Lifebox Pulse Oximeter

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 SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$250.00

Target Users (Target Impact Group)

Household, Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

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

Manufacturing/Building Method

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

Intellectural Property Type

Select Type

User Provision Model

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.

Distributions to Date Status

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

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

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

Technical Support

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

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

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 Parameters

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 Status

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.

Safety

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

None

Academic Research and References

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.

Lifebox. “FDA-standard for the low-resource setting“, 2013

Compliance with regulations

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

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

None

Comments from the Community

3 Comments

CarolineS_Fellow says:

August 29, 2018 at 9:41 pm

It is important to consider the battery life per charge cycle as resource constrained environments are constantly handling high volumes of patients and limited access to medical devices and staff. It would be ideal for the battery to last up to 8-12 hours or more to account for extended usage in these environments. It is also important to consider whether preventative maintenance is required throughout the 2 year lifetime of the product and the level of training that would be required for technical staff to perform on-site repairs. Additionally, if the probes are intended to be reusable than they must be able to be able to withstand cleaning methods used in the target settings.
CarolineS_Fellow says:

August 29, 2018 at 9:41 pm

Academic literature and evaluation is extensive for a product designed for use in resource constrained clinic environments.
CarolineS_Fellow says:

August 31, 2018 at 9:28 am

Additionally, this product requires a reliable source of power.