Transtek Medical Electronics SBM69 B01 User Manual
PM
9
x
04.07.201
LARO
Item No. / No. de artículo: 659.59
UPPER ARM BLOOD PRESSURE MONITOR /
2
TENSIÓMETRO DE BRAZO
UPPER ARM BLOOD PRESSURE MONITOR
Instructions for use and safety notes
TENSIÓMETRO DE BRAZO
Notas sobre el uso y la seguridad
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Signs and symbols ...................................................Page 5
Description of signal words ...............................Page 5
Customer service .......................................................Page 6
List of pictograms used .........................................Page 6
Introduction ..................................................................Page 7
Intended use ....................................................................Page 8
Improper use ....................................................................Page 8
Parts description...............................................................Page 9
Scope of delivery .............................................................Page 11
Technical data .................................................................Page 11
LARO
Important safety notes ..........................................Page 14
Safety warnings for batteries ..........................................Page 27
Initial use ................................................................ Page 30
Inserting / Replacing batteries .........................................Page 30
App / web version of “HealthForYou” ...........................Page 31
Configuring the date / time / Bluetooth
®
........................Page 31
Measuring blood pressure .................................Page 33
Attaching the cuff .............................................................Page 33
Adopting the correct posture ..........................................Page 36
Selecting a memory .........................................................Page 37
Carrying out the blood pressure measurement .............Page 38
Transferring measurements
via Bluetooth
®
..............................................................Page 39
Evaluating measurements ..................................Page 40
Risk indicator ....................................................................Page 41
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Saving, requesting and deleting measurements
Page ......................................................................................43
Cleaning and care .....................................................Page 44
Storage ............................................................................Page 45
Troubleshooting ......................................................... Page 46
Disposal ........................................................................... Page 47
Three year limited warranty ............................. Page 47
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Signs and symbols
The following signs are used in the safety section
and in these instructions for use.
CAREFULLY READ THIS ENTIRE MANUAL, THE
SAFETY SECTION AND ALL INSTRUCTIONS AND
WARNINGS BEFORE USING THIS PRODUCT.
FOLLOW ALL SAFETY NOTES AND WARNINGS
TO AVOID HAZARDOUS SITUATIONS AND TO
ENSURE CORRECT PRODUCT USE.
The following terms indicate safety and property damage messages, and the hazard level.
DESCRIPTION OF SIGNAL WORDS
WARNING indicates a hazardous situation that, if not avoided,
could result in death or serious injury.
CAUTION indicates a hazardous situation that, if not avoided,
could result in minor or moderate injury.
NOTICE indicates information considered important, but not
hazard related (e.g. messages related to property damage).
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CUSTOMER SERVICE
Call customer service at
1 (844) 543-5872
Visit the Website Customer Service Platform at
www.lidl.com/contact-us
Visit a LIDL store for further assistance.
IAN 326870
Please have your IAN number ready.
List of pictograms used
Safety note related to possible damage to the device / components
Safety notes
Instructions
Observe instructions for use
Direct current
Storage /
Transport
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Permissable storage and transport temperature
and humidity
Operating
Permissible operating temperature and humidity
Permissible storage, transport and operating air
pressure
Applied part, type BF
Serial number
Device protected against foreign matter ≥ 0,49 inch /
IP21
12.5 mm and against water falling vertically
Upper Arm Blood Pressure Monitor
Introduction
Congratulations on your purchase. You have selected a quality product. The instructions for use
are a part of the product. They contain important
information about the safety, use and disposal of the product. Before using the product, please learn about all the safety
information and usage instructions. Only use the product as
described and for the specified applications. If you lend the
product to someone else, please also give all the instructions.
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Intended use
This upper-arm blood pressure monitor is intended to measure
and monitor the arterial blood pressure values and the heart
rates of adults with an arm circumference of 8.7 in to 16.5 in
(22 cm to 42 cm), in a non-invasive way.
Using this device, you can quickly and easily measure your
blood pressure, save the measurements and display the
progression and average of these measurements. You are
warned in cases of pre-existing cardiac arrhythmia. The
values determined are classified and evaluated graphically.
Any use other than previously mentioned or any product
modification is prohibited and may result in injuries and / or
product damage. The manufacturer assumes no liability for
damage arising out of improper use. The product is only
intended for use in private environments (at home).
Improper use
Failure to observe the following
warnings may result in death or serious injuries.
Do not use this product on newborns and preeclampsia
patients. We recommend consulting your doctor before
using the product if you are pregnant.
The device is not suitable for use by patients with implanted
electrical devices such as pacemakers or defibrillators.
The measurements determined by you are only intended
for your information - they do not replace a medical examination. Discuss the measurements with your doctor.
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Do not self-diagnose or self-treat based on the measurement results without consulting your attending physician.
Do not start new medication without consulting a doctor
and do not modify the type and / or dosage of current
medications.
The product may not be used in conjunction with a
high-frequency surgical unit.
Failure to observe the following
warnings may result in injuries or property
damage.
Using the blood pressure monitor outside the domestic
environment or under the influence of movement (e.g.
whilst riding in cars, ambulances or helicopters as well
as whilst practising physical activities such as sport) can
impact the accuracy of the measurement and lead to
measurement errors.
Parts description
1
Cuff
2
Cuff tubing
3
Cuff plug
4
Display
5
Memory button M
6
Settings button SET
7
Function button -/+
8
START/STOP button
9
Risk indicator
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10
Connection for cuff plug
11
Battery compartment
1 2 3 4
10
9
5
8
11
7
Display indicators
12
Time and date
13
Systolic pressure
14
Diastolic pressure
15
Pulse value determined
16
Symbol for cardiac arrhythmia
17
Symbol for replace battery
18
Memory display: Average value (A), morning (AM),
Symbol for pulse
6
evening (PM), number of the memory space
19
Risk indicator
20
Release air
21
User memory
22
Symbol for Bluetooth® transfer
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22
12
13
21
20
161718 1519
14
Scope of delivery
1 Upper arm blood pressure monitor
1 Upper arm cuff (Material no. 164.137) with cuff tubing
4 Batteries 1.5 V type AAA LR03
1 Instructions for use
1 Quick start guide
Technical data
Type: SBM 69
Measuring method: Oscillometric, non-invasive blood pres-
sure measurement on the upper arm
Measurement range: Cuff pressure 0–299 mmHg,
systolic 60–230 mmHg,
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diastolic 40–130 mmHg,
pulse 40–199 beats per minute
Display accuracy: systolic ± 3 mmHg,
diastolic ± 3 mmHg,
pulse ± 5 % of the displayed value
Measurement
uncertainty: max. permissible standard deviation
according to clinical testing: systolic
8 mmHg / diastolic 8 mmHg
Memory: 4 x 30 memory spaces
Dimensions: L 5.44 in x W 3.944 in x H 2.01 in /
L 138,2 mm x W 100,2 mm x
H 51,0 mm
Cuff: suitable for an arm circumference
between 8.7 in / 22 cm and
16.5 in / 42 cm
Weight: 0.87 lb / 395 g (with cuff, without
batteries)
Permissible
operating conditions: 41 °F to 104 °F / +5 °C to +40 °C,
15 % to 90 % relative humidity
(non-condensing), 700‒1060 hPa
ambient pressure
Permissible storage
conditions: - 4 °F to 140 °F / -20 °C to +60 °C,
≤ 93 % relative humidity
Power supply: 4 x 1.5 V AAA batteries
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Product expected
lifespan: 5 years
Battery life: 225 measurements, depending on
blood pressure level and inflation
pressure / Bluetooth
®
transfer
Components: instructions for use, 4 x 1.5 V AAA
LR03 batteries, storage pouch
Classification: Internal supply, IP21, no AP or APG,
continuous operation, applied part
Type BF
Data transfer via
Bluetooth
wireless technology: The product uses Bluetooth
®
®
low
energy technology, frequency band
2.402‒2.480 GHz, maximum
transmission power radiated in the
frequency band < 4 dBm, compatible
with Bluetooth
®
≥ 4.0 smart
phones / tablets
For a list of compatible smartphones,
information about the “HealthForYou”
app and software, as well as further
details about the devices, please visit:
www.healthforyou.lidl
System requirements
of the “HealthForYou“
web version: - MS Internet Explorer
- MS Edge
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- Mozilla Firefox
- Google Chrome
- Apple Safari
(in the respective updated version)
System requirements
of the “HealthForYou”
app iOS from Version ≥ 10.0, Android
from Version ≥ 5.0, Bluetooth
®
≥ 4.0.
Technical specifications subject to change without notice
due to updates.
Important safety
notes
TM
Failure to observe the following
warnings may result in death or serious injuries.
Consult your physician or pharmacist before starting
to measure your blood pressure.
Read and understand all instructions and warnings
before using this device.
Like any oscillometric blood pressure measurement
devices, certain medical conditions can affect the
measurement accuracy, among others:
– disorder of the cardiac rhythm
– very low blood pressure
– patients in shock
– patients with very low blood perfusion
– diabetes
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– vessel anomalities
– people with electrical implants, such as a cardiac
pacemaker
– women who are pregnant.
Due to their condition the oscillometric measurement
method can produce incorrect readings. This represents
a risk for your health, since values may be interpreted
incorrectly. Always consult your physician to determine
what will be suitable for you.
This product does not and is not intended to provide a
medical diagnosis. Measurements results are for refer-
ence only. Self-diagnosis and treatment, e.g. regarding
medication, using measured results represent a risk for
your health. Always consult with a licensed physician
for determination of appropriate medication and dos-
age thereof. Follow the instructions of your physician or
licensed healthcare provider. If you have or suspect that
you have a medical problem, promptly consult your
physician. If you have an emergency please call 911
immediately.
Only a physician or a trained health care professional
who is familiar with your medical history is able to ac-
curately interpret your blood pressure measurements.
Consult your physician before starting blood pressure
monitoring.
This product is not intended to serve as a substitute for
the advice of a physician or medical professional. This
product is not intended to substitute for regular medical
checkups. Contact your physician for specific informa-
tion about your blood pressure.
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Please note that technically related measuring tolerances
are possible. Please see section “Technical data” for
details.
Note: A single measurement does not provide an ac-
curate indication of your true blood pressure. You need
to take and record several readings over a period of
time. Try to measure your blood pressure at the same
time each day for consistency.
Any cuff related blood pressure measurement in high
repetition rates, can lead to severe measurement side
effects, e.g.
– any nerv compression with temporary arm
/ hand
paralysis
– the release of an arterial or venous thrombus, which
can cause a life threatening situation.
Please contact your physician about the specific risks of
cuff pressure in your specific case.
The ’irregular heartbeat’ function does not replace a
cardiac examination, but may help to detect potential
pulse irregularities at an early stage. Always consult
your physician to determine what will be suitable for
you.
The ’irregular heartbeat’ function is not designed for di-
agnosing or treating an arrhythmic disorder. Arrhythmia
can only be ascertained by a licensed physician.
The JNC chart is not intended to replace a medical di-
agnosis. This chart is only a reference for different clas-
sifications of blood pressure.
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If you notice abnormal or suspicious variations in blood
pressure measurements, consult your physician immedi-
ately.
Women who underwent a breast or axillar lymph node
removal operation should consult a physician or licensed
healthcare provider before starting blood pressure
measurements.
Prior to use, you have to ensure that the blood pressure
monitor is free of damage. If in doubt, do not use the
unit and contact customer service at 1-800-536-0366.
This device is intended only for personal, non-commer-
cial, adult use in measuring blood pressure and pulse
rate. Do not use the product for any other purpose. This
product is not intended for use in a hospital, physician’s
office, or any other health care facility.
The unit must be used in accordance to the specified
ambient conditions, otherwise the accuracy of readings
might be affected. See section “Cleaning and care”
and section “Technical data” for details.
Do not wrap the cuff around body parts other than your
arm. Misuse represents a risk to your health.
Please do not share the cuff with other persons, to avoid
cross infection.
Use this monitor only on humans.
This product is not intended for use by or on children,
toddlers and infants or on persons who cannot express
their consent, e.g. persons with mental disorders or the
like. Consult your physician for alternative methods of
measuring a child’s blood pressure.
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This product is not a toy. Keep it out of reach of children,
toddlers, and infants.
Keep the product out of the reach of pets.
Packaging materials are a deadly hazard for children
and can cause suffocation. Remove all packaging ma-
terials immediately and keep them away from children
at all times.
This product contains small parts that may present a
choking hazard to children. Keep the unit and all parts
out of reach of children. NEVER LEAVE CHILDREN OR
THOSE WHO REQUIRE CLOSE SUPERVISION UNAT-
TENDED WITH THIS DEVICE.
The tubing presents a strangulation hazard. Keep this
product away from children and those who require close
supervision, e.g. people with mental disorders. NEVER
LEAVE CHILDREN OR THOSE WHO REQUIRE CLOSE
SUPERVISION UNATTENDED WITH THIS DEVICE.
Do not drape tube around neck. This presents a stran-
gulation hazard.
People with disabilities, activity limitations, or who are
physically frail, should be assisted by another person
when using this unit.
Proper cuff size is important for accurate measurements.
Only use the device on adults who have the right upper
arm circumference for this instrument. See section
“Technical data” for suitable upper arm circumferences.
Do not use any cuffs, tubes, parts and accessories other
than those explicitly recommended by the manufacturer
for use with this product. Parts and accessories not
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