VOCARE vitals360 Installation guide

VITALS360 TRAINING
MANUAL

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Contents
Device Overview ...........................................................................................................................................2
Device User Interface....................................................................................................................................2
Training Sections...........................................................................................................................................3
Important Safety Information.......................................................................................................................5
Intended User Population.............................................................................................................................6
Table 1 Intended Users .............................................................................................................................6
Intended Use.................................................................................................................................................7
Open Packaging and Remove Contents........................................................................................................8
Identifying Major Vitals360®Device Components .......................................................................................9
Charging the Vitals360® Device ..................................................................................................................12
Turning on and off the Vitals360® Device...................................................................................................13
Correctly Identifying Test Selection Buttons ..............................................................................................14
Logging on the Vitals360® Device...............................................................................................................19
After Measuring..........................................................................................................................................23
Measure Blood Pressure and Pulse Rate....................................................................................................24
Measure Pulse and SP02.............................................................................................................................31
Measure Forehead Temperature................................................................................................................38
Measure ECG...............................................................................................................................................42
Record Height Manually .............................................................................................................................46
Record Weight Manually ............................................................................................................................49
Record Weight Using a Bluetooth Weight Scale.........................................................................................52
Acquiring a Photograph ..............................................................................................................................54
Choosing Language to Display ....................................................................................................................56
Cleaning the Vitals360 Device.....................................................................................................................58

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Device Overview
The VITALS360® device is a professional grade mobile medical device. The device was designed to
capture and display vital sign results to healthcare providers and lay persons in a clinical or home
environment. The device is available only through prescription by a healthcare provider and is intended
for spot-checking blood pressure, pulse, blood oxygen saturation, ECG, respiration rate, heart rate,
infrared temperature, weight and height. The User Manual and Quick Start User Guide are additional
reference materials made available that does not substitute for training by a healthcare professional
prior to use. These vital sign measurements can be stored on the device for display or sent by way of a
third-party Medical Device Data System (MDDS) platform. The device natively does not perform any
decision support functions or provide alerts to the user.
The device operates on Android OS® and utilizes a Qualcomm Gobi® chip enabling the VITALS360®
device to connect with most wireless carriers.
There are three modes in which the device can be used: spot-checking in the field, checking vital signs in
a clinical setting and checking vital signs by the patient or lay person in a remote location.
In the first scenario, the healthcare provider takes the device into the field and uses the device as a
standard medical device for spot-checking patient vital signs. In this scenario, patient registration is not
required. The device works completely offline and does not associate any vital sign measurement with
patient data. It is up to the healthcare provider to communicate and, if needed, associate (on other
external physical or digital media) the measured vital signs for a patient. The operating mode
corresponding to this scenario is called Single Test Mode.
In the second scenario, the healthcare professional is in a clinical setting, checking the vital signs of
known, registered outpatients. The measured vital signs are associated with the patient and are stored
in a 3rd party Class I Medical Device Data System (MDDS). The operating mode corresponding to this
scenario is called Multi-test and Share Mode.
In the third scenario, the device is given or otherwise shipped to a patient or layperson, who uses it at
home to check their vital signs. The measured vital signs are associated with that patient and stored in
the third-party MDDS. The operating mode corresponding to this scenario is called Test and Share
Mode.
Device User Interface
The Vitals360® device interface display is a 3.66 inch (diagonal) 800-by-400-pixel resolution at 458 ppi
multi-touch LED screen with a 2,000,000:1 contrast ratio. The user interface allows for large selection
buttons, text labeling of key buttons as well as on-screen keyboard, number pad and scrolling numeric
entry wheels. The device natively supports the following language and keyboard configurations: English
(Australia, UK, U.S.), Chinese (Simplified), French (Canada, France), Spanish (Latin America, Mexico,
Spain), and Arabic.

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Training Sections
The training manual will cover three distinct modes of operation for the device, recognizing one mode is
to be operated by a patient or layperson and the other two modes are to be operated by a healthcare
professional. All device measurements covered in the training manual are independent of operating
mode being used; the modes of operation will simply determine if the data will reside on the device
and/or be sent by way of a third-party Medial Device Data System (MDDS) platform. Modes of
Operation and intended user is illustrated below:
Mode of Operation
Intended User
Single Test Mode
Healthcare Professional
Multi-test and Share Mode
Healthcare Professional
Test and Share Mode
Patient or Layperson
Recognizing these vital sign measurements can be stored on the device for display or sent by way of a
third-party Medical Device Data System (MDDS) platform, for training purposes only, a training MDDS
environment must be established prior to training taking place to enable pre-loading of mock patient
registration information to illustrate the full functionality of the device in training sessions. The setup of
the necessary training MDDS environment is directly tied to the MDDS platform of choice by the client
purchasing the device, as to where they will be choosing to send the collected data, and is therefore not
within scope of this training manual; setup of the connecting MDDS training environment and pre-
loading of mock patient registration information is the responsibility of the client purchasing the device.
For purposes of training, mock patient names and related information will be referenced in this manual
for ease of understanding functionality being demonstrated.
The training participants should use the Vitals360® touch screen when interacting with the Vitals360®
device. The Vitals360® device can use the default screen and font settings installed during the
manufacturing process. The Vitals360® device will need to be setup to use client specific Wi-Fi for user
connectivity during training to authenticate the entered username and password when necessary.

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The following tasks will be covered in the training for proper safety and usability of the Vitals360®
device.
Training Tasks
Open Packaging and remove contents
Identifying Major Vitals360 Device
Components
Charging the Vitals360 Device
Turning on the Vitals360 Device
Logging on the Vitals360 Device
Correctly Identifying Test Selection Buttons
Measuring Blood Pressure
Measuring Pulse and Sp02
Measuring Forehead Temperature
Obtaining ECG
Entering Weight and Height
Acquiring a Photograph
Choosing Language to Display
Cleaning the Vitals360 Device

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Important Safety Information
The user must carefully read and fully understand the instructions for Vitals360® device use
contained in the USER MANUAL before operating the device.
To ensure proper operation of the device, and correct test results, the instructions and warnings
contained in the USER MANUAL must be carefully reviewed and followed prior to and during
operation of the device.
Keep the USER MANUAL in the vicinity of the device so that it can be easily referenced.
The following symbols can be referenced in the USER MANUAL, QUICK START GUIDE, LABELING,
PACKING and must be fully reviewed and understood prior to use of the device:
WARNINGS
Indicates a potentially hazardous situation which, if NOT avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if NOT avoided, may result in minor or moderate
injury to the user or patient or damage to the device or other property.
NOTES
Contain important information that may be overlooked or missed.
CONSULT INSTRUCTIONS FOR USE
Indicates the need for the user to consult the instructions for use.

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Intended User Population
The Vitals360® device is intended as a prescription-only device and is not intended to be sold over the
counter. The device's intended users are healthcare professionals who wish to collect vital signs on
patient populations that are seen in a clinic, long-term care facility, home care, or home hospice
environment are on job sites. The use of the Vitals360® device in these environments allows collecting
vital signs that the healthcare provider can interpret as part of the patient's ongoing clinical care. The
device is not intended for continuous monitoring or use in a hospital or critical care facilities, and all
healthcare providers have required training in the use of the device before using the device in a clinical
setting. Healthcare provider training includes an explanation of the Vitals360® device and accessories,
how to charge the device safely, and training in the correct use of the device to collect the device's vital
sign measurements and appropriate cleaning.
The Vitals360® device is also intended for laypersons who may have chronic diseases but are not
critically ill. The device is not intended for use in a pediatric population and will only be provided to
laypersons, male and female, between 18-80 years of age as a prescription item that will require
orientation and training by a healthcare professional before the patient can use the device at home. The
training aides include a User Manual and a Quick Start User Guide. Training by the healthcare
professional includes explaining the Vitals360® device and accessories, how to charge the device safely,
and training in the correct use of the device to collect the vital sign measurements and cleaning of the
device between uses. The device is preconfigured before distribution to layperson users. The device's
intended use by laypersons is in a home environment to collect pertinent vital sign measurements as
instructed by a healthcare professional. The vitals sign measurements will be stored on the device or
transcribed by the patient into a log at the healthcare provider's discretion.
The intended user population of the Vitals360® device might include healthcare professionals and
laypersons, as shown in Table 1 below.
Table 1 Intended Users
Healthcare Professionals
Laypersons greater than 18 years of age
Physicians
Patients with chronic medical conditions
Physician Assistants
Homebound patients such as the elderly
Nurse Practitioners
Patients post-hospital discharge
Medical Assistants
Patients enrolled in a clinical study
Nurses’ Aides
Patients quarantined at home with an infectious disease
Registered Nurses
Paramedics\EMT
Home Health Aides
Athletic Trainers
Physical Therapists

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Intended Use
Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive
blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18
years of age.
This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.
This VITALS360® device is intended for use in a clinical or home environment.
This VITALS360® device is a reusable device following thorough cleaning between uses.
CAUTION: Federal law restricts this device to sale (or use) on the order of a healthcare
provider.

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Open Packaging and Remove Contents
For training purposes, participants should find the following Vitals360® components in their packaging:
ITEM
QTY
a. VITALS360 ® Device
1
b. Arm Cuff
1
c. AC Adapter
1
d. Type-C Cable
1
e. SIM Card
1
f. User Manual
1
g. Quick Start User Guide
1
h. Leather Carrying Case
1
i. Weight Scale
1
j. Disinfecting wipes
1
k. Vitals360® Packaging
1

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Identifying Major Vitals360®Device Components
1. Vitals360® Packaging (Exploded View)
2. Vitals360® User Manual
3. Vitals360® Quick Start User Guide

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4. Vitals360® Leather Carrying Case
5. Vitals360® Type C Cable and AC Adapter
6. Blood Pressure Arm Cuff
7. SIM Card
8. Bluetooth Scale

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9. Disinfecting Wipes
10. Vitals360® Device

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Charging the Vitals360® Device
Please ensure the device is fully charged before beginning the training process.
When charging, ensure the charger is plugged into an AC main plug that is in close proximity to
the device. The charger must be easy to access.
Fully insert the power plug.
The USB power cable is considered as a separate device to the charging adapter.
Use ONLY the authorized VITALS360®AC Adapter included with this device.
The charging process takes approximately 5 hours.
Disconnect the power plug if the product will NOT be used for an extended period.
WARNINGS CAUTION NOTES
Please refer to the User Manual, paying special attention to any Warnings, Caution and Notes identified
for this section.

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Turning on and off the Vitals360® Device
Please ensure the device is turned on after it is fully charged before beginning the training process.
The device has a touch-screen display, please note that a touchscreen responds best to a light touch
from the pad of your finger or a non-metallic stylus. Using excessive force or a metallic object when
pressing on the touchscreen may damage the tempered glass surface and void the warranty.
For more information, please refer to Chapter 16 "Limited Warranty" within the User Manual.
TAP & HOLD the switch button for more than 3 seconds and the device will power off when
device is turned on.
WARNINGS CAUTION NOTES
Please refer to the User Manual, paying special attention to any Warnings, Caution and Notes identified
for this section.

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Correctly Identifying Test Selection Buttons
Upon turning on the device, there are three distinct modes of operation for the device, recognizing one
mode is to be operated by a patient or layperson and the other two modes are to be operated by a
healthcare professional. All device measurements covered in the training manual are independent of
operating mode being used; the modes of operation will simply determine if the data will reside on the
device and/or be sent by way of a third-party Medial Device Data System (MDDS) platform. Modes of
Operation and intended user table is illustrated once again below:
Mode of Operation
Intended User
Single Test Mode
Healthcare Professional
Multi-test and Share Mode
Healthcare Professional
Test and Share Mode
Patient or Layperson
As shared in the Device Overview section of this Training Manual, the Single Test Mode is intended for
the healthcare provider to take the device into the field and use the device as a standard medical device
for spot-checking patient vital signs. In this scenario, patient registration is not required. The device
works completely offline and does not associate any vital sign measurement with patient data. It is up to
the healthcare provider to communicate and, if needed, associate (on other external physical or digital
media) the measured vital signs for a patient.
In the Multi-test and Share Mode, the healthcare professional would be in a clinical setting, checking the
vital signs of known, registered outpatients. The measured vital signs are associated with the patient
and are stored in a 3rd party Class I Medical Device Data System (MDDS).
In the Test and Share Mode, the device is given or otherwise shipped to a patient or layperson, who uses
it at home to check their vital signs. The measured vital signs are associated with that patient and stored
in the third-party MDDS.
Once the device has been turned on, please select the desired mode of operation, to follow along in the
training steps in the next section, titled Logging on the Vitals360® device.

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Test Operating Mode Selection:
The application can function at a given time in one of three operating modes:
Single Test Mode
Multi-test and Share Mode
Test and Share Mode
The operating mode affects what features are available on the device, what happens to the
measurement data and where measurement data is stored. Before the Healthcare Provider can start
using the device, the Healthcare Provider must select an operating mode.
An individual may switch between the operating modes, subject to the following rules:
NOTES
a remote patient is not allowed to change the operating mode from Test and Share Mode Error!
Reference source not found.to another mode
when in Test and Share Mode or Multi-test and Share Mode, a healthcare provider must
authenticate before switching operating modes
switching operating modes will clear any patient data stored on the device
This mode mimics standard medical devices. The VITALS360 ® Device can be used without patient
registration, as a convenient multi-vitals device for spot checking patient vital signs.
NOTES
This mode will not require the Healthcare Provider to authenticate in order to enter or exit Single
Test Mode
This mode will allow the Healthcare Provider to enter or exist Single Test Mode even if no network
connection is available.

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This mode mimics Test and Share Mode, with the exception of being used for multiple individuals with
thorough cleaning of the device required between uses. In Multi-test and Share Mode the device must
not only measure, but also store vital sign measurements. The stored measurements must be
associated with a patient. When the device is in Multi-test and Share Mode, the Healthcare Provider
will begin with authentication, or the Healthcare Provider has finished checking the vital signs of a
patient and would like to select the next patient whose vital signs are going to be checked next by
choosing Patient List on the main menu.
1. The device obtains a list of patients the Healthcare Provider is authorized to view from the third-
party MDDS and displays the patients in a list, with the options to select, search, view patient
details and register a new patient.
2. The Healthcare Provider selects a patient from the list.
3. The device stores the selected patient identifier and displays the main menu from where the
Healthcare Provider may select measurements to perform.
4. The device will require the Healthcare Provider to authenticate in order to enter or exit Multi-test
and Share Mode.
NOTES
a. In order to give access to patient data, the device must establish that the user is a
Healthcare Provider. In order to give access only to the patients of the Healthcare Provider,
the device must establish the Healthcare Provider’s identity.
5. The device will allow the Healthcare Provider to enter or exit Multi-test and Share Mode even if
no network connection is available.
NOTES
a. While at the clinic, the Healthcare Provider uses the device in Multi-test and Share Mode.
The Healthcare Provider might leave for field work to an area without network connection,
yet forgets to switch to Single Test Mode before leaving. It will be possible for the
Healthcare Provider to exit Multi-test and Share Mode and enter Single Test Mode once
the Healthcare Provider arrives at their destination.
6. When the Healthcare Provider exits Multi-test and Share Mode, the device shall clear all patient
and measurement data stored on the device.
7. If there is no network connection available and there is measurement data stored on the device,

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then the device will display a warning to the Healthcare Provider before exiting Multi-test and
Share Mode indicating that all offline measurement data will be lost.
NOTES
a. The Healthcare Provider might not realize that there are measurements stored on the
device which will be lost if he or she exits Multi-test and Share Mode.
8. The device will allow the Healthcare Provider to cancel exiting Multi-test and Share Mode if offline
measurement data could be lost.
NOTES
a. The Healthcare Provider might decide to postpone this action until a network connection
is available and the offline measurement data can be uploaded to the third-party MDDS.
This mode mimics standard medical devices, similar to Single Test Mode, with additional capability of
sending data outside of the device. In Test and Share Mode the device must not only measure, but also
store vital sign measurements. The stored measurements must be associated with a patient. A device
may be purchased by a Patient and remain permanently in the Patient’s possession. However, it is also
possible that a Patient is given a device by a Healthcare Provider for a set period of time, after which the
Patient must return the device for thorough cleaning before further use. The Healthcare Provider is then
able to switch the cleaned device into another operating mode.
1. The device obtains a list of patients the Healthcare Provider is authorized to view from the third-
party MDDS and displays the patients in a list, with the options to select, search, view patient
details and register a new patient.
2. The Healthcare Provider selects a patient from the list.
3. The device stores the selected patient identifier and displays the main menu from where the
Healthcare Provider or patient may select measurements to perform.
4. The device will require the Healthcare Provider or patient to authenticate in order to enter or exit
Test and Share Mode.
NOTES
a. In order to give access to patient data, the device must establish that the user is a
Healthcare Provider or patient. In order to give access only to the patients of the
Healthcare Provider, the device must establish the Healthcare Provider’s identity.

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5. The device will allow the Healthcare Provider or patient to enter or exit Test and Share Mode even
if no network connection is available.
NOTES
a. While at the clinic, the Healthcare Provider or patient uses the device in Test and Share
Mode. The Healthcare Provider or patient might leave the clinic to an area without
network connection, yet forgets to switch to Single Test Mode before leaving. It will be
possible for the Healthcare Provider or patient to exit Test and Share Mode and enter
Single Test Mode once the Healthcare Provider or patient arrives at their destination.
6. When the Healthcare Provider or patient exits Test and Share Mode, the device shall clear all
patient and measurement data stored on the device.
7. If there is no network connection available and there is measurement data stored on the device,
then the device will display a warning to the Healthcare Provider or patient before exiting Test
and Share Mode, indicating that all offline measurement data will be lost.
NOTES
a. The Healthcare Provider or patient might not realize that there are measurements stored
on the device which will be lost if he or she exits Test and Share Mode.
8. The device will allow the Healthcare Provider or patient to cancel exiting Test and Share Mode if
offline measurement data could be lost.
NOTES
a. The Healthcare Provider or patient might decide to postpone this action until a network
connection is available and the offline measurement data can be uploaded to the third-
party MDDS.
WARNINGS CAUTION NOTES
Please refer to the User Manual, paying special attention to any Warnings, Caution and Notes identified
for this section.

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Logging on the Vitals360® Device
Now that you have selected the desired mode of operation as outlined in the prior section, please follow
training steps below to complete the login process.
.
A. Single Test Mode
1. TAP & SELECT the Single Test Mode button on the screen and you will go to the home page of
this particular test mode; no additional login steps are required.
2. Swipe forward and backward to navigate between screens and find more functions. Also take
special note below to the Back Button and the Home Button for ease of navigation while using the
device in all three modes of operation.