Oxygen concentrator/SET

GENERAL DESCRIPTION
A mains electricity powered device that concentrates oxygen from ambient air and delivers the concentrated oxygen in a controlled manner to a patient requiring oxygen therapy, up to 10 L/min.

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 (93 ± 3%) derived from room air, to a maximum rate of 10 L/min.
Contains oxygen monitor to verify concentration.
Single oxygen outlet provided with controllable flowmeter.
Outlet pressure: 40-70 kPa // 6-10 psi
Audible and/or visual alarms for low oxygen concentration (<85%).
Audible and/or visual alarms for high temperature, low/high pressure, and power supply failure.
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, or equivalent.
Flowmeter minimum continuous flow rate of 0.5 L/min.
Flowmeter continuously adjustable, with markings of at most 0.5 L/min intervals.
Flowmeter control to allow 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 securely mounted and sheltered to reduce risk of being broken or bent.
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 shall be included in the instructions for use.

Electrical characteristics:
Electrical power requirements to be locally compatible.
Available in 250V/50Hz only.
Plug types available: B, C, D, E, F, G, I.
Mains power cable length: 2 m.
Capacity for safe operation from at least ± 10% of rated voltage.
Electrical protection by replaceable fuses, fitted in both neutral and live lines.

ENVIRONMENTAL CONDITIONS
Capable of being stored continuously in ambient temperature from -40 to 55 °C, RH ≤ 95% and elevation from 0 to at least 2000 m.
Capable of supplying the specified oxygen concentration continuously in ambient temperature from 10 to 40 °C and RH from 30% to 85%, simultaneously, and elevation up to 2286 m.

(At altitudes >2286m, the oxygen concentrator will output lower purity. For such situations kindly advise at time of order placement so the necessary adjustments can be made to the machine by the manufacturer so it will be operating well in high altitude areas).

SUPPLIED WITH
4 x adult cannula, with 2m kink-resistant tubing with standard connectors.
4 x paediatric cannula, with 2m kink-resistant tubing with standard connectors.
4 x neonatal cannula, with 2m kink-resistant tubing with standard connectors.
4 x humidifiers bottle, rated to the maximum flowrate of the concentrator (10L/min)
All necessary filters for 2 years’ operation at 15 hours per day, which includes:
-- 6 x Spare coarse filters
-- 3 x Spare pre-filters
-- 3 x Spare inlet-filters
-- 3 x Spare bacterial-filters
1 x spare mains power cable, length 2m. Plug type to be specified at the time of ordering.
2 x replacement spare fuses
1 x DISS to 6mm barbed adaptor for each outlet
1 x set user and maintenance manuals, hard and soft copies, in English
1 x certificate of calibration and inspection
1 x list of all spares and accessories, with part numbers and photos

SHELF LIFE
15 months

WEIGHT AND VOLUME
Weight: 29.5 kg (packaged)
Volume: 0.121104 m3 (packaged)

ESTIMATED LEAD TIME
2-3 weeks to FCA port/airport

WARRANTY
24 months

MATERIAL SAFETY DATA SHEET INFORMATION (MSDS)
Not regulated

REGULATION & CONFORMITY REQUIREMENTS
Class IIa under EU 93/42/EEC
CE Certified by Tüv Rheinland (Notified body 0197)

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 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

ALTERNATIVE PRODUCTS
S0845033, Oxygen concentrator, 10 LPM, dual flow
S0845038, Oxygen concentrator, 10 LPM, single flow
S0845213, Oxygen concentrator, 10 LPM, up to 1500m
S0845195, Oxygen concentrator, 8LPM, single flow
S0845008, Oxygen concentrator, 8LPM, double flow
S0845041, Oxygen concentrator, 5 LPM