Infant Warmer Phototherapy Unit

• 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