Oxygen concentrator, 8LPM, single flow

GENERAL DESCRIPTION
Oxygen concentrator, 8 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
OXYGEN PRODUCTION
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 a single oxygen outlet provided with controllable flowmeter.
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).

CASING AND ENVIRONMENT
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 CHARACTERISTICS
Electrical power requirements to be locally compatible.
230 Volt, 50 Hz, 2.1 amps (110 Volt units available upon request)
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.

SUPPLIED WITH
SUPPLIED WITH
2 x adult nasal cannulas
1 x T connector
1 x Humidifier bottle
1 x Dust filter
1 x Paper filter
1 x Mains power cable
1 x user manual.

ENVIRONMENTAL CONDITIONS
Operating conditions: 5 to 40°C, 10 to 85% relative humidity non-condensing
Storage conditions (packaged): -20 to 45°C, 10 to 95% relative humidity non-condensing
Operating altitude range: 0 - 2,000 meters
For altitudes between 2,000 and 4,000 at 5 LPM the oxygen concentration would be approximately 92%.

ESTIMATED LEAD TIME
4 weeks

MATERIAL SAFETY DATA SHEET INFORMATION (MSDS)
The unit is equipped with a 9 volt zinc cardon battery which is not classified as a dangerous good.

WEIGHT/VOLUME
Weight: 29 kg (packaged)
Volume: 0.15 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
S0845033, Oxygen concentrator, 10 LPM, dual flow
S0845038, Oxygen concentrator, 10 LPM, single flow
S0845041, Oxygen concentrator, 5 LPM
S0845044, Oxygen concentrator/SET

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

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

SAFETY & PRODUCT STANDARDS
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: GeneralRequirements for Safety and essential performance
IEC 60601-1-2: 2007, Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral Standard: Electromagnetic
IEC 60601-1-6: 2007, Medical Electrical Equipment - Part 1-6 Part1-6:General requirements for basic safety and essential performance –Collateral standard: Usability
IEC 60601-1-8: 2007, Medical Electrical Equipment - Part 1-8: Generalrequirements for basic safety and essential functions – Paralle lstandard: General requirements, tests and instructions for alarm systemsin electromedical equipment and electromedical systems
IEC 60601-1-11: 2010, Part 1-11: General requirements for basic safetyand essential performance – Collateral Standard: Requirements formedical electrical equipment and medical electrical systems used in thehome healthcare environment
ISO 8359:2013 Oxygen concentrators for medical use – Safety requirements

PACKAGING / LABELLING
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 showingthe 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 harmonisedsymbol)

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