(54 days)
A&J 5L POCA series Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy at home, in nursing homes, at patient care facilities. A&J 5L POCA series is available by prescription only under the supervision of a physician.
A&J 5L POCA series Oxygen concentrator is AC power electrically operated. The unit separates oxygen from room air (ambient air) which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room, it will not affect the normal amount of oxygen in your room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized value and protected from over pressurization by the compressor's pressure relief value.
Oxygen provided by the A&J 5L POCA series Oxygen concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy.
The front panel of the A&J 5L POCA series Oxygen concentrator contains the controls and indicators. These include the status lights (included power light, normal oxygen light, fow oxygen light and service required light), standard power switch, flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, an oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc.). The user could operate the device conveniently according to the instructions.
Here's an analysis of the provided text regarding the A&J 5L POCA series Oxygen Concentrator, focusing on acceptance criteria and supporting studies:
Summary of Acceptance Criteria and Device Performance
The device is claiming substantial equivalence to a predicate device (A&J 5L Oxygen Concentrator, Model: POCA01) and therefore the acceptance criteria are implicitly met by demonstrating that its performance is comparable or better than the predicate, and it complies with relevant standards. The table below summarizes the key performance elements compared.
| Elements of Comparison | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Does Device Meet Criteria? |
|---|---|---|---|
| Operating Conditions | Temperature: 10-35 ℃, Humidity: 30-70 %, Atmospheric Pressure: 50~106 kPa | Temperature: 10-40 ℃, Humidity: 30-70 %, Atmospheric Pressure: 50~106 kPa | Yes (Wider temp range) |
| Storage Conditions | Temperature: -40 | Temperature: -40 | Yes |
| Power Input | 115 V, 60 Hz, 1.8A (Max.) | 115V, 60Hz, 3.1A | Yes (Complies with IEC 60601-1) |
| Degree of Protection Against Electric Shock | Type B Equipment | Type B Equipment | Yes |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Yes |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Yes |
| Delivery Rate | 0 to 5 LPM | 0 to 5 LPM | Yes |
| Oxygen Percentage | 93% ± 2% | 93% ± 2% | Yes |
| Outlet Pressure | 8.5 psi (58.6 kPa) | 8.5 psi (58.6 kPa) | Yes |
| Sound Level | 45-47 dbA (Overall Average) |
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).