Oxygen concentrator, 10 LPM, dual flow

IMPORTANT INFORMATION:
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.

GENERAL DESCRIPTION:
Oxygen concentrator, 10 LPM – single flow

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 flowmeter.
Audible and/or visual alarms for low oxygen concentration (<82%) and powersupply failure.
Audible and/or visual alarms for high temperature, no flow rate andlow/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 achievedby a combination of the concentrator and a separately supplied flowmeterstand (details under RELATED PRODUCTS).
Flowmeter continuously adjustable, with markings of at most 0.5 L/minintervals.
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 Oxygen tubing, 15m
2 x Humidifier bottle, reusable, up to 10 LPM
2 x DISS to 6mm barbed adaptor, 1 for each outlet
Internal and external filters and spare parts for user fitting (as described in user manual) for 2 years’ operation at 15 hours per day, including:
-1 x Gross particle filter
-1 x Felt filter
1 x 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 contact details 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.

IMPORTANT USER INFORMATION
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.

WEIGHT:
29.9 Kg

VOLUME:
0.108 M3

WARRANTY:
3 years

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
S0845038, Oxygen concentrator, 10 LPM, single flow
S0845041, Oxygen concentrator, 5 LPM
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