Catalogue values for Low Temperature Hydrogen Peroxide Gas Plasma Sterilizer
| Category | Specification | Bid Requirement (Allowed Values) |
|---|---|---|
| GENERAL | Product Description | Low temperature Hydrogen Peroxide Gas Plasma Sterilizer |
| PRODUCT INFORMATION | Type of Hydrogen Peroxide Gas Sterilisation Technology | Plasma technology |
| Sterilizer is environment friendly and have no toxic by products or harmful residuals | Yes | |
| Shape of Sterilization Chamber | Rectangular | |
| Usable capacity of Sterilization Chamber | 101 to 140 liters | |
| Sterilization Chamber Door | Pneumatically or electrically controlled door with complete safety protocol with multiple locking. | |
| Control System | Microprocessor controlled system with clear user interface for control and display of cycle phases, parameters values and text messages. | |
| Sterilizer has facility to completely monitor its operations with audiovisual alarms and alarm history | Yes | |
| Built in facility for recording and printing cycle details | Yes | |
| Mobility | Mobile on castor wheel and compact in design | |
| Cycle temperature range | 35 degree to 60 degree centigrade | |
| Have pre programmed sterilisation cycles for flat instruments, and for hollow and flexible items | Yes | |
| Built in safety features available | Emergency stop, Door safety, Over heat protection, Electrical safety | |
| Have an easy to troubleshoot by display interface and all services access available from the front | Yes | |
| Interface for remote supervision and data storage | Digital interface for remote supervision and data storage | |
| Consumables be provided with each Sterilisation Unit sufficient for running full load Sterilization cycles(at least) | 200 | |
| Sterilizing Chamber has sufficient dimensions for sterilizing rigid telescope units | Yes | |
| Sterilization Cycle time (±5 Minutes) | 60 Minutes | |
| Capable to distribute the plasma homogenously through the Chamber | Yes | |
| Have diagnostic system to detects & remove excess moisture thus eliminating chances of contamination due to residual bio burden prior to sterilization cycles & self-test functions | Yes | |
| Power Supply | 220-240V/50Hz | |
| CERTIFICATIONS | Compliance to Medical Device Rules (MDR) 2017 as amended till date | Yes |
| Availability of valid 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 | |
| Certification for manufacturing unit | ISO:13485 (Latest) | |
| Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date | Yes | |
| Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement | Yes | |
| WARRANTY | Warranty in years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) | 5 Or higher |
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