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 powersupply 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

2 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 foam filter

1 felt filter

DISS to 6mm barbed adaptor for each outlet (if relevant)

1 x set user and maintenance manuals, hard and soft copies, in local
language, or in agreed other language if local is not available.

1 x certificate of calibration and inspection.

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

S0002640, Oxygen Analyzer, electrochem, handheld

S0002639, 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