Disputed (2021)

(2017) Pulse Oximeter Model Ab-F1/Ah-S1/Ah-M1

by ACARE TECHNOLOGY CO., LTD.

About this oximeter:

Acare has made several oximeter models. The Hypoxia Lab has published data on the 2013 AH-MX which performed to meet FDA standards with Arms < 3%. The Hypoxia Lab has also tested the newer generations of AH-M1 2017 which performed with Arms of 3.67, and the AH-M1 2020 performed with an Arms of 4.89. Of note, the 2017 and 2020 AH-M1 have been found to be highly accurate in an oxygen saturation range of 80-100%. Testing is underway with the latest version for 2023. For more information please review the Lifebox Clinical Guidance on the use of the Acare AH-M1.

Click here to see more information.

Handheld

Type

3.7%

Arms

YES

Signal quality indicator

Waveform

indicator

OpenOx 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. 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 how details on how many subjects have been tested as well as details of skin color testing.

Arms 3.7%

Purchase Cost

Here we report retail purchase costs (US $) 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.

250

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 below to see the formula and adjust this assumptions to your local data.

600.00

Lifetime Cost

Beta

ACARE TECHNOLOGY CO., LTD.

(2017) Pulse Oximeter Model Ab-F1/Ah-S1/Ah-M1

See details

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 below to see the formula and adjust this assumptions to your local data.

600.00

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 below to see the formula and adjust this assumptions to your local data.

600.00

Purchase Cost

US$

Probe Cost

US$

Time to probe replacement

Years

Time to processor replacement

Years

Monthly power cost (e.g batteries)

US$

Lifetime is assumed to be 10 years. Salvage cost at the end of 10 years is assumed to be zero for all devices. Cost of device maintenance or repair is not assumed to be zero. We assume probe and device replacement intervals based on evolving input from clinician collaborators around the world based on device type alone (i.e. fingertip, handheld, etc), though note these vary widely by setting and manufacturer. These intervals attempt to grossly account for wear and tear, damage or misplacement and theft.

Specification Overview

Model

(2017) Pulse Oximeter Model Ab-F1/Ah-S1/Ah-M1

Alias Rebranding

Some oximeters may be rebranded, relabeled and sold by multiple distributors under different names. We are attempting to compile 'aliases' for devices.

Lifebox

Type

We categorize devices as fingertip, handheld, benchtop, multimodal, phone-based or wearable.

Handheld

Reflectance or Transmittance

Some devices may have capability to function as transmission and reflectance modes using different probe types. Read more about the difference between reflectance and transmittance 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, Pediatrics, Neonates

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.

Taiwan

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.

IP22

Cost

Here we report retail purchase costs (US $) 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.

$250

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 below to see the formula and adjust this assumptions to your local data.

$600.00

Features

Here we try to report device features such as signal quality indicator, waveform, carboxy-Hb, perfusion index and ability to measure Hb.

Perfusion Index, Extended low perfusion performance testing

Standard Performance info

Producer claimed Arms (root mean square error) for SpO2 70-100%

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. 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 how details on how many subjects have been tested as well as details of skin color testing.

3.7%

Data independent Arms data collected

This is the date that the Open Oximetry collected data in the UCSF Hypoxia Lab data to 'verify' or 'dispute' device performance. If Arms data were obtained from a source other than the Hypoxia Lab, please review the date for that source. Of note, device performance may be specific to a model year (even if the model name has not changed).

01/01/2021

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 'disputed' depending on study findings.

UCSF Hypoxia Lab

510k

FDA 510k approval. Read more about FDA and 510k approvals on our FAQ.

510k date

Date FDA 510k approved

12/22/2011

CE-XXXX

Open Oximetry attempts to request CE certificates from manufacturers and distributors though this is not always possible. Read more about CE marking in our FAQ..

CE -

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.

Low 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 later in 2023.

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 later in 2023.

Not Available

Real world clinical data

Here we link to studies conducted in the clinical settings

Not Available

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