Microlife WatchBP Home S Home blood pressure monitor with AFIB* technology Instruction manual

WatchBP Home S makes screening
for AFIB and hypertension simple
and convenient.
Instruction Manual
EN
Microlife WatchBP Home S is the world’s leading digital blood pressure measurement device for the early detection
of atrial fibrillation (AF) and hypertension. These are the two top risk factors of heart disease and stroke which
increase the risk of getting a stroke or heart disease in the future. It is important to detect AF and hypertension at
an early stage, even though you may not experience any symptoms. Appropriate treatment can reduce your risk of
suffering a stroke. For this reason, it is recommended taht you to visit your doctor when the WatchBP Home S gives an
AFIB signal during your blood pressure measurement. The AFIB algorithm of Microlife has been clinically investigated
by several prominent clinical investigators and showed that the device detects patients with AFIB at 97-100%
certainty. 1,2
Stergiou GS, Karpettas N, Protogerou A, Nasothimiou EG, & Kyriakidis M. Diagnostic accuracy of a home blood
pressure monitor to detect atrial fibrillation. J Hum Hyperten 2009; 1–5
1
Wiesel J, Fitzig L, Herschman Y, & Messineo FC Detection of Atrial Fibrillation Using a Modified Microlife Blood
Pressure Monitor. Am J Hypertens 2009; 848–852
2
Table of Contents
Before using WatchBP Home S for the first time
Product description .................................................... 3 – 4
Appendix
Batteries and power adaptor ........................................ 12
Activating the device ...................................................... 5
Selecting the correct cuff................................................. 6
Safety, care, accuracy test and disposal ................. 13 – 14
Taking measurements using
WatchBP Home S....................................................... 7 – 8
Important facts about AFIB and blood pressure..... 17 – 18
Appearance of the AFIB
Indicator & Hypertension....................................... 9 – 10
Warranty card................................................................. 20
Error messages ....................................................... 15 – 16
Technical specifications . ............................................... 19
AFIB indicator....................................................................9
Hypertension indicator.....................................................9
Continue-to-measure indicator..................................... 10
Going-to-doctor indicator.............................................. 10
Viewing and deleting measurements.......................11
EN
Before using WatchBP Home S for the first time
/min
Pulse
mmHg
DIA
SYS
mmHg
Product description
SYS
mmHg
DIA
mmHg
Cuff Socket
Pulse
/min
Puls
/min e
DIA
mmHg
SYS
mmHg
button lock switch
3
Display
Power Socket
ON/OFF Button
M Button (Memory)
Battery Compartment
Time
Date
Pulse Indicator
Movement indicator
Systolic Value
Relax
Button lock Indicator
Average
Stored Value
Low Battery Indicator
Hypertension Indicator
AFIB indicator
Diastolic Value
Number of Data
Pulse Rate
Continue-to-Measure
Going-to-Doctor
4
EN
Before using WatchBP Home S for the first time
Activating the Device
Pull out the protective strip from the battery
compartment.
Press ON/OFF button to confirm
Press M button to make selection
2) Set the month – Use the M button to set the month.
Press the ON/OFF Button to confirm.
Setting Up your Meter
1) Set the year – Upon removing the protective strip or
installing new batteries, the year number flashes in
the display. Use the M button to select the year. Press
the ON/OFF button to confirm your selection.
5
3) Set the day – Press the M button to set the day.
Press the ON/OFF Button to confirm.
Selecting the correct cuff
The WatchBP Home S device is available with different
cuff sizes. If you believe the cuff size provided with your
device is incorrect, please contact Microlife.
5) If you want to change the date and time, briefly
take out and put back one battery from the battery
compartment. The year number will flash. Complete
the process as described above.
/min
mmHg
DIA
mmHg
SYS
* please use only Microlife cuffs!
Pulse
SYS
mmHg
DIA
mmHg
/min
Pulse
4) Set the time – Once you have set the hour and
Minutes and pressed the ON/OFF button, the date
and time are set, and the current time is displayed.
M (Medium size)
22 - 32 cm (8.75 - 12.5 inches)
M is the correct size for most people.
L (Large size)
32 - 42 cm (12.5 - 16.5 inches)
6
EN
Taking measurements using WatchBP Home S
1) Before the measurement – Avoid taking
measurements directly after eating, drinking
or smoking. Prepare a chair and table for the
measurement. The chair should have a vertical backrest and the table should allow for your upper arm to
rest at the same height as your heart. Sit down and
relax for at least 5 minutes before the measurement.
mmHg
3) Start the measurement – Press the ON/OFF
Button to start measurement. The cuff will inflate
automatically.
DIA
mmHg
Pulse
/min
*Prior to pressing the ON/OFF button, ensure that the button
lock switch is at unlock. Switch to lock to avoid accidental
activation of the buttons after use.
mmHg
SYS
/min
Pulse
mmHg
7
SYS
DIA
2) Applying the cuff – Remove all clothing covering or
constricting the arm to be measured. Fit the cuff closely
around the arm, but not too tight, and be placed 2~3cm
above the elbow with the tube on the inside of the arm.
Support the arm at the same height as the heart
during measurement.
4) Automated triple measurement– The WatchBP
5) Finishing the measurement– Once the three readings
Home S automatically takes three consecutive
are complete, the measured data is automatically
measurements at 15 second intervals. Because blood
averaged and displayed.
pressure constantly fluctuates, a result determined in 6) Storing measurement data- WatchBP Home S
this way is more reliable than one produced by a single
automatically stores the average of the 3 consecutive
measurement. During the measurement do not move,
measurements, along with the date and time. A
cross your legs, or tense your arm muscles. Breath
total of 30 average measurements can be stored.
normally and do not talk.
When memory is full, each new measurement will
automatically overwrite the earliest measurement.
1
15 sec.
*
15 sec.
2
3
15 sec.
The last three measurements will be saved for future
review. Please refer to page 11 “viewing measurements”.
* If one of the individual measurements was questionable, a
fourth one would automatically be taken.
* If the start/stop button is pressed during countdown it
will start measuring immediately; if the start/stop button
is pressed during measurement it will terminate the
measurement; the reading or average readings from the
measurements are displayed.
8
EN
Appearance of the AFIB Indicator & Hypertension Indicator
1) AFIB Indicator– This device is able to detect atrial
2) Hypertension Indicator– The Hypertension indicator
fibrillation (AF). If AFIB is present during blood
is displayed if the average of blood pressures
pressure measurement, the AFIB Indicator
(BP) is greater than or equal to the cut-off point
is displayed. It is highly recommended to take an
135/85mmHg for systolic and diastolic BP.The
additional measurement an hour later to increase
indicator is displayed in three different conditions:
the specificity of the detection. The Going-to-Doctor
(1) Both of the systolic and diastolic blood pressures are
animation is triggered to remind you to visit your doctor
greater than or equal to 135/85mmHg.
for further examinations.
(2) The systolic BP is greater than or equal to 135mmHg.
(3) The diastolic BP is greater than or equal to 85mmHg.
SYS >=135 mmHg,
DIA >=85 mmHg
SYS >=135 mmHg,
DIA <85 mmHg
SYS <135 mmHg,
DIA >=85 mmHg
* Sometimes the device will detect atrial fibrillation even when it is not there. This can happen if the arm moves during the
reading or another rhythm problem is present. Keep the arm still during the reading. Visiting your doctor with this device may
be necessary to check out any rhythm problems.
* This device may not detect atrial fibrillation in people with pacemakers or defibrillators.
9
4) Going-to-doctor indicator – If the 3-day average
3) Continue-to-measure Indicator –
of blood pressure is still more than 135/85mmHg,
If the average of blood pressures (BP) is greater than
either systolic BP or diastolic BP, the Going-to-doctor
or equal to the cut-off point 135/85mmHg for systolic
animation is triggered. This happens when the M
and diastolic BP, a continue-to-Measure symbol
button is pressed to recall the measurements. It is a
is displayed together with hypertension indicator
reminder for you to visit your doctor.
to remind you to take another 3 days measurement
period to optimally determine the height of your blood
pressure. It is highly recommended to take another
Avg
3 days measurement period to get the usual level of
oder
oder
blood pressure if the Continue-to-Measure Indicator is
displayed. Do not share WatchBP Home S with others
during the 3-day measurment session.
oder
oder
* 3 days don’t need to be 3 consecutive days.
* In the monitoring of hypertension, the Going-to-doctor
animation is triggered only if 3-day measurement session is
complete.
10
EN
Viewing and deleting measurements
Viewing measurements
Deleting measurements
1) When the M button is pressed, it displays the total
number of measurements stored, e.g. N=28, followed
immediately by the total number of measurements
with AFIB and then the average of all the
measurements. Every average reading can be viewed
by pressing the M button repeatedly.
deleting data, be sure that the measurement data is
* Before
not required. When your BP values are too high or when your
values show AFIB it is recommended to show your BP values
to your doctor.
1) Press the M button and hold it for 7 seconds until the
clear symbol shows up.
2) Release the M button and press it once more. This will
delete all the measurements.
SYS
SYS
mmHg
mmHg
DIA
mmHg
Pulse
/min
Total No. of
readings
Total No. of
readings with AFIB
mmHg
Pulse
/min
Average
2) The last three individual measurements can be viewed
by pressing and holding the M button until a “1” is
displyed on the screen. The values will be displayed
sequentially.
11
DIA
Press and hold
M button for 7
seconds
Press M button
once again
Batteries and power adaptor
Battery indicator
Using a power adaptor
When the batteries have ¼ power
supply left, the Battery Symbol will
flash each time the device is switched
on. Replace with new batteries when
battery indicator appears.
The WatchBP Home S device can also be operated using
a Microlife power adaptor (DC 6V, 600mA).
Replacing new batteries
1) Plug the adaptor cable into the Power Plug in the
WatchBP Home S device.
2) Plug the adaptor plug into the wall socket. When
the power adaptor is connected, no battery power is
consumed.
DIA
mmH
g
Puls
/min e
g
SYS
mmH
SYS
mmHg
DIA
mmHg
Puls
/min e
When the batteries need to be replaced, the Battery
Symbol will flash each time the device is switched on.
1) Open the battery compartment at the back of the
device.
2) Replace the batteries – ensure correct polarity as
shown by the symbols in the compartment.
* Only use Microlife branded power adaptors.
* Use 4 new, long-life 1.5V, size AA batteries.
* Do not use batteries beyond their date of expiry.
batteries, if the device will not be used for a
* Remove
prolonged period.
12
EN
Safety, care, accuracy test and disposal
Safety and protection
This device may be used only for the purpose described
in this booklet. The device comprises of sensitive
components and must be treated with caution. The
manufacturer cannot be held liable for damage caused by
incorrect application.
Observe the storage and operating conditions described
in the “Technical specifications” section of this manual.
Protect the device from water and moisture
Protect the device from direct sunlight
Protect the device from extreme heat and cold
• Ensure that children do not use the device unsupervised;
some parts are small enough to be swallowed.
• Only activate the pump when cuff is installed.
• Do not use the device if you think it is damaged or if
anything appears unusual.
• Read the further safety instructions in the individual
sections of the instruction manual.
13
Avoid proximity to electromagnetic fields, such as
those produced by mobile phones
Never open device
Protect device from impact and drops
Device care
Cuff care
Clean the device with a soft, dry cloth.
DO NOT wash the cuff. DO NOT iron the cuff cover.
Do not wash the cuff!
Puls
/min e
DIA
mmHg
SYS
mmHg
Do not iron the cuff!
Accuracy test
We recommend the WatchBP Home S device be tested
for accuracy every 2 years orType
afterBF
mechanical
impact
applied part
(e.g. being dropped). Please contact Microlife to
arrange for an accuracy test.
Disposal
Batteries and electronic instruments must
be disposed of in accordance with the locally
applicable regulations, and not as domestic waste.
14
EN
Error messages
If an error occurs during measurement, the
measurement is interrupted and an error message
«Err» is displayed.
Please contact your local
• Microlife
service center, if this
•
15
or any other problem occurs
repeatedly.
If you think the results are
unusual, please read through
the information in this
instruction manual carefully.
Error
Description
Potential cause and
remedy
«Err 1»
Signal too
weak
The pulse signals on the cuff
are too weak. Re-position
the cuff and repeat the
measurement.
«Err 2»
Error signal
During the measurement,
error signals were detected
by the cuff, caused for
instance by movement or
muscle tension. Repeat the
measurement, keeping
your arm still.
«Err 3»
No pressure
in the cuff
An adequate pressure
cannot be generated in
the cuff. A leak may have
occurred. Replace the
batteries if necessary.
Repeat the measurement.
«Err 5»
Abnormal
result
The measuring signals are
inaccurate and no result
can therefore be displayed.
Read through the checklist
for performing reliable
measurements and then
repeat the measurement.
«HI»
Pulse or cuff
pressure too
high
The pressure in the cuff
is too high (over 300
mmHg) OR the pulse is
too high (over 200 beats
per minute). Relax for 5
minutes and repeat the
measurement.
«LO»
Pulse too
low
The pulse is too low (less
than 40 beats per minute).
Repeat the measurement.
16
EN
Important facts about AFIB and Blood Pressure
What is Atrial Fibrillation (AF)?
Normally, your heart contracts and relaxes to a regular beat.
Certain cells in your heart produce electrical signals that cause
the heart to contract and pump blood. Atrial fibrillation occurs
when rapid, disorganized electrical signals are present in the
heart’s two upper chambers, called the atria, causing them to
contract quickly fast and irregularly (this is called fibrillation).
Atrial fibrillation is the most common form of heart arrhythmia
young as 40 can exhibit AF. Early diagnosis can help reduce the
risk of a stroke.
WatchBP Home S provides a convenient way to screen for AF
Knowing your blood pressure and knowing whether or not you or
your family members have AF can help reduce the risk of stroke.
WatchBP Home S provides a convenient way to screen for AF
whilt taking your blood pressure.
Risk Factors You Can Control
or irregular heart beat. You can live with atrial fibrillation, but it
High blood pressure and AF are both considered ‘controllable’ risk factors
can lead to other rhythm problems, chronic fatigue, heart failure
for strokes. Knowing your blood pressure and knowing whether or not you
and —worst of all — a stroke. You’ll need a doctor to help you
have AF is the first step in proactive stroke prevention.
control the problem.
How does AF impact my family or myself?
One in every six strokes are AF-related. Whilt individuals
above the age of 65 are more likely to have AF, individuals as
17
Important facts about AFIB and Blood Pressure
Evaluating blood pressure data
The table on right classifies blood pressure data for adults
in accordance to the guidelines of the European Society of
Hypertension (ESH) in 2007. Data in mmHg.
The higher value is the one that determines the
evaluation. Example: a readout value between 150/85
or 120/98 mmHg indicates «Grade 1 Hypertension».
Category
Systolic
Diastolic
Optimal
< 120
< 80
Normal
120 - 129
80 - 84
High normal
130 - 139
85 - 89
Grade 1 Hypertension
140 - 159
90 - 99
Grade 2 Hypertension
160 - 179
100 - 109
Grade 3 Hypertension
≥ 180
≥ 110
lsolated Systolic
Hypertension
≥ 140
< 90
18
EN
Technical specifications
• 10 - 40 °C / 50 - 104 °F
• 15 - 90 % relative maximum humidity
Storage temp.:
• -20 °C to 55 °C / -4 °F to 131 °F
• 15 - 90 % relative maximum humidity
Weight:
• 412 g (including batteries)
Dimensions:
• 154 x 94 x 40 mm
Measuring Method: • Oscillometric
Measurement range: • 30 - 280 mmHg – blood pressure
• 40 - 200 beats per minute – pulse
Cuff pressure display: • Range: 0 - 299 mmHg
• Resolution: 1 mmHg
• Static accuracy:
Operating temp.:
•
Voltage source:
19
pressure within ± 3 mmHg or 2% of the
reading above 200 mmHg
Pulse accuracy:
± 5 % of the readout value
• 4 x 1.5 V alkaline batteries; size AA
• Mains adapter DC 6V, 600 mA (optional)
Reference to
standards:
Device corresponds to the requirements of the
standard for non-invasive blood pressure monitor:
EN 1060-1, EN 1060-3, EN 1060-4, IEC 60601-1,
IEC 60601-1-2, IEC 60601-1-11
Battery lifetime:
approx. 920 measurements
IP20:
Protected against solid foreign particles with a
diameter of more than 12.5 mm, no protection
against water
Expected service life: 5 years
2 years
Cuff:
Electromagnetic
compatibility
Device fulfills the stipulations of the standard IEC
60601-1-2
The stipulations of the EU Directive 93/42/EEC for
Medical Devices Class IIa have been fulfilled.
Microlife reserves the right to alter technical specifications
without prior written notice.
Microlife AG, Espenstrasse 139
9443 Widnau, Switzerland
Guarantee card
This device is covered by a five-year guarantee from
the date of purchase. This guarantee is valid only on
presentation of the guarantee card completed by
the owner confirming date of purchase or purchase
receipt. Batteries, cuff and wearing parts are not
covered by this guarantee.
Name:
Address:
Date:
Telephone:
Email:
Product: WatchBP Home S
m
S
SY mHg
Product Number: BP3MX1-5
m
DIAmHg
L
PU/min
Date:
DC
6V
Europe / Middle-East / Africa
Asia
North / Central / South America
Microlife AG
Espenstrasse 139
9443 Widnau, Switzerland
Tel. +41 71 727 7000
Fax +41 71 727 7011
Email: [email protected]
www.watchbp.com
Microlife Corporation
9F, 431, RuiGang Road, NeiHu
Taipei, 114, Taiwan, R.O.C.
Tel. +886 2 8797 1288
Fax.+886 2 8797 1283
Email: [email protected]
www.watchbp.com
Microlife Medical Home Solutions, Inc.
2801 Youngfield St., Suite 241
Golden, CO 80401, USA
Tel. +1 303 274 2277
Fax +1 303 274 2244
Email: [email protected]
www.watchbp.com
Type BF applied part
Read the instruction manual carefully before using this
device, especially the safety instructions, and keep the
instruction manual for future use.
IB WatchBP Home S BP3MX1-5 5016