Fingertip
TypeYES
Signal quality indicatorWaveform
indicatorOpenOx Performance
Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.
*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.
No data
Purchase Cost
Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.
20
Lifetime Cost
Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.
Lifetime Cost
Beta
Hunan Accurate Bio-Medical Technology Co., Ltd.
FS10A/FS20A
See detailsEstimated Lifetime Cost:
Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.
Estimated Lifetime Cost:
Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.
Adjust the assumptions below to estimate the 10-year lifetime cost for this device:
Purchase Cost
Time to processor replacement
Monthly power cost (e.g batteries)
Specification Overview
Manufacturer
Model
FS10A/FS20A
Alias Rebranding
Some oximeters may be rebranded, relabeled and sold by multiple distributors under different names. We are attempting to compile 'aliases' for devices.
Ulaif FS 20E
Type
We categorize devices as fingertip, handheld, tabletop, multiparameter, phone-based or wearable.
Fingertip
Reflectance or Transmittance
Some devices may have the capability to function with transmission or reflectance probes. Read more about the difference between reflectance and transmission devices in our FAQ.
Transmittance
Patient population
This indicates the intended patient populations for the device (adult, pediatrics, neonates), as specified by our review of the manufacturers' published specifications. Use in certain patient populations may require procurement of a separate probe.
Adult
Where made
This indicates the location where the device is manufactured as stated by the manufacturer (or the stated location of the manufacturer). Please note, devices may contain components manufactured in different location.
China
Ingress Protection (IP)
"Ingress Protection" ratings define levels of sealing effectiveness of devices from foreign bodies (e.g. dust) and moisture. Read more at our FAQ.
IPX2
Cost
Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.
$20
Lifetime Cost
Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.
760.00
Features
Here we report device features such as signal quality indicator, waveform, carboxy-Hb, perfusion index and ability to measure Hb. These are based on review of manufacturers' manuals and may be incomplete.
Extended low perfusion performance testing
Standard Performance info
Manufacturer claimed Arms (root mean square error) for SpO2 70-100%
Here we report the root mean square error (ARMS) as provided in the manufacturer’s product manual or other literature, which may include data from the 510(k) submission.
1.1-2%
Independent Arms (root mean square error) for SpO2 70-100%
Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.
*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.
No data
Source of independent Arms data
Root mean square error (ARMS) is a common measure of pulse oximeter device performance. 'ARMS' may be ascertained from manufacturers' published data, 510k reports, package inserts or primary data from testing conducted by the UCSF Hypoxia Lab. Devices independently tested by the Open Oximetry Project will be marked 'verified' or 'failed' depending on study findings.
Manufacturer spec sheet
510k date
Date FDA 510k approved
12/04/2014
CE-XXXX
Open Oximetry attempts to request CE certificates from manufacturers and distributors though this is not always possible. CE numbers shown here are largely obtained from manufacturer's literature and are unverified by our team. Read more about CE marking in our FAQ..
CE-0123
Extended Performance info
Peer reviewed Manuscripts
Here are select manuscripts published in the peer-reviewed literature.
Data published by manufacturer
We are working to gather device performance data published directly by manufacturers.
Perfusion performance data
We are working to gather data on device performance during varying conditions such as low perfusion. We are also working to standardize protocols for such testing. Read more on 'perfusion' in our FAQ.
Not Available
Raw PPG data
We are working to gather raw data for device performance to share for independent analysis. We expect to launch this feature soon.
Not Available
In vitro (simulator) performance data
We are working on novel in vitro testing protocols for both commercially available devices (e.g. Fluke ProSim8) and novel in vitro devices. We expect to report data for this testing soon.
Not Available
Real world clinical data
Here we link to studies conducted in the clinical settings.
Not Available
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