VOCARE vitals360 User manual

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User
Manual

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DEVICE 4
01 IMPORTANT SAFETY INFORMATION 5
01.1 Symbols Bank 5
01.2 Environmental Requirements 6
01.3 Electromagnetic & RF Immunity 7
01.4 Static Electricity 7
01.5 Applicable People 8
01.6 Applicable Area 8
01.7 Human Exposure 8
01.8 Before Measuring 8
01.9 Self-Diagnosis 9
01.10 Inappropriate Storage 10
01.11 Care & Maintenance 10
01.12 Environmental Protection & Discard 10
01.13 Risk of Electrical Shock (AC Adapter Usage) 11
01.14 Battery Use & Safety 12
01.15 Display/Touch-Screen 13
02 DEVICE OVERVIEW 13
02.1 Know Your Monitor 13
02.2 Unpacking & Checking 15
02.3 Test Operating Mode Selection 15
02.4 Intended Use 19
02.5 Accessories 19
03 BEFORE MEASURING 20
03.1 Using the AC Adapter 20
03.2 Turn On/Off 21
03.3 Symbols & Items Bank 21
03.4 Login 22
03.5 Display of Home Page 24
03.6 Symbols Bank - Home Page 25
03.7 Symbols Bank - Settings 26
03.8 User Setting 26
03.9 Setting - Volume Adjustment 27
03.10 Setting - Unit of Measurement Switch 27
03.11 Setting - Language 28
03.12 Setting - ECG 29
03.13 Setting - Date/Time 29
04 MEASURING BLOOD PRESSURE 30
04.1 Overview 30
04.2 Safety Information 31
04.3 Display & Symbols Bank 32
04.4 Applying the Arm Cuff 33
04.5 For Accurate Measurement 34
04.6 Taking A Reading 36
04.7 Read the Blood Pressure Display 39
04.8 Illustrated Example of Measuring BP 39
04.9 Troubleshooting 40
TABLE OF CONTENTS

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05 MEASURING BLOOD OXYGEN (SPO2) 42
05.1 Overview 42
05.2 Safety Information 44
05.3 Display & Symbols Bank 46
05.4 Taking A Reading 47
05.5 If Using Oxygen 49
05.6 Illustrated Example of Measuring
Blood Oxygen Saturation 51
05.7 Troubleshooting 52
06 MEASURING FOREHEAD TEMPERATURE 53
06.1 Overview 53
06.2 Safety Information 53
06.3 Display & Symbols Bank 54
06.4 Taking A Reading 55
06.5 Illustrated Example of Measuring
Forehead Temperature 56
06.6 Troubleshooting 57
07 ECG SCANNING & RECORDING 58
07.1 Overview 58
07.2 Safety Information 58
07.3 Display & Symbols Bank 60
07.4 Taking A Reading 61
07.5 Illustrated Example of Measuring ECG 63
07.6 Troubleshooting 63
08 MEASURING and STORING
WEIGHT & HEIGHT 64
08.1 Overview of Manual Process 64
08.2 Manual Display & Symbols bank 64
08.3 Manual Height & Weight 64
08.4 Illustrated Example of
Manually Storing Height 66
08.5 Illustrated Example of Manually
Storing Weight 66
08.6 Troubleshooting 67
08.7 Overview of Measuring Weight
using a Bluetooth Weight Scale 67
08.8 Measuring Weight using a
Bluetooth Weight Scale 68
09 STORING BLOOD GLUCOSE 70
09.1 Overview of Manual Process 70
09.2 Manual Display & Symbols bank 70
09.3 Manual Blood Glucose 71
09.4 Illustrated Example of
Manually Storing Blood Glucose Data 72
09.5 Troubleshooting 73
10 CAMERA 74
10.1 Overview 74
10.2 Display & Symbols Bank 74
10.3 Illustrated Example of Taking
a Picture and Adding in Comments 74
11 AFTER MEASURING 75
11.1 Measurement Processing 75
11.2 View the Measuring Result 75
11.3 Display & Symbols Bank 76
11.4 Check the History 76
12 INTRODUCE 78
13 MODE SWITCHING 78
14 CLEANING & DISINFECTING 79
14.1 The Difference between Cleaning &
Disinfecting 79
14.2 Safety Information 79
14.3 How to Clean the Device 80
14.4 How to Disinfect the Device 83
14.5 Approved Cleaning & Disinfecting Product 84
14.6 How to Clean & Disinfect the Arm Cuff 84
15 STORAGE &MAINTENANCE 85
15.1 Storage 85
15.2 Safety Information 86
15.3 Maintenance 87
15.4 Discarding 87
16 SPECIFICATIONS 88
17 LIMITED WARRANTY 90
17.1 Manufacturer's Warranty 90
17.2 Limitations of Warranty 90
17.3 User Responsibility 91
17.4 What's NOT Covered by Warranty 92
17.5 Precautions for Transfer and Disposal 92
17.6 End User License Agreement for Software 93
18 COMPLIED STANDARDS LIST 94
19 IEC60601-1-2 EMC & RF STATEMENT 96
IMPORTANT INFORMATION REGARDING
ELECTRO MAGNETIC COMPATIBILITY (EMC) 96
GUIDANCE & MANUFACTURER'S
DECLARATION 97

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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, blood
glucose, ECG, respiration rate, heart rate, infrared temperature,
weight and height. The User Manual is a reference 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 provider 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

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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.
01.1 Symbols Bank
01 IMPORTANT SAFETY INFORMATION
• The user must carefully read and fully understand the instructions for 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 this USER MANUAL in the vicinity of the device so that it can be easily referenced.
The following symbols are referenced in the USER MANUAL, QUICK START GUIDE, LABELING, PACKING and must be fully reviewed
and understood prior to use of the device:
Tap & Select
Tap & Select
Tap & Select Tap & Select
Tap & Select

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CAUTION: Federal law restricts this device to sale (or use) on the order of a healthcare provider.
01.2 Environmental Requirements
General Operang Environment
Temperature: 68ºF to 82.4ºF / +20°C to +28°C (TEMP, NIBP)
51ºF to 95ºF / +5°C to +35°C (ECG, SpO2)
Humidity: 40% to 70% RH
Air Pressure: 70KPa to 106KPa
WARNINGS
• Make sure that the operating environment of the device meets the specific requirements in this USER MAN AL. If
NOT, it may result in damage to the device or cause an inaccurate reading.

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CAUTION
• DO NOT measure with the device and accessories near heat sources such as in direct sunlight, near a fireplace or
stove, and harsh environments.
• DO NOT use the device in the bathroom or moist circumstance.
• To ensure accurate readings, keep the device at room temperature for more than 30 Minutes before use.
• When the device and accessories are carried from a cold environment to a warm or humid environment, please DO
NOT use it immediately. When the device is moved from one place to another, condensation may occur as a result of
temperature or humidity difference.
WARNINGS
• DO NOT expose or use the device in an MRI or CT environment. The induced current could cause burns to the user.
• DO NOT use the device in the presence of high-power appliances such as high voltage cables, X-ray machines,
ultrasound equipment or a defibrillato .
• DO NOT use the device under the conditions of a strong electromagnetic field e.g. medical RF equipment) that
radiates interference signal or electrical fast transient/burst signal. Both of these may result in an operational
failure.
• DO NOT use this device during defibrillation
CAUTION
• Magnetic and electrical fields are capable of interfering wth the proper performance of the device.
• Measurements can be affected by certain environmental conditions, errors in applying the sensor, and certain
patient conditions. For this reason, make sure that all external devices operated in the vicinity of the equipment
complies with this USER MANUAL EMC Requirements.
• This device may cause radio interference or may disrupt the operation or can be disrupted by external nearby
equipment.
• Upper-frequency electrosurgical interference may cause inaccurate readings.
• During measurement, DO NOT use a cell phone or any other device that may cause electromagnetic interference, or
emit electromagnetic fields, near the d vice. This may result in incorrect operation of the device.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
01.3 Electromagnetic & RF Immunity
WARNINGS
• DO NOT allow the electrodes of the device to come into contact with other conductive parts (including earth).
• DO NOT expose the device to electric shocks.
• DO NOT expose the device to any static electricity.
01.4 Static Electricity

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CAUTION
• To prevent electrostatic damage to the device, ensure that your body is free of static electricity before using the
device. Static electricity can damage electronic components, contact with earthed objects or devices will discharge
the energy that has built up and cause electrostatic discharge.
01.5 Applicable People
WARNINGS
• The device is NOT designed for patients less than 18 years of age.
• NOT for use on critically ill patients, patients in shock, dehydrated patients, or hyperosmolar patients.
• The device has NOT been tested for use on animals. DO NOT use on pets or any other animals.
CAUTION
• The device should NOT be used by patients who are, or may become, pregnant as possible effects of this device on a
fetus are unknown.
• The device is NOT intended for use by individuals who are disabled without supervision by an adult or qualified
caregiver.
01.6 Applicable Area
WARNINGS
• The device DOES NOT have an alarm that sounds when exceeding a limit.
• DO NOT use the device in critical situations or where alarms are required. In case of emergency, immediately
contact your local emergency services.
01.7 Human Exposure
• All materials used in the device that the patient will be in contact during use have been tested and found to comply
with the requirements of ISO 10993 STANDARD.
• The software was developed in compliance with IEC60601-1-4.
• All VoCare Inc. & Vitals360® devices are designed to comply with rules and regulations in locations they are sold
and are labeled as required.
WARNINGS
• To minimize potential skin irritation, DO NOT place the device sensor over broken or damaged skin.
• DO NOT place the device on swollen or tender tissue or broken or damaged skin.
CAUTION
• Discontinue use and consult your healthcare provider if your skin is irritated or inflamed during use of the d vice.
01.8 Before Measuring
WARNINGS
• Check the device to make sure that there is NO visible damage that may affect the user's safety and measurement
performance. Stop using the device if it is damaged.

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• Chemicals from a broken LCD panel are toxic when ingested. Use caution when the device has a broken display
screen.
• DO NOT operate the device if it is wet or in a wet or moist environment.
• DO NOT take measurements more than necessary.
• Any data erased from the device CANNOT be recovered.
• DO NOT use the device when charging.
CAUTION
• DO NOT measure in a moving vehicle or during physical activity.
• DO NOT operate the device while using other electrical devices.
• To obtain accurate results, the device should be used in a quiet and comfortable environment.
• Please check and ensure that the batteries are working properly.
• DO NOT have low battery or dead battery warning message before use the device.
• When the device is in use, ensure that the batteries are sufficiently chaged to avoid startup abnormalities or
inaccurate data measurements.
• Remain still during measurement. DO NOT move your body or arms.
• DO NOT speak, talk to avoid affecting the accuracy of the measurement.
• The device may NOT work for all patients. If you are unable to achieve stable readings, please discontinue use and
discuss with your healthcare provider.
01.9 Self-Diagnosis
WARNINGS
• All medical concerns and issues should be discussed with your healthcare provider. The device is intended ONLY as
an adjunct in patient assessment.
• The measurement of healthcare data using the device DOES NOT represent or substitute for a healthcare provider's
medical examination.
• You should NOT interpret the measurement results yourself.
• DO NOT attempt self-diagnosis or self-treatment based on the measurement results and analysis, self-diagnosis or
self-treatment may lead to deterioration in your condition.
• DO NOT change your therapy or treatment without independent confirmation from our healthcare provider
following a complete medical examination.
• Always consult your healthcare provider before beginning or modifying any exercise program.
• This device is NOT intended for treatment.
CAUTION
• The device allows you to monitor healthcare data ONLY as referenced in this USER MANUAL.
• The data and messages displayed on the device are for reference ONLY and CANNOT be directly used for diagnostic
interpretation. It must be used in conjunction your healthcare provider who can fully assess your healthcare needs
and symptoms.
• The device may NOT work for all patients.
• The values displayed by the device are the values at the time of measurement. Medical conditions can change
suddenly.
• If measured values exceed the normal range or you are concerned with any reading obtained by the device, please
contact a healthcare professional or healthcare provider immediately to obtain specific healthcare advice
• If you notice any change in your condition, consult your healthcare provider, regardless of the measurement results.
• If you are taking medication, consult your healthcare provider to determine the most appropriate time to measure
your physiological data.

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• NEVER change prescribed medication without consulting your healthcare provider.
• The device is NOT a substitute for seeking medical attention.
• If you believe you are experiencing any adverse medical event seek immediate medical attention.
01.10 Inappropriate Storage
WARNINGS
• CHOKING HAZARD
• The device may contain small parts that may cause a choking hazard if swallowed by infants. Keep away from
children under the age of 3 Years.
CAUTION
• The device is NOT a toy. Children must be supervised around the device and the device should be stored in a secure
location.
• DO NOT stack with other equipment as it could result in improper operation.
• DO NOT expose the device to strong shocks or vibrations.
• Avoid dropping, stepping on, or shaking the device.
• For routine device storage, please refer to Chapter 14 "Storage & Maintenance" as indicated in this USER MANUAL.
01.11 Care & Maintenance
WARNINGS
• DO NOT dismantle the device as this may result in damage or malfunctions.
CAUTION
• It is recommended that the device be inspected before use to make sure that there is NO visible damage that may
impact safety and performance. Discontinue use of the device if damaged.
• Parts that are broken, worn, distorted or contaminated should be replaced immediately. Should any repair or replacement
become necessary, we recommend contact your local VOCARE INC. representative or call 1-855-986-2273.
• For routine care & maintenance of the device, please refer to Chapter 14 "Storage & Maintenance" in this USER
MANUAL.
01.12 Environmental Protection & Discard
WARNINGS
• DO NOT dispose of in fire, contains lithium battery that my explode.
• DO NOT dispose of the device with household waste.
• DO NOT dispose of this device as "UNSORTED MUNICIPAL WASTE." The disposal of scrap device and its
accessories and packing (including battery, plastic bags, foams, and paper boxes) should follow the local laws and
regulations.
• For environmental reasons, unlawful disposal may cause environmental pollution. If you have any questions
concerning the disposal of the device, we recommend contact your local VOCARE INC. representative or call 1-855-
986-2273.
• For routine discard, please refer to Section 14.4 "Discarding" in this USER MANUAL.

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01.13 Risk of Electrical Shock (AC Adapter Usage)
WARNINGS
UL CERTIFIED CHARGER
• The Charger for this device meets applicable UL Safety Requirements. Please adhere to the following safety
instructions per UL Guidelines:
FAILURE TO FOLLOW THE INSTRUCTIONS OUTLINED MAY LEAD TO SERIOUS PERSONAL INJURY AND POSSIBLE
PROPERTY DAMAGE.IMPORTANT SAFETY INSTRUCTIONS - SAVE THESE INSTRUCTIONS.
DANGER
• To reduce the risk of fire or electric shock, carefully folow these instructions.
• For connection to a supply NOT in North America, use an attachment plug adaptor of the proper configu ation for
the power outlet.
• This power unit is intended to be correctly oriented in a vertical or horizontal or floor mount position
• If the USB power cable is damaged or the plug loosens, stop using the cable at once as continued use may result in an
electric shock, short circuit of the charger, or a fire
• DO NOT use the AC adapter if the device or the power cord is damaged. Turn off the power and unplug the power
cord immediately.
• DO NOT plug or unplug the power cord into the electrical outlet with wet hands.
• DO NOT overload power outlets. Plug the device into the appropriate voltage outlet.
• DO NOT use with outlet adaptors.
• 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.
• Connect charging dock to the recommended charger and the power supply (110~240V/50~60Hz/0.5A max).
• Use ONLY the original AC adapter designed for the device. Use of unsupported adapters may damage and/or maybe
hazardous to the device. An improper power voltage may cause a fire or a malfunction of the charge.
• DO NOT use a power cable that is NOT approved or supplied by VOCARE INC.
• DO NOT connect the charge station to any power source or external equipment other than described in this USER
MANUAL.
• DO NOT disassemble, crush, puncture, shred, or otherwise attempt to modify the battery.
• DO NOT put pressure on the battery as this can cause leakage or an internal short-circuit, resulting in overheating,
fire or xplosion.
• DO NOT let the device or battery come in contact with liquids.
• Liquids can get into the device's circuits, leading to corrosion posing a safety hazard. If the device and/or battery get
wet, have them checked by your local VOCARE INC. representative
• or call 1-855-986-2273, even if they appear to be working properly.
• Read and follow the “Important information regarding Electro Magnetic Compatibility (EMC) ".
CAUTION
• Fully insert the power plug.
• The USB power cable is considered as a separate device to the charging adapter.
• Output rating of charger 5.0V 2.0A
• The charging process takes approximately 5 hours.
When handling the power cord, observe the following:
• Wipe any dust off the power plug.
• Disconnect the power plug if the product will NOT be used for an extended period.
• Disconnect the power plug when performing maintenance of the device.
• When disconnecting the power plug, DO NOT pull the power cord. Be sure to remove by holding the power plug.

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When handling the power cord, take care NOT to do the following:
• DO NOT damage.
• DO NOT tamper with it.
• DO NOT twist.
• DO NOT pinch.
• DO NOT break it.
• DO NOT forcibly bend or pull.
• DO NOT bundle during use.
• DO NOT place under heavy objects.
• To avoid inadvertent disconnection, route all cables to prevent a stumbling hazard. Wrap and secure excess cabling
to avoid a risk of entanglement or strangulation by the users.
01.14 Battery Use & Safety
WARNINGS
• DO NOT place your battery in or near a heat source. Excessive heating can damage the device or the battery and
could cause the device or the battery to explode.
• DO NOT dry a wet or damp battery with an appliance or heat source such as a microwave oven, hairdryer, iron, or
radiator.
• Avoid leaving your device in your car in high temperatures.
• Handle and store batteries properly to avoid injury or damage. Most battery issues arise from improper handling of
batteries and the continued use of damaged batteries.
• DO NOT dispose of the device or the battery in a fire. The d vice or the battery may explode when overheated.
• DO NOT handle a damaged or leaking battery.DO NOT let leaking battery fluid come in contact with our eyes, skin
or clothing. For safe disposal options, please contact your local VOCARE INC. representative or call 1-855-986-
2273.
• Avoid dropping the device. Dropping the device or the battery, especially on a hard surface, can damage the device
and battery. If you suspect damage to the device or battery, take
• it to your lo cal VOCARE INC. representative for inspection or call 1-855-986-2273.
• NEVER use any battery that is damaged in any way.
• DO NOT allow the battery to touch metal objects. Accidental short-circuiting can occur when a metallic object (coin,
key, jewelry, clip, or pen) causes a direct connection between the "+" and "-" terminals of the battery (metal strips on
the battery).
• Short-circuiting the terminals may damage the battery or the device causing short-circuiting. Use ONLY VOCARE
INC. approved batteries and recharge your battery ONLY with VOCARE INC. approved chargers specifically
designed for your device.
• Use of a non-VOCARE INC. - approved battery or charger may present a risk of fire, xplosion, leakage, or other
hazards.
• VOCARE INC.'s warranty DOES NOT cover damage to the device caused by non-VOCARE INC. - approved batteries
and/or chargers.
• DO NOT use incompatible batteries and chargers. Consumers should purchase manufacturer or carrier-
recommended products and accessories. If unsure about whether a replacement battery or charger is compatible,
please contact your local VOCARE INC. representative for inspection or call 1-855-986-2273.
• Misuse or use of incompatible batteries and charging devices could result in damage to the device and a possible risk
of fire, xplosion, or leakage, leading to serious injuries, damages to your device, or other serious hazards.

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01.15 Display/Touch-Screen
WARNINGS
WARNING REGARDING DISPLAY
The display on the device is made of glass or acrylic and could break if the device is dropped or receives a significant
impact. DO NOT use if the screen is broken or cracked as this could cause injury.
WARRANTY DISCLAIMER: PROPER USE OF A TOUCH-SCREEN DEVICE
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 xcessive 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."
02 DEVICE OVERVIEW
02.1 Know Your Monitor
a. Device

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b. Arm Cu
c. AC Adapter
d. Type-C Cable
e. SIM Card
CAUTION
CAUTION
To ensure accurate measurements, VOCARE INC.
recommends annual replacement of the arm cuff.
The SIM Card is installed in the device by the
manufacturer before packing.

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f. User Manual h. Carrying Case
g. Quick Start Guide
CAUTION NOTES
02.2 Unpacking & Checking
02.3 Test Operating Mode Selection
ITEM QTY CHECK
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 Guide 1
h. Leather Carrying Case 1
If any of these items are missing from your kit,
contact your local VOCARE INC. Representative or
call 1-855-986-2273.
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.
The device will operate in one of the three test modes: Single
Test Mode, Multi-test and Share Mode, and Test and Share
Mode. An individual may switch between the operating modes,
subject to the following rules:
• a remote patient is not allowed to change the
operating mode from Test and Share Mode 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

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Single Test Mode
Mul-test and Share Mode
TAP & SELECT ”Single Test Mode” button on the screen and you will go to the home page of Single Test Mode.
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.
TAP & SELECT ”Multi-test and Share ” button on the screen and you will go to the home page of Multi-test and Share
Mode.
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. 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. 2. The Healthcare Provider selects a patient from the list.
3. 3. The device stores the selected patient identifier and displ ys the main menu from where the
Healthcare Provider may select measurements to perform.
4. 4. The device will require the Healthcare Provider to authenticate in order to enter or exit Multi-test and
Share Mode.
NOTES
• 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.

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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
• 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, et 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, 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
• 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
• 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-part MDDS.
Mul-test and Share Mode
TAP & SELECT ”Test and Share” button on the screen and you will go to the home page of Test and Share Mode.
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 tmode.

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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 displ ys 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.
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
• 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.
NOTES
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
• 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. 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
• 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 th third-party MDDS.

19
02.4 Intended Use
02.5 Accessories
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 proficientl.
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.
Patient
Category
Measurement
Site
Limb
Circumference
Adult Arm 22~35 cm
Parts and Accessories Model No.
Cuff VC 0011
AC Adapter LXCP12-005200XFG
Type-C Cable VC 0012
Super Sani-Cloth ( EPA* reg. No. 9480-4 ) VC 0013
Bluetooth Weight Scale VC 0014
VOCARE Backpack VC 0015