Table 2 Performance characteristics defined for each TPP

All 15 Product Categories

Scope of Test / Device and Safety Standards

Intended Use; Target Operator; Target Population; Target Setting; Quality Management; Regulation

Purchasing Considerations

Instrument Pricing; Consumable Pricing

Training and Maintenance

User Instructions; Warranty; Decontamination

Utility Requirements

Power Source; Battery; Voltage

Product Categories

Technical Characteristics

1. Syringe Pump

Benchtop Measurement Accuracy (for Flow Rate); Flow Rate Requirements; Occlusion Detection; Syringe Requirements; Drug Library; Alarm Characteristics; Size; Weight

2. Phototherapy

Irradiance; Effective Treatment Area; Peak Wavelength; Light Source; Bulb Lifetime; Ease of Replacing Bulbs; Irradiance Meter

3. Bilirubinometer

Linear Range; Accuracy; Results; Format; Result Units; Precision; Sample; Calibration; Kit Stability & Storage; Equipment Required

4. Glucometer

5. Haemoglobinometer

6. pH Monitor

7. CPAP

Flow Driver; Oxygen Flow Capacity; Pressure; Total (blended) Flow; Humidification; Alarms; Accessories; Consumables

8. Flow Splitter

Air Flow per Patient; Flow Control; Number of Outputs; Indication

9. Oxygen Concentrator

Flow Meter; Minimal Flow Rate; Flow Rate; Time to Reach 95% of Specified Performance; Oxygen Purity; Alarms; Indicators; Mobility; Oxygen Monitor; Oxygen Outlet; Noise Level; Weight; Durability and Robustness; Usage Meter

10. Pulse Oximeter

Pulse rate; Pulse rate accuracy; Pulse rate resolution; Sp02 Accuracy; Sp02 Range; Alarms; Alarm Limits – PR; Alarm Limits—Sp02; Continuous Measurement; Patient Interface; Size; Weight

11. Respiratory Rate/Apnea Monitor

Apnea Detection; Respiratory Rate Accuracy; Respiratory Rate Range; Alarm; Patient Interface; Respiratory Rate Alarm Limits; Apnea Intervention

12. Suction Pump

Pressure; Bottle Capacity; Noise Level; Cleaning; Maintenance; Operation Mode

13. Radiant Warmer

Benchtop Measurement Accuracy; Clinical Measurement Accuracy; Stability; Includes Timer; Includes Scale

Mobility; Time to Indicate Accurate Temperature; Uniformity; Alarm Characteristics; Alarm Limits; Operating Temperature; Patient Interface; Patient Accessibility and Visibility; Temperature Control

14. Temperature Monitor

Benchtop Measurement Accuracy; Clinical Measurement Accuracy; Time to Indicate Accurate Temperature; Alarm Characteristics; Alarm Limits; Patient Interface; Size; Weight

15. Conductive Warmer

Form Factor; Benchtop Measurement Accuracy; Conductive Surface Temperature of Baby (required if servo-controlled); Clinical Measurement Accuracy (Compare to another gold standard); Maximum CO2 Concentration (If Enclosed Device); Maximum Temperature (of the conductive surface); Humidification (If Enclosed device); Surface Temperature overshoot when the temperature control is set to its maximum setting; Time to Indicate Accurate Temperature of baby; Uniformity (If Enclosed, then uniformity of air)(If Not Enclosed, then uniformity of mattress); Alarm Characteristics; Patient Interface; Patient Accessibility and Visibility; Temperature Control; Operating Conditions