Quanta Computer MH3 Users manual

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MH3418-01 Version: 3A
Contents
Safety Instructions .................................................................................... 3
Introduction ............................................................................................... 5
Indication for Use ............................................................................................... 5
Package Contents .............................................................................................. 5
Product Overview ............................................................................................... 6
Product Requirements ........................................................................................ 6
Getting Started .......................................................................................... 7
Fitting the Finger Sleeve .................................................................................... 7
Charging the Device ........................................................................................... 8
Installing the APP ............................................................................................... 9
Creating User Profile .......................................................................................... 9
Using the Device ..................................................................................... 11
Pairing the Device with Your Smartphone ........................................................ 11
Performing Measurement ................................................................................. 12
Viewing Real-time Readings ............................................................................ 13
Switching Measurement Mode ......................................................................... 14
Viewing History ................................................................................................. 15
Editing User Profile ........................................................................................... 16
Clear Data ........................................................................................................ 17
Reset the Device .............................................................................................. 17
Exit APP ........................................................................................................... 17
Specifications ......................................................................................... 18
Pulse Oximeter Specifications .......................................................................... 18
Charger Specifications ..................................................................................... 19
Additional Information ............................................................................ 20
Troubleshooting ................................................................................................ 20
Cleaning ........................................................................................................... 20
Customer Support ............................................................................................ 21
EU Representative ........................................................................................... 21
Manufacture Date ............................................................................................. 22
Supplier’s Declaration ...................................................................................... 23
Federal Communications Commission (FCC) Statement . 錯誤! 尚未定義書籤。
Rugulatory Marks ............................................................................................. 29
MH3418-01 EN-2
Safety Instructions
Read the Safety Instructions thoroughly before using this device. Failure to follow these instructions can cause measuring abnormality or device malfunction.
The Quanta Pulse Oximeter is to be used for sleep assessment and personal
reference only. The Quanta Pulse Oximeter is not intended for diagnostic use.
The Quanta Pulse Oximeter 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.
Do not allow the metal connectors to come into contact with any kind of power
source during use.
When the Quanta Pulse Oximeter 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 Pulse Oximeter 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).
The light (the infrared light is invisible) emitted from the device is harmful to the
eyes, so service technician or user should not stare at the light.
Do not clip Quanta Pulse Oximeter on edema or tender tissue. Do not use the Quanta Pulse Oximeter in a flammable environment. Quanta Pulse Oximeter is not a treatment device. Pay attention to ensure that the Quanta Pulse Oximeter is not swallowed by
pets or children.
Please read through this user manual carefully before using the Quanta Pulse
Oximeter.
If the Quanta Pulse Oximeter must be used to take measurements over an
extended period of time, please inspect the contact point of the emitter and receiver that they are in the right position.
When the Quanta Pulse Oximeter 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 Pulse Oximeter.
The Quanta Pulse Oximeter can only take measurements when the subject is
stationary (e.g. while sitting or lying down). Any activities not permitted by the attending physician may affect the accuracy of the measurements.
Do not use the Quanta Pulse Oximeter in an excessively humid environment
and never submerge it directly under water.
Do not clean or wipe the Quanta Pulse Oximeter with corrosive and abrasive
cleaning agents.
The Quanta Pulse Oximeter has been tested and certified to international
electro-magnetic compatibility (EMC) standards for medical equipment (EN 60601-1 and EN 60601-1-2).
MH3418-01 EN-3
The Quanta Pulse Oximeter and its accessories should be disposed of properly. Battery Caution: There is a risk of explosion if the battery for the Quanta Pulse
Oximeter is replaced by an incorrect type.
The Quanta Pulse Oximeter is intended for adult use. Quanta Pulse Oximeter does not provide with a low SpO2 alarm condition or
pulse rate physiological alarm condition.
Quanta Pulse Oximeter does not support low perfusion detection. Clean the skin of Quanta Pulse Oximeter sensor and charger with 75% alcohol;
and clean the finger sleeve in wash machine.
If you wear Quanta Pulse Oximeter too long, it may cause uncomfortable by
long time pressure. Please check if you have any on the finger every eight hours.
Quanta Pulse Oximeter Sensor is a compact all-in-one design with Emitter /
Receiver embedded inside. So that it doesn’t have to verify the compliance of monitor, probe extenders and cable before use.
Quanta Pulse Oximeter has been validated and tested for compliance with
international standard ISO 80601-2-61.
The self life of Quanta Pulse Oximeter is 2 years. Quanta Pulse Oximeter is calibrated to display functional oxygen saturation. The pulse rate accuracy is verified by the root-mean-square(rms) method which
is the difference between pulse rate data recorded by Quanta Pulse Oximeter and with pulse rate data set by the SpO2 simulator.
Do not use any unauthorized oximeter simulator to assess the accuracy of
Quanta Pulse Oximeter. And if there has any question please contact Quanta Customer Support.
The SpO2 accuracy validation, Quanta Pulse oximeter clinical trial was
performed in accordance with ISO 80601-2-61 and FDA guidance. The study population is healthy volunteers who consent to induced hypoxia and arterial blood sampling more than 200 data points. Participated subjects is including Asian, Caucasian, African, Male, and Female. Their ages are from 21 to 50 years old. The statistically study result indicated that the SpO2 accuracy (±Arms)
of Quanta Pulse Oximeter was less than ±3 % in the SpO2 range 70% ~100% complied with the accuracy requirement.
When the finger sleeve is not viscous, or it is recommended to use finger sleeve
for a month if it’s used every day.
MH3418-01 EN-4
Introduction
Indication for Use
The Quanta Pulse oximeter is intended for use in the non-invasive measurement of patient blood oxygen (SpO2) and pulse rate in healthcare institute, and home environments. The Quanta Pulse oximeter will process SpO2 signals and calculate pulse rate. SpO2 value and pulse rate data will be transferred to a display device via Bluetooth, and further displayed on the display device screen with a dedicated App called Q-SPO2 APP. The device should be worn on the index finger, middle finger and ring finger along with a finger sleeve and it’s for adult use only. The Quanta Pulse oximeter is sold to professional organizations such as home care givers, clinics, or trained patient rather than to the general public. Unauthorized installation by users is not allowed.
Package Contents
The following items come with your package. If any of the items is missing, please contact your dealer.
Pulse Oximeter Charger Finger Sleeve
Adapter User Manual
Adaptor: Manufacture by ASIAN POWER DEVICES INC.
Model No: WB-10G05FG
Input: 90-264V,47~63Hz
Output: 5V/2A
MH3418-01 EN-5
Power button
with LED
Probe
(sensor)
pin
Product Overview
Pulse Oximeter
Charger
Pogo charging port
Pogo
Product Requirements
In order to properly use the Quanta Pulse Oximeter the following items are required:
The Qunata Pulse Oximeter Sensor Finger Sleeve A Bluetooth-enabled Android Smartphone* (with Android version 5.0 or above and a
display resolution of 1920x1080 or 2560x1440)
The Quanta Pulse Oximeter App Q-SPO2*.
* Items not included in the product package.
MH3418-01 EN-6
Getting Started
Fitting the Finger Sleeve
Before inserting the device into the finger sleeve, observe the openings on the finger sleeve.
To fit the finger sleeve, do the following:
1. With the charging port is facing outwards, insert the bottom side of the device halfway into the bottom opening of the finger sleeve.
2. Insert the upper side of the device into the upper opening of the finger sleeve. Then push the device firmly into the finger sleeve until it fully seated.
3. Use the Velcro strip to fit the device snugly around the finger sleeve.
MH3418-01 EN-7
Charging the Device
It is recommended that you charge your device prior to first use. It takes approximately 1.5 hours to fully charge.
To charge the battery, do the following:
1. Connect the other end of the charger to the USB port of the adapter.
2. Detach the Velcro strip and flip it over to another side of the finger sleeve so
that you can access the pogo charging port.
3. Align and attach the pogo pin of the charger with the charging port of the device.
4. Plug the adapter to a wall outlet.
The Power LED lights orange while the battery is charging. Once the Power LED lights green, this indicates the battery is fully
charged.
Note: You can also directly charge the device before fitting it into the finger sleeve.
MH3418-01 EN-8
Installing the APP
To obtain the readings from the device, you have to install Q-SPO2 APP first on your smartphone.
1. Make sure your smartphone is connected to the Internet.
2. Launch Google Play Store application and search for Q-SPO2 APP.
3. Follow the on-screen instructions to download and install Q-SPO2 APP on
your smartphone.
Note: In order to install the Q-SPO2 app your smartphone will need at least 8MB of
storage capacity available.
.
Creating User Profile
The first time you launch Q-SPO2 APP, you will be prompted to create a user profile.
1. Launch Q-SPO2 APP ( ). The welcome screen appears.
2. Enter your personal data into the required entry fields.
IMPORTANT: It is important to enter the correct resting heart rate to
ensure the reading accuracy.
MH3418-01 EN-9
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