S0845044

Oxygen concentrator/SET


A mains electricity powered device that concentrates oxygen from ambient air and delivers the concentrated oxygen in a controlled manner to a patient requiring oxygen therapy, up to 10 L/min.
Indicative Price 720.00 USD

IMPORTANT INFORMATION
Oxygen concentrators are not suitable to be used as an oxygen source to other medical equipment providing respiratory support, such as ventilators, CPAP devices, High Flow Nasal Oxygen, etc.

TECHNICAL SPECIFICATIONS
Device concentrates oxygen from ambient air
On 4 antistatic swivel castors, 2 with brakes
Integrated handle allows for easy moving and positioning
Device weight: 28 kg
Provides continuous flow of concentrated oxygen 93% ± 3%
Oxygen sensing device is integrated and measures concentration at flow meter entrance.
Oxygen outlet durable, with approx.6mm barbed fitting or equivalent
Flowmeter range: 1 to 10 LPM
Flowmeter continuously adjustable with markings at 0.5 L intervals
Maximum output flow: 10 LPM
Outlet pressure: 40-70 kPa // 6-10 psi
Continuous monitoring, with visual and audible alert for: Low/ high output pressure, no flow, low oxygen concentration < 82%, power failure
Sound level produced: less than 52 dB (A)
Power requirements: 220V-240V, 50Hz-60Hz or 110V 50/60Hz
User interface easy to operate with numbers and displays that are clearly visible
Digital or analogue meter to display cumulative hours of device operation

SUPPLIED WITH
1 x Power cord
2 x Adult cannula, with 2 m kink-resistant tubing with standard connectors.
4 x Infant cannula, with 2 m kink-resistant tubing with standard connectors.
4 x New-born cannula, with 2 m kink-resistant tubing with standard connectors.
4 x Humidifiers.
4 x Tubing adapter kit.
6 x Spare course filters
3 x Spare pre-filters
3 x Spare inlet-filters
3 x Spare bacterial-filters
1 x Instruction for assembly, use and maintenance, and list of accessories and spare parts with product reference code, in 3 languages(English, French, Spanish)

ENVIRONMENTAL CONDITIONS
Operating conditions: 10°C to 40°C / RH: 15 to 85%
Storage conditions: -40°C to 55°C / RH: ≤ 95%
Operating altitude: 0 to 2286m above sea level

WEIGHT AND VOLUME
Weight: 31 kg (packaged)
Volume: 0.140 m3 (packaged)


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ALTERNATIVE PRODUCTS:
S0845033, Oxygen concentrator, 10 LPM, dual flow
S0845038, Oxygen concentrator, 10 LPM, single flow
S0845213, Oxygen concentrator, 10 LPM, up to 1500m
S0845195, Oxygen concentrator, 8LPM, single flow
S0845008, Oxygen concentrator, 8LPM, double flow
S0845041, Oxygen concentrator, 5 LPM

ESTIMATED LEAD TIME
4-6 weeks to FCA port/airport

WARRANTY
24 months

MATERIAL SAFETY DATA SHEET INFORMATION (MSDS)
Not regulated

RISK CLASSIFICATION
Class IIa under EU 93/42/EEC

REGULATORY APPROVAL
CE Certified by Tüv Rheinland (Notified body 0197)

QULITY MANAGEMENT SYSTEMS
ISO 13485:2016 Tüv Rheinland (Notified body 0197)
FDA 510(K)

PACKAGING & LABELLING
Unit presentation: 1 (one) Oxygen concentrator/SET
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 harmonised symbol)
- Information for handling, if applicable (or equivalent harmonised symbol)
Over packaging: Packaging unit
Labelling on the packaging unit: Labelling to be the same as primary packaging
Extra information required: Number of units per box
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