1. GMDN Name & code(s)

2. Definition: A device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution, it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia.

3. Clinical purpose : designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency.Used by Intensive care unit (ICU), radiology department, orthopedics, emergencies.

4. Functional requirements : A syringe containing medication is securely mounted on the drive arm.Alarms indicate if any error situations occur. The drive arm infuses the medication at a steady, programmed rate.

5. Technical characteristics (specific to this type of device) 1. Flow rate programmable range at least from 0.1 to 200 ml/hr, in steps of 0.1 ml/hr; and at least from 100 to 1200 ml/hr in steps of 1 ml/hr 2. Saves last infusion rate even when the AC power is switched off 3. Bolus rate should be programmable to approx 500 ml, with infused volume display. 4. Selectable occlusion pressure trigger levels selectable from 300, 500 and 900 mmHg. 5. Must work on commonly available 20, 50 and 100 ml syringes 6. Accuracy of ±2% or better. 7. Maximum pressure generated ≤ 20 psi 8. Automatic detection of syringe size and proper fixing. 9.9. Anti-bolus system to reduce pressure on sudden release of occlusion. 10. Pause infusion facility required 11. Self-check carried out on powering on 12. Comprehensive alarm package required including: occlusion alarm, near end of infusion pre-alarm and alarm, volume limit pre-alarm and alarm, low battery pre-alarm and alarm, AC power failure, drive disengaged, syringe loading error, maintenance required 13. Should include KVO (Keep vein open) enabling feature .

6. Settings: Single loadable with one syringe of minimum 20ml.

7. User's interface

8. Inbuilt software and/or standard of communication.

9. Configuration : Tamper-resistant case made of impact resistant material Securely mountable on tabletop, IV stand or bed fitting.

10. Mobility, portability

11. Noise (in dBA) : Noise free

12. Voltage (value, AC or DC, mono phase or triphase)

13. Battery operated.

14. Tolerance (to variations, shut downs) (%)

15. Protection.

16. Power consumption (watt)

17. Accessories (mandatory, standard, optional)

18. Consumables / reagents.

19. Operating condition :- Capable of operating continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90% in ideal circumstances.

20. Warranty

21. Training of staff (Medical, paramedical, Technician)

22. Product should be CE or FDA certified; Manufacturer / supplier should have ISO 13485 certificate for quality standard. Electrical safety conforms to standards for electrical safety IEC-60601-1, class II Shall meet IEC 60601-1-2 EMC standard requirements Certified to IEC-60601-2-24: Particular requirements for the safety of infusion pumps and controllers.