BeneVision Central Monitoring System

K220058 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MSX · Jun 1, 2022 · Cardiovascular

Device Facts

• Record ID: K220058
• Device Name: BeneVision Central Monitoring System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MSX · Cardiovascular
• Decision Date: Jun 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The indications for use of the BeneVision Central Monitoring System include: - Real time viewing of patient clinical data and alarms . - . Storage and Historical review of patient clinical data and alarms - Printing of real time and historical patient data - Configuration of local settings as well as synchronizing settings across the network to a remote device - Transfer of patient clinical data and settings between several CentralStations - Provides a Resting 12 Lead interpretation of previously stored data The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WIFI (WLAN), and Wireless WMTS. The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors. The Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors. The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80 and TM70. The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data. The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, . SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60. . The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG. SpO2. NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70. The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

Device Story

Networked patient monitoring system; acquires physiological data (ECG, SpO2, NIBP, Resp) from compatible Mindray telemetry transmitters/monitors (TMS-6016, Telepack-608, TMS60, TM80, TM70). System displays, stores, prints, and transfers data; supports bi-directional configuration of connected monitors. Used in professional healthcare facilities; operated by clinicians. Features include real-time viewing, historical review, and resting 12-lead interpretation of stored data. Output allows clinicians to monitor patient status, adjust alarm settings, and make clinical decisions based on analyzed physiological trends. Benefits include centralized oversight of ambulatory and bedside patients.

Clinical Evidence

No clinical data. Bench testing only. Functional and system-level testing validated performance against specifications and consensus standards, including IEC 60601-2-25:2011 for electrocardiographs.

Technological Characteristics

Networked monitoring system; supports Ethernet, WIFI, and WMTS. Software-based; runs on Windows 10/Server 2016/Server 2019. Features include arrhythmia detection, ST-segment analysis, QT analysis, and resting 12-lead interpretation. Connectivity via CMS+ and ELAN protocols. Supports bi-directional configuration. Complies with IEC 60601-2-25.

Indications for Use

Indicated for adult and pediatric patients (TMS60/TM80/TM70 for patients >3 years) in professional healthcare facilities for remote monitoring of ECG, SpO2, NIBP, Resp, and pulse rate; includes arrhythmia, QT, and ST-segment analysis; provides resting 12-lead interpretation of stored data.

Regulatory Classification

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.

Predicate Devices

• BeneVision Central Monitoring System (K193391)

Reference Devices

• M3290B Patient Information Center iX Release C.01 (K163584)
• BeneVision N Series Patient Monitors (K202405)
• TMS-6016 (K183238)
• TMS60 (K183238)
• Telepack-608 (K183238)
• TM80 (K193391)
• TM70 (K193391)
• DPM3 (K072235)
• DPM4/5 (K070791)
• DPM6/7 (K092449)
• Passport 12m/17m (170876)
• Passport8/12 (K153448)
• Passport V (K091834)
• Accutorr 7/VS-900 (K170712)
• T1 (K152902)
• Spectrum (K062098)
• Spectrum OR (K062098)
• Passport II (K020550)
• V12/21 (K150352)
• VS 8/8A/9 (K211475)
• ePM Series Patient Monitors (K200015)

Submission Summary (Full Text)

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June 1, 2022

Shenzhen Mindray Bio-Medical Electronics Co., LTD Li Lei Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China

Re: K220058

Trade/Device Name: BeneVision Central Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX. DRT, DQA, DXN, DSB, MHX, DRO Dated: December 27, 2021 Received: January 6, 2022

Dear Li Lei:

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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

### 510(k) Number (if known) K220058

### Device Name

BeneVision Central Monitoring System

### Indications for Use (Describe)

The indications for use of the BeneVision Central Monitoring System include:

- Real time viewing of patient clinical data and alarms .
- . Storage and Historical review of patient clinical data and alarms
- Printing of real time and historical patient data
- Configuration of local settings as well as synchronizing settings across the network to a remote device
- Transfer of patient clinical data and settings between several CentralStations
- Provides a Resting 12 Lead interpretation of previously stored data

The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WIFI (WLAN), and Wireless WMTS. The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors. The Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors.

The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80 and TM70.

The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.

The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.

The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, . SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

. The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG. SpO2. NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

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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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the BeneVision Central Monitoring System is provided below.

#### SUBMITTER 1.

| Applicant: | SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone] |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: Li Lei<br>Title: Manager Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | December 27, 2021 |

#### 2. DEVICE

| Device Trade Name: | BeneVision Central Monitoring System |
|------------------------------------|------------------------------------------------------------------------------|
| Device Common Name: | System, network and communication, physiological monitors |
| Classification Name and Regulation | 21 CFR 870.2300, Cardiac monitor (including cardiotachometer and rate alarm) |
| Primary Product Code: | MSX - System, network and communication, physiological monitors |
| Regulatory Class | Class II |
| Panel | Cardiovascular |

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| Product<br>Code | Regulation<br>Number | Panel | Regulation description | Device Common Name |
|-----------------|----------------------|----------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| DRT | 21 CFR<br>870.2300 | Cardiovascular | Cardiac Monitor<br>(including<br>cardiotachometer and rate<br>alarm) | Monitor, cardiac (incl.<br>cardiotachometer & rate<br>alarm) |
| DQA | 21 CFR<br>870.2700 | Anesthesiology | Oximeter | Oximeter |
| DXN | 21 CFR<br>870.1130 | Cardiovascular | Noninvasive blood<br>pressure measurement<br>system | System, measurement,<br>blood-pressure, non-<br>invasive |
| DSB | 21 CFR<br>870.2770 | Cardiovascular | Impedance<br>plethysmograph | Plethysmograph,<br>impedance |
| MHX | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and<br>alarm (including ST-<br>segment measurement and<br>alarm). | Monitor, physiological,<br>patient (with arrhythmia<br>detection or alarms) |
| DRQ | 21 CFR<br>870.2060 | Cardiovascular | Transducer signal<br>amplifier and conditioner | Amplifier and signal<br>conditioner, transducer<br>signal |

| Table 1: | Secondary Product Codes |
|----------|-------------------------|
|----------|-------------------------|

### 3. PREDICATE DEVICE

Predicate Device: K193391 - BeneVision Central Monitoring System (SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD)

K163584 - M3290B Patient Information Center iX Release C.01(Philips Reference Device: Medical Systems)

> K202405 - BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1) (SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD)

#### DEVICE DESCRIPTION 4.

The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.

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#### INTENDED USE/INDICATIONS FOR USE 5.

The indications for use of the BeneVision Central Monitoring System include:

- . Real time viewing of patient clinical data and alarms
- . Storage and Historical review of patient clinical data and alarms
- Printing of real time and historical patient data ●
- Configuration of local settings as well as synchronizing settings across the network to a ● remote device
- . Transfer of patient clinical data and settings between several CentralStations
- Provides a Resting 12 Lead interpretation of previously stored data

The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.

The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors. The BeneVision Central Monitoring System supports bi-directional configuration of the compatible monitors.

The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80 and TM70.

- The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.
- The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor . ECG and SpO2 physiological data.
- . The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
- . The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

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### SUBSTANTIAL EQUIVALENCE 6.

# Comparison of Indications

Both the predicate device and the subject device are patient monitoring systems intended to be used in healthcare facilities under the direction of clinical professionals.

The indications for use statement of the subject BeneVision Central Monitoring System has been modified to include support a resting 12 Lead interpretation. Although this feature is not present in the predicate BeneVision Central Monitoring System, it is present in Mindray's N Series Monitors (K202405).

In conclusion, the difference of the indications for use do not change the fundamental intended use of the BeneVision Central Monitoring System.

## Technological Comparisons

The table below provides a comparison of the technological features of the BeneVision CentralStation, WorkStation, ViewStation, and CMS Viewer compared to the CentralStation, WorkStation, ViewStation, and CMS Viewer cleared in K193391. The features in gray are features which are different between the predicate device and the subject devices. These changes marked with an asterisks (*) are non-significant.

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Feature

| Technological Comparison | | | | | |
|--------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------|
| As Cleared in K193391 | Modificatio<br>ns Made to<br>Subject<br>Device | Applied To | | | |
| | | CentralSt<br>ation | WorkSta<br>tion | ViewSta<br>tion | CMS<br>Viewer |
| Microsoft Windows<br>7/8/10/Server 2012/Server<br>2016 | 1.Added<br>Microsoft<br>Windows<br>Server 2019<br>* | A<br>(CentralSt<br>ation only<br>supports<br>Windows<br>10/Server | A<br>(WorkSta<br>tion only<br>supports<br>Windows<br>10) | A<br>(ViewSta<br>tion only<br>supports<br>Windows<br>s 10) | A<br>(CMS<br>Viewer<br>only<br>supports<br>Windows |
| | 2. Deleted | | | | |

Table 2: Technological Com

| | | ns Made to<br>Subject<br>Device | CentralSt<br>ation | WorkSta<br>tion | ViewSta<br>tion | CMS<br>Viewer |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Operation<br>System | Microsoft Windows<br>7/8/10/Server 2012/Server<br>2016 | 1.Added<br>Microsoft<br>Windows<br>Server 2019<br>*<br>2. Deleted<br>Microsoft<br>Windows 7<br>3.The<br>CentralStati<br>on supports<br>installation<br>on the<br>Virtual<br>Machine<br>Platform<br>when<br>running as<br>service such<br>as VMWare<br>and Hyper-<br>V | A<br>(CentralSt<br>ation only<br>supports<br>Windows<br>10/Server<br>2016/Serv<br>er 2019) | A<br>(WorkSta<br>tion only<br>supports<br>Windows<br>10) | A<br>(ViewSta<br>tion only<br>supports<br>Window<br>s 10) | A<br>(CMS<br>Viewer<br>only<br>supports<br>Windows<br>8/10/Serv<br>er 2012) |
| Display<br>(including<br>touchscree<br>n<br>capability) | resolution:1920 x<br>1080,1280*1024 | No change | A | A | A | A |
| Audio | Built-in speakers | No change | A | A | A | NA |
| Recorder | Mindray thermal array<br>module product | No change | A | A | A | NA |
| Network | 100 Mbps, Ethernet 802.3 | No change | A | A | A | A |
| Max<br>connection<br>sare<br>supported<br>for one<br>CentralStat<br>ion | Up to 32 WorkStation or<br>ViewStation connections<br>are supported for one<br>CentralStation | No change | A | NA | NA | NA |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | Applied To | | | |
| | | | CentralStation | WorkStation | ViewStation | CMS Viewer |
| Patient Monitor Numbers – Number Supported | 1.Support 32 monitors running as application.<br>2. Running as service<br>Up to 128 montors with no patient display, the display is provided by WorkStations | Support 64 monitors running as application * | A | A | A | A (CMSViewer only support 36 monitors) * |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | Applied To | | | |
| | | | CentralStation | WorkStation | ViewStation | CMS Viewer |
| Telemetry Systems and monitors | Supports the following telemetry systems and monitors:<br>– TMS-6016 (K183238)<br>– TMS60 (K183238)<br>– Telepack-608 (K183238)<br>– TM80(K193391)<br>– TM70(K193391) | No change | A | A | A | A |
| Communication protocol (and compatible monitors) | CMS+ protocol:<br>DPM3 (K072235 )<br>DPM4/5 (K070791)<br>DPM6/7 (K092449)<br>Passport 12m/17m (170876)<br>Passport8/12 (K153448)<br>Passport V (K091834)<br>Accutorr 7/VS-900 (K170712)<br>T1 (K152902)<br>ELAN protocol:<br>Spectrum (K062098)<br>Spectrum OR (K062098)<br>Passport II (K020550)<br>V12/21 (K150352)<br>MD2 protocol:<br>CMS Viewer (K193391)<br>ViewStation (K193391)<br>WorkStation (K193391)<br>TM80 (K193391)<br>TM70(K193391)<br>BeneVision N22/N19/N17/N15/N12/N 1(K199391) | 1.Added VS 8/8A/9(K21 1475) *<br>2.Added ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M) (K200015) * | A | A | A | A |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | Applied To | | | |
| | | | CentralStation | WorkStation | ViewStation | CMS Viewer |
| Bi-directional<br>Configuration | Patient demographics, alarm settings and parameter settings<br>For TM80: patient demographics, alarm settings and parameter setup information can be set by both the CentralStation and TM80.<br>The QRS threshold, ST point/ISO point/J point, and ST and QT template can only be set by the CentralStation. | No change | A | A | NA | NA |
| Calculations | Supports five calculation mode:<br>Drug Calculation<br>Hemodynamics Calculation<br>Oxygenation Calculation<br>Ventilation Calculation<br>Renal Calculation | No change | A | A | A | NA |
| View<br>Other Bed | Provides the user the ability to remotely view 32 patient's parameters, waveforms, and alarms from a patient monitor connected to anotherBeneVision Central Monitoring System | No change | A | A | A | NA |
| HL7<br>Output | Provide HL7 interface output | No change | A | NA | NA | NA |
| Paging<br>Interface | Enables transmission of configured alarm notifications to a third-party paging system | No change | A | A | NA | NA |
| Data Review | | | | | | |
| Dynamic<br>short trend | 8 hours | No change | A | A | A | A |
| Trend<br>review | 240 hours | No change | A | A | A | A |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | CentralStation | WorkStation | ViewStation | CMS Viewer |
| Wave review | 240 hours of full-disclosure waveforms and compressed waveforms | No change | A | A | A | A |
| NIBP review | Most recent 3000 NIBP measurements | No change | A | A | A | A |
| Event review | 3000 events | No change | A | A | A | A |
| 12-lead review | 720 12-lead analysis results, 12 analysis waveforms for each analysis result | No change | A | A | A | A |
| ST review | Most recent 240 hours of ST segments | No change | A | A | A | A |
| Cardiac output review | 720 measurements | No change | A | A | A | A |
| Print | Patient information, real-time waveform, real-time alarm, Alarm Settings, Multi-lead ECG Report, CSA Report, waveform review, Arrhythmia Statistic Result, Trend Review, C.O. measurement, events, 12-lead Review, ST review, QT View Report, drug calculations, hemodynamics calculations, oxygenation calculations, ventilation calculations, renal calculations, ICG hemodynamic parameter, CCO hemodynamic parameter, SvO2/ScvO2 oxygenation parameters | No change | A | A | A | A |
| Feature | As Cleared in K193391 | Modificatio<br>ns Made to<br>Subject<br>Device | Applied To | | | |
| | | | CentralSt<br>ation | WorkSta<br>tion | ViewSta<br>tion | CMS<br>Viewer |
| Records | Patient information, real-<br>time waveform, real-time<br>alarm, waveform review,<br>C.O. measurement, events,<br>12-lead Review, ST<br>review, drug calculation,<br>hemodynamics<br>calculations, oxygenation<br>calculations, ventilation<br>calculations, renal<br>calculations, ICG<br>hemodynamic parameter,<br>CCO hemodynamic<br>parameter, SvO2/ScvO2<br>oxygenation parameters | No change | A | A | A | NA |
| Data<br>storage | The patient data will be<br>saved in an encrypted file. | No change | A | NA | NA | NA |
| ECG Features | | | | | | |
| ECG<br>Algorithm | Supports Mindray and<br>Mortara | No change | A | A | A | A |
| ECG<br>Functions | 3-lead, 5-lead, 6-lead<br>selectable,<br>Arrhythmia detection, ST<br>segment analysis, QT<br>Analysis, Heart rate | No change | A | A | A | A |
| HR | Adult:<br>Range:15~300 bpm<br>Accuracy : ±1 bpm or<br>±1%, whichever is<br>greater<br>Pediatric:<br>Range:15~350 bpm<br>accuracy : ±1 bpm or<br>±1%, whichever is<br>greater | No change | A | A | A | A |
| ST | Range: -2.0~2.0mV<br>Accuracy: ±0.02mV or<br>±10%, whichever is<br>greater, in the range of -<br>0.8mV to +0.8mV; not<br>specified in other range | No change | A | A | A | A |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | CentralStation | WorkStation | ViewStation | CMS Viewer |
| J Point Auto Detection | J-point Auto detection for ST algorithm. Supports automatically detecting the location of the J-point on the ST template. | No change | A | A | A | A |
| ARR | Mindray algorithm:<br>Asystol, V-Fib/V-Tach, V-Tach, Vent Brady, Extreme Tachy, Extreme Brady, PVCs/min, Vent Rhythm, Couplet, Bigeminy Trigeminy, R on T, Run PVCs, PVC, Tachy, Brady, Missed Beats, Pacer Not Pacing, Pacer Not Capture, Multiform PVC, Nonsus V-Tach, Pause, Irr Rhythm, Pauses/min, and A-Fib<br><br>Mortara algorithm:<br>Asystol, V-Fib, V-Tach, Vent Rhythm, Couplet, Run PVCs, PVCs/min, Bigeminy Trigeminy, R on T, Multiform PVC, Irr Rhythm, Tachy, Brady, Pacer Not Pacing, Pacer Not Capture, Extreme Tachy, Extreme Brady, Pause and Pauses/min | No change | A | A | A | A (CMS Viewer receives ARR alarms from CentralStation and only displays ARR alarms, therefore there are no modification) |
| Adjustable Leads for Arrhythmia Analysis | Adjustable Leads for Arrhythmia Analysis.<br>Supports selectable ECG leads as primary detection lead, secondary detection lead and beat classification lead for arrhythmia analysis | No change | A | A | NA | NA |
| Feature | As Cleared in K193391 | Modifications Made to Subject Device | Applied To | | | |
| | | | CentralStation…