Infant Warmer Phototherapy Unit

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Infant warmer With Phototherapy Unit /Resuscitaire with Phototherapy Unit importance has taken prime place in the Medical surgical technology worldwide. Neonatal Effective during the Process from labour to delivery and there on the warming therapy and clinical emergency while resuscitation. Bio Gene Resuscitaire or Infant Warmer with phototherapy model BTI/IW/E/PU becomes an automatic choice. Bio Gene Machine are manufactured under strict WHO norms Confirming to IEC-60601, FDA, CE, ISO.

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  • Applications
  • Features
  • Control
  • Construction
  • Specification

We are one of the leading manufacturer and supplier of superior quality Neonatal and Infant warmer With Phototherapy Unit /Resuscitaire With Phototherapy Unit. These Neonatal and Infant warmer With Phototherapy Unit/Resuscitaire With Phototherapy Unit are in good demand in the market due to high quality and durability. This Resuscitaire With Phototherapy Unit provides automatic over heat and over temperature protection in both manual and servo modes. Quartz Infrared heater element with very effective heat Radiation. 

  • Microprocessor controller with servo operation/Manual Controls.
  • Quartz infrared heater element with very effective heat radiation
  • Radiation type heater operated by both timer and skin temperature Regulation, selectable between the two Servo controlled.
  • This Infant warmer With Phototherapy Unit/ Resuscitaire with Phototherapy Unit provides automatic over heat and over temperature protection in both servo modes.
  • The CFL with Phototherapy lamp source place on the upper surface.
  • The Single Surface CFL Phototherapy unit is a combination of the CFL.
  • Thermister based high sensitive temperature probe ensure an accuracy of ±0.2°C.
  • Height adjustable facility.
  • With Timer system.
  • Probe is inter-changeable without calibration.
  • An integral Bed with up down tilting facility.
  • Trendelenburg and inverse Trendelenburg positions.
  • Optimum bed dimensions ensure optimum work space for the nursing staff.
  • Display of set temperature and Resuscitaire with Phototherapy Unit temperature.
  • Comprehensive Alarms and safety cut offs.
  • Wide base for stability and Castors with brakes for good mobility.
  • Easy to use and clean. Convenient storage tray for keeping essential things
  • Halogen lamp for observations.
  • Software upgrade: - lifespan 10 Years.

DISPLAY

ALARM

  • Audio Visual  
  • Temperature High/low Alarm.
  • Temperature and probe failure.
  • Power failure Alarm.

STANDARDS

  • ISO   13485:2003   Medical   devices   --   Quality management   systems   --   for regulatory purposes (Australia, Canada and EU).
  • ISO 14971:2007 Medical devices -- Application of risk management to medical devices.
  • IEC  60601-1:2012  Medical  electrical  equipment  - Part 1: General requirements for basic safety and essential performance.
  • IEC 60601-1-1:2000 Medical electrical equipment -Part 1-1: General requirements for safety – Collateral standard: Safety for medical electrical system.
  • IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General for basic safety and essential  performance   -   Collateral   standard:  Electromagnetic compatibility 
  • IEC    60601-2-21:2009 (Part    2-21:    basic  safety  and  essential  performance of infant radiant warmers)
  • FDA, CE or UL approved product. Quality standards: Manufacturing standards ISO 9001.
  • Electrical safety conforms to standards for electrical safety IEC-60601-1. ISO certificate for quality standard and ISO 13485.
  • Material: Mild steel.
  • Type: Heat reflective surfaces.
  • Heater:  Electric, Finned Stainless steel Air Heater 
  • Control: Thermostat.
  • Protection: Wire mesh guard.
  • Dimensions: Approximately  :- D300x W250x 150 H mm
  • Power: 240V, 50 Hz, A.C
  • standards CE/ISO/GMP/IEC,EN.

REGULATIONS

  • US regulations
  • 21 CFR part 820
  • 21 CFR section 880.5130
  • JP regulations
  • MHLW Ordinance No.169
  • Bio Gene Infant warmer With Phototherapy Unit /Resuscitaire With Phototherapy Unit are manufactured under strict Electro mechanical medical devices NICU, thermo regulation.
  • Microprocessor controller with servo operation/Manual Controls.
  • A  mains  electricity  (AC-powered)  mobile  device  that contains an infrared (IR) heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/ Resuscitative patient requiring supplemental Heat. 
  • This device is equipped with wheels so that it can easily be moved to different areas of a room, ward, or department.
  • Provides a controlled environment with radiation heat in an open space for critical treatment of newborns.
  • Health  centre,  district hospital,  provincial  hospital, specialized hospital Neonatal  intensive  care  unit  (NICU),  Toco-surgery,
  • Emergency room (ER) Functional requirements: Provides thermal support, oxygen  and  suction  for newborn  Infant Warmer With Phototherapy Unit / Resuscitaire With Phototherapy Unit.
  • Compact trolley castor wheels fitted with locks. 
  • Bio Gene Infant warmer With Phototherapy Unit / Resuscitaire has stable bassinette and is secure and easy to sterilize.
  • Mattress made  of  flame  retardant  material  , washable, antibacterial and resistant to: corrosion, water, detergent soap, 70% ethylic alcohol solution with & without nitrite and (HCL).
  • Patient temperature range -34°C to 38°C/93.2°F -100.4°F.
  • Tilting infant bed, through Bassinet.
  • Temperature alarm programmable.
  • Easy access to the infant from Three sides.
  • Height adjustable infant table 10-100 cm.
  • Bassinet size 65 x 40 cm.
  • Tilting table swivel 1 – 150
  • Drawer for storage with 2 trays.
  • Swing side panels to access infant table.
  • Suction pump, bottled oxygen racks & fittings.
  • Examination light with independent power switch X-Ray chassis tray underneath bassinette.
  • Integrated Open-bassinet, heater unit and control unit.
  • Castor wheeled base, with locking arrangement.
  • Monitor shelf load 20 Kg.
  • Working temperature Range: - 0 to 50 deg C.
  •  Humidity: - 15 to 90%.
  • Operating temperature: - 10 to 40 deg C.
  • Heater power switches with a range of 0 to 100%.Self-test facility on power. 
  • Patient temperature range control from 35°C/95°F to 37°C/98.6°F
  • Temperature resolution at least ±0.5 deg C.
  • Heater power switches with a range of 0 to 100%.Self-test facility on power.
  • Patient temperature range control from 35°C - 37°C / 95°F - 98.6°F
  • Temperature resolution at least ±0.5 deg C.
  • Apgar Score monitor.
  • Heater power output :- 200 W. 

Electrical Supply

  • Power supply: 220 V, 50 Hz, ±10% Single Phase.
  • Battery  powered  alarm  in  the  event  of  power failure,  with  temporary  silence  feature. 
  • Voltage stabilizer ± 30% voltage.
  • Over current breakers.
  • Cable 3.2 meter.

ACCESSORIES & CONSUMABLES

  • Mattresses.
  • Sensors.
  • Oxygen cylinder.
  • Operation Manual
  • Oxygen cylinder  capacity 10  litters
  • Humidifier
  • Oxygen  tubes
  • Reflective sensor 
  • Flux meter

SPARE PARTS

  • Fuses
  • Warmer 

 

An ISO 9001Certified EC, EU