VOCARE vitals360 User manual

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Table of Contents
DEVICE ................................................................................................................................................................... 6
01 IMPORTANT SAFETY INFORMATION ................................................................................................................. 8
01.1 Symbols Bank ........................................................................................................................................ 9
01.2 Environmental Requirements .............................................................................................................. 10
01.3 Electromagnetic & RF Immunity .......................................................................................................... 10
01.4 Static Electricity ................................................................................................................................... 12
01.5 Applicable People ................................................................................................................................ 13
01.6 Applicable Area ................................................................................................................................... 13
01.7 Human Exposure ................................................................................................................................. 13
01.8 Before Measuring ................................................................................................................................ 14
01.9 Self-Diagnosis ...................................................................................................................................... 14
01.10 Inappropriate Storage ........................................................................................................................ 15
01.11 Care & Maintenance .......................................................................................................................... 16
01.12 Environmental Protection & Discard ................................................................................................. 16
01.13 Risk of Electrical Shock (AC Adapter Usage) ...................................................................................... 16
01.14 Battery Use & Safety .......................................................................................................................... 18
01.15 Display/Touch-Screen ........................................................................................................................ 19
02 DEVICE OVERVIEW ......................................................................................................................................... 20
02.1 Know Your Monitor ............................................................................................................................. 20
02.2 Unpacking & Checking ......................................................................................................................... 23
02.3 Test Operating Mode Selection ........................................................................................................... 24
02.4 Intended Use ....................................................................................................................................... 29
02.5 Accessories .......................................................................................................................................... 29
03 BEFORE MEASURING ...................................................................................................................................... 30
03.1 Using the AC Adapter .......................................................................................................................... 30
03.2 Turn On/Off ......................................................................................................................................... 31
03.3 Symbols & Items Bank ......................................................................................................................... 32
03.4 Login .................................................................................................................................................... 33
03.5 Display of Home Page .......................................................................................................................... 35
03.6 Symbols Bank - Home Page ................................................................................................................. 37

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03.7 Symbols Bank - Setting ........................................................................................................................ 38
03.8 User Setting ......................................................................................................................................... 38
03.9 Setting - Volume Adjustment .............................................................................................................. 39
03.10 Setting - Unit of Measurement Switch .............................................................................................. 39
03.11 Setting - Language ............................................................................................................................. 40
03.12 Setting - ECG ...................................................................................................................................... 41
03.13 Setting - Date/Time ........................................................................................................................... 41
03.14 Setting - Admin Setting ...................................................................................................................... 42
04 MEASURING BLOOD PRESSURE ...................................................................................................................... 44
04.1 Overview ............................................................................................................................................. 44
04.2 Safety Information ............................................................................................................................... 45
04.3 Display & Symbols Bank ...................................................................................................................... 47
04.4 Applying the Arm Cuff ......................................................................................................................... 48
04.5 For Accurate Measurement ................................................................................................................. 49
04.6 Taking A Reading .................................................................................................................................. 52
04.7 Read the Blood Pressure Display ......................................................................................................... 55
04.9 Troubleshooting ................................................................................................................................... 56
05 MEASURING BLOOD OXYGEN (SPO2) ............................................................................................................. 57
05.1 Overview ............................................................................................................................................. 57
05.2 Safety Information ............................................................................................................................... 58
05.3 Display & Symbols Bank ...................................................................................................................... 61
05.4 Taking A Reading .................................................................................................................................. 62
05.5 If Using Oxygen .................................................................................................................................... 64
05.7 Troubleshooting ................................................................................................................................... 66
06 MEASURING FOREHEAD TEMPERATURE ........................................................................................................ 67
06.1 Overview ............................................................................................................................................. 67
06.2 Safety Information ............................................................................................................................... 67
06.3 Display & Symbols Bank ...................................................................................................................... 68
06.4 Taking A Reading .................................................................................................................................. 69
06.6 Troubleshooting ................................................................................................................................... 71
07 ECG SCANNING & RECORDING ....................................................................................................................... 73
07.1 Overview ............................................................................................................................................. 73
07.2 Safety Information ............................................................................................................................... 73
07.3 Display & Symbols Bank ...................................................................................................................... 75
07.4 Taking A Reading .................................................................................................................................. 76

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07.6 Troubleshooting ................................................................................................................................... 78
08 MEASURING and STORING WEIGHT & HEIGHT .............................................................................................. 79
08.1 Overview of Manual Process ............................................................................................................... 79
08.2 Manual Display & Symbols bank ......................................................................................................... 79
08.3 Manual Height & Weight ..................................................................................................................... 79
08.6 Troubleshooting ................................................................................................................................... 81
08.7 Overview of Measuring Weight using a Bluetooth Weight Scale ........................................................ 81
08.8 Measuring Weight using a Bluetooth Weight Scale ............................................................................. 81
09 CAMERA ......................................................................................................................................................... 84
09.1 Overview ............................................................................................................................................. 84
09.2 Display & Symbols Bank ...................................................................................................................... 84
10 AFTER MEASURING ........................................................................................................................................ 85
10.1 Measurement Processing .................................................................................................................... 85
10.2 View the Measuring Result .................................................................................................................. 85
10.3 Display & Symbols Bank ...................................................................................................................... 86
10.4 Check the History ................................................................................................................................ 86
11 INTRODUCE .................................................................................................................................................... 88
12 MODE SWITCHING .......................................................................................................................................... 89
13 CLEANING & DISINFECTING ............................................................................................................................ 90
13.1 The Difference between Cleaning & Disinfecting ................................................................................ 90
13.2 Safety Information ............................................................................................................................... 90
13.3 How to Clean the Device ..................................................................................................................... 91
13.4 How to Disinfect the Device ................................................................................................................ 93
13.5 Approved Cleaning & Disinfecting Product ......................................................................................... 94
13.6 How to Clean & Disinfect the Arm Cuff ............................................................................................... 95
14 STORAGE &MAINTENANCE ............................................................................................................................ 96
14.1 Storage ................................................................................................................................................ 96
14.2 Safety Information ............................................................................................................................... 96
14.3 Maintenance ....................................................................................................................................... 97
14.4 Discarding ............................................................................................................................................ 98
15 SPECIFICATIONS ............................................................................................................................................ 100
16 LIMITED WARRANTY ..................................................................................................................................... 102
16.1 Manufacturer's Warranty .................................................................................................................. 102
16.2 Limitations of Warranty ..................................................................................................................... 103
16.3 User Responsibility ............................................................................................................................ 103

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16.4 What's NOT Covered by Warranty ..................................................................................................... 104
16.5 Precautions for Transfer and Disposal ............................................................................................... 105
16.6 End User License Agreement for Software ........................................................................................ 105
17 COMPLIED STANDARDS LIST ......................................................................................................................... 108
18 IEC60601-1-2 EMC & RF STATEMENT ........................................................................................................... 110
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC) ............................ 110
GUIDANCE & MANUFACTURER'S DECLARATION ....................................................................................... 111

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DEVICE
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 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.

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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.

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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 operat ion 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:
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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01.1 Symbols Bank
TAP & SELECT TAP & HOLD PRESS & SWIPE UP & DOWN
PRESS & SWIPE FORWARD & BACKWARD ENTER TEXT OR NUMBER IN
CAUTION: Federal law restricts this device to sale (or use) on the order of a healthcare provider.

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01.2 Environmental Requirements
General Operating 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
MANUAL. If NOT, it may result in damage to the device or cause an inaccurate reading.
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 devi ce 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.
01.3 Electromagnetic & RF Immunity
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 defibrillator.
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 with 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.

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• During measurement, DO NOT use a cell phone or any other device that may cause electromagnetic
interference, or emit electromagnetic fields, near the device. 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.

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01.4 Static Electricity
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.
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.

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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 device.

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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.
• 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 charged 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 your 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.

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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.
• 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.

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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 may 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.
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 follow these instructions.
• For connection to a supply NOT in North America, use an attachment plug adaptor of the proper
configuration for the power outlet.

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• 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 charger.
• 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 explosion.
• 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.
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.

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• 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 device 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
your 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 local 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, explosion, 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, explosion, 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 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."

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02 DEVICE OVERVIEW
02.1 Know Your Monitor
a. Device