Lifebox Pulse Oximeter

Lifebox

The Lifebox Pulse Oximeter is a device for monitoring oxygen saturation in low-resources settings.

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
Feedback

Product description Brand name and product description

The Lifebox Pulse Oximeter is a rechargeable monitor for oxygen saturation that can be used for adults and children. It is especially designed for use in low-resource settings.

Target region(s) Target region for distribution/implementation (listed by country if specified)

Worldwide

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

Lifebox, Mercy Ships, Smile Train are building partnerships with the manufacturer to distribute the pulse oximeter.

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

250 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

Nonin Go2, ChoiceMMed pulse oximeter, Biolight M800

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

Health care workers

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

The pulse oximeter is manufactured by Acare Technology Co. Ltd. which specializes in monitoring and anesthesia devices.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

The Lifebox sensor research disclosure can be found here.

User Provision Model Where can the product be purchased/acquired by end users?

The pulse oximeter can be purchased directly from the manufacturer and is also distributed by partner NGOs (including Mercy Ships and Smile Train), national anesthesia societies and local facilities.

Distribution to date Number of units that have been deployed, downloads or users to date

As of July, 2021, Lifebox has distributed 28,000 pulse oximeters in over 116 countries across the globe.

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Consumables

probes and batteries

Detection sensitivity

+/- 2%

Indispensable equipment for function (Y/N)

Maintenance or calibration required by user at time of use? (Y/N)

Number of Tests Performed

Power supply type: Continuous, Recharging only (V, time required, battery life), Other

Continuous, Recharging with the battery runtime of 14 hours

Time required for procedure (minutes)

Continuous monitoring

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

The Lifebox Pulse Oximeter is designed for settings with inconsistent electrical power, as the charger protects the device from surges and the battery(3 AA Alkaline batteries or Lithium ion rechargeable battery) has a life of 14 hours in case of a power outage. It can be paired with two probes: a universal probe for 3+ months and a pediatric probe, both of which are included with the device purchase.

The product has the following specifications:

Pulse rate range: 25 – 250 bpm

Resolution : 1 bpm

It has a display type 2.4” color display 320 x 240 pixels with the following parameters on display; Digital SpO2, Pulse Rate, Pleth bar & SpO2 waveform

Product schematics Design and assembly illustrations

No schematics are available.

Technical support Technical support provided by

The first line of technical support is the instructional video, user manual, and troubleshooting guide.

Additional support can be found by contacting the manufacturer.

Replacement components Availability of replacement components (in-country, by order,...)

The product comes in a package that includes:

Pulse oximeter
Universal probe for 3+ months age
Pediatric probe
Pillow clip
Multi region charger
Multi language education DVD

These components can be replaced but the internal components of the oximeter cannot.

Lifecycle Disposal and warranty

2+ years for the oximeter, 1 year for the probes

Sterilization (with a cloth and disinfectant) is required and described in the user manual. Some maintenance is also required. Instructions for both are provided in the user manual.

Manufacturer specified performance targets Designer / Manufacturer specified targets

Lifebox says their pulse oximeter

is suitable and sustainable for use under-resourced environments
is durable,
is able to survive severe voltage fluctuations when plugged in
has long-lasting battery for use during power outages
is easy to use
is inexpensive
is light and compact
is handheld
has a high resolution, 2.4” color display

Vetted performance Findings of manufacturer evaluations or independent testing centers

There are no performance‐specific accuracy data on this instrument. The accuracy of the Lifebox pulse oximeter is comparable to FDA-approved pulse oximeters designed for high income countries.

The Lifebox oximeter was found to meet USA FDA 510(k) standards for the detection of hypoxia.

Testing organizations Independent lab, academic research centers, etc.

The pulse oximeter was tested by Lifebox and by the University of California San Francisco and Duke University Medical Center.

Safety Potential hazards / risks related to operation of this product

If surges more severe than EN61000-4-5 +- 1KV line to line or +- 2KV line to ground are likely to occur, a surge protector should be used when charging the oximeter.

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

None

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

Dubowitz G, Breyer K, Lipnick M, Sall JW, Feiner J, Ikeda K, Macleod DB, Bickler PE. Accuracy of the Lifebox pulse oximeter during hypoxia in healthy volunteers. Anaesthesia. 2013;68(12):1220–1223.

Finch LC, Kim RY, Ttendo S, Kiwanuka JK, Walker IA, Wilson IH, Weiser TG, Berry WR, Gawande AA. Evaluation of a large-scale donation of Lifebox pulse oximeters to non-physician anaesthetists in Uganda. Anaesthesia. 2014;69(5):445–451.

Albert V, Mndolo S, Harrison EM, Osullivan E, Wilson IH, Walker IA. Lifebox pulse oximeter implementation in Malawi: evaluation of educational outcomes and impact on oxygen desaturation episodes during anaesthesia. Anaesthesia. 2017;72(6):686–693.

Sama HD, Maman AFOBN, Walker IA. Incidence of hypoxia and related events detected by pulse oximeters provided by the Lifebox Foundation in the maternity unit at Sylvanus Olympio University Teaching Hospital, Togo. Journal of Anesthesia. 2015;29(6):971–973.

Desalu I, Diakparomre OI, Salami AO, Abiola AO. The effect of nail polish and acrylic nails on pulse oximetry reading using the Lifebox oximeter in Nigeria. The Nigerian Postgraduate Medical Journal. 2013;20(4).

Enright A, Merry A, Walker I, Wilson I. Lifebox: A Global Patient Safety Initiative. A & A Case Reports. 2016;6(12):366–369.

Compliance with regulations Product certifications and standards referenced by designer/manufacturer

The Lifebox Pulse oximeter complies with the World Health Organization and World Federation of Societies of Anesthesiologists standards for suitable application in under-resourced environments.

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

The accuracy of the Lifebox pulse oximeter was compared against arterial hemoglobin oxygen saturation by academic researchers. It was also compared in accuracy to FDA-approved pulse oximeters.

Other information