Dictum Health eVER-HOME User manual

Title: DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
ECO#: DC00287
Document#: 870-00052-01
Originating Author: R Massie
Contributing Authors: K Hobbs, P Landesman
Date Created: 9/04/2018
Date Modified: 05/27/2020
Revision: E
Page: 1 of 170
eVER-HOME
Instructions for Use

Title:
DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
Document #
870-00052-01
Revision:
E
Page:
2 of 170
***Confidential and Proprietary of Dictum Health***
1.1 Warranty Statement....................................................................................................... 6
1.2 Indications for Use......................................................................................................... 7
1.3 Contraindications........................................................................................................... 7
1.4 General Warnings.......................................................................................................... 8
1.5 General Cautions........................................................................................................... 9
2.1 Start............................................................................................................................. 10
2.2 Home Screen............................................................................................................... 10
2.3 Accessories ................................................................................................................. 23
3.1 Weight & Height........................................................................................................... 25
3.2 Blood Pressure............................................................................................................ 37
1Introduction.................................................................................................................. 5
2The eVER-HOME monitoring platform..................................................................... 10
Tap START to sign-in to the eVER-HOME........................................................... 10
Tests and Services............................................................................................... 11
Action Bar Settings............................................................................................... 12
Bluetooth.............................................................................................................. 14
Cellular................................................................................................................. 14
Wi-Fi..................................................................................................................... 16
Switching Network Connectivity ........................................................................... 16
To Troubleshoot Network Connectivity:................................................................ 17
Dictum Health Server........................................................................................... 17
Battery.................................................................................................................. 18
Messages............................................................................................................. 19
Help...................................................................................................................... 20
To navigate the Instructions for Use (IFU):........................................................... 20
Virtual Exam Room (VER) Status......................................................................... 21
3Testing........................................................................................................................ 25
Weight test using Bluetooth.................................................................................. 25
Weight manual entry ............................................................................................ 27
Height manual Entry............................................................................................. 30
Weight & Height results........................................................................................ 31
A&D Deluxe Connected Weight Scale (UC-352BLE) User Manual...................... 34

Title:
DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
Document #
870-00052-01
Revision:
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Page:
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3.3 Thermometer............................................................................................................... 69
3.4 Pulse Oximeter............................................................................................................ 83
3.5 Glucose...................................................................................................................... 113
3.6 Pain............................................................................................................................ 149
Blood Pressure Warnings and Cautions............................................................... 37
Blood pressure testing using Bluetooth................................................................ 39
If the blood pressure monitor isn’t paired to the eVER-HOME. ............................ 39
Pairing the A&D Blood Pressure Monitor ............................................................. 40
Pairing the Omron Blood Pressure Monitor.......................................................... 42
Automatic Blood Pressure Test............................................................................ 44
Blood Pressure test manual entry ........................................................................ 45
Blood Pressure results ......................................................................................... 47
A&D Blood Pressure Monitor Model (UA-651BLE) User Manual ......................... 50
Omron Blood Pressure Monitor Model (BP7450) User Manual............................ 55
Thermometer Warnings and Cautions.................................................................. 69
Thermometer testing using Bluetooth................................................................... 71
Thermometer manual entry.................................................................................. 73
Thermometer results............................................................................................ 75
Fora IR20 Ear Thermometer User Manual........................................................... 78
Pulse Oximeter Warnings and Cautions............................................................... 83
Pulse Oximeter Test using Bluetooth................................................................... 84
Using the ChoiceMMed SpO2 monitor................................................................. 84
Using the Nonin SpO2 monitor............................................................................. 86
Using the Wellue SpO2 monitor........................................................................... 87
Pulse Oximeter manual entry............................................................................... 88
Pulse Oximeter Results........................................................................................ 90
ChoiceMMed Fingertip Pulse Oximeter (MD300C1218) User Manual................. 93
Nonin Fingertip Pulse Oximeter (3230) User Manual........................................... 95
Wellue Fingertip Pulse Oximeter (PC-60FW) User Manual.................................. 98
Accu-Chek Guide Glucose Test using Bluetooth................................................ 113
Accu-Chek Guide manual entry.......................................................................... 115
Accu-Chek Guide results.................................................................................... 118
Accu-Chek Guide Glucometer User Manual ...................................................... 121
Accu-Chek Instant Glucose test using Bluetooth................................................ 132
Accu-Chek Instant manual entry ........................................................................ 135
Accu-Chek Instant results .................................................................................. 137
Accu-Chek Instant Glucometer User Manual ..................................................... 140

Title:
DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
Document #
870-00052-01
Revision:
E
Page:
4 of 170
***Confidential and Proprietary of Dictum Health***
3.7 Camera...................................................................................................................... 153
3.8 Virtual Exam .............................................................................................................. 156
4.1 Haptic feedback......................................................................................................... 161
4.2 Tablet features........................................................................................................... 162
4.3 Device specifications ................................................................................................. 163
5.1 General Use............................................................................................................... 164
5.2 Cleaning AND Disinfecting......................................................................................... 164
8.1 System error and warning messages ........................................................................ 169
8.2 Virtual Exam messages............................................................................................. 170
Pain manual entry .............................................................................................. 149
Pain results ........................................................................................................ 150
Capture images:................................................................................................. 153
Initiate a Virtual Exam ........................................................................................ 156
4eVER-HOME Specifications and information ........................................................ 161
5Maintenance............................................................................................................. 164
Advanced disinfecting ........................................................................................ 164
6Symbols.................................................................................................................... 165
7Clinical References.................................................................................................. 167
8Troubleshooting ...................................................................................................... 168

Title:
DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
Document #
870-00052-01
Revision:
E
Page:
5 of 170
***Confidential and Proprietary of Dictum Health***
1 INTRODUCTION
Read and understand the Instructions for Use (IFU) (Rev E) in its entirety prior to using the
eVER-HOME. It is important to read, understand, and follow all warnings, cautions and
safety information.
The eVER-HOME is a mobile, easy-to-use, Remote Patient Monitoring (RPM) device for
home use by patients or caregivers with an 8th grade reading level. The eVER-HOME
monitors patient weight, height, BMI, blood pressure, temperature, oxygen saturation level,
pulse rate, and glucose through Bluetooth connected accessories. It also includes Pain
reporting. Patients can capture medical images to send to their clinician from one of two
internal cameras.
Patients connect to clinicians by using a wireless network and Dictum Health’s Virtual
Exam Room (VER) technology for consultation and assessment. All data and images are
stored on the eVER-HOME and simultaneously, securely delivered to HIPAA-compliant
cloud services and the clinician’s EMR/ EHR network for review. In the event of network
outage, the information will be stored and automatically forwarded when the network is
available. This manual is written for patients at home and their caregivers. All users must
be trained to use the eVER-HOME and accessories prior to use. Before using, preparing,
configuring, or troubleshooting the eVER-HOME you must read and understand this
manual and all other information accompanying the device and related options or
accessories. Dictum Health assumes no responsibility for any injury to anyone, or for any
illegal or improper use of the product, that may result from failure to use this product in
accordance with the instructions, cautions, warnings, or statement of intended use
published in this manual.

Title:
DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
Document #
870-00052-01
Revision:
E
Page:
6 of 170
***Confidential and Proprietary of Dictum Health***
1.1 WARRANTY STATEMENT
Read the warranty statement at the following link:
https://www.dictumhealth.com/s/eVER-HOME-warranty_1905-2.pdf
If the eVER-HOME fails to function properly or if assistance, service, or spare parts are
required, contact Dictum Health:
email: [email protected]
Dictum Health Inc.
255 3rd Street, Suite 102
Oakland, CA 94607
[phone] (U.S. only)
www.dictumhealth.com/service

Title:
DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
Document #
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Revision:
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Page:
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***Confidential and Proprietary of Dictum Health***
1.2 INDICATIONS FOR USE
The eVER-HOME is intended for use to collect patients' vital signs, glucose, and pain levels
for patient populations based on the indication of use from the Bluetooth connected
accessories synced with the eVER-HOME. Manual entry of data is also allowed. The
following patient data are automatically transmitted to the eVER-HOME using the following
Bluetooth connected accessories or manual input capabilities from other methods:
•Weight: A&D Deluxe Connected Weight Scale Model UC-352BLE
•Blood Pressure: A&D Blood Pressure Monitor Model UA-651BLE, Omron
10-series Wireless Upper Arm Blood Pressure Monitor Model BP7450
•Temperature: Fora IR20 Ear Thermometer
•Pulse Oximetry: for the non-invasive measurement of functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate: ChoiceMMed
Fingertip Pulse Oximeter Model MD300C1218, Nonin Bluetooth® Low
Energy OEM External Wireless Pulse Oximeter Model 3230, Wellue
OxySmart™ Fingertip Pulse Oximeter Model PC-60FW
•Glucose: Accu-Chek Guide or Accu-Chek Instant
The following patient data are manual input only:
•Height
•Pain
Other features include: Virtual Exam Room (VER) one-to-one video conferencing between
a patient and a clinician, capture and send medical images, send and receive textual
messages directly from clinical staff, previous result data is available for each test, viewable
in graphical or tabular format.
1.3 CONTRAINDICATIONS
There are no known contraindications for the recording of vital signs. Please follow the
User Manual of the connected accessories for full warnings and precautions.

Title:
DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
Document #
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Revision:
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1.4 GENERAL WARNINGS
The following warning statements apply to the general use of the eVER-HOME. Warning
statements indicate conditions or practices that could lead to illness, injury, or death.
DO NOT immerse the eVER-HOME in any fluid, place fluids on top, or attempt to clean it
with any liquid detergents or cleaning agents. This may cause an electrical hazard. If
immersion occurs, please return to Dictum Health.
DO NOT use the eVER-HOME for any purpose other than specified in this manual
without written consent and approval from Dictum Health.
DO NOT use the eVER-HOME in the presence of flammable anesthetics: mixtures
containing air, oxygen, or nitrous oxide.
Electric shock hazard. Do not open the eVER-HOME or attempt repairs. There are no
user-serviceable parts inside. Only perform routine cleaning and maintenance
procedures specifically described in this direction for use.
For proper patient electrical isolation and battery charging, use only the provided power
cord and adaptor.

Title:
DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
Document #
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Revision:
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1.5 GENERAL CAUTIONS
The following caution statements apply to the general use of the eVER-HOME.
Excessive movement can interfere with the operation and results. Patients should be
warm, relaxed, and still to ensure accurate test performance.
Use only parts and accessories supplied with the eVER-HOME. The use of accessories
other than those specified may result in erroneous performance.
Portable and mobile RF communications equipment can affect the performance.
To prevent touchscreen damage, use only fingertips. Do not use sharp or hard objects.
The eVER-HOME should not be placed where it might fall or slip off a surface.
The eVER-HOME should not be stacked with other equipment.
The device is susceptible to extreme environmental variables. Avoid direct sunlight or
locations where it may be affected by significant changes in temperature, humidity,
ventilation, or airborne particles.
Use the device within stated operating temperature ranges. The device will not meet
performance specifications if used outside these temperatures’ ranges:
•Operating Temperature: -20–60C, -4–140F
•Charging Temperature: 0–45C, 32–113F
•Storage Temperature and humidity: recommended 21–25C, 69.8–77F;
recommended 40–80% humidity.
•Operating Temperature: -20–60C, -4–140F
•Charging Temperature: 0–45C, 32–113F
•Storage Temperature and humidity: recommended 21–25C, 69.8–77F;
recommended 40–80% humidity.
•Always unplug the power cord and adaptor from the outlet before moving
the device to a new location.

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2 THE EVER-HOME MONITORING PLATFORM
2.1 START
Tap START to sign-in to the eVER-HOME.
2.2 HOME SCREEN
After starting the device, you will be shown the Home screen where you will find the buttons
to launch your tests and other services. The table below explains each icon.

Title:
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Revision:
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Tests and Services
Weight/Height Test
Blood Pressure Test
Thermometer
Pulse Oximeter with Pulse
Glucose
Pain
Images
Virtual Exam

Title:
DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
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Revision:
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Action Bar Settings
These items are available from each screen in the app.
Top Action Bar
Sign out –only shown when on the Home screen
Home
Back
Bluetooth
Cellular If your device has cellular connectivity this icon will appear.
For help connecting to your cellular network, refer to Section 2.2.4 .
Wi-Fi This is the wireless network you are connected to. For help
connecting to your Wi-Fi network, refer to Section 2.2.5 .
Dictum Health Server (DH) This screen shows the status of the
connection between the eVER-HOME and your doctor’s office.
Battery This screen shows the status of the battery.

Title:
DICTUM HEALTH eVER-HOME INSTRUCTIONS FOR USE
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Bottom Bar
MR#:
Medical Record Number (MR#) This is the number used to identify you
to your device. This number is assigned by your doctor’s office and
helps keep your information private.
Messages Tap to open two-way text messages between you and your
clinician.
Help Tap to open the Instructions for Help (IFU) and view
troubleshooting tips.
VER status Tap to change Virtual Exam Room (VER) availability
Date and
Time
Current Date and Time

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Bluetooth
To confirm that Bluetooth is on, tap the Bluetooth icon to open the Bluetooth
status screen.
The Enable Bluetooth switch shows the selected status: Yes (On) or No (Off).
Notice: If the Bluetooth isn’t functioning correctly, tap No (Off) to disable it and then
tap Yes (On) to enable it again.
Cellular
Tap the Cellular icon to view the cellular status and connect to a cellular
network.

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The Enable Cellular Data switch shows the selected status: On (Yes) or Off
(No).
The Status shows whether the cellular SIM is Active or Inactive.
Data shows whether the cellular data path is Connected or Not Connected.
APN shows the AT&T access point name for the network.
If the APN is NOT iot0119.com.attz, then tap SETTINGS and then Access
Point Names and choose iot0119.com.attz from the list of available access
points. If you do not see this access point, contact your administrator.
Tap the back arrow at the bottom of the screen to return

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Wi-Fi
To view Wi-Fi status and to connect to a Wi-Fi network, tap the Wi-Fi icon to
open the Wi-Fi Status screen.
The Enable Wi-Fi switch shows the selected status: On (Yes) or Off (No).
The Status shows whether the device is connected. If the device is
connected, the name of the connected network is displayed.
Tap Settings to show a list of available Wi-Fi networks. Choose your local
network to connect.
Switching Network Connectivity
The tablet is typically shipped with Wi-Fi turned on and ready to discover and connect
to available Wi-Fi networks.
To switch from Wi-Fi to cellular connectivity, first, turn off the Wi-Fi by tapping
the Wi-Fi signal icon and selecting “No” under the Enable Wi-Fi setting.

Title:
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Then tap the Cellular icon on the tool bar. Select “Yes” under the Enable
Cellular Data setting. Wait several seconds while the cellular signal connects.
Confirm that the Status is showing “Active”, and that Data is showing
“Connected”.
Confirm that the CONNECT button is active. Tap the CONNECT button.
Confirm that the message “Successfully connected to Internet” appears.
To Troubleshoot Network Connectivity:
If the Status does not show “Active” or Data does not show “Connected”, then
confirm that the APN (Access Point Name) states “iot0119.com.attz”.
If it does not, tap SETTINGS. Tap Access Point Names. Confirm that you
see “iot0119.com.attz” in the list and select it. If you do not see
“iot0119.com.attz” in the list, contact your Administrator.
Exit the Settings. Confirm that the APN states “iot0119.com.attz”.
Note: As with any device that has Wi-FI and cellular connectivity options, if the Wi-Fi
and cellular are both on and have available networks to connect to, the Wi-Fi will take
priority and the system will use that network to communicate over. This means that
even if the Wi-Fi network has a lower quality than the cellular network, it will still use
the Wi-Fi network to connect, if available.
Dictum Health Server
Tap the Dictum Health Server (“DH”) to view the server status screen.

Title:
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The Status shows whether the device is connected to the Dictum Health
services. If the device is connected, the Status says “Syncing”.
If the Status says, “Not Syncing”, confirm that the eVER-HOME is connected
to a Wi-Fi network.
Battery
Tap the Battery Status icon.
The Battery Status screen.

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Messages
Tap the Messages button to create and respond to short textual messages
from clinicians.
A red number next to the envelope icon means unread messages await.

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Tap NEW to create a new message. Choose the Set Priority flag to mark the
message as high priority.
When you’re done creating your message, choose SAVE to send the
message. Choose CANCEL to return to the previous screen without sending
a message.
Help
Tap Help button on the Home screen to open the Instructions for Use (IFU).
To navigate the Instructions for Use (IFU):
Scroll the Table of Contents up or down as necessary to find a particular
topic.
Use the Search field above the Table of Contents to search for a term or
topic.
Tap a topic name to open that topic in a reading screen.