Oxygen concentrator, 10 LPM, resilient

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 via a single outlet up to 10 L/min.

This device has been co-developed by UNICEF with suppliers to be fit-for-purpose in low-resource setting environments: resilient in conditions of high heat, humidity, dust, and poor-quality power, up to 70% more energy efficient and solar-friendly, and easier to use and repair. For more information about this project, visit: https://www.unicef.org/innovation/resilient-oxygen-concentrators

INTENDED USE
This device is intended to provide supplemental oxygen to patients requiring oxygen therapy. The device may be used in the home or a clinical setting.

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.
Equipped with one oxygen outlet, provided with controllable flow meter.
Outlet pressure: 58.6 ± 3.5 kPa (8.5 ± 0.5 psi)
Contains oxygen monitor to verify concentration.

Resilience and robustness:
Includes self-sealing check valves to protect critical components from the effects of heat and humidity during planned and un-planned shutdowns (e.g. power outages).
Components (e.g. flow meters, outlets, etc.) have been designed for durability and recessed to minimize accidental damage.

Power efficiency:
Power consumption varies with flow, providing up to 70% better power efficiency compared to conventional oxygen concentrator models (e.g., 1 LPM – 218 W, 5 LPM – 216 W, 10 LPM – 464 W), making it less expensive to run on grid or generator power.
Soft start feature reduces in-rush current at start-up (making it solar-friendly and lighter on health facility power grids).

Usability features:
Audible and visual reminder for clinical users to check, clean, or replace external filter every 170 hours.
Audible and visual reminder for technicians to check, clean, or replace internal filter every 3200 hours.​
An easy-to-interpret multi-coloured display indicating normal oxygen function green (>82%-96%), low oxygen yellow (60-82%), and critical low oxygen red (<60%) to give clear information and confidence to users. 
All key information for setup, operation, and maintenance of the device is included in the labelling on the device (e.g. stickers, graphics, visual instructions) in multiple languages.

Alarms:
Audible and visual alarms for low oxygen concentration (<82%).
Audible and visual alarm for power supply failure.
Audible and visual alarms for high temperature, no flow rate and low/high pressure.

General specs:
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 1 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 <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 available: universal 110-240V, 50/60Hz.
Mains power cable length 2m (one each of plug type C, G and A included). 
Capacity for safe operation from at least ± 10% of rated voltage.
Designed to withstand extensive power fluctuations in low-quality power settings.
Electrical protection by resettable circuit breakers, fitted in both neutral and live lines.

ITEMS SUPPLIED WITH
4 x adult nasal cannulas, with 2m kink-resistant oxygen tubing with standard connectors
​4 x pediatric nasal cannulas, with 2m kink-resistant oxygen tubing with standard connectors
​4 x neonatal nasal cannulas, with 2m kink-resistant oxygen tubing with standard connectors
​1 x reusable humidifier bottle 
​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): 
​-- 1 x extra cabinet metal air filters 
​-- 1 x extra intake air filters
​1 x DISS to 6mm barbed adaptors
1 x plastic protective dust cover
1 x set of 10 replacement fuses
1 x set user and maintenance manuals in English, French, and Spanish (hard copy included and soft copy available via QR code on device casing).
​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 QR code printed on the casing/user interface which directs the user to a product-dedicated website with multi-lingual User Manual, training videos, troubleshooting instructions, and contact information for the manufacturer and local service providers. 

ENVIRONMENTAL CONDITIONS
Operating conditions: ambient temperature from 5 to 40°C, relative humidity from 15 to 95% non-condensing 
Storage conditions (packaged): -25 to 70°C, 15 to 95% relative humidity non-condensing 
Operating altitude range: 0 - 2,000 meters 

WARRANTY
24 months

WEIGHT AND VOLUME
Weight: 27.0 kg (packaged)
Volume: 0.134 m³ (packaged)

INSTALLATION REQUIREMENTS
The User Manual supplied with the device details all installation instructions which can be undertaken by users.

USER TRAINING REQUIREMENTS
The User Manual supplied with the device details all operation procedures for the user.

This device has been specifically designed for usability in low-resource settings, including complete multi-lingual labelling on the device with instructions and visuals for ease of setup, operation, and maintenance.

Additionally, this device has a QR code printed on the casing/user interface which directs the user to a product-dedicated website with multi-lingual User Manual, training videos, troubleshooting instructions, and contact information for the manufacturer and local service providers.

TECHNICAL TRAINING REQUIREMENTS
The User Manual supplied with the device details all maintenance and troubleshooting procedures which can be undertaken by users.

This product has been specially designed for improved ease of use, repair, and access to information for users and technicians. This includes an internal diagnostic troubleshooter with LED status indicators that can help technicians to diagnose and resolve technical problems with the device.

COMPONENT OF A KIT 
Not part of a kit. 

QUALITY MANAGEMENT SYSTEM
Manufacturer is certified to ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.

REGULATION & CONFORMITY REQUIREMENTS
Health Canada as Device Class 2.

SAFETY & PRODUCT STANDARDS
Complies with the following standards: 
​​ISO 80601-2-69:2020 Medical electrical equipment — Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment 
​IEC 60601-1:2020 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance 
​IEC 60601-1-2:2020, Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic disturbances – Requirements and Tests 
​IEC 60601-1-6:2020, Medical Electrical Equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
​IEC 60601-1-8:2020, 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 60601-1-9:2020, Medical Electrical Equipment - Part 1-9: General requirements for safety - Collateral standard: Requirements for environmentally conscious design 
​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 

NOMENCLATURE
GMDN code: 31321