iHealth Labs 550BT Blood Pressure Monitor User Manual Labels and labelings

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Document ID	2872092
Application ID	7fKRwgizwYyWtAwOCwyhTQ==
Document Description	15_KN-550BT UserMan
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Document Type	User Manual
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Date Submitted	2016-01-14 00:00:00
Date Available	2016-01-14 00:00:00
Creation Date	2015-12-22 10:08:22
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Document Title	Labels and labelings
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Document Author:	0110

Fully Automatic iHealth Track Connected Arm Blood Pressure Monitor
USER MANUAL
Note: This is a shortened practical version of the user manual. For the full version of this
user manual, please visit www.ihealthlabs.eu/support
MEASURING BLOOD PRESSURE – A FEW BASICS
Blood Pressure Monitor that uses the oscillometric principle to measure your blood
pressure and pulse rate. Blood pressure fluctuates continually day and night. Any physical
activity or excitement will influence your blood pressure. Because of this, it is unusual to
obtain identical multiple blood pressure readings. This is why it is recommended that you
measure your blood pressure at approximately the same time every day.
1. Relax for 5 minutes before taking your blood pressure.
2. Sit comfortably at a table when measuring your blood pressure.
3. The cuff should be placed at the same level as your heart.
4. Do not talk or move during a measurement.
5. Use the same arm every time.
6. Remove the batteries from the device if it is not used for a month or more to avoid
battery leakage.
7. This blood pressure monitor is designed for adults and should not be used on children.
8. It is not recommended for people with serious arrhythmia to use this device.
9. Do not use any other cuff than the one supplied by iHealth.
10. Relax…
WHAT YOUR DEVICE SHOULD LOOK LIKE
Memory/Sync button
Start/Stop button
The explanation of symbols on the display:
Bluetooth Symbol
Synchronization Symbol
Release Air Symbol
Memory Indicator
Low Battery Indicator
Irregular Heartbeat Symbol
Blood Pressure Level Classification Indicator
WHY YOU SHOULD CONNECT YOUR DEVICE
Taking a measurement is easy. It’s what you do with the measurement that is important.
You can use your device as a stand-alone device just to measure your blood pressure, but
when you connect it to the free iHealth MyVitals App you will be able to track, store,
manage and share your results with your family, doctor or care givers. Simply download
iHealth MyVitals on the Apple Store or on GooglePlay and start managing your health.
Your iHealth account also gives you access to the free and secure iHealth cloud service so
that you can manage your data, watch your trends and share your data. To do this, visit
www.ihealthlabs.eu and log in using the same account as you used with your App.
The iHeath Track Blood Pressure Monitor is designed to be used with Bluetooth 4.0 Apple
devices and selected Bluetooth 4.0 Android smartphones. Please note that the compatible
devices
are
subject
to
change.
For
the
latest
compatibility
list
visit
www.ihealthlabs.eu/support.
HOW TO USE YOUR BLOOD PRESSURE MONITOR
1. BATTERIES
a. Open the battery cover at the back of the device.
b. Load four “AAA” size batteries. Please pay attention to polarity.
c.
Close the battery cover.
When the display shows the battery symbol (
ones.
), replace all the batteries with new
Rechargeable batteries are not suitable for this monitor.
The monitor, the batteries and the cuff must be disposed of according to local
regulations at the end of their usage.
2. HOW TO PLACE THE CUFF ON YOUR ARM
The iHeath Track Blood Pressure Monitor has a universal size cuff. This means that it
will fit any arm with a circumference between 22 and 42cm. If your arm is too large to
fit in this cuff, you might consider using a wrist blood pressure monitor.
a.
Place the cuff tube downwards, around a bare arm
about 2cm above the elbow joint.
b.
Sit with your feet flat on the floor without crossing
your legs. While seated, place your palm upside in
front of you on a flat surface such as a table.Lying
Down During Measurement：（You can also lie
on your back and place your left arm straight along
your side with your hand palm-side up.） Position
the air tube in the middle of your arm in line with your middle finger.
c.
Close the cuff with the Velcro fastener.
d.
The cuff should fit comfortably around your arm. You should be able to insert
one finger between your arm and the cuff.
Note: If the cuff becomes dirty, remove it from the monitor and wipe it with a
lightly moistened soft cloth. Then air-dry the cuff. Do not machine
wash.Cleaning the cuff after every 200 measurements is recommended.
3. CONNECTING THE CUFF TO THE DEVICE
Once you have determined that the cuff fits your arm (22 – 42cm), simply insert the
cuff connector into the socket on the side of the monitor. Ensure that the connector is
completely inserted to avoid air leakage. Avoid compression or restriction of the
connection tubing during measurement，which may cause inflation error, or harmful injury
due to continuous cuff pressure.
4. SETTING THE DATE AND TIME
Insert the batteries in the device and connect it with the iHealth MyVitals App on your
smartphone. The time and date will automatically be updated. If you change the batteries,
please readjust the time and date again.
5. TAKING A BLOOD PRESSURE MEASUREMENT
a. After placing the cuff on your arm and relaxing for a few minutes, press the
“START/STOP” button. All display characters are shown for self-test, please
contact the service center if segment is missing.
b. The monitor will inflate the cuff and then slowly release pressure from the cuff
as the blood pressure is measured. When the measurement is finished the
blood pressure and pulse rate will be displayed on the display. The blood
pressure will be displayed in different colours (green for normal, yellow for
slightly elevated, and red for high) according to the recommendations of the
WHO (World Health Organization), The result will automatically be stored in
the memory bank of the monitor.
c.
If an Irregular Heartbeat (IHB) is detected during a measurement, the IHB
symbol will be displayed (blinking). If an IHB is detected, the results of the
blood pressure measurement may be inaccurate. Please consult your
physician for an accurate assessment.
d. At any time you can synchronize your device with the iHealth MyVitals App so
that you can better manage your blood pressure.
e. The monitor will automatically switch off after one minute to save the batteries.
Alternatively, you can press the “START/STOP” button to turn off the monitor
manually.
f.
At any time during a measurement, you can interrupt a measurement by
pressing the “START/STOP” button.
CLASSIFICATION OF BLOOD PRESSURE AND BACKLIGHT INDICATOR
BLOOD PRESSURE
CLASSIFICATION
Systolic mmHg
Diastolic mmHg
BACKLIGHT
INDICATOR
Optimal
91–119
and 61 - 79
Green
Normal
120–129
and 80 -84
Green
High-normal
130–139
or 85 - 89
Yellow
Grade 1 Hypertension
140–159
or 90 - 99
Flashing Yellow
Grade 2 Hypertension
160–179
or 100–109
Red
Grade 3 Hypertension
≥180
or
≥110
Flashing red
6. MEMORIES
You can review previous readings by pressing the “M” button twice. The first memory
displayed will be the average of the last three measurements. When the average of the
last three measurements display, press the “M” button, the newest measurement will
display. Press “M” button again to review the next measurement. During display the
memories, keep on pressing button "M" for three seconds, all results in the current
memory bank will be deleted.
If no result stored, LCD will show zero.
The monitor will automatically switch off after one minute to save the batteries.
Alternatively, you can press the "START/STOP" button to turn off the monitor manually.
7. SYNCHRONIZING WITH THE IHEALTH MYVITALS APP
Before you can synchronize all your blood pressure readings, you need to download the
iHealth MyVitals App on your smartphone from the Apple Store (for iOS devices) or on
GooglePlay Store (for Android). You then need to create your own iHealth account on the
App.
To synchronize:
1. Place your phone next to your blood pressure monitor.
2. Start the iHealth MyVitals App on your smartphone (ensure that your Bluetooth is
activated in your settings).
3. Press the “M” (Memory) button on the blood pressure monitor. The number of
readings in the memory will be displayed. After a few seconds the iHeath Track
Blood Pressure Monitor will automatically start synching the readings to the iHealth
MyVitals App. While it is synchronizing you will see the readings numbers
gradually come down on the blood pressure monitor, until they reach zero. When
zero is displayed on your monitor, it means that all the readings have been
synchronized and that you can new view all your data in the “List” of the iHealth
MyVitals App.
4. If no result stored, the number of readings in the memory will be displayed zero.
8. TROUBLESHOOTING
Problem
LCD
shows
Explanation
low
Solution
Low Battery
Change all the batteries
battery symbol
LCD shows “Er 0”
Pressure
system
unstable
is
before
measurement
LCD shows “Er 1”
Fail
to
Try again without
detect
moving
systolic
pressure
LCD shows “Er 2”
Fail to
detect diastolic
pressure
LCD shows “Er 3”
Pneumatic system blocked
or cuff is too tight during
inflation
LCD shows “Er 4”
Apply the cuff correctly
Pneumatic
system
and try again
leakage or cuff is too loose
during inflation
LCD shows “Er 5”
LCD shows “Er 6”
Cuff
pressure
above
300mmHg
Measure again after 5
More than 3 minutes with
minutes. If the error is
cuff pressure above 15
still
there,
please
mmHg
contact
LCD shows “Er 7”
EEPROM accessing error
iHealth distributor
your
LCD shows “Er 8”
Device
local
parameter
checking error
LCD shows “Er A”
Pressure
sensor
parameter error
No response when
Incorrect
operation
or
Take out the batteries,
you press button or
strong
install battery
interference.
electromagnetic
wait five minutes and
then reinstall batteries
Please visit the support section of the www.ihealthlabs.eu website to see our
comprehensive Frequently Asked Questions on blood pressure.
9. GENERAL SAFETY AND PRECAUTIONS
1. Carefully read the user guide before operating the device.
2. Consult your physician for any of the following situations:
a) The application of the cuff over a wound or inflamed area.
b) The application of the cuff on the arm on the side of a mastectomy.
c) Simultaneous use with other medical monitoring equipment on the same limb.
d)The application of the cuff on any limb with intravascular access or therapy, or an
arteriovenous (A-V) shunt.
e)The blood circulation of the user needs to be checked.
3. Do not use this product in a moving vehicle as this may result in inaccurate
measurements.
4. The IHB symbol will be displayed under 2 sets of circumstances:
a) The coefficient of variation (CV) of pulse period >25%.
b) The difference of adjacent pulse period is ≥0.14s and more than 53% of the total
number of pulses readings falls within this definition.
5. Please do not use any cuff other than that supplied by the manufacturer as this may
result in inaccurate measurements.
6. The monitor will show 'HI' or 'Lo' as technical alarm on LCD with no delay if the
determined blood pressure (systolic or diastolic) is outside the rated range specified in part
SPECIFICATIONS. In this case, you should consult a physician or check if your operation
violated the instructions. The technical alarm condition (outside the rated range) is pre-set
in the factory and cannot be adjusted or inactivated. This alarm condition is assigned as
low priority according to IEC 60601-1-8. The technical alarm is non-latching and needs no
reset. The signal displayed on LCD will disappear automatically after about 8 seconds.
This Monitor is designed for adults and should never be used on infants, young
children or patients with preeclampsia.
This product might not meet its performance specifications if stored or used
outside the specified temperature and humidity ranges.
Please do not share the cuff with any infectious person to avoid cross-infection.
The monitor, cable, battery and cuff must be disposed of according to local regulations at
the end of their usage.
7.Prolonged over-inflation of the bladder may cause bruises of your arm.
10. CARE AND MAINTENANCE
1.
Do not drop the monitor or subject it to strong impacts.
2.
Avoid high temperature and direct exposure to the sun. Do not immerse the monitor in
water.
3.
If this monitor is stored near freezing temperatures, allow it to acclimate to room
temperature before use.
4.
Do not attempt to disassemble this monitor.
5.
If you do not use the monitor for a long time, please remove the batteries.
6.
It is recommended that the performance of this monitor be checked every 2 years.
7.
Please clean monitor with a soft dry cloth. Do not use any abrasive or volatile
cleaners.
8.
The supplier will make available on request the circuit diagrams, component part lists,
descriptions, calibration instructions, or other information which will assist the user’s
appropriately qualified technical personnel to repair those parts of equipment which
are designated by the manufacturer as repairable.
9.
It is recommended that if the cuff is used in a hospital or a clinic, it be disinfected twice a
week. Wipe the inner side (the side that contacts skin) of the cuff with a soft cloth lightly
moistened with Ethyl alcohol (75-90%). Then air dry the cuff.
10. The monitor can maintain the safety and performance characteristics for a minimum
of 10,000 measurements or three years, and the cuff integrity is maintained after
1,000 open -close cycles of the closure.
11. AFTERSALES AND WARRANTEE
This device has been developed by iHealth together with a team of medical specialists
and engineers. We have taken the utmost care to manufacture a device that is user
friendly and clinically accurate. It has been validated against the exacting standard of
the ESH (European Society of Hypertension) and as such can be used by a medical
professional in clinical practice. The iHeath Track Blood Pressure Monitor carries a
two-year warrantee according to European legislation.
If you have any questions regarding the aftersales or usage of the product, please visit
www.ihealthlabs.eu and consult our Frequently Asked Questions on blood pressure (in
our support section). If you do not find the answers you are looking for, please send us
a query directly from the website. If you have any suggestions so that we can improve
our products, please send us a mail at support@ihealthlabs.eu.
12. EXPLANATION OF SYMBOLS ON PACKAGING
Symbol for "THE OPERATION GUIDE MUST BE READ"
(The sign background color: blue. The sign graphical symbol: white.）
Symbol for “Warning”
Symbol for “Type BF Applied Parts” (cuff only)
Symbol for "ENVIRONMENT PROTECTION – Waste electrical products should
not be disposed of with household waste. Please recycle where facilities exist.
Check with your local authority or retailer for recycling advice".
Symbol for "KEEP DRY"
Symbol for “Manufacturer”
Symbol for “DATE OF MANUFACTURE”
带格式的: 非删除线
6V
SN:
0197
BLOOD PRESSURE MONITOR
ANDON HealthAUTOMATIC
Co.,Ltd
NO. 31,Changjiang Road,Nankai District,Tianjin, P.R.China
MODEL: Lotus
KD-5907
Global Co.,Ltd
EC REP
6V
Symbol
for "EUROPEAN
47
Spenlow
HouseREPRESENTATIVE"
Bermondsey London SE16 4SJ
SN:Symbol for "SERIAL NUMBER"
0197
CE conformity mark
ANDON Health Co.,Ltd
NO. 31,Changjiang Road,Nankai District,Tianjin, P.R.China
Lotus Global
Co.,Ltd
iHealthLabs
Europe
EC REP
47 Spenlow3 House
Bermondsey
London SE16 4SJ
rue Tronchet,
75008, Paris, France
support@ihealthlabs.eu
www.ihealthlabs.eu
ANDON HEALTH CO., LTD
Add:No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China.
Tel: 86-22-60526161
iHealth is a trademark of iHealth Lab Inc.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG,
Inc. and any use of such marks by iHealth Lab Inc. is under license.
Other trademarks and trade names are those of their respective owners.
13. SPECIFICATIONS
Product name: iHeath Track Blood Pressure Monitor
Model: KN-550BT
Classification: Internally powered, type BF applied part; IPX0, No AP or APG; Continuous
operation
Machine size: 98 × 98 × 46mm
Cuff circumference: 22 - 42cm
Weight: 348g (batteries and cuff included)
Measuring method: oscillometric method, automatic inflation and measurement
Memories:99
Power source: 4x1.5V
SIZE AAA batteries
Measurement range:
Cuff pressure: 0 - 300mmHg
Systolic: 60 - 260mmHg
Diastolic: 40 - 199mmHg
Pulse rate: 40 - 180 beats/minute
Measuring accuracy: Pressure: ±3mmHg, Pulse rate: ±5%
Environmental temperature for operation: 10～40°C
Environmental humidity for operation: ≤85%
Environmental temperature for storage: -20～50°C
Environmental humidity for storage: ≤85%
Environmental pressure: 80～105kPa
Battery life: Approximately 250 readings
This blood pressure measurement system includes accessories: pump, valve, cuff, and
sensor.
Note: These specifications are subject to change without notice.
This device bears the CE conformity mark. The quality of this wireless device has been
verified and conforms to the provisions of the IEC 60601-1:2005 corr.1 (2006) + corr.2
(2007)/EN 60601-1:2006/AC:2010 (Medical electrical equipment – Part 1: General
requirements for safety); IEC 60601-1-2:2007 /EN 60601-1-2:2007 /AC:2010 (Medical
electrical
equipment
–
Part
1:
General
requirements
for
safety;
Collateral
Standard-Electromagnetic compatibility - Requirements and tests); EN 1060-1: 1995 + A1:
2002 + A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements); EN
1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers - Part 3:
Supplementary requirements for electro-mechanical blood pressure measuring systems);
IEC80601-2-30:2009+Cor. ： 2010 (Medical electrical equipment –Part 2-30: Particular
requirements for the basic safety and essential performance of automated non-invasive
sphygmomanometers).
R&TTE mention: Hereby, iHealth declares that the BP Track KN-550BT is in compliance
with the essential requirements and other relevant provisions of Directive 1999/5/EC.
Directive 1999/5/EC Declaration of Conformity and all iHealth certification and regulatory
documents
can
be
downloaded
on
the
following
link:
https://www.ihealthlabs.eu/support/certifications.
For information regarding potential electromagnetic or other interference between the
iHeath Track Blood Pressure Monitor and other devices together with advice regarding
avoidance of such interference, please visit www.ihealthlabs.eu/support/electromagnetic.
It is suggested that the Wireless Blood Pressure Monitor should be operated at least 10
metres away from electric or wireless devices (e.g. routers, microwave oven, etc.).
KN-550BT-SMSP01 V1.0
NOTE: 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
Changes or modifications not expressly approved by the party 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 harmful interference, and
(2) this device must accept any interference received, including interference that may
cause undesired operation.
This device complies with Industry Canada licence-exempt RSS
standard(s). Operation is subject to the following tow conditions:
(1)this device may not cause interference, and(2) this device must
accept any interference, includinginterference that may cause
undesired operation of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada
applicables auxappareils radio exempts de licence. L'exploitation
est autorisée aux deux conditions suivantes :(1) l'appareil ne doit
pas produire de brouillage, et(2) l'utilisateur de l'appareil doit
accepter tout brouillage radioélectrique subi, même si le brouillage
est susceptible d'en compromettre lefonctionnement.

---

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