Catalogue values for BiPAP Machine (V2)
| Category | Specification | Bid Requirement (Allowed Values) |
|---|---|---|
| GENERAL | Product Description | BiPAP Machine |
| PRODUCT INFORMATION | Airflow generator pressure(IPAP pressure) | 4 to 25 cm of H2O or more |
| Airflow generator pressure(EPAP pressure) | 4 to 20 cm of H2O or more | |
| Mode of operation | Manual | |
| Modes available | Spontaneous, Timed, Volume assured pressure support, Spontaneous with time, Manual CPAP | |
| Range of Back up respiratory rate(in BPM) | 5 to 30 or more | |
| Sensitivity settings | Appropriate triggering and cycling setting available for better patient synchronization | |
| Range of Minimum Respiration time(sec) | 0.1 to 0.3 | |
| Maximum Respiration Time(sec) | 0.3 to 3.00 | |
| Range of Rise Time(in ms) | 150 to 600 or More | |
| Humidifier provided | Yes | |
| Inspiration trigger for auto start | Yes | |
| Provision of Auto stop option when put-off mask | Yes | |
| Provision of Inspiratory and expiratory trigger sensitivity adjustment | Yes | |
| Provision of Inspiratory and expiratory slope adjustment provided | Yes | |
| Alarms available | Power off Alarms and Disconnection Alarms, High leak, Apnea, Low minute ventilation, Low tidal volume | |
| Unit should be compatible for OSA / Obesity hypo ventilation therapy | Yes | |
| Heated tube for flexibility and patient comfort provided | No | |
| Leakage compensation | Yes | |
| Humidification | Integrated DC humidifier or equivalent with anti counter current water trap | |
| Memory Storage | Embedded memory storage for full raw data and facility for longer storage | |
| Ramp Setting for BiPAP pressure | Yes | |
| The range of RAMP (in minutes) | 0 to 45 or more | |
| Sound level | <=40 | |
| Mask size check feature | Yes | |
| Type of display | LCD | |
| Display size in Inch | >=2 | |
| ACCESSORIES | Reusable Mask | 1 Medium |
| Disposable Mask | 10 Small | |
| Tube | Standard | |
| Filter | Pack of 10 | |
| ELECTRICAL REQUIREMENTS | Power Supply | 220-240V, 50Hz |
| Battery provided | External | |
| Minimum Battery backup time(Hrs) | >=2 | |
| CERTIFICATIONS & REPORTS | Compliance to Medical Device Rule (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 | |
| Manufacturing unit certification | ISO:13485 (Latest) | |
| Conformity to safety Standards | IEC-60601-1-2 or equivalent BIS standard | |
| Availability of Test Report for each supplied batch/product as per Medical Device Rules (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 and/or along with supplies as per buyer requirement | Yes | |
| MISCELLANEOUS REQUIREMENTS | OEM/Reseller shall ensure uninterrupted availability of all spares for 10 years | Yes |
| Availability of toll free facility for technical support maintened by OEM or authorized agencies | Yes | |
| Details of equipments and procedures required for local calibration and routine maintenance to be supplied and advanced maintenance task documentation also to be furnished | Yes | |
| List of important spares and accessories, with their part numbers to be supplied to the buyer at the time of supplying the equipment | Yes | |
| Installation and Demonstration of equipment and training to be provided after completing supplies before acceptance | Yes | |
| Calibration certificates as per NABH/JCI requirement | Yes | |
| Time to attend breakdown calls | within 48 hrs | |
| WARRANTY | Warranty (Years) | 3 |
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