The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians.

All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making.

Indications for Use Statement:

The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.

Device Description

The eCareManager (eCM) system is a software platform that enables enterprise telehealth. The system includes an interface to acquire patient data from the electronic medical record and bedside devices. eCM provides a history of the patient population in clinic and provides a clinical decision support feature to aid in the proactive delivery of consultative care for the patient

AI/ML Overview

The provided text describes the eCareManager 4.0.1, a telehealth software, but does not contain a table of acceptance criteria or detailed results of a study proving the device meets specific performance criteria. The document is a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance metrics against pre-defined acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred regarding performance data and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or quantitative reported device performance metrics are explicitly stated in a table format within the provided document. The document primarily focuses on demonstrating substantial equivalence through comparison with predicate devices and mentions that "Verification and validation activities have been conducted to establish the performance, functionality, and usability characteristics of the new device with respect to the predicate, intended use and defined requirements."

It does highlight key features like the Sepsis Screening Prompt and validates its performance against the IntelliVue Protocol Watch SSC. The comparison table (Table 5-2) implies that the eCareManager's sepsis screening model "yielded higher discrimination for identifying severe sepsis than traditional criteria as used in the Intellivue SSC model," suggesting a performance improvement, but without specific metrics or acceptance thresholds.

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "Clinical validation for the Philips eCareManager software release 4.0.1 included both model development and post-implementation studies to evaluate the performance of the Sepsis Screening Prompt algorithm." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. It generally refers to "trained medical staff" and "clinicians" as the intended users and those who would follow up on sepsis assessments.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for establishing ground truth in the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus is on the algorithm's performance and its role in providing "supplemental remote support" and "clinical decision support notifications."

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance evaluation of the Sepsis Screening Prompt algorithm was done. The document states "Clinical validation for the Philips eCareManager software release 4.0.1 included both model development and post-implementation studies to evaluate the performance of the Sepsis Screening Prompt algorithm." The comparison with the IntelliVue Protocol Watch SSC (K113657), which also has a sepsis screening feature, indicates a standalone assessment of the eCareManager's algorithm.

7. Type of Ground Truth Used:

The document itself does not explicitly state the type of ground truth used for the sepsis screening algorithm. However, given that the algorithm is based on "2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med 2003 Vol 31, No.4" and assesses criteria like "Temperature, Heart Rate, Respiratory Rate, White Blood Cell Count/Bands, Mental Status, Serum Glucose, Ileus, INR, Lactate," it is highly probable that the ground truth for training and evaluation was established based on clinical criteria, patient outcomes, and potentially expert clinical review or diagnosis of sepsis. It references "higher discrimination for identifying severe sepsis," which implies a comparison against a clinical gold standard for sepsis diagnosis.

8. Sample Size for the Training Set:

The document does not provide the sample size for the training set used for the model development of the Sepsis Screening Prompt algorithm.

9. How the Ground Truth for the Training Set Was Established:

The document states the sepsis screening criteria are based on the "2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med 2003 Vol 31, No.4." This strongly suggests that the ground truth for the training set was established using consensus-based clinical definitions and guidelines for sepsis. It is implied that patient data meeting these established criteria would have been used to train and validate the algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with a design above them that resembles a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 30, 2016

Visicu, Inc. Daniel Plonski Manager, Quality and Regulatory 217 East Redwood Street, Ste. 1900 Baltimore, Maryland 21202

Re: K153156

Trade/Device Name: eCareManager 4.0.1 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MSX, PLB, OUG, NSX Dated: September 19, 2016 Received: September 19, 2016

Dear Daniel Plonski:

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 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.

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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.

Mude Jellman
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) K153156

Device Name eCareManager 4.0.1

Indications for Use (Describe)

Intended Use Statement:

Indications for Use Statement:

The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.

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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Image /page/3/Picture/1 description: The image shows the Philips logo in blue, with the text "K153156" above it. Below the logo, the text "eCareManager" and "Traditional 510(k)" are displayed. The text is centered and the Philips logo is in a bold, sans-serif font.

510(k) Summary eCareManager 4.0.1

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92(c).

Date Prepared: September 22, 2016

l. Submitter's name and address

Manufacturer:	Visicu, Inc.217 East Redwood StreetSuite 1900Baltimore, MD 21202
Contact Person:	Daniel R. PlonskiSenior Manager, Quality and RegulatoryPhone: 410-246-5357Fax: 410-276-1970E-mail: daniel.plonski@philips.com

II. Device information

Device Name:	eCareManager 4.0.1
Common Name:	Telehealth Software
Classification panel:	Cardiovascular

Classification	ProCode	Description
870.2300, II	PLB	Multivariate Vital Signs Index
870.2450, Enf. Dis.	NSX	Software, Transmission and Storage, Patient Data
870.2300, II	MSX	System, Network and Communication, Physiological Monitors
880.6310, I	OUG	Medical Device Data System

III. Predicate device information

Trade name:	Argus System
Manufacturer:	Visicu, Inc.
510(k) clearance:	K012171
Classification name:	System, network and communication, physiological monitors
Device class:	Class II
Classification regulation:	21 CFR 892.2300
Classification panel:	Cardiovascular
Product code:	MSX

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Image /page/4/Picture/0 description: The image contains the Philips logo in blue, with the text "K153156" above it. Below the logo, the text "eCareManager" is displayed, followed by "Traditional 510(k)". The text is centered and appears to be part of a product or regulatory information.

Trade name:	Philips IntelliVue Patient Monitors
Manufacturer:	Philips Medizin Systeme Boeblingen Gmbh
510(k) clearance:	K113657
Classification namealarms)Device class:	Patient Physiological Monitor (with arrhythmia detection orClass II
Classification regulation:	21 CFR 892.2300
Classification panel:	Cardiovascular
Product code:	MHX, DSI, MLD, DSJ, DSK, DXN, DXGKRB, DRQ, DRT, DPS, MLC, DRW, KRC, DRJ, DQA, DSB,DSH, DSF, DRS, DSA, MSX, DRG, CCK, CBQ, NHO, NHP,NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI, GWR,GWS, FLL

IV. Device Description

V. Intended use/ Indications for Use

Intended Use:

Indication for Use:

The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.

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Image /page/5/Picture/0 description: The image shows the Philips logo in blue, with the text "eCareManager" and "Traditional 510(k)" below it. Above the logo is the text "K153156". The Philips logo is a simple, bold design, and the text is clear and easy to read. The image is likely from a product label or marketing material.

VI.Comparison of Technological Characteristics with the Predicate Device

The eCareManager software is Telehealth software. which employs and further builds on the same fundamental scientific technology as the Argus System software (K012171). The Sepsis Screening Prompt included in eCareManager has the same intended use and technological characteristics as the sepsis screening feature (Protocol Watch SSC) marketed with several models of the Philips IntelliVue Patient Monitors (K113657).

A comparison matrix (Table 5-1) shows the similarities and differences. The eCareManager software with the listed enhancements is substantially equivalent to the previously cleared Arqus System. The Intended Use has been modified to clarify and modernize the wording; however, the concept has not changed. Technological characteristics and principles of operation remain the same, Differences in the available features, as discussed below, do not present any new questions of safety or effectiveness. Table 5-2 presents a comparative summary of the sepsis screening features of eCareManager and the IntelliVue Patient Monitors with ProtocolWatch SSC.

Specification /Feature	eCareManager(Subject Device)	Argus System(Predicate device -K012171)	Comparison
Intended Use / Indications for Use / Target population
Intended Use	The eCareManager Systemis a software tool intendedfor use by trained medicalstaff providing supplementalremote support to bedsidecare teams in themanagement and care ofin-hospital patients. Thesoftware collects, storesand displays clinical dataobtained from the electronicmedical record, patientmonitoring systems andancillary systemsconnected throughnetworks. Using this data,clinical decision supportnotifications are generatedthat aid in understandingthe patient's currentcondition and changes overtime. The eCareManagerSystem does not provideany alarms. It is notintended to replace bedsidevital signs alarms orproactive patient care fromclinicians.	The Argus System -Continuous Expert CareNetwork (CXCN) with SmartAlarms enhancement is foruse in data collection,storage and clinicalinformation managementwith independent bedsidedevices, and ancillarysystems that are connectedeither directly or throughnetworks. It is alsointended to provide patientinformation and surveillanceof monitored patients at thepoint of care location and ata remote supplementarycare location through widearea networking technologyand dedicated telephonelines.	Same intent, however,language modified to clarify thefollowing with regard toeCareManager:• Intended for use by trainedmedical staff• Intended for supplementalsupport of bedside care team• Does not provide any alarms• Does not replace bedsidevital sign alarms• Does not replace proactiveclinical care• Supports medicaljudgement, does not replace it• Not intended to be solesource of information fordecision making.
Specification /Feature	eCareManager(Subject Device)	Argus System(Predicate device -K012171)	Comparison
	All information andnotifications provided by theeCareManager System areintended to support thejudgement of a medicalprofessional and are notintended to be the solesource of information fordecision making.
Indications forUse	The eCareManagersoftware is indicated for usein hospital environment orremote locations withclinical professionals. It isnot indicated for home use.	The Argus System isintended to provide patientinformation and surveillanceof monitored patients at thepoint of care location and ata remote supplementarycare location through widearea networking technologyand dedicated telephonelines.	Same but with eCareManageremphasis on not for home use.
Targetpopulation	In-hospital patients	In-hospital patients	Same
Technological Characteristics
Systemcomponents	Software Only	Software Only	Same
Interfaces tohospital systems	HL-7	HL-7	Same
Bedside toRemoteCommunications	Audio/Video	Audio/Video	Same
MeasurementFeatures	None	None	Same
System Alarms	None	None	Same
WaveformTransmission	None	None	Same
User Access andPatient DataSecurity	User Authenticationservices, roles-based dataaccess, logging for audittrail	User Authenticationservices, roles-based dataaccess, logging for audittrail	Same
Patient Administration Features
Patient Census	Patient Census screen withstatus indicators	Patient Census screen withstatus indicators	Same
GraphicalCensus	Graphical display of patientstatus	None	Provides visual representationof patient status
Patient Profile	Summary of patientinformation includingdiagnosis, treatments, bestpractices and trends	Summary of patientinformation includingdiagnosis, treatments, bestpractices and trends	Same but modifications toscreen layout
Stroke Profile	Summary of clinical data	None	Summary of patient data basedon NIHSS guidelines
Specification /Feature	eCareManager(Subject Device)	Argus System(Predicate device -K012171)	Comparison
Care Plan	Summary of clinical careplan and therapeuticobjectives	Summary of clinical careplan and therapeuticobjectives	Same but modifications toscreen layout
Task List	Communication andtracking of clinical caretasks	Communication andtracking of clinical caretasks	Same
Flowsheets	Electronic charting of vitalsigns and infusions, intakeand output, nursingassessments and care,respiratory therapy, andlines, tubes and drains	Electronic charting of vitalsigns and infusions, intakeand output, nursingassessments and care,respiratory therapy, andlines, tubes and drains	Same but modifications toscreen layout
Order Entry	Medication and non-medication orders. Druginteraction and allergyscreening	Medication and non-medication orders. Druginteraction and allergyscreening	Same
Patient Notes	Supports entry of patientnotes with configurabletemplates	Supports entry of patientnotes with configurabletemplates	Same
Program Forms	Configurable data entryforms for tracking clinicalprogram performance,based on customerinitiatives	None	New administrative feature
Reports	Operational, Clinical Careand Billing reports provided	Operational, Clinical Careand Billing reports provided	Expanded list of preconfiguredreports
Clinical Decision Support Features
Vital SignsMonitoring	Retrospective data display.	Near-real time	Technology is the samehowever, "Retrospective datadisplay" is more accurate thanpreviously used "near-real-time"
LaboratoryResults	Received via hospitalsystem interface or manualentry	Received via hospitalsystem interface or manualentry	Same
Smart Alerts	Visual cues based onautomated assessment ofpatient data. Patientspecific configuration	Visual cues based onautomated assessment ofpatient data. Patientspecific configuration	Technical differences incomputation methods havebeen validated to demonstrateno negative effects on safetyand effectiveness
Specification /Feature	eCareManager(Subject Device)	IntelliVue w/ProtocolWatchSSC (K113657)	Comparison
Intended Use / Indications for Use / Target Population (for the overall device/software application)
Intended Use	The eCareManager System isa software tool intended foruse by trained medical staffproviding supplementalremote support to bedsidecare teams in themanagement and care of in-hospital patients.The software collects, storesand displays clinical dataobtained from the electronicmedical record, patientmonitoring systems andancillary systems connectedthrough networks. Using thisdata, clinical decision supportnotifications are generatedthat aid in understanding thepatient's current condition andchanges over time.The eCareManager Systemdoes not provide any alarms.It is not intended to replacebedside vital signs alarms orproactive patient care fromclinicians.All information andnotifications provided by theeCareManager System areintended to support thejudgement of a medicalprofessional and are notintended to be the sole sourceof information for decisionmaking.	The monitors are indicated foruse by health careprofessionals whenever thereis a need for monitoring thephysiological parameters ofpatients.The monitors are intended tobe used for monitoring andrecording of, and to generatealarms for, multiplephysiological parameters ofadults, pediatrics, andneonates.The monitors are intended foruse by trained healthcareprofessionals in a hospitalenvironment.The MX500/MX550 monitorsare additionally intended foruse in transport situationswithin hospital environments.The monitors are only for useon one patient at a time. Theyare not intended for homeuse. Not therapeutic devices.The monitors are forprescription use only.	Similarities:Both devices are intended foruse by medical professionalsin a hospital environment.Both devices collect andrecord data for patientmonitoring.Both devices provide clinicaldecision support tools(including sepsis screening).Neither device is intended toprovide any diagnosis ortreatment.Both devices are forprescription use only.Neither device is intended forhome use.Differences:eCareManager does notprovide any alarms.eCareManager is notindicated for paediatrics orneonates.eCareManager is notindicated for use in transportsituations.eCareManager is intended toprovide information to remoteclinicians. IntelliVue isintended to provideinformation to bedsideclinicians.
Indicationsfor Use	The eCareManager softwareis indicated for use in hospitalenvironment or remotelocations with clinicalprofessionals. It is notindicated for home use.	The SSC Sepsis Protocol, inthe ProtocolWatch clinicaldecision support tool, isintended for usewith adult patients only.	Both devices provide sepsisscreening features intendedfor adult patients.
Specification /Feature	eCareManager(Subject Device)	IntelliVue w/ProtocolWatchSSC (K113657)	Comparison
Targetpopulation	In-hospital patients	In-hospital patients (Sepsisfeatures only for adults)	Same
ScreeningPurpose	The eCare Manager SepsisScreening Prompt monitorspatients at risk for sepsis. Byautomating sepsis monitoringfor patients, the feature canhelp clinical teams detectearly signs of sepsis, so theycan begin assessment andtreatment plans quickly.	The intention of the SevereSepsis Screening is to provideclinicians with the "link"between the signs andsymptoms of the patient andthe possibility of sepsisdevelopment. Once this isachieved, the clinician isprompted to seek authorizedclinician review.	Same:Both applications aredesigned to assist cliniciansin recognizing the early signsand symptoms of sepsis andproactively getting the patientthe appropriate level of careat an early stage.Both systems recommendhuman follow-up for sepsisassessment.
SepsisScreeningCriteria	• Temperature• Heart Rate• Respiratory Rate• White Blood CellCount/Bands• Mental Status• Serum Glucose• Ileus• INR• Lactate	• Temperature• Heart Rate• Respiratory Rate• White Blood Cell Count• Mental Status• Hyperglycemia• Chills with rigors	eCareManager automaticallyassesses 9 criteria from the2003 international consensusconference for screening.Intelliview automaticallyassesses 3 criteria from the1992 consensus conferenceand has the clinician assesthe remaining items manually.The eCareManager sepsisscreening model, yieldedhigher discrimination foridentifying severe sepsis thantraditional criteria as used inthe Intellivue SSC model.
Basis ofCriteria	2001SCCM/ESICM/ACCP/ATS/SISInternational SepsisDefinitions Conference. CritCare Med 2003 Vol 31, No.4	2001SCCM/ESICM/ACCP/ATS/SISInternational SepsisDefinitions Conference. CritCare Med 2003 Vol 31, No.4	Same

Table 5-1 Comparison Table (eCareManager/Argus System)

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Image /page/6/Picture/0 description: The image shows the Philips logo in blue, with the text "eCareManager" and "Traditional 510(k)" below it. Above the logo, the text "K153156" is displayed. The logo and text are all in a simple, clean font.

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Image /page/7/Picture/0 description: The image shows the logo for Philips eCareManager. The logo includes the word "PHILIPS" in blue block letters. Above the right side of the logo is the text "K153156", and below the logo is the text "eCareManager Traditional 510(k)".

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Image /page/8/Picture/0 description: The image shows the Philips logo in blue. Above the logo is the text "K153156". Below the logo is the text "eCareManager Traditional 510(k)". The text is in black.

Table 5-2 Comparison Table (eCareManager/IntelliVue ProtocolWatch SSC)

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Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in a large, bold, blue font. Above the word "PHILIPS" is the text "K153156". Below the word "PHILIPS" is the text "eCareManager Traditional 510(k)".

VIL Performance Data

The following performance data were provided in support of the substantial equivalence determination:

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Image /page/10/Picture/0 description: The image shows the Philips logo in blue, with the text "eCareManager" and "Traditional 510(k)" below it. Above the logo, the text "K153156" is visible. The logo and text are all aligned to the left.

Summary of Non-clinical testing

No performance standards for telehealth systems or components have been issued under the authority of Section 514. eCareManager was tested in accordance with Philips verification and validation processes. Quality Assurance measures were applied to the system design and development, including:

Risk Analysis
Product Specifications
Design Reviews
Verification & Validations

Summary of Clinical Testing

Clinical validation for the Philips eCareManager software release 4.0.1 included both model development and post-implementation studies to evaluate the performance of the Sepsis Screening Prompt algorithm.

Conclusions drawn from the Non-clinical and Clinical testing

Verification and validation activities have been conducted to establish the performance, functionality, and usability characteristics of the new device with respect to the predicate, intended use and defined requirements. Testing included detailed functional, system level, usability and clinical performance testing. Test results demonstrate that eCareManager software release 4.0.1 meets all device specifications and user needs.

VIII. Conclusion

eCareManager is substantially equivalent to the predicate device Argus System (K012171) in terms of design features, fundamental scientific technology, intended use, safety and effectiveness. Differences in computational methods, as noted above, do not alter the intended use nor do they present any new questions of safety and effectiveness. Substantial equivalence was demonstrated with non-clinical and clinical performance testing, which complied with the requirements specified in the international and FDA-recognized consensus standards.

The non-clinical and clinical performance tests provided in this 510(k) premarket notification demonstrate that the subject device, eCareManager, is as safe and effective as the predicate device without raising any new safety and/or effectiveness concerns.

The Sepsis Screening Prompt included in eCareManager is substantially equivalent to the IntelliVue Protocol Watch SSC. Based on eCareManager's intended use to provide supplemental remote support to bedside care teams, eCareManager is as safe as the Intellivue device and clinical validation demonstrates adequate performance for its intended use.

Regulation Number and Section

§ 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).