FAQs

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Clinical

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
  • Temperature (skin)
  • Continuous BP (cNIBP)
    • Non-invasive, cuff-less, with A-Line accuracy
    • On ambulatory patients
    • Cuff-based calibration only every 8 hours
Q:
What are Examples for FDA Approved Medical Devices That Run Operate On 802.11 Wireless Networks?
A:
  • There are already multiple medical devices which are 510(k) approved such as:
  • Infusion pumps
  • Monitoring devices
  • The definite trend over the past several years has been to incorporate 802.11radios into medical devices and make this a part of the overall enterprise infrastructure or solution design. This includes both patient monitoring and smart infusion pumps.
  • All companies have either received FDA 510K, or a predicate letter has been filed.
  • Finally, all the major infusion pump companies, CareFusion, Hospira, Baxter, Sigma, BBraun, and Smiths Medical have introduced wireless smart infusion pumps to the market.
Q:
Why Does the ViSi Mobile Monitor Screen Go Blank Periodically?
A:
The display may be blank for one of the following reasons:
  • The display may be in Quiet Monitoring Mode. Touch the screen with one finger for two seconds to activate display or plug in a sensor to initiate monitoring.
  • The display may be in Hibernation Mode. Plug in a sensor to initiate monitoring.
  • The battery charge may be too low. Disconnect all sensors from the ViSi Mobile Monitor, clean, and place it in the Charger.
Q:
Why Don’t I See a HR Numeric Or ECG Waveform?
A:
  • The ECG electrodes may not be connected to lead wires. Ensure that the lead wires are snapped securely onto the ECG electrodes.
  • The ECG electrodes may not be firmly attached to the patient’s chest. Ensure that the ECG electrodes are securely attached to the chest also that the ECG electrode sites are clean and free of excess hair.
  • ECG electrode gel may be dry, if so replace the ECG electrodes.
  • The lead wires may be broken or damaged, if so replace damaged Chest Sensor Cable.
  • Chest Sensor Cable may not be securely plugged into the Monitor. Check to make sure Chest Sensor Cable is securely plugged into the Monitor.
Q:
Why Does the Heart Rate Seem Erratic?
A:
  • ECG electrodes are may not be all the same. Check and use all the same ECG electrode type, size, materials, and manufacturer.
  • ECG electrode gel may be dry, if so replace the ECG electrodes.
  • The ECG electrodes may not be firmly attached to the patient’s chest. Ensure that the ECG electrodes are securely attached to the chest also that the ECG electrode sites are clean and free of excess hair.
Q:
Why Does the ECG Waveform Display So Small?
A:
  • If using a 3-lead Chest Sensor Cable the Lead II may have low amplitude. LD II only available with a 3-lead Chest Sensor Cable. Select alternate ECG electrode sites; prepare skin sites; connect lead wires to new ECG electrodes and place on the chest. Also you can try replacing 3-lead Chest Sensor Cable with 5-lead Chest Sensor Cable.
  • If using a 5-lead Chest Sensor Cable the selected lead may have low amplitude. Select a different lead to view.
Q:
Why Don’t I See a RESP Numeric?
A:
  • The ECG electrodes may not be connected to lead wires. Ensure that the lead wires are snapped securely onto the ECG electrodes.
  • The ECG electrodes may not be firmly attached to the patient’s chest. Ensure that the ECG electrodes are securely attached to the chest also that the ECG electrode sites are clean and free of excess hair.
  • ECG electrode gel may be dry, if so replace the ECG electrodes.
  • The lead wires may be broken or damaged, if so replace damaged Chest Sensor Cable.
  • Chest Sensor Cable may not be securely plugged into the Monitor. Check to make sure Chest Sensor Cable not securely plugged into the Monitor.
  • The Monitor may not be capable of measuring RESP. See your Bio Med for more information.
Q:
Why Is the RESP Erratic?
A:
  • ECG electrode gel may be dry, if so replace the ECG electrodes.
  • The ECG electrodes may not be firmly attached to the patient’s chest. Ensure that the ECG electrodes are securely attached to the chest also that the ECG electrode sites are clean and free of excess hair.
Q:
Why Don’t I See a TEMP Numeric?
A:
  • The Chest Module sensor may be placed on the patient with the Temperature Sensor facing away from the patient. If so, place the Chest Module sensor on the patient such that the Temperature Sensor is in direct contact with the patient’s chest.
  • The sensor may not be attached to the patient’s chest. If not, secure the Chest Sensor Cable to the chest and make sure that a change in position does not affect the sensor’s contact with the skin.
Q:
Why Is the TEMP Erratic?
A:
  • Chest Sensor Cable may not be in contact with the skin completely and securely. If not, secure the Chest Sensor Cable to the chest and make sure that a change in position does not affect the sensor’s contact with the skin.
  • The skin may not be clean and dry. Clean and dry the skin thoroughly and secure the Chest Sensor Cable to the chest.
Q:
Why Don’t I See a SpO2 Numeric?
A:
  • The Thumb Sensor may be broken or damage. Replace the Thumb Sensor.
  • Ensure nothing is blocking the optics or detector.
  • Make sure the Thumb Sensor is securely in the Thumb Sensor cradle and secured at the base of the thumb.
  • Ensure that the Thumb Sensor is securely plugged into the Monitor.
Q:
Why Is the SpO2 Erratic?
A:
  • Ensure nothing is blocking the optics or detector.
  • Make sure the Thumb Sensor is securely in the Thumb Sensor cradle and secured at the base of the thumb.
  • The Thumb Sensor may not be in the correct location. Reorient the Thumb Sensor at the base of the thumb and secure with the Thumb Wrap.
  • The Thumb Sensor may be too tight. Loosen the Thumb Strap making sure that it is still secure.
Q:
Why Don’t I See a NIBP Measurement?
A:
  • The battery charge may be too low. Replace with a charged Cuff Module.
  • Make sure that the Cuff Module is plugged securely into the Monitor.
  • You may not be set up for automatic measurements. From the NIBP Settings screen, select an automatic interval.
  • The time from the last measurement may exceed the period of time to display a measurement. Initiate a measurement from the Vital Signs screen.
Q:
Why Doesn’t the NIBP Measurement Match My Auscultatory Measurement?
A:
  • The measurements may not have been taken at the same time. Retake the measurements ensuring they are done at the same time.
  • Ensure the measurements were taken on the same arm. Retake the measurements ensuring they are done at the same time and on the same arm.
  • Also ensure the BP cuff size is the same on both arms, and the correct size for the arm.
  • Both arms may not have been at the same level when the BP was measured. Retake the measurement and ensure the arms are positioned at the same level relative to the heart.
Q:
Why Does the LED On the Cuff Module Display Red When In the Charger?
A:
Voltage or current level or over temperature protection current temperature may have exceeded its expectation. Remove the Cuff Module from the Charger and report the problem to Sotera Wireless Inc. Customer Service Department +1 (866) 794-5526 (North America), +1 (858) 373-4870 (International), or the Sotera Wireless representative in your area.
Q:
Why I Don’t Receive a Response to Touching Any Buttons On the Screen?
A:
Ensure you are not touching the screen with more than “one” finger and not using a pen or stylus. Also ensure the button you are touching is an active button.
Q:
Can the Patient Access the Monitoring Functions?
A:
  • No, if the proper authentication code is used by the Healthcare worker, the system display can be locked from patient tampering.
  • Make sure to lock the screen each time you complete your interactions. Remind the patient that this is a medical device, and that tampering may result in missing important clinical events.
  • It’s also possible the patient guessed the PIN correctly. Make sure to define appropriate PIN codes (not 0000 for example).
Q:
The Batteries Do Not Appear to Be Charging In the Monitor and/or Cuff Module?
A:
  • Make sure that the Monitor and Cuff Module are securely seated in the Charger in the right direction.
  • Ensure that the plug is securely plugged into an active wall socket and there is a green light on the Battery Charger. Also make sure the AC Adaptor is plugged into the Charger.
  • Make sure that the power cord is not damaged.
Q:
Is ViSi Mobile Approved to Be Used On Children (pediatrics)?
A:
No, the product is not cleared for use in the pediatric age group.
Q:
What Is the Range Of the ViSi Mobile Monitor From a Wireless Access Point?
A:
The ViSi Mobile Monitor will sustain a wireless connection from 17 to 57 feet from the wireless access point depending on a variety of variables, including the orientation / posture of the patient’s arm and type/ number of physical partitions (walls etc.) between the ViSi Mobile Monitor and the wireless access point.
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: the product roadmap for the ViSi Mobile Appliance (Server) and the Patient Data Software contains plans to send information to various EMR systems.
Q:
Is the ViSi Mobile Appliance Capable Of Interfacing with a Nurse Call System (e.g. Vocera)?
A:
The ViSi Mobile Appliance does not interface with a Nurse Call System. However, in future feature releases the ability to use the ViSi Mobile Monitor as a two-way communication device will be available.
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Technical

Q:
Why Does the LED On the Cuff Module Display Red When In the Charger?
A:
Voltage or current level or over temperature protection current temperature may have exceeded its expectation. Remove the Cuff Module from the Charger and report the problem to Sotera Wireless Inc. Customer Service Department +1 (866) 794-5526 (North America), +1 (858) 373-4870 (International), or the Sotera Wireless representative in your area.
Q:
Can the Patient Access the Monitoring Functions?
A:

  • No, if the proper authentication code is used by the Healthcare worker, the system display can be locked from patient tampering.

  • Make sure to lock the screen each time you complete your interactions. Remind the patient that this is a medical device, and that tampering may result in missing important clinical events.

  • It’s also possible the patient guessed the PIN correctly. Make sure to define appropriate PIN codes (not 0000 for example).

Q:
The Batteries Do Not Appear to Be Charging In the Monitor and/or Cuff Module?
A:

  • Make sure that the Monitor and Cuff Module are securely seated in the Charger in the right direction.

  • Ensure that the plug is securely plugged into an active wall socket and there is a green light on the Battery Charger. Also make sure the AC Adaptor is plugged into the Charger.

  • Make sure that the power cord is not damaged.

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 Devices Integrate with A Hospital Network?
A:
  • The ViSi Mobile devices integrate with a hospital’s existing 802.3 and 802.11 networks.
  • The standard system consist of 3 main components:
    • ViSi Mobile Monitor – worn by the patient and communicates with the ViSi Mobile Appliance over the wireless network using an 802.11b radio.
    • ViSi Mobile Appliance – a 1U racked server that collects, compiles and distributes patient information to the ViSi Mobile Remote Viewer(s) using multicast.
    • ViSi Mobile Remote Viewer – a wired or wireless computer or tablet running Java based software that allows the user to view patient vital signs and other data.
Q:
Can the ViSi Mobile Devices Operate In a Routed Environment? Can the Client Workstations and Server Hardware Be On Different Subnets?
A:
  • Yes the devices can operate in a routed environment and be different networks within a hospital.
  • However, operating over a WAN or a large campus is not recommended because the data is latency sensitive.
Q:
What Type of Security Does the ViSi Mobile Monitor Support?
A:
ViSi Mobile supports WPA2 Personal (PSK).
Q:
Does the ViSi Mobile Monitor Require a Dedicated SSID?
A:
The Monitor does not require a dedicated SSID. However, a dedicated SSID may be required if the proposed SSID does not support the Monitor’s minimum wireless network requirements.
Q:
Do the ViSi Mobile Devices Require Static IP Addresses?
A:
  • Only the ViSi Mobile Appliance requires a static IP address for the primary and secondary Ethernet ports.
  • All other ViSi Mobile devices will accept an IP address from a DCHP server.
Q:
Can Your Device Interact With a RFID System?
A:
Our devices meet the requirements to be located on a RFID designed / enabled wireless network. Further testing is required to determine the ability of our ViSi Mobile system to interface with a locator system.
Q:
We Understand That You Use an 802.11b Radio, Why Are You Not Using 802.11g/n or 802.11a/n Radio?
A:
At present we are using the GainSpan GS1011 ultra low power Wireless Single Chip which contains an 802.11b radio, media access controller (MAC) and baseband processor, on-chip flash memory and SRAM and an applications processor all on a single package. Our application does not place huge demands of bandwidth on the network, so the use of an 802.11b radio on the client end is sufficient. It is our plan to migrate to an 802.11a/g/n at a future time.
Q:
Are There Any Specific Network Requirements For the ViSi Mobile Devices To Operate (i.e. QoS, Multicast, Dedicated VLAN, etc.)?
A:
Multicast must be enabled and configured on the wired and wireless network in order for the ViSi Mobile Appliance to distribute patient data to the ViSi Mobile Remote Viewers.
Q:
What Is the Size Of the File Transferred Over the LAN/WAN?
A:
Standard TCP/IP packet size of about 20 Kilobytes /second.
Q:
How Will the ViSi Mobile Monitor Handle “Roaming” (i.e., patients that will move between areas of the hospital, yet still stay connected to the ViSi Mobile Appliance)?
A:
Depending on the location of the next wireless access point there will be a short drop-out when the ViSi Mobile Monitor moves from one AP to another (real-time transmission to ViSi Mobile Remote Viewer interrupted for an average of 10 to 30 seconds).
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. ViSi Mobile Monitor is also Wi-Fi Certified which certifies our ability to interoperate with other Wi-Fi Certified devices.
  • In addition, co-existence testing is required for FDA approval. Our co-existence testing involved over 20 different yet common medical devices from differing manufactures.
Q:
We Currently Use Cisco Systems, Inc. LWAPP (Lightweight Access Point Protocol) and CAPWAP (Control and Provisioning of Wireless Access Points) Network. Is Your Product Certified For Use On Cisco Systems, Inc?
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 and gained 510(k) approval in August 2012.
  • The ViSi Mobile Monitor is Wi-Fi alliance certified.
Q:
Our IT Department Is an Aruba Networks shop. Have You Tested and Are You Certified For Use on Aruba network?
A:
Further testing is required, however all indicators show that the ViSi Mobile Monitor will operate on an Aruba network.
Q:
What Is the Range Of the ViSi Mobile Monitor From a Wireless Access Point?
A:
The ViSi Mobile Monitor will sustain a wireless connection from 17 to 57 feet from the wireless access point depending on a variety of variables, including the orientation / posture of the patient’s arm and type/ number of physical partitions (walls etc.) between the ViSi Mobile Monitor and the wireless access point.
Q:
Can the Sotera Wireless ViSi Mobile Appliance (Server) Work In a Virtual Environment (e.g. VMware)?
A:
  • No, the Appliance (Server) based Patient Data Software is not qualified to operate in any “virtual” environment.
  • The application requires on-demand CPU cycles to effectively process the waveform data being collected. The CPU cycle time increases as the number of ViSi Mobile Monitor’s increase. This real-time requirement may present issues in a virtual environment where the Server is hosting many sessions across multiple applications.
Q:
What Is the Recommended Configuration For the ViSi Mobile Appliance (Server)?
A:
  • 1 U Rack Mount
  • CPU: An Intel XEON E5620, 4 Core, 2.4 GHz (or equivalent) is recommended.
  • RAM: A minimum of 8GB is recommended.
  • Drives: 4 500GB drives configured as Raid 10
  • Power Supplies: Dual
  • Network Interface Cards: Dual
  • Operating System: SUS Linux Enterprise v. 11.4
Q:
What Is the Approximate Price Of a Server Configured To Function As a ViSi Mobile Appliance (Server)?
A:
Appliance (Server) recommended for Small installations (1-32 ViSi Monitors) Dell or HP server configured appropriately should cost approximately $4200.
Q:
Does the Application Have Policies and Procedures In Case Of a Security Breach?
A:
Yes, the application is HIPAA compliant for PHI data handling.
Q:
Is the Hospital Responsible for Storing, Backing Up and Retaining This Application Data? If So, How Much Data? Retained For How Long?
A:
Daily incremental backups and Weekly complete system image backups are recommended
Q:
Will the ViSi Mobile Appliance Software Operate on Microsoft Windows Server 2003 Standard 32 bit with SP2?
A:
  • No, the Patient Data Software is not compatible with MS Windows Server.
  • The Appliance (Server) Operating Systems is SUSE Linux Enterprise Ver. 11.4.
Q:
Does the ViSi Mobile Appliance Capture Protected Heath Information (PHI) / Financial information?
A:
No
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: the product roadmap for the ViSi Mobile Appliance (Server) and the Patient Data Software contains plans to send information to various EMR systems.
Q:
Is the ViSi Mobile Appliance Capable Of Interfacing with a Nurse Call System (e.g. Vocera)?
A:
The ViSi Mobile Appliance does not interface with a Nurse Call System. However, in future feature releases the ability to use the ViSi Mobile Monitor as a two-way communication device will be available.
Q:
Does the ViSi Mobile Appliance (Server) Require Remote Secure VPN Access?
A:
Yes, remote access is required for the ViSi Mobile Appliance (Server) for troubleshooting and software updates a secure VPN required or (Enexity/SecureLink) is recommended.
Q:
What Is the Recommended Configuration For the ViSi Mobile Remote Viewer?
A:
  • CPU Speed -3.10 GHz is recommended to process the real-time waveforms being generated
  • RAM – >A minimum of 4GB is recommended.
  • Screen Resolution: 1920 x 1080
Q:
How Many Monitored Patients Can Be Displayed On the ViSi Mobile Remote Viewer?
A:
  • Thirty two (32) patient sessions can be displayed simultaneously on one ViSi Mobile Remote Viewer
  • ViSi Mobile Remote Viewers are desktop or laptop computers, or tablets that have been qualified for use with our ViSi Mobile Remote Viewer Software. Desktop Computers (maximum display size) that have been qualified include:
    • HP 9300 All-in-One Touch Screen Computer with 23” 1920X1080 resolution display
    • HP 8200 All-in-One Non-touch screen computer with 23” 1920X1080 resolution display
Q:
What Remote Viewer Software Is Required?
A:
  • Operating System: Microsoft Windows 7, 64 bit only
  • Does not require local admin rights for normal usage
Q:
What Type Of Client Software Must Be Loaded On Remote Viewing Devices (laptops and tablets) To Interact with Your Application?
A:
A Java runtime applet is loaded on the workstations. Once a Java – server session is created, the application will keep the Java runtime applet updated with latest revisions.
Q:
Are There Known Conflicts with Anti-Virus Products and /or Scans?
A:
No known conflicts.
Q:
Will the ViSi Mobile Software Co-exist with 3rd Party Software On a Tablet, Laptop, or Desktop Computer?
A:
Yes, our software uses a Java runtime applet and will co-exist with other applications and software running on the same machine.
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