Omron M7 Intelli IT User manual

Automatic Upper Arm
Blood Pressure Monitor
M7 Intelli IT (ALRU)
Instruction Manual
EN
RU
2895901-4A_HEM-7361T-ALRU_IM_M01_221028.pdf
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Table of Contents
Introduction ...........................................EN2
Operational principle of work ..........EN2
Safety Instructions ..........................EN2
Intended Use ..................................EN2
Application ......................................EN3
Intended Users ...............................EN3
Circumstances When to Consult a
Physician ........................................EN3
Indication for Use ............................EN4
Contraindications for Use ...............EN4
Side Effects .....................................EN4
Minor Repairs .................................EN4
Before the First Use ........................EN4
Important Safety Information ...............EN5
1. Know Your Monitor ..........................EN9
1.1 Contents/Product Includes .....EN9
1.2 Monitor and Arm Cuff .............EN9
1.3 Display and Symbols ............EN12
2. Preparation .....................................EN18
2.1 Installing Batteries ................EN18
2.2 Using the AC Adapter ...........EN19
2.3 Setting the Date and Time ....EN20
2.4 Blood Pressure
Measurement Tips ................EN22
2.5 Applying the Arm Cuff ...........EN23
2.6 Sitting Correctly ....................EN25
2.7 Selecting a User ID ..............EN25
3. Using Your Monitor without a
Smart Device ..................................EN26
3.1 Taking a Measurement .........EN26
4. Using Your Monitor with a Smart
Device .............................................EN31
4.1 Pairing Your Monitor with a
Smart Device ........................EN31
4.2 Taking a Measurement .........EN32
4.3 Disabling/Enabling
Bluetooth ..............................EN33
5. Using Memory Function ................EN34
5.1 Viewing the Readings
Stored in Memory .................EN34
5.2 Viewing the Average
Reading ................................EN35
5.3 Viewing Weekly Averages ....EN36
6. Other Settings ................................EN38
6.1 Deleting All Readings
Stored in Memory .................EN38
6.2 Restoring Your Monitor to
the Default Settings .............. EN39
7. Error Messages and
Troubleshooting ............................ EN41
8. Maintenance ................................... EN48
8.1 Maintenance ......................... EN48
8.2 Storage ................................. EN48
8.3 Cleaning ............................... EN49
8.4 Calibration and Service ........ EN49
9. Description of accessories,
medical devices, or non-medical
devices intended for use in
combination with the automatic
blood pressure monitor
OMRON M7 Intelli IT. ..................... EN50
10. Specifications ................................ EN51
11. Guidance and Manufacturer’s
Declaration ..................................... EN55
12. Useful Information ......................... EN66
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Introduction
Thank you for purchasing the OMRON M7 Intelli IT (ALRU) Automatic
Upper Arm Blood Pressure Monitor.
Operational principle of work
Oscillometric method:
The beat in the pulsation generated by the contraction of the heart is
captured as the pressure inside the cuff to measure the blood
pressure. If the cuff wrapped around the upper arm is pressurized
sufficiently, the blood flow stops, but the beat of the pulsation is
present and the pressure inside the cuff receives this and oscillates.
Next, as the pressure inside the cuff gradually decreases, the
oscillation of the pressure within the cuff gradually increases and
reaches a peak. As the pressure within the cuff decreases further, the
oscillation decreases from its peak. The pressure within the cuff and
the relationship with the increase and decrease of the oscillation
within the cuff in this series of processes are stored into memory,
calculations are carried out, and the blood pressure value is
determined. The oscillometric method does not determine the blood
pressure value instantly like a microphone type automatic blood
pressure gauge with the auscultation method, but rather determines it
from the series of change curves as explained above. Therefore, it is
not easily affected by external noise, an electric scalpel or other
electro surgical instruments.
Safety Instructions
This instruction manual provides you with important information about
the OMRON M7 Intelli IT (ALRU) Automatic Upper Arm Blood
Pressure Monitor. To ensure the safe and proper use of this monitor,
READ and UNDERSTAND all of these instructions. If you do not
understand these instructions or have any questions, contact
your OMRON retail outlet or distributor before attempting to use
this monitor. For specific information about your own blood
pressure, consult with your physician.
Intended Use
This device is a digital monitor intended for use in measuring blood
pressure and pulse rate in adult patient population. This monitor
detects irregular heartbeats during measurement and displays
corresponding indication along with measurement results.
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Introduction
The device can detect an irregular pulse suggestive of Atrial
Fibrillation (Afib). Please note that the device is not intended to
diagnose Afib. A diagnosis of Afib can only be confirmed by an
Electrocardiogram (ECG). If the Afib symbol appears, consult with
your physician.
Application
It is mainly designed for general household use.
Intended Users
This device is designed to measure blood pressure in adults 18 years
and older, in which the circumference of the shoulder corresponds to
the size of the cuff.
Circumstances When to Consult a Physician
OMRON recommends to always consult your physician before using
home healthcare equipment.
Self-diagnosis of measurement results and self-treatment without
professional medical supervision can lead to incomplete or incorrect
diagnosis and/or under or over medication. In cases where the
measurement results or treatment effect does not agree with
expected results, OMRON always recommends to consult your
physician.
Consult with your physician before using this monitor if you have
common arrhythmias such as atrial or ventricular premature beats or
atrial fibrillation; arterial sclerosis; poor perfusion; diabetes;
pregnancy; pre-eclampsia or renal disease.
Consult with your physician before using this monitor on an arm
where intravascular access or therapy, or an arterio-venous (A-V)
shunt, is present because of temporary interference to blood flow
which could result in injury.
Consult with your physician before using this monitor if you have
severe blood flow problems or blood disorders as cuff inflation can
cause bruising.
Consult your physician before using this monitor if you had a mastectomy.
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Introduction
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EN
If the irregular heartbeat continues to appear, we recommend you to
consult with and follow the directions of your physician.
Indication for Use
This product can be used for monitoring blood pressure and pulse
rate in order to confirm e.g. medication efficacy or lifestyle
improvement programs. The product can be used for trending of
these parameters in general home situation.
Contraindications for Use
The product should not be used in case the cuff location is damaged
by trauma or if other treatment interferes with proper use. This
product should not be used on patients on which it causes high
anxiety as the results will not reflect the actual user's blood pressure
values.
DO NOT apply the arm cuff on your arm while on an intravenous drip
or blood transfusion.
DO NOT use this monitor on infants, toddlers, children or persons
who cannot express themselves.
Side Effects
•DO NOT take measurements more often than necessary because
bruising, due to blood flow interference, may occur.
•Inflating to a higher pressure than necessary may result in bruising
of the arm where the cuff is applied.
•Stop using this monitor and consult with your physician if you
experience skin irritation or discomfort.
Minor Repairs
Besides replacement of depleted batteries (where applicable) and
re-fitting with approved accessories (mentioned in Instruction manual)
due to wear and tear, no further minor repairs are to be carried out on
the main product. If a defect occurs, consult your OMRON retail outlet
or distributor as mentioned on the packaging.
Before the First Use
Remove this monitor from the packaging and inspect for damage. If
this monitor is damaged, DO NOT USE and consult with your
OMRON retail outlet or distributor.
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Important Safety Information
Read the Important Safety Information in this instruction manual
before using this monitor.
Follow this instruction manual thoroughly for your safety.
Keep for future reference. For specific information about your own
blood pressure, CONSULT WITH YOUR PHYSICIAN.
Warning Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
• DO NOT use this monitor on infants, toddlers, children or persons who cannot
express themselves.
• DO NOT adjust medication based on readings from this blood pressure
monitor. Take medication as prescribed by your physician. ONLY a physician
is qualified to diagnose and treat high blood pressure and Afib.
• DO NOT use this monitor on an injured arm or an arm under medical
treatment.
• DO NOT apply the arm cuff on your arm while on an intravenous drip or blood
transfusion.
• DO NOT use this monitor in areas containing high frequency (HF) surgical
equipment, magnetic resonance imaging (MRI) equipment, computerized
tomography (CT) scanners. This may result in incorrect operation of the
monitor and/or cause an inaccurate reading.
• DO NOT use this monitor in oxygen rich environments or near flammable gas.
• Consult with your physician before using this monitor if you have common
arrhythmias such as atrial or ventricular premature beats or atrial fibrillation;
arterial sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or
renal disease. NOTE that any of these conditions in addition to patient motion,
trembling, or shivering may affect the measurement reading.
• NEVER diagnose or treat yourself based on your readings. ALWAYS consult
with your physician.
• To help avoid strangulation, keep the air tube and AC adapter cable away from
infants, toddlers and children.
• This product contains small parts that may cause a choking hazard if
swallowed by infants, toddlers and children.
Data Transmission
• This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use
this product in locations where RF is restricted, such as on an aircraft or in
hospitals. Turn off the Bluetooth® feature in this monitor, remove batteries
and/or unplug the AC adapter when in RF restricted areas.
AC Adapter Handling and Usage
• DO NOT use the AC adapter if this monitor or the AC adapter cable is
damaged. If this monitor or the cable is damaged, turn off the power and
unplug the AC adapter immediately.
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Important Safety Information
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EN
• Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a
multi-outlet plug.
• NEVER plug in or unplug the AC adapter from the electric outlet with wet
hands.
• DO NOT disassemble or attempt to repair the AC adapter.
Battery Handling and Usage
• Keep batteries out of the reach of infants, toddlers and children.
Caution
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to the user or
patient, or cause damage to the equipment or other property.
• Stop using this monitor and consult with your physician if you experience
skin irritation or discomfort.
• Consult with your physician before using this monitor on an arm where
intravascular access or therapy, or an arterio-venous (A-V) shunt, is present
because of temporary interference to blood flow which could result in injury.
• Consult with your physician before using this monitor if you have had a
mastectomy.
• Consult with your physician before using this monitor if you have severe
blood flow problems or blood disorders as cuff inflation can cause bruising.
• DO NOT take measurements more often than necessary because bruising,
due to blood flow interference, may occur.
• ONLY inflate the arm cuff when it is applied on your upper arm.
• Remove the arm cuff if it does not start deflating during a measurement.
• When the monitor malfunctions, it may get hot. DO NOT touch the monitor if it
occurs.
• DO NOT use this monitor for any purpose other than measuring blood
pressure and/or detecting the possibility of Afib.
• During measurement, make sure that no mobile device or any other electrical
device that emits electromagnetic fields is within 30 cm of this monitor. This
may result in incorrect operation of the monitor and/or cause an inaccurate
reading.
• DO NOT disassemble or attempt to repair this monitor or other components.
This may cause an inaccurate reading.
• DO NOT use in a location where there is moisture or a risk of water splashing
this monitor. This may damage this monitor.
• DO NOT use this monitor in a moving vehicle such as in a car or on an aircraft.
• DO NOT drop or subject this monitor to strong shocks or vibrations.
• DO NOT use this monitor in places with high or low humidity or high or low
temperatures. Refer to section 10.
• During measurement, observe the arm to ensure that the monitor is not
causing prolonged impairment to blood circulation.
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Important Safety Information
• DO NOT use this monitor in high-use environments such as medical clinics or
physician offices.
• DO NOT use this monitor with other medical electrical (ME) equipment
simultaneously. This may result in incorrect operation of the devices and/or
cause an inaccurate reading.
• Avoid bathing, drinking alcohol or caffeine, smoking, exercising and eating
for at least 30 minutes before taking a measurement.
• Rest for at least 5 minutes before taking a measurement.
• Remove tight-fitting or thick clothing from your arm while taking a
measurement.
• Remain still and DO NOT talk while taking a measurement.
• ONLY use the arm cuff on persons whose arm circumference is within the
specified range of the cuff.
• Ensure that this monitor has acclimated to room temperature before taking a
measurement. Taking a measurement after an extreme temperature change
could lead to an inaccurate reading. OMRON recommends waiting for
approximately 2 hours for the monitor to warm up or cool down when the
monitor is used in an environment within the temperature specified as
operating conditions after it is stored either at the maximum or at the
minimum storage temperature. For additional information on operating and
storage/transport temperature, refer to section 10.
• DO NOT use this monitor after the durable period has ended. Refer to section
10.
• DO NOT crease the arm cuff or the air tube excessively.
• DO NOT fold or kink the air tube while taking a measurement. This may cause
an injury by interrupting blood flow.
• To unplug the air plug, pull on the plastic air plug at the base of the tube, not
the tube itself.
• ONLY use the AC adapter, arm cuff, batteries and accessories specified for
this monitor. Use of unsupported AC adapters, arm cuffs and batteries may
damage and/or may be hazardous to this monitor.
• ONLY use the approved arm cuff for this monitor. Use of other arm cuffs may
result in incorrect readings.
• Inflating to a higher pressure than necessary may result in bruising of the arm
where the cuff is applied. NOTE: refer to “If your systolic pressure is more
than 210 mmHg” in section 3 of this instruction manual for additional
information.
• Read and follow the “Correct Disposal of This Product” in section 11 when
disposing of the device and any used accessories or optional parts.
Data Transmission
• DO NOT replace batteries or unplug the AC adapter while your readings are
being transferred to your smart device. This may result in incorrect operation
of this monitor and failure to transfer your blood pressure data.
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Important Safety Information
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AC Adapter Handling and Usage
• Fully insert the AC adapter into the outlet.
• When unplugging the AC adapter from the outlet, be sure to safely pull from
the AC adapter. DO NOT pull from the AC adapter cable.
• When handling the AC adapter cable:
DO NOT damage it.
DO NOT break it.
DO NOT tamper with it.
DO NOT forcibly bend or pull it.
DO NOT twist it.
DO NOT use it if it is gathered in a bundle.
DO NOT pinch it.
DO NOT place it under heavy objects.
• Wipe any dust off of the AC adapter.
• Unplug the AC adapter when not in use.
• Unplug the AC adapter before cleaning this monitor.
Battery Handling and Usage
• DO NOT insert batteries with their polarities incorrectly aligned.
• ONLY use 4 “AA” alkaline or manganese batteries with this monitor. DO NOT
use other types of batteries. DO NOT use new and used batteries together. DO
NOT use different brands of batteries together.
• Remove batteries if this monitor will not be used for a long period of time.
• If battery fluid should get in your eyes, immediately rinse with plenty of clean
water. Consult with your physician immediately.
• If battery fluid should get on your skin, wash your skin immediately with
plenty of clean, lukewarm water. If irritation, injury or pain persists, consult
with your physician.
• DO NOT use batteries after their expiration date.
• Periodically check batteries to ensure they are in good working condition.
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EN9
1. Know Your Monitor
1.1 Contents/Product Includes
Monitor, arm cuff (HEM-FL31), AC adapter (HHP-CM01), 4 “AA”
batteries, storage case, instruction manual, setup instructions,
guarantee card, blood pressure pass
1.2 Monitor and Arm Cuff
Front of the monitor
Display
[Memory] button
[Morning/Evening average] button
[Forward/Backward] buttons
[User ID selection] switch
[START/STOP] button
f
a
d
c
e
b
a
b
c
d
e
f
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1. Know Your Monitor
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Left and right side of the monitor
Back and bottom of the monitor
Air jack
AC adapter jack
[Connection] button
(Date/Time)
Battery compartment
g
h
g
h
i
j
i
j
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1. Know Your Monitor
Arm cuff
(Upper arm circumference: 22 - 42 cm)
Air plug
Air tube
k
k
l
l
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1. Know Your Monitor
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1.3 Display and Symbols
Evening average symbol Diastolic blood pressure
reading
Morning average symbol Average value symbol
Memory symbol User ID symbol
Systolic blood pressure
reading
Bluetooth ON / OFF symbol
Comparison display Sync symbol
Pulse display / Memory
number
Low battery symbol /
Depleted battery symbol
Deflation symbol Date / Time display /
Consecutive measurement
number for Afib
A
C
B
D
E
F
G
H
W
I
J
T
S
U
V
L
M
N
O
Q
P
R
K
O
Q
T
R
S
W
N
A
H
B
I
C
J
D
K
E
L
F
M
G
N
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1. Know Your Monitor
Afib mode symbol /
Afib indicator symbol
Cuff wrap guide symbol
(loose)
OK symbol Pulse display / Interval counter
for Afib
Hypertension symbol /
Morning hypertension symbol
Heartbeat symbol
Movement error symbol Cuff wrap guide symbol (OK)
Irregular heartbeat symbol
Evening average symbol
Appears when viewing the weekly average readings
taken in the evening over the past 7 weeks.
Morning average symbol
Appears when viewing the weekly average readings
taken in the morning over the past 7 weeks.
Memory symbol
Appears when viewing readings stored in the
memory.
Systolic blood pressure reading
Comparison display
Displays past readings. Refer to section 5 for more information.
Pulse display / Memory number
Pulse rate appears after the measurement.
When pressing the button, the memory number appears for
approximately 1.5 seconds before the pulse rate appears on the
display.
Deflation symbol
Appears during cuff deflation.
Diastolic blood pressure reading
O
T
P
U
Q
V
R
W
S
A
B
C
D
E
F
G
H
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1. Know Your Monitor
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Average value symbol
Flashes when viewing the average of the latest 2 or
3 readings taken within the most recent 10 minute
timeframe.
User ID symbol
The user ID number appears when selecting the
user with the [user ID selection] switch.
Bluetooth ON symbol
Appears when your readings are being transferred.
Bluetooth OFF symbol
Appears when Bluetooth is disabled.
Sync symbol
Flashes/appears when your data needs to be
transferred because the stored memory is either
almost, or completely full. Once you pair your
monitor with your smart device, transfer your
readings immediately before the monitor deletes the
oldest reading. Up to 100 readings can be stored in
the internal memory of your monitor per user.
Low battery symbol
Flashes when batteries are low.
Depleted battery symbol
Appears when batteries are depleted.
Date / Time display /
Consecutive measurement number for Afib
I
J
K
L
M
N
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1. Know Your Monitor
Afib mode symbol
Appears when a measurement is taken if the Afib
mode is enabled.
The Afib mode automatically takes 3 consecutive
readings at 30-second intervals and displays the
average.
To use the Afib mode, refer to sub-section 3.1.
To view your readings in Afib measurement, refer to
sub-section 5.1.
Afib indicator symbol
Appears if a possibility of atrial fibrillation (Afib) was
detected during the Afib mode measurement.
In the Afib mode, this particular irregularity of the
heart rhythm is indicated if it deviates +/- 25 % than
the average rhythm detected while your monitor is
measuring blood pressure.
If it continues to appear, we recommend you to
consult with and follow the directions of your
physician.
OK symbol
Flashes when your monitor is connected to your
smart device or readings are transferred
successfully.
Hypertension symbol
Appears if your systolic blood pressure is 135 mmHg
or above and/or the diastolic blood pressure is
85 mmHg or above.
Morning hypertension symbol
Appears when the morning weekly average is 135/
85 mmHg or above.
O
P
Q
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1. Know Your Monitor
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EN
Movement error symbol
Appears with your reading when your body is moving
during a measurement. The body movement
function is disabled when the possibility of Afib or
irregular heartbeat is detected during a Afib mode
measurement. If it appears, remove the arm cuff and
wait for 2 to 3 minutes. Then, reapply the cuff,
remain still and take another measurement.
Irregular heartbeat symbol
Appears when irregular rhythm is detected 2 or more
times during a measurement.
It does not appear during a Afib mode measurement.
An irregular heartbeat rhythm is defined as a rhythm
that is 25 % less or 25 % more than the average
rhythm detected while your monitor is measuring
blood pressure.
Irregular heartbeat symbol may be displayed when
the monitor detects arm movements. Refer to
section 7 for more information.
If it continues to appear, we recommend you to
consult with and follow the directions of your
physician.
Cuff wrap guide symbol (loose)
Appears if the arm cuff is not wrapped around the
arm correctly while taking a measurement. It also
appears when viewing past readings.
Pulse display / Interval counter for Afib
Pulse rate appears after the measurement. Counts the seconds
for next Afib measurement during Afib mode.
R
S
Short Long
Irregular Heartbeat
Normal Heartbeat
T
U
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1. Know Your Monitor
The difference between Afib indicator function and irregular
heartbeat function
Afib indicator function: Detects Afib possibility in 3-times
measurement. (based on the clinical paper*)
Irregular heartbeat function: Detects irregular heartbeat including Afib
in 1 measurement.
2018 ESH/ESC** Guidelines for the management of arterial
hypertension
Definitions of hypertension by office and home blood pressure levels
These ranges are from statistical values for blood pressure.
Warning
• NEVER diagnose or treat yourself based on your readings. ALWAYS consult
with your physician.
Heartbeat symbol
Flashes while taking a measurement.
Cuff wrap guide symbol (OK)
Appears if the arm cuff is wrapped around the arm
correctly while taking a measurement. It also
appears when viewing past readings.
* M. Ishizawa, T. Noma, T. Minamino et al. Multiple measurements with
automated blood pressure monitor can detect atrial fibrillation with high
sensitivity and specificity in general cardiac patients, ESC Congress 2018
Office Home
Systolic Blood Pressure ≥140 mmHg ≥135 mmHg
Diastolic Blood Pressure ≥90 mmHg ≥85 mmHg
** European Society of Hypertension (ESH) and European Society of
Cardiology (ESC).
V
W
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EN
2. Preparation
2.1 Installing Batteries
1. Push down on
the hook of the
battery cover
and pull
upward.
2. Insert 4 “AA”
batteries as
indicated in the battery compartment.
3. Close the battery cover.
As soon as batteries are correctly installed, the year flashes
on the display.
Refer to sub-section 2.3 to set the date and time manually, or
refer to sub-section 4.1 to pair your monitor to set the date
and time automatically.
Note
•When the “ ” symbol flashes on the display, it is recommended
you replace batteries.
•To replace batteries, turn your monitor off and remove all
batteries. Then replace with 4 new batteries at the same time.
•Replacing batteries will not delete previous readings.
•The supplied batteries may have a shorter life span than new
batteries.
•Disposal of used batteries should be carried out in accordance
with local regulations.
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EN19
2. Preparation
2.2 Using the AC Adapter
Note
•Make sure not to place your monitor in a location where it is difficult
to plug and unplug the AC adapter.
•We recommend keeping batteries in your monitor at all times, even
if you choose to use the AC adapter. If only the AC adapter is used
without keeping batteries in your monitor, you may need to reset the
date and time each time you unplug and plug back the AC adapter.
The readings will not be deleted.
1. Insert the AC adapter plug into the AC adapter
jack on the right side of your monitor.
2. Plug the AC adapter into an electrical outlet.
To unplug the AC adapter, unplug the AC adapter from the
electrical outlet and then remove the AC adapter plug from
the monitor.
Caution
• ONLY use the AC adapter, arm cuff, batteries and accessories specified for
this monitor. Use of unsupported AC adapters, arm cuffs and batteries may
damage and/or may be hazardous to this monitor.
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