Phototherapy machine for SNCU

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Description

Performance Parameters

Purpose The system emits light for reducing the concentration of bilirubin
Type of phototherapy machine On Mobile Floor stand
Phototherapy technology LED
Light unit shall be made of easily cleanable plastic or fibre material Yes
Type of coolinf Natural cooling
The range of main radiation spectrum in nm 400-550
Peak wavelength of light in nm 450 to 465
Minimum spectral Irradiance in μW/cm2/nm 35 – 40 μW/cm2/nm at 45 cm height
Irradiance shall be free from UV and IR radiation Yes
Availability of digital hour meter showing time Patient Treament time
Machine should have timer to indicate monitoring therapy hours resettable and LED usage non resettable yes
Interruption and a restoration of the power supply do not change preset values Yes
Average Effective light field in mm2 1000-1500
LED life hours for LED light unit in hours above 20000-upto 30000
Facility of Over temperature safety cut out Yes
Mininmum height of phototherapy light unit from floor to use near the mother bed in mm 1100
Maximum height of phototherapy light unit from floor to use near the mother bed in mm 1600
LED should not topple on 10 deg inclined angle Yes
The irradiance ratio (min to max) on mattress more than 40%
Indicator light shall be provided to indicate that equipment is in use Yes
Free fall protection for LED Spring Counter balance with locks
Phototherapy unit can be used with infant care trolley , radiant warmer and incubator and The base of the unit should be such that it will go beneath any incubator/bed/trolley with minimum of 100 mm floor clearance Yes
Facility of adjustment of light intensity Continuous vriable
Mobile stand with movable castors and height adjustment facility along with easy swiveling of source box Yes
Number of castors 4
Number of brakes 2
All surfaces to be made of corrosion resistant materials Yes
Noise (in dB) 0
Phototherapy unit shall be equipped with white light for observation purpose Yes
Phototherapy unit shall be provided with irradiance measurement meter in μW/cm2/nm With external flux meter
Phototherapy unit shall consist of backlit LCD Yes
Complete unit shall be easily washable and sterilizable using both alcohol and chlorine agents Yes
Length of main cable in meter with power socket of standard indian make to be provided 3
Power supply 230 ± 10 VAC, 50Hz
Maximum temperature range of machine in degree Celsius 40ᵒC
Warranty in years 2

Additional Parameters

Availability of Electrical protection by resettable over current breakers or replaceable fuses, fitted in both live and neutral lines Yes
Power consumption in watts upto 45
Number of replacement sets of fuses 1
Number of Infant eye masks of different sizes Not provided
Operating temperature and humidity Operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%

Reports

Certifications for product CE
Certification No and date to be indicated ERTL(E)/TES/S455/0034/09-07 Dated 17.9.2007
Quality Management System Certification of manufacturer ISO 13485 latest
Quality Certification No and date to be indicated 13417 Dated 1.2.2018
Saftey standards IEC 60601-2-50 :2009
Safety Certification No and date to be indicated 13417 Dated 1.2.2018
Copies of certifications to be provided to buyer on demand at time of supplies Yes

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