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Burn Navigator
®
Active
User's Manual
February 2021
Burn Navigator Active
Manual-1153
Version 6.4.2
Revision A

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Summary of Contents for Arcos Burn Navigator Active

  • Page 1 Burn Navigator ® Active User’s Manual February 2021 Burn Navigator Active Manual-1153 Version 6.4.2 Revision A...
  • Page 2: Table Of Contents

    Contents Description ..........................3 Intended Use ......................... 3 Safety Information ......................... 3 Use Warnings........................3 Incoming Device Setup, Cleaning & Maintenance, Handling ..........5 Tablet Description ......................... 7 First-time Operation ......................8 Using the Burn Navigator App .................... 10 Splash screen ........................10 Main Menu ........................
  • Page 3: Description

    Burn Navigator® is a Clinical Decision Support tool to help health care providers manage IV Description fluid therapy for adult and pediatric severe burn patients. Each Burn Navigator device allows resuscitation of only one patient at a time. The Burn Navigator is indicated for use in the care of adult patients with 20% or more Total Intended Use Body Surface Area (TBSA) burned, or pediatric patients, 24 months old or older, weighing at least 10 kg with 15% or more TBSA burned, as a fluid resuscitation monitor and calculator...
  • Page 4 in a particular patient, such as can happen with acute renal failure or use of diuretics, consult with attending physician for appropriate fluid therapy. WARNING! The Weight-based protocol is not intended for patients weighing less than 10 kg, because immature kidneys may not regulate output during hypovolemia.
  • Page 5: Incoming Device Setup, Cleaning & Maintenance, Handling

    Incoming Device Setup, Cleaning & Maintenance, Handling Incoming device setup • Connect to the internet via Wi-Fi to check for updates and ensure you have the latest software version. The product will also automatically synchronize its clock when connected to the internet. •...
  • Page 6 Place the computer on a flat stable surface. Do not place the computer upright or turn it over. If the Operational environment computer is exposed to an extremely strong impact, it may become damaged. Do not expose the skin to this product when using the product in a hot or cold environment. If the computer is wet in temperatures of 0 °C {32 °F} or below, freeze damage may occur.
  • Page 7: Tablet Description

    Tablet Description The Burn Navigator Active device uses a Samsung Galaxy Tab Active Pro tablet. Front 1. Display 2. Back key 3. Home key 4. Menu key Back 5. Camera 6. Stylus receptacle 7. Power key 8. Volume Up/Down keys 9.
  • Page 8: First-Time Operation

    First-time Operation AC-USB 3.1 Adapter (1) & USB A-to-C 3.5’ Cable (1) Protective Cover (1) Battery Pack (1) CMP-1805 CMP-1803 CMP-1806 Stylus (1) CMP-1804 The tablet ships with a battery pre-installed. To replace the battery, do the following: Installing or Replacing the Battery 1.
  • Page 9 • Check the battery level regularly. Charge the battery as needed or when the battery level drops below 20 About the battery for this tablet percent. To extend the lifetime of the battery, disconnect the charger once the battery level is above 80 percent.
  • Page 10: Using The Burn Navigator App

    Using the Burn Navigator App CAUTION Before using the Burn Navigator, assess the patient and perform any lifesaving interventions needed. The Burn Navigator is a fluid calculator and does not provide direct therapy to the patient. When the app starts, you will see the splash screen. Press “OK” to close the splash screen and Splash screen go to the main menu.
  • Page 11: New Patient Setup

    New Patient Setup From the Main Menu, press “Start New Patient” or “Training Mode”. 1. If you chose “Training Mode”, there will be an automatically generated patient ID. Otherwise, select the patient ID field and enter the patient ID using the touch keyboard that appears. If you enter a patient ID that starts with “training”, then the new patient will be started in training mode.
  • Page 12 3. Choose the protocol. a. Adult predictive algorithm: Targets 30-50 mL/hr Urine Output (UO). This protocol uses the Salinas algorithm developed by the US Army Burn Center (Salinas, J et al, Computerized decision support system original study, Crit Care Med 2011, 39(9), 2031-8). The improves fluid resuscitation following severe burns: An Salinas algorithm uses the trend of the last three hours of UO to recommend the next hour’s IV infusion rate.
  • Page 13 4. Enter the total burned surface area (TBSA). Diagrams are provided for reference. Use the age group radio buttons change the displayed diagram. CAUTION: Only include 2 and 3 degree burns when calculating the TBSA! 5. Patient height is an optional field for the Adult predictive protocol.
  • Page 14 On the Recommendation screen, you may choose the primary resuscitation fluid type. Lactated Ringer’s is selected by default. a. Options include albumin protocols, where the primary fluid to be titrated is composed of, e.g., 2/3 LR and 1/3 Albumin 5%. If you choose one of these protocols, you will see the calculated rate for each fluid under the “Recommended rate”...
  • Page 15: Checklist

    After you start a new patient, a pop-up message will Checklist ask you to complete a patient assessment checklist. Press “Yes”. On the checklist screen you can enter vitals and labs, as well as completing extremities steps and observations. The Checklist allows you to track other indicators of resuscitation status other than urine output.
  • Page 16: Hourly Fluid Updates

    The Fluid Update Wizard (series of screens) will Hourly Fluid Updates appear automatically when it is time to do an hourly fluid update. The Urine Data screen shows the “From” and “To” times for this update. a. The “From:” time is the last time you entered data (new patient setup or last hourly update).
  • Page 17 • The Burn Navigator does not communicate with your fluid infusion pump(s), so it does not know when or by how much you may have changed pump flow rates during the time period, unless you update the pump setting changes timely on the Home screen or provide the total volume during the fluid update.
  • Page 18 5. Next, you’ll see the New Rate screen. This screen shows you the previous rate and the recommended rate with a percent change indicator. You may enter a different fluid rate by pressing the white box indicating “New rate.” a. In Monitor Only mode, you won’t see a recommendation.
  • Page 19: Patient Resuscitation Screens

    The patient resuscitation screens show a top bar, a row of six tabs to select the six patient Patient Resuscitation Screens resuscitation screens, and a row of functional buttons along the bottom of the first three screens. The top bar shows the Patient ID, patient weight and TBSA, the current Hour Post Burn Top Bar (HPB), and the current time.
  • Page 20: Functional Buttons

    Along the bottom of the Home, Patient and Notes screens is a row of Functional buttons. Functional Buttons The “Next Update” button is visible only in Training Mode. Note that for an inactive patient file, the only available action is Main Menu: The first button, “Hourly Update”...
  • Page 21: Enter Notes

    Pressing the Enter Notes button takes you Enter Notes to a keyboard screen for entering notes. a. This text field is multi-line, so you can enter more than one line of notes at a time. b. The notes will appear on the Status screen.
  • Page 22: Home

    The Home screen shows: Home 1) The current primary fluid 2) The current infusion rate 3) When the next update is due 4) By hour post burn 10, the Projected 24 hour volume. The Next Update Due will show a number of minutes until the update is due, or it will show “NOW”...
  • Page 23 On the Patient tab, select the Minimum rate field to see the Minimum rate screen. The Minimum rate screen shows the lowest recommendation the Burn Navigator will provide for a patient. a. First 8 hours post burn (HPB): the minimum rate is determined by the 2mL/kg/TBSA formula.
  • Page 24: Notes

    The Notes screen has two sections. Notes The Notes section on the left shows any notes that have been entered through the “Enter Notes” button, as well as various Burn Navigator- generated notes. The first note, “Resuscitation Plan” is automatically added based on the options chosen in the new patient setup.
  • Page 25: I/O Table

    The I/O Table shows all the fluid information for the patient. I/O Table On the left of the screen is a list of fluids and other information: the UO (in mL and in mL/kg/hr), Recommended Rate for that time period, Actual Primary Fluids given to the patient, and Total Additional Fluids.
  • Page 26 Note: The I/O Graph screen shows the values from the Hourly Averages view of the I/O Table. If you notice an error in the I/O Table, you can correct it only in the Actual Times (edit) Editing Data view. Press the column representing the time period you want to edit. The first column records the pre-Burn Nav fluid measurements as entered during patient setup.
  • Page 27: Volume

    The volume graph shows the cumulative volume of all fluids that the patient has received Volume since the burn occurred. Note: The Cumulative Volume graph includes both primary and additional fluids. There are four or five lines overlaying the volume graph: Green: Modified Brooke formula (2 mL/kg/TBSA in 24 hours) Yellow: Parkland formula (4...
  • Page 28: I/O Graph

    The I/O Graph indicates Fluids In on top portion of the graph and Urine Output on the I/O Graph bottom. Each bar is one clock hour (each hour post burn (HPB)). The data seen in the I/O Graph is the Hourly Averages data from the I/O Table.
  • Page 29: Safety Features

    The Burn Navigator comes with a number of safety features to help ensure the patient is Safety Features getting adequate fluid resuscitation without excessive fluids. There are several safety rules included in the recommendation algorithm. For example: • The recommendations won’t change more than 40% from the last infusion rate. •...
  • Page 30 The Volume graph has the Modified Brooke and Parkland resuscitation guidelines, as well as the 200 mL/kg/24 hours and 250 mL/kg/24 hours alert lines. The Volume graph also changes colors when the two alert levels are reached. The 24 hour volume projection can be used as a safety trigger to start an intervention, such as albumin or plasmapheresis, to...
  • Page 31: Settings

    Settings The Settings screen is accessible from the main menu by pressing the “Settings” button. Clinical settings The Clinical settings tab allows you to change certain default settings for resuscitations. General settings These settings apply to all patients. • Hourly update sound — If checked, the software will play an alert sound when it is time to do an hourly fluid update.
  • Page 32: Burn Nav Web Integration

    NOTE: Burn Nav Web integration is currently available only for subscribers based in the USA. NOTE: At present, there is no means to unlink a device from a Burn Nav Web account. Contact Arcos for support. Importing Clinical Settings When the device is linked to Burn Nav Web, the Admin Settings tab will have a new button “Import Settings from Web”.
  • Page 33: Handoff

    Handoff The Handoff wizard is accessible via the “Handoff” button on the main menu. Bluetooth Handoff Bluetooth handoff allows to transfer patient records between two Android or iOS devices. In order to use this feature, both devices must support Bluetooth low energy, and must have installed version 6.3.0 or later of the Burn Navigator app.
  • Page 34: Web Handoff

    Web Handoff Web handoff can be used to securely upload a patient record to Arcos servers so that users can continue resuscitation using the web edition of Burn Navigator. A Burn Nav Web enterprise subscription (sold separately) is required to use web handoff.
  • Page 35: Security And Privacy Safeguards & Best Practices

    It is assumed that organizations will have appropriate physical access controls in place to protect the device against theft or access by unauthorized persons. Arcos does not enter into a business associate agreement with you or your organization solely by virtue of your purchase and/or use of the Burn Navigator tablet.
  • Page 36: Faq - Frequently Asked Questions

    8. Why is the first bar in the Fluids I/O graph so short? FAQ – Frequently Asked Questions a. The first bar represents the entire clock hour (e.g., 4:00 to 4:59am) in which the patient was burned. If the patient wasn’t burned exactly at the beginning of that hour (e.g., burned at 4:50am), then the patient didn’t receive fluids the whole hour.
  • Page 37 a. Yes. The recommendations are only intended until the next top of the hour (e.g., Do the recommendations expire? until 4:00pm, 5:00pm, etc.). It is important to check the patient’s urine output and other resuscitation indicators at the top of each hour. If a fluid update time period ends within the last 15 minutes of a clock hour (e.g., from 3:45 to 3:59pm), then the software will wait until the top of the next full clock hour for another hourly fluid update (e.g., 5:00pm).
  • Page 38: Troubleshooting

    Troubleshooting The device does not ● Connect the AC adapter. Starting Up boot. ● Insert a fully charged battery. ● Remove the battery pack and the AC adapter, and then connect them again. Cannot turn on the • Leave it in an environment of 5 °C {41 °F} to 35 °C {95 °F} for about an tablet.
  • Page 39: Software Warnings, Alerts, And Messages

    The Burn Navigator displays warnings, alerts, and messages during patient care. Below is a Software Warnings, Alerts, and Messages list of the Warnings, alerts, and messages along with their triggering events. Myoglobinuria indicated WARNING! Gross myoglobinuria may require a high target urine Cause of Warning Warning Text by user...
  • Page 40 Upon starting a new patient, “It is time to complete the patient checklist. Please Cause of Alert or Message Alert or Message Text periodically, and when reaching certain complete the checklist and notify the attending cumulative volume levels physician. Do you want to go to the checklist now?“...
  • Page 41 User changes the infusion rate from the “Please consult with the attending physician Cause of Alert or Message Alert or Message Text Home screen (not in the hourly fluid before changing the infusion rate. Do you want to update) change the rate?” In the hourly fluid update, the user “You have not recorded a urinary output.
  • Page 42 The user indicates that the patient is “Alert! Consult with attending physician about an Cause of Alert or Message Alert or Message Text hypotensive, hyperglycemic, on appropriate fluid rate during presence of pressors or on diuretics when the hypotension, hyperglycemia, pressors or algorithm recommends a decrease in diuretics.”...
  • Page 43 The user presses the Hourly Update “It is not yet time to do the hourly fluid update or Cause of Alert or Message Alert or Message Text button, but it is too late to redo the last the 10 minute edit window has expired. hourly update and it is not yet time for a new hourly update.
  • Page 44: Hardware Information

    Hardware Information Note: This equipment has been tested and found to comply with the limits for a Class B digital device, Federal Communications Commission Radio Frequency Interference Statement pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
  • Page 45 If a Hardware Malfunction or Trouble Occurs, Immediately Stop Use • The device is damaged If Any of These Hardware Malfunctions Occur, Immediately Unplug the AC Plug and the Battery Pack. • Foreign object inside the device • Smoke emitted •...
  • Page 46 resulting condition may lead to short-circuiting or insulation defects, etc. which may in turn lead to a fire or electric shocks. Pulling on the cord may damage the cord, resulting in a fire or electric shock. Hold the Plug When Unplugging the AC Plug The AC cord may be damaged, resulting in fire or electric shock.
  • Page 47 Do Not Use This Product with a Battery Pack Other Than the One Specified by Getac or supplied by Arcos may present a safety hazard (generation of heat, ignition or rupture). Continued use of a damaged battery pack may result in heat generation, ignition or battery rupture.
  • Page 48 • The battery pack may become warm during recharging or normal use. This is completely normal. NOTE • Recharging may not commence if internal temperature of the battery pack is outside of the allowable temperature range (0 °C to 50 °C {32°F to 122 °F}). Once the allowable range requirement is satisfied, charging begins automatically.
  • Page 49 Tablet Specifications Model Burn Nav Active (Product no. 1153) 2 GHz, 8-core Qualcomm SDM670 Main Specifications Main Memory* 4 GB RAM Internal Storage* 64 GB internal flash storage External Storage* MicroSD card (up to 512 GB) (sold separately) Interface USB 3.1 Type-C connector 10.1”...
  • Page 50: Service & Technical Support

    Shipping information will be provided. Copyright The Burn Navigator app software is © 2012-2021 Arcos, Inc. Copying, redistribution, translation, decompilation, or modification of the Burn Navigator software is strictly prohibited without prior written authorization from Arcos, Inc. Infringement is subject to civil and/or criminal penalties under U.S.
  • Page 51: Index

    Index Information, 44 Battery Inserting and About, 8 Precautions, 47 Spare, carrying, 6 Specifications, 49 Troubleshooting, 38 Burn Nav Web, 32, 34 Checklist, 15 Frequently Asked Questions (FAQ), 36 Handoff, 33 Button, 20 Hourly Update Process, 16 Intended Use, 3 Question, 11 Myoglobinuria Warning, 39...
  • Page 52 Arcos, Inc. 4714 Riverstone Blvd Ste 200 Missouri City, TX 77459 support@arcosmedical.com 877-542-8025 Copyright © 2021 Arcos, Inc. All rights reserved. Burn Navigator® User’s Manual Page 52...

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