Catalogue values for Hemodialysis Machine with SLED and HDF
| Category | Specification | Bid Requirement (Allowed Values) |
|---|---|---|
| GENERAL FEATURES | Patient category | Pediatrics and adults |
| PRODUCT FUNCTIONAL FEATURES | The Machine should be of latest technology with microprocessor controlled | Yes |
| Dialysis facility | Acetate & Bicarbonate Dialysis | |
| Features Available | Efficacy of dialysis Volumetric UF, Sodium/UF profiling, online help options | |
| Should be a closed system design with volumetric balancing system i e volume in= volume out for fresh & used dialysate | Yes | |
| Volumetric dilution of concentrates with RO water & volumetric UF | Yes | |
| Automatic self test after switching ON | Yes | |
| Leak sensor & Connection test as additional safety | Yes | |
| Machine should have Single Needle dialysis facility | With single blood pump | |
| Blood pump flow rate shall be of any range in between value of 10 to 600 (ml/min) | Yes | |
| Effective blood rate should be displayed in accordance with the setting | Yes | |
| Tubing size diameter (mm) | 2 to 10 | |
| Emergency hand crank is provided to enable reinfusion in case of power failure | Yes | |
| Emergency button enabled bolus, UF control | Yes | |
| Emergency air free measurement on arterial line in view of reducing chance of blood clot | Yes | |
| Heparin infusion start/stop | Automatic | |
| Machine should have Heparin Pump infusion rate with increments of half ml/hr | Yes | |
| Auto Bolus administration should be available and programmable from half to 5 ml approx | Yes | |
| Venous pressure monitoring & adjustment in case of alarm condition | Yes | |
| Venous Pressure Monitoring range(Minimum) | -100mmHg to +500mmHg | |
| Air and bubbles detection over entire blood flow range | Yes | |
| Arterial pressure monitoring & adjustment in case of alarm condition | Yes | |
| Arterial Pressure Monitoring range(Minimum) | -300mmHg to +300mmHg | |
| Sensitivity of detection mechanism should be specified in terms of air bubble size | Yes | |
| On detection of excessive air, venous clamp should activate & blood pump stop | Yes | |
| Sodium and bicarbonate profiling facility with volumetric ultrafilteration | Yes | |
| Variable dialysate flow shall be of any range in between value of 100 to 1000 (ml/min) | Yes | |
| Dialysate Temperature shall be of any range in between value of 32 to 39 (degree C) | Yes | |
| Photo detector used for blood leak detection | Yes | |
| Alarm will be activated for blood loss rate not greater than Half ml/min | Yes | |
| Volumetric UF control range with accuracy +/-1% | 0 to 4L/hr | |
| Adjustable UF volume (ltr) | 0 to 9.99 | |
| TMP monitoring range | -100 to +600mmHg | |
| Isolated/Sequential Ultra Filtration process provided | Yes | |
| User friendly online preparation of bicarbonate dialysis fluid facility available | Yes | |
| rovision for Endotoxin retention capacity not less than 10 million EU/mL | Yes | |
| Machine is automatic programmable to change filter, including emptying and filling cycles with reminder facility | Yes | |
| Minimum Life span of filter | 12 weeks or 100 treatments | |
| Bacterial filters provided | 2 | |
| Pre-dilution and post-dilution of blood facility available | Yes | |
| Automatic control substitution program with pre/post dilution identity integrate function | Yes | |
| Online preparation of substitution fluid for priming and rinsing of extracorporeal circuit for HD/HDF/HF or as injection-bolus and infusion at the end of treatment | Yes | |
| Substitution fluid delivery rate (ml/min) | 25 to 600 | |
| Maximum Substitution fluid exchange volume (ltr) | 210 | |
| Inbuilt measurement and monitoring of effective Urea clearance K | Yes | |
| DISINFECTION AND CLEANING | Both chemical and heat disinfection can be performed | Yes |
| Various programmable cleansing cycles with different phases and timings in accordance with different disinfectants | Yes | |
| Fully automatic one-touch disinfecting system including pre-rinse, chemical-intake for combined disinfection and decalcification, post-chemical mandatory rinse without the need of end-user handling during the whloe disinfection process | Yes | |
| ADDITIONAL FEATURES AND SAFETY | Machine should be upgradable to future software development and can be linked for Data Management System | Yes |
| 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, | Yes | |
| ELECTRICAL FEATURES | Auto ON/OFF Facility | Yes |
| LED indicator on front panel for status of machine | Yes | |
| Power supply (with Indian plug) | 220+/-10% V, 50Hz, AC Single phase | |
| Machine should have Automatic battery backup of minimum 15 minutes to complete Extracorporeal blood system during power failure | Yes | |
| UPS of suitable rating with voltage regulation and spike protection for 60 minutes back up | Yes | |
| USER INTERFACE | High resolution screen with functional keys | Yes |
| Colour panel display size (inch) | 10 to 15 inch | |
| Cumulative graphical display of treatment data, physiological trends including Sodium & UR profiles | Yes | |
| Display of different menus indicating blood system, preparation, dialysate, UF, treatment re-infusion, cleaning and system parameters including the parameters including the parameters Arterial pressure, | Yes | |
| Clearance monitor, conductivity evaluation and temperature evaluation | Yes | |
| Data protection while power goes off | Yes | |
| Memory for storage of records | Yes | |
| USB and Ethernet for file sharing | Yes | |
| CERTIFICATIONS & REPORTS | Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| Availability of valid drug license/medical device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes | |
| Manufacturing unit certification | ISO:13485 (Latest) | |
| Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date | Yes | |
| Compliance to electrical safety specific to the device | IEC 60601-2-16 or Equivalent BIS Standard | |
| Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission and/or along with supplies as per buyer requirement | Yes | |
| INSTALLATION & TRAINING | Supplier to perform installation, safety and operation checks before handover | Yes |
| Training of users in operation and basic maintenance shall be provided | Yes | |
| WARRANTY & MAINTENANCE | Warranty in Years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) | 5 |
| User technical and maintenance manual detailing complete maintaining schedule with routine maintenance should be provided | Yes | |
| Contact details of manufacturer, supplier and local service agent to be provided | Yes | |
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