VitalScan ANS

K191266 · Medeia, Inc. · JOM · Jan 15, 2020 · Cardiovascular

Device Facts

• Record ID: K191266
• Device Name: VitalScan ANS
• Applicant: Medeia, Inc.
• Product Code: JOM · Cardiovascular
• Decision Date: Jan 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2780
• Device Class: Class 2

Intended Use

VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems. VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD). The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals. The physician has the responsibility of interpreting the significance of the resulting data.

Device Story

VitalScan ANS is a multi-parameter diagnostic system for cardiovascular assessment in clinical settings. It collects ECG, PPG, PVR, blood pressure, and SpO2 data. The system uses USB-connected hardware and PC-based software to perform HRV analysis (autonomic nervous system function) and calculate ABPI/ABI/PVR (peripheral arterial disease risk). It executes controlled testing procedures, including paced respiration, orthostatic tests, and autonomic challenge tests. The physician interprets the resulting data to support clinical decision-making; the device provides no direct diagnosis. Benefits include non-invasive, rapid assessment of cardiovascular and autonomic function.

Clinical Evidence

No clinical testing was necessary to determine substantial equivalence. Evidence consists of bench testing, including ECG, HRV, SpO2, blood pressure accuracy, communication integrity, EMC, electrical safety, and software verification/validation. Usability testing was also conducted.

Technological Characteristics

System includes USB hardware and PC software. Sensing: ECG (electrodes), PPG (infrared/red LEDs), oscillometric NIBP (cuffs/pump/valve). Connectivity: USB. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, AAMI/ANSI 60601-2-27, ISO 80601-2-61, AAMI/ANSI/IEC 80601-2-30, AAMI/ANSI EC57.

Indications for Use

Indicated for transitional adolescents and adults, including those with unilateral lower limb amputation, for non-invasive cardiovascular assessment, including HRV, blood pressure, and PAD screening via ABPI/ABI and PVR in clinical settings.

Regulatory Classification

Identification

A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.

Predicate Devices

• ANSHA-QHRV1 (K083735)
• Critical Care Assessment (K101983)
• ABPI MD (K172655)

Reference Devices

• Tonoport V (K012647)

Submission Summary (Full Text)

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January 15, 2020

Medeia, Inc. % Daniel Lehtonen Regulatory Consultant Compliance and Regulatory Services LLC 3771 Southbrook Dr Dayton, Ohio 45430

Re: K191266

Trade/Device Name: VitalScan ANS Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, Pneumatic, or Photoelectric Plethysmographs Regulatory Class: Class II Product Code: JOM, DPS, DXN Dated: December 11, 2019 Received: December 16, 2019

Dear Daniel Lehtonen:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K191266

Device Name

VitalScan ANS

Indications for Use (Describe)

VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems.

VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD).

The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals.

The physician has the responsibility of interpreting the significance of the resulting data.

Type of Use (Select one or both, as applicable)

| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the "M" in green and blue, and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, sans-serif font.

# 510(k) SUMMARY

This summary of 510(k) information is submitted in accordance with the Requirements of Safe Medical Device systems Act 1990 and 21 CFR Sec. 807.92

510(k) Number:

K191266

### a1 APPLICANT INFORMATION:

| Date Prepared: | 03 May 2019 |
|----------------|---------------------------------------------------------------|
| Name: | Medeia, Inc. |
| Address: | 7 W. Figueroa Street<br>Suite 300<br>Santa Barbara, CA, 93101 |

| Contact Person: | Slav Danev |
|-----------------|------------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Email: | [e-mail] |

### a2 NAME OF DEVICE:

| Trade Name: | VitalScan ANS |
|----------------------|------------------------------------------------------------------------------------------------------|
| Common Name: | Plethysmograph, photoelectric, pneumatic or hydraulic |
| Classification Name: | Plethysmograph, photoelectric, pneumatic or hydraulic<br>21 CFR 870.2780 (JOM)<br>Electrocardiograph |
| | 21 CFR 870.2340 (DPS)<br>Noninvasive blood pressure measurement system |
| | 21 CFR 870.1130 (DXN) |

### аЗ PREDICATE DEVICES:

| Primary Predicate Device: | K083735; ANSHA-QHRV1 |
|-----------------------------|-----------------------------------|
| Secondary Predicate Device: | K101983; Critical Care Assessment |
| Secondary Predicate Device: | K172655; ABPI MD |
| Reference Device: | K012647; Tonoport V |

The FDA database for recalls was searched on 20 March 2019 during the preparation of the 510(k) submission and no recalls for the devices noted above were found.

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Image /page/4/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the "M" in green and blue and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, blue sans-serif font.

### INDICATIONS FOR USE: a4

VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems.

VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD).

The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals.

The physician has the responsibility of interpreting the significance of the resulting data.

### a5 DESCRIPTION OF THE DEVICE:

VitalScan ANS system collects multi-parameter patient data including: Electrocardiography (ECG), Plethysmogram (PPG), Pulse Volume Recording (PVR), Blood Pressure, Heart Rate, and Peripheral capillary Oxygen saturation (SpO2).

The system comprises: USB plug and play device hardware and Software installed on a computer.

VitalScan ANS is intended to measure a patient's variations in the heart rate (R-R beat-to-beat intervals from ECG) and perform Heart Rate Variability (HRV) analysis to assess Autonomic Nervous System (ANS) Function;

VitalScan ANS also measure a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assess the risk of developing peripheral arterial disease (PAD).

The results are saved in a backup and can also be printed.

The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.

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Image /page/5/Picture/0 description: The image shows the logo for Medeia. The logo has a large letter "M" in green and blue, followed by the rest of the word "edeia" in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in blue.

#### a6 TECHNOLOGICAL CHARACTERISTIC COMPARISON:

VitalScan ANS product share similar device characteristics, intended use, performance, specifications, sensors and is the same in design, function, and application to the predicate devices.

The comparison table, beginning on page 5, demonstrates that the VitalScan ANS device is substantially equivalent to the predicate devices. The nonclinical data support the safety of the device and the hardware and software verification and validation demonstrate that the VitalScan ANS device should perform as intended in the specified use conditions.

Based on comparisons of device technological characteristics, features, materials, intended use and performance the VitalScan ANS has been shown to be substantially equivalent to the commercially available predicate devices.

### NON-CLINICAL TESTING: b1

The VitalScan ANS device was subjected to the following non-clinical performance testing:

Bench testing was carried out on the following characteristics:

- Electrocardiograph (ECG)
- Heart rate variability (R-R interval)
- Heart rate
- SpO2 and Plethysmogram ●
- Blood-Pressure Measurement accuracy
- Communication, data transmission and storage integrity
- Electromagnetic compatibility (EMC)
- Electrical safety testing
- Software verification and validation testing
- Biocompatibility verification

In addition to the above, usability testing was also conducted.

Referenced Standards and Performance Testing:

The VitalScan ANS device was tested and meets the applicable requirements of following performance Standards and is in accordance with FDA Class II Special Controls Guidance Document:

- IEC 60601-1 Medical Electrical Equipment - Part 1: Basic safety and essential performance Ed 3.1 2005+A1:2012
- . IEC 60601-1-2 Medical Electrical Equipment - Basic safety and essential performance-EMC-Edition 3: 2007-03
- IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability; Edition 3.1 2013-10
- AAMI / ANSI 60601-2-27 Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 2011
- . ISO 80601-2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment 2011

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Image /page/6/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the "M" in green and blue and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, blue sans-serif font.

- . AAMI / ANSI / IEC 80601-2-30 Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers 2009 + A1:2013
- . AAMI / ANSI EC57 - Testing and reporting performance results of cardiac rhythm and stsegment measurement algorithms 2012 [Select clauses to support device performance]

### Software Verification and Validation Testing

Software verification and validation testing were conducted following the FDA guidance document for software contained in medical devices. The software was considered to be a "moderate" level of concern since a failure or latent flaw could indirectly result in a minor injury to the patient through incorrect or delayed information or through action of the operator.

### b2 CLINICAL TESTING:

No Clinical testing was necessary to determine substantial equivalence.

### b3 CONCLUSIONS DRAWN FROM TESTING:

Based on information obtained on the predicate device with reference to the design specification, electrical safety / EMC testing and intended use, the VitalScan ANS device was subjected to the same type of testing. The results support the conclusion that the VitalScan ANS device is substantially equivalent to the Predicate devices.

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Image /page/7/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in black font, with the first letter "M" in green and blue. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller blue font.

## Comparison Table

In section a 3 Predicate Devices section of this Summent, The Critical Care Assessment (CCA) device (K101983) is included as a predicate. The Critical Care Assessment device is a re-labeled ANSHA-QHRV1 device with the only difference being the name of the following comparison table includes only the ANSHA-QHRV1 device for direct comparison as all rows for the CCA device would be identical.

| Feature | VitalScan ANS | Primary Predicate | Secondary Predicate | Reference Device | Substantial Equivalence<br>Comments |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | ANSHA-QHRV1 | ABPI MD | Tonoport V | |
| 510(k) Number | Subject Device | K083735 | K172655 | K012647 | -- |
| Device name | VitalScan ANS | ANSHA-QHRV1 | ABPI MD | Tonoport V | -- |
| Manufacturer | Medeia Ltd. | Medeia Ltd. | MESI | PAR Medizintechnik<br>GmbH | -- |
| Regulation<br>Numbers | 21 CFR 870.2780<br>21 CFR 870.2340<br>21 CFR 870.1130 | 21 CFR 870.2780<br>21 CFR 870.2340 | 21 CFR 870.2780 | 21 CFR 870.1130 | CFR numbers of the<br>subject device include<br>those of the predicate and<br>reference devices |
| Product Codes | JOM, DPS, DXN | JOM, DPS | JOM | DXN | Product Codes of the<br>subject device include<br>those of the predicate and<br>reference devices |
| | VitalScan ANS | Primary Predicate | Secondary Predicate | Reference Device | Substantial Equivalence<br>Comments |
| Feature | | ANSHA-QHRV1 | ABPI MD | Tonoport V | |
| Indications for Use | VitalScan ANS is intended for non-<br>invasive measurements of pulse<br>waveforms by photoelectric<br>plethysmography (PPG), heart rate<br>electrocardiograph (ECG), Heart<br>Variability measurements (HRV)<br>and blood pressure (NIBP) in<br>response to paced respiration and<br>controlled testing procedures for<br>physician assessment of the<br>Cardiovascular Systems.<br>VitalScan ANS also<br>measures/calculates a patient's<br>Brachial and Ankle Blood Pressure,<br>Ankle Brachial Pressure Index<br>(ABPI) and Ankle Brachial Index<br>(ABI) and provides Pulse Volume<br>Recording (PVR) / volume<br>plethysmography for assessing<br>development of peripheral arterial<br>disease (PAD).<br>The device is intended for use on<br>transitional adolescents and<br>adults, including those with<br>unilateral lower limb amputation,<br>in medical clinics, healthcare<br>practices and out-patient<br>departments of hospitals.<br>The physician has the<br>responsibility of interpreting the<br>significance of the resulting data. | ANSHA-QHRV1 is intended for<br>non-invasive measurements of<br>pulse waveforms by<br>photoelectric<br>plethysmography and heart<br>rate electrocardiograph.<br>The system is intended for use<br>of patients in medical clinics,<br>healthcare practices and in<br>out-patient department of<br>hospitals. | The ABPI MD system is<br>indicated for use on adult<br>subjects at risk of having or<br>developing peripheral arterial<br>disease (PAD).<br>The ABPI MD system is<br>intended for the rapid<br>measurement of ankle-<br>brachial pressure index (ABPI),<br>or ankle-brachial index (ABI)<br>and pulse volume recording<br>(PVR) / volume<br>plethysmography in adults.<br>It is suitable for wound care<br>assessment, for assessing<br>symptomatic PAD, and as a<br>screening device for PAD. It<br>may also be used on patients<br>with venous or arterial ulcers<br>prior to application of<br>compression therapy.<br>The ABPI MD system can be<br>used on patients with<br>unilateral lower limb<br>amputation. The ABPI MD<br>system is intended to be used<br>to spot-check patients. The<br>ABPI MD system provided<br>information regarding patient<br>risk. The physician has the<br>responsibility of making<br>proper judgements based on<br>this information. | [Excerpt of IFU] The Tonoport<br>V is a compact, lightweight,<br>patient-borne, non-invasive<br>blood pressure (NIBP) bolter<br>using the oscillometric<br>method. The cuff is borne on<br>the upper arm and an<br>electrical pump inside the<br>device generates the pressure<br>in the cuff. Tonoport V is<br>intended to be used for<br>measuring the systolic,<br>diastolic, mean blood pressure<br>and the heart rate of human<br>beings for periods up to 30<br>hours. The intended patient<br>populations are adults and<br>children (but not neonates)<br>with a circumference of the<br>upper arm in the range of 17<br>cm to 42 cm. A measurement<br>with Tonoport V is combined<br>with other measurements and<br>medical examinations at the<br>patient, so that a diagnosis<br>about the patient's health<br>condition depends not alone<br>from the measurement of the<br>Tonoport V. | There are no differences in the<br>intended use of the devices.<br>The indications for use are<br>clarified, but not changed.<br>The measurements made by<br>the ANSHA-QHRV1 are used<br>for the same purposes as the<br>VitalScan ANS device - analysis<br>of HRV, PWV, and PVR. The<br>VitalScan ANS uses the same<br>algorithms as the ANSHA-<br>QHRV1 for PPG and ECG<br>acquisition and analysis.<br>The measurements made by<br>the ABPI-MD device are used<br>for assessing symptomatic PAD<br>or for screening for PAD. The<br>VitalScan ANS makes<br>measurements for the same<br>purposes.<br>The VitalScan ANS uses the<br>same algorithm as the<br>Tonoport V for NIBP<br>measurements.<br>The VitalScan ANS and<br>predicate/reference devices<br>are used for the adult<br>population in professional<br>settings and a medical<br>professional is responsible for<br>interpreting the data /<br>determining its significance<br>related to the patient's health. |
| | | Primary Predicate | Secondary Predicate | Reference Device | Substantial Equivalence |
| Feature | VitalScan ANS | ANSHA-QHRV1 | ABPI MD | Tonoport V | Comments |
| Measurements | HRV – by ECG using<br>electrodes placed on the<br>chest or on hands. The<br>monitoring program has<br>been developed according to<br>the standards and<br>mathematical procedures for<br>short-term HRV Autonomic<br>nervous system analysis as<br>well as for performing and<br>evaluating blood pressure,<br>blood flow and autonomic<br>challenge tests.<br>Test Administration:<br>Cardio respiratory Coupling<br>and Autonomic Balance<br>(Sympathetic and<br>Parasympathetic Tone),<br>Autonomic dysregulation<br>Stress Analysis. Time: 4.30<br>minutes<br>Parasympathetic Breathing<br>Reflex.<br>Time: 1 minute<br>Sympathetic<br>Vasoconstriction Reflex;<br>Time: 1.30 minutes<br>Orthostatic Test,<br>Cardiovascular Reflex,<br>Cardiovascular Fitness<br>Analysis<br>Time: 5.00 minutes<br>Systolic, Diastolic and Ankle<br>Brachial pressures using the<br>oscillometric method | HRV – by ECG using<br>electrodes placed on the<br>chest or on hands. The<br>monitoring program has<br>been developed according to<br>the standards and<br>mathematical procedures for<br>short-term HRV Autonomic<br>nervous system analysis as<br>well as for performing and<br>evaluating blood flow and<br>autonomic challenge tests.<br>Test Administration:<br>Cardio respiratory Coupling<br>and Autonomic Balance<br>(Sympathetic and<br>Parasympathetic Tone),<br>Stress Analysis. Time: 4.30<br>minutes<br>Parasympathetic Breathing<br>Reflex.<br>Time: 1 minute<br>Sympathetic<br>Vasoconstriction Reflex<br>Time: 1.30 minutes<br>Orthostatic Test,<br>Cardiovascular Reflex,<br>Fitness Analysis<br>Time: 5.00 minutes | Ankle brachial pressure index<br>using the oscillometric<br>method<br>Systolic blood pressure using<br>the oscillometric method<br>Diastolic blood pressure<br>using the oscillometric<br>method<br>Heart rate using the<br>oscillometric method | Measuring the systolic,<br>diastolic and mean blood<br>pressure and the heart rate<br>using the oscillometric<br>method | For HRV / PWV / PVR the<br>VitalScan ANS device is<br>identical to the ANSHA-<br>QHRV1. The measurements<br>and test protocol are the<br>same betwe…