Transtek Medical Electronics SBM69 B01 User Manual

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Transtek Medical Electronics SBM69 B01 User Manual

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Item No. / No. de artículo: 659.59

UPPER ARM BLOOD PRESSURE MONITOR / TENSIÓMETRO DE BRAZO

UPPER ARM BLOOD PRESSURE MONITOR

Instructions for use and safety notes

TENSIÓMETRO DE BRAZO

Notas sobre el uso y la seguridad

IAN 326870

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Instructions for use and safety notes

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US-ES

Notas sobre el uso y la seguridad

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Signs and symbols ...................................................

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Description of signal words ...............................

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Customer service .......................................................

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List of pictograms used .........................................

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Introduction ..................................................................

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Intended use ....................................................................

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Improper use....................................................................

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Parts description...............................................................

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Scope of delivery.............................................................

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Technical data .................................................................

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Important safety notes..........................................

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Safety warnings for batteries ..........................................

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Initial use................................................................

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30

Inserting / Replacing batteries.........................................

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30

App / web version of “HealthForYou” ...........................

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31

Configuring the date / time / Bluetooth® ........................

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31

Measuring blood pressure .................................

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33

Attaching the cuff.............................................................

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33

Adopting the correct posture ..........................................

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Selecting a memory.........................................................

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Carrying out the blood pressure measurement .............

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Transferring measurements

 

 

via Bluetooth®..............................................................

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39

Evaluating measurements ..................................

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Risk indicator....................................................................

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41

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Saving, requesting and deleting measurements

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43

 

Cleaning and care.....................................................

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Storage ............................................................................

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Troubleshooting.........................................................

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Disposal...........................................................................

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Three year limited warranty.............................

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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 Permissable storage and transport temperature and humidity

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Operating

Permissible operating temperature and humidity

Permissible storage, transport and operating air pressure

Applied part, type BF

Serial number

IP21

Device protected against foreign matter ≥ 0,49 inch / 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

 

Cu

1

 

Cu tubing

2

 

Cu plug

3

 

Display

4

 

Memory button M

5

 

Settings button SET

6

 

Function button -/+

7

 

START/STOP button

 

 

8

 

 

 

Risk indicator

9

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10 Connection for cu plug

11 Battery compartment

1

2

3

4

 

 

 

10

 

 

 

9

 

 

 

5

 

 

 

6

 

 

 

8

 

11

 

7

Display indicators

12Time and date

13Systolic pressure

14Diastolic pressure

15Pulse value determined

16

Symbol for cardiac arrhythmia

Symbol for pulse

17Symbol for replace battery

18Memory display: Average value (A), morning (AM), evening (PM), number of the memory space

19Risk indicator

20Release air

21User memory

22Symbol for Bluetooth® transfer

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12

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21

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Scope of delivery

1 Upper arm blood pressure monitor

1 Upper arm cu (Material no. 164.137) with cu 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 pressure measurement on the upper arm

Measurement range: Cu 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

 

 

 

 

Cu :

suitable for an arm circumference

 

 

 

 

 

between 8.7 in / 22 cm and

 

 

 

 

 

16.5 in / 42 cm

 

 

 

 

Weight:

0.87 lb / 395 g (with cu , 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, AndroidTM from Version ≥ 5.0, Bluetooth® ≥ 4.0.

Technical specifications subject to change without notice due to updates.

Important safety notes

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 a ect 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 reference 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 dosage 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 accurately 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 information 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 accurate 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 cu related blood pressure measurement in high repetition rates, can lead to severe measurement side e ects, 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 cu 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 diagnosing or treating an arrhythmic disorder. Arrhythmia can only be ascertained by a licensed physician.

The JNC chart is not intended to replace a medical diagnosis. This chart is only a reference for di erent classifications of blood pressure.

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If you notice abnormal or suspicious variations in blood pressure measurements, consult your physician immediately.

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 o ce, 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 a ected. See section “Cleaning and care” and section “Technical data” for details.

Do not wrap the cu around body parts other than your arm. Misuse represents a risk to your health.

Please do not share the cu 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 su ocation. Remove all packaging materials 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 UNATTENDED 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 strangulation hazard.

People with disabilities, activity limitations, or who are physically frail, should be assisted by another person when using this unit.

Proper cu 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 cu s, 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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