Kinpo Electronics BC XYZlife Patch User Manual
Kinpo Electronics Inc XYZlife Patch
User manual
Instruction Manual
Portable ECG Monitor
Thank you for purchasing XYZlife portable ECG monitor.
Please read this entire instruction manual. If you are using this
device for the very first time, please follow the instructions and
use it correctly. Please keep the instruction manual for future
reference.
XYZlife does not bear legal responsibilities for any casualty
or product damage caused by users’misuse.
Caution ...........................................................................................................2
Safety Conditions
Product Description and Indication of Use .........................................4
Components and Accessories
Procedure of Set-up ....................................................................................7
Initial Set Up
XYZlife BC1 Patch Procedure (with Optional Electrode Patch)
Battery .............................................................................................................9
Important Notes on Taking a Reading .................................................9
Care and Maintenance .............................................................................10
Sound and Lighting Messages
App Error Messages Display
Trouble Shooting
Storage
FCC Statement ............................................................................................13
Specification ................................................................................................15
Table of Contents
Caution
2
Safety Conditions
This product is designed to monitor ECG (Electrocardiogram) only.
Do not use for any other purpose: such as monitoring life signal or emergency.
Use for self-diagnosis or self- treatment is dangerous, please always consult
your doctor if you notice any change in your condition, regardless of your
measurement result.
The measurement result is used for monitor purpose only.
Do not read it yourself and conduct any treatment without consult from medical
professionals.
This product does not support Pacing Spikes function.
Patients with cardiac pacemaker are not recommended to use this product.
Notification
• Do not sterilize this device in an autoclave or gas sterilizer
(EO, formaldehyde, high density ozone, etc.)
• Use at temperature within +10 to +45°C, and humidity between 30 and 85%RH.
• Do not wash this device with water.
• Do not store the device in the following ambient conditions:
Locations subject to high temperatures and high humidity.
Near fires or open flames.
Locations exposed to strong vibration.
Locations exposed to strong electromagnetic fields.
Locations exposed to direct sunlight.
Wet or damp locations where water may get on the device.
Dusty locations.
Attention
• Do not expose the unit to static environment.
Always avoid any static electricity from your body before handling the device.
• The chest electrode patch will be influenced by body hair. Regularly remove
hair at the electrode patch contact point.
• Do not take measurement with used electrode patch.
• Do not take measurements in a moving vehicle.
• Do not disassemble, repair, or modify the device.
Caution
3
WARNING！
• Do not use the device in ICU or operation room.
• Do not use the device in hospital or other medical institutions without the
permission of physicians. This product could impact other medical devices.
• Do not use the device together with defibrillator (AED).
• Avoid flammable materials, anesthetics, drugs or pressurized oxygen
(such as in a hyperbaric chamber, ultraviolet sterilizer or oxygen tent).
• Do not attempt self-diagnosis or self-treatment based on the measurement results.
Always consult your doctor. Self-diagnosis or self-treatment may lead to
deterioration in your condition.
• Do not use this device on people with sensitive skin or allergic condition.
With some situations, it may cause rashes, skin allergies or eczema.
• Please pay special attention to the cable of the charger to avoid the risk
for tangling around the kid’s neck.
• Do not strongly shock or vibrate the device. Do not drop or strike on the device.
• Avoid the areas that conduct electricity on the device to touch those of others.
• Please make sure your skin is clean and dry, avoid to use after bathing and sweating.
• Keep out of reach of children, self-care deficits or people who cannot express their consent.
• Do not use for any purpose other than obtaining an electrocardiogram.
• Do not work the device together with other test and measurement
equipments to avoid risks.
• Do not take measurements where the device will be exposed to strong
electromagnetic environment.
• Do not use the device on the children under age 12.
Single lead portable ECG monitor, is addressed as“device”below.
The device is used to measure user’s ECG continuously.
Recordings can be transmitted, and viewed by the collaborative App.
Product Description
4
The device consists of three main components:
(1) BC1 main unit.
It attaches to user’s body via electrode patch (optional) ,
using blue tooth to keep communication with mobile devices.
(2) App: This App is used to collect, view, store, and wirelessly transfer the readings from
device, it must be applied with electrode patch when taking readings.
(3) A user-supplied compatible mobile device.
Intended use of the product:
BC1, is a portable Electrocardiograph recording device which is designed to be
used in combination with an individual’s smartphone to create a portable
health monitoring system. The BC1 record and store user’s physical data,
wirelessly transmit such data to and display on user’s smartphone.
BC1 is intended to be use on users who require monitoring for non-life
threatening arrhythmias at home.
This device has features of ECG recordings that are available to prescription users only.
This device enables a user to:
• Detect and store single-channel ECG recordings using the mobile device.
• Store user information data associated with the recording.
• Request professional clinical interpretation and analysis of your ECG recordings.
• Wirelessly transmit ECG recordings in real time to your mobile device.
*Determing Heart Rate: use 5 second ECG to caluate R-peak inveral time,
take reciprocal and then multiply 60.
Important Notification:
Please notice that ECG recordings cannot detect all heart symptoms, and are used for
physicians’ references only. Individuals who discover any change on measurement
result, or diagnosed with heart disease, regardless of stable readings on
electrocardiogram, should always consult doctor.
*Photos might have slightly difference on the appearance compared to the real product.
A. Power Button
A
B
C
D E
F
Main Unit
Component 1 / Main Unit
Function
B. Battery LED
C. Status LED
D. Calling Key
E. Charging hole
F. Electroded
Buckle
LED light to display current battery life
Green light: Full power / Flashing red light: Charging /
Red light: Battery hour is less than 6 hours
LED light to show system status
LED light to display current battery life
Green light: Power above 60%
Red light: Power less than 20%(low power)
Flashing red light: in charging
Press the 1st time to call, 2nd time to cancel calling
Under battery power sufficient circumstance,
calling Key is working even the power is off.
For charging purpose only
Buckle on electrode patch use
5
Press 1st time to power ON, 2nd time to power OFF
Product Description
Component 2 / Carry Bag
Component 3 / Charger
Electrode Patch
USB Connector
* Please use charger designated for
XYZlife Patch only
Buckle connecting point
Easy carry and protection of device
6
Model:GS2U-006-050-A
Input: 100-240V~0.2A 60/50Hz
Output: 5V 1200mA 6W Max
Charger is complied with 60601-1 3.0 regulation
Device Name: Medi-Trace 200 and
Medi-Trace 200-30 ECG Electrodes
510(k) Number: K960968
Product Description
Initial Set Up
Initial Set Up
1.Charging
Take out BC1 main unit, and use USB cable start charging.
2.Download BC1 App to your mobile device (The device supports Android4.4
or more updated version, as well as iOS7.0 or more updated version.)
Please find and download Apps for XYZlife Patch on Google Play or App store).
3.Follow APP instruction to complete initial set up and Bluetooth connection.
Set up the device according to selected options
7
XYZlife Patch mode set up procedure
(with optional electrode patch)
1. Sync main unit and Bluetooth connection
-Press the power button to turn on power.
(see the photos on the right) make sure that
battery LED is green.
-Sync the device with your mobile APP
(1st time initial setting please follow the APP
instruction) and make sure the status LED is
green (connect successfully). If fail to sync
APP, please connect manual following the
APP instruction.
2.Electrode patch and adhesive method
-At patch contact point, remove body hair or grease.
-Buckle up main unit with patch.
Remove electrode patch protect film.
Stick patch on the center of your chest (see
the right photo, The electrode patch should
stick vertically with calling key at downward side.
WARNING:
Calling key must be placed downward;
otherwise will lead incorrect readings.
Device sticks on center of chest,
calling key in parallel with nipples
Initial Set Up
8
3. Calling Key
-Press the calling key on the front of the
main unit to make warning beep sounds.
-After 30 seconds, the main unit will send
calling texts to preset contact persons.
WARNING：
Press calling key again to stop mis-trigger
(Warning beep sounds will stop)
4. How main unit works with APP
-Please keep main unit and mobile device
within 8 meters distance
-Farer distance or additional blocks might
cause data transmitting or reading issues
Note: At lease 5 minutes to accumulate
storage data. Data cannot be saved if
removed device within first 5 minutes.
5. How to turn off the device
Press the power button on the side of
the device; the main unit will disconnect
automatically to APP on mobile device.
Battery
Caution during measurement
Battery Life and Charge
1. The product is using Li ion rechargeable battery.
2. Use designated charger to charge the battery. Please charge fully in first time use.
3. Battery LED displays GREEN light when charging is completed.
4. The battery with full power works continuously for 8 hours.
5. Battery can be recharged at 500 times.
6. It takes around 2.5 hours to fully charge the battery.
To obtain correct ECG readings, make sure you wear it correctly.
Please read below notes carefully when using the device for the very first time
Make sure to pay attention to the following notes at each use :
• Make sure the electrical buckle up firmly and correctly on patch.
• Excessive body movement could influence the measurement result: including
moving, exercising, sneezing, or coughing etc.
• Electronic devices can cause interference to measurement readings.
• If you have questions about the product, consult local agent or physicians.
9
Care and Maintenance
Sound and Flashing
App Error Messages
Beep/
1 short beep
Continuous
beeps Calling
Please refer to troubleshooting
Battery power is less than 60%
Sound Message Note
Note
1. Confirm POWER ON/OFF
2.Detect ECG signal
System Error
Battery LED / Red Lighting
/ Red Flashing
/ OFF
/ Red Light
/ Red Light Flashing
Status LED / Green Lighting
Flashing Light Message
Battery is less than 20%
Charging
Connecting with APP
APP disconnection
System Error Please refer to APP
Error Messages
ECG signal disconnection
Error 001
Error 002
Error 003
Error 004
Battery warning Low battery
Abnormal
sensor signal
Storage memory
failed or damaged
Please Charge
1. Reboot the device
2. Please contact local
agent if Step 1 can not
solve the problem
Error＃ Message Cause Solution
Temp. sensor failed
G sensor failed
Barometer sensor failed
Error 005 Internal storage
memory error
10
Beep/
3 long beeps
Beep/
5 long beep
Care and Maintenance
Troubleshooting
1. Mobile device
bluetooth is OFF
2. Mobile device bluetooth
version is older than 4.0
3. Android system is older
than 4.4 or iOS older
than 7.0
Problem Cause Solution
Unable power ON
Device unable to
sync with mobile
Abnormal
Bluetooth
pairing
ECG data is
disappeared
while using
The ECG readings
appear upside
down, Or unusual
readings
To many noise
or interference
in readings.
Battery is exhausted and
voltage is too low
Please charge the device,
waiting for GREEN light.
Make sure the distance
between device and mobile
device is within 8meters.
Sync APP with device manually
Distance between the device
and mobile is too far.
1. Battery is exhausted.
2. Bluetooth connection is
not working properly
1. Charging battery
2. Make sure that mobile Bluetooth
is on and sync with your device.
1. Make sure the electrode patch is
positioned correctly
2. Unusual readings appear:
- make sure whether you use it
correctly
- consult your physician
Noise may come from
interference from outside
Circumstances.
Possible interferences
might be:
-the device attaches
body improperly
-excessive body movement
-EMC interference
1. Please make sure Bluetooth
is working
2. Please make sure mobile
device and Bluetooth version
is updated
1. The device is
positioned incorrectly
2. ECG signal is weak
1. Make sure electrode patch is new
2. Do not exercise excessively while
using the product
3. Make sure electrode patch is
positioned correctly
4. Keep yourself away from high EMC
Environment, such as stereo, video,
or similar equipments
5. Remove body hair and clean the skin
in electrode patch contact point
11
Care and Maintenance
Storage
1. Do not place any object on the top of the main unit, or strike it.
This could damage it.
2. Do not wipe the device or electrode connecting point with benzene,
gasoline, paint thinner, concentrated alcohol, or other solvent detergents.
3. Do not disassemble the device. Repairs should only be carried out by
authorized personnel. Disassemble and repair are for authorized personnel only.
4. Do not sterilize this device in an autoclave or gas sterilizer
(EO, formaldehyde, high density ozone, etc.)
5. The product does not need regular maintenance or calibration.
If user requests the repair, please contact your local agent or our website.
12
FCC statement
Emission test Compliance Electromagnetic environment - guidance
Guidance and manufacturer’s declaration - electromagnetic Emissions
The BC1 ECG monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of the BC1 ECG monitor should assure
that it is used in such an environment.
Recommended separation distances between portable and
mobile RF communications equipment and BC1 monitor
BC1 monitor is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or user of the BC1
ECG monitor can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment
(transmitters), the BC1 ECG monitor as recommended below, according to
the maximum output power of the communications equipment.
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions IEC
61000-3-3
Group1
Class B
N/A
N/A
The device’s RF emissions are very low
and are not likely to cause any interference
in nearby electronic equipment.
BC1 is suitable for use in all
establishments other than domestic
and those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Rated maximum
output power of
transmitter (W)
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
Separation distance according to frequency of transmitter (M)
150 kHz to 80 MHz 80 kHz to 800 MHz 80 kHz to 2.5 GHz
13
14
FCC Statement
Immunity test Compliance Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Guidance and manufacturer’s declaration - electromagnetic immunity
IEC 60601
Test level
3V/m
3V
NOTE 1 - At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 - These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects, and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast,
and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which
BC1 ECG Monitor is used exceeds the applicable RF compliance level above,
BC1 ECG Monitor should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the BC1 ECG Monitor.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
3 V/m
80 MHz
to
2.5 GHz
3 Vrms
150 kHz to
80 MHz
The BC1 ECG monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of the BC1 ECG monitor should assure
that it is used in such an environment.
Portable and mobile RF communications
equipment should be used no closer to any part
of BC1 ECG monitor, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
D =1.2√P
D =1.2√P 80 MHz to 800 MHz
D =2.3√P 800 MHz to 2.5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and D is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked
with the right side symbol:
This Device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received,
including interference that may cause undesired
operation.
Notice：The changes or modifications not expressly
approved by the party responsible for compliance could
void the user’s authority to operate the equipment.
IMPORTANT NOTE: To comply with the FCC RF exposure
compliance requirements, no change to the antenna or
the device is permitted. Any change to the antenna or the
device could result in the device exceeding the RF
exposure requirements and void user’s authority to
operate the device.
15
Specification
CE Theproduct follows EC 93/42/EEC regulation
The important message regarding EMC
With the increase use of electronic devices, such as personal computer or
smart phones, any medical device might have risk of being interfered by
electromagnetic from them. Any interference might lead to the medical
abnormal function, causing dangerous situations.
This medical device should not interfere other devices. EN60601-1-2 regulation
has been applied. The purpose for EMC regulation is to screen out insecure
products. This regulation defines the bearable interference level from any
medical device, and the level of output electromagnetic.
XYZlife manufactured medical device is complied with EN60601-1-2:2012
regulation. However, it is strongly recommended to follow WARNING points below:
1.Do not use the device near high volt or EMC filed.
This may lead to device abnormal and cause some safety concern.
2.It is recommended to keep the distance of the device between
them more than 8 meters
3.More EN60601-1-2:2012 documents, please go to www.xyz-life.com
official website.
Information on Disposal for Users of Waste
Electrical & Electronic Equipment (WEEE)
This symbol on the product(s) and / or accompanying documents means
that used electrical and electronic products should not be mixed with general
household waste.
For proper treatment, recovery and recycling, please take this product(s) to designated
collection points where it will be accepted free of charge.
User and product retail shall contact your local authority for further details of
recycle this product safely. The product is not allowed to be mix disposal with other
commercial waste. The product does not contain hazardous substances.
Battery disposal method shall comply with locally regulation to proceed.
xxxx
Model: BC1
ECG Channel: single channel
ECG wave measuring range : 0-2mV( 0.1mV error)
Heart rate range: 25 to 250 BPM ( 5BPM)
Frequency response : 0.67Hz to 40Hz / Sample rate: 200Hz
Ingress Protection Rating: IP22
Protection type and range against electrical shock: TYPE BF
ECG electrode is applied Part
Battery: Rechargeable Lithium ion battery
Operation Temp. : +10℃ to +45℃ Operation Humidity : 30% to 95%
Operation atmospheric pressure: 700-1060 mbar
Storage Temp. : -20℃ to +60℃ Storage Humidity: 10% to 95%
Weight: Approximate 37 g (including batteries)
Dimensions : 73mm(W) X 38mm(H) X 16mm(D)
Battery Spec. : Li-ion, 620mAh
Charger Spec. : Input: 100-240V~0.2A 60/50Hz / Output: 5V 1200mA 6W Max
Contents : BC1 main unit, Charger (comply with medical device regulatory),
Carry bag, Instruction Manual, Quick guide/ Manual
Other symbols: Please carefully read the manual
NOTE: Specifications may be changed without prior notice.
Manufacture: Kinpo Electronics, Inc.
Address: 10F, No. 99, Sec5, NanJing E. Rd, Taipei City 105, Taiwan
Website: www.xyz-life.com
Manufactured in Thailand
Manufacturer
16
Specification
17
Symbols Used for Product or Package
Manufacture: Kinpo Electronics, Inc.
Address: 10F, No. 99, Sec5, NanJing
E. Rd, Taipei City 105, Taiwan
Website: www.xyz-life.com
Manufactured in Thailand
Manufacturing batch / lot No.
Protection type and range against
electrical shock
(Body Floating isolated applied part)
Date of manufacture,
Century year xxxx month xx date xx
European Conformity Mark
Please follow WEEE regulation
for properly disposal
To signify that the instruction
manual/booklet must be read
Symbols Meanings
Refer to instruction
manual/booklet
TEL: +31 658 768 735
Symbols Used for Product or Package
18
Serial Number of product
WARNING and Cautions
Please follow the instructions carefully
Transportation and
storage temp. requirement
Transportation and storage
humanity requirement
Warning symbol denoting a device's
susceptibility to electrostatic discharge.
Radio frequency fields beyond this
point may exceed the FCC, etc.
The device complies with Federal
Communications Commission
Recycling Symbol
International protecting mark
Symbols Meanings
NOTE
NOTE
NOTE
HDWM4912Z00