The ViSi Mobile Surveillance Monitoring System is a patient-worn, wireless vital sign monitoring platform that is designed to detect patient deterioration (including life-threatening arrhythmias, vital sign changes, and patient falls) and alert bedside staff earlier without causing alarm fatigue. The system is connected to your hospital’s wireless infrastructure to allow:

a.    Your patient’s information is to be sent to the wrist device for easier patient assigning
b.    Data for all patients on the monitoring system is to be displayed at a central location
c.    Patient data is to be sent directly to the patient’s medical record
d.    Alarms indicating patient deterioration are to be sent directly to the staff phones

The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. The ViSi Mobile System has a CE mark and is FDA cleared for Non-Invasive Blood Pressure (NIBP) monitoring (single cuff inflation) and continuous monitoring of Heart/Pulse Rate, SpO2, Respiration Rate, and Skin Temperature. The system also has patented technology that allows for Continuous Non Invasive Blood Pressure (cNIBP), which has not previously been available for general care floors. Additionally, it can display a continuous ECG waveform and can detect and alarm for atrial fibrillation, ventricular tachycardia, ventricular fibrillation, and asystole. 

Adults age 18 or over

Vital Signs captured by ViSi Mobile System, include the following:

• SpO₂ / Pulse Rate
• ECG / Heart Rate
• Respiration Rate
• Skin Temperature
• Non-invasive Blood Pressure (NIBP)
• Continuous Non-Invasive Blood Pressure (cNIBP)

There are 5 single, patient-use components:
•    Wrist cradle and strap
•    Chest Cable securement set 
•    Disposable ECG Electrodes (recommend 3M™)
•    Blood Pressure Cuff (validated with Welch Allyn® Flexiport™ &  GE Critikon™ Soft-CufT™) 
•    Thumb wrap/Thumb tape

Both the Wrist Transceiver and Cuff Module are powered by internal rechargeable Li-Ion batteries that are recharged in either an 8-bay or 2-bay charger depending on the bedside workflow. The Wrist Transceivers last 12-14 hours, and the Cuff Module will need to be recharged after approximately 30 inflations. Both will take approximately 4 hours to charge from fully depleted. 

Cuff is only applied during initial application and calibration.

Once the system has been set up and calibrated, the cuff is removed.

There are several situations when the patient must wear the blood pressure cuff. The cuff is utilized to establish the initial patient-specific calibration.  Following a successful calibration, the cuff can be removed, and the ViSi Mobile System will display beat-to-beat blood pressure continuously without the need for cuff inflations. If the system needs to be recalibrated, the cuff will be needed.

ViSi’s patented technology allows for continuous blood pressure to be measured non-invasively on a beat-to-beat basis without the need for frequent cuff inflations. The system first detects the onset of the R wave via the chest sensor and then measures the time it takes for the resulting pulse to be detected by the thumb sensor. Once it has determined the average time for the pulse to arrive at the thumb sensor (AKA “pulse arrival time” or PAT), the system prompts the user to obtain an initial “calibrating cuff measurement” and uses that measurement along with the PAT to calculate pulse wave velocity and convert the measurements into a usable blood pressure in mmHg(or kPa).  Once the calibrating cuff measurement is obtained, the cuff can be removed, the patient’s beat-to-beat blood pressure is displayed at the wrist, and the RVD and the value is refreshed every 3 seconds for real-time measurements.

The ViSi Mobile System cNIBP technique has been compared in clinical trials to invasive arterial lines and has shown accuracy in these studies within five mmHg.  The systolic pressure increases as a pulse wave travels down the arterial system. This is noticeable when comparing systolic blood pressure measured via an invasive arterial line versus auscultation. To adjust for this change in systolic pressure, the blood pressure obtained during cuff calibration for the cNIBP is set to calibrate against the gold standard of a manual blood pressure (auscultatory method). 

•    If the system detects a Significant change in Mean Arterial Pressure (alert)
•    If the system detects that a sensor has been disconnected for an extended period of time (alert)
•    If a vasopressor has been administered, we recommend recalibration (no alert)
•    Required every 24 hours to ensure accuracy (alert)

A “Calibrate cNIBP” alert will display on the monitor & RVD if the last known cNIBP calibration was more than 24 hours ago.  cNIBP will continue to display with the alert until the next device swap.  If a clinician sees the alert during device swap, cNIBP must be recalibrated.  If the alert is not present at the time of the device swap, the calibration will transfer to the next monitor.  

We recommend enabling an optional clinical authentication code to prevent patient tampering and avoid the access of PHI. The patient will only be able to view their own vital signs, waveforms, and menu options (only accessible using the clinical authentication code).

All components, with the exception of the Cuff Module, are waterproof and can be submerged in water. Because the water on the patient’s skin will cause noise in the vital sign measurements and potentially false alarms, it is not recommended that the patient shower while wearing the ViSi Mobile System. Follow the Pause Monitoring workflow outlined in the User Manual if the patient will need to shower or bathe. 

Yes, the Monitor’s ECG channel is capable of monitoring patients with an Implanted Pacemaker (PM), Implantable Cardioverter-Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) device. A vertical dashed line before the P wave (atrial pace), and before the QRS (ventricular pace) indicate paced events. In the case of biventricular pacing (CRT), two vertical dashed lines occur before the QRS.

Yes, the system can be used during defibrillation without damaging or affecting the system. A Heart Rate reading will be displayed within 20 seconds after a defibrillation event. An ECG waveform will be displayed within 5 seconds after a defibrillation event.

The patient-worn ViSi Mobile monitor itself is the primary alarming device. When integrated with a hospital’s wireless network, the alarms are then propagated to the Remote Viewer Display (central monitor) and will only alarm at the wrist monitor if the Wi-Fi connection is unavailable. 

To clean the ViSi Mobile Monitoring System components
•    Hand wash the System components using mild soap or detergent (e.g. Alconox) and water
•    Cuff module is NOT waterproof, so clean it with a damp cloth
•    Use moistened cloths to remove residual cleaner 
•    Dry the System components
•    Visually examine each System component to ensure all soil contaminants have been removed

To disinfect the ViSi Mobile System Components
•    follow the recommended application of the disinfectant or use a basic wipe moistened with 70% isopropyl alcohol
•    Avoid hydrogen peroxide and/or bleach (see user guide for additional details)
•    Dry thoroughly

Yes. The ViSi Mobile System has been designed to reduce the number of non-actionable alarms per patient. Clinical alarms will annunciate based on configured parameter thresholds and delays set by the clinical staff. The majority of technical alarms (alerts) will only visually annunciate.

Yes. In June of 2022, Sotera Wireless, Inc. filed for a fictitious business name to be able to use Sotera, Inc. (without Wireless) to conduct business. Both Sotera and Sotera Wireless are legally acceptable names for our organization. You may also see the company referred to as Sotera Digital Health, Digital Health is a tagline.