Quanta Computer CI2 User Manual
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QUANTA COMPUTER INC.
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HUAYA PLANT
Wearable ECG Monitoring
Device
User Manual
Ver. 1.0
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2014 Quanta Computer Inc. Huaya Plant
CI2418-01_2A
All rights reserved.
QUANTA COMPUTER INC. Wireless Home Health Management System
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INDEX
WARNINGS AND REMINDERS ............................................................................. 2
W
ARNINGS
R
EMINDERS
: ........................................................................................................................................................ 2
:....................................................................................................................................................... 3
YEAR OF MANUFACTURE ..................................................................................... 5
SUPPLIER'S DECLARATION ................................................................................. 7
REGULATORY MARKS ......................................................................................... 10
INTRODUCTION ....................................................................................................... 12
EQUIPMENT ............................................................................................................... 13
A.NB / PC ....................................................................................................................................................... 13
EQUIPMENT OPERATING INSTRUCTIONS................................................ 15
A. P
ERSONAL COMPUTER
B. Q
UANTA
COMPUTERS
C. NYA B
D. NYA B
E. ECG E
F. NYA C
ECG M
(NB / PC)] ......................................................................................................................... 16
ODY MONITOR
ODY MONITOR ACCESSORY
LECTRODES
HARGER
........................................................................................................................................ 27
(NB/ PC) ....................................................................................................... 15
ONITOR APPLICATION,
........................................................................................................................... 21
.................................................................................................................................. 26
NYA- D
.................................................................................................. 25
ATA-
CMD [
FOR USE ON PERSONAL
CLEANING OF THE WIRELESS HOME HEALTH MANAGEMENT
SYSTEM ........................................................................................................................ 29
PRODUCT SPECIFICATIONS ............................................................................. 29
PRODUCT LIST ......................................................................................................... 30
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QUANTA COMPUTER INC. Wireless Home Health Management System
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Warnings and Reminders
Warnings:
The NYA Quanta Wireless Home Health Management System is to be used for
clinical assessment and reference only. The NYA Quanta Wireless Home Health
Management System is not intended for diagnostic use.
The NYA Quanta Wireless Home Health Management System consists entirely of
sophisticated medical electrical devices so maintenance can only be carried out by
professional technicians. Unauthorized disassembly of the device by the user is not
allowed.
The NYA Quanta Wireless Home Health Management System must be used with
the specified "accessories" and "electrodes". The use of accessories and electrodes
from other brands may lead to faulty readings.
Do not allow the metal connectors to come into contact with any kind of power
source during use.
Before using the NYA Quanta Wireless Home Health Management System. Please
make sure that all of the machine's indicator lights are clearly readable in the
current usage environment.
Damaged or faulty accessories and electrodes should not be used.
When the NYA Quanta Wireless Home Health Management System experiences an
error, it will automatically stop taking measurements and the corresponding
indicator lights will blink.
When the NYA Quanta Wireless Home Health Management System is low on
power, it will automatically stop taking measurements and the corresponding
indicator lights will be blink.
When the NYA Quanta Wireless Home Health Management System 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 the blood pressure meter will
affect the measurement of the pulse).
When the NYA Quanta Wireless Home Health Management System 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 NYA Quanta Wireless Home Health Management System is continuing to
take measurements normally.
NYA-specific accessories are defined in this user guide. The use of accessories
from other brands may damage the device.
Do not use the NYA Quanta Wireless Home Health Management System in a
flammable environment.
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QUANTA COMPUTER INC. Wireless Home Health Management System
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Reminders:
Please read through this user guide carefully before using the NYA Quanta
Wireless Home Health Management System.
If the NYA Quanta Wireless Home Health Management System 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 from the user.
Do not use medical electrical equipment such as "defibrillators" when using the
NYA Quanta Wireless Home Health Management System.
When the NYA Quanta Wireless Home Health Management System is taking
measurements, if a stable reading cannot be taken then stop taking the measurement
right away (not everyone is suitable for monitoring with the NYA Quanta Wireless
Home Health Management System).
The NYA Quanta Wireless Home Health Management System can only take
measurements when the subject is stationary (e.g. while sitting or lying down) or
engaging in ordinary exercise. Any activities not permitted by the attending
physician may affect the accuracy of the measurements.
Do not use the NYA Quanta Wireless Home Health Management System in an
excessively humid environment and never submerge it directly under water.
Do not clean or wipe the NYA Quanta Wireless Home Health Management System
with corrosive and abrasive cleaning agents.
The NYA Quanta Wireless Home Health Management System consists entirely of
sophisticated medical electrical devices so maintenance can only be carried out by
professional technicians. Unauthorized disassembly of the device by the user is not
allowed.
When the NYA Quanta Wireless Home Health Management System is low on
power, please insert it in the charger for re-charging as soon as possible.
The disposal of the NYA Quanta Wireless Home Health Management System and
its accessories should comply with the relevant local regulations.
The NYA Quanta Wireless Home Health Management System has been tested and
certified to international electro-magnetic compatibility (EMC) standards for
medical equipment (EN 60601-1 and EN 60601-1-2) for the user's peace of mind.
The NYA Quanta Wireless Home Health Management System and its accessories
should be disposed of properly. If you are uncertain about the proper disposal
method, please contact customer service at Quanta Computer Inc. Huaya Plant for
assistance.
The accuracy of the medical electrical equipment may be affected if used near
high-frequency communications equipment.
Battery Caution
Risk of explosion if battery is replaced by an incorrect type.
Dispose of used batteries according to the instructions
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Federal Communications Commission (FCC) Statement
15.21
You are cautioned that changes or modifications not expressly approved by the part
responsible for compliance could void the user’s authority to operate the
equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions:
1) this device may not cause interference and
2) this device must accept any interference, including interference that may cause
undesired operation of the device.
15.105(b)
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation.
This equipment generates uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
.
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QUANTA COMPUTER INC. Wireless Home Health Management System
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Year of Manufacture
The year of manufacture label and format of the wireless home health management
system's body monitor, charger and ECG electrodes are shown below:
Sensor
Charger
In the serial number on the
product label, the 7th
character starting from the
left (“14” in the shown
example) represents the
sensor and charger's year of
manufacture.
Example:
If the serial number is “QTCI2C425001”
The 7th characters is mean “14”
Then the year of manufacture is 2014 AD.
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ECG Electrodes
The effective date of the ECG electrodes is labeled along the lower edge of the
packaging in impact type (not printed) as shown below:
Example: 220801X 2015-07
Explanation: 220801X Manufacturer lot number
2015-07 Valid before July 2015
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QUANTA COMPUTER INC. Wireless Home Health Management System
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Supplier's Declaration
The NYA Quanta Home Health Management System conforms to the international EN
60601-1 and EN 60601-1-2 standards for electromagnetic compatibility with medical
electrical devices and systems.
Emission Testing
The recommended electromagnetic environment for this instrument is shown in the
table below. The customer or user should ensure that this instrument is used in the
described environment.
Compliant
Standard
Electromagnetic Environment Guidelines
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic
Emissions
Voltage
Fluctuations/
Flicker
Emissions
Testing
The recommended electromagnetic environment for this instrument is shown in the
table below. The customer or user should ensure that it is used in the described
environment.
Electrostatic
Discharge
(ESD)
IEC 61000-4-2
Power Frequency
(50/60Hz)
Magnetic Field
IEC 61000-4-8
Group 1
Class B
IEC 61000-3-2
IEC 61000-3-3
IEC 60601-1-2
testing
±6 kV contact
±8 kV air
3 A/m 3 A/m
Radio-frequency is only used by the internal
functions of this instrument. The emission
energy is also very low and does not interfere
with nearby electronic instruments.
This instrument is suitable for home use
(including residential or other mixed
residential/public low-voltage power grids)
Compliant
Standard
±6 kV contact
±8 kV air
Electromagnetic
Environment
Guidelines
The floor should be
timber, concrete or
ceramic tile. If the
floor is covered in a
synthetic material then
it should have a
relative humidity of at
least 30%.
Power frequency and
magnetic field in
representative
commercial or hospital
environments.
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Supplier's declaration and guidelines—Electromagnetic Immunity
Testing
IEC 60601-1-2
testing
Compliant
Standard
Electromagnetic Environment
Guidelines
The recommended electromagnetic environment for this instrument is shown in the table
below. The customer or user should ensure that it is used in the described environment.
No part of the NYA Quanta Wireless Home health management System should be placed
near portable and mobile radio-frequency communications equipment. The recommended
safety distance can be calculated using the radio frequency and the following formula.
Radio-frequency
IEC 61000-4-6
Radio-frequency
IEC 61000-4-3
3 V/m
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
[3] V
[3] V/m
Recommended safety distance
d=1.17
P
d
=1.17
d
=2.33
P
80 MHz to 800MHz
P
800MHz to 2.5 GHz
P
is the maximum output of the
transmitter (Unit: Watt)
d
is the recommended safety
distance (Unit: Meter)
The field intensity of the fixed RF
transmitter (after an EM site
survey) should be lower than the
recommended values for the above
frequency ranges.
Interference may be produced near
instruments that have the
following symbol:
The field intensity of fixed RF transmitters (e.g. radio, mobile phone, ham radio, FM and AM
radio broadcasts and TV stations) cannot be predicted from the frequency alone. To evaluate
the EM field intensity of the environment, an EM site survey may be necessary. If the
measured field intensity for a region exceeds the above recommended range, the device
should be observed or checked to make sure it operates normally. If abnormal operation is
observed, further action such as adjusting the direction or re-positioning of the equipment
should be taken.
Attention: For frequencies between 80 MHz and 800 MHz, use the higher frequency range.
Attention: These guidelines may not be applicable to all situations. Electromagnetic waves
can be absorbed or reflected by buildings, objects and people.
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QUANTA COMPUTER INC. Wireless Home Health Management System
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Recommended safety distance
The following table lists the recommended safety distance between the device and mobile RF
communications equipment.
The recommended EM environment for the NYA Quanta Wireless Home Health Management
System is where RF interference is controlled. The user should maintain the recommended
safety distance with the devices and portable/mobile RF communications equipment listed in
the following table (corresponding to the maximum output of the RF transmitter).
Recommended Safety Distance (corresponding to RF transmitter
output)
Maximum output of
RF transmitter (Watt)
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
If the maximum output of the transmitter is not shown in the above table, use the formula to
derive the recommended safety distance d (Meter) with P (Watt) being the maximum output
of the transmitter.
150 kHz to 80 MHz
d
=1.17
P
80 MHz to 800 MHz
d
=1.17
P
800 MHz to 2.5 GHz
d
=2.33
P
Attention: For frequencies between 80 MHz and 800 MHz, use the higher frequency range.
Attention: These guidelines may not be applicable to all situations. Electromagnetic waves
can be absorbed or reflected by buildings, objects and people.
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User Manual V1.0 Page: 9
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