LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream

K153719 · Honeywell Hommed, LLC · DRG · Jun 3, 2016 · Cardiovascular

Device Facts

• Record ID: K153719
• Device Name: LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
• Applicant: Honeywell Hommed, LLC
• Product Code: DRG · Cardiovascular
• Decision Date: Jun 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface. LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages. LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

Device Story

LifeStream 5 is a prescription-based software platform for retrospective management of patient vital signs. It receives data from Honeywell HomMed monitors (e.g., Genesis Touch) and third-party MDDS devices via web services or Bluetooth. The system consists of a hosted web server, database, and Windows/web client interfaces. Healthcare professionals use the software to view tabular/graphical trends, patient messages, and user-defined alerts. It does not perform real-time monitoring or emergency response. The device aids clinical decision-making by organizing and displaying historical patient data for review. It is intended for use in clinical environments.

Clinical Evidence

Bench testing only. Evidence includes functional, validation, automated regression, black box, localization, and deployment testing, plus external evaluation by the Honeywell clinical team. No clinical data presented.

Technological Characteristics

Software-based system operating on commercial PCs (Windows Vista/7, .NET Framework 2.0). Connectivity via Internet/POTS. Data encrypted in transit and storage. Database hosted on secure servers with firewall/antivirus protection. C# programming language.

Indications for Use

Indicated for healthcare professionals in clinical settings to retrospectively receive, display, and store patient vital signs and related data (NIBP, SpO2, weight, blood glucose, temperature, medication, ECG, peak flow, prothrombin time, PERS messages). Not for emergency use or real-time monitoring.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• Central Station v4.0 branded LifeStream Manager 4.0 (K072272)

Reference Devices

• A&D Digital UA-767 Plus BT-Ci (K040371)
• A&D Digital UA-767BT (K040371)
• Contec CMS50EW (K090671)
• Nonin Onyx II 9560 (K081285)
• ChoiceMed MD300C318 (K092620)
• Entra Health Systems MyGlucoHealth (US) MGH-BT1 (K081703)
• Exergen Temporal Thermometer (K011291)
• et medical devices SpA ECG@home (K091054)
• Genesis DM (K101242)
• Genesis Touch (K141792, K112858)
• MedPartner (K053122)
• Sentry Monitors (K993938, K004044, K014025, K040651, K061088)
• Genesis Monitors (K040799, K061087)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing right, with flowing lines representing hair or clothing.

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

June 3, 2016

Honeywell Hommed, LLC % John Ziobro Spectramedex, LLC 3215 Gold Road Delafield. Wisconsin 53018

Re: K153719

Trade/Device Name: LifeStream™ 5 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: April 28, 2016 Received: May 2, 2016

Dear John Ziobro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Shawn W. Forrest -S 2016.06.03 10:52:43 -04'00'

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

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## Indications for Use

510(k) Number (if known) K153719

Device Name LifeStream™ 5

#### Indications for Use (Describe)

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healtheare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface.

LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages.

LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## Honeywell HomMed LifeStream™ 5 510(k) Summary Statement

Summary Date: 12/17/2015

| Applicant Name:<br>and Address: | Honeywell HomMed, LLC<br>3400 Intertech Drive, Suite 200<br>Brookfield, Wisconsin 53045<br>Ph: (262) 252-783-5440<br>Establishment Registration #3004183721 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Site: | Honeywell HomMed, LLC<br>3400 Intertech Drive, Suite 200<br>Brookfield, Wisconsin 53045<br>Ph: (262) 252-783-5440<br>Establishment Registration #3004183721 |
| Corporate Contact: | Greg Lillegard, Operations, Vice President<br>Honeywell HomMed, LLC<br>Ph: [phone]<br>Fax: [phone] |

Contact Person: John Ziobro

Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, WI 53018 Ph: (262) 719-89228 Fax: [phone]

Model Number LifeStream™ 5

Common Name: Patient Vital Signs Monitor Viewing Station

LifeStream™ 5 Brand/Trade Names:

Reason for Traditional 510(k) : New Submission

#### Indications For Use:

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthicare professionals. It consists of a hosted web server a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface.

LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, related data. temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages.

LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

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| Regulation<br>Number | Review Panel | Product<br>Code | Classification Name | Device<br>Class |
|--------------------------------------------------------------------------------------------|-----------------------|-----------------|-----------------------------------------------------------------|-----------------|
| 870.2910 | Cardiovascular | DRG | Radiofrequency physiological signal<br>transmitter and receiver | II |
| Subsequent product codes also supported by LifeStream by means of separate medical devices | | | | |
| 870.1130 | Cardiovascular | DXN | Noninvasive blood pressure measurement<br>system | II |
| 880.2700 | General<br>Hospital | FRI | Patient Weight Scale | I |
| 870.2700 | Anesthesiology | DQA | Oximeter | II |
| 862.1345 | Clinical<br>Chemistry | NBW | Glucose Test System | II |
| 868.1860 | Anesthesiology | BZH | Meter, Peak Flow, Spirometry | II |
| 864.7750 | Hematology | GJS | Test, Time, Prothrombin | II |
| 890.5050 | Physical<br>Medicine | NXB | Dispenser, solid medication | I |
| 880.6310 | General<br>Hospital | OUG | Medical Device Data System | I |
| 880.2910 | General<br>Hospital | FLL | Clinical Electronic Thermometer | II |
| 870.2340 | Cardiovascular | DPS | Electrocardiograph | II |

Central Station, Version 4.0, K072272, branded as the LifeStream™ 4.0. Predicate Device(s):

#### Predicate Classification Information:

| Regulation<br>Number | Review Panel | Product<br>Code | Classification Name | Device<br>Class |
|----------------------|----------------|-----------------|--------------------------------------------------|-----------------|
| 870.1130 | Cardiovascular | DXN | Noninvasive blood pressure measurement<br>system | II |

#### Device Description:

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server and two types of client interfaces, one that is provided by Windows client and one that is provided by a web client interface. LifeStream 5, like the predicate LifeStream 4.0, is configured to accept patient data that is acquired periodically and displayed retrospectively from Honeywell HomMed Patient Monitors (e.g. Genesis Touch). LifeStream 5 can also interface with 3nd party compatible medical device data systems (e.g. Govsphere TV). LifeStream 5 has the same intended use as the predicate, LifeStream 4.0. LifeStream 5, like LifeStream 4.0 is not intended for emergency use or real-time monitoring. Both are designed to retrospectively receive, display and store scheduled vital sign parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, ECG, peak flow, prothrombin time and retrospective PERS messages.

#### Technological Characteristics

Both the subject device and predicate device are software programs" with substantially equivalent intended uses, users, and use environments that were written in C# that operate on PCs powered by AC Mains / battery power.

#### Predicate Device Comparison:

As shown in the tables below, LifeStream 5 is substantially equivalent in operation and performance to predicate the LifeStream Central Station 4.0 cleared under K072272. See also the Substantial Equivalence (SE) table, attached.

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led, LLC

| LifeStream Manager 4.0 Predicate | | | | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------------------------------|
| | Manufacturer, Model | Description | 510(k) Number | Communication<br>Method |
| Vital Signs Data Acquisition (communicates with Monitors) | | | | |
| Blood Pressure<br>Systolic mmHg,<br>Diastolic mmHg | A&D Digital UA-767 Plus BT-<br>Ci<br>A&D Digital UA-767BT | noninvasive blood pressure<br>monitor<br>noninvasive blood pressure<br>monitor | K040371<br>K040371 | Bluetooth |
| Pulse Oximetry<br>Pulse Rate and Oxygen<br>Saturation | Contec CMS50EW<br>Nonin Onyx II 9560<br>ChoiceMed MD300C318 | Fingertip pulse oximeter<br>Fingertip pulse oximeter<br>Fingertip pulse oximeter | K090671<br>K081285<br>K092620 | Bluetooth |
| Weight<br>Pounds, lbs or<br>Kilograms, Kgs | Honeywell HomMed<br>5002100A1<br>A&D Medical UC-321PBT<br>NCI Technology Inc. Accuro<br>HRS305 | Scale<br>Scale<br>Hand rail scale | exempt<br>exempt<br>exempt | Bluetooth |
| Blood Sugar<br>mg/dL | Entra Health Systems<br>MyGlucoHealth (US) MGH-<br>BT1 | Glucometer | K081703 | Bluetooth |
| ECG | No longer manufactured | Electrocardiograph | N/A | N/A |
| Vital Signs Monitors/Medicine Dispenser (Communicates with Honeywell Secure Servers | | | | |
| Genesis DM | Honeywell HomMed | Single/Multi-patient Monitoring<br>System | K101242 | Web Services |
| Genesis Touch | Honeywell HomMed | Single-patient Monitoring<br>System | K141792<br>K112858 | Web Services |
| Medicine Dispenser | MedPartner | Daily Activity Assist Device | K053122 | Web Services |
| Disease Management<br>Protocol | Pre-defined by User | Users: Various | N/A | Honeywell Secure<br>Servers<br>(central servers) |
| Graphical user interface | Honeywell HomMed,<br>LifeStream Management Suite<br>4.0 | Windows-based Software<br>Application used by Healthcare<br>Provider to manage data<br>received from Genesis Monitor s | K072272 | Honeywell Secure<br>Servers<br>(central servers) |

| LifeStream Manager 5.0 Subject Device | | | | |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------|--------------------------|
| | Manufacturer, Model | Description | 510(k) Number | Communication to Monitor |
| Blood Pressure<br>Systolic mmHg,<br>Diastolic mmHg | A&D Digital UA-767 Plus BT-Ci<br>A&D Digital UA-767BT | noninvasive blood pressure monitor<br>noninvasive blood pressure monitor | K040371 | BlueTooth |
| Pulse Oximetry<br>Pulse Rate and Oxygen<br>Saturation | Contec CMS50EW<br>Nonin Onyx II 9560<br>ChoiceMed MD300C318 | Fingertip pulse oximeter<br>Fingertip pulse oximeter<br>Fingertip pulse oximeter | K090671<br>K081285<br>K092620 | BlueTooth |
| Weight<br>Pounds, lbs or<br>Kilograms, Kgs | Honeywell HomMed<br>5002100A1<br>A&D Medical UC-321PBT<br>NCI Technology Inc. Accuro HRS305 | Scale<br>Scale<br>Hand rail scale | exempt | BlueTooth |
| Blood Sugar<br>mg/dL | Entra Health Systems<br>MyGlucoHealth (US) MGH-BT1 | Glucometer | K081703 | BlueTooth |
| MDDS<br>Communications<br>Device | Govsphere VITAL Tablet;<br>Govsphere VITAL TV | Medical device data system | exempt | BlueTooth |
| Temperature | Exergen Temporal<br>Thermometer | Temporal scanner thermometer | K011291 | Wire |
| ECG | et medical devices SpA<br>ECG@home | Electrocardiograph | K091054 | N/A |
| Vital Signs Monitors/Medicine Dispenser (Communicates with Honeywell Secure Servers | | | | |
| Genesis DM | Honeywell HomMed | Single/Multi-patient Monitoring<br>System | K101242 | Web Services |
| Genesis Touch | Honeywell HomMed | Single-patient Monitoring<br>System | K141792<br>K112858 | Web Services |
| Medicine Dispenser | MedPartner | Daily Activity Assist Device | K053122 | Web Services |

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Image /page/6/Picture/0 description: The image contains the logo for Honeywell Life Care Solutions Honeywell HomMed, LLC. The word "Honeywell" is in red, and the words "Life Care Solutions" are in gray. The words "Honeywell HomMed, LLC" are in black.

| Disease Management Protocol | Pre-defined by Honeywell HomMed or/and User | Users: Various<br>Honeywell: COPD, Diabetes, CHF | N/A | |
|-----------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------------------------------------|
| Graphical user interface | Honeywell HomMed,<br>LifeStream Management Suite<br>5.0<br>(central viewing station) | Windows-based Software<br>Application or Web-based used<br>by Healthcare Provider to<br>manage data received from<br>Genesis Monitor s and<br>compatible 3rd party monitors | Subject Device | Honeywell Secure<br>Servers<br>(central servers) |

### Substantial Equivalence (SE) table

| Predicate Device(s) | | 510(k) Application | |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Feature/<br>Function | Central Station v4.0 branded LifeStream Manager 4.0;<br>K072272 | LifeStream Manager 5.0 | |
| | | Subject Device | |
| | GENERAL DESCRIPTIONS | | |
| Intended Use /<br>Indications for<br>Use | Central Station's intended use is to retrospectively receive,<br>display and store monitored vital signs parameters and<br>related data. Central Station displays the data and system<br>alerts for review and interpretation by a healthcare<br>professional. Central Station is not intended for emergency<br>use or real-time monitoring. | LifeStream 5 is a stand alone, prescription-based software<br>program designed to operate in a clinical setting by healthcare<br>professionals. It consists of a hosted web server, a hosted<br>database server and two types of client interfaces - one that is<br>provided by Windows client and one that is provided by a web<br>client interface.<br>LifeStream software's intended use is to retrospectively receive,<br>display and store monitored vital signs parameters and related<br>data. Such data includes patient blood pressure (NIBP), oxygen<br>saturation (SpO2), weight, blood glucose, temperature, dispensed<br>medicine, ECG, peak flow, prothrombin time and retrospective<br>PERS messages. | |
| | | LifeStream retrospectively displays the data, user-defined data<br>alerts and system alerts for review and interpretation by a<br>healthcare professional. LifeStream is not intended for emergency<br>use or real-time monitoring. | |
| User Population | Health care professionals | Health care professionals | |
| Environment of<br>Use | Intended to be used in a healthcare related environment by<br>healthcare providers. | Intended to be used in a healthcare related environment by<br>healthcare providers. | |
| Content | For informational purposes only and does not provide<br>professional medical advice, diagnosis, or treatment. | For informational purposes only and does not provide<br>professional medical advice, diagnosis, or treatment. | |
| Contraindications<br>and Use<br>Limitations | LifeStream Manager 4.0 is not intended for emergency use<br>or real-time monitoring.<br>LifeStream Manager 4.0 is not intended to be accessed or<br>used directly by patients | LifeStream is NOT an emergency medical response system.<br>LifeStream does NOT provide real-time, critical-care monitoring<br>of patient vital signs. Reports generated by LifeStream are NOT<br>intended to be used as a patient medical record or patient vital<br>sign reporting documentation. LifeStream does not analyze or<br>perform calculations on the data collected by the peripheral<br>devices. | |
| Regulation<br>Number &<br>Product Code | 870.1130, DXN, Class II | 870.2910, DRG, Class II<br>Subsequent/additional regulation numbers & codes<br>870.1130<br>DXN<br>880.2700<br>FRI<br>870.2700<br>DQA<br>862.1345<br>NBW<br>868.1860<br>BZH<br>864.7750<br>GJS<br>890.5050<br>NXB<br>880.6310<br>OUG<br>880.2910<br>FLL<br>870.2340 DPS | |
| | Hardware-Related Technological Characteristics | | |
| Hardware<br>Platform | Commercial PC<br>Computer/Processor: 1 GHz or faster x86- or x64-bit<br>processor<br>Memory: 1 gigabyte (GB) RAM (32-bit); 2 gigabytes (GB)<br>RAM (64-bit)<br>Hard Disk: 1 gigabyte (GB) of disk space available<br>Display: 1024x768 or higher resolution monitor | Commercial PC<br>Computer/Processor: 1 GHz or faster x86- or x64-bit processor<br>Memory: 1 gigabyte (GB) RAM (32-bit); 2 gigabytes (GB) RAM<br>(64-bit) or greater<br>Hard Disk: 1 gigabyte (GB) of disk space available<br>Display: 1024x768 or higher resolution monitor | |
| Predicate Device(s) | 510(k) Application | | |
| Feature/<br>Function | Central Station v4.0 branded LifeStream Manager 4.0;<br>K072272 | LifeStream Manager 5.0 | |
| | | Subject Device | |
| Hardware<br>Compliance/<br>Conformity<br>Standards | The medical device is software installed or accessed using<br>off-the-shelf PCs and not subject to EN60601-1-2. | The medical device is software accessed using off-the-shelf PCs<br>and not subject to IEC 60601-1 & 60601-1-2. | |
| Hardware Power<br>Supply | AC Mains or battery | AC Mains or battery | |
| | Software-Related Operating Environment / Principles / Technological Characteristics | | |
| Operating System | Operating System<br>Windows XP with all available Microsoft service packs<br>Windows Vista<br>Windows 7<br>NET Framework version 2.0<br>Web browser: Internet Explorer 9 | Operating System<br>Windows Vista<br>Windows 7<br>NET Framework version 2.0<br>Web browser: Internet Explorer 9 or higher | |
| Peripherals | Internet connection; mouse or compatible pointing device | Internet connection; mouse or compatible pointing device | |
| Programming<br>Language | C# | C# | |
| | Communications into LifeStream Database Server from the Patient Monitoring System | | |
| Transmission | POTS, Internet, SkyTel, PageNet | POTS, Internet | |
| Output Devices | Fax, Printer, email | Fax, Printer, email | |
| | Communications out of LifeStream Database Server to the Patient Monitoring System | | |
| Transmission | Web services ( | Web services | |
| Output Devices | Fax, Printer, email | Fax, Printer, email | |
| User Interface | LifeStream Windows Client | LifeStream Windows Client and LifeStream Web Client | |
| Database | Honeywell hosted Database service | Honeywell hosted Database service | |
| FDA Software<br>Level of Concern | Moderate | Moderate | |
| | Clinical Features of the Software | | |
| Patient Task<br>Screen | Alert Limits, Vitals Current Status, Demographics,<br>Equipment & Question Setup/Configuration, Patient<br>Information, Patient List, Vitals Tabular Trends, Patient<br>Messages | Alert Limits, Vitals Current Status, Demographics, Equipment &<br>Question Setup/Configuration, Patient Information, Patient List,<br>Vitals Tabular Trends, Questions graph, Patient Messages | |
| Organization<br>Screen | Care Providers, Diagnoses, Equipment List, Insurers,<br>Medications, Sites/Categories, System Configuration, Users | Care Providers, Diagnoses, Equipment List, Insurers,<br>Medications, Sites/Categories, System Configuration, Users | |
| Tools Screen | Change Password, System Log, User Settings | Change Password, System Log, User Settings | |
| System Screen | Logoff, Exit | Logoff, Exit | |
| Standard Patient<br>Data Displayed | Weight, Systolic, Diastolic, SpO2, Heart rate, Temperature,<br>Questions & Question responses | Weight, Systolic, Diastolic, SpO2, Heart rate, Temperature,<br>Questions & Question responses, Pain Answers | |
| Option…