Convective Air Patient Warming System

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Type of Certifications for product USFDA
Certification no and date 2081762CE04
Confirmity for electrical safety standard IEC-60601-1-1 or equivalent BIS
Conformity for general requirements for electro magnetic compatibility IEC-60601-1-1-2-or equivalent BIS

Performance Parameters

Purpose Used in operation theaters and recovery rooms or critical care environment and clinical areas where patients are at risk of hypothermia
Cross compatibility of blankets Yes
Components Should have basic warming unit and disposable blankets
Suitability of Air warming system as per type of blanket used Adult and pediatric patients
Temperature Management Unit The warming system shall be provided with a temperature management unit to generate high flow of warm air
components of the basic warming unit electric motor,fan ,electric heating element,thermostat ,air filter and hose
Mode of working Fan draws air through filter which is heated by heating element to selected temperature controlled by thermostat and heated air pass through hose to blanket which inflates and hot ait permeates through surface of blanket and moves over skin of patient transferring heat through convection
Type of digital Display for temperature and settings LED
The convective air patient warming system should have fast warming system and should set temperature in degree centigrade with in 60 seconds Yes
Range of temperature setting in degree centigrade 32-44 ᵒC
The control unit should be light weight and small in size easily mountable with a fixing claw Yes
Multiple Mounting options for the warming unit to be available Bed rail ,IV Pole,Cart,Floor,Trolley
Availability of thermal cut out in case of thermostat failure and temperature goes higher Yes (If temp goes more than 48ᵒC)
Availability of audio alarm in case of thermostat failure Yes
The alarm sytem should work for over temperature and under temperature Yes
Length of hose in cm 180
Auto heating cut off facility to control the set temperature and sensors to prevent patient burn Yes
Details of filtering system provided Hepa Filter 0.2-0.3 filtration efficacy
Availability of hose end thermostat for effective delivery of set temperature to patient and to prevent burns Yes

Blanket Parameters

Number and type of Blankets supplied with system 50 numbers of adult Full body Blanket,Upper Body Blanket,Lower Body Blanket and pediatric full body blanket
Blankets supplied with convective air patient warming system should be compatible with the basic Warming system Yes
Blankets shall function when covered with surgical drapes Yes
Blankets should be latex free Yes
Material of blanket made of 2 ply material Non woven outer layer and Polyethylene inner layer.Should be precision dye cut to have an even air flow and smooth surface
Blankets shall be precision dye cut to have an even air flow and smooth surface Yes
Blankets shall be disposable Yes
Blankets should have uniform perforation patern across the blanket surface for even convective warming Yes

General Parameters

Operating Temperature and humidity range 10 to 50 degree centigrade and 15 to 90 % Humidity
Power Supply 220-240 Volt 50 Hz Single phase
Protection on water ingress Should mmet IEC 529 level 4 (IPX4)(SPRAYING WATER) FOR ENCLOSURE PROTECTION ,WATER INGRESS
OEM service center or OEM Authorised service centre to be available in India Yes
Warranty in years 5
CMC (Comprehensive maintenance contract) to be provided in years ) 5
Product catalogue,operating and service instructions ,trouble shooting details to be provided with 2 copies in original Yes
Demonstration,and trainig to be provided after supplies before acceptance Yes


ISO certification for quality management systems ISO 13485:2016
ISO certification date and number 2081762
Copies of Relevant certifications tand reports to be furnished to buyer on demand Yes


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