FAQs

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  Clinical
Q:
What is the ViSi Mobile?
A:
The ViSi Mobile System is a platform that is designed to detect deterioration earlier and keep clinicians connected to their patients. Featuring wearable sensors that allow for freedom of movement, the system enables highly accurate, continuous monitoring of core vital signs.
Q:
What is the Indication for Use?
A:
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 received CE mark and is currently FDA cleared for continuous monitoring of ECG, Heart/Pulse Rate, SpO2, Blood Pressure (cuff-based and cuffless on beat-to-beat basis), Respiration Rate and Skin Temperature in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments. The ViSi Mobile Monitoring System may be used as standalone devices or networked to a ViSi Mobile Remote Viewer through wireless 802.11 communication.
Q:
What is the spectrum of vitals captured by ViSi Mobile?
A:
Vital Signs captured by ViSi Mobile, include the following:
    • SpO2 / PR
    • ECG / HR
    • Respiration
    • Skin Temperature
    • Non-invasive Blood Pressure (NIBP)
    • Continuous BP (cNIBP)
    • Non-invasive, cuffless with A-Line accuracy
Q:
How is the ViSi Mobile powered?
A:
The ViSi Mobile Monitor and Cuff Module are powered by rechargeable Li-Ion batteries. Sotera Wireless offers an 8-bay or 2-bay charger to recharge devices. The Chest Sensor and Thumb Sensor do not require batteries. The Monitor’s battery charge will last at least a shift. The Cuff Module will last approximately 30 inflations. ViSi Mobile also has an optional Power Pack that plugs into the monitor while on the patient to extend the monitor’s battery. The Power Pack can fully charge a ViSi Mobile monitor while on a patient and is also powered by a rechargeable Li-Ion battery.
Q:
Can the patient access the monitoring functions?
A:
It is possible to enable an optional clinical authentication code to prevent patient tampering.
Q:
Can the patient shower with the ViSi Mobile?
A:
All components with the exception of the Cuff Module are water proof 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.
Q:
Will the Monitor identify pacemaker spikes?
A:
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.
Q:
Can the Monitor be used during defibrillation?
A:
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.
Q:
Does the Monitor have clinical and technical alarm capabilities?
A:
Yes. The ViSi Mobile System has been designed with smart alarming 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. If the alert has been determined to have high severity, it will also audibly annunciate.
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Technical
Q:
Do you have a network topology diagram?
A:
Hospital networks will vary, below is a high-level diagram of how the ViSi Mobile System devices integrate with a hospital network. Once an installation is complete a network diagram will be created for that particular hospital:
Q:
How does ViSi Mobile Monitor integrate with a hospital network?
A:
The ViSi Mobile Monitors integrate with a hospital’s existing 802.11 networks. The standard system consists of 3 main components:
  • ViSi Mobile Monitor – Worn by the patient and communicates with the ViSi Mobile Appliance over the wireless network using an 802.11 radio.
  • ViSi Mobile Appliance – Compiles and distributes patient information to the ViSi Mobile Remote Viewer(s) using unicast or multicast.
  • ViSi Mobile Remote Viewer – Central station that allows the user to view patient vital signs and other continuous data
Q:
What co-existence Issues with other products might arise given a hospital’s wireless network may provide connectivity to multiple devices of differing manufactures?
A:
The ViSi Mobile Monitor can coexist with various medical and enterprise devices based on our lab and live testing. Our co-existence testing involved over 20 different yet common medical devices from differing manufactures..
Q:
On which wireless networks is the ViSi Mobile certified?
A:
The Sotera Wireless enterprise solution has been tested and validated on a Cisco network. The testing and output of these findings were submitted to the FDA for the initial 510(k) approval and was approved in August 2012.
  • The ViSi Mobile Monitor is also Aruba certified.
Q:
Is the application HIPAA compliant?
A:
Yes. The application isolates PHI from patient vital sign information for HIPAA
Q:
Can the ViSi Mobile Appliance be deployed virtually?
A:
Yes, it can be deployed on a virtual machine.  An onsite assessment and validation will be required.
Q:
Will the ViSi Mobile Appliance send data to another system or pull data from another system?
A:
  • Inbound: The ViSi Mobile Appliance (Server) communicates via the hospital wired network to the Hospital Admission/Discharge/Transfer (ADT) via the Health Level 7 (HL7) standard. The inbound ADT data is utilized by the Sotera application to provide patient identity information for display on the ViSi Mobile Monitors.
  • Outbound: Sotera Wireless has an Open API capable of interfacing with 3rd party systems like an EMR or Remote Alarming via a middleware or device connectivity engine.
Q:
Does the ViSi Mobile Appliance require remote secure VPN access?
A:
Yes, remote access via SecureLink is required for the ViSi Mobile Appliance (Server) for troubleshooting and software updates.
Q:
What Remote Viewer software is required?
A:
  • Operating System: Microsoft Windows 7, 64 bit only
  • Java Run-Time Version 1.7.0_06-624
Q:
How will Sotera Wireless manage windows updates?
A:
Wireless Customer Support will coordinate with the site’s technical resources to implement software updates of the RVD workstation software configuration or updates to the Windows Operating System (OS).  However, the customer is responsible for validating in a non-production environment.  This technical assistance is included with a Sotera System Support Agreement.
Q:
Are there known conflicts with Anti-Virus products and /or scans?
A:
Although there are no known conflicts, the customer should validate the system functionality in combination with the preferred Anti-Virus product.
Q:
What equipment is needed for non-production testing for integrations?
A:
The ViSi Mobile monitor and sensors are required along with disposables.  A charger is recommended to ensure the device is charged.  A virtual server and RVD are setup by Sotera Wireless.
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