Convective Air Patient Warming System

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Description

Standards

Type of Certifications for productUSFDA
Certification no and date2081762CE04
Confirmity for electrical safety standardIEC-60601-1-1 or equivalent BIS
Conformity for general requirements for electro magnetic compatibilityIEC-60601-1-1-2-or equivalent BIS

Performance Parameters

PurposeUsed in operation theaters and recovery rooms or critical care environment and clinical areas where patients are at risk of hypothermia
Cross compatibility of blanketsYes
ComponentsShould have basic warming unit and disposable blankets
Suitability of Air warming system as per type of blanket usedAdult and pediatric patients
Temperature Management UnitThe warming system shall be provided with a temperature management unit to generate high flow of warm air
components of the basic warming unitelectric motor,fan ,electric heating element,thermostat ,air filter and hose
Mode of workingFan 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 settingsLED
The convective air patient warming system should have fast warming system and should set temperature in degree centigrade with in 60 secondsYes
Range of temperature setting in degree centigrade32-44 ᵒC
The control unit should be light weight and small in size easily mountable with a fixing clawYes
Multiple Mounting options for the warming unit to be availableBed rail ,IV Pole,Cart,Floor,Trolley
Availability of thermal cut out in case of thermostat failure and temperature goes higherYes (If temp goes more than 48ᵒC)
Availability of audio alarm in case of thermostat failureYes
The alarm sytem should work for over temperature and under temperatureYes
Length of hose in cm180
Auto heating cut off facility to control the set temperature and sensors to prevent patient burnYes
Details of filtering system providedHepa Filter 0.2-0.3 filtration efficacy
Availability of hose end thermostat for effective delivery of set temperature to patient and to prevent burnsYes

Blanket Parameters

Number and type of Blankets supplied with system50 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 systemYes
Blankets shall function when covered with surgical drapesYes
Blankets should be latex freeYes
Material of blanketmade 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 surfaceYes
Blankets shall be disposableYes
Blankets should have uniform perforation patern across the blanket surface for even convective warmingYes

General Parameters

Operating Temperature and humidity range10 to 50 degree centigrade and 15 to 90 % Humidity
Power Supply220-240 Volt 50 Hz Single phase
Protection on water ingressShould 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 IndiaYes
Warranty in years5
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 originalYes
Demonstration,and trainig to be provided after supplies before acceptanceYes

Certifications

ISO certification for quality management systemsISO 13485:2016
ISO certification date and number2081762
Copies of Relevant certifications tand reports to be furnished to buyer on demandYes

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