(125 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the descriptions of the device and performance studies do not mention any AI/ML components or methodologies.
No
The device is described as providing continuous physiological information "as an aid to diagnosis and treatment," but it does not perform treatment itself. It measures, monitors, and records data, which assists healthcare professionals in making therapeutic decisions, but it is not a therapeutic device.
Yes
The device explicitly states its intention to provide continuous physiological information "as an aid to diagnosis."
No
The device description explicitly states it is a "skin-mounted, bio-integrated sensor" that collects biosignals, indicating it is a hardware device with integrated software.
Based on the provided information, the ANNE Chest device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- ANNE Chest Function: The ANNE Chest is a wearable sensor that measures physiological signals directly from the patient's body (ECG, accelerometry, temperature) to derive vital signs and other information. It does not analyze samples taken from the body.
The device's intended use, device description, and the type of data it collects all point to it being a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardioaraphy (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.
Product codes
DRG, FLL, MWJ, KMI, BZQ, MWI
Device Description
The ANNE Chest Sensor is a skin-mounted, bio-integrated sensor that collects real-time biosignals including electrocardiography (ECG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, body position, fall detection, and skin temperature. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data. The ECG signal obtained by the ANNE Chest sensor is not intended for manual discrimination of any arrhythmias or cardiac conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest (for sensor placement)
Indicated Patient Age Range
12 years of age or older
Intended User / Care Setting
Healthcare professionals in clinical and home environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A clinical validation study was conducted in n=40 healthy adult and adolescent subjects to evaluate respiratory rate measurements with the ANNE Chest sensor against an End Tidal Carbon Dioxide (EtCO2) monitor reference. Testing encompassed a range of patient demographics including age, gender, and BMI. Participants were asked to breathe along with a metronome at 8, 13, 23, 27, and 35 breaths per minute. The test also evaluated respiratory rate at different body positions and after motion activities.
Summary of Performance Studies
Study Type: Clinical validation study for respiratory rate accuracy.
Sample Size: n=40 healthy adult and adolescent subjects.
AUC: Not Found
MRMC: Not Found
Standalone Performance: The mean absolute error (MAE) between the ANNE Chest sensor and capnography was 1.27 breaths per minute.
Key Results: The study demonstrated the accuracy of respiratory rate measurements from the ANNE Chest sensor compared to a capnography reference. The device's performance characteristics, taken together with general safety and performance testing data, demonstrated substantial equivalence to the predicate device.
Key Metrics
Respiratory Rate Mean Absolute Error (MAE): 1.27 breaths per minute.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 3, 2024
Sibel Health Inc. Sarah Coughlin Regulatory Affairs Manager 2017 N Mendell Unit 2SE Chicago, Illinois 60614
Re: K240251
Trade/Device Name: ANNE Chest Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, FLL, MWJ, KMI, BZQ, MWI Dated: May 10, 2024 Received: May 10, 2024
Dear Sarah Coughlin:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
ANNE Chest
Indications for Use (Describe)
The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardioaraphy (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
-Submitter:
Sibel Health Inc. 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859
Official Correspondent: Sarah Coughlin, Regulatory Affairs Manager 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859
Date Prepared: 05/09/2024
. Device Information
Name of Device: ANNE Chest 510K Number: K240251 Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulation: 21 CFR §870.2910 Regulatory Class: Class II Product Classification Code: DRG, FLL, MWJ, KMI, BZQ, MWI
lll. Predicate Device
Primary Predicate Trade Name: ANNE One 510(k): K223711 Device Manufacturer: Sibel Health Inc.
Secondary Predicate
Trade Name: Portrait Mobile Monitoring Solution 510(k) Number: K230626 Manufacturer: GE Medical Systems Information Technologies, Inc.
IV. Device Description
The ANNE Chest Sensor is a skin-mounted, bio-integrated sensor that collects real-time biosignals including electrocardiography (ECG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, body position, fall detection, and skin temperature. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data. The ECG signal
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obtained by the ANNE Chest sensor is not intended for manual discrimination of any arrhythmias or cardiac conditions.
V. Indications for Use
The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardiography (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.
VI. Performance Data
The following consensus standards and bench testing were used to evaluate the substantial equivalence of ANNE Chest:
- Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI . ES60601-1:2005/(R) 2020 and IEC 60601-1-2:2014 standards. Electrical safety testing in the home healthcare environment per IEC 60601-1-11:2015.
- Biocompatibility testing according to ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021 for patient contacting materials.
- Wireless coexistence testing according to ANSI IEEE C63.27-2017.
- . Software verification and validation testing according to IEC 62304:2015 and the FDA guidance document, Content of Premarket Submissions for Software Contained in Medical Devices.
- Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC . 60601-2-47:2012.
- . Defibrillation testing according to Section 8.5.5 of ANSI/AAMI ES60601-1:2005/(R)2012
- Shelf life testing of the adhesive to demonstrate performance over the intended device life cycle.
- Bench testing to demonstrate the mechanical durability of the sensors.
- Usability testing in accordance with the FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices.
- Performance testing of heart rate, respiratory rate, skin temperature, activity, and posture. ●
- Cybersecurity evaluation according to the FDA guidance document, Cybersecurity in ● Medical Devices: Quality System Considerations and Content of Premarket Submissions
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VII. Clinical Studies
Respiratory Rate Accuracy: A clinical validation study was conducted in n=40 healthy adult and adolescent subjects to evaluate respiratory rate measurements with the ANNE Chest sensor against an End Tidal Carbon Dioxide (EtCO2) monitor reference. Testing encompassed a range of patient demographics including age, gender, and BMI. Participants were asked to breathe along with a metronome at 8, 13, 23, 27, and 35 breaths per minute. The test also evaluated respiratory rate at different body positions and after motion activities. The mean absolute error (MAE) between the ANNE Chest sensor and capnography was 1.27 breaths per minute.
VIII. Conclusion
The results of the substantial equivalence assessment, taken together with safety and performance testing data, demonstrate that ANNE Chest's performance characteristics are substantially equivalent to the predicate device in both technology and intended use.
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| | Subject device
Sibel Health Inc. | Primary Predicate device
Sibel Health Inc. | Secondary Predicate
GE Medical Systems
Information
Technologies, Inc. | Variances / Equivalence | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade
Name | ANNE Chest | ANNE One | Portrait Mobile Monitoring
Solution | | |
| 510(k)
Number | K240251 | K223711 | K230626 | | |
| Class | II | II | II | Equivalent | |
| Product
Code | DRG, FLL, KMI, MWJ,
BZQ, MWI | DRG, MWI, FLL, DQA,
MWJ, KMI | MHX, MSX, DRG, BZQ,
DQA | Equivalent
BZQ is a product code in
the subject device that
was not present in the
predicate device.
However, the predicate
device did monitor
breathing frequency. The
K230626 secondary
predicate is used to
support the BZQ product
code. | |
| Regulation
Number
and
Regulation
Name | 870.2910
Transmitters and
Receivers, Physiological
Signal, Radiofrequency | 870.2910
Transmitters and
Receivers, Physiological
Signal, Radiofrequency | 870.1025
Arrhythmia Detector and
Alarm (Including
ST-Segment Measurement
and Alarm) | Equivalent | |
| Indications
for Use | The ANNE Chest is a
wearable, wireless sensor
intended for the
measurement of
electrocardiography (ECG)
waveforms, heart rate,
respiratory rate, activity,
fall detection, body
position, and skin
temperature. The ANNE
Chest sensor is not
intended to monitor or
measure respiratory rate
while the patient
undergoes significant
motion or is active. The
ANNE Chest sensor
communicates with
compatible software
applications for the display.
storage, and analysis of
data. The device is
intended to provide
continuous physiological
information as an aid to
diagnosis and treatment | ANNE One is a wireless
monitoring platform
indicated for the
measurement of
electrocardiography (ECG)
waveforms, heart rate,
respiratory rate, functional
oxygen saturation of
arterial hemoglobin
(SpO2), pulse rate, activity,
body position, fall
detection, skin
temperature, and body
temperature by qualified
healthcare professionals in
home and healthcare
settings. ANNE One is
compatible with third-party,
FDA-cleared devices for
noninvasive blood
pressure, SpO2, pulse
rate, and body
temperature
measurements. The
device is indicated for
monitoring ECG | Portrait Mobile Monitoring
Solution: The Portrait
Mobile Monitoring Solution
is intended to acquire,
store, calculate, display
and export patient
monitoring data as well as
provide real time alarming
for monitoring adult and
pediatric patients (3 years
of age and older, and
weighing more than 10
kg).
Physiological parameters
and waveforms supported
are:
• Pulse oximetry
(SpO2/pulse rate)
• Respiration rate (RR)
Continuous pulse oximetry
and respiration rate
monitoring may be used
for patients at risk of | Similar
The subject device utilizes
the same ANNE Chest
sensor for the monitoring
of ECG, heart rate,
respiratory rate, body
position, activity, and skin
temperature as the
predicate device ANNE
One. The ANNE One
predicate has additional
outputs including SpO2,
pulse rate, body
temperature, and
non-invasive blood
pressure. This difference
does not affect safety or
effectiveness of the output
parameters indicated for
use in the subject device. | |
| | | | | | |
| | | by healthcare
professionals in general
care patients who are 12
years of age or older in
clinical and home
environments. The device
is not intended for use on
critical care patients. | waveforms and heart rate
on ambulatory patients.
The device is not intended
to monitor or measure
respiratory rate, SpO2,
pulse rate, or noninvasive
blood pressure while the
patient undergoes
significant motion or is
active.
ANNE One continuously
monitors the orientation of
patients to aid in the
prevention of pressure
ulcers for at-risk patients.
The system provides
visual notification when the
patient's position has not
changed from a preset
threshold of time.
The device is intended for
use on general care
patients who are 12 years
of age or older as a
general patient monitor to
provide continuous
physiological information
as an aid to diagnosis and
treatment. The data from
ANNE One are transmitted
wirelessly for display,
storage, and analysis. The
device is not intended for
use on critical care
patients. | cardiorespiratory and
infectious complications.
The Portrait Mobile
Monitoring Solution is
intended for use under the
direct supervision of a
licensed practitioner, or by
personnel trained in proper
use of the equipment in a
professional healthcare
facility.
This device is not an
Apnea monitor (i.e., do not
rely on the device for
detection or alarm for the
cessation of breathing).
This device should not be
used for life
sustaining/supporting
purposes. The Portrait
Mobile Monitoring Solution
is not intended for use in a
controlled Magnetic
Resonance (MR)
environment. | |
| | Target
Population | 12 years of age and older | 12 years of age and older | 3 years of age and older,
weighing more than 10 kg | Equivalent |
| | Use
Environment | Home and healthcare
settings | Home and healthcare
settings | Professional healthcare
facility | Equivalent |
| | Reprocessing | Multiple patient reusable | Single patient reusable | Semi-disposable | Different
The subject device is
reusable on multiple
patients. Validation of the
cleaning process and
mechanical testing
demonstrate that this
difference does not impact
safety or effectiveness. |
| | Sensor
Placement | Chest | Finger and Chest | Portrait Wearable
Respiration Rate Sensor
and Portrait RR Electrode
Patch: | Equivalent
Placement location of the
ANNE Chest sensor is the
same between the subject |
| | | | Chest | and predicate devices.
The predicate device
includes an additional
sensor, the ANNE Limb
Sensor, that is worn on the
finger. The ANNE Limb
Sensor is not part of the
scope of the subject
device. | |
| Heart Rate | 30 - 270 bpm
(the greater of ±10% or
±5bpm) | 30-270 bpm
(the greater of ± 10% or ±
5 bpm) | N/A | Equivalent | |
| Respiratory
Rate | Accelerometer and ECG
derived
8 - 35 bpm (±3 bpm
RMSE) | Accelerometer-derived
8 - 30 bpm (± 3 bpm
RMSE) | Derived from impedance
and biopotential signals
Accuracy range from 4 to
60 breaths/minute (± 3
bpm RMSE) | Similar
The range for respiratory
rate has been extended in
the subject device from the
K223711 predicate. The
range is less than the
K230626 secondary
predicate. Respiratory rate
over the output range for
the subject device meets
the same accuracy
specification as both
predicates. | |
| Skin
Temperatur
e | 73.4°F - 109.4°F (±0.54°F)
23°C - 43°C (±0.3°C) | 73.4°F - 109.4°F (±0.54°F)
23°C - 43°C (±0.3°C) | N/A | Equivalent | |
| Body
Temperatur
e | Not Applicable | ± 0.05 °C ( ± 0.1 °F )
during 35.00 °C ~38.00°C
(95.00 °F ~100.40°F) ±
0.1°C ( ± 0.2 °F ) during
T38.00°C (100.40°F)
with use of an optional
compatible thermometer | N/A | Different
The subject device does
not have body temperature
functionality. | |
| SpO2 | Not Applicable | ARMS ≤ 3% (range
70-100%) | ARMS ≤ 2% (range
70-100%)
Low perfusion: ARMS ≤ 3%
With motion: ARMS ≤ 3% | Different
The subject device does
not have SpO2
functionality. | |
| Pulse Rate | Not Applicable | 30-300 bpm
(the greater of ± 10% or ±
5 bpm) | 30-250 bpm
≤ 2bpm (30 to 250 bpm)
With motion: ≤5bpm | Different
The subject device does
not have pulse rate
functionality. | |
| Activity | Accelerometer | Accelerometer | N/A | Equivalent | |
| Posture | Body Position | Body Position | N/A | Equivalent | |
| Non-Invasiv
e Blood
Pressure | Not Applicable | 0 - 300 mmHg (± 3 mmHg) | N/A | Not Applicable | |
| (NIBP) | | with use of an optional
compatible blood pressure
cuff | | The subject device does
not have NIBP
functionality. | |
| ECG
Waveform | Compliant to IEC
60601-2-27
Compliant to IEC
60601-2-47 | Compliant to IEC
60601-2-27
Compliant to IEC
60601-2-47 | N/A | Equivalent | |
| ECG
Sampling
Frequency | ECG Sampling Frequency:
512 Hz
Streaming Frequency: 256
Hz | ECG Sampling Frequency:
512 Hz
Streaming Frequency: 256
Hz | N/A | Equivalent | |
| ECG
Resolution | 18 bit | 18 bit | N/A | Equivalent | |
| Data | Data is transmitted
wirelessly via Bluetooth
from the sensor to the
Sibel SDK, which may be
integrated within software
applications for the display
and storage of data. | Data is transmitted
wirelessly via Bluetooth
from the sensors to a
mobile device. Data may
be downloaded for later
storage and analysis. | Data is transmitted
wirelessly from the Portrait
Sensor Battery to the
Portrait Mobile Patient
Monitor over a wireless
Medical Body Area
Network (MBAN) using a
proprietary protocol. | Similar
The subject device allows
communication with
compatible software
applications for the display,
storage, and analysis of
data. | |
| Notification | No notification ability. | Provides visual notification
on patient orientation. | Real time alarming | Similar
The subject device
provides a visual
notification on patient
orientation. | |
| Motion | Respiratory rate
measurements should not
be taken during motion.
Heart rate and ECG may
be taken during motion. | Respiratory rate, SpO2,
and pulse rate
measurements should not
be taken during motion.
Heart rate and ECG may
be taken during motion. | Ambulatory monitoring | Equivalent
Equivalent for applicable
parameters | |
| Measureme
nt modality | Continuous measurements | Continuous measurements | Continuous measurements | Equivalent | |
| Monitoring
type | Real time monitoring | Real time monitoring
Data storage for later
analysis | Real time monitoring | Equivalent | |
| Apnea
Claims | Not an apnea alarm | Not an apnea alarm | Not an apnea alarm | Equivalent | |
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