Oxygen concentrator, 10 LPM, up to 1500m

GENERAL DESCRIPTION:
Oxygen concentrator, 10 LPM – single flow, for ambient temperatures up to 35C and elevation up to 1,500m.

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%/-6%) 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.
Outlet pressure: 138 ± 7 kPa (20.0 ± 1.0 psi)
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.
Oxygen outlet to be securely mounted and sheltered to reduce risk of being broken or bent.
Whole unit movable with wheels on at least two feet
Unit weight <20 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 available: 230V/50 Hz or 120V/60Hz.
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 nasal cannulas, up to 15 LPM
4 x pediatric nasal cannulas, standard
1 x humidifier bottle, up to 15 LPM
All necessary filters for 2 years’ operation at 15 hours per day, which includes the following (in addition to those already included with the unit):
-- 3 x extra cabinet air filters
-- 1 x extra extended long-life bacteria filter
1 x spare power cord, in addition to cord supplied with unit (NOTE: EU plug type, others may
be requested)
2 x DISS to 6mm barbed adaptors
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 (found within User Manual).
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.

ENVIRONMENTAL CONDITIONS
Operating conditions: ambient temperature from 5 to 35°C, relative humidity from 15 to 93% non-condensing
Storage conditions (packaged): -25 to 70°C, 15 to 93% relative humidity non-condensing
Operating altitude range: 0 - 1,500 meters

ESTIMATED LEAD TIME
2 – 6 weeks

MATERIAL SAFETY DATA SHEET INFORMATION (MSDS)
Not applicable.

WEIGHT AND VOLUME
Weight: 21.0 kg (packaged)
Volume: 0.112 m³ (packaged)

WARRANTY
24 months

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

SAFETY & PRODUCT STANDARDS
Complies with the following standards:
ISO 13485:2016 Medical devices - Quality management systems -- Requirements for regulatory purposes
ISO 80601-2-69:2014 Medical electrical equipment — Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
IEC 60601-1: 2006/AC:2010 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic disturbances – Requirements and Tests
IEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-11:2010, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

RELATED PRODUCTS:
S0370105, Prongs,nasal,Oxygen,adult,s.u.
S0370115, Prongs,nasal,Oxygen,child,s.u.
S0370125, Prongs,nasal,Oxygen,neonate,s.u.
S0370130, Face mask, venturi, adult, single use
S0370131, Face mask, venturi, child, single use
S0845049, Nasal Catheter, 8 Fr
S0002031, Monitor,patient,portable,w/access
S0845014, Pulse oximeter,portable,w/access
S0845017, Pulse oximeter, handheld, incl.resp. rate
S0845212, Pulse oximeter,handheld,cont,w/resp rate
S0845013, Pulseoximeter,spot-check,w/accessories
S0845039, Flow splitter,for oxygen concentrator
S0845043, Tubing, oxygen supply, 7.6 mtr
S0002632, Voltage stabilizer, 1 kVA
S0002073, Uninterruptible power supply, 1kVA

ALTERNATIVE PRODUCTS:
S0845038, Oxygen concentrator, 10 LPM, single flow
S0845033, Oxygen concentrator, 10 LPM, dual flow
S0845044, Oxygen concentrator/SET
S0845195, Oxygen concentrator, 8LPM, single flow
S0845008, Oxygen concentrator, 8LPM, double flow
S0845041, Oxygen concentrator, 5 LPM