Us fda approved.
Other Specifications Download Specification | |
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Conformity To ISO 80601-2-69:2014 Of The Medical Electrical Equipment – Part 2-69: Particular Requirements For Basic Safety And Essential Performance Of Oxygen Concentrator Equipment | Yes |
Flow Rate (Minimum) At 93% + - 3% Oxygen Purity | 93 Litres per minute |
Type | Portable |
Battery Duration (If Battery Operated Or Electrical Cum Battery Operated) | 0 Hrs |
Battery Charging (If Battery Operated Or Electrical Cum Battery Operated) | 0 Hrs |
Oxygen Outlet(s) | Single |
Outlet Pressure | 7 KPa |
Power Consumption | 290 Watt |
Operating Temperature Range | 53 degree C |
Operating Humidity Range | 70 % |
Operating Altitude Range | 300 Meters |
Type Of Operation | Continuous Flow Type |
Adjustable Air Delivery Mechanism | Yes |
Oxygen Concentration Monitor | Yes |
Oxygen Tank Capacity | 5 Ltrs |
Noise Level | 40 dB |
Continuous Flow | 5 LPM |
Digital Display | LED |
Audio Alarm | YES |
Visual Alarm | YES |
Alert Of Technical Fault | YES |
Alert Of Wrong Battery | YES |
Alert Of Depleted Battery | YES |
Alert Of High Breath Rate | YES |
Alert Of Low Oxygen Purity | YES |
Alert Of No Breath | YES |
Alert For No Flow | YES |
Alert For Low Flow | YES |
Alert For High Flow | YES |
Alert Of Low Pressure | YES |
Alert Of High Pressure | YES |
Alert Of High Temperature | YES |
Alert For Power Failure | YES |
Alert For Service Requirement | YES |
Weight | 13.6 Kg |
Dimensions (Length) | 14 mm |
Dimensions (Width) | 9 mm |
Dimension (height) | 23 mm |
Flame Retardant | YES |
Manufacturer Warranty Period | 3 Years |
Spare Part Availability | YES |
Comply With International Standards | YES |
Name Of International Standards | US FDA |
FDA Approved | YES |
Availability Of Test Report CE Or EC Certification In Accordance With Appendix II(excluding Section 4) Of Medical Device Directive 93/42/EC & Its Amendment Or Equivalent | 3443-4-2016 |
Availability Of Test Report From Central Govt./NABL/ILAC Accredited Lab To Prove Conformity To Specification | 3443-4-2016 |
Test Report No. | 3443-4-2016 |
Test Report Date | 15/04/2016 |
Name Of The Lab | Department of Health & Human Resources |
Address Of The Lab | Food & Drug Administration 10903 New Hampshire Avenue Silver Spring MD 20993 |
Power Source | Electrical Operated |
Power Efficiency | 290 W/LPM |