BeneVision Central Monitoring System

K183238 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MSX · Mar 13, 2019 · Cardiovascular

Device Facts

• Record ID: K183238
• Device Name: BeneVision Central Monitoring System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MSX · Cardiovascular
• Decision Date: Mar 13, 2019
• 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 The Bene Vision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthes 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 Bene Vision 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. No data processing is done by the BeneVision Central Monitoring System for data received from 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, and TM80. · 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 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. 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; centralizes data from bedside/telemetry monitors (TMS-6016, Telepack-608, TMS60, TM80). Inputs: physiological signals (ECG, SpO2, NIBP, Resp) via Ethernet, Wi-Fi, or WMTS. System displays, stores, prints, and transfers data; supports bi-directional configuration of connected monitors. Used in professional healthcare facilities by clinicians. Output: real-time waveforms, alarms, and historical trends. Facilitates remote patient surveillance; aids clinical decision-making through centralized alarm management and patient data review. TM80/TMS60 transmitters allow ambulatory monitoring. System includes CentralStation, ViewStation, WorkStation, and CMSViewer.

Clinical Evidence

Bench testing only. Functional and system-level testing confirmed performance equivalence to predicate. Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 60601-2-49, and ISO 80601-2-61 standards verified.

Technological Characteristics

Networked monitoring system; components include CentralStation, ViewStation, WorkStation, CMSViewer, and telemetry transmitters. Materials: PPSU RADEL R-5800, Kalix 5950 HFFR, POM MP90-44. Connectivity: Ethernet, Wi-Fi (802.11a/b/g/n), WMTS. OS: Windows 10/Server 2016. Cybersecurity: TLS 1.2, MLDAP authorization. Sterilization: Disinfection via various chemical agents (e.g., isopropyl alcohol, bleach, hydrogen peroxide).

Indications for Use

Indicated for adult and pediatric patients (TMS60/TM80 >3 years) in professional healthcare facilities for remote monitoring of ECG, SpO2, NIBP, and Resp physiological data via networked telemetry transmitters and central stations.

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 (K162607)

Reference Devices

• Philips IntelliVue Patient Monitor MP2 (K161531)
• Nellcor USB Pulse Oximetry Monitor Interface Cable (K172482)
• Passport 12m/17m (K170876)

Submission Summary (Full Text)

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March 13, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, 518057 CN

Re: K183238

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, DRQ, MHX, DRT, DXN, DQA, DSB Dated: February 7, 2019 Received: February 8, 2019

Dear Yanhong Bai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Arielle Drummond -S

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) K183238

#### 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

The Bene Vision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthes 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 Bene Vision 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. No data processing is done by the BeneVision Central Monitoring System for data received from 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, and TM80.

· 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 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. 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(K) SUMMARY

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.

| Device Common Name: | System, network and communication, physiological<br>monitors |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | BeneVision Central Monitoring System |
| 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: | Yanhong Bai<br>Manager Regulatory Affairs<br>SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | November 9, 2018 |
| Classification Regulation: | 870.2300 - Cardiac Monitor (including cardiotachometer<br>and rate alarm)<br>Class II |
| | |
| Panel: | Cardiovascular |
| Product Code: | MSX –System, network and<br>communication, physiological monitors |

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| Subsequent Product Codes: | DRQ- amplifier and signal conditioner,<br>transducer signal<br>MHX - monitor, physiological, patient (with<br>arrhythmia detection or alarms)<br>DRT - monitor, cardiac (incl.<br>cardiotachometer & rate alarm)<br>DXN - system, measurement, blood-<br>pressure, non-invasive<br>DQA- Oximeter<br>DSB- Impedance plethysmograph |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | K162607 - BeneVision Central Monitoring<br>System |
| Reference devices: | K161531-Philips IntelliVue Patient Monitor MP2:<br>provided as a reference device for the TM80<br>intelligent alarm function that has been added to the<br>subject TM80.<br>K172482-Nellcor™ USB Pulse Oximetry Monitor<br>Interface Cable: provided as a reference device for<br>the Nellcor module that has been added to the<br>subject TM80 and TMS60<br>K170876- Passport 12m/17m: provided as a<br>reference device for the beat annotation feature |

## Device Description:

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. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors.

The BeneVision Central Monitoring System consists of the following components:

- 1. CentralStation
- 2. ViewStation
- 3. WorkStation
- 4. CMSViewer
- 5. Telemetry Systems (TMS 6016. Telepak-608. TMS60. TM80)

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The TMS 6016, Telepak-608, TMS60 telemetry monitoring systems operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.

The TM80 telemetry monitor uses the Wireless WIFI connection to transmit data to the CentralStation for processing, display, and alarm.

# Indication for 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

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. No data processing is done by the BeneVision Central Monitoring System for data received from 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, and TM80.

- 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 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.

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

#### 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.

TM80 local monitoring function has been added to the indications for use of the subject TM80 device, including local ECG, SpO2, RESP, NIBP physiology alarm, arrhythmia analysis, ST segment analysis and display, and QT analysis and display. The local functions were previously performed for the predicate TM80 (K162607) via the CentralStation and thus the modifications do not constitute a new intended use for a patient monitoring system.

#### Comparison of Technological Characteristics:

The technological characteristics of the subject device are compared to the predicate device in the table below.

| Feature | Predicate Device - K162607<br>(CentralStation, WorkStation,<br>ViewStation, and CMS Viewer) | Subject Device (CentralStation,<br>WorkStation, ViewStation, and CMS<br>Viewer) |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation System | Microsoft Windows 7 Professional<br>Embedded SP1 | Added Microsoft Windows 10 and Windows<br>Server 2016 to CentralStation, WorkStation,<br>ViewStation. |
| Host | The Central Station supports 3 options for<br>host computers:<br>- HP Compaq 8380 Elite MT<br>- HP EliteDesk 800 G1 SFF<br>- Kontron KISS 2U V2 KTQ87FLEX | Added support for the following host<br>computers:<br>- HP EliteDesk 800 G3 SFF<br>- Added HP ProDesk 600 G3 DM (Only<br>supports WorkStation and ViewStation)<br>- Added HPE Proliant DL360 Gen9 (Only<br>supports CentralStation)<br>No longer supports the following host<br>computer:<br>- HP EliteDesk 800 G1 SFF |
| Display (including<br>touchscreen capability) | 1920 x 1080 resolution, 16:9 widescreen<br>LCD display 19", 21.5" and 23" | No change |
| Audio | Built-in speakers | No change |
| Recorder | Mindray thermal array module product | No change |
| Network | 100 Mbps, Ethernet 802.3 | No change |
| Patient Monitor Numbers -<br>Number Supported | Up to 16 monitors in the single-screen<br>mode for 1280*1024 resolution<br>Up to 24 monitors in the single-screen<br>mode for 1920 x 1080 resolution<br>Up to 32 monitors in multi-screen mode | No change |
| Feature | Predicate Device - K162607<br>(CentralStation, WorkStation,<br>ViewStation, and CMS Viewer) | Subject Device (CentralStation,<br>WorkStation, ViewStation, and CMS<br>Viewer) |
| | Supports up to four local displays | |
| Telemetry System | Supports the following telemetry systems:<br>— TMS-6016 (K162607)<br>— TMS60 (K162607)<br>— Telepack-608 (K162607)<br>— TM80(K162607) | No change |
| Communication protocol<br>(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>CMSViewer (K162607)<br>ViewStation (K162607)<br>WorkStation (K162607)<br>TM80 (K162607) | No change |
| Bi-directional Configuration | Patient demographics, alarm settings and<br>parameter settings | For TM80: patient demographics, alarm<br>settings and parameter setup information can<br>be set by both the CentralStation and TM80.<br>The QRS threshold, ST point/ISO point/J<br>point, and ST and QT template can only be<br>set by the CentralStation.<br>For other devices: No change. |
| Calculations | Supports five calculation mode:<br>Drug Calculation<br>Hemodynamics Calculation<br>Oxygenation Calculation<br>Ventilation Calculation<br>Renal Calculation | No change |
| View Other Bed | Provides the user the ability to remotely<br>view one patient's parameters,<br>waveforms, and alarms from a patient | Provides the user the ability to remotely<br>view 32 patients' parameters, waveforms,<br>and alarms from a patient monitor connected |
| Feature | Predicate Device - K162607<br>(CentralStation, WorkStation,<br>ViewStation, and CMS Viewer) | Subject Device (CentralStation,<br>WorkStation, ViewStation, and CMS<br>Viewer) |
| monitor connected to another BeneVision<br>Central Monitoring System | to another BeneVision Central Monitoring<br>System. | |
| HL7 Output | Provide HL7 interface output | No change |
| Paging Interface | Enables transmission of configured alarm<br>notifications to a third-party paging<br>system | No change |
| Dynamic short trend | 8 hours | No change |
| Trend review | 240 hours | No change |
| Wave review | 240 hours of full-disclosure waveforms<br>and compressed waveforms | No change |
| NIBP review | Most recent 1000 NIBP measurements | No change |
| Event review | 1000 events | No change |
| 12-lead review | 720 12-lead analysis results, 12 analysis<br>waveforms for each analysis result | No change |
| ST review | Most recent 240 hours of ST segments | No change |
| Cardiac output review | 720 measurements | No change |
| Print | Patient information, real-time waveform,<br>real-time alarm, Alarm Settings, Multi-<br>lead ECG Report, CSA Report, waveform<br>review, Arrhythmia Statistic Result,<br>Trend Review, C.O. measurement, events,<br>12-lead Review, ST review, QT View<br>Report, drug calculations, hemodynamics<br>calculations, oxygenation calculations,<br>ventilation calculations, renal<br>calculations, ICG hemodynamic<br>parameter, CCO hemodynamic parameter,<br>SvO2/ScvO2 oxygenation parameters | No change |
| Records | Patient information, real-time waveform,<br>real-time alarm, waveform review, C.O.<br>measurement, events, 12-lead Review, ST<br>review, drug calculation, hemodynamics<br>calculations, oxygenation calculations,<br>ventilation calculations, renal<br>calculations, ICG hemodynamic<br>parameter, CCO hemodynamic parameter,<br>SvO2/ScvO2 oxygenation parameters | No change |
| Data storage | The patient data will be saved in an<br>encrypted file. | No change |
| ECG Algorithm | Supports Mindray and Mortara | No change |
| ECG Functions | 3-lead, 5-lead, 6-lead selectable,<br>Arrhythmia detection, ST segment<br>analysis, QT Analysis, Heart rate | No change |
| Feature | Predicate Device - K162607<br>(CentralStation, WorkStation,<br>ViewStation, and CMS Viewer) | Subject Device (CentralStation,<br>WorkStation, ViewStation, and CMS<br>Viewer) |
| HR | Adult:<br>Range:15~300 bpm<br>Accuracy: ±1 bpm or ±1%,<br>whichever is greater<br>Pediatric:<br>Range:15~350 bpm<br>accuracy: ±1 bpm or ±1%,<br>whichever is greater | No change |
| ST | Range: -2.0~2.0mV<br>Accuracy: ±0.02mV or ±10%, whichever<br>is greater, in the range of -0.8mV to<br>+0.8mV; not specified in other range | No change |
| J Point Auto Detection | J-point Auto detection for ST algorithm.<br>Supports automatically detecting the<br>location of the J-point on the ST template. | No change |
| ARR | Mindray algorithm:<br>Asystol, Vfib/Vtac, Vtac, Vent. Brady,<br>Extreme Tachy, Extreme Brady,<br>PVCs/min, Vent. Rhythm, Couplet,<br>Bigeminy Trigeminy, R on T, Run PVCs,<br>PVC, Tachy, Brady, Missed Beats, Pacer<br>Not Pacing, Pacer Not Capture, Multif.<br>PVC, Nonsus.Vtac, Pause, Irr. Rhythm,<br>Pauses/min, and Afib<br>Mortara algorithm:<br>Asystol, Vfib, Vtac, Vent.Rhythm,<br>Couplet, Run PVCs, PVCs/min,<br>Bigeminy Trigeminy, R on T,<br>Multif.PVC, Irr.Rhythm, Tachy, Brady,<br>Pacer Not Pacing, Pacer Not Capture,<br>Extreme Tachy, Extreme Brady, Pause<br>and Pauses/min | Mindray algorithm:<br>The following name changes were made to<br>improve clarity:<br>- 'VFib/Vtac' to 'V-Fib/V-Tach'<br>- 'Vtac' to 'V-Tach'<br>- 'Vent.Brady' to 'Vent Brady',<br>- 'Nonsus.Vtac' to 'Nonsus V-Tach'<br>- 'Vent.Rhythm' to 'Vent Rhythm'<br>- 'Afib' to 'A-Fib'<br>- 'Multif.PVC' to 'Multiform PVC'<br>- 'Irr. Rhythm' to 'Irr Rhythm'<br>Mortara algorithm:<br>The following name changes were made to<br>improve clarity:<br>- 'VFIB' to 'V-Fib'<br>- 'VTAC' to 'V-Tach'<br>- 'Vent.Rhythm' to 'Vent Rhythm'<br>- 'Multif.PVC' to 'Multiform PVC'<br>- 'Irr. Rhythm' to 'Irr Rhythm' |
| Adjustable Leads for<br>Arrhythmia Analysis | Adjustable Leads for Arrhythmia<br>Analysis.<br>Supports selectable ECG leads as primary<br>detection lead, secondary detection lead<br>and beat classification lead for arrhythmia<br>analysis | No change |
| QT Analysis | Mindray algorithm:<br>QT measurement range: [200, 800] ms | No change |
| Feature | Predicate Device - K162607<br>(CentralStation, WorkStation,<br>ViewStation, and CMS Viewer) | Subject Device (CentralStation,<br>WorkStation, ViewStation, and CMS<br>Viewer) |
| | - QT accuracy [200, 800] ms: ± 30 ms,<br>beyond this range is not specified<br>- QT resolution: [200, 800] ms: 4 ms,<br>beyond this range is not specified<br>- QTc measurement range: [200, 800] ms<br>- QTc resolution [200, 800] ms:<br>1 ms, beyond this range is not<br>specified<br>- QT-HR measure…