Description
Definition And Clinical Purpose
| Definition | 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/infant 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. |
| Clinical purpose &Overview of functional requirements | It is an electrically powered device with a radiant heating source intended to maintain the thermal balance of an infant by direct radiation of energy in the infrared region of the electromagnetic spectrum. It is a microprocessor controlled unit with heater placed on the over head panel. This work on both servo and manual mode options to maintain the baby temperature at the set value. There are two modes of operation manual and baby (servo) mode. It has Digital displays reading the set and baby observed temperatures seperately. |
Technical Characteristics (Specific To This Type Of Device)
| facility to display skin set, skin observed temperature in degree C and heat power separately | Yes |
| have user friendly touch panel control | Yes |
| Type of heater: | calrod heater |
| Audiovisual alarm facility for: | Overheating beyond set temperature range,Power failure,Heater failure,Patient temperature less/Greater than required/set temperature |
| Warmer head should be rotatable in different direction, so as to allow taking X-ray | Yes |
| Observation light Luminance and Colour temperature | > = 1000 Lux , Colour temperature range from 3700K to 5100K |
| Battery back up facility for Power failure indication during power fail | Yes |
| desired temperature range | 25 to 40 degree C |
| setable temperature 32 to 38 deg C | 32 to 38 deg C |
| temperature resolution should be: | <= 0.1 degree C |
| Temperature accuracy should be | <= 0.2 degree C |
| facility to lock the keyboard to avoid unwanted user modification of the set parameters | Yes |
| should have separate Bassinet trolley, bed should be tilt-able and have suitable provision for x-ray cassette holder, Mattress foam density should be minimum 25 kg/cm3, transparent collapsible side walls easily detachable for cleaning | Yes |
| Should have a Feather Touch operation with large digital display and comprehensive alarms, Control Panel should be liquid proof and allow easy and hygienic disinfection | Yes |
| Manual Mode can adjust Heater Output 10 -100 %, with 10% increment, an auditory and visual alarm shall be given at least every 15 min | Yes |
| Under manual mode, heater cut off / switch off , if the maximum irradiance at any point of the mattress area exceeds a total irradiance level of 10 mW/cm2 (between 10 to 30 minutes) | Yes |
| Bed height from Floor | 90 centimeter |
| Bed Distance from the heat source | 85 centimeter |
| should have lockable castor wheels | Yes |
| Green indicator light shall be indicate that warmer is ready for normal use | Yes |
| Markings on the bassinet and X-Ray cassette holder to enable proper positioning of the baby while doing the X-Ray | Yes |
| Number of tubing ports (edges covered by silicon rings) on the side walls (For cable management) | 4 |
| Height of the side walls over the mattress | 1400 millimeter |
| Provision of X-Ray cassette tray of at least 750 mm X 350 mm size, suitable to adopt <= 20mm thick X-Ray cassette | Yes |
| bay bed should be crevice free for ease of cleaning, infection control | Yes |
| mattress used should be of biocompatible material | Yes |
| Skin temperature probe should be small in size [Diameter <= 10 mm & Height <= 4 mm] with biocompatible Baby contact material | Yes |
| Mobility, portability | On castors (2 of the castors should have brakes) & Castor size >= 4 inch. |
Settings
| Settings with facility to clearly display the selected mode,Option of Selecting either Manual mode and Baby (Servo) mode settings, Provision for Set temperature range (in servo mode) from 32 to 38 deg C | Yes |
| User’s interface | Manual and Servo controlled temperature regulation |
| Software and/or standard of communication(where ever required) | LED Display and inbuilt software; Interruption and restoration of the power supply does not change the preset values |
| Others: | 1. Device shall not overbalance when placed in any transport position of normal use on a 10° inclined plane from the horizontal plane. 2. Transformers of devcie shall be protected against overheating in the event of short circuit or overload of any output winding. 3. Patient leakage current should be less than 100 μA in normal condition 4. Temperature on the baby mattress should not exceed 43 deg C when the warmer is operating under steady temperature condition 5. Temperature of HEATER GUARDS should not exceed 85 °C in normal use. 6. The Temperature differences on the mattress shall not exceed 2 °C. |
PHYSICAL CHARACTERISTICS
| Overall Height of equipment | 1800 millimeter |
| Overall Width of equipment | 850 millimeter |
| Overall Length of equipment | 1000 millimeter |
| Overall weight of equipment | 128 kilogram |
| Heat source Configuration | >= 60 degree angle adjustment must be possible in the heat source, it should provide shielding to the infant in case of breakage of tubes/bulbs and all surfaces to be made of corrosion resistant material |
| Noise | Auditory alarm shall have a sound level of at least 65 dBA at a distance of 3 m from the front of the infant radiant warmer, and the sound level of the alarm shall not exceed 80 dBA on the mattress |
| Heat dissipation | Should maintain desired set temperature and uniform heat distribution in baby cradle |
ENERGY SOURCE
| Power Requirements | 220 to 240V, 50 Hz AC, ± 10% of input |
| Battery operated | Power failure indication during power fail |
| Protection | OVP, earth leakage protection |
| Power consumption | 90 Watt |
| Compatible to alternate energy supply source; Solar Heating in addition to AC power source): | Yes |
| Thermal reflector to fix the skin probe | >= 50 units to be supplied with each equipment unit |
ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATIONS
| Atmosphere / Ambiance | Operating condition: -Capable of operating continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90% in ideal circumstances. – an ambient air velocity is less than 0.3 m/s. |
| User’s care, Cleaning, Disinfection & Sterility issues | Complete unit to be easily washable and sterilizable using both alcohol and chlorine agents. |
STANDARDS AND SAFETY
| Certificates, | CE European |
| Performance and safety standards (specific to the device type); Local and/or international | IEC-60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility -Requirements and tests (Or Equivalent BIS). Shall neet IEC 60601 -2- 21: 2009 Medical Electrical Equipment – Part 2¬21: Particular Requirement for the basic safety and essential performance of infant radiant warmers . should meet IEC 60601-1:2005(or latest) standard requirements. Baby contact material should be biocompatible. Manufacturer should be ISO 13485 certified |
| Availability of Type Test report from any Govt/ NABL accredited /iLAC approved laboratory (To be produced by Seller on Buyer’s demand if indicated available) | Yes |
TRAINING AND INSTALLATION
| Pre-installation requirements for the equipment | Availability of 5 amp/15 Amp. Electrical socket (2 nos) for each warmer at Buyer’s facility. |
| Documentation required to be provided by Seller: | User & Operating manual,Certificate of Calibration, Factory inspection report, user training manual |
WARRANTY
| Warranty Scope | Shall be onsite and comprehensive i.e. with free service and spares |
| Warranty period for equipment(Other than nickel chrome wire filament and tube of quartz, that shall have lifetime warranty) | 3 year |
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