(253 days)
The Checkme Pro Health Monitor is intended to be used for measuring, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities.
This device is not intended to subspital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio-defibrillators (ICDs).
The Checkme Pro Health Monitor is a lightweight, portable health monitor for use in the home or health care facility. The Checkme Pro Health Monitor is used for measuring, displaying, reviewing and storing of multiple physiological parameters including ECG, pulse oxygen saturation (SpO2), pulse rate and temperature. This device is not intended to substitute for a hospital diagnostic ECG device. The device is capable of measuring and storing data for up to twelve users.
The provided text describes the regulatory clearance for the Viatom Checkme Pro Health Monitor, which includes functionalities for ECG, oxygen saturation (SpO2), pulse rate, and temperature measurement. The document details performance testing for each function against recognized standards.
Here's a breakdown of the requested information based on the provided text, focusing on the ECG, SpO2, and Thermometer functionalities as these are the core medical measurements. The Pedometer function is also listed but does not have detailed acceptance criteria or performance study information similar to the medical functions within this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Function | Parameter | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|---|
| ECG | ECG algorithm | IEC 60601-2-47: Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. | The ECG algorithm used in the Checkme Pro Health Monitor has been tested according to the requirements of IEC 60601-2-47. (Implies compliance) |
| Heart Rate Range | Predicate K062894 (InstantCheck RTD-ECG Monitor): 45 to 180 bpm | Subject Device (Checkme Pro): 30~250 bpm, ±2 bpm or ±2% whichever is larger. This indicates the Checkme Pro has a wider range with a specified accuracy. | |
| SpO2 | Accuracy (Integrated Sensor) | ISO 80601-2-61: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. | The Checkme Pro Health Monitor has been tested and shown to comply with the requirements of ISO 80601-2-61. (Implies compliance). Specific accuracy stated as: 70%-100%: ± 3% (Arms:2.11) with further breakdown: 70-80%: ± 3%, 80-90%: ± 3%, 90-100%: ± 2%. 0% - 69% not defined. This is compared to the predicate's (K131762's external sensor) 70%-100%: ± 2% (Arms:1.88) with 70-80%: ± 3%, 80-90%: ± 2%, 90-100%: ± 2%. While slightly different, the subject device's performance is listed and implicitly accepted through the substantial equivalence claim. |
| Accuracy (External Sensor) | ISO 80601-2-61: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. Additional predicate (K131762) has an accuracy of 70% - 100%: ± 2% (0% - 69% not defined). | Same compliance as above. Specific accuracy stated as: 70%-100%: ± 2% (Arms:1.88) with further breakdown: 70-80%: ± 3%, 80-90%: ± 2%, 90-100%: ± 2%. 0% - 69% not defined. This meets the predicate's overall accuracy for 70-100%. | |
| PR Accuracy | Predicate K131762: 25-250 BPM, ± 1 bpm or ± 2% whichever is larger. | Subject Device (Checkme Pro): 30-250 BPM, ± 2 bpm or ± 2% whichever is larger. While the predicate has slightly better absolute bpm accuracy, the overall accuracy within 2% is similar. | |
| Thermometer | Body Mode Accuracy | ISO 80601-2-56:2009: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. | The Checkme Pro has been tested and shown to comply with the requirements of ISO 80601-2-56:2009. (Implies compliance). Specific accuracy stated as: ±0.4°F. This is compared to the predicate's (K100953) 36°C to 39°C (96.8°F to 102.2°F): +/- 0.2°C / 0.4°F, and 34.0°C to 35.9°C (93.2°F to 96.6°F), 39.1°C to 42.2°C (102.4°F to 108.0°F): +/- 0.3°C/0.5°F. The subject device's +/- 0.4°F falls within the predicate's accuracy range for its primary operating range. |
2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes (number of patients/cases) for the clinical performance tests (ECG, SpO2, Temperature). It only states that the device was tested according to relevant IEC and ISO standards. These standards typically involve specific test methodologies, which may include human subjects or simulations, but the details of the sample size or whether the data was retrospective or prospective, or country of origin are not disclosed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The performance claims are based on compliance with international standards, which would outline how ground truth is established within their testing protocols, but the specifics (e.g., number of expert clinicians, their qualifications) are not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The adjudication method for establishing ground truth within the test sets is not specified in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with AI assistance. The device is a monitor that provides measurements and waveforms, not an AI-assisted diagnostic tool that interprets complex medical images or data requiring human reader assessment of improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The performance testing described (ECG algorithm testing, SpO2 compliance, Thermometer compliance) assesses the device's inherent function, which is a standalone performance of the algorithms and sensors. For instance, the ECG algorithm's compliance with IEC 60601-2-47 means its performance in calculating heart rate and waveform display meets the standard without human intervention for results generation. Similarly for SpO2 and temperature, the listed accuracies are for the device's direct measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for each test. However, for devices like these, ground truth would typically be established by:
- ECG: Reference highly accurate diagnostic ECG devices or expert interpretation of standard 12-lead ECGs for heart rate and morphology analysis (as per IEC 60601-2-47).
- SpO2: Co-oximetry for blood oxygen saturation levels for absolute accuracy, or a calibrated reference pulse oximeter for comparative accuracy (as per ISO 80601-2-61).
- Temperature: Calibrated reference thermometers (e.g., rectal thermometers for core body temperature, as per ISO 80601-2-56).
8. The sample size for the training set
The document does not mention any training set size. This device appears to be primarily a physiological monitor with direct measurement capabilities rather than a complex machine learning model that requires explicit training data in the context of this regulatory submission. The "ECG algorithm" mentioned would likely refer to signal processing algorithms for heart rate detection and waveform filtering, which are typically designed and validated through engineering methods rather than machine learning training sets in the same sense.
9. How the ground truth for the training set was established
Since no training set is mentioned in the context of machine learning, this information is not applicable and therefore not provided in the document.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
Viatom Technology Co., Ltd. % Donna-Bea Tillman Senior Consultant Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 Alexandria, Virginia 22314
Re: K150869
Trade/Device Name: CheckMe Pro Health Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: November 6, 2015 Received: November 10, 2015
Dear Donna-Bea Tillman:
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. 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
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150869
Device Name Checkme Pro Health Monitor
Indications for Use (Describe)
The Checkme Pro Health Monitor is intended to be used for measuring, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities.
This device is not intended to subspital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio-defibrillators (ICDs).
| 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
| Device Common Name: | Multiparameter Monitor |
|---|---|
| Device Trade Name: | Checkme Pro Health Monitor |
| Applicant: | Viatom Technology Co., Ltd.C607,Languang Park, No. 7 Xinxi Road, Hi-TechPark(north) Nanshan, Shenzhen, 518057, P.R.Chinawww.viatomtech.com |
| Contact: | Zhou SaixinGeneral ManagerViatom Technology Co., Ltd.C607,Languang Park, No. 7 Xinxi Road, Hi-TechPark(north) Nanshan, Shenzhen, 518057, P.R.ChinaPhone: +86 755 86638929Fax: +86 755 22649904Email: zhousaixin@viatomtech.com |
| Prepared by: | Donna-Bea Tillman, Ph.D.Senior Consultant, DevicesBiologics Consulting Group, Inc.Phone: 410-531-6542Email: dtillman@bcg-usa.com |
| Date Prepared: | November 6, 2015 |
| Classification Regulation: | 21 CFR 870.2300 – Cardiac Monitor |
| Panel: | Cardiovascular |
| Product Code: | MWI, Physiological Patient Monitor |
| Secondary Product Codes: | DQA (21 CFR 870.2700) |
| DPS (21 CFR 870.2340) | |
| FLL (21 CFR 880.2910) | |
| DRT (21 CFR 870.2300) | |
| Predicate Device: | K131762, M800 Handheld Monitor |
| Secondary Predicates: | K062894, InstantCheck RTD-ECG Monitor |
| K100953, Microlife Non-Contact Infrared Forehead |
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Indications for Use:
The Checkme Pro Health Monitor is intended to be used for measuring, displaying, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities.
This device is not intended to substitute for a hospital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardiodefibrillators (ICDs).
Device Description:
The Checkme Pro Health Monitor is a lightweight, portable health monitor for use in the home or health care facility. The Checkme Pro Health Monitor is used for measuring, displaying, reviewing and storing of multiple physiological parameters including ECG, pulse oxygen saturation (SpO2), pulse rate and temperature. This device is not intended to substitute for a hospital diagnostic ECG device. The device is capable of measuring and storing data for up to twelve users.
| Functions | Measured parameters | Features |
|---|---|---|
| ECG | ECG waveformHeart Rate (HR) | Cable or cable-free, four modes, 30s waveformreplay, voice memo, 100 measurements storage |
| Pulse Oximeter:Spot-check | Pleth waveformSpO2, Pulse Rate (PR) | Cable or cable-free, 20 second measurement, 100measurements storage |
| Pulse Oximeter:ContinuousRecording(adult only) | Total duration, <90% STAT,Average saturation, Lowestsaturation | Recording for up to 10 hrs |
| Thermometer | Temperature | Integrated infrared sensor, 3 second measurement,or °F configurable |
| Pedometer | Steps, distance, calories, fatburned, speed | Built-in high accuracy 3D smart sensor, algorithmto calculate distance |
Measurements Provided by Checkme Pro
Performance Testing:
The performance testing provided for the Checkme Pro Health Monitor consists of the following:
ECG Testing
The ECG algorithm used in the Checkme Pro Health Monitor has been tested according to the requirements of IEC 60601-2-47. Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
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SpO2 Testing
The Checkme Pro Health Monitor has been tested and shown to comply with the requirements of ISO 80601-2-61. Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Thermometer Testing
The Checkme Pro has been tested and shown to comply with the requirements of the FDArecognized standard ISO 80601-2-56:2009: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
Home Healthcare Testing
The Checkme Pro has been tested and shown to comply with the following FDA-recognized standard: IEC 60601-1-11 MEDICAL ELECTRICAL EQUIPMENT - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
System Level Testing
Viatom conducted system level performance testing to demonstrate that the device meets its specifications.
The device passed all tests and performed according to specifications.
Biocompatibility Testing:
It is a surface contacting device with less than 24 hours contact duration. The patient contacting materials were testing in accordance with ISO 10993-1: 2009/AC 2010.
Software Verification and Validation:
Similar to the predicate device, the software level of concern for the Checkme Pro Health Monitor is MODERATE. Per FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff", the required software documentation for a MODERATE Level of Concern device has been provided.
EMC and Electrical Safety:
The following EMC and Electrical Safety tests were performed on the device:
- . IEC 60601-1: 2005 + Corrigendum 1 + Corrigendum 2 + AM1 (2012) IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- EN 60601-1-2: 2007 + AC: 2010 medical electrical equipment part 1-2: general . requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. (General II (ES/EMC))
The results of these tests demonstrate the electrical safety and electromagnetic compatibility of the Checkme Pro device.
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The Checkme Pro Health Monitor is provided with a rechargeable lithium ion polymer battery. Therefore, Viatom has also conducted battery safety testing in accordance with the FDArecognized standard IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. The battery passed all required tests, and therefore has been shown to be safe for the proposed intended use.
The device comparison table below compares the primary features of the proposed Checkme device and the predicate M800 device.
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K150869 | K131762 |
| Applicant | Viatom Technology Co. Ltd. | GUANGDONG BIOLIGHTMEDITECH CO., LTD |
| Device Name | Checkme Pro Health Monitor | M800 Handheld Monitor |
| ClassificationRegulation | 870.2300 - Physiological PatientMonitor | 870.2300 – Physiological PatientMonitor |
| Product Code(Primary) | MWI | MWI |
| Indications for Use | The Checkme Pro HealthMonitor is intended to be used formeasuring, displaying, reviewingand storing of ECG (adults only),oxygen saturation and pulse rate(adults only for continuous datacollection and recording, adultsand pediatrics for spot checking)and temperature in the home or inhealthcare facilities.This device is not intended tosubstitute for a hospitaldiagnostic ECG device and alsonot to be used on patients withimplanted cardiac devices, suchas pacemakers and/or implantedcardio-defibrillators (ICDs). | M800 handheld monitor is intended forcontinuously monitoring or spotchecking of SpO2, PR, ECG and HR ofadult, pediatric and neonatal patients inhospital, hospital type facilities as wellas in the home care environment. |
| PhysiologicalParameters Monitored | ECG, HR, SpO2, Temperature | ECG, HR, SpO2 |
| Location | Home and Hospital | Home and Hospital |
| Rx or OTC | Rx | Rx |
| Power Supply | 560mAh rechargeable lithium-ionpolymer battery | Rechargeable Lithium Battery or AAalkaline or lithium batteries |
Device Comparison Table
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The comparison of ECG Measurements table below provides a more detailed comparison of the Checkme device with the additional predicate for ECG monitoring, the DailyCare InstantCheck RTD-ECG Monitor (K062894)
Comparison of ECG Measurements
| Subject Device | Predicate Device (Additional) | ||
|---|---|---|---|
| 510(k) Number | K150869 | K062894 | |
| Applicant | Viatom Technology Co. Ltd. | Daily Care BioMedical, Inc. | |
| Device Name | Checkme Pro Health Monitor | InstantCheck RTD-ECG Monitor | |
| ClassificationRegulation | 870.2300 – Physiological PatientMonitor | 870.2340 - Electrocardiograph | |
| Measured ECGParameter | ECG waveform, Heart Rate (HR) | ECG waveform, Heart Rate (HR), STsegment and QRS interval | |
| ECG RhythmClassification | Not included | Regular Heart RateFast Heart RateSlow Heart RateHigh ST ValueLow ST ValueHigh QRS ValueIrregular Heart RateImpossible to Analyze | |
| ECG Lead Type | External ECGCable andElectrodes | IntegratedECGElectrodesExternal and Integrated ECG Electrodes | |
| Input impedance | > 10 M Ohm | > 20 M Ohm | |
| Input dynamic range | +/- 3 mV | +/- 3 mV | |
| Bandwidth | 0.05 – 40 Hz | 0.1 - 40 Hz | |
| A/D conversion | 16 bit | 12 bit | |
| Sampling Rate | 500 samples/sec | 250 samples/sec | |
| Measurement Time | 30 seconds | 30 seconds | |
| Display | 400*240 Dot-matrix LCD display | 240 X 128 Dot-matrix LCD display | |
| Input | Dry conduction electrodes and/orexternal auxiliary electrodes | Dry conduction electrodes and/or externalauxiliary electrodes | |
| Heart rate Range | 30~250 bpm, ±2 bpm or ±2%whichever is larger | 45 to 180 bpm | |
| Subject Device | Predicate Device | ||
| 510(k) Number | K150869 | K131762 | |
| Device Name | Checkme Pro Health Monitor | M800 Handheld Monitor | |
| ClassificationRegulation | 870.2300 - Physiological PatientMonitor | 870.2300 - Physiological PatientMonitor | |
| Display Data | SpO2, Pulse Rate (PR) | SpO2, Pulse Rate (PR) | |
| Mode | Continuous Recording and Spot-Check | Continuous Recording and Spot-Check | |
| Sensor Types | Integrated and external | External | |
| Population | Adult and Pediatric (continuousrecording only for adult) | Adult, Pediatric and Neonate | |
| SpO2 Display Range | 0 - 100% | 0 - 100% | |
| Accuracy | IntegratedSensor70%-100%:$\pm$ 3%(Arms:2.11)70-80%: $\pm$ 3%80-90%: $\pm$ 3%90-100%: $\pm$ 2%0% - 69% notdefined | External Sensor70%-100%: $\pm$ 2%(Arms:1.88)70-80%: $\pm$ 3%80-90%: $\pm$ 2%90-100%: $\pm$ 2%0% - 69% notdefined | 70% - 100%: $\pm$ 2%0% - 69% not defined |
| Resolution | 1% | 1% | |
| PR range | 30-250 BPM | 25-250 BPM | |
| PR Accuracy | 30-250 BPM, $\pm$ 2 bpm or $\pm$ 2%whichever is larger | 25-250 BPM, $\pm$ 1 bpm or $\pm$ 2%whichever is larger | |
| Resolution | 1bpm | 1bpm | |
| Subject Device | Predicate Device (Additional) | ||
| 510(k) Number | K150869 | K100953 | |
| Applicant | Viatom Technology Co. Ltd. | Microlife Intellectual Property, GMBH | |
| Device Name | Checkme Pro Health Monitor | Microlife Non-Contact InfraredForehead Thermometer | |
| ClassificationRegulation | 870.2300 - Physiological Patient Monitor | 880.2910 - Thermometer, Electronic,Clinical | |
| Measurementtechnique | infrared sensor (thermopile) | infrared sensor (thermopile) | |
| Measurementsite | Forehead | Forehead | |
| Unit | °F | °C/°F | |
| Body modemeasuringrange | 93.2°F to 108.0°F | 34°C to 42.2°C (93.2°F to 108.0°F) | |
| Body modeAccuracy | ±0.4°F | 36°C to 39°C (96.8°F to 102.2°F): +/-0.2°C /0.4°F34.0°C to 35.9°C (93.2°F to 96.6°F),39.1 °C to 42.2°C (102.4°F to 108.0°F): |
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The Comparison of Pulse Oximeter Measurement and Analysis table below provides a more detailed comparison of the pulse oximetry feature of the Checkme device with the primary predicate, theM800 Handheld Monitor.
Comparison of Pulse Oximeter Measurement and Analysis
The Comparison of Temperature Measurement and Analysis table below provides a more detailed comparison of the Checkme and the additional predicate for temperature measurement, the Microlife Non-Contact Infrared Forehead Thermometer (K100953).
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Comparison of Temperature Measurement and Analysis
Substantial Equivalence Conclusion:
The primary predicate device for the Checkme Pro Health Monitor is M800 Handheld Monitor cleared in K131762. The M800 is also a handheld device for monitoring physiological parameters in the home or health care environment.
The Checkme Pro Health Monitor has three primary medical device functions, and each of these has been compared to a predicate device. While there are some minor differences in technological characteristics, this do not raise different questions of safety and effectiveness. Each function has been tested in accordance with the appropriate standards, and the results of testing demonstrate that the Checkme Pro Health Monitor complies with the standards and has equivalent performance to the reference predicate devices.
Therefore, the Checkme Pro Health Monitor has been shown to be substantially equivalent to the M800 Handheld Monitor.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).