Patient Monitor

K192972 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · May 7, 2020 · Cardiovascular

Device Facts

• Record ID: K192972
• Device Name: Patient Monitor
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: May 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BeneVision N12/N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, reviewing, storing, and transfering of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: · The arrhythmia detection, BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only: · C.O. monitoring is intended for adult patients only; · ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg. · rSO2 monitoring is intended for use in individuals greater than 2.5kg. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport. hospital ambulance, or home use. The BeneVision N1 Patient Monitor is intended for monitoring, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: · The arrhythmia detection and PAWP is intended for adult and pediatric patients only. The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

Device Story

Multiparameter patient monitors (N1, N12, N15, N17, N19, N22) collect physiological signals (ECG, SpO2, IBP, CO2, etc.) via sensors. Data processed by internal modules; displayed on integrated touchscreens. Used in healthcare facilities by clinicians for real-time monitoring, alarming, and data storage. N1 supports transport. Features include arrhythmia detection, ST-segment analysis, early warning scores (MEWS/NEWS/NEWS2), GCS, and SepsisSight. Output aids clinical decision-making by providing continuous vital sign trends and alerts. Benefits include early detection of patient deterioration and support for hemodynamic/anesthetic management.

Clinical Evidence

Bench testing only. Functional and system-level testing validated performance against specifications and consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 62133-2, IEC 60601-2-26). No clinical data presented.

Technological Characteristics

Multiparameter monitors with touchscreen displays (12.1"-22"). Connectivity: Wireless (2.4G/5G), network/CMS integration. Power: Lithium-ion batteries/AC. Data storage: SSD or eMMC. Software: Windows 10 (iView platform). Standards: ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 62133-2, IEC 60601-2-26. Security: AES128 encryption.

Indications for Use

Indicated for monitoring physiological parameters (ECG, Resp, Temp, SpO2, PR, NIBP, IBP, PAWP, C.O., CCO, SvO2/ScvO2, CO2, O2, AG, ICG, BIS, RM, NMT, EEG, rSO2) in adult, pediatric, and neonatal patients in healthcare facilities. Specific parameter restrictions apply based on patient age/size (e.g., C.O. for adults only; ICG for specific adult height/weight; rSO2 for >2.5kg).

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• BeneVision N Series Patient Monitors (K182075)

Reference Devices

• Passport 12m, Passport 17m, T1 (K190011)
• Hemosphere Monitor (K163381)
• Edwards Vigilance II monitor (K043103)
• Vigileo monitor (K103094)
• EV1000 monitor (K160552)

Submission Summary (Full Text)

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May 7, 2020

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, China 518057

Re: K192972

Trade/Device Name: Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA Dated: April 7, 2020 Received: April 8, 2020

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

K192972

#### Device Name

BeneVision N Series Patient Monitors (Including BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1)

Indications for Use (Describe) BeneVision N12/N15/N17/N19/N22

The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: · The arrhythmia detection, BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only:

· C.O. monitoring is intended for adult patients only;

• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.

· rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport. hospital ambulance, or home use.

(Continue on next page for N1 Indications for Use)

Type of Use (*Select one or both, as applicable*)

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510(k) Number (if known): K192972 Indications for Use (con't)

BeneVision N1 Patient Monitor:

The BeneVision N1 Patient Monitor is intended for monitoring, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• The arrhythmia detection and PAWP is intended for adult and pediatric patients only

The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mindray BeneVision N Series Monitors is provided below.

#### 1. SUBMITTER

| 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: Yanhong Bai<br>Title: Manager Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | October 22, 2019 |
| 2. | DEVICE |
| Device Trade Name: | BeneVision N Series Patient Monitors (Including<br>BeneVision N12, BeneVision N15, BeneVision N17,<br>BeneVision N19, BeneVision N22, BeneVision N1) |
| Device Common Name: | Patient Monitor |
| Classification Name: | 21 CFR 870.1025, Class II, Arrhythmia detector and<br>alarm (including ST-segment measurement and alarm) |
| Regulatory Class: | Class II |
| Primary Product Code: | MHX - Monitor, Physiological, Patient (with<br>arrhythmia detection or alarms) |

| Table 1:<br>Secondary Product Codes |
|-------------------------------------|
|-------------------------------------|

| Regulation Number/Class | Product Code | Regulation description | Device Common Name |
|----------------------------|-----------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| 870.1025, II | DSI | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | Detector and alarm, arrhythmia |
| Regulation<br>Number/Class | Product<br>Code | Regulation description | Device Common Name |
| 870.1025, II | MLD | Arrhythmia detector and alarm<br>(including ST-segment measurement<br>and alarm) | Monitor, st segment with alarm |
| 870.2300, II | DRT | Cardiac Monitor (including<br>cardiotachometer and rate<br>alarm) | Monitor, cardiac (incl.<br>cardiotachometer & rate alarm) |
| 870.1130, II | DXN | Noninvasive blood pressure<br>measurement system | System, measurement, blood-pressure,<br>non-invasive |
| 870.1110, II | DSK | Blood pressure computer | Computer, blood-pressure |
| 880.2770, II | DSB | Impedance plethysmograph. | Plethysmograph, impedance |
| 880.2700, II | MUD | Oximeter | Oximeter, tissue saturation |
| 870.2340, II | MLC | Electrocardiograph | Monitor, st segment |
| 870.2370, II | KRC | Electrocardiograph surface electrode<br>tester. | Tester, electrode, surface,<br>electrocardiographic |
| 880.2910, II | FLL | Clinical electronic thermometer | Thermometer, electronic, clinical |
| 870.2700, II | DQA | Oximeter | Oximeter |
| 870.2300, II | MSX | Cardiac monitor (including<br>cardiotachometer and rate alarm). | System, network and communication,<br>physiological monitors |
| 870.2910, II | DRG | Radiofrequency physiological signal<br>transmitter and receiver. | Transmitters and receivers,<br>physiological signal, radiofrequency |
| 868.1400, II | CCK | Carbon dioxide gas analyzer | Analyzer, gas,<br>carbon-dioxide, gaseous-phase |
| 870.1435, II | DXG | Single-function, preprogrammed<br>diagnostic computer | Computer, diagnostic, pre-<br>programmed, single-function |
| 870.1100, II | DSJ | Blood pressure alarm | Alarm, blood-pressure |
| 870.2850, II | DRS | Transducer, blood-pressure,<br>extravascular | Extravascular blood pressure<br>transducer. |
| 868.1500, II | CBQ | Enflurane gas analyzer. | Analyzer, gas, enflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1500, II | NHO | Enflurane gas analyzer. | Analyzer, gas, desflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1500, II | NHP | Enflurane gas analyzer. | Analyzer, gas, sevoflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1500, II | NHQ | Enflurane gas analyzer. | Analyzer, gas, isoflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1620, II | CBS | Halothane gas analyzer. | Analyzer, gas, halothane, gaseous-<br>phase (anesthetic conc.) |
| 868.1700, II | CBR | Nitrous oxide gas analyzer. | Analyzer, gas, nitrous-oxide, gaseous<br>phase (anesthetic conc.) |
| 868.1720, II | CCL | Oxygen gas analyzer. | Analyzer, gas, oxygen, gaseous-phase |
| Regulation<br>Number/Class | Product<br>Code | Regulation description | Device Common Name |
| 868.2775, II | KOI | Electrical peripheral nerve stimulator. | Stimulator, nerve, peripheral, electric |
| 882.1400, II | OLW | Electroencephalograph. | Index-generating<br>electroencephalograph software |
| 882.1400, II | OLT | Electroencephalograph. | Non-normalizing quantitative<br>electroencephalograph software |
| 882.1400, II | OMC | Electroencephalograph. | Reduced-montage standard<br>electroencephalograph |
| 882.1400, II | ORT | Electroencephalograph. | Burst suppression detection software<br>for electroencephalograph |
| 882.1320, II | GXY | Cutaneous electrode. | Electrode, cutaneous |

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#### 3. PREDICATE DEVICES

- Predicate: K182075 BeneVision N Series Patient Monitors (Including BeneVision N12, ● BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1)
#### REFERENCE DEVICES 4.

- K190011 Passport 12m, Passport 17m, T1: provided as reference devices for ● the BIS module that has been added to the subject BeneVision N Series Patient Monitors.
- K163381 Hemosphere Monitor: provided as a reference device in support the device ● integration functionality and PPV parameters.

#### 5. DEVICE DESCRIPTION

The subject BeneVision N Series Patient Monitors includes six monitors:

- BeneVision N12 Patient Monitor ●
- BeneVision N15 Patient Monitor ●
- BeneVision N17 Patient Monitor ●
- BeneVision N19 Patient Monitor ●
- BeneVision N22 Patient Monitor
- BeneVision N1 Patient Monitor ●

Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

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#### INTENDED USE/INDICATIONS FOR USE 6.

### BeneVision N12/N15/N17/N19/N22 Patient Monitors:

The BeneVision N12/N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, reviewing, storing, and transfering of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (Sv02/Scv02), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

- The arrhythmia detection, BIS, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only;
- C.O. monitoring is intended for adult patients only; ●
- ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
- rSO2 monitoring is intended for use in individuals greater than 2.5kg. ●

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.

### BeneVision N1 Patient Monitor:

The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

- The arrhythmia detection and PAWP is intended for adult and pediatric patients only ●
The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical

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professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

#### 7. SUBSTANTIAL EQUIVALENCE

### Comparison of Indications

Both the predicate devices and the subject devices are multiparameter patient monitors intended to be used under the direction of clinical professionals.

The indications for use statement of the subject BeneVision N12/N15/N17/N19/N22 has been modified to include the BIS parameter used on adult and pediatric patients. Although this feature is not present in the primary predicate devices, it is present in other cleared multiparameter patient monitors such as the Passport series Patient Monitors (K190011, Passport 17m. T1). The inclusion of BIS in the indications for use does not constitute a new fundamental intended use.

The indications for use statement of the subject BeneVision N1 has not been changed.

In conclusion, the minor difference in the indications for use statement does not change the fundamental intended use of the N Series monitors as multiparameter monitors.

### Technological Comparison

The tables below compare the key technological feature of the subject devices to the predicate device (N series Patient Monitors, K182075). The features in gray are features which are different between the predicate devices and the subject devices.

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#### Table 2: Device Comparison Table (BeneVision 22/N19/N17/N15/N12)

| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------------------------|----------------------------------------------------|--------------|--|
| | | | Cleared in K182075 | | | | | Subject Device | | | |
| Primary display<br>and touchscreen | 22"<br>1680*1050<br>pixels. | 19"<br>1680*1050<br>pixels. | 18.5"<br>1920*1080<br>pixels. | 15.6"<br>1920*1080<br>pixels. | 12.1"<br>1280*800<br>pixels. | No<br>change | No<br>change | No change | No<br>change | No<br>change | |
| Secondary<br>display | Independent control and<br>display. | Independent control and<br>display. | Independent<br>control and<br>display.<br>Size:18.5";<br>Model:<br>ET1919LM; | Mirrored display.<br>Size:18.5";<br>Model: ET1919LM; | | No change | No change | Independent<br>control and<br>display.<br>Size: 21.5";<br>Model:2203L | Mirrored display.<br>Size: 21.5";<br>Model: 2203L; | | |
| iView | iView is an isolated PC platform that allows<br>the user to run 3rd party applications using a<br>limited set of functions. The iView system is<br>not intended to be used as a primary alarm<br>device.<br>Capacity of RAM: 4GB<br>Model of CPU: J1900<br>Windows 7 | | | Not supported. | | Change the PC platform<br>Capacity of RAM: 8GB<br>Model of CPU: N4200<br>Windows 10 | | Change the PC platform<br>Capacity of RAM: 8GB<br>Model of CPU: N4200<br>Windows 10 | No change | No change | |
| Wireless radio<br>module | The 2.4G/5G module for connecting to a network wirelessly, constructing a<br>monitoring network with a central monitoring system (CMS). | | | | | | No change | | | | |
| Module rack | Must be connected to the<br>main unit to provide up to<br>8 standard module slots. | Must be connected to the<br>main unit to provide up to<br>8 standard module slots. | Optional for the patient<br>monitors, adding 8 standard<br>module slots to extend the<br>measurement capabilities of<br>the system. | Not<br>supported. | Not<br>supported. | No change | | | | | |
| Power supply | | | One rechargeable Lithium-ion battery or AC power supply. | | | No change | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| | | | Cleared in K182075 | | | | Subject Device | | | | |
| Battery | Chargeable Lithium-Ion, 11.3 VDC, 5600 mAh. | | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh. | | | Chargeable Lithium-Ion, 10.8 VDC, 5600 mAh. | | Chargeable Lithium-Ion, 10.95 VDC, 4500 mAh. | | | |
| Data storage | Solid State Hard Drive (SDD) | | Embedded Multi Media Card (eMMC). | | | No change | | | | | |
| Data recorder | Supports the thermal recorder module, needs to be plugged into the SMR. | | Supports the thermal recorder module and the built-in thermal recorder, but they cannot work at the same time. | | | No change | | | | | |
| Speaker | Provides audible alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation. | | | | | | No change | | | | |
| Alarm system | Supports alarm volume escalation. The alarm lamp will light cyan, yellow, or red depending on alarm type. | | | | | | No change | | | | |
| Support T1/N1 as a Module | Support T1/N1 acting as a module. | | |…