MATRx Plus
Device Facts
| Record ID | K181996 |
|---|---|
| Device Name | MATRx Plus |
| Applicant | Zephyr Sleep Technologies |
| Product Code | MNR · Anesthesiology |
| Decision Date | Nov 21, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
Indications for Use
The device is indicated for use by the Health Care Professional (HCP), where it may aid in the diagnosis and assessment of sleep disordered breathing for adult patients. MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing. The device is intended for home and hospital use under the direction of an HCP.
Device Story
MATRx plus is a 5-channel battery-powered ventilatory effort recorder; collects respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort, and body position during sleep. Inputs: nasal cannula (pressure), finger oximeter, and inductance-based respiratory effort belt. Device worn on patient's chest; wirelessly transmits data via Bluetooth to a bedside tablet. Tablet guides user through setup and study conduct; stores data. Post-study, data uploaded to secure portal for HCP access via Data Viewer. Software generates reports with calculated indices (ODI, AHI, pulse/saturation metrics) to aid HCP in sleep disordered breathing diagnosis. Used in home or hospital settings under HCP direction. Benefits include automated data collection and analysis to facilitate clinical decision-making.
Clinical Evidence
Clinical validation study with 27 individuals with suspected/confirmed sleep apnea. Compared MATRx plus autoscoring algorithm for apnea/hypopnea detection against gold standard polysomnography. Results demonstrated comparable sensitivity and accuracy to predicate devices (e.g., Embletta MPR).
Technological Characteristics
Battery-powered (3.7V Li-Ion) ventilatory effort recorder. Sensors: nasal cannula (350 Hz), finger oximeter (1 Hz), inductance-based effort belt (25 Hz), 3D accelerometer for position. Dimensions: 2.48" x 3.11" x 0.83". Connectivity: Bluetooth to tablet, web portal upload. Standards: IEC 60601-1:2005+1, IEC 60601-1-11:2010, IEC 60601-1-2:2014, IEC 62133:2012. Software includes autoscoring algorithms for respiratory events.
Indications for Use
Indicated for adult patients with suspected or confirmed sleep disordered breathing to aid in diagnosis and assessment. Contraindicated for use near MRI devices; not for use as an apnea monitor or in life-supporting/life-sustaining situations.
Regulatory Classification
Identification
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.
Predicate Devices
- MATRx plus (K163665)
Reference Devices
Submission Summary (Full Text)
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November 21, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized depiction of a human figure, and the text reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The logo is simple and professional, and it is easily recognizable.
Zephyr Sleep Technologies Sabina Bruehlmann Director, Technology #102, 701 64th Ave SE Calgary, Alberta, Canada T2H-2C3
Re: K181996
Trade/Device Name: MATRx Plus Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: July 18, 2018 Received: July 26, 2018
Dear Sabina Bruehlmann:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely.
# Amy K. Levelle - S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K181996
Device Name MATRx plus
Indications for Use (Describe)
The device is indicated for use by the Health Care Professional (HCP), where it may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
MATRx plus records the following data: patient respiratory nasal airflow. snoring, blood oxygen saturation, pulse. respiratory effort and body position during sleep.
The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing. The device is intended for home and hospital use under the direction of an HCP.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image is a logo for Zephyr Sleep Technologies. The logo has the word "ZEPHYR" in a large, bold, blue font. Below that is the phrase "Sleep Technologies" in a smaller, but still bold, blue font. The logo also includes the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada" in a smaller, non-bold font.
#### Section 5 - 510k Summary - MATRx plus
| Date: | July 18, 2018 |
|------------------------------------|--------------------------------------------------------------|
| Manufacturer Name: | Zephyr Sleep Technologies, Inc. |
| Contact Name: | Sabina Bruehlmann, PhD |
| Title: | Director, Technology |
| Postal Address: | #102, 701 64th Ave SE<br>Calgary, Alberta, Canada<br>T2H-2C3 |
| Phone Number: | 587-332-0285 |
| Establishment Registration Number: | 3008960597 |
| Device Proprietary Name: | MATRx plus |
| Classification Name: | CFR 868.2375 Ventilatory Effort Recorder |
| Classification Code: | Class II |
| Product Code: | MNR |
| Predicate Device: | K163665 MATRx plus |
| Reference Device: | K122516 Embletta MPR Sleep Data<br>Recording System |
#### Device Description:
The MATRx plus device is a ventilatory effort recorder. The MATRx plus recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation, snoring, and body position during sleep. The physician-prescribed device is worn on the patient's abdomen attached to a reusable effort belt, and all relevant respiratory information during sleep is collected via nasal cannula, pulse oximeter, and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and positioned at the patient's nose. The cannula is dual lumen and functions to individually sample the pressure from each naris. The oximetry sensor is fixed at the patient's finger and connects directly to the device. The Recorder receives
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Image /page/4/Picture/0 description: The image is a logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in large, bold, blue letters, with the words "Sleep Technologies" in a smaller font underneath. To the right of the word "ZEPHYR" is a graphic of a crescent moon and a star. Below the logo is the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
input from the sensors and wirelessly transmits the data to a bedside Tablet during the study.
The Tablet is set up through a connection to the web portal by the Health Care Professional (HCP) prior to deploying the device to the patient for use in the home. The Tablet runs the MATRx plus application. The Tablet records and stores the data. The MATRx plus application on the Tablet is also used to guide the user through the set up and conduct of the study through a stepwise user interface. At the end of a recording the Tablet advises the patient if sufficient data for analysis were recorded during the night.
After recording, the MATRx plus must be returned to the HCP. The data are automatically uploaded to the secure Portal where they can be accessed and downloaded to the Data Viewer. The Data Viewer can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis.
#### Intended Use:
The device is indicated for use by the HCP, where it may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort, and body position during sleep.
The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing. The device is intended for home and hospital use under the direction of an HCP.
## Technology:
The MATRx plus subject device is an update to the predicate MATRx plus (K163665) and includes the following changes:
- Expansion of the oxygen desaturation index to include 3% desaturation -
- Addition of an apnea-hypopnea index for both 3 and 4% desaturation -
- Addition of option to toggle between a moving average baseline (previously cleared) and a preceding peak baseline (new)
- -Modifications to the event scoring algorithms
## Comparison to Predicate Device:
The MATRx plus subject device is substantially equivalent to the MATRx plus device [K163665 Summary, Exhibit 12-01], manufactured by Zephyr Sleep Technologies, Inc. The following tables provide a detailed comparison of the MATRx plus technological characteristics in comparison of the intended use for the predicate.
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Image /page/5/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, bold, teal font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a graphic of a crescent moon with a star.
| | #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada<br>MATRx plus (K163665) | Proposed MATRx plus<br>(subject device) | Discussion of<br>Differences |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | MNR, Ventilatory Effort<br>Recorder | MNR, Ventilatory Effort<br>Recorder | Identical |
| Indications for<br>Use | The MATRx plus™ is<br>indicated for<br>use by the Health Care<br>Professional (HCP), where<br>it may aid in the diagnosis<br>and assessment of sleep<br>disordered breathing for<br>adult patients.<br>MATRx plus records the<br>following data: patient<br>respiratory nasal airflow,<br>snoring, blood oxygen<br>saturation, pulse,<br>respiratory effort and body<br>position during sleep.<br>The device uses these<br>recordings to produce a<br>report for the HCP that<br>may aid in the diagnosis of<br>sleep disordered breathing.<br>The device is intended for<br>home and hospital use<br>under the direction of an<br>HCP. | The MATRx plus™ is<br>indicated for<br>use by the Health Care<br>Professional (HCP), where<br>it may aid in the diagnosis<br>and assessment of sleep<br>disordered breathing for<br>adult patients.<br>MATRx plus records the<br>following data: patient<br>respiratory nasal airflow,<br>snoring, blood oxygen<br>saturation, pulse,<br>respiratory effort and body<br>position during sleep.<br>The device uses these<br>recordings to produce a<br>report for the HCP that<br>may aid in the diagnosis of<br>sleep disordered breathing.<br>The device is intended for<br>home and hospital use<br>under the direction of an<br>HCP. | Identical |
| Patient<br>Population | Adults | Adults | Identical |
| Environment<br>of Use | Deployed from Clinics,<br>Hospitals. Used<br>unsupervised in the Home<br>or Clinic. Analyzed from<br>physician's office. | Deployed from Clinics,<br>Hospitals. Used<br>unsupervised in the Home<br>or Clinic. Analyzed from<br>physician's office. | Identical |
| Outcome | 1) Data to assist in the<br>diagnosis of sleep<br>disordered breathing | 1) Data to assist in the<br>diagnosis of sleep<br>disordered breathing | Identical |
| Contraindications | The MATRx plus system<br>must not be used in the<br>vicinity of an MRI device.<br>This device is not to be<br>used as an apnea monitor<br>or in a life supporting or<br>life sustaining situation. | The MATRx plus system<br>must not be used in the<br>vicinity of an MRI device.<br>This device is not to be<br>used as an apnea monitor<br>or in a life supporting or<br>life sustaining situation. | Identical |
| | MATRX plus (K163665) | Changes from the predicate (K163665;<br>MATRX plus) | Discussion of Differences |
| Sensors | | | |
| Pulse<br>Oximeter | Third party oximeter<br>sensor (Masimo SET 2040)<br>attaches to patient worn<br>recorder, measures degree<br>of oxygen saturation of the<br>blood and pulse rate.<br>Sampling frequency of 1<br>Hz. | Third party oximeter<br>sensor (Masimo SET 2040)<br>attaches to patient worn<br>recorder, measures degree<br>of oxygen saturation of the<br>blood and pulse rate.<br>Sampling frequency of 1<br>Hz. | Identical |
| Airflow | Dual channel nasal cannula<br>attaches to patient worn<br>recorder; records pressure<br>and translates to airflow<br>and snoring. Sampling<br>frequency of 350 Hz. | Dual channel nasal cannula<br>attaches to patient worn<br>recorder; records pressure<br>and translates to airflow<br>and snoring. Sampling<br>frequency of 350 Hz. | Identical |
| Respiratory<br>Effort | Respiratory effort channel<br>to measure the respiratory<br>effort using an inductance<br>principle.<br>Third-party belt (Sleep<br>Sense, K042253).<br>Sampling frequency of 25<br>Hz. | Respiratory effort channel<br>to measure the respiratory<br>effort using an inductance<br>principle.<br>Third-party belt (Sleep<br>Sense, K042253).<br>Sampling frequency of 25<br>Hz. | Identical |
| Position | Channel to determine body<br>position of the patient<br>during sleep by 3D axis<br>accelerometer. | Channel to determine body<br>position of the patient<br>during sleep by 3D axis<br>accelerometer. | Identical |
| Snoring | Nasal airflow fluctuation<br>envelope<br>signal (between 10 and 70<br>Hz). Set threshold. | Nasal airflow fluctuation<br>envelope<br>signal (between 10 and 70<br>Hz). Set threshold. | Identical |
| Other channels | None | None | Identical |
| Method of<br>connection to<br>the patient | Plastic tubing and cannula<br>for pressure sensing; belts<br>for respiratory effort;<br>probes or Flexi Wrap for<br>oximetry; touch proof<br>electrode cables; belts for<br>attaching of device and clip<br>straps to secure position of<br>device. The device is worn<br>on the patient's chest. | Plastic tubing and cannula<br>for pressure sensing; belts<br>for respiratory effort;<br>probes or Flexi Wrap for<br>oximetry; touch proof<br>electrode cables; belts for<br>attaching of device and clip<br>straps to secure position of<br>device. The device is worn<br>on the patient's chest. | Identical |
| Device Design | | | |
| #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada | | | |
| | MATRX plus (K163665) | Changes from the predicate (K163665; MATRX plus) | Discussion of Differences |
| Sensor Connection | Sensors (airflow, oximeter, effort belt) are attached to a body worn recorder unit. | Sensors (airflow, oximeter, effort belt) are attached to a body worn recorder unit. | Identical |
| Recorder Dimensions | Recorder: 2.48" x 3.11" x 0.83"<br>Oximeter: 1.9"x 0.6"x 1.3" | Recorder: 2.48" x 3.11" x 0.83"<br>Oximeter: 1.9"x 0.6"x 1.3" | Identical |
| Recorder Weight | 230 g | 230 g | Identical |
| Data collection | All sensors connect direct to recorder.<br>Study data are wirelessly transferred (Bluetooth) from recorder to tablet and stored on the tablet until study conclusion. Data are wirelessly collected via device to web portal at the end of the study. | All sensors connect direct to recorder.<br>Study data are wirelessly transferred (Bluetooth) from recorder to tablet and stored on the tablet until study conclusion. Data are wirelessly collected via device to web portal at the end of the study. | Identical |
| Processor | Recorder microprocessor system (ARM Cortex M4 based, STM32 F4, 168 MHz) processes the patient's data (1MB).<br>Tablet minimum requirements: 1.33 GHz processor, 1 GB RAM.<br>The MATRx plus includes a Tablet to store the data and guide user interactions. | Recorder microprocessor system (ARM Cortex M4 based, STM32 F4, 168 MHz) processes the patient's data (1MB).<br>Tablet minimum requirements: 1.33 GHz processor, 1 GB RAM.<br>The MATRx plus includes a Tablet to store the data and guide user interactions. | Identical |
| Indicators | Via Tablet User interface:<br>Test Started<br>Test Paused | Via Tablet User interface:<br>Test Started<br>Test Paused | Identical |
| Oximetry Connection<br>Effort Sensor Connection | Additional feedback provided to the MATRx plus user to help facilitate the test. | Additional feedback provided to the MATRx plus user to help facilitate the test. | Identical |
| Recording Time | 6 x 8 hours. The total number of study hours in the MATRx plus is set by the software. Internal memory is > 100 hours | 6 x 8 hours. The total number of study hours in the MATRx plus is set by the software. Internal memory is > 100 hours | Identical |
| #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada | | | |
| | MATRX plus (K163665) | Changes from the predicate (K163665; MATRx plus) | Discussion of Differences |
| Internal<br>memory | 48 hours | 48 hours | Identical |
| Battery Cover | Tamper-proof and locked.<br>MATRX plus battery is<br>recharged and is not<br>replaceable by the user. | Tamper-proof and locked.<br>MATRX plus battery is<br>recharged and is not<br>replaceable by the user. | Identical |
| Study Set up and Management | | | |
| Patient Set up | Set up on device software<br>and transferred to Device<br>via internet. | Set up on device software<br>and transferred to Device<br>via internet. | Identical |
| Data Storage<br>and<br>Access | Data are stored and<br>accessible via database.<br>Database is located on<br>manufacturer's secure<br>internet accessible server.<br>Copies are downloaded<br>locally for analysis. | Data are stored and<br>accessible via database.<br>Database is located on<br>manufacturer's secure<br>internet accessible server.<br>Copies are downloaded<br>locally for analysis. | Identical |
| Design - Data Viewer (PC Application) | | | |
| Data Display | Real time waveforms<br>displayed for all channels;<br>Autoscored oxygen<br>desaturation events are<br>temporally displayed in<br>relation to the airflow,<br>oxygen, pulse rate and<br>other signals. Summary<br>data is calculated. | Real time waveforms<br>displayed for all channels;<br>Autoscored 4% or 3%<br>oxygen desaturation and<br>4% or 3% apnea-hypopnea<br>events are temporally<br>displayed in relation to the<br>airflow, oxygen, pulse rate<br>and other signals.<br>Summary data are<br>calculated. | Addition of<br>3% oxygen<br>desaturation<br>index, 4% and<br>3% apnea-<br>hypopnea<br>index. Option<br>for HCP to<br>select moving<br>average<br>baseline (used<br>in predicate)<br>or preceding<br>peak baseline. |
| Data Reporting | Data related to patient<br>respiratory nasal airflow,<br>snoring, blood oxygen<br>saturation, pulse,<br>respiratory effort and body<br>position can be<br>analyzed/displayed by<br>Software and a report can<br>be generated automatically. | Data related to patient<br>respiratory nasal airflow,<br>snoring, blood oxygen<br>saturation, pulse,<br>respiratory effort and body<br>position can be<br>analyzed/displayed by<br>Software and a report can<br>be generated automatically. | Addition of<br>ODI 3% and<br>AHI<br>parameters<br>automatically<br>generated on<br>report. |
| Data Analysis | The following indices are<br>generated from the<br>MATRx plus software:<br>ODI, average saturation, | The following indices are<br>generated from the<br>MATRx plus software:<br>ODI (4% and 3%), AHI | Addition of<br>calculation of:<br>ODI 3%, AHI<br>(3% and 4%) |
| | MATRX plus (K163665) | Changes from the predicate (K163665; MATRX plus) | Discussion of Differences |
| | minimum saturation,<br>maximum saturation, min<br>pulse rate, max pulse rate,<br>average pulse rate. | (4% and 3%), AI (4% and<br>3%), average saturation,<br>minimum saturation,<br>maximum saturation,<br>minimum pulse rate,<br>maximum pulse rate,<br>average pulse rate. | AI (3% and<br>4%). |
| Components in<br>Patient contact | Recorder and Sensors<br>(Nasal cannula, finger<br>oximeter, effort belt). | Recorder and Sensors<br>(Nasal cannula, finger<br>oximeter, effort belt). | Identical |
| Biocompatibility | All body contacting<br>components previously<br>cleared. | All body contacting<br>components previously<br>cleared. | Identical |
| Reprocessing | Patient contacting and<br>indirectly contacting<br>components are<br>reprocessed. | Patient contacting and<br>indirectly contacting<br>components are<br>reprocessed. | Identical |
| Safety Testing | Tested to IEC 60601-1-11:<br>2010; Tested to IEC<br>60601-1-2:2007; Tested to<br>IEC 60601-1:2005. | Tested to the new IEC<br>60601-1-2:2014 standard.…
