NOISELESS VACUUM ASSISTED DELIVERY SYSTEM

TENDER SPECIFICATIONS

1. The system should have an airflow rate of up to 30 liters per minute and be capable of handling
   various procedures and surgeries in the operating theater, trauma units, ICU, and wards.
2. Airflow & suction can be adjusted with single knob for ease of use/operations and it shouldn’t
   have a separate or individual button to change the Air flow/vacuum
3. The system must be equipped with bacteria and hydrophobic filters.
4. The noise level should be less than 45 dB at the maximum flow rate.
5. The system should operate at vacuum levels ranging from 0 to -95 kPa (713 mmHg).
6. The system must be low-vibration and operate quietly.
7. The system must have piston-cylinder friction-free technology.
8.  The system must include a membrane-type vacuum regulator.
9.  The system should have Type BF electrical certification, providing complete protection against
   electric shock.
10. The system must feature equipotential conductors in the main unit and trolley to safeguard
    against electric shock.
11. The system should come with autoclavable, unbreakable, and reusable polysulfone jar, each with
    a capacity of 5 liters and a mechanical overflow protector with an auto shutoff feature.
12. The jar must have autoclavable lids to maintain complete sterility and should be airtight.
13. The system should comply with IP20 standards.
14. An integrated foot switch for on/off operation must be provided with the machine.
15. The system should be mounted on a well-balanced trolley equipped with four antistatic castors.
16. The system must operate oil-free.
17. The system should have valid European CE and USFDA certifications as per the 93/42/EEC
    directive on Medical Device Directives (MDD).
18. The equipment must have a valid ISO 13485 certificate.
19.  The quoted model must hold a valid CDSCO license, as mandated by the government of India. A
    valid CDSCO license must be submitted.
20. The system should come with a comprehensive 5-year warranty.
21. All mandatory accessories should be provided with each machine,
    21.1.1. Patient tubing: 01 pc
    21.1.2. 5-liter Polysulfone jars with lids :01 pc
    21.1.3. Vac Sil Cup 02pc
    21.1.4. Any other mandatory accessory