Medical Devices

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Calibration of Medical Devices:

Calibration of Medical Devices is the process of verifying and adjusting the accuracy of medical devices to ensure they provide reliable and precise measurements, which is crucial for patient safety and effective treatment. This involves comparing the device’s readings against known standards and making necessary adjustments to Align it with the required specifications.

S.N.Instruments NameParameter to be calibratedStandard Used
1Anesthesia WorkstationPressure, Flow rate, Volume, Time, Oxygen Concentration & Electrical Safety TestGas Flow Analyzer & Electrical Safety Analyzer
2AutoclaveTemperature & PressureDigital Thermometer & Pressure Calibrator
3Baby IncubatorTemperature, Airflow, Humidity, Sound Level & Electrical Safety TestIncubator Analyzer & Electrical Safety Analyzer
4Baby Weighing ScaleWeights (Upto 30 Kg)Stainless Weights
5BipapPressure (EPAP & IPAP), Inspiration Time, Respiration Rate & Electrical Safety Test (If applicable)Gas Flow Analyzer & Electrical Safety Analyzer
6Blood Gas Analyzer, Haematology Analyzer, OT Table, Semi-Auto AnalyzerElectrical Safety TestElectrical Safety Analyzer
7Boyles ApparatusFlow Rate & Oxygen ConcentrationGas Flow Analyzer & Electrical Safety Analyzer
8BP Instruments_DigitalPressure Test (NIBP)Vital Signs Simulator
9BP Instruments_ManualPressure Test & Leak TestVital Signs Simulator
10CPAPPressure (CPAP) & Electrical Safety Test (If applicable)Gas Flow Analyzer & Electrical Safety Analyzer
11DefibrillatorEnergy Output, Charge Time & Electrical Safety TestDefibrillator Analyzer & Electrical Safety Analyzer
12Dialysis MachineFlow Rate, Conductivity, Pressure, pH, Temperature & Electrical Safety TestDialysis Reference Meter & Electrical Safety Analyzer
13ECGHeart Rate, Amplitude & Electrical Safety testDefibrillator Analyzer & Electrical Safety Analyzer
14Electronic Bed, EEG, EMGElectrical Safety TestElectrical Safety Analyzer
15Electronic TourniquetPressure, Time & Electrical Safety TestGas Flow Analyzer & Electrical Safety Analyzer
16Electrosurgical Unit/Diathermy/ RF CauteryPower Output, REM Test, HF Leakage & Electrical Safety TestElectrosurgical Unit Analyzer & Electrical Safety Analyzer
17ETO MachinePressure TestPressure Calibrator
18Fetal Monitor/CTG MachineFetal Heart Rate & Electrical Safety TestFetal Simulator with Mechanical Heart & Electrical Safety Analyzer  (If Applicable)
19Flowmeter with HumidifierFlow Rate, Temperature, Oxygen Concentration & Electrical Safety Test (If applicable)Gas Flow Analyzer, Digital Thermometer & Electrical Safety Analyzer
20Foetal DopplerFetal Heart RateFetal Simulator with Mechanical Heart
21Heart-lung machineFlow Rate, Oxygen Concentration, rpm & Electrical Safety TestGas Flow Analyzer, Tachometer & Electrical Safety Analyzer
22Hemotherm MachineTemperature & Electrical Safety TestDigital Thermometer & Electrical Safety Analyzer
23IABPHeart Rate, Amplitude & Electrical Safety testDefibrillator Analyzer & Electrical Safety Analyzer
24Infusion PumpFlow Rate, Volume, Occlusion/Back Pressure & Electrical Safety TestInfusion Device Analyzer & Electrical Safety Analyzer
25NebulizerFlow Rate, Pressure & Electrical Safety Test (If applicable)Gas Flow Analyzer & Electrical Safety Analyzer
26OT LightLight IntensityLuxmeter
27Oxygen ConcentratorFlow Rate, Oxygen Concentration & Electrical Safety Test (If applicable)Gas Flow Analyzer & Electrical Safety Analyzer
28Patient MonitorHeart Rate, Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Respiration Rate, SpO2 Level, Temperature & Electrical Safety TestVital Signs Simulator & Electrical Safety Analyzer
29Patient WarmerTemperature & Electrical Safety TestDigital Thermometer & Electrical Safety Analyzer
30PhototherapyIrradiance & Electrical Safety TestIrradiance Meter & Electrical Safety Analyzer
31Pressure Gauge of Oxygen CylinderPressure TestPressure Calibrator
32Pulse OximeterSpO2 Level,Heart Rate & Electrical Safety Test (If applicable)Vital Signs Simulator & Electrical Safety Analyzer (If Applicable)
33Radiant WarmerTemperature, Airflow, Humidity, Sound Level & Electrical Safety TestIncubator Analyzer & Electrical Safety Analyzer
34Suction MachinePressure Test & Electrical Safety TestGas Flow Analyzer & Electrical Safety Analyzer
35Syringe PumpFlow Rate, Volume, Occlusion/Back Pressure & Electrical Safety TestInfusion Device Analyzer & Electrical Safety Analyzer
36Temporary pacemaker/External PacemakerPulse Rate (PPM) & Pulse Current AmplitudeDefibrillator Analyzer
37TMT MachineHeart Rate, Amplitude & Electrical Safety testDefibrillator Analyzer & Electrical Safety Analyzer
38VentilatorPressure, Flow Rate, Volume, Time, Oxygen Concentration & Electrical Safety TestGas Flow Analyzer & Electrical Safety Analyzer

  • Patient Safety: Accurate measurements are essential for correct diagnoses and treatment, preventing errors that could harm patients.
  • Regulatory Compliance: Many medical devices require regular calibration to meet industry standards and regulations.
  • Reliable Results: Calibration of medical devices ensures that the equipment functions as intended, producing consistent and trustworthy results.
  • Preventing Equipment Failure: Regular calibration of medical devices can help identify potential issues before they lead to device failure, minimizing downtime and associated costs.
  • Extending Equipment Lifespan: Proper maintenance, including calibration, can help prolong the life of medical devices.

INFUSION DEVICE ANALYZER– Pressure, Flow Rate, Volume

ELECTRICAL SAFETY ANALYZER– Protective Earth Resistance, Insulation Resistance (Low Range @ 50V DC, Low Range @>50V DC, High Range @ 500V DC, High Range @ 250V DC), Leakage Current (Direct Leakage, Differential Leakage, Alternative Leakage), Voltage, Current, Power

VITAL SIGNS SIMULATOR– Heart Rate, Invasive Blood Pressure (IBP), Non-Invasive Blood Pressure (NIBP) (Integrated Pump, Manometer), Respiration Rate, Temperature, Amplitude (Fetal ECG1 Amplitude, Fetal ECG2 Amplitude, Maternal ECG Amplitude), Leak Test, O2 Saturation

DEFIBRILLATOR ANALYZER– Energy, Charge Time, Heart Rate, ECG Amplitude

DIALYSIS REFERENCE METER– Conductivity, Temperature (Air Convection, Skin Sensor), Pressure (High Pressure, Differential Pressure, Flow Channel Pressure), Flow Rate, Timer

GAS FLOW ANALYZER– Flow Rate, Volume, Gas Temperature, Respiration Rate, Time, I:E Ratio, Oxygen Concentration, Compliance

ELECTROSURGICAL ANALYZER– Power, Resistance, Current, CQM, Voltage (rms)

IRRADIANCE METER– Irradiance

INCUBATOR ANALYZER– Airflow, Sound Level, Relative Humidity

FETAL SIMULATOR WITH MECHANICAL HEART– ECG (Fetal ECG1, Fetal ECG2, Maternal ECG), Intra-Uterine Pressure | pH METER- pH

DIGITAL LUXMETER (KUSAM-MECO)– Light Intensity (LUX)

DIGITAL TACHOMETER– “Non-Contact (2.5 rpm to 99999 rpm)”, “Contact (0.5 rpm to 99999 rpm)” “Surface Speed (0.05 m/min to 1999.9 m/min)” | WEIGHTS (UPTO 30 KG)

RTD SENSOR WITH INDICATOR

PRESSURE CALIBRATOR

  • Comparison with Standards: Medical Devices are compared to known standards or reference equipment.
  • Adjustments and Corrections: If deviations are found, adjustments are made to bring the medical device within acceptable limits.
  • Testing and Documentation: Calibration of medical devices involves various tests and measurements, and the results are documented for record-keeping and compliance.
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