Annexure-a

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Annexure-A Technical Specification of ENT Equipments Contents Equip Equipment name sr. no 1 Diode laser Quantity 2 ENT treatment unit with patient chair and with work station 9 3 Operating microscope with viewing tube & endo camera with monitor 6 4 Operating microscope wall mounted for OPD with zoom, 4 5 Headlight with internal fiber optic light cable fully adjustable 11 6 Headlight with internal fiber optic light cable fully adjustable with camera 8 7 Wireless endoscope 4 8 Heavy duty shadow less operating light for ENT OT similar make major+minor(O.T.) 36 9 Otoscope pen torch 30 10 Rigid Esophagoscopy set 4 11 4 12 Bronchoscope set (pediatric & adult) complete set with all accessories including forceps Drill engine complete with micro foot control and connecting cord 13 ENT heavy duty operation table 16 14 Video laryngoscope with telescope 4 15 Distending operating laryngoscope 5 16 Impedence audiometer or middle ear analyzer 2 17 Micro laryngeal forceps 6 18 CO2 laser system 3 19 Bipolar RFA for ablation in ENT region with auto stop function. 6 20 Electronystagmography (ENG) machine 5 21 Cryotherpy unit 4 22 Skeeter Otologic Drill Sysytem 1 23 Facial Nerve Monitor 1 24 Cochlear Implant Kit 1 3 10 Annexure-A 25 Burrs 1 26 ENT operating microscope for minor operation theatre 1 27 Temporal bone lab microscope 1 28 DrilL Machine with mastoid set for temporal bone lab 1 29 Cryosurgery Unit 1 30 Micro Drill with hand piece with burrs of sizes 1 1.Diode Laser Equipments Name Diode Laser Technical specification Specifications Wavelength (nm) 780nm Diode Power (mW):5/20 Annexure-A Operation Voltage:3~5v Beam Diameter:3mm Beam Divergence: < 0.5mrd Operating Current at 25Deg C <50mA Collimating lens: Aspheric plastic lens Case material: Brass MTIF (Mean Time ToFailure)2000 hrs. of operation Specifications of Laser Diode Module of 30mW 830nm Modulation Frequency 100 KHz Modulation Level 100% (signal on) & 20% (off) of optic output power Max. Optical Output power ~ 70% of max. diode power (w/o front cover, 7mm aperture) Wavelength (nm) 830nm Diode Power (mW)30mW Operation Voltage:5V/12V Operation Temperature -10 +/-40/50/60/700C Beam Diameter 7mm (w/o front. cover), 4mm (w/front cover) Beam Divergence <0.8mrd Bore Sighting <15mrd Operating Current at 250 C <50mA; Collimating· Iens 3-element glass lens Case Material: Black. Anodized (Aluminium) Life time·2000 hrs. of operation. Certification : USFDA/European CE approved 2. ENT treatment unit with patient chair and with work station Sr. No. 1 2 3 4 5 6 11 12 13 14 15 Description of Technical Specification ENT Treatment unit with patient chair and with work station Compact design with thermal resistant workshop and auto touch control panes Large aluminium pull out tray with dividers for keeping various sterile instruments Containers with flap openings for keeping used instruments and wastes 2 power sockets 230V should work on 230 V with deviation of 50/60 hz Should be equipped with, Large LCD monitor connected to an external PC managing Camera System with recording and editing software. e) Endoscopy counter with telescope 0 degree view 4 mm diameter & 175 mm working length f) Suction use counter which should have – Suction hand pieces with tubing capacity 60 Ltrs per minute, vacuum 0.85 bar, receptacle with overflow valve for suction system, suction tip 1 mm, 1.5 mm and 2.5 mm. g) Compressed air system with spray hand pieces h) Warm water irrigation system i) Inline water filter with connectors: Water purification filter (4 weeks life span) to be connected to the hand piece combined to the autonomous system with 5 litre distilled water tank. 16 j) Ear rinse cap 17 k) l) m) n) o) p) q) r) s) Pre heated for mirrors Microscope with minimum 3 step magnification charger and spare bulb Compatible digital video camera C mount adopter Microscope beam splitter with integral endoscope adopter 17 inch TFT monitor with LCD Flat screen Integrated fiber optic light source with fiber optic cable for telescope fiber optic light source 150 W halogen for head light fiber optic head light with integrated fiber optic cable 18 19 20 21 22 23 24 25 Annexure-A 26 27 28 29 30 31 t) Cautery Power out put- 80W Cautery which should be European CE/US FDA Certified. u) doctor stool with – 360 degree ratable adjustable back and height cross type base v) patient chair with – electrical height adjustment, arm rest, footrest, flat diagnosis program should be compatible with future development protection cover for microscope and work station 3. Operating microscope with viewing tube & endo camera with monitor Equipment Name Operating microscope with viewing tube & endo camera with monitor Technical Specification Operating Microscope with side viewing tube & integrated endo camera with motorized zoom. Motorised with foot control objective lenses 200, 300, 400 with side tube and with Monitor. Added- Should be US FDA approved. 4. Operating microscope wall mounted for OPD with zoom Equipment Name Operating microscope wall mounted for OPD with zoom Technical Specification Operating Microscope wall mounted for OPD with Zoom and with integrated HD Camera. Objective lenses 200, 300, 400 with side tube and with Monitor 17". Product should be US FDA approved. 5. Headlight with internal fiber optic light cable fully adjustable Equipment Name Headlight with internal fiber optic light cable fully adjustable Technical Specifications Headlight, light model illuminated area 65 mm in diameter with 46 cm working distance; with thin integral fiber optic light cable, diameter 2.5 mm, with fully adjustable, comfortable headband - Headlight adjustable in 3 dimensions vertical adjustment at the headband, front part Rotatable through 45° to the left and to the right and 165° downward - Self retaining in any position no deviation from desired position 6. Headlight with internal fiber optic light cable fully adjustable with camera Annexure-A Equipment Name Headlight with internal fiber optic light cable fully adjustable with camera Technical Specifications Headlight, light model illuminated area 65 mm in diameter with 46 cm working distance; with thin integral fiber optic light cable, diameter 2.5 mm, with fully adjustable, comfortable headband - Headlight adjustable in 3 dimensions vertical adjustment at the headband, front part Rotatable through 45° to the left and to the right and 165° downward - Self retaining in any position no deviation from desired position With adjustable focus & field controller 7. Wireless endoscope Equipment Name Wireless endoscope Technical Specification 1/18" Color camera Pixel :320x240( NTSC ) TV Lines 0. 77mm/F3.0 2Lux / Fl.2 DC 3.3 V dimensions: (D) 7.5mm x 12.5mm (D) 3.5mm X 23mm 8. Heavy duty shadow less operating light for ENT OT Equipment Name Heavy duty shadow less operating light for ENT OT Technical Specifications (a) The double dome operating light must be designed for the use in high demanding surgical procedures. State-of-the-art LED bulbs should be used to ensure a low energy consumption and a long service life. (b) The LED OT Light unit should be US FDA approved. (c) Outer handles at the light head should be provided to allow for non-sterile positioning. (d) Light head must be designed with smooth transitions and surfaces, without slots, gaps or exposed screwing to ensure fast and effective cleaning. (e) The light head with streamlined shape is favourable within laminar flow. The light head must be resistant to disinfectant. (f) For sterile positioning an ergonomic, exchangeable and centrally positioned sterile handle within the light head should be provided. (g) All main joints of surgical light must be provided with unlimited rotation (360°). Light head and suspension must be sealed dustproof. (h) Classification a. Protection class acc. to IEC 60601-1 i. Mains connection component - Protection class 1 ii. Light head – SELV Annexure-A b. Protection class acc. to IEC 60529 i. Arm system/mains connection component IP 30 ii. Light head - IP 42 c. Classification in accordance with EU Directive 93/42/EEC Annex IX - Class I d. UMDNS-Code (Universal Medical Device Nomenclature System ) - 12-282 e. IEC 60601-1 - Medical electrical equipment – Section 1-1 f. IEC 60601-2-41 - Medical electrical equipment – Section 241 g. IEC 60601-1-2 - Medical electrical equipment – Section 1-2 h. Should have US FDA approved, certificate must to be provided. (i) The surgical light should be complete with all components for ceiling mount and electrical feed-in, incl. finalised installation. (j) Technical data for main dome: - 1nos. i. Central illumination intensity Ec 160.000 lux ii. Light field diameter at a distance of 1 m 200 mm iii. Depth of illumination L1+L2 -1300 mm iv. Average Color rendering index Ra- 95 v. Color rendering index R9 (red)- 93 vi. Color temperature - 5000K vii. Central illumination at 1m distance with: I. Tube-100% II. one mask:40% III. tube and one mask:40% IV. two masks:48% V. tube and two masks: 48% viii. Central irradiance Ee- 580 W/ m² ± 50 W/ m² ix. Ee/Ec ratio - 3.5 W/m2 x Lux x. Adjusting the illumination intensity- 40000 to 160000 Lux xi. Number of LED- 66 units xii. Number of LED stripes- 11 units xiii. Service life LED bulbs- approx. 30000 hours xiv. Replacement of LED bulbs- possible xv. Ambient light mode (Endolight)- 300 Lux xvi. Diameter of light head- 620 mm Annexure-A (k) Technical data for satellite dome - 1nos. i. Central illumination intensity Ec160.000 lux ii. Light field diameter - 200mm iii. Depth of illumination L1+L2 - 1300 mm iv. Average Color rendering index Ra- 95 v. Color rendering index R9 (red)- 93 vi. Color temperature -5000K vii. Central illumination at 1m distance with: I. Tube- 100% II. one mask:41% III. tube and one mask:41% IV. two masks:49% V. tube and two masks:49% viii. Central irradiance Ee- 430 W/m2 ± 50 W/m2 ix. Ee/Ec ratio- 3.5 W/m2 x Lux x. Adjusting the illumination intensity-40000 to 120000 Lux xi. Number of LED- 48 units xii. Number of LED stripes-8 units xiii. Replacement of LED bulbs- possible xiv. Service life LED bulbs- approx. 30000 hours xv. Ambient light mode (Endolight)-300 Lux xvi. Diameter of light head-620 mm 9. Otoscope pen torch Equipment Name Otoscope pen torch Technical Specification Model Magnification Ring illumination with Halogen bulb attachment for air pressure (changes Battery Operated using AA pen torch cells Spare Batteries and spare Bulbs 3 Certificate: USFDA/European CE approved 10. Rigid Esophagoscopy set Equipment Name Rigid Esophagostomy set Technical Specifications Oval Esophagoscopes with fibreoptic light carrier distal illumination with handle. length 30 cm OD 10 mmx14 mm length 50 cm OD8mmx12mm length 30 cm and OD 12 mmx16mm Optical pediatric and adult forceps for esophagoscopes, optical alligator forceps, optical forceps for peanmt and soft foreign Annexure-A bodies and optical universal forcep Esophagoscopic forceps, alligator grasping peanut grasping, circular cup biopsy, punch biopsy, scissors straight, trituration of bone, universal biopsy and grasping forcep. Certificate: USFDA/European CE approved 11. Bronchoscope set (pediatric & adult) complete set with all accessories including forceps Equipment Name Bronchoscope set (pediatric & adult) complete set with all accessories including forceps Technical Specification Straight Forward Telescope 0°, Fiber optic light transmission incorporated.-01 Bronchoscope pediatric Bronchoscope, length 30 cm size 6 -01 Bronchoscope, length 30 cm size 5.5 - 01 Bronchoscope, length 30 cm size 5 -01 Bronchoscope, length 30 cm size 4.5 -01 Bronchoscope, length 30 cm size 4 - 01 Bronchoscope, length 30 cm size 3.5 -01 Bronchoscope, length 30 cm size 3 - 01 Bronchoscope adult Forward-Oblique Telescope0°, diameter 5.5 mmlength 50 cm, - 01 Forward-Oblique Telescope30°,\diameter 5.5 mm, length 50 cm, - 01 Bronchoscope tube universal, with fiber optic light carrier, length 43 cm, size 8.5 - 01 Bronchoscope tube universal, with fiber optic light carrier, length 43 cm size 6.5 -01 Accessories for bronchoscopy Prismatic light deflector with connection for fibreoptic cable light Carrier.-01 Glass window plug -01 Instrument guide for aspiration catheter -01 Adaptor to respiratorSealing plug for respirator connection -01 Annexure-A Rigid suction tube 50 cm – 01 length x2.5 mm dia, 35cm – 01 lengthx2.0mm dia, 25 cm -01 length x2.0 mm dia. -01 Optical Bronchoscopic forceps Peanut grasping 50 cm length x2.5mm diameter – 01 Crocodile alligator forceps straight, Lt & Rt - 01 each Circular cup biopsy forceps standard 35 cm -01 lengthx2.5mm diameter – 01 Alligator grasping 45cm length x2.0 mm dia – 01 12. Drill engine complete with micro foot control and connecting cord Equipment Name Drill engine complete with micro foot control and connecting cord Technical Specification Output-DC30V/0.5A, Input-AC 110V/220V 50/60 Hz, Motorbrush motor RPM- Handpiece Max. Micromotor For forward and reverse cutting 35000 RPM (max) Straight Handpiece Contra angled Handpiece NSK Ex-6B NSK Certificate : European CE/ USFDA approved 13. ENT heavy duty operation table Equipment Name ENT heavy duty operation table Technical Specifications ENT heavy duty operation table with complete hydraulic and gear system tilt in any direction. Table operating-remote controlled electronic with European CE mark/USFDA Technical specification: length 1910mm, minimum width 520mm,maximum height 950mm, minimum height 750mm or better, trendlenberg Upto 30 Deg or more , reserve trendlenberg, up to 20 Deg. or more lateral tilts 20 Deg. both side. Should supply following accessories: 1. Head support and Arm board 14. Video laryngoscope with telescope Equipment Name Technical Specifications Annexure-A Video laryngoscope with telescope Video laryngoscope with telescope Special features Straight forward telescope 15˚, diameter 4 mm working length 18 cm autoclavable Video laryngoscope working length 18 cm for adults medium size 15. Distending operating laryngoscope Equipment Name Distending operating laryngoscope Technical Specifications Distending operating laryngoscope Pediatric size length 13.5 cm for use with fibre optic light carrier and suction tube Fibre optic light carrier diameter 4 mm for use in central channel laryngoscope Suction tube to remove vapour for laser treatment diameter 2 mm for use in central channel of laryngoscope length 10.5 cm Certificates should be European CE/USFDA approved 16. Impedance audiometer or middle ear analyzer Equipment Name Technical Specifications Impedence audiometer or middle ear analyzer Technical data Tympanomatry mode Prob frequency , intensity – 226Hz =/- 1%, 85 db spl into cm3 High frequency – 678hz /800 hz /1000hz Pressor range - +300 to 600 dapa Volume range .1 to 6 ml Accuracy + /- 5% or +/- 10dapa Test time <3 second Reflex mode test frequency - 500,1000,2000,4000, hz +/- 2 % Noise stimuli - WN/HP/LP Annexure-A Test method - ipsilateral , contralateral Intensities ipsilateral - 70….105 db HL Intensities contralateral – 70…110 db HL with button contra phone 70…120 db HL eith TDH 39 contraphone Ipsilateral reflex test – with AGC Intensity setting – automatic or manual Reflex decay mode Test time - 13 sec , 10 sec , auto tone present Eustachian tube mode Pressure range +400 to – 400 dapa With printer , and portable Product should be European CE/ US FDA approved product. 17.Micro laryngeal forceps Equipment Name Micro laryngeal forceps Technical Specifications Required 2 each Instrument Micro laryngeal forceps serrated jaw 25cm , 35 cm, left 25 cm, right 25 cm, upward 25 cm, cup jaw straight 25 cm, left , right and upward 25 cm Micro laryngeal scissor straight , left , right and upward 25 cm JACKSON grasping forceps 25,35,45,55 cm Foreign body forceps 25,35,45,55 cm PATTERSON biopsy forceps 25,35,45,55 cm Biopsy cup forceps 25,35,45,55 cm Biopsy punched forceps 25,35,45,55 cm JACKSON foreign body forceps 25,35,45,55 cm JACKSON alligator forceps 25 ,35,45,55 cm Annexure-A Certificates USFDA/European CE approved 18. CO2 laser system Equipment Name CO2 laser system Technical Specification TECHNICAL SPECIFICATIONS for CO2 LASER SYSTEM LASER TYPE - Ultra Pulsed CO2 Laser with Micromanipulator / Coupler, Operating Microscope, CCD Camera / Coupler, Beam Splitter, 22”Flat Screen LCD Monitor, Electrically operated 180 Degree Inclinable, Hight Adjustable - Patient Treatment Chair and Hydraulic / Mechanical Lever operated - Doctor’s chair. LASER CONFIGRATION - SEALED OFF CO2 GAS, DC EXCITED. WAVE LENGTH 10600nm – 10.6 Micron. MODE STRUCTURE TRUE WG TEMoo MODE POWER TO TISSUE CONTINUOUS, PULSED, ULTRA PULSED 1 - 40W PULSE DURATION SUPER PULSE:400-800ms ULTRA PULSE < 300ms PEAK POWER 300-1200W MICROPROCESSOR SELF DIAGNOSTIC & SELF CALIBERATION PURGE AIR AUTO PURGE AIR. HAND PIECES 50mm & 100mm SPOT SIZE 0.1mm - 0.2mm at Focus. DISPLAY LCD Touch Screen MEMORY USER PROGRAMMABLE MEMORY SETTINGS BEAM DELIVERY ARTICULATED ARM 7 MIRRORS TITANIUM. AIMING BEAM 635-670nm, 5mw,Red Diode ADJUSTABLE BRIGHTNESS, COOLING SYSTEM CLOSED CYCLE PURIFIED WATER TO AIR POWER INPUT 3-6A, 220V AC / 50Hz. WEIGHT 60KGs. Power Output 1-40 watt and 60 watt. Energy Delivery System through endobronchial fibre and articulated arm with micromanipulator and scanner mode Certificates : USFDA/European CE approved 19. Bipolar RFA for ablation in ENT region with auto stop function Equipment Name Bipolar RFA for ablation in ENT region with auto stop function Technical Specification Specification of Radio Frequency Induced Thermotherapy Units (ENT) Should be based on the principle of Radiofrequency induced Thermotherapy for minimal invasive surgeries. Annexure-A Should be interstitial form of therapy which can be performed under local anaeshtesia. Surface of the organ should remain intact. Current should be induced through bipolar applicators. Should not need any neutral electrodes. Tissue should be heated over 60 deg. C. Should provide a rapid procedure. Should have constant real-time monitoring of the coagulation process Should provide end-of-procedure signal. Should have automated power control to exclude overdosing. Should have footswitch control. Should be a compact unit and should be supplied with different applicators and probes. Should be certified acc. to CE and IEC601.10 safety standards. Consumables Probes for treatment of Habitual snoring & Hyperplastic palatine tonsils in adults and children with conical tip & 1.3mm dia Probes for treatment of mild obstructive sleep apnea with trocar tip & 1.3mm dia Probes for treatment of Hyperplasia of the nasal concha, Habitual snoring (combined treatment) and Mild obstructive sleep apnea (combined treatment) with conical tip & 1.1 mm dia Probes for treatment of Nasal polyps, especially recurrent polyps with conical tip and 1.3mm dia Angled and bayonet Forceps with cables for tissue and vessel coagulation to stop bleeding in ENT and surgery. Should use Bipolar RFITT for the cutting system Should not require any neutral electrode Should have the power setting of 1-25Watts Annexure-A Should be compatible with cutting electrodes of 0.2mm dia & 10mm length Should be supplied with Surgical Forceps Electrodes, Cutting Electrode Grip & connecting cables Consumables Cutting Electrodes Certificates:USFDA/European CE approved 20. Electronystagmography (ENG) machine Equipment Name Electronystagmography (ENG) machine Technical Specification SYSTEM CAPABILITIES :Input channels:4 Low filter:1,2 or 4 seconds High filter:7.5/ 15/ 30 Hz Coupling:DC Response Input offset voltage Range:+ 16mV CMMR:> 14 dB Noise: < 5microV peak to peak max with input shorted Notch filter:50/60 Hz Resolution(ADC):14 bit Sampling rate: 500 Hz Sweep speed:5/10/20 mm/sec Range of eye position tracked :+ 30 degree horizontal and vertical Linearity.Horizontal:1% full scale Vertical:1.2% full scale Input power:120/240 VAC , 50/60Hz OPTICAL STIMULUS:Type:Light bar Annexure-A Patient to bar distance :1 metre Target position:Gaze targets + 30 degrees Pursuits and saccades: computer controlled Target size:< ½ degree Optokinetic:6 targets ELECTRODES :Type:Ag/Ag Cl Disc electrodes MINIMUM COMPUTER CONFIGURATION :CPU: PC IBM Compatible with P-IV, 512 MB , 80 GB HDD, 1 SL, 1 parallel, 4 USB Port. Monitor:15 inch colour Operating system:Windows Vista Printer :Windows compatible Inkjet/Laser jet With soft wares Certification : USFDA/European CE approved 21. Cryotherpy unit Equipment Name Cryotherpy unit Technical Specification Pressure indicator Interchangeable tip Foot pedal control 22. Skeeter Otologic Drill System Equipment Name Skeeter Otologic Drill System Technical Specification • Hand piece weighs only 2 oz. • Variable speed, footswitch-controlled • Speeds up to 12,000 RPM • Self-powered or use with MPS console with optional adapter • Full range of color-coded Oto-Flex burs available • Drill is also compatible with XPS 2000 Console including: Otologic Drill System Ultra-Lite Hand piece Accelerator Foot Control Annexure-A 9V Batteries (package of 12) Otologic Metric Scale Oto-Flex Bur Set (6 burs) Certificcation: USFDA/European CE approved 23. Facial Nerve Monitor Equipment Name Facial Nerve Monitor Technical Specifications  Monitor  Stimulator  Current output 0.0- 10.0 milliamperes (mA)  Pulse width 0.0002 sec + 20 micro seconds  Pulse off time 0.1998 seconds  Pulse frequency 0.200 seconds (5 Hz) + 5 milliseconds Certification: USFDA/European CE approved 24. Cochlear Implant Kit Equipment Name Technical Specifications Cochlear Implant Kit Including: 1. Stimulator Template 2. TEMPO+/OPUS Template 3. Skin Flap Gauge 6 4. Surgical Claw Angled 5. Micro Forceps Left Angled 6. Micro Forceps Right Angled 7. Diamond Burr 1.2 mm 8. Diamond Burr 0.6 mm 9. Sterilization Tray Certifications : USFDA/ European CE approved 25. Burrs Equipment Name Technical Specification Burrs Burrs: Cutting 0 to 5 number -one each Polishing 0 to 5 number - one each Annexure-A Diamond 0 to 5number- one each 26. ENT operating microscope for minor operation theatre Equipment Name ENT operating microscope for minor operation theatre Technical Specifications Operating Microscope with side viewing tube & integrated endo camera with motorized zoom. Motorised with foot control objective lenses 200, 300, 400 with side tube and with Monitor.Product should be US FDA approved. 27. Temporal bone lab microscope Equipment Name Temporal bone lab microscope Technical Specification Operating Microscope wall mounted for OPD Zoom. objective lenses 200, 300, 400 with side tube and integrated HD camera. Monitor should also be supplied along with other standard supply and as asked in the specifications. Certificates: USFDA/European CE approved 28. Drill Machine with mastoid set for temporal bone lab Equipment Name Drill Machine with mastoid set for temporal bone lab Technical Specification International Standards for a High Speed Micro Motor drill for use in ENT High Speed Micro Motor System with motor control display with Hand pieces Straight & Contra angled to be used in Sinus Surgery, Otology, Ethmoid , Mastoid & Temporal Bone surgeries with foot control, integrated irrigation system, speed greater than 50,000 rpm, burrs for special applications Burrs: Cutting 0 to 5 number -1 each Polishing 0 to 5 number – 1 each Diamond 0 to 5number- 1 each Certification : USFDA/European CE approved 29. Cryosurgery Unit Equipment Name Cryosurgery Unit Technical Specification  Consoles containing cryogen gas cylinders,pressureregulators,indicators and operating Annexure-A controls.  Hypodermic needles  Silencer  Probe tips Certification : USFDA/European CE approved 30. Micro Drill with hand piece with burrs of sizes Equipment Name Micro Drill with hand piece with burrs of sizes Technical Specifications High Speed Micro Motor System with motor control display with Hand pieces (Straight & Contra angled) with quick tool clamping type to be used in Sinus Surgery, Otology, Ethmoid , Mastoid & Temporal Bone surgeries with foot control, integrated irrigation system, speed greater than 50,000 rpm, burrs for special applications Burrs: Cutting 0 to 5 number -10 each Diamond 0 to 5number- 10 each Quality Certificate- European CE/ US FDA approved