Annexure 12 — WORKS_MANUAL
Original Rule Text
S.No Name of Medical Device/ Equipment 1 Intra-aortic balloon Pump (IABP) 2 Video Assisted Thoracic Surgery (VATS) and Minimally Invasive Cardiac Surgery instrument set 3 Flow Track Cardiac Output Monitoring (EV1000) 4 Sander's Jet Ventilator for Emergency Airway 5 ENT Coblator system with standard set of wands 6 Automated Identification and antibiotic susceptibly system 7 Automated Semen Analyzer 8 Histopathology fully automated H& E slide Stainer 9 Fully Automated IHC Stainer 10 Auto PAP cervical cancer screening system with HPV 11 Automatic components preparation machine 12 Visual Field Analyzer 13 Cystoscope paediatric cystoscope 14 Flow Cytometer 15 Flexible cysto-nephoscopy 16 T Piece Resuscitator 17 CO2 Fraction Laser 18 Diode Laser 19 Q-Switched ND YAD Laser 20 Video Bronchoscope set Adult, Paediatric, and Neonatal 21 Surgical Opera 22 Cavitational /Cavitron - Ultrasonic Surgical Aspirator (CUSA) 23 Endobronchial Ultrasound System 24 Rotary Microtome 25 Magnifying surgical loups 26 Endoscopic Saphenous Vein Harvesting (EVH) System 27 Intra operative Imaging and TTFM for CT Surgery 28 DEXA Scan 29 Radio surgery equipment 30 Near Infrared Spectroscopy 31 Fluid therapy 32 Near Infrared Spectrometer (NIRS) 33 Electro Physiology (EP) System 34 TOF Monitor/Watch for Neuro Muscular block 35 Transcranial Doppler 36 Low Temperature Hydrogen Peroxide Gas Steriliser 37 Mannequins (Laerdal) for training of CPR for COVID Preparedness a) Intubation b) Cardio Pulmonary Resuscitation (CPR) c) Peripheral, Central and Arterial Cannulation d) Front of neck Access (Cricothyroidotomy and tracheostomy)
[Refer para 3.5.6 (e)]
Annexure 12: List of Medical Devices and IVDs, where local manufacturers are not available, as on 17.12.2021 (as verified with the Medical Devices Manufacturing Associations)
S.No Name of Medical Device/ Equipment 38 Image Analysis Tools/Trinocular Compound Phase Contrast Microscope for Andrology Lab 39 Gas Analysis Apparatus Halden’s Student Type 40 Gas Analyzer Automatic for CO2,O2 and N2 41 High end Operating Microscope 42 Plasma Coblation System 43 Stroboscope 44 ENT Skull Base Navigation System 45 Automated Microbial Identification and Sensitivity System 46 NAT Analyzer 47 Cryostat 48 Vitek2-Automated Microbiology Susceptibility Testing Analyser 49 FFR Machine (Fractional Flow Reserve) 50 VIDAS 51 Kingfisher Flex 52 ACL Elite 53 Cytoprep Centrifuge withVortex Mixer 54 Antigen Retrieval System 55 Trans Oesophageal Echo Cardiograph 56 IVUS -Volcano 57 STERRAD-100 NX All Clear 58 Minimally Invasive Cardiac Instruments 59 Impella 60 Endourology set 61 Cystoscope Karl Storz 62 Video Endoscopy Systems 63 Floppy wire with extra support 0 Coronary Angioplasty 64 Fully Automated Non-Contact Tonometer 65 Optical Biometer 66 Phaco Machine with Posterior and Anterior Vitrectomy 67 Portable Ultrasound Machine for Anaesthesia and Vascular Access 68 Activated Clotting Time Machine 69 Thromboelastogram (TEG)/ Thromboelastometer/ ROTEM 70 Bone Anchored Hearing Aid (BAHA) Sound Processor with Soft Band. 71 CI Speech Processor for Cochlear Implant 72 Bi-Ventricular Pacemaker with Quadripolar LV Lead 73 DDDR with Matching Electrodes Pacemaker 74 MRI Conditional Automatic Implantable Cardioverter Defibrillator (AICD) 75 MR1 Conditional Cardiac Resynchronisation Therapy - Pacing (CRT- P) 76 Single Chamber (SSI) MRI Compatible Pacemaker 77 Single Chamber Temporary Pacemaker 78 Non-complain /semi complain /CTO coronary balloon. 79 Vacuum Heart Stabilizer System for off Pump CABG 80 Expandable Corpectomy device 81 Biomimetic Synthetic Absorbable Dural substitute of sizes 82 AO TRS Modular Drive for Drill/Reamer 83 AO TRS Modular Sagittal saw system 84 Battery Oscillator 85 Arthroscopy Systems 86 Navigation System for Neurosurgery & Orthopaedic Surgery 87 Time Lapse Embryo Imaging System 88 Portable Mobile Endoscopy Unit
S.No Name of Medical Device/ Equipment 89 Cryoprobe 90 Isothermal Calorimeter (ITC) 91 Electrical Impedance Tomography 92 FNIRS (Functional Near Infra-Red Spectroscopy) System 93 Automated Hand-Held Analyzer 94 Automated High Throughput Liquid Based Cytology (LBC) System 95 Automated IHC (Immuno Histochemistry Stainer) 96 Automated Slide Stainer for Histopathology 97 3T Digital PET/MR 98 Dual Particle Cyclotron on buyback basis 99 Sweat Collection and Chloride Estimation 100 Automated Bronchoscope Cleaning Equipment 101 Electronics and console for the existing 700 MHz NMR Spectrometer 102 Video bronchoscope with mobility of tip in four directions 103 Freeze Facture System 104 Cryo Plunge Freezing Unit 105 Biological High- Resolution Atomic Force Microscopy 106 Carbon Coater (Evaporator) for grids 107 Hemostasis Analyzer System 108 Auricular Reconstruction Set 109 Thin Layer Chromatography Liner Analyser for lipid analysis 110 Digital Slide Scanner System 111 Full Endoscopic lumbar IT & ED set 112 Rapid Blood/Fluid Flow warmer 113 Fully Automated Computerized Archival System for Histopathology & Cytology Slides 114 Vacuum Assist Drainage Controller Device 115 VAP Care System 116 Cryoablation Unit 117 3D Printer Hardware with SLA (LFSJ TM Technology and Machine interface software 118 Transcutaneous Oxygen Monitor 119 Non-Invasive Jugular Oximetry Monitor 120 Dedicated Solid-state cardiac SPECT Camera 121 Hemodynamic Recorded for Cardio Vascular Lab 122 Gel Documentation System 123 Automatic Colony Counter 124 Droplet Digital Polymerase Chain Reaction System (PCR) 125 Multi-block PCR Machine 126 Integrated Automated Charting System upgradable for ICU Monitoring System 127 Viscoelastic Global coagulation Testing Device 128 Robotic Surgery System with accessories