermometer Temperature 800

36.Laryngoscope, Bronchoscope, Foetoscope, Colposcope

Luminance, ESA* 400

37. Thermometer(ILC) Temperature 40038. Pipette Volume 500

39. Air quality Temperature, Humidity, Pressure, Co2, O2, Co 1200

40. ILR Temperature 800

* Based on availability, the test will be performed.

18 www.nhhid.orgnhhidcalib@gmail.com

Terms and Conditions1. GST @18% and other applicable taxes at the time of payment.

2. Report Delivery: Within 20 days after settling full payment.

3. Execution of work: Within 14 days from your confirmed order.

4. Billing: Variations from the work order will be taken into account and based on that final bill will be prepared

5. The Standards used for calibration are traceable to National/ International Standards.

6. Quality of service will not be compromised for any reasons.

7. 50% Advance payment before start of work to proceed with PO.

8. Accommodation charges will be bared by the customer, when calibration was performed outside Chennai.

9. Onsite Calibration other than Chennai will be performed only when the number of equipments was more than 150.

Radiological Equipments

S.No Equipment Testing Parameters

Unit Charges

(Rs)

1 X ray As per AERB protocols 5500

2 CT As per AERB protocols 9500

3 Mammography As per AERB protocols 5000

4 Radiation Survey As per AERB protocols 2000

19GO INDIGENOUS SERVE MANKIND

OUR REACH

13000+ 250+

Total Number of Equipment

Calibrated so far

Calibration Capability 59 Different types of devices

Total Number of Hospitals Catered

so far

and counting . . .

nhhidcalib@gmail.com20 www.nhhid.org

KEY EVENTS

To create awareness as well as to provide this service to IMA-NHB hospitals, a meeting was held at Koodal Hall of Anna University between NHHID and IMA-TNSB office bearers on 16th April 2016. As an outcome of this meeting, 44 IMA-NHB hospitals in Chennai, Erode, Coimbatore, Madurai and Vellore were benefited by the testing and calibration of their medical equipment. NHHID appeals to the Tamil Nadu hospitals to make use this facility fully to ensure that the treatment rendered in their premises is with calibrated instruments and of higher quality and reliability. Together we should make this joint initiative of DST-TDT and Anna University a big success and worthy model to emulate throughout the country.

MoU between DME and Anna University

DIVMED workshop

Meeting with Indian Medical Association Tamilnadu branch

Inauguration of calibration centre