Oxygen concentrator, 8LPM, double flow

A mains electricity powered device that concentrates oxygen from ambient air and delivers the 93% concentrated oxygen in a controlled manner to patients requiring oxygen therapy, via two outlets up to 8 LPM.
Indicative Price 714.88 USD
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Oxygen concentrator, 8 LPM – double flow.

Oxygen concentrators are not suitable to be used as an oxygen source to other medical equipment providing respiratory support, such asventilators, CPAP devices, High Flow Nasal Oxygen, etc. Additional important user information specific for dual flow units is provided below under the header: IMPORTANT USER INFORMATION.

Provides a continuous, variable flow of concentrated oxygen 93% (±3%) derived from room air, to a maximum rate 8 L/min.
Contains oxygen monitor to verify concentration.
Equipped with two oxygen outlets each provided with controllable flow meter.
Audible and/or visual alarms for low oxygen concentration (<82%) and power supply failure.
Audible and visual alarms for high temperature and pressure failure.
Power efficiency ≤ 70 W/LPM.
Digital meter that displays cumulative hours of device operation.
Oxygen outlet(s) with 6 mm (¼-inch) barbed fitting.
Flowmeter minimum flow rate of 2 L/min. Lower flow rates may be achieved by a combination of the concentrator and a separately supplied flow splitter (details under RELATED PRODUCTS).
Flowmeter continuously adjustable, with markings of at most 0.5 LPM intervals.
Noise level <60 dB(A).

Case to be hard, to be cleanable with standard hospital cleaning materials.
Oxygen outlet to be securely mounted and sheltered.
Whole unit to be movable with four wheels.
The unit includes internally and externally mounted filters for cleaning the air intake.
All user-removable filters are cleanable. Cleaning instructions for filters are included in the instructions for use.

Electrical power requirements to be locally compatible.
230 Volt, 50 Hz, 2.1 amps (110 Volt units available)
Mains power cable to have length ≥ 2.5 m.
Capacity for safe operation from at least ± 10% of rated voltage.
Electrical protection by resettable circuit breakers or replaceable fuses.

4 x Adult nasal cannula
4 x Infant nasal cannula
4 x Neonatal nasal cannula
1 x T connector
2 x Humidifier bottle
1 x Bacterial filter (inside device)
1 x Dust filter (back of device)
8 x Paper filter (1 inside device, 7 spares)
1 x Power cord
1 x User manual, English
1 x Inspection report
1 x Packing list, listing spare parts and consumables
1 x List of contact information on the manufacturer

Capable of supplying the specified oxygen concentration continuously in elevation up to 2000m.
Operating conditions: 10 to 40 deg. C, 15 to 85% relative humidity non-condensing
Storage conditions (packaged): -20 to 45 deg. C, 10 to 95% relative humidity non-condensing
For altitudes between 2000m and 4000m at 5 LPM the oxygen concentration would be approximately 92%.

4 weeks

Concentrators are designed to work up to a maximum flowrate; if used beyond this maximum, oxygen concentration could drop below 82%, triggering a low concentration alarm. Typically, all flowmeters on an oxygen concentrator are graduated to the maximum capacity of the concentrator (e.g. if maximum flow capacity is 10L/min then there may be 2 flowmeters on the device each graduated to 10L/min flow). However, while both flowmeter ports may be used simultaneously, the maximum flowrate at which the device can produce 85-95.5% oxygen remains the same (e.g., a 10 L/min oxygen concentrator can only produce 10 L/min of oxygen at a time, regardless of the number of ports or splitters in use). Combined flowrate from all ports during use must not exceed the total recommended flow rate. Should the combined flowrate go over the maximum capacity of the oxygen concentrator, the produced oxygen purity will drop, decreasing the oxygen delivered to the patient.

The unit is equipped with a 9 volt zinc carbon battery which is not classified as a dangerous good.

Weight: 29 kg (packaged)
Volume: 0.15 m3 (packaged)

24 months

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CE mark conforming to Medical Device Directive 93/42/EEC
CE Certificate (class IIa or higher)

93/42/EEC Risk class IIa or higher– CE certificate

Must comply with the following standards:
ISO 13485:2003 Medical devices -Quality management systems --Requirements for regulatory purposes
IEC 60601-1: 2006/AC:2010 Medical Electrical Equipment - Part 1: Genera lRequirements for Safety and essential performance
IEC 60601-1-2: 2007, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic
IEC 60601-1-6: 2007, Medical Electrical Equipment - Part 1-6 Part 1-6:General requirements for basic safety and essential performance –Collateral standard: Usability
IEC 60601-1-8: 2007, Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential functions – Parallel standard: General requirements, tests and instructions for alarm systems in electromedical equipment and electromedical systems
IEC 60601-1-11: 2010, Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
ISO 8359:2013 Oxygen concentrators for medical use – Safety requirements

Unit presentation: 1 (one)
Labelling on primary packaging must include:
- Name and/or trademark of the manufacturer
- Manufacturer's product reference
- Type of product and main characteristics
- If the packaging is not transparent, it must bear a diagram showing the essential parts of the product
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonisedsymbol)
- Information for handling, if applicable (or equivalent harmonised symbol)

Over packaging: Packaging unit
Labelling on the packaging unit: Labelling to be the same asprimary packaging
Number of units per box: one
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