Clinical incubators or infant warmers Clinical Incubators Or Infant Warmers ( 6 ) Technical Specifications Specification Specification Name Values Allowed Values Definition and Clinical Purpose Definition Mains electricity (AC- powered) mobile device that contains an infrared (IR) heating element(s) designed to emit controlled

Clinical incubators or infant warmers Clinical Incubators Or Infant Warmers ( 6 ) Technical Specifications Specification Specification Name Values Allowed Values 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 - 1/8 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 true - have user friendly touch panel control Yes - Type of heater: ceramic ceramic

quartz infrared

calrod heater Audiovisual alarm facility for: Overheating beyond set temperature range

Spurt in Heater output i.e. more than 60% heater output for 10 minutes system should raise alarm and cutoff heater

Power failure

Heater failure

Patient temperature less/Greater than required/set temperature

Probe failure Overheating beyond set temperature range

Probe failure Warmer head should be rotatable in different direction

so as to allow taking X-ray true true

false Yes is better 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 - 2/8 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 - - Bed Distance from the heat source - - should have lockable castor wheels Yes - 3/8 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 110 - 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 - 4/8 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 1000 - Overall Width of equipment - - Overall Length of equipment - - Overall weight of equipment - - 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 - 5/8 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 600 - Compatible to alternate energy supply source; Solar Heating in addition to AC power source): true true

false Yes is better 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

US FDA

CE European - Performance and safety standards (specific to the device type); Local IEC-60601-1-2:2007 Medical electrical equipment Part 1-2: - 6/8 and/or international 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) true - 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 3

5 Higher is better * Bold specifications are the golden parameters. 7/8 Consignees and Quantity S.No. Consignee Address Quantity Delivery Days 1 Ram Krishna Bhatt 228001

MEJARFGANJ SULTANPUR 6 15