The Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of continuous monitoring along with extended features in which 72-hour trend data can be stored for each patient and displayed in the form of Waveform recall, Graphical and Tabular Trends. Alarm records for 72-hours too are recorded and stored for each patient connected to the system software.

Skyline 55 Ver1 is intended to conduct centralized monitoring for adult, pediatric and neonatal patients' vital sign information from multiple monitors in a hospital, the monitoring parameters include ECG, NIBP, SPO2, RESP, IBP, TEMP, CO2 and Anesthesia agents.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The system software permits patient monitoring with adjustable visible and audible alarm signals. The system software is not intended for home use.

Device Description

Central Nursing Station is a kind of medical information system widely applied in clinical monitoring, whose operation requires specific hardware environment such as a PC loaded with an Operating System and a software application. The loaded PC system is connected with multiple individual bedside monitors through a communication channel (In Skyline55 case wired Ethernet 802.3 and wireless 802.11bg). It can collect the monitoring information of the patient transferred via interface from the bedside monitor. It can also display and export the integrated information from bedside monitors so as to free-up doctors from clinical monitoring work and create centralized monitoring management.

The Skyline55 Ver1 is such Central Nursing Station software which is loaded in a PC of recommended specifications. The system set-up includes a FCC approved highperformance PC hardware system, the application software and Windows operation system (Windows XP). Through applying Larsen & Toubro specified protocol, the Central Monitoring System receives physiological information from cleared bedside monitors manufactured by Larsen & Toubro, includes: Planet 50, Star 50, Galaxy, Planet 55, Star 55 and Galaxy 55.

Skyline 55 Verl can maximally support the simultaneous interfacing of 16 bedside monitors. TCP/IP protocol is applied to ensure reliable transmission of data between the bedside monitors and the Central Nursing Station using Cat5e cable.

Skyline 55 Ver1 offers centralized display of physiological information of many patients who are monitored simultaneously. The software can support one display with display information from up to 16 bedside monitors. If any of the bedside monitors gives off a patient vital sign parameter alarm (also referred as Red Alam), prompt information will be immediately displayed by means of audible and visual alarm for medical personnel attention.

The physiological waveforms displayed on Skyline 55 Ver1 include: ECG, RESP, CO2, SPO2, IBP and Anesthesia agents. The physiological parameters displayed on the central monitoring system include: HR, RR, SPO2, SysDia/Mean NIBP and IBP, TEMP and CO2, Archythmia, ST indications and Anesthesia agents. The software also performs notification directly for Red alarms from the bedside monitor. Moreover database technology is applied to store these from the bedside monitor.

Skyline 55 Ver1 is used to provide a secondary display/announcement for the physiological parameters based on the bedside monitor and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions.

AI/ML Overview

The provided document is a 510(k) summary for the Skyline 55 Version 1 Central Nursing Station software. It compares the device to predicate devices and states its intended use. However, it does not include detailed information regarding specific acceptance criteria, test methodologies, sample sizes for test sets, expert qualifications, adjudication methods, or separate training set details, which are typical for studies proving device performance.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a detailed performance study with acceptance criteria in the manner often seen for novel algorithms or diagnostic devices. Substantial equivalence relies on comparing the technological characteristics and intended use of the new device to a predicate.

Based on the provided text, here's what can be extracted and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit "acceptance criteria" and "reported device performance" in a quantitative, metrics-based format typically used for evaluating the diagnostic performance of a device (e.g., sensitivity, specificity, accuracy against a gold standard).

Instead, the conclusion of the 510(k) summary acts as the overarching "acceptance," stating:
"The conclusions drawn from testing and validation of Skyline 55 Ver1 demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate devices Skyline55 Ver0 (K081552) and the Hypervisor VI Central Monitoring System (K062194, by Shenzen Mindray Bio-Medical Electronics Co., Ltd, China)."

This is a qualitative statement of equivalence, not a quantitative performance report against a set of statistical criteria. The "performance" is implicitly deemed equivalent to the predicate devices through functional comparison and validation.

Instead of a criteria table, the document provides a "Technological Characteristics" comparison with predicate devices:

Feature/Characteristic	Skyline 55 Ver1 (New Device)	HypervisorVI (Predicate 1)	Skyline 55 Ver0 (Predicate 2)
Intended Use	Centralized patient monitoring for adult, pediatric, neonatal patients in a hospital. Secondary display/announcement for physiological parameters. Not a patient monitoring device (clinician references primary bedside monitor). Not for home use.	Centralized patient monitoring in a hospital.	Centralized patient monitoring in a hospital.
Connection	Wired Ethernet 802.3 and wireless 802.11bg	Wired Ethernet 802.3 and 802.11 (wireless)	Wired Ethernet 802.3 and 802.11 (wireless)
Operating System	Windows XP	Windows XP	Windows XP
PC Processor (Host CPU)	Core 2 duo processor 1.8 GHz	P IV 2.0G	(Not specified, assumed less than Ver1 due to upgrades)
Max. Simultaneous Monitors	16	32	(Not specified, implied less than Ver1 due to upgrades)
Max. Displays	1	1 or 2	(Not specified)
Recorder Provision	No dedicated provision (uses standard printer)	Yes	(Not specified)
Printer Functionality	Standard computer printer for parameter trend, alarm recall, patient discharge summary.	(Implied standard printing functionality)	(Implied standard printing functionality)
72-hour Trend Data Storage	Yes (Waveform recall, Graphical, Tabular)	(Implied)	Extended from 24 hours in Ver0 to 72 hours in Ver1
72-hour Alarm Records Storage	Yes	(Implied)	Extended from 24 hours in Ver0 to 72 hours in Ver1
ECG + 2 user selectable waveform storage for 72 hours	Added in Ver1	(Implied)	Not present in Ver0
Monitor to CNS bi-directional patient admission	Added in Ver1	(Implied)	Not present in Ver0
ECG strip for 36 seconds for each alarm in last 72 hours	Added in Ver1	(Implied)	Not present in Ver0

2. Sample size used for the test set and data provenance

The document states "testing and validation of Skyline 55 Ver1" was performed, but does not specify any sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typical for performance studies of diagnostic or AI-driven systems, but less so for substantial equivalence evaluations of monitoring software which rely more on functional verification and validation.

3. Number of experts used to establish the ground truth for the test set and their qualifications

This information is not provided in the document. The concept of "ground truth" established by experts is usually relevant for diagnostic devices where accuracy is assessed against expert opinion or definitive diagnostic methods. For a central nursing station software, the primary "truth" is the data transmitted from the bedside monitors, and the software's performance is gauged by its ability to accurately receive, display, and manage this data.

4. Adjudication method for the test set

This information is not provided. Given the nature of the device (central monitoring software, not a diagnostic algorithm requiring interpretation), an adjudication method for a test set (e.g., 2+1, 3+1) is unlikely to be applicable or described in this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and effect size of human readers improving with AI vs without AI assistance

An MRMC study was not conducted or described. This type of study is typically performed for AI or CAD devices where the AI is intended to assist human readers in making a diagnosis or improving efficiency. The Skyline 55 is a central monitoring system, not an AI-assisted diagnostic tool. Its purpose is to aggregate and display data from bedside monitors, not to interpret or assist in interpretation in a manner that would be assessed via MRMC.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document does not describe a standalone performance study for an algorithm. The Skyline 55 is described as software for a "Central Nursing Station" which provides a "secondary display/announcement" for physiological parameters, emphasizing that it is "NOT a patient monitoring device" and clinicians should "always reference the primary bedside monitor." This implies the device's role is inherently "human-in-the-loop" as a data display and alert system, rather than a standalone diagnostic algorithm.

7. The type of ground truth used

The "ground truth" for verifying the functionality of the Skyline 55 Ver1 is implicitly the physiological data transmitted from cleared bedside monitors. The software's performance is validated by its ability to accurately receive, display, and store this information, as well as correctly generate alarms based on parameters from these primary sources. There's no indication of 'pathology' or 'outcomes data' being used as ground truth for this device's performance.

8. The sample size for the training set

This information is not provided. As this is software for a central monitoring system, designed for data display and management rather than a machine learning or AI algorithm, the concept of a "training set" in the context of model development is not directly applicable in the typical sense. The software would have undergone standard software development, verification, and validation, which might involve testing with simulated or captured data, but not a "training set" for an algorithm.

9. How the ground truth for the training set was established

This information is not provided, and as explained above, the concept of a "training set" for this type of software is not explicitly detailed or applicable in the way it would be for an AI device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo with a circle surrounding two mirrored and stylized "L" shapes. The "L" shapes are positioned horizontally, facing each other within the circle. The logo is black and white and appears to be a simple, geometric design.

Image /page/0/Picture/1 description: The image shows the text "K092153 pg 1 of 5" in black ink on a white background. The text appears to be handwritten. The top line contains the alphanumeric code "K092153", and the bottom line indicates the page number as "pg 1 of 5".

LARSEÑ & TOUBRO LIMITED

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS -

Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel: +91 (821) 2405000 • Fax : +91 (821) 2402468

E - Mail :

Rel :

发":"

ﺎﻧﺘﻬﺎ

นที่ હેજા

ﺔ ﻓﻲ ﺃﻳﻀﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

な

公:

. . ?

,要

ిప్ప

彩

NOV 2 0 2009.

学。
『『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『』『『』『

Date: 24.09.2009 Page: 01 of 05

510(K) SUMMARY

(Per section 807.92 ©)

CONTACT DATA
Submitter's Name	Larsen & Toubro Limited
Address	KIADB Industrial Area, Hebbal Hootagalli,Mysore – 570018, Karnataka, INDIA
Telephone	91-821-2405439	Fax	91-821-2402468
Contact Person	A.B.Deshpande	Title	Head – Quality Assurance &Management Representative
E-Mail address	DeshpandeAB@myw.ltindia.com
Date the summary was prepared	24th September 2009

DEVICE
Trade name	Skyline 55 Ver 1
Common name	Central Nursing Station or CentralMonitoring System
Classification name	Monitor, Physiological, Patient Monitor
CFR21 Section	870.2300	Product code	MWI

PREDICATE DEVICE IDENTIFICATION
CFR21 Section	870.2300	Product code	MWI
Classification panel	Cardiovascular
Device Class	Class II
Legally marketed Comparison Device /K#	• SKYLINE 55 Ver 0 / K081552• Mindray HYPERVISOR VI / K062194

Regd. Off : L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 ● Phone:+91(22)67525658 Website : www.LNTEBG.com

":"/

ા વાર

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo consisting of two stylized letters, 'L' and 'T', enclosed within a circle. The 'L' and 'T' are designed with sharp, angular lines, giving them a modern and geometric appearance. The logo is presented in black against a white background, creating a high contrast and making it easily visible. The overall design is simple yet distinctive, suggesting a corporate or brand identity.

t092153
pg 2 of 5

ARSEÑ & TOUBRO LIMITED

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 · Tel. +91 (821) 240500 · Fax : +91 (821) 2402468

E - Mail :

Ref .

な . कुछ Date: 24.09.2009 Page: 02 of 05

DEVICE DESCRIPTION

Regd. Off : L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 · Phone : +91(22)67525656 Website : www.LNTEBG.com

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo consisting of two stylized letters, 'L' and 'T', enclosed within a circle. The 'L' is on the left side of the circle, and the 'T' is on the right side. The letters are designed with a bold, geometric style, and they appear to be interconnected or overlapping slightly. The logo is presented in black and white, with the letters and the circle outline in black against a white background.

Image /page/2/Picture/1 description: The image shows the text "K092153 pg 3 of 5". The text appears to be handwritten in black ink on a white background. The text is likely a page number or document identifier.

& TOUBRO LIMITED

ECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel: +91 (821) 2405000 • Fax : +91 (821) 2402468

E - Mail :

Rel .

1 - 4

Date: 24.09.2009 Page: 03 of 05

STATEMENT OF INTENDED USE

The Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of The system bening with extended features in which 72-hour trend data can be stored for each patient and displayed in the form of Waveform recall, Graphical and Tabular Trends. Alarm records for 72-hours too are recorded and stored for each patient connected to the system software.

Skyline 55 Verl is intended to conduct centralized monitoring for adult, pediatric and neonatal patients' vital sign information from multiple monitors in a hospital, the monitoring parameters include ECG, NIBP, SPO2, RESP, IBP, TEMP, CO2 and Anesthesia agents.

The user, responsible to interpret the monitored data made available, will be a The ason, responder. The system software permits patient monitoring with adjustable visible and audible alarm signals. The system software is not intended for home use

Regd. Off : L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 · Phone : +9 1(22)67525856 Website : www.LNTEBG.com

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo with two stylized, mirrored 'L' shapes inside of a circle. The 'L' shapes are thick and bold, and they are positioned so that they appear to be facing each other. The logo is black and white, with the shapes and the circle being black and the background being white. The logo has a simple and modern design.

K092153
pg 4 of S

LARSEN & TOUBRO LIMITED

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 · Tel: +91 (821) 2402468

E - Mail :

Hef :

Date: 24.09.2009 Page: 04 of 05

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

The Skyline55 Ver1 Central Nursing Station is substantially equivalent to the currently marketed predicate devices HypervisorVI and Skyline55 Ver0 Central Monitoring System. All Skyline55 Ver1 and predicate devices HypervisorVI and Skyline55 Ver0 free-up doctors from clinical monitoring work at each bedside monitor and create centralized monitoring management. All systems get connected to bedside monitors through Ethernet interface 802.3(wired) and 802.11(wireless). The requirement of Operating system in the PC for both the software is same, which is Windows XP professional.

The notable differences between the technical specifications of Skyline 55 Verl and HypervisorVI are as mentioned below:

The PC processor (host CPU) requirement is little different; HypervisorVI requires P l . IV 2.0G, while Skyline55 Ver1 requires Core 2 duo processor 1.8 GHz.
1. For HypervisorVI, the maximum number of simultaneously connected and displayed monitors is 32 whereas for Skyline55 Ver1, the number is 16.
1. For HypervisorVI either 1 or 2 displays can be simultaneously connected whereas for Skyline55 Ver1, only 1 display can be connected.
1. There is no provision to connect a recorder in SkylineS5Ver1 whereas HypervisoVI has provision to connect a Recorder. In Skyline55 Ver1, a standard computer printer can be connected with the PC by loading the appropriate Printer Driver and parameter trend, alarm recall and patient discharge summary can be printed on normal paper.

The notable differences between the Skyline55 Verl and Skyline55 Ver0 are as mentioned below: ·

1. ECG + 2 user selectable waveform storage for 72 hours added in Skyline55 Verl which is not there in Skyline55 Ver0
1. Tabular tread, graphical trend and alarm recall storage is extended up to 72 hours from 24 hours in Skyline55 Ver0
1. Monitor to CNS bi-directional patient admission is added in Skyline55 Verl which is not there in Skyline55 Ver0
1. ECG strip for 36 seconds for each alarm in last 72 hours is added in Skyline55 Verl which is not there in Skyline55 Ver0

Regd. Off:L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 ● Phone:+91(22)67525656 Website : www.liNTEBG.com

ー: )

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a logo consisting of the letters 'L' and 'T' inside of a circle. The 'L' is on the top left, and the 'T' is on the bottom right. The letters are stylized and connected to each other.

Image /page/4/Picture/1 description: The image shows handwritten text. The top line reads '2092153'. The bottom line reads 'pg 5 of 5'.

LARSEN & TOUBRO LIMITED

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Campus, KIADB Industrial Area, Hebbal - Hootagaili, Mysore - 570 018 • Tel: +91 (821) 2405000 • Fax : +91 (821) 2402468

E - Mail :

Ref :

్యాల

文

Date: 24.09.2009 Page: 05 of 05

The detailed feature-by-feature comparison of Skyline55 Ver1 with predicate device HypervisorVI and Skyline55 Ver0 has been given in the document titled as `Predicate Device Comparison Document'.

Conclusion:

The conclusions drawn from testing and validation of Skyline 55 Ver1 demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate devices Skyline55 Ver0 (K081552) and the Hypervisor VI Central Monitoring System (K062194, by Shenzen Mindray Bio-Medical Electronics Co., Ltd, China)

(N. Ravindran) Head - Design & Development

Regd. Off : L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 · Phone : +91(22)67525858 Website : www.LNTEBG.com

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle, with its wings forming a symbolic representation of protection and care. The text is arranged in a circular pattern around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Larsen & Toubro Limited c/o Mr. E.J. Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114

NOV 2 0 2009

Re: K092153

Skyline 55 Version 1 Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MWI Dated: October 6, 2009 Received: October 6, 2009

Dear Mr. Smith:

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.

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.

{6}------------------------------------------------

Page 2 - Mr. E.J. Smith

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

W. M. D.

Co. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known) K092153

Device name: Skyline55 Ver 1

Indication for use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The -Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Devies Evaluation (ODE)

ence of CDRH, Office of Device Evaluati

Page 1 of 1

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number

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).