| S. N. | Purchaser’s Specifications |
| Name of Bidder | |
| High flow nasal cannula therapy device | |
| Manufacturer | |
| Brand | |
| Type/Model | |
| Country of Origin | |
| 1 | Description of Functions |
| 1.1 | High flow nasal cannula therapy device (HFNC)is a kind of oxygen therapy device that directly transports a certain oxygen concentration of air oxygen mixed with high flow gas to patients through a soft nasal cannula. |
| 2 | Operational Requirements |
| 2.1 | It shall operate from the mains supply/ central oxygen supply, inbuilt air source. |
| 3 | Technical Specifications |
| 3.1 | It should be single system for treating paediatric and adult patients. |
| 3.2 | It should be complaint for use on patients in ICU, wards and emergency department oxygen therapy. |
| 4.3 | It shall have LCD/LED display to monitor for temperature, flow rate, Therapy air Fio2, mode of operation and fault error. |
| 4.4 | Inbuilt flow generator capable of delivering wide range of flows:2-25 liters in paediatric mode and 10-80 liters in adult mode. |
| 4.5 | Inbuilt Air/O2 blending and Fio2 monitoring, facility to deliver wide range of oxygen concentration (Fio2) from 21 to 100%. |
| 4.6 | It should have inbuilt Air source |
| 4.7 | It should have integrated heated humidifier with temperature control range of 31°C to 37°C. |
| 4.8 | It should have Visual and audible alarm indication for:
High/Low oxygen, temperature, power failure etc. |
| 4.9 | Should be supplied with heated wire patient breathing tube and nasal cannula of different sizes. |
| 4.10 | Paediatric nasal cannula should be made of kink proof material with adhesive pads to stick on skin. |
| 4.11 | It should commonly be used on tracheostomy patients and covid patients |
| 4.12 | System shall come with appropriate trolley, basket/drawer and tubing holder set. |
| 5 | Accessories, Spare Parts and Consumables |
| 5.1 | All standard accessories/consumables/parts required for the proper operation of the above item shall be included in the offer. Bidders shall specify, in a separate Excel worksheet, the quantity and details of any items included in this offer which have not been specified in this Technical Specifications Forms. |
| 5.2 | Each high flow nasal cannula device should have supply following Standard accessories
– Mobile trolley. – Tubing Holder Set – Servo control auto heated humidifier with accessories – Oxygen hose – Power cable – Nasal cannula for adult – 1 Pcs each. – Nasal cannula for pediatric –1 Pcs each – Tracheostomy set for adult-1pcs each – Heating circuit- 1 pcs each |
| 6 | Operating Environment |
| 6.1 | Power supply: 220 – 240 VAC, 50Hz fitted with appropriate plug. The power cable must be at least 3 meters in length. |
| 7 | Standards & Safety Requirements |
| 7.1 | Must submit ISO13485:2003/AC:2007 for Medical Devices AND |
| 7.2 | European CE issued by a notified body registered in the European commission or USFDA approved product certificate. Self-declaration of CE will not valid. |
| 7.3 | Document evidence shall be submitted for evaluation. |
| 8 | User Training |
| 8.1 | The Supplier shall conduct user training for this equipment to enable operators to use the equipment properly. The training shall include the use of all operational functions of the equipment, as well as routine checks and maintenance expected by users. |
| 9 | Warranty |
| 9.1 | The warranty period for this item shall be 2 years after acceptance of the Goods. |
| 10 | Maintenance Service During Warranty Period |
| 10.1 | During the warranty period supplier must ensure planned preventive maintenance (PPM) along with corrective/breakdown maintenance whenever required. |
| 11 | Installation and Commissioning |
| 11.1 | The bidder must arrange for the equipment to be installed and commissioned by certified or qualified personnel; any prerequisites for installation to be communicated to the purchaser in advance, in detail. |
| 12 | Documentation |
| 12.1 | User (Operating) manual in English |
| 12.2 | Service (Technical / Maintenance) manual in English |
| 12.3 | Original catalog or e-copy |
| 12.4 | Must submit valid manufacturer’s authorization letter |
| 12.5 | Certificate of calibration and inspection from factory. |
| Bidders must completely fill the Technical Specification Form (TSF). Only YES/NO/COMPLY should not be written. Page number in the catalog must be clearly mentioned and highlighted. Failure in doing so may lead to rejection of bid from technical committee. |