Quanta Computer CI3 User Manual

Smart Wearable ECG Monitoring Device User
Manual V 1.0
TABLE OF CONTENTS
Safety Notes ............................................................... 5
Product Overview ...................................................... 8
Indication for Use ....................................................................... 8
Product Configurations ....................................................................................... 10
Components ............................................................................. 10
Sensor ................................................................................................................... 10
Charger ................................................................................................................. 11
Body Strap Patch ................................................................................................. 12
Direct Wear Patch ................................................................................................ 13
Product Requirements ............................................................ 14
Before You Start ......................................................15
Charging the Battery ............................................................... 15
Installing the App ..................................................................... 15
Enabling Bluetooth .................................................................. 15
Getting Started.........................................................16
Creating a Profile ..................................................................... 16
Pairing........................................................................................ 17
Wearing the ECG Sensor ........................................................ 18
Wearing the ECG Sensor with the Body Strap B1............................................. 18
Wearing the ECG Sensor with the Body Strap B2............................................. 19
Direct Wear ........................................................................................................... 20
The Q-COR App .......................................................23
Main Screen .............................................................................. 23
Menu .......................................................................................... 24
History ................................................................................................................... 24
Profile .................................................................................................................... 27
Pairing ................................................................................................................... 27
Reset ..................................................................................................................... 28
Quit ........................................................................................................................ 28
Additional Information ...........................................29
LED Indicators .......................................................................... 29
Status Indicator (Sensor)..................................................................................... 29
Charging Indicator (Charger) .............................................................................. 29
Cleaning .................................................................................... 29
ECG Electrode Information ..................................................... 29
Specifications ........................................................................... 30
Sensor Specifications .......................................................................................... 30
Charger Specifications ........................................................................................ 31
Trouble shooting ...................................................................... 31
Customer Support.................................................................... 31
EU Representative ............................................................................................... 31
Federal Communications Commission (FCC) Statement... 32
Manufacture Date ..................................................................... 33
Smart Wearable ECG Monitoring Device (CI3) .................................................. 33
Charger (CI3-C)..................................................................................................... 33
Supplier’s Declaration ............................................................. 34
Supplier's declaration and guidelines — Electromagnetic Immunity.............. 34
Recommended safety distance........................................................................... 35
Regulatory Marks ................................................................................................. 36
SAFETY NOTES
The Quanta Smart Wearable ECG Monitoring Device is to be used for clinical assessment and personal reference only. The Quanta Smart Wearable ECG Monitoring Device is not intended for diagnostic use.
The Quanta Smart Wearable ECG Monitoring Device consists entirely of sophisticated medical electrical parts so maintenance can only be carried out by professional technicians. Unauthorized disassembly of the device by the user is not allowed.
The Quanta Smart Wearable ECG Monitoring Device must be used with the specified “accessories” and “electrodes”. The use of accessories and electrodes from other brands may lead to faulty readings. For more information, see Product Requirements.
Do not allow the metal connectors to come into contact with any kind of power source during use.
Damaged or faulty accessories and electrodes should not be used.
When the Quanta Smart Wearable ECG Monitoring Device is low on power, it will
automatically stop taking measurements and the corresponding indicator lights will blink. Please charge the sensor as soon as it shows a low battery state.
When the Quanta Smart Wearable ECG Monitoring Device is taking measurements, please try and avoid using any instruments or devices that may affect the accuracy of the readings (e.g. the use of a blood pressure meter will affect the measurement of the pulse).
When the Quanta Smart Wearable ECG Monitoring Device is taking measurements, please try and avoid using other electronic devices nearby. If it must be used with other electronic devices simultaneously, please check to make sure that the Quanta Smart Wearable ECG Monitoring Device is continuing to take measurements normally.
The Quanta Smart Wearable ECG Monitoring Device-specific accessories are defined in this user guide. The use of accessories from other brands may damage the device.
Do not use the Quanta Smart Wearable ECG Monitoring Device in a flammable environment.
When the environment temperature is 45degC, the surface temperature of Quanta Smart Wearable ECG Monitoring Device will be 46degC.
When ambient temperature is 40~45degC, do not use the Quanta Smart Wearable ECG Monitoring Device for more than 4 hours to avoid low-temperature burns.
Users have to buy ECG electrodes themselves when using the direct wear patch. The specification for ECG electrodes can be found in ECG Electrode Information.
Pay attention to ensure that the Quanta Smart Wearable ECG Monitoring Device is not swallowed by pets or children.
Cardiac pacemakers or other electrical stimulators may affect the accuracy of the measurements for the Quanta Smart Wearable ECG Monitoring Device.
The conductive parts of the electrodes and associated connectors for type CF applied parts, including the neutral electrode, should not make contact with other conductive parts including the ground.
Please read through this user guide carefully before using the Quanta Smart Wearable ECG Monitoring Device.
If the Quanta Smart Wearable ECG Monitoring Device must be used to take measurements over an extended period of time, please inspect the contact point of the electrodes at least once every 8 hours to make sure that the electrodes are in the right position and there is no allergic skin reaction on the user.
Do not use high-frequency instruments or electrical medical equipment such as “defibrillators” when using the Quanta Smart Wearable ECG Monitoring Device.
When the Quanta Smart Wearable ECG Monitoring Device is taking measurements and a stable reading cannot be taken then stop taking measurements right away as not everyone is suitable to sensor using the Quanta Smart Wearable ECG Monitoring Device.
The Quanta Smart Wearable ECG Monitoring Device can only take measurements when the subject is stationary (e.g. while sitting or lying down) or engaging in ordinary activity. Any activities not permitted by the attending physician may affect the accuracy of the measurements.
Do not use the Quanta Smart Wearable ECG Monitoring Device in an excessively humid environment and never submerge it directly under water.
Do not expose the Quanta Wearable ECG Monitoring Device to extremely temperature, moist environment, dust or direct sun light.
Do not clean or wipe the Quanta Smart Wearable ECG Monitoring Device with corrosive and abrasive cleaning agents.
The disposal of the Quanta Smart Wearable ECG Monitoring Device and its accessories should comply with the relevant local regulations.
The Quanta Smart Wearable ECG Monitoring Device has been tested and certified to international electro-magnetic compatibility (EMC) standards for medical equipment (EN 60601-1 and EN 60601-1-2).
The Quanta Smart Wearable ECG Monitoring Device and its accessories should be disposed of properly.
Battery Caution: There is a risk of explosion if the battery for the Quanta Smart Wearable ECG Monitoring Device is replaced by an incorrect type.
The Quanta Smart Wearable ECG Monitoring Device’s use is not intended for infants weighing less than 10 kg.
The expected service life of Quanta Smart Wearable ECG Monitoring Device is 3 years.
PRODUCT OVERVIEW
Indication for Use
The Quanta Smart Wearable ECG Monitoring Device is intended for use in the non­invasive measurement of a functional Electrocardiography (ECG) and heart rate (HR) in hospital, healthcare institute, and home environments by trained medical professionals and trained-adults. The Smart Wearable ECG Monitoring Device will process ECG signals and calculate HR. ECG and HR data will be transferred to a smartphone via Bluetooth, and further displayed on the smartphone screen via a dedicated app called Q-COR. The device should be worn on the human body along with a belt or a patch with gel electrodes. The Quanta Smart Wearable ECG Monitoring Device is sold to professional organizations such as home care givers, clinics, or hospitals rather than to the general public. It can only be installed by trained adults or medical personnel. Unauthorized installation by users is not allowed.
Direct Wear
Patch x 1
Body Strap
Patch x 1
Body Strap
B1
x 1
Body Strap
B2
x 1
User Manual
Pin x 1
User Manual x 1
Package Contents
After purchasing the Smart Wearable ECG Monitoring Device please check the product package to ensure that the following items are included:
ECG Sensor x 1 Charger x 1
USB Charging Cable x 1 5V/2A Adapter x 1
(For Select Models)
(For Select Models)
(For Select Models)
(For Select Models)
Product Configurations
Part Name
Model Number
CI3SKU1
CI3SKU2
CI3SKU3
Body Strap Patch
CI3-P2 V
V
The following is a table that lists the various product configurations for the Quanta Smart Wearable ECG Monitoring Device and the components included for each configuration.
Product Configuration
Smart Wearable ECG Sensor Charger CI3-C V V V Direct Wear Patch CI3-P1 V
Body Strap B1 CI3-B1 V Body Strap B2 CI3-B2
CI3 V V V
Components
Sensor
Front
1
Status Indicator (see LED Indicators for more information)
1 Patch Connectors
3
LED Indicators
3
3
Back
2 Charging Contacts 3 Bluetooth Pairing Button
Charger
1 Charging Contacts 2 USB Charging Port
Charging Indicator (see
for more information)
Body Strap Patch
Front
1 Sensor Connectors
Back
1 Electrode Connectors
IMPORTANT: If any wear or damage to the wire shielding is found on the patch during use, replace immediately.
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