Unverified, testing underway

Nonin CO-Pilot Wireless Handheld Multi-Parameter System (H500), Model SP-BLE (bluetooth device), Model D-HH (monitor)

by NONIN MEDICAL, INC.

About this oximeter:

This is a multiwavelength device with 8-wavelengths between 600 and 910 nanometers.

Click here to see more information.

Handheld

Type

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.

No data

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.

7000

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.

No data

Specification Overview

Manufacturer

Model

Nonin CO-Pilot Wireless Handheld Multi-Parameter System (H500), Model SP-BLE (bluetooth device), Model D-HH (monitor)

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

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.

USA

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.

IP33

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.

$7000

Features

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

Carboxy-Hb, Extended skin pigmentation performance testing

Standard Performance info

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

No data

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.

No data

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-123

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.

Extended skin color data

When available, here we show data on the forehead color for healthy volunteer subjects on which the device was tested. Each square represents a single study subject. The square's color is the RGB color derived from the L*a*b* color space using a Konica Minolta CM700d reflectance spectrophotometer. More info on skin color quantification.

Here we show data on the forehead color for healthy volunteer subjects on which the device was tested. Each square represents a single study subject. The square's color is the RGB color derived from the LAB color space using a Konica Minolta CM700d reflectance spectrophotometer.

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.

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.

Real world clinical data

Here we link to studies conducted in the clinical settings

Submit a question
About Community Device Data Raw Data Protocols Publications Oximetry FAQ