Equipment Specifications for Haemodialysis Machine

UNSPSC Code: ECRI Code: 1 Description of Function Sl Name Technical Bidders Specs Deviation quoted by if any bidder

1.1 Haemodialysis, is a method for removing waste products such as potassium and urea, as well as free water from the blood when the kidneys are incapable of this (i.e. in renal failure). It is a form of renal dialysis and is therefore a renal replacement therapy. 2 Operational Requirements Sl Name Technical Bidders Specs Deviation quoted by if any bidder

2.1 Machine should have facility for Acetate, Bicarbonate, Sequential dialysis (Isolated UF) 2.2 Upgradable to future software developments and can be linked with Patient Data Management System 2.3 The blood pump should be able to run from 50 to 600 ml/min and adaptable to standard A-v blood lines and should run even in the absence of water or dialysis flow. 3 Technical Specifications Sl Name Technical Bidders Specs Deviation quoted by if any bidder

3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8

Should have facility for conventional and High flux dialysis. Machine should have two bacterial filter (Pyrogen filters) one at water inlet and one before water going to dialyser Battery back-up for 20-30 minutes to run complete machine with heater supply Should have Na, Bicarbonate and UF profiling Dialysate temperatures selectable between 35 degrees C to 39 deg. C Variable conductivity setting between 12 to 15 Should have variable dialysate flow 350-800 ml/mt and should have increasing facilty to step up by 2o ml Should have facility to show trends curve of all parameter for 1520 minutes

3.9 3.10 3.11

Heparin pump with syringe sizes up to 50 ml with pump flow rate from 1-10 ml/hr( 0.1 ml increments) Stroke pressure operated short term single needle dialysis Ultrafiltration 0.1 to 2.5 litres/hr. .The in and out fluid circuit must be separated so that there is no chance of contamination in the event of membrane rupture. Treatment parameter should be displayed by graph and digitally both Should have integrated heat and chemical disinfection facility with both short and long disinfection programme with day knight week schedule Should have accurate feedback control conductivity mixing technique. Should have drain facility. Should have accurate UF control by flow by volume control measurement technique. Extra facilities like Blood Volume sensor,Bicart Select technique and online clearance kt/V All important data should be presetted so that machine can be used anytime without feeding data every time Should have automatic self test facility Should have auto ON/OFF Facility Should have touch button screen and large colour TFT Screen Automatic diagnosis of malfunctioning with on line ability to show the faults with trouble (Technical service Mode) Machine can be connected to computer to feed all data and trouble shoot whenever any problem Blood pump rate from 20-500 ml/min adaptable to stndard A-V bloodliness Ability to monitor pulse rate and NIBP with graphic and tabulated trends. Audio visual alarms on limit violation of conductivity,blood leak, air leak, transmembrane pressure alarms,, Dialysis temperature alarm,dialysis can empty alarm, end of disinfection alarm,bypass alarm and blood pump stop alarm Alarm for reverse Ultrafiltration and also be able to do sequential dialysis On line in build NIBP recording .

3.12 3.13

3.14 3.15 3.16 3.17 3.18 3.19 3.20 3.21 3.22 3.23 3.24 3.25 3.26

3.27

3.28

On line cleatrence clearance monitoring build in device for measurement and monitoring of effective urea clearance and dialysis dose(KT/V)

4 System Configuration Accessories, spares and consumables Sl Name Technical Bidders Specs Deviation quoted by if any bidder

4.1 System as specified4.2 All consumables required for installation and standardization of system to be given free of cost. 4.3 To be supplied free of cost Bacterial filters 2 sets extra , 100 polysulfone 1 m2 dialyzers and tubings 5 Environmental factors Sl Name Technical Bidders Specs Deviation quoted by if any bidder

5.1 The unit shall be capable of being stored continuously in ambient temperature of 0 -50deg C and relative humidity of 15-90% 5.2 The unit shall be capable of operating continuously in ambient temperature of 10 -40deg C and relative humidity of 15-90% 6 Power Supply Sl Name Technical Bidders Specs Deviation quoted by if any bidder

6.1 Power input to be 220-240VAC, 50Hz fitted with Indian plug 6.2 UPS of suitable rating with voltage regulation and spike protection for 60 minutes back up. 7 Standards, Safety and Training Sl Name Technical Bidders Specs Deviation quoted by if any bidder

7.1 Should be FDA , CE,UL or BIS approved product 7.2 Manufacturer/Supplier should have ISO certification for quality standards. 7.3 Shall comply with IEC 60601-2-16 SAFETY requirements of medical electric equipment part2- particular requirements for the safety of Haemodialysis equipment. 7.4 Should carry warranty of two years.

Rate of AMC for next 5 years to be quoted and should have spare parts for next 10 years. Supplier should have adequate experience and maintenance of similar equipment in at least 3 to 4 major hospitals.

7.5 Comprehensive training for lab staff and support services till familiarity with the system. 7.6 Should have local service facility .The service provider should have the necessary equipments recommended by the manufacturer to carry out preventive maintenance test as per guidelines provided in the service/maintenance manual. 8 Documentation Sl Name Technical Bidders Specs Deviation quoted by if any bidder

8.1 User/Technical/Maintenance manuals to be supplied in English. 8.2 Certificate of calibration and inspection. 8.3 List of Equipments available for providing calibration and routine Preventive Maintenance Support. as per manufacturer documentation in service/technical manual. 8.4 List of important spare parts and accessories with their part number and costing. 8.5 Log book with instruction for daily , weekly, monthly and quarterly maintenance checklist. The job description of the hospital technician and company service engineer should be clearly spelt out