[EN. | Purchaser’s Specifications Haomédialy hine with RO. Bidder's Offer Page No. in eatalogue(Submit Hacmoiialysis Machine with RO Manufacturer 7 ted document) Brand "Type / Modal Country of Origin Description of Fifuetion Haemodialysis is a method for removing wasle products such a potassiim and urea, as well as free water from the blood when Ae Maneys are incapable of this (.e. in renal failure). Wis & form of renal lysis and is therefore nee ‘renal replacement Operational Requirements Machine must have facili __ | solated UF), lave facility for Acetate and Sequential dialysis ‘System Configuration Haemodialysis Machine, ea a : ine, complete unit accessories. PI it with complete ‘Technical Specifications The system should be reliable, durable, easy to use System With the ability of monitoring: * Online KT/V * Blood pressure * Blood Volume Blood Temperature 42 |The haemodialysis unit shall have en enlarged and high resolution LED touch color screen for dialysis data display. The screen is rotatable for easy viewable. 43 | Shall have rechargeable battery backup for more thay 30 minutes to run extracorporeal blood circuit. 44 | The system should have Bicarbonate cartridge connection to optimize hygiene, cleanliness and sefety %5_| Must have Na and UF profiling. 4.6. | The system shall be equipped with heperin pump designed for multiple syringe sizes with auiomated syringe size deteetion, self test alarm system and heparin profiling 47_| The system shall have air detector with dual ultrasonic and optical monitoring system for precise bubble catching, safe blood return and continuous micro-bubble detection 4B | The system shall have single stage endotoxin filtration for high purity HD ; 49 | The blood flow rate of the machine should be 20 to 600 mL/min with an accuracy of (+-) 10%. 410 | Ultrafiltration rate of the machine shall be 0 —4000mL/Hr FIT] Shall have improved hemoperfusion mode to reduce self test duration andconsumption of water and concen come ili sure 12 | Shall have facility for Bod 93 TT ad eet We ue ae ee \ree - Qi and non-invas[ER] Purchaser's Specifications na tae Pn ene, OE S.N. aay a3 + ta | Shall have variable conductivity setting from 12. “Shall have variable dialysate flow 300-800 ml/min or better [als | fe 3 Bidder’s Offer Page No.in catalogue(Submit ted document) table between 35°C to 40°C. Dialysate temperatures selec Sto 16 mS/em. te flow resolution ofthe system shall be TmL/min__| a 3% 4.16 | The dialysa 417 |_| scot Shall have dug] control system along with multiple pressure G20 | Treatment parameter must be displayed Goth by graph and Must have facility to show trends curve of all parameter for 15- 20 minutes. Heparin purop with syringe sizes 10-30 ml with pump flow rate 18 from 0-10 mi/hr. (0.1 mi increments) and injection rate 10 to detectors, conductivity detectors, air detectors and blood leakage detectors for safety and reliability purpose. a2t a2 | Must have accurate feedback control conductivity mixing digitally. Must have integrated heat and chemical disinfection fecility with both short and long disinfection prog i va schedule. Programme with day night w techaique. 723_| Must have drain facility. 9.24 | Must have accurate UF control by flow measurement technique. 4.25 | Shall have built in device for time measurement and monitoring 426 of effective urea clearance and dialysis dose (KT/V). All important data must be pre-set so that machine can be used Ta7_| Shall have automatic self-test facility. anytime without feeding data every time. 4 28 | Must have auto ON/OFF facility. ‘to service, trouble shoots and calibrate. 4.29 | Easy 4.30 Machine can be connected to computer to feed all data and trouble shoot whenever any problem arise. 431 The NIBP range shall be 0 to 300 mmHg. "32_| Pulse monitoring range shall be30 to 220 BPM 4. [ae 33 Shall have audio visual alarms on limit violation of conductivity, blood leak, air leak, trans membrane pressure alarms,, Dialysis temperature alarm, dialysis can empty alarm, end of disinfection slarm, bypass alarm and blood pump stop alarm. 34 | Alarm for reverse Ultrafiltration shall be availble. j1| The a «i 4,35 | Shall be able to do sequential dialysis. 4.36 | Automatic self test for UF cell during treatment to ensure accurate fluid removal a7 | Machine shall have complete treatment history to navigate treatment parameter during the treatment $s ‘Accessories, spares and consumables 3.1 | All standard accessories, consumables and parts required to operate the equipment, including all standard tools and cleaning and lubrication mates to be included in the offer, Bidders must specily the quantity of every item included in their offer (including items not specified above). © _| Operating Environment 6 st offered shall be designed to be stored and to operate Bi pen * 2. ie ra aeraat _ [ENC] Parchaser's Specitictions ay aa Wilder's Offer | Page Necin fesse stead calalopue(Submit a athe ted document) nomnally under the eondions oF We pare ROTs coumty- TRC conditions include Power Humidity, ete, Power supply: 220 — 240 VAG a 0HTe Tied" wit appropiate —_{ log. Me power cabie must hog least 3 metre in length, [| Standards ond Sater, en 7 72 Supply, Climate, Temperature, quirements Mast subm 200MAC2007 for Medical Devices AND CE (9342 'G Directives) or USEDA approved product cenificate, 73 | Shall comply with TEC 60601216 Safety requirements of Medical Electrical Equipment para. Particular requirements for thesafety of Naemodialysis equ ent, User Training " er training (including how to use and maintain sheequipment), [Warranty ified CPMENI to be Installed and si insalleng, °% Waliied personnel; en Prerequisites for installation to communist fo ihe purchaser in edvance, in detail 12_| Documentation 121 | User (Operating) m 122 | Service (Technical Maintenance) manual ia Engi 123 | List of important spare paris aoa seeessories with thelr par surmbers and costing! 124 | Cenificate of calibration and 12.5 | Bidder mast submit the valid nanual in English, inspection fom Fctog, authorization letter of the product Reverse Osmosis Unit SN. | Purchaser's Specifications Reverse Osmosis Unit for Haemodialysi Manufacturer Brand Typ: / Model Country of Origin Description of Function Reverse Osmosis Plant is rey Aslosized pure water for dialysis, | Operational Requirements 21 [The system must be sufficient Tor online tnachines with pure water capacity of 200-300 | System Configuration Reverse Osmosis Unit standard accessories, wired 10 produce absolutly operation of 4&5 litres per hour, it for Haemodialysis complete with allap tan A, fo Technical Specifications [41 [The system must comprise of pretreatment MUIR for high purity water. [42 [All pre-treatment modules must have programmable back wash and regeneration facility, These stages must be designed to handle water flow of 300-500 litresyhour 43] RO Unit must be compact in steck cabinet, housing membrane, high pressure pump and b ass mechanism, 44] The control unit must’ be microprocessor! mierooonvoller controlled. a3 A$ micron filter shall protect the menibrane a 46 /RO. Unit must bave adequate monitoring oF input and output |__| water conductivity, feed water pressure and ejection flow rate, Ths system must have protection alarm against low Teed water, high output conductivity i 4S | The system must inch machines in loop so th R.O. unit thus saving on water rejection. 49 |The unit . must have programmable and automatic Finsing/flushing facility, at regular intervals, when system is not uss to prevent drying of filter media and R.O, Membrane 4.10 |The system “must have Programmable disinfection /de- calcification facility using commonly available isinfection / decalcification chemicals. AIL) The system must accept feed water wilh Towa disolved sole (TDS) up to 1500 mefitre and hardness up to | alt with 039% tejection of TDS & hardness and 99% rejection of bacteria ood endotoxins. 412 |"The unit must be designed for maximum saving of aw Waki with efficiency of 60-70%. 4.13 |The water distribution loo} of stainless steel. Storage bbe made of good quality level controller. ip and booster pump musi be made up water tank, wherever nesestery must triple layer plastic and must have water S| Accessories, spares and consumables SL | Accessori + Adequate filter cartridges, for 2 years of operation =| __+ Media or resins for 02 years 52° |All standard nccessories, consumables and pants Tequized to operate the equipment, including all standard iools and cleaning and lubrication materials, to be included in the offer. Bidders must specify the quantity of every item included in thelr offer including items not specified above). 6 | Operating Environment 6.1 | The product offered shall be designed to be stored and fo operate normally under the conditions of the purchasers country. The Conditions include Power Supply, Climate, Temperature, Humidity, ete. | 6.2 | Power supply: 220-240V/ 50 Hz AC Single phase or 380-400V_ LAC 50 Hz Three phase fitted with appropriate plugs and sockets, | {7__ | Standards and Safety Requirements J.1_| Must submit ISO 9001 /1S013485:200/AC:2007 J 12 f USEDA approved product certificate. : T 2, fer quality shall msich AAMI (Associaton Tortie