Oxygen concentrator, 10 LPM, single flow

GENERAL DESCRIPTION:
Oxygen concentrator, 10 LPM – single flow

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:
Provides a continuous, variable flow of concentrated oxygen (>82%) derived from room air, to a maximum rate 10 L/min.
Contains oxygen monitor to verify concentration.
Equipped with one oxygen outlet, provided with controllable flow meter.
Audible and visual alarms for low oxygen concentration (<82%) and power supply failure.
Audible and visual alarms for high temperature, no flow rate and low/high pressure.
Power efficiency < 70 W/L/min.
Digital meter that displays cumulative hours of device operation.
Oxygen outlet(s) with 6 mm (¼-inch) barbed fitting and DISS connector.
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 L/min intervals.
Flowmeter control allows shutting off flow (i.e. 0 L/min) by user.
Noise level <60 dB(A).

Casing and environment
Hard case, cleanable with standard hospital cleaning materials.
Whole unit movable with wheels on at least two feet
Unit weight <27 kg
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 characteristics
Electrical power requirements are locally compatible.
230 Volt, 50 Hz, 3.0 amps (120 Volt units available)
Mains power cable length > 2.5 m.
Capacity for safe operation from at least ± 10% of rated voltage.
Electrical protection by resettable circuit breakers, fitted in both neutral and live lines.

ITEMS SUPPLIED WITH
4 x adult cannula with 2m kink-resistant oxygen tubing with standard connectors.
4 x paediatric cannula with 2m kink-resistant oxygen tubing with standard connectors.
1 x humidifier bottle
1 x DISS to 6mm barbed adaptor (if relevant)
Internal and external filters (as described in user manual) for user fitting for 2 years’ operation at 15 hours per day.
1 x set user manual, in local language, or in agreed other language if local is not available.
1 x list of equipment and procedures required for local cleaning, disinfection, troubleshooting, calibration and routine maintenance.
1 x list of all spares and accessories, with part numbers and contactdetails for parts supply.
1 x document with contact details of manufacturer, supplier and local service agent.

ITEMS REQUIRED, BUT NOT SUPPLIED
S0845030, Oxygen Analyzer, electrochem, handheld 
S0845029, Oxygen Analyzer, ultrasonic, handheld 

OPERATING CONDITIONS
- Temperature: 10 °C to 40 °C,
- Relative humidity: 15% to 90%
- Elevation above sea level: 0 to 2000m

STORAGE CONDITIONS
- Temperature: 0 °C to 40 °C,
- Relative humidity: 15% to 95%
- Elevation above sea level: 0 to 2000m

ESTIMATED LEAD TIME
4 – 6 weeks

INSTALLATION REQUIREMENTS
The User Manual supplied with the device details all installation which can be undertaken by users.

USER TRAINING REQUIREMENTS
The User Manual supplied with the device details all operation procedures for user.

TECHNICAL TRAINING REQUIREMENTS
The User Manual supplied with the device details all maintenance and troubleshooting procedures which can be undertaken by users.

WEIGHT AND VOLUME
Weight: 29.9 kg (packaged)
Volume: 0.108 m3 (packaged)

WARRANTY
24 months

RELATED PRODUCTS:
S0002031, Monitor,patient,portable,w/access
S0845014, Pulse oximeter,portable,w/access
S0002073, Uninterruptible power supply, 1kVA
S0845039, Flow splitter,for oxygen concentrator
S0845017, Pulse oximeter, handheld, incl.resp. rate
S0845013, Pulseoximeter,spot-check,w/accessories
S0002624, Pulse oximeter, tabletop
S0002632, Voltage stabilizer, 1 kVA
S0002635, Spares/tool kit for oxygen concentrator
S0845049, Nasal Catheter, 8 Fr
S0845043, Tubing, oxygen supply, 7.6 mtr
S0370105, Prongs,nasal,Oxygen,adult,s.u.
S0370115, Prongs,nasal,Oxygen,child,s.u.
S0370125, Prongs,nasal,Oxygen,neonate,s.u.

ALTERNATIVE PRODUCTS:
S0845008, Oxygen concentrator, 8LPM, double flow
S0845041, Oxygen concentrator, 5 LPM
S0845033, Oxygen concentrator, 10 LPM, dual flow
S0845044, Oxygen concentrator SET

PACKAGING / LABELING:
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 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