Technical specification BIPAP

S.N. Purchaser’s Specifications
  Name of Bidder
BIPAP (Bi-level Positive Airway Pressure)
  Type / Model
  Country of Origin
1 Description of Function
1.1 BIPAP (Bi-level Positive Airway Pressure) incorporates the comfort of BiLevel technology to deliver comfortable therapy at higher prescription pressures. The goal is reducing the average pressure for the Patient.
2 Operational Requirements
2.1 Should have Real-time display – LCD display shows actual pressure, leak rate and patient breathing parameters such as breath rate, I/E ratio, minute volume and tidal volume, On board Filter Clean Reminder, etc.
2.2 Should have Integrated heated humidification system without requiring a separate hose or power cord.
3 System Configuration
3.1 BIPAP (Bi-level Positive Airway Pressure) should be complete unit with all standard accessories.
4 Technical Specifications
4.1 The device should offer patented flow rounding technology, which further enhances comfort by allowing for adjustment of transitions in and out of ipap and epap.
4.2 IPAP:  approx. 3 to 25cmH2O.
4.3 EPAP:  approx. 3 to 25cmH2O.
4.4 Breath rate: approx.0 to 30BPM with spontaneous for time mode.
4.5 Timed inspiration: approx. 0.5 to 3.0s.
4.6 Should have ramp function to lower the pressure at initial phase and slowly increase to allow pressure.
4.7 Should have automatic leakage compensation
4.8 Should have low noise level less than or equivalent to 30dBA.
4.9 Should have customizable and the sensitivity of the trigger should be adjustable
4.10 Should have operating mode of CPAP, Spontaneous, timed, PAC/PC (Pressure Assisted Control/Pressure Control)
4.11 Should provide with carry bag
5 Accessories, spares and consumables
5.1 All standard accessories, consumables and parts required to operate the equipment to be included in the offer. Bidders must specify the quantity of every item included in their offer (including items not specified above).
6 Operating Environment
6.1 The product offered shall be designed to be stored and to operate normally under the conditions of the purchaser’s country. The conditions include Power Supply, Climate, Temperature, Humidity, etc.
6.2 Should have Auto Switching universal Power supply of: 100 – 240 VAC, 50Hzto 60Hz and must be operated from 12 V DC source.
7 Standards and Safety Requirements
7.1 Must submit ISO13485:2003/AC:2007 for Medical Devices AND
7.2 CE (93/42 EEC Directives) or USFDA approved product certificate.
7.3 Electrical safety conforms to standards for electrical safety IEC 60601-1 General requirement for Electrical safety of Medical Equipment.
8 User Training
8.1 Must provide user training (including how to use and maintain the equipment).
9 Warranty
9.1 Comprehensive warranty for 2 years after acceptance.
10 Maintenance Service During Warranty Period
10.1 During warranty period supplier must ensure corrective/breakdown maintenance whenever required.
11 Installation and Commissioning
11.1 Supplier must accomplish proper commissioning of equipment onsite.
12 Documentation
12.1 User (Operating) manual in English.
12.2 Service (Technical / Maintenance) manual in English.
12.3 List of important spare parts and accessories with their part numbers and costing.
12.4 Certificate of calibration and inspection from factory.